Friday, August 29, 2008

Friday Fun

We're allowed to be completely silly on a Friday afternoon, heading into a weekend that marks the end of summer, aren't we?

The instructions on this website are in Japanese. In English, here's what you do:

1. Click on "start."'
2. The game will count down "3, 2, 1," and then start.
3. You'll see a few numbers. Remember the order of the numbers, from lowest to highest.
4. The numbers will then disappear and be replaced with circles. Click on the circles in the order of where the lowest to highest numbers used to be.
5. At the end of game, the computer will tell you the age of your brain.

http://flashfabrica.com/f_learning/brain/brain.html

We're not sure if you'd rather have an old brain or a young one -- what matters more? energy or experience? -- but at least you'll know.

Enjoy both the game and the holiday.

Thursday, August 28, 2008

Manufacturer Ordered To Provide Experimental Drug

A little over a year ago we caught considerable flak for our posts about Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc), the case that ruled against any constitutional right of patient access to unapproved, experimental, but potentially lifesaving drugs. We said then that we were on the fence about the constitutional right itself, but that we agreed with the result for practical reasons – because the inevitable next step would be suits brought against the pharma companies themselves. After all, drugs don’t come from the FDA – only from drugmakers.

A number of folks, especially over at the Volokh Conspiracy, thought we were full of it. Some of the critics thought that we were either ignorant or intentionally playing dumb about whether drug companies could be “state actors” for constitutional purposes. We readily conceded that we’re not constitutional scholars – but we stoutly maintained, then and now, that we don’t play on this blog. What you see is what you get.

We ended our part in that discussion at basically the same point we started it:

Our concern was that terminally ill patients who are permitted to take unapproved drugs must get the drugs from somewhere. The only place to get the drugs is from the people who have them – the pharmaceutical companies. Terminally ill patients will thus predictably turn handstands to try to force pharmaceutical companies to provide those drugs. And the emotional appeal of lawsuits filed to obtain access to those drugs will be truly compelling. Plaintiffs will be telling judges that they are terminally ill and have no hope for survival unless they are permitted to take an experimental drug. In that context, shouldn’t the drug manufacturer provide the drug, so the patient can have a chance to live?

The scholars at Volokh criticized our thinking in two ways. First, they insist that drug companies are not “state actors,” so no court would ever find that the fundamental constitutional right alleged in Abigail Alliance applies to them. As we said in our previous post, we’re far less sanguine about that than the academics are. The FDA regulates drug companies awfully closely, and judges will bend over backwards to find in favor of plaintiffs in the emotionally-charged situation we’ve just described. In that situation, we would not be surprised to find a judge (wrongly) ordering a company to provide an experimental drug.

Well, we hate to say “we told you so….”

Actually, let’s be honest about it – we love to say “we told you so.” It’s a natural human instinct, and as lawyers it’s a large part of what we do (come to think of it, in one form or another, that’s virtually all our adversaries on the other side of the “v.” do).

What the Internet allows us to do is say “I told you so” to a larger audience.

Well, even without a constitutional right, a terminally ill plaintiff very recently succeeded in getting a judge to issue an injunction ordering a drug company to provide him with an unapproved, experimental drug. What’s worse, it’s on an ad hoc, extra-regulatory basis – a tort suit – precisely the sort of thing that will encourage everyone else in a similar situation to start trying to build their own cases.

Our practical concerns, it appears, weren’t just the crocodile tears of big pharma lawyers after all.

The opinion, Gunvalson v. PTC Therapeutics, Inc., has already received some comment on the Net – the New York Times ran a story, and the usual suspects over at Pharmalot picked up on it, as did a couple other denizens of the blogosphere. Oddly, nobody seems to have provided a link to the Gunvalson opinion itself, so we’ll rectify that oversight.

Something else nobody seems to have done is examine the practical implications of judges taking it upon themselves to issue this kind of an order. As usual, we’re taking it upon ourselves to fill this much needed gap in the literature.

So what was Gunvalson about? As we predicted (that’s another way of saying “we told you so”), it’s a case with “truly compelling” “emotional appeal.” The plaintiff (not technically, but in reality) is a young boy with a nasty, invariably fatal condition – Duchenne muscular dystrophy. If he had an average case of the disease, he’d likely be dead in less than a decade. And the plaintiff’s case seems to be worse than average, which is a big part of the legal problem.

The defendant has a drug in development (something called “PTC124,” but the name isn’t important) that’s showed promise in treating Duchenne. That’s a really big deal, because right now, there isn’t any proven cure at all. In short, a Duchenne diagnosis is effectively a death sentence.

Most people will do just about anything to avoid death, so the plaintiff quickly entered the world of experimental drug treatments and ongoing clinical trials. That brought the plaintiff into contact with the defendant, as well as with at least one other potentially useful – but clinically unproven – treatment for Duchenne.

That also made for some tough medical choices. The first thing this plaintiff tried was something called Gentamicin, another experimental Duchenne treatment apparently sponsored by somebody other than defendant PTC (we’re assuming, anyway, although that’s not entirely clear from the opinion). Slip op. at 2.

The problem was, that to enter PTC’s clinical trial, plaintiff would have to stop taking the other drug (another drug would create a confounding factor, so presumably the protocol for the trial excluded polypharmacy (a fancy term for taking more than one drug at once)). A muscle biopsy (a procedure where a small chunk of muscle is surgically removed) was also required. Id.

At this time, plaintiff (or more properly plaintiff’s mother and presumably his doctor) had some direct communications with PTC that ultimately formed the basis of their lawsuit. Slip op. at 2-3.

Stop right there – that’s problem number one – If direct company-patient communications can be the basis for expensive and disruptive litigation, those of us representing companies will advise our clients either not to engage in such communication at all, or to do so only through formal, recorded procedures. As a matter of medical practice and more than that, simple human compassion, we don’t think it’s a good idea to inhibit such communication between desperate, terminally ill people, and companies that might just be in a position to help. But as lawyers, our first duty is to our clients.

So that’s our first objection to what happened in Gunvalson – if lawyers insist upon turning companies like this into defendants, they will necessarily act defensively.

Anyway, what was said during these conversations is now disputed. Our bias is to believe the defendant, of course, but readers can compare the back and forth in the opinion and draw their own conclusions. We’re more concerned about how it was said.

In a nutshell, what seems to have occurred is that the course of Duchenne (like a lot of serious diseases) isn’t exactly predictable. The plaintiff had to make a choice among treatments. He wasn’t doing too badly with his current drug regimen, so staying on it was a viable option. At that time he also wasn’t doing too badly – for a Duchenne sufferer – from a general medical standpoint, so another option seemed to be to join a later phase of the defendant’s clinical trial. Slip op. at 2-3.

But things changed. For one thing, the defendant’s drug turned out to work pretty well against Duchenne. Slip op. at 3 (“[t]he trial was a success”). Thus plaintiff had every incentive to change his mind and enroll in one of the defendant’s studies. But that wasn’t possible because of a second change – his Duchenne apparently took an abrupt turn for the worse, and by the time he came back to PTC he was too sick to participate in its trial – given the protocol for the study. Id. (plaintiff’s “condition had severely deteriorated by this point”).

“[G]rowing desperate,” id., plaintiff tried to get the defendant to give him the drug through the FDA’s “compassionate use” regulations. PTC said “no.” While we don’t claim to be experts in “compassionate use,” we took a quick look at the relevant regulation, 21 C.F.R. §312.34. We note in particular that anybody implementing a “compassionate use” program has to comply with a bunch of other regulations “including the regulations governing informed consent and institutional review boards and. . .applicable provisions. . .including distribution of the drug through qualified experts, maintenance of adequate manufacturing facilities, and submission of IND safety reports.” 21 C.F.R. §312.34(d). In other words, it takes a lot of money and effort to offer a drug for compassionate use. Also, (assuming the discussion in the initial Abigail Alliance opinion is right) “compassionate use” drugs, can only be supplied “at cost.” 445 F.3d at 474.

Basically, a drug company would be crazy to open a compassionate use program just for one person – nor could one person afford to pay the “cost” of all the overhead compassionate use required.

The court dismissed these cost considerations as “trivial.” Slip op. at 8. They’re not. Otherwise the compassionate use regulation would not be, as the Abigail Alliance plaintiffs asserted, “available only to a fraction of those in desperate need.” 445 F.3d at 474. And in Gunvalson the plaintiff sure wasn’t offering to foot the bill (and in all likelihood couldn’t conceivably afford to) for the defendant’s compassionate use obligations in return for receiving the drug.

But a one-person compassionate use regime (as least by analogy) was precisely what plaintiff in Gunvalson demanded when it came to litigation. Being, as the court said, “desperate,” plaintiff took the position that whatever the defendant had said about later participation in its trials amounted to a promise to provide him with its experimental drug no matter what, even if he no longer qualified for any research protocol that would provide any data that would be useful to the defendant’s ongoing research.

Thus, the defendant in Gunvalson got nothing at all of value to it, and everything it’s required to do comes off its bottom line – making it more difficult and expensive to bring its lifesaving product to market for other Duchenne sufferers.

Plaintiff invoked theories of “promissory estoppel, fraudulent misrepresentation and negligent misrepresentation,” slip op. at 3, to demand essentially that PTC should be compelled to give him its drug for nothing. And because plaintiff was seeking a preliminary injunction, he didn’t even have to win – all he had to show was that it was “reasonably likely” to succeed, a standard that “need not show anything approaching a certainty of success.” Slip op. at 4.

So Gunvalson presented the difficult combination of a deathly ill plaintiff suing under a quite malleable legal standard. It’s a classic example of bad facts making bad law, and vice versa.

What did the court do to evaluate the chances of success? Just what no sane drug company would ever do. It applied the FDA’s standards for compassionate use to an individual claim. Slip op. at 4-5. Never mind that the FDA’s regulations are expressly voluntary (“may be”). And never mind that there is no private right of action under the FDCA. And finally, never mind that, under the law of every state that we know of (press reports indicate that the plaintiff is from Minnesota) a government enactment cannot be used as a legal standard in a tort case (negligence per se) unless that enactment is mandatory in its own right. E.g., Mervin v. Magney Construction Co., 416 N.W.2d 121, 123 (Minn. 1987).

Well, the defendant’s drug – like virtually any experimental drug possibly useful in the treatment of an otherwise fatal disease – satisfied the FDA’s voluntary compassionate use regulations. It wasn’t even a hard call. Slip op. at 4-5. Of course not, since the FDA’s regulation was expressly written to allow compassionate use for as wide a universe of experimental drugs as possible. But the court’s injunction converted a voluntary program into a mandatory legal duty.

The crux of the rationale for that legal legerdemain was a disputed oral promise that the plaintiff claimed entitled him to a life-long supply of the defendant’s experimental drug. The expansive doctrine of promissory estoppel makes even promises without “consideration” (a legal term for giving something to get something in return) legally enforceable if there’s been “detrimental reliance.” Slip op. at 5. The oral promise at issue, of course, was subject to considerable factual dispute. The opinion details the various disputes at considerable length. Id. at 6-8. For purposes of the injunction, all the court had to hold was that it was “reasonably likely” that such a promise had been made. Id. at 6-7.

We weren’t there, so we can’t say what really happened either, so we won’t go into that.

But another aspect of the opinion is clearer. The allegedly “detrimental” reliance was the plaintiff’s medical decision to continue with a treatment that seemed to be doing OK at the time, rather than switch to the alternative of the defendant’s drug (which, afterwards, clinical data showed to work better). Slip op. at 5, 7. This exercise of medical judgment may be “reliance” but it only proved “detrimental” with the benefit of 20/20 hindsight. Nobody knew at the time how the defendant’s ongoing clinical studies were going to turn out, nor was it apparent that the plaintiff’s Duchenne was going to deteriorate so rapidly. All the plaintiff essentially did was make the best informed medical judgment he could at the time. To allow legal liability to turn on such a choice seems, to us, a form of legal “heads, I win; tails you lose.” The defendant’s drug turned out to be a lifesaver. But it’s reward for developing the drug turns out to be an injunction requiring it to give its drug away.

To justify its result, the court cites (slip op. at n.3) as “similar” Dahl v. HEM Pharmaceuticals Corp., 7 F.3d 1399, 1401 (9th Cir. 2003). So we looked at Dahl. It did affirm an injunction mandating the supply of an experimental drug – but the facts were critically different in two respects. First, the plaintiffs in Dahl were already “enrolled” in the defendant’s clinical trial. 7 F.3d at 1401. That means a limited universe of plaintiffs. Second, and even more important, because of plaintiffs’ enrollment, their claim of entitlement to the drug was based on express language (“you will be offered [the drug]”) in the contract of enrollment, a contract drafted by the defendant. Id. at 1401-02. That means there was a written promise intentionally made by the defendant, for consideration (enrollment in the study). It further means that the defendant had the ability to eliminate this kind of liability simply by writing a different contract.

That’s the second big problem – Gunvalson is thus hugely different from Dahl. Any poor soul who, when staring death in the face, succeeds in opening communication with the maker of a promising experimental treatment for his/her condition can take a shot at a “promissory estoppel” lawsuit by alleging a consideration-less oral promise under the rationale in Gunvalson. The stark, unavoidable fact is that people at risk of imminent death literally have nothing to lose. The scope of potential liability under the legal theory permitted in Gunvalson essentially runs to anybody whom a defendant’s unapproved, experimental drug might conceivably help, and who does nothing more than gets the defendant to talk to him/her, not just the actual clinical trial participants in Dahl.

And, of course, the differences between Gunvalson and Dahl tie back to our first concern: the only way to avoid Gunvalson-type liability is for a defendant to restrict its oral communication with desperate people who might later turn into plaintiffs, as well as patients. We don’t think it’s a good idea to force manufacturers to go that route.

Finally, the court in Gunvalson dismisses the defendant’s “floodgates” concerns as “unpersuasive.” Slip op. at 8-9. The court goes out of its way to characterize the plaintiff’s mother’s “involvement” with the defendant as “unique” in terms of the “unusually close relationship.” Id.

We respectfully disagree. While it may be that, under Gunvalson few plaintiffs would actually succeed (and we have doubts about that), that doesn’t mean that there won’t be plenty of people desperate enough to try. Dahl, after all, involved seventeen people even though it drew from a much smaller universe of potential plaintiffs.

Gunvalson adopted a broadly applicable liability theory that allows injunctive relief where the plaintiff shows nothing more than a disputed assertion of an oral promise with no consideration – only “reliance” in the form of a medical decision that seemed perfectly rational at the time it was made.

One lesson we draw from our mass tort experience is: “If you build it, they will come.”

And we’re not dealing with totally rational actors here. The plaintiff in Gunvalson had no other straw to grasp at and his counsel worked pro bono (for free). Ask yourself these questions: Would you beg, plead, and cajole to get into an experimental drug trial if it was the only thing that might possibly save your life? If you wouldn’t do it for yourself, would you do it for your son or daughter? How about if by filing a lawsuit you could jump the drug trial queue altogether and get this potentially lifesaving treatment for free – and apparently forever?

A whole lot of lawsuits have been filed over a whole lot less.

Wednesday, August 27, 2008

Accutane Affirmed

Just one week after oral argument, the Eleventh Circuit has issued an unpublished per curiam opinion affirming the trial court's decision to exclude plaintiffs' expert testimony supposedly linking Accutane to inflammatory bowel disease. The key sentence in the one-page decision is this:

"We have considered the briefs, the relevant parts of the record, and the well-reasoned opinion by the district court and conclude that the district court did not abuse its discretion by excluding the evidence and properly granted summary judgment."

Here's a link to what little there is.

Issue Preclusion in Mass Torts

We haven't yet read this one, but we like the sound of it.

Byron Stier, of Southwestern Law School, has posted at SSRN his manuscript, "Another Jackpot (In)Justice: Verdict Variability and Issue Preclusion in Mass Torts." Here's what the abstract tells us:

"If there are no prior inconsistent verdicts, non-mutual offensive issue preclusion generally allows a finding by a single jury to bar relitigation, in future cases, of the issue by the defendant who lost in the prior case. This approach, however, ignores the possibility that the first verdict delivered may have been an outlier if further verdicts were permitted to be delivered. In mass tort litigation, such a flawed approach may result in critical issues such as defect or negligence being resolved by only six jurors, whose potentially outlier verdict is then applied to resolve the cases of thousands, perhaps bankrupting a company or an industry when most juries would not so hold. Focusing on mass tort litigation, this article presents the growing empirical evidence of verdict variability and then critiques the use of issue preclusion, whose downside is applied only against defendants, not plaintiffs, because only defendants were parties to the prior action. As a result, the article argues that courts should exercise their discretion to deny issue preclusion in mass tort litigation. Instead, courts should join the emerging consensus of mass tort management that ultimately better serves the goals of efficiency and public respect supposedly underlying issue preclusion: allow multiple verdicts to unfold a more balanced view of liability that will frequently be used for well-informed and far-reaching settlements."


Hat tip to the Mass Tort Litigation Blog.

Brickman on "Litigation Screenings in Mass Torts"

We have no creativity.

Professor Lester Brickman, of Cardozo School of Law, posted on SSRN his article about mass torts. Brickman asks a provocative question in his title: "The Use of Litigation Screenings in Mass Torts: A Formula for Fraud?"

If we were answering that question, we would have just written: "Yes."

But that wouldn't have been long enough to publish in a scholarly journal.

That's probably why Brickman's in academia and we're toiling away in private practice.

Anyway, Brickman includes these sentences in his abstract at SSRN:


"By my count, approximately 1,500,000 potential litigants have been screened in the asbestos, silica, fen-phen (diet drugs), silicone breast implant, and welding fume litigations. Litigation doctors found that approximately 1,000,000 of those screened had the requisite condition that could qualify for compensation, such as asbestosis, silicosis, moderate mitral or mild aortic value regurgitation or a neurological disorder. I further estimate that lawyers have spent at least $500 million and as much as $1 billion to conduct these litigation screenings, paying litigation doctors and screening companies well in excess of $250 million, and obtaining contingency fees well in excess of $13 billion.

On the basis of the evidence I review in this article, I conclude that approximately 900,000 of the 1,000,000 claims generated were based on 'diagnoses' of the type that U.S. District Court Judge Janis Jack, in the silica MDL, found were 'manufactured for money.'"


Okay, you got us. We may not be creative, but we understand when we're duty-bound to flip through an academic piece and post a quick summary on the blog.

So we did. And we really liked what we read.

Brickman accurately notes that there's a ton of literature about the use of junk science to try to prove "general causation" in mass torts. But Brickman is among the first to examine the use of a different type of junk science -- litigation screenings -- to try to prove "specific causation" in mass torts.

To make his point, Brickman trots through in great detail, and with all the usual footnotes, the mass tort screenings that plaintiffs' counsel undertook in the asbestos, silica, silicone breast implants, fen-phen, and welding rod cases. He reviews the evidence that those litigation screenings "have been designed to and did generate specious if not fraudulent claims." Article at 11. Brickman then deplores the fact that "those who profit from this process, most especially the doctors who have been paid hundreds of millions of dollars for their medical reports and services," have faced neither civil nor criminal sanctions. Id.

It's awfully hard for practicing lawyers to plow through 177 pages of scholarship as recreational reading. But this wouldn't necessarily be recreational. If you're ever trying to show a court that litigation screenings are prone to generate inaccurate diagnoses, Brickman's article would be a great place to start your research. Brickman has the goods on the screenings that took place in each of the mass torts that he puts in his sights.

Brickman also proposes some solutions to the problems posed by mass litigation screenings. Some of his proposed solutions could be implemented unilaterally by judges (such as allowing "defendants to discover all of the medical reports prepared by a litigation doctor for other screened claimants if that doctor prepared a medical report for a litigant before the court," whether or not the doctor is an expert). Id. at 163. Other of his proposed solutions -- such as expanding the rights of defendants to remove individual cases in mass torts, which would permit aggregation (and analysis) of all of a screening doctor's cases before a single judge -- would require new laws to be passed, which is a dicier proposition.

But we'll take the article for what it does achieve, whether or not it prompts reform. This is a great resource for lawyers trying to expose the evil underbelly of the litigation screening process.

Monday, August 25, 2008

Exploring The New CBE Rule

We've now had a chance to review the new "change being effected" (or "CBE") rule finalized by the FDA last week. (Here's a link.) Here are the cites: 73 FR 49603, 2008 WL 3874230. For drugs, the rule is 21 C.F.R. Sec. 314.70(c)(6).

This is what we found.

First, the FDA made one change from the draft rule that it proposed in January to the final rule that it adopted last week. The draft rule said that "newly acquired information" included data "derived from new clinical studies, reports of adverse events of a different type or greater severity or frequency than previously included in submissions to FDA, or new analyses of previously submitted data."

The final rule changes the location of the italicized words. In the final rule, "newly acquired information" includes data "derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA."

This change clarifies that the (what the heck is that? an adjectival phrase?) applies to all of the types of data, rather than just the adverse event reports.

We found some stuff we like in the FDA's responses to the comments submitted about the draft rule. At page 6, you'll see the FDA's statement that, "A sponsor's submission or FDA's acceptance of a CBE supplement does not necessarily mean that a drug product actually has caused any particular adverse event or type of adverse event." That should go without saying, but we're glad to see it said nonetheless.

One commenter suggested that the FDA should distinguish situations in which a drug company "must" warn of a risk from situations in which a sponsor "may" warn. The FDA rejected that suggestion because the FDA-approved warning on a drug is both a floor and a ceiling on the risk information that should be provided: "FDA has previously stated and reiterates here that it 'interprets the Act to establish both a 'floor' and a 'ceiling', such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise misleading.'" Id. at 7.

As the FDA (and the Supreme Court) has said before, "FDA does not believe that the absence of an express preemption provision with respect to drugs affects the application of the doctrine of implied preemption." Id. at 8.

The FDA devotes a couple of paragraphs to explaining the "rule of construction" found in the recently enacted Food and Drug Administration Amendments Act of 2007. Among other things, "the rule of construction operates to preserve Federal labeling obligations only in the face of an argument that 'this paragraph' . . . 'affects' [the drug manufacturer's] responsibilities." Since the rule of construction is limited to that one paragraph, it cannot be read to apply to the FDAAA (or the FDCA) as a whole.

The FDA rejected one comment's proposal that the agency "provide a comprehensive, written response to every CBE supplement submitted to the agency by a sponsor, describing FDA's ground for approval, disapproval, or, as the case may be, request for modification to the submitted CBE supplement." Id. at 18. The FDA's position may disappoint those who favor Catherine Sharkey's "agency deference" model of preemption, but it does save the agency a lot of work.

Finally, the FDA repeats that the new CBE rule simply codifies what had been the agency's longstanding CBE practice (id. at 22) and repeats the FDA's now oft-stated views on preemption. Id. at 23. And, in a sentence that may occasionally prove useful in litigation, the FDA writes that "at least when a sponsor did not meet the standard to change its labeling through a CBE supplement under this rule to include the warning a plaintiff alleges should have been added to labeling, State law liability that is premised on a failure to warn is preempted." Id. at 24.

We liked this rule when it was proposed back in January, and we still like it today.

Friday, August 22, 2008

The New CBE Rule Is Final

The FDA has finalized the new CBE rule. (That's the so-called "Change Being Effected" rule at 21 C.F.R. Sec. 314.70(c)(6) for drugs.)

Here was our post on that subject when the FDA proposed the rule in January. (We explain there why this change is a big deal.)

And here's a link to the final rule that went up at the FDA website today.

"The Case For Field Preemption of State Laws In Drug Cases"

We can't figure out how to italicize the title of a post, so we'll repeat that title here, with our emphasis added:

"The Case for Field Preemption of State Laws in Drug Cases."

That's the provocative title of Richard Epstein's piece posted yesterday at Northwestern University Law Review's Colloquy site. Here's a link.

Everyone argues for conflict preemption in drug cases, but one rarely sees an argument for field preemption.

Epstein has made this argument before. See Richard A. Epstein, "Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda," 1 J. Tort. L. art. 5 (2006), available at http://www.bepress.com/jtl/vol1/iss1/art5/ (link).

It's nice to see him make it again, particularly with Wyeth v. Levine pending in the Supreme Court.

In a nutshell, Epstein criticizes the Kessler/Vladeck argument against preemption on two grounds: That argument ignores both (1) the incentives that cause the FDA to delay (or refuse) approval of beneficial drugs, which can cause more harm than premature (or incorrect) approval, and (2) the reasons why the tort system is ill-equipped to decide complex pharmaceutical product liability cases.

Epstein also criticizes Catherine Sharkey's "agency reference" model for preemption. See Catherine M. Sharkey, "What Riegel Portends for FDA Preemption of State Law Products Liability Claims," 102 Nw. U. L. Rev. Colloquy 415 (2008), available at http://www.law.northwestern.edu/lawreview/colloquy/2008/24/LRColl2008n24Sharkey.pdf (link).

In Epstein's words, the burdens of analyzing an agency's decision-making record in a typical situation "are trivial compared to wading through the normal complex FDA record. In addition, this onerous task would have to be done in thousands of separate cases. The sheer weight of litigation would open up the possibility of third-party depositions of present and past FDA employees, and extensive discovery of FDA doctrines."

Additionally, "Sharkey’s proposal does not correct the deficient error-cost analysis in the Kessler-Vladeck plan. Nor does it take into account the substantive weaknesses of the current duty to warn law in most states, with the high risks of false positives on liability. The proposal’s ex ante effects are also likely to deter new drug innovation by adding private law sanctions to the impressive administrative obstacles that now impede new drug development. Finally, its helter-skelter results undermine the uniformity that grounds the public acceptance of the law."

We have two reactions to this.

First, we're always pleased to see a public debate on issues of importance (and particularly pleased when really smart people jump in on our side).

Second, Northwestern's Colloquy site may well represent the future of a certain type of legal scholarship. There will probably always be room in the law reviews for timeless articles about "law and poetry" and the "law of pre-Columbian civilizations." But, for people who are trying to engage in discourse on a hot topic of the day, the Colloquy format is better. It's great to see Sharkey post an intelligent (if not quite law review length) article on July 21 and to see Epstein's intelligent (if not quite law review length) response posted a month later. For subjects such as these, the debate should not be drawn out by a year-long editing process at the law reviews.

Kudos to the participants, and kudos to Northwestern.

Thursday, August 21, 2008

(New) Medical Device Preemption Scorecard

After Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), was decided, we decided it was time to retire our old device preemption scorecard. The big question, whether PMA device manufacturers are protected by preemption, was resoundingly answered “yes.”

But since then, we’ve said repeatedly that we don’t expect plaintiffs to just fold their tents and go away - and they haven't. Rather, we expect the other side to look for loopholes in Riegel – even if we don’t think there are any – especially in the area of so-called “parallel” claims.

Anyway, it’s been six months since Riegel was decided, and the decisions addressing such arguments are starting to pile up. So we’ve decided to resurrect and revamp our device preemption scorecard with special emphasis on what Riegel “loophole” arguments are made and how courts decide them. So here goes (drumroll, please), the new and updated druganddevicelaw device preemption scorecard:

  1. Strini v. Edwards Lifesciences Corp., 2008 WL 820192 (Mag. N.D.N.Y. March 26, 2008). Heart valve prosthesis case.  Preemption issues cannot be decided in context of a discovery motion. “Parallel” violation claims might escape preemption.
  2. Stevens v. Pacesetter, Inc., 2008 WL 2637417 (D.S.C. April 1, 2008).  Device not stated, but probably some sort of pacemaker.  No “parallel” violation claims pleaded; action preempted in its entirety.
  3. Despain v. Bradburn, 282 S.W.3d 814 (Ark. April 10, 2008). Plaintiff’s claims preempted against manufacturer of hearing device. No manufacturing defect claim pleaded.
  4. O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008), mandamus denied, 24 So.3d (Fla. App. 2009). Drug eluting coronary stent.  Off-label use does not preclude preemption where the defect (in design claim) or risk (in warning claim) is common to both on- and off-label use. True “parallel” violation claims, including off-label promotion are not preempted. Express warranty claims are not preempted. Fraud claims amounting to fraud on the FDA are preempted under Buckman. Unfair trade practice claims are preempted.
  5. Troutman v. Curtis, 185 P.3d 930 (Kan. June 20, 2008). Plaintiff barely pleaded, and entirely failed to prove, any unpreempted “parallel” violation claims against manufacturer of suturing device.
  6. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008). Novasure endometrial ablation device.  A claim based on the activities of defendant’s on-site representative escapes preemption as not regulated by the FDA.
  7. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008). Taking judicial notice of FDA PMA for defendant's adhesion barrier device. Plaintiff failed to plead any unpreempted “parallel” violation claims either before or after FDA approval. Express warranty claims are unpreempted but inadequately pleaded. Leave granted to amend.
  8. Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 31, 2008). Plaintiff failed to prove any unpreempted “parallel” violation claims involving Targis microwave device. Negligent failure to train claims are preempted as “in addition to” the FDA’s requirements imposed upon the device.
  9. McCutcheon v. Zimmer Holdings, Inc., 586 F. Supp.2d 917 (N.D. Ill. Aug. 6, 2008). Violation claims involving information the manufacturer of a knee implant provided to the FDA are preempted by Buckman. No evidence supports post-approval claims, even if they could be unpreempted. Riegel overrules contrary anti-preemption precedent. Congressional legislation to overturn Riegel is of no significance until it is passed.
  10. Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008). FDA filed suit against manufacturer of cochlear ear device for violating Good Manufacturing Practices requirements. Plaintiff's strict liability and implied warranty claims that manufacturer sold adulterated product not preempted under Riegel.  Renewed motion denied, Purcel v. Advanced Bionics Corp.slip op. (N.D. Tex. June 24, 2010).
  11. Clark v. Medtronic, Inc., 572 F. Supp.2d 1090 (D. Minn. Aug. 18, 2008). Doctrine of res ipsa loquitur cannot be invoked to show that a device that failed had necessarily been manufactured improperly. Allegations about information withheld from FDA are preempted by Buckman, and would be an improper private right of action to enforce the FDCA. All claims in case involving an implantable cardioverter-defibrillator, including consumer protection, and breach of unspecified warranties, are preempted.
  12. Kavalir v. Medtronic, Inc., 2008 WL 4087950 (N.D. Ill. Aug. 27, 2008). Preemption motion to dismiss denied because available information did not conclusively establish that the  implantable cardioverter-defibrillator in question had PMA approval.
  13. Walker v. Medtronic, Inc., 2008 WL 4186854 (S.D.W. Va. Sept. 9, 2008). Preemption motion denied without prejudice in infusion pump case. Plaintiff could amend complaint to allege "parallel" FDCA violations, but the issue would be rejoined after discovery concerning the defendant's evidence that it was in full compliance.
  14. Carson v. Depuy Spine, Inc., 2008 WL 7258800, order (C.D. Cal. Sept. 17, 2008). Summary judgment on preemption grounds granted against all claims spinal disc implant case. Allegations of off-label promotion as "parallel" claim failed: (1) because mere sales rep presence during an off-label surgery isn't promotion, and (2) for lack of evidence of reliance or causation.  Affirmed 365 F. Appx. 812 (9th Cir. 2010).
  15. Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. Oct. 22, 2008). Motion to dismiss on preemption grounds granted in hip implant case. Plaintiff failed to plead any facts supporting "parallel" claims. Preemption cannot be avoided by reference to adulteration and misbranding because there is no private right of action under the FDCA. Express warranty claims involving product labeling are preempted.
  16. Rollins v. St. Jude Medical, 583 F. Supp.2d 790 (W.D. La. Oct. 20, 2008). Motion to dismiss plaintiff's claim that defendants failed to abide by FDA reporting requirements granted in part and denied in part in Angio-Seal case. Plaintiff conceded that all claims were preempted except failure to manufacture/package in accordance with FDA specifications, failure to train, and failure to abide by reporting requirements. Noncompliance claims not preempted. Manufacturing defect claim based on product recall not preempted. Failure to train claim preempted to the extent of FDA compliance. Failure to report claim dismissed for lack of causation.
  17. Link v. Zimmer Holdings, Inc., 604 F. Supp.2d 1174 (N.D. Ill. Nov. 26, 2008). Summary judgment granted against all claims concerning total knee replacement prosthesis. No factual dispute as to compliance with FDA requirements. Rejected loopholes: fraud on the FDA (preempted), post-approval defect (relies on dissent; no proof); congress might change the statute (hasn't).
  18. Lake v. Kardjian, 22 Misc.3d 960, 874 N.Y.S.2d 751 (N.Y. Sup. Dec. 17, 2008). Summary judgment granted against all claims concerning Targis transurethral microwave therapy system. Plaintiff failed to identify any specific statement exceeding FDA-approved warnings that could qualify as an unpreempted express warranty. Post approval failure to report claims are preempted either as fraud on the FDA or prohibited private FDCA violation claims.
  19. Huber v. Howmedica Osteonics Corp., 2008 WL 5451072 (D.N.J. Dec. 31, 2008). Motion to dismiss denied against complaint alleging solely a claim for express warranty in total hip replacement litigation. The court considered itself bound by pre-Riegel Third Circuit precedent. The question whether express warranty claims are preempted was certified to the Third Circuit. Huber v. Howmedica Osteonics Corp., 2009 WL 2998160 (D.N.J. March 10, 2009).
  20. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. Jan. 5, 2009), reconsideration denied, 2009 WL 294353 (D. Minn. Feb. 5, 2009), leave to amend complaint denied, 2009 WL 1361313 (D. Minn. May 12, 2009). Motion to dismiss granted against all claims in Sprint Fidelis MDL. Manufacturing defect claims not "parallel" because no specific violations alleged, or allegable given generality of FDA regulations. Parallel claims do not exist without a specific FDA regulation for state-law claims to parallel. Adulteration claims amount to prohibited private attempts to enforce the FDCA. Negligence per se only supplies a standard of care, and cannot resurrect an otherwise preempted claim. An express warranty of "safety" would require a jury to find a device unsafe, which is preempted. This is an appealable order, motion practice in the district court appears exhausted, and the matter is currently on appeal.
  21. Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. Jan. 12, 2009). Motion to dismiss denied as to claims "based on theories that [defendant] failed to comply with federal requirements for manufacturing" a hip replacement prosthesis. Surviving claims include those for express and implied warranty and consumer fraud. All non-violation claims had been voluntarily dismissed.
  22. Means v. Howmedica Osteonics Corp., 2009 WL 347407 (S.D. Ind. Feb. 11, 2009), minute order following Hofts in hip replacement prosthesis case.
  23. Blunt v. Medtronic, Inc., 315 Wis.2d 612, 760 N.W.2d 396 (Wis. Feb. 17, 2009). Pre-Riegel ruling in favor of PMA preemption affirmed in implantable defibrillator case. Both PMA and supplemental PMA have equal preemptive effect. Supplemental approval does not diminish the preemptive effect of initial approval.
  24. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009). Motion to dismiss granted as to claims involving total hip prosthesis. All claims except manufacturing defect are preempted, including consumer fraud. Warning letters and recalls not involving the device in question do not create parallel claims. A plaintiff must plead how a particular violation caused injury. The manufacturing claim must be more specifically pleaded. Express warranty claims not based on the approved labeling would escape preemption.
  25. Shertzer v. Howmedica Osteonics Corp., 2009 WL 535997 (S.D. Ind. March 3, 2009), minute order following Hofts in hip replacement prosthesis case.
  26. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009). Motion to dismiss granted in part and denied in part as to claims involving hip prosthesis. Violation claims, even if not preempted under Lohr, are preempted as attempted private FDCA enforcement under Buckman. Express warranty claims are not preempted, but are insufficiently pleaded. Manufacturing defect claims are preempted without specific allegations of a deviation from FDA-approved specifications.
  27. Dorsey v. Allergan, Inc., 2009 WL 703290, slip op. (M.D. Tenn. March 11, 2009). Summary judgment granted as to claims involving investigational breast implants. Riegel applies to Class III devices marketed pursuant to an IDE or its equivalent. FDA approval of both adjunct (equivalent to an IDE) and core studies (an actual IDE) has preemptive effect.
  28. Gortarez v. White Memorial Medical Center, 2009 WL 8710587 (Cal. Super. March 23, 2009).   Summary judgment granted as to claims, including failure to train physicians, involving a laser and shaft unit.  Training requirements were part of the PMA approval.  Fraud on the FDA claims are preempted by Buckman.  No parallel claims were alleged.
  29. Mitaro v. Medtronic, Inc., 23 Misc. 3d 1122(A), 886 N.Y.S.2d 71, 2009 WL 1272398 (N.Y. Sup. April 9, 2009) (unreported). Motion to dismiss granted against almost all claims, including consumer fraud, in implantable cardiac defibrillator case. Manufacturing defect claim could be a parallel violation claim. Negligence per se claim is preempted both as restating other preempted claims and as attempted private FDCA enforcement. Express warranty claim preempted only to the extent it relies upon FDA-approved statements. Claims predicated on false statements to the FDA are preempted under Buckman. A product recall does not vitiate preemption.  The Appellate Division affirmed in a one-paragraph opinion, Mitaro v. Medtronic, Inc., 73 A.D.3d 1142, 900 N.Y.S.2d 899 (N.Y.A.D. May 25, 2010).
  30. Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009). Motion to dismiss granted as to all claims in anti-adhesive surgical barrier case. Negligence per se claims related to events that post-dated plaintiff's injuries and thus couldn't possibly be causal. All other claims are preempted. Express preemption claims based on FDA-approved language are preempted.
  31. Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226 (D. Nev. May 1, 2009). Granting summary judgment against all claims in a spinal implant disc case, including express warranty because the claimed warranty concerned aspects of device safety and effectiveness. Plaintiff had no evidence to support allegations of violation of FDA manufacturing standards. Allegations of fraud on the FDA are preempted under Buckman and as they are a prohibited attempt at private FDCA enforcement, would not constitute negligence per se under Nevada law.
  32. Mullin v. Guidant Corp., 114 Conn.App. 279, 970 A.2d 733 (Conn. App. May 12, 2009), affirming Mullin v. Guidant Corp., 2008 WL 2785498 (Conn. Super. April 8, 2008). All claims, including manufacturing defect and express and implied warranties, are preempted in action involving implantable defibrillator. Plaintiff did not plead anything that could be considered a “parallel” violation claim. Preemption does not deprive a court of subject matter jurisdiction.  The Connecticut Supreme Court declined to review the case.  292 Conn. 921, 974 A.2d 722 (2009).
  33. Riley v. Cordis Corp., 625 F. Supp.2d 769 (D. Minn. June 5, 2009). Judgment on the pleadings granted as to all claims in drug eluding stent case. A "parallel" claim involves conduct "forbidden" by the FDCA. Even a claim involving prohibited conduct may be impliedly preempted as an improper private FDCA action under Buckman. To escape Buckman, a claim must rely on traditional state tort theories. Preemption applies to off-label uses. A combination of a drug and a device will be treated as a device for preemption purposes where the FDA has regulated the product as a device.  The device cannot be divided into components.  Allegations that the FDA is poorly run do not defeat preemption. Allegations of promoting off-label use escape preemption only if, in addition to violating the FDCA, the promotion failed to warn of risks in violation of the common law. All other warning related claims are preempted. Fraud claims must be specifically pleaded. Express warranty claims based upo the device's label are preempted. Manufacturing defect claims must allege a violation in the particular device at issue. Any claims not dismissed with prejudice must be repleaded. This case is reportedly on appeal in the Eighth Circuit at No. 09-2870.
  34. Bencomo v. Guidant Corp., 2009 WL 1951821, slip op. (E.D. La. June 30, 2009). Summary judgment on preemption granted against express warranty claims involving embolis capture system. Alleged contradiction between patient material and product labeling could not support a claim where the language in both sets of material were FDA approved. A claim dependent upon the falsity of FDA approved language cannot be a parallel claim.
  35. Colombini v. Westchester County Health Care Corp., 24 Misc.3d 1222(A), 899 N.Y.S.2d 58, 2009 WL 2170230 (N.Y. Sup. July 6, 2009). Summary judgment granted against all claims in action involving an MRI device. That the device had been downclassified to Class II did not eliminate preemption, as the device was initially PMA approved. Plaintiffs could not point to any FDA design requirement that defendant violated, therefore there was no viable parallel claim.
  36. Prudhel v. Endologix Inc., 2009 WL 2045559 (E.D. Cal. July 9, 2009). Motion to dismiss granted in part in aortic stent case. Alleged express warranty of safety was preempted. Alleged parallel claims are preempted when they impose greater requirements on compliant manufacturers. Parallel claims that require "more than mere noncompliance" are not preempted. A manufacturing defect claim, involving product recalls, survives preemption. Strict liability, negligence, and implied warranty claims are preempted.
  37. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009). Motion to dismiss granted against all claims in ceramic total hip replacement case. Finding broad preemption of state tort claims that "incidentally" regulate medical devices. Parallel violation allegations can escape express preemption, but are subject to implied preemption. Rejects argument that preemption may only be decided on summary judgment. Rather than vitiating the preemption defense, allegations of fraud on the FDA are themselves preempted. FDA warning letters issued after plaintiff's surgery, and thus not relating to the product implanted in plaintiff cannot support an unpreempted parallel claim. To plead an unpreempted parallel violation claim requires alleging a specific federal requirement, how it was violated, and how the violation caused this plaintiff's injury. Express warranty and consumer fraud claims are too vaguely pleaded to escape preemption.
  38. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 2600517, slip op. (M.D. Ga. Aug. 24, 2009). Motion to dismiss granted against punitive damages claim asserted under New Jersey law because fraud on the FDA exception to the statutory ban on punitive damages against FDA-approved products is barred by preemption under Buckman.  Cautionary note:  this opinion was vacated on state-law grounds (whether the product was covered by the statutory ban in the first place) in In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 4280829 (M.D. Ga. Nov 24, 2009).
  39. William Beaumont Hospital v. Medtronic, Inc., 2009 WL 2849546 (E.D. Mich. Aug. 31, 2009). Motion to dismiss granted in part. All claims based on alleged inadequacy of warnings are preempted in case concerning pain pump refill kits. Contribution claims based upon the negligent distribution of an incorrect free sample that was not in fact the same device as represented are not preempted.
  40. Williams v. Cyberonics, Inc., 654 F. Supp.2d 301 (E.D. Pa. Sept. 10, 2009). Summary judgment granted against all claims in two cases involving vagus nerve stimulation devices. Unknown manufacturing defects inferred from alleged device malfunction were preempted because proof of a failure to manufacture the device to comply with FDA design requirements was shown.  Affirmed memorandum, 388 F. Appx. 169 (3d Cir. July 30, 2010).
  41. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009). Summary judgment granted against all claims in ruptured breast implant case involving IDE device. Claims of lack of valid consent are factually false. No pleaded facts support any violation claim. That PMA approval occurred only after the plaintiff's device was implanted does not prevent preemption, since essentially the same device was approved. A non-waiver clause in an informed consent form does not override preemption.
  42. In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867, slip op. (Minn. Dist. Hennepin Co. Oct. 20, 2009). Motion to dismiss granted against all claims in state court Sprint Fidelis litigation. Express warranty and consumer fraud claims preempted. Purported "parallel" claims dismissed because: (1) they are disguised private attempts to enforce the FDCA, which are impliedly preempted under Buckman; (2) there is no parallel state law claim for failure to follow the conditions of an FDA PMA; (3) there is no federal requirement to submit a CBE (it's strictly voluntary); (4) claims challenging the sufficiency of a defendant's submissions to the FDA are disguised fraud-on-the-FDA claims; (5) plaintiffs' design claims would impose rigid specificity that FDA regulations do not; (6) nothing in the FDA's regulations requires withdrawal of a device because an allegedly "safer" model was later approved; (7) there is no obligation to submit a PMA supplement immediately after learning of problems with an existing device; (8) certain alleged violations were not causally connected to any plaintiff's injuries; (9) adulteration claims are disguised private attempts to enforce the FDCA; negligence per se claims are disguised private attempts to enforce the FDCA; (10) a statute that does not authorize a private cause of action cannot be the basis of a negligence per se claim under state law; and (11) the regulations subject to plaintiff's negligence per se claims are only administrative requirements and do not prescribe standards of care owed to any individual.
  43. Williams v. Endologix, Inc., slip op., 2009 WL 3554581 (Ky. Cir. Oct. 30, 2009). Summary judgment granted against all claims in some kind (aortic stent?) of PMA device litigation, except claims "premised upon" FDCA violations, which the court considered parallel claims.
  44. McQuiston v. Boston Scientific Corp., 2009 WL 4016120, slip op. (W.D. La. Nov. 19, 2009). Summary judgment granted against all claims in a drug eluting stent case involving a combination device. Express warranty claim preempted. Plaintiff did not plead a "parallel violation" claim.
  45. Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009) (bench opinion).  Motion to dismiss granted against all claims, including express warranty, in ceramic total hip prosthesis case.  No violation claims were properly pleaded.  A 2006 recall cannot be causally relevant to a device implanted in 2003.  Twiqbal bars speculative parallel violation claims.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  The New Jersey punitive damages exception is preempted as based upon fraud on the FDA.  Rejecting Hofts.
  46. Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. Dec. 28, 2009).  Motion to dismiss granted against plaintiff's sole "negligence per se" claim involving a medication pump.  The allegedly violated Good Manufacturing Practices were too "vague and open-ended" to constitute a non-preempted parallel violation claim because they "would necessarily result in the imposition of standards that are different from or in addition to those imposed by the FDCA."
  47. Risavich v. Heart Rhythm Consultants, 2010 WL 9585790 (N.Y. Sup. Feb. 1, 2010).  Summary judgment granted against all claims in action involving an inplantable cardiac defibrillator.  Both PMA and supplemental PMA have equal preemptive effect.  Plaintiff failed to plead a parallel claim with specificity.  Implied warranty claims are preempted.
  48. Banner v. Cyberonics, Inc., 2010 WL 455286 (D.N.J. Feb. 4, 2010), summary judgment granted on all claims in action involving a vagus nerve stimulator.  A claimed that a device is a "lemon" because it malfunctioned in unspecified ways does not establish any FDA violation. There was no dispute that the device was manufactured according to FDA specifications.
  49. McGuan v. Endovascular Technologies, Inc., 182 Cal. App.4th 974, 106 Cal. Rptr.3d 277 (Cal. App. Feb. 9, 2010), affirming Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008), and McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008).  Summary judgment affirmed against all claims in case involving an endograft device.  Claimed "parallel" violation claim was really a preempted fraud on the FDA claim.  The defendant's guilty plea did not establish the exception to Buckman because the FDA reapproved the device after the alleged fraud and the guilty plea did not require removal of the device from the market.
  50. Rankin v. Boston Scientific Corp., 2010 WL 672135 (E.D. Ky. Feb. 19, 2010), summary judgment granted on all claims in action involving a balloon catheter.  An allegation that the product failed under normal use does not establish a violation of FDA regulations.
  51. Heisner v. Genzyme Corp., 2010 WL 894054, slip op. (N.D. Ill. March 8, 2010).  Dismissing with prejudice a complaint that had been amended three times (see above for two earlier dismissals).  The device CBE requirements, being voluntary, could not be parallel to a post-sale duty to warn.  A failure to report adverse events to the FDA was not "defect" as required by strict liability.  Negligence per se claims involving post-injury events could not possibly be causal.
  52. Wheeler v. Depuy Spine, Inc., 706 F. Supp.2d 1264 (S.D. Fla. March 9, 2010), summary judgment granted on almost all claims in action involving off-label use of an artificial spinal disc.  Non-violation-related product liability claims are preempted.  Claims seeking to enforce the FDCA, that defendant "permitted" off-label use, and that defendant withheld adverse reaction reports were all preempted under Buckman.  A hearing will be held on express warranty claims, which are vulnerable to both preemption and non-preemption defenses.  Express warranty claim later dismissed on non-preemption grounds, 740 F. Supp.2d 1132.
  53. Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. March 15, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  Preemption of product liability claims was conceded.  Redhibition is equivalent to a breach of implied warranty and it preempted.
  54. Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. March 23, 2010), motion to dismiss granted against all claims involving hip prosthesis.  Plaintiffs pleaded no violation claims, so all tort claims were preempted.  Express warranty were inadequately pleaded.
  55. Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010), motion to dismiss granted on all claims involving total hip prosthesis. Generalized manufacturing defect allegations that do not mention FDCA violations cannot be recast as parallel violation claims. No causal link pleaded between FDA warning letters and device implanted in plaintiff.
  56. Adams v. I-Flow Corp., 2010 WL 1339948 (C.D. Cal. March 30, 2010), motion to strike claim that defendants failed to warn the FDA stricken as a fraud on the FDA claim preempted by Buckman.
  57. Lewkut v. Stryker Corp., 724 F. Supp.2d 648 (S.D. Tex. April 16, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  All claims, including manufacturing defect and consumer fraud, are preempted.  Plaintiff's claim that his device was "adulterated" because a component was recalled for GMP issues is preempted under 21 U.S.C. §337(a) because adulteration claims are improper private enforcement of the FDCA.  Reconsideration denied, Lewkut v. Stryker Corp., 2010 WL 2542215 (S.D. Tex. June 21, 2010).
  58. Franklin v. Medtronic, Inc., 2010 WL 2543579 (Mag. D. Colo. May 12, 2010), adopted, 2010 WL 2543570 (D. Colo. June 22, 2010), summary judgment granted on all claims involving implantable defibrillator. Failure to recall claim was not a parallel claim because recall under the FDCA is a voluntary remedial action. Express warranty claims are preempted. FDA regulatory claim was conclusory under TwIqbal, and an improper attempted private FDCA cause of action.
  59. Van Dyke v. Howmedica Osteonics Corp., 2010 WL 8490858, tr. at 22-30 (D. Mont. May 14, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  Express warranty claims and consumer fraud claims based on FDA-approved labeling are preempted.  Claims asserting a right to sue for FDCA violations are preempted by Buckman.
  60. Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010), motion to dismiss denied as to "parallel" violation claims in total hip prosthesis case where a device recall applied to the plaintiff's device.   A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  The public FDA record is subject to judicial notice.  Manufacturing defect theories based upon a claimed FDCA violation that formed the basis for the recall of the plaintiff's device adequately states an unpreempted claim.  Reconsideration denied, 2010 WL 4238594 (E.D. Tenn. Oct. 21, 2010).
  61. Huber v. Medtronic, Inc., 2010 WL 4602686 (Cal. Super. June 4, 2010), summary judgment granted against all claims involving implanted PMA device.  No parallel claims alleged. 
  62. Kallal v. Ciba Vision Corp., 2010 WL 2330365 (N.D. Ill. June 9, 2010), motion to dismiss granted in part on claims involving Optix contact lens.  All design and testing claims are preempted.  A parallel violation claim was sufficiently pleaded.  Plaintiff's pleading that the violated standard was FDA-imposed was sufficient; defendant's argument that the standard was only internal will not be decided on motion to dismiss.  There is a reasonable inference that a product purchased shortly before a recall was covered by the recall; it was not necessary to plead product identification numbers.  Remaining violation claim later dismissed on summary judgment because plaintiff could not prove a violation or causation, see below 2013 WL 328985.
  63. Howard v. Sulzer Orthopedics, Inc., 382 F. Appx. 436 (6th Cir. June 16, 2010) (unpublished), order preempting negligence per se claim in knee prosthesis case reversed.   While the FDA Good Manufacturing Practice plaintiff claims was violated could be read two different ways, other FDA materials suggest that a specific duty was imposed, therefore the regulation was enforceable.
  64. Steen v. Medtronic, Inc., 2010 WL 2573455 (N.D. Tex. June 25, 2010), motion to dismiss granted on all claims, including express and implied warranty, involving an Adapta pacemaker.  No parallel violation claim alleged.
  65. Poole v. Hologic, Inc., 2010 WL 3021528 (W.D. La. July 29, 2010), judgment on the pleadings granted on all claims, including express and implied warranty, involving a "controlled endometrial ablation aystem."  No parallel violation claim alleged.
  66. Raleigh v. Alcon Laboratories, Inc., 403 Ill. App.3d 863, 934 N.E.2d 530 (Ill. App. Aug. 6, 2010), affirming summary judgment order preempting all claims in intraocular lens case.  No parallel violation claim alleged.  Further appeal denied, 942 N.E.2d 461 (Ill. 2010).
  67. Gow v. Medtronic, Inc., 2010 WL 3643754 (Ky. Cir. Aug. 26, 2010), summary judgment granted against all claims involving implantable infusion pump, including express preemption and consumer fraud.  Plaintiff fail to plead violation of FDA requirements with any detail and does not identify what was violated.  An FDA recall did not affect PMA approval.
  68. Aaronson v. American Medical Systems, 2010 WL 3603618 (E.D.N.Y. Sept. 7, 2010), motion to dismiss denied in case involving penile implant.  It was unclear at the pleading claim whether the device was actually a PMA device. Limited discovery on the device's regulatory status is allowed and, if it is a PMA device, plaintiff has 14 days to file a more specific complaint.  Dismissed for failure to file amended complaint, 2012 WL 1712378.
  69. Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010), motion to dismiss granted on all claims involving a total hip prosthesis.  Preemption extends to express warranty and consumer fraud claims.  Plaintiff fail to plead violation of FDA manufacturing requirements with any detail.  Rejecting "lax" pleading standard of Hofts.  Plaintiff must plead a "device-specific" violation and causation by the violation.  Later decision dismissing most claims, 788 F. Supp.2d 145, see below.
  70. Sanders v. Advanced Neuromodulation Systems, Inc., 44 So.3d 960 (Miss. Sept. 30, 2010), summary judgment affirmed on all claims involving a spinal cord stimulator.  Preemption was not defeated by the manufacturer's unsuccessful attempt to have the device downclassified to Class II.  The FDA did not misinterpret its regulations in deciding that the device was Class III and requiring premarket approval.
  71. Bagumyan v. Medtronic, Inc., 2010 WL 4009891 (Cal. App. Oct. 14, 2010) (unpublished), summary judgment affirmed on all claims involving a Sprint Fidelis pacemaker lead. Supplemental PMA approval is equally preemptive as initial approval. The PMA process cannot be re-examined to test the quality of the FDA's actual review.  Parallel requirements arguments fail for lack of any citation to anything allegedly violated.  Affirming 2008 WL 8071256 (Cal. Super. Dec. 29, 2008).
  72. In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. Oct. 15, 2010), summary judgment affirmed on all claims involving the Sprint Fidelis MDL.  With respect to parallel claims, express preemption under Riegel and implied preemption under Buckman create only a "narrow gap" for state-law claims.  Failure to warn claims not alleging any violation of FDA regulations are not "parallel" claims and are preempted.  Even if additional warnings were allowed they were not required; thus the claim is "different from or in addition to" and is preempted.  Levine, involving implied preemption, is inapposite.  There is no federal requirement that unmodified products be removed from the market when a modified device is approved.  Claims that the defendant provided the FDA with insufficient information or withheld adverse event reports are private enforcement barred by Buckman.  Absent "concrete" allegations of FDCA violations, design defect claims are preempted.  General allegations of failure to comply with FDA Good Manufacturing Practices are too vague to escape preemption, and are a "frontal assault" on the FDA's risk/benefit conclusion.  Express warranty claims based on "safety and effectiveness" would require a jury to find a device unsafe, creating a preempted conflict.
  73. Scoggins v. Boston Scientific Corp., 2010 WL 8911977, slip op. (Mass. Super. Oct. 18, 2010), summary judgment granted in part and denied in part in action involving drug eluting stent.  Off-label use does not preclude preemption.  Design defect claims are preempted.  Manufacturing defect claims that also allege FDCA violations escape preemption.  Attacks on off-label promotion allowed by the FDCA safe harbor are expressly preempted.  Most warning claims are preempted, unless plaintiff can show a reporting violation that also violates state common law.  A parallel claim for illegal off-label promotion that is also false escapes preemption.   Express warranty and consumer fraud claims based on FDA-approved statements are preempted, but any other statements are not.
  74. Cenac v. Hubble, 2010 WL 4174573, slip op. (E.D. La. Oct. 21, 2010), motion to dismiss granted on all claims in SynchroMed medication pump case.  GMPs and certain other regulations are too vague to support a "parallel" violation claim.  Allegations of post-PMA adverse event reporting violations are preempted fraud on the FDA claims.  Express and implied warranty claims are preempted.
  75. Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010), motion to dismiss granted on all claims in Trident total hip implant case.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  Plaintiff should have modified allegations concerning the applicability of a product recall once the facts were clear, but Rule 11 sanctions will not be imposed.  A product recall not involving the product at issue cannot form the basis of a "parallel" violation claim.  An adulteration claim is a prohibited private FDCA right of action.
  76. Bishoff v. Medtronic, Inc., 2010 WL 4852650, slip op. (N.D.W. Va. Nov. 22, 2010), motion to dismiss granted on all claims in pacemaker lead case.  Manufacturing defect/negligence per se claims were improperly pleaded because they didn't identify "how or why" there was a regulatory violation.  Express warranty claims were improperly pleaded.  Implied warranty for a particular purpose claims were preempted.
  77. Norks v. Endovascular Technologies, Inc., 2010 WL 4681417 (Cal. App. Nov. 19, 2010) (unpublished), summary judgment affirmed (2008 WL 5267875) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.  Fraud on the FDA claims were preempted, thus an amendment was properly denied as futile.
  78. Robinson v. Endovascular Technologies, Inc., 190 Cal. App.4th 1490, 119 Cal.Rptr.3d 158 (Cal. App. Nov. 19, 2010), summary judgment affirmed (2008 WL 5267874) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.
  79. Burgos v. Satiety, Inc., 2010 WL 4907764 (E.D.N.Y. Nov. 30, 2010), summary judgment granted on all claims, including breach of warranty, in investigational gastric stapling system device case.  IDE devices are subject to FDA supervision that's identical to PMA for preemption purposes.  Blanket reference to violation of unspecified statutes and regulations cannot suffice to state a parallel violation claim.  Plaintiff can amend.  Motion to dismiss (2011 WL 1327684) and summary judgment (2013 WL 801729) later granted against all claims, see below.
  80. Warren v. Howmedica Osteonics Corp.2010 WL 5093097 (E.D. Mo. Dec. 8, 2010), motion for reconsideration denied, 2011 WL 1226975 (March 29, 2011), claims based solely on FDCA violations survive preemption in Trident total hip implant case.  The court follows Hofts with respect to pleading and allows violation claims without pleading causation.
  81. Pardo v. Medtronic Inc., 2010 WL 5300847 (E.D. La. Dec. 15, 2010), summary judgment granted on all claims in case involving brain stimulation device.  Terse order is unclear which claims are barred as preempted and which are barred for other reasons.  Off-label use does not defeat preemption.
  82. Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. Dec. 23, 2010), reversing Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008), manufacturing-related claims based solely on FDCA violations survive a motion to dismiss on the basis of preemption in Trident total hip implant case.  Violation claims related to FDA GMPs are sufficiently specific, at the pleading stage, to escape preemption.  The claims are not impliedly preempted because as pleaded there is no conflict with the federal regulations.   Before a plaintiff has discovery, it is not necessary to plead specifically what regulation was violated and how, as to do so may be impossible.
  83. Couvillier v. Allergan, Inc., 2011 WL 8879258, slip op. (Mag. W.D. La. Jan. 20, 2011), adopted 2011 WL 8879259 (W.D. La. Feb. 9, 2011), motion to dismiss granted against all claims involving breast implant.  No parallel claims mentioned.
  84. Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. Jan. 21, 2011), reversing Hughes v. Boston Scientific Corp., 669 F. Supp.2d 701 (S.D. Miss. Nov. 12, 2009).  All warning and design product liability claims were properly dismissed as preempted.  Violation claims that paralleled traditional state warning and negligence per se claims were not preempted under Riegel.  A formal FDA finding of violation is not required to avoid preemption.  Unexplained FDA silence is not equivalent to approval.  Because the plaintiff's violation claims paralleled existing state tort claims, there was no preemption under Buckman.
  85. Funk v. Stryker Corp., 631 F.3d 777 (5th Cir.  2011), affirming Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009), dismissal of all claims against hip implant as preempted is affirmed.  Dismissal of violation claims based upon res ipsa loquitur are implied preempted.  Plaintiff failed to plead any other violation claim with sufficient specificity.  It was proper to take judicial notice of FDA PMA documents.
  86. Cafferty v. Cayuga Medical Center, 2011 WL 541809 (N.D.N.Y. Feb. 8, 2011), motion to dismiss granted against all claims against intraocular lens.  Without any positive allegation of a violation of FDA regulations, a manufacturing defect claim is preempted.  Res ipsa loquitur cannot establish a regulatory violation.
  87. Cohen v. Guidant Corp., 2011 WL 637472slip op. (C.D. Cal. Feb. 15, 2011), motion to dismiss granted against all claims involving pacemaker.  Plaintiff pleaded only boilerplate FDA regulations as a parallel claim with no attempt to plead that they caused him injury.
  88. Timberlake v. Synthes Spine, Inc., 2011 WL 711075 (S.D. Tex. Feb. 18, 2011), summary judgment granted against all claims, including express warranty, involving artificial intervertebral spinal disc.  Plaintiff's fraud on the FDA claim was impliedly preempted by Buckman.  Plaintiff had no evidence to establish a causal violation claim.
  89. Nimtz v. Cepin, 2011 WL 831182 (S.D. Cal. March 3, 2011), motion to dismiss granted against all claims involving pacemaker. Plaintiff did not allege a parallel violation claim.
  90. Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. March 8, 2011), summary judgment affirmed against all claims against spinal pain pump system.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff is not entitled to any inference of defect due to the loss of a critical component because a defect was not the most probable cause of injury with other causes not ruled out.  Claims against sales representative dismissed under same rationale.  Affirming 641 F. Supp. 2d 1270 (M.D. Fla. July 22, 2009).
  91. Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303 (D.P.R. March 8, 2011), summary judgment granted against some claims against impulse generator.  Plaintiff's claim that he did not receive any of the FDA-approved warnings concerning the device is not preempted because it does not seek any changes in the approved warnings.  Manufacturing defect claims are preempted because a failure does not equal a violation and because plaintiff does not tie a subsequent recall to the device at issue.  Design defect claims are preempted.
  92. White v. Stryker Corp., 818 F. Supp.2d 1032 (W.D. Ky. March 25, 2011), motion to dismiss granted against all claims involving hip implant.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff neither pleaded a violation of a device-specific FDA requirement, nor that any violation pertained to the implanted device.
  93. Warren v. Stryker Corp., 2011 WL 1226975 (E.D. Mo. March 29, 2011), motion to dismiss denied in part against parallel violation claims involving hip implant.  Allowing plaintiffs to use discovery to determine which particular PMA specifications defendants may have violated.
  94. Knight v. St. Jude Medical, 2011 WL 1230815 (W.D. Mich. March 31, 2011), motion to dismiss granted against all claims involving internal cardiac defibrillator except allegations that manufacturer's representative was aware of the malfunctioning of the particular device and failed to warn the treating physicians.  Adopting 2011 WL 1230819 (Mag. W.D. Mich. Jan. 11, 2011).  Summary judgment granted against remaining claims, 2012 WL 5878804 (W.D. Mich. Nov. 21, 2012).
  95. Schwartz v. Mulhall, 2011 WL 10989741 (N.Y. Sup. April 12, 2011), summary judgment granted against all claims involving penile prosthesis.  Claims were indistinguishable from Riegel.  No parallel claim mentioned.
  96. Godfrey v. Advanced Neuromodulation Systems, Inc., 2011 WL 7768092 (W.D. La. April 4, 2011), summary judgment granted against all claims involving implantable pulse generator.  A manufacturing defect claim predicated on violation of FDA regulations would not have been preempted, but plaintiff alleged only deviations from the manufacturer's own standards, and the latter claim is preempted.  Design and express warranty claims are preempted.
  97. Burgos v. Satiety, Inc., 2011 WL 1327684 (E.D.N.Y. April 5, 2011), motion to dismiss granted against most claims involving IDE stomach stapling device.  Negligent manufacturing claim is dismissed as it does not allege a parallel violation claim.  Regulatory claim involving record-keeping fails because plaintiff claims injury from the device, not from faulty records.  Vague allegations of failure to comply with IDE survive motion to dismiss and will be the subject of "cabined" discovery.  Summary judgment (2013 WL 801729) later granted against remaining claims, see below.
  98. Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. April 18, 2011), motion to dismiss granted against all but two claims involving hip implant.  Manufacturing-based parallel claim survived preemption because an FDA warning letter specified the nature of the claimed violation.  Failure to warn and failure to report claims are preempted.  Information dating from after the plaintiff's surgery could have no plausible causal effect.  Claims concerning failure to identify and correct device problems are preempted.  Claims concerning failure to control a nonconforming product are preempted.  Claims alleging failure to develop practices and procedures are preempted.  Express warranty claims based upon statements beyond what the FDA required are not preempted.  Other express warranty claims are dismissed either as preempted or as inadequately pled.  Implied warranty claims escape preemption only to the extent they incorporate unpreempted manufacturing claims, but are barred by the statute of limitations.
  99. Kinetic Co. v. Medtronic, Inc., 2011 WL 1485601, slip op. (D. Minn. April 19, 2011), motion for judgment on the pleadings granted against all but one claim brought by third-party payer concerning recalled implantable cardiac defibrillator.  Express warranty and consumer fraud claims are preempted.  Allegations of misrepresentations to the FDA are preempted private attempts to enforce the FDCA.  Having not pleaded any warning-related claims that come close to surviving preemption, plaintiff is not entitled to discovery "to fish for claims of which it is not aware."  Claim based on alleged promise to pay for certain expenses has nothing to do with the FDA and is not preempted.
  100. Llado-Carreno v. Guidant Corp., 2011 WL 6223409 (S.D. Fla. May 16, 2011), motion to dismiss granted in case involving an implantable cardiac defibrillator.  A conclusory violation claim cannot defeat preemption.  Any violation claim must state specifically what regulation was violated.
  101. Walsh v. Abbott Vascular, 2011 WL 2038572 (E.D. Cal. May 23, 2011), summary judgment denied in case involving a perclose device.  Defendant failed to establish that the Class III device was in fact the one used in the plaintiff's surgery.
  102. Wilhite v. Howmedica Osteonics Corp., 833 F. Supp.2d 753 (N.D. Ohio June 20, 2011), summary judgment granted against all claims in case involving hip implant.  The complaint does not contain parallel violation requirements.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.
  103. DeLeon v. Johnson & Johnson, 2011 WL 2618957 (S.D. Tex. July 1, 2011), motion to dismiss granted against all claims in case involving an artificial spinal disc.  No parallel violation claim asserted.
  104. Purchase v. Advanced Bionics, LLC, ___ F. Supp.2d ___, 2011 WL 9688280, slip op. (W.D. Tenn. Aug. 4, 2011), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Claims based on:  (1) failure to submit PMA, (2) failure to identify a change in a report to the FDA, and (3) adulteration based on (1) and (2)  are preempted.  PMA approval and reporting requirements are administrative, not safety, requirements.  Failure to submit claims are disguised fraud on the FDA claims.  Claims of deviation from PMA supplement manufacturing/design requirements and failure to test a modified device are not preempted.  All other GMP claims are too vague and general to support a parallel neglilgence per se claims.
  105. Norton v. Independence Technology, LLC, 2011 WL 3584491 (E.D. Cal. Aug. 15, 2011), motion to dismiss granted against all claims in case involving a motorized, stair-climbing wheelchair.  No parallel violation claim asserted.
  106. Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011), motion to dismiss technically denied due to plaintiff's request to amend complaint.  All claims, including express and implied warranty, as pleaded are preempted.  A conclusory violation claim cannot defeat preemption.  Any violation claim must state specifically what regulation was violated, how the violation occurred, and how the violation was causal.  Rejecting Hofts.  A negligence per se claim that merely alleges an FDCA violation is an impliedly preempted private right of action.  A parallel claim cannot be based on the learned intermediary rule, since the rule's duties are not identical to FDA regulations, and are thus not "genuinely equivalent."  FDA-approved statements cannot serve as a basis for breach of express warranty or fraud.  An unjust enrichment claim contingent upon preempted claims is likewise preempted.
  107. Horn v. Boston Scientific Neuromodulation Corp., 2011 WL 3893812 (S.D. Ga. Aug. 26, 2011), summary judgment granted against all but one claim involving spinal cord stimulator.  Implied warranty is preempted.  Plaintiff's negligence per se claim is preempted because it only alleges non-specific violations of broad, generic quality system regulations.  An express warranty claim based on a promise of a five-year battery life, was not preempted.  That promise is not a preempted general promise of safety.
  108. Malbroux v. Jancuska, 2011 WL 3816104 (W.D. La. Aug. 29, 2011), motion to dismiss granted against all claims involving penile prosthesis.  Preemption under Riegel includes devices approved under product development protocols.  No FDCA violation claim alleged.
  109. Haynes v. Cyberonics, Inc., 2011 WL 3903238 (N.D. Ga. Sept. 6, 2011), summary judgment granted agains all claims, including an express warranty claim, involving vagal nerve stimulator.   Plaintiff did not have evidence of any violation of FDA regulations that could serve as the basis of a parallel claim.
  110. Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. Sept. 13, 2011), motion to dismiss granted against all claims involving hip implant.  No parallel violation claims asserted in the original complaint.  Leave to amend denied.  Amended violation claims were generic and did not specify what federal regulations were violated, or how.  Rejecting Hofts (plaintiff lifted his amended allegations verbatim from Hofts).  Plaintiff's amended express warranty claim, asserting generalized safety promises, was also preempted.
  111. Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011), motion to dismiss granted against all claims involving hip implant. Plaintiff failed to plead what FDA requirements were violated, or how.  General allegations about FDA "warnings" were insufficient.
  112. Hanna v. Kaiser Foundation Hospitals, 2011 WL 10621777 (Cal Super. Sept. 13, 2011), demurrer sustained against all claims involving unstated device.  No parallel claims asserted.  Leave to amend parallel claims permitted;
  113. Tierney v. AGA Medical Corp., 2011 WL 7400469, slip op. (D. Neb. Nov. 18, 2011), motion to dismiss granted against all claims involving septal occluder.  FDA documents concerning the device are subject to judicial notice.  Claims alleging an allergy to an FDA-approved ingredient are preempted.  Plaintiff will be permitted to amend to allege factually supported violation claims concerning design or manufacture.  Plaintiff is not entitled to discovery beyond publicly available documents.  Motion to amend denied, 2012 WL 395545 (D. Neb. Feb. 7, 2012), plaintiff belatedly pleaded an amended failure to report claim that has nothing to do with the facts of his injury. 
  114. Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443 (E.D. Pa. Nov. 29, 2011), motion for summary judgment granted against all claims involving an insulin delivery system, except express warranty.  The entire system underwent PMA or a PMA supplement.  Preemption relates to a device as a whole, not its component parts.  A recall of a related, but different product, does not affect preemption.  Plaintiff has no evidence of violations of FDA manufacturing, doctor's prescription, or warning requirements.  A plaintiff who had not yet been implanted with a device when it was recalled, and who received FDA-approved post-recall warnings, was not within the scope of the recall.
  115. Bush v. Thoratec Corp., 837 F. Supp.2d 603 (E.D. La. Nov. 29, 2011), motion to dismiss granted (with leave to amend) against all claims involving a ventricular assist system.  The limited savings clause in §360h(d) does not defeat express preemption under §360k.  An attempted parallel claim that the defendant's failure to report to the FDA resulted in a less strict voluntary recall is preempted under Buckman because it turns upon speculation about what the FDA might have done.  Claims alleging breach of disclosure duties owed to the FDA are preempted.  Almost all remaining claims dismissed, 2012 WL 2513669 (E.D. La. June 28, 2012), see below.
  116. Callaway v. American Medical Systems, Inc., 2011 WL 7724268 (Mag. W.D. La. Dec. 8, 2011), adopted, 2012 WL 1354573 (W.D. La. Jan. 24, 2012), motion to dismiss granted against all claims involving a penile prosthesis.  The complaint is utterly devoid of factual content suggesting an unpreempted claim.
  117. Erickson v. Boston Scientific Corp., 846 F. Supp.2d 1085 (C.D. Cal. Dec. 12, 2011), judgment on the pleadings granted against all claims involving several pacemakers.  PMA and product development protocol supplements are equivalent to PMA and are preemptive.  Parallel violation claims must allege specifically what was violated.  A product recall does not vitiate preemption. 
  118. Duggan v. Medtronic, Inc., 840 F. Supp.2d 466 (D. Mass. Jan. 10, 2012), summary judgment granted against all claims involving insulin delivery system.  The entire system underwent PMA or a PMA supplement.  Preemption relates to a device as a whole, not its component parts.  Preemption is governed by the scope of the FDA's approval letter, not reassessment of the PMA.
  119. Walker v. Medtronic, Inc.670 F.3d 569 (4th Cir. Jan. 25, 2012), affirming grant of summary judgment on all claims in spinal pain pump case.  The claimed violation did not involve any aspecct of the device that was mandatory.  The only mechanism for creating a binding performance requirement is through creation of an FDA performance standard.  Treating non-binding standards as if they were binding creates a different standard and is therefore preempted.   Affirming 2010 WL 4822135 (S.D.W. Va. Nov. 24, 2010).
  120. Gillman v. Boston Scientific Corp., 2012 WL 892239 (Mag. D. Or. Jan. 27, 2012), approved, 2012 WL 882788 (D. Or. March 13, 2012), motion to dismiss granted against most claims involving spinal cord stimulator.  No parallel violation claim is alleged.  Negligent misreprestentation that there were trained doctors available in the state to which plaintiff was moving did not involve an FDA-approved statement and escaped preemption.  However, there was no special relationship to support that claim.
  121. Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. Jan. 31, 2012), affirming in part and reversing in part grant of motion to dismiss on all claims in a knee replacement case.  PMA approval is a legal conclusion and should not be taken as true on a motion to dismiss.  Judicial notice of PMA status from publicly available FDA documents is proper.  The entire device system was PMA approved, not just some components.  Plaintiff successfully stated a parallel claim based on alleged FDCA manufacturing violations that paralleled state manufacturing defect claims.  Plaintiff alleged what FDA standards were violated, that the violation affected the device actually implanted, specifically alleged the violation, and alleged how the violation could have caused the particular injury that the plaintiff suffered.  The preliminary nature of an FDA warning letter did not matter for purposes of pleading.  A formal finding by the FDA is not a prerequisite.  The general nature of some FDA regulations becomes specific when the particular PMA is approved.  A claim can be based on a manufacturer's failed to satisfy a standard required by the FDA in its approval of the PMA for the device.  Plaintiff cannot make a claim based on a manufacturer's failure to do something different than what the FDA approved.  Since the FDA found a violation, there is little chance that litigation would produce a different reading of the standard than the FDA.  A FDA violation based negligence claim is not a purely FDCA-based claim violating Buckman where state law provides an equivalent manufacturing defect theory.  Even if negligence per se is not available, the violation could be evidence of simple negligence.  The manufacturing violation-based claim survives whether sounding in strict liability, negligence, or warranty.  All warning and "marketing" claims are preempted.  Express warranty claims are preempted.  Affirming and reversing 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010).
  122. Viserta v. St. Jude Medical, 2012 WL 667814 (D.S.C. Feb. 29, 2012), motion to dismiss granted against all claims involving cardiac defibrillator leads.  Plaintiff's attempt to plead a parallel manufacturing claim fails for lack of any specificity as to what standards were violated how.  Adverse event reports, are not linked to anything relevant to this plaintiff.
  123. Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. March 14, 2012), motion to dismiss granted against all claims involving artificial hip prosthesis.  A product recall is not an admission of regulatory violations.  Negligence and res ipsa claims are preempted.  Violations of FDA regulations are too vaguely pleaded.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Warranty claims based on FDA-approved labeling are preempted.  Non-device specific good manufacturing practices relied on by plaintiff are too vague to serve as a parallel claim.
  124. Cameron v. Boston Scientific Corp., 2012 WL 1592535 (N.D. Ohio April 12, 2012), summary judgment granted against all claims involving thermal ablation device. Plaintiffs have no evidence to support any parallel claim.  Adopted 2012 WL 1592532 (N.D. Ohio May 4, 2012).
  125. Cooley v. Medtronic, Inc., 2012 WL 1380265 (E.D. Ky. April 20, 2012), motion to dismiss granted against all claims involving implantable cardiac defibrillator, including express warranty, fraud, and emotional distress.  Plaintiff did not assert any parallel claims.
  126. Hinkel v. St. Jude Medical, Inc., 869 F. Supp.2d 739 (E.D. La. April 23, 2012), summary judgment granted against all claims involving an implantable spinal pulse generator, including express warranty under LPLA.  FDA standards are not the same as the LPLA.   
  127. Lowe v. Medtronic, Inc., 2012 WL 3656468, slip op. (C.D. Cal. May 9, 2012), motion to dismiss granted against all claims involving implantable difibrillator.  Failure to report claims are impliedly preempted by Buckman.  Parallel claims inadequately preempted due to failure to plead the violation or causation with specificity.  A warning letter and a recall do not establish a parallel claim. 
  128. Cline v. Advanced Neuromodulation Systems, 914 F. Supp.2d 1290 (N.D. Ga. June 15, 2012), motion to dismiss granted in part and denied in part in case involving implantable pulse generator.  An express warranty of battery life, beyond the FDA-approved labeling, was not preempted.  Vague allegations of violations of good manufacturing practices were inadequate to plead a parallel claim.  Motion to amend allowed, 2012 WL 7009687 (N.D. Ga. Nov. 7, 2012), see belowMost claims preempted, 2014 U.S. Dist. Lexis 56669 (N.D. Ga. March 31, 2014) see below.
  129. Reuter v. Medtronic, Inc., 2012 WL 3635955, slip op. (New Jersey Super. Law. Div. June 18, 2012), summary judgment granted against all claims involving a pacemaker.  No parallel claim alleged.  Motion to amend to add negligence claim based on presence of a technician denied, since the technician could not advise the physician on medical procedures.
  130. Bush v. Thoratec Corp., 2012 WL 2513669 (E.D. La. June 28, 2012), motion to dismiss granted against all claims involving a heart pump except post-sale duty to warn-based claim predicated on non-compliance with FDA regulation regarding contents of recall letter.  Vague regulations can support violation claims at the pleading stage.  A prior FDA finding of violation is not required. Whether the claimed violation is genuinely parallel can only be decided on summary judgment.
  131. Phillips v. Medtronic, Inc., 2012 WL 3641487slip op. (Mass. Super. July 10, 2012), motion to dismiss granted against all claims involving a spinal pain pump.  Alleged FDA regulatory violations could not be causal because they did not involve risk of the injuries plaintiff alleged.  While negligent pharmacovigilence claims paralleling federal regulations are not expressly preempted, they are impliedly preempted under Buckman.
  132. Steiden v. Genzyme Biosurgery, 2012 WL 2923225 (W.D. Ky. July 17, 2012), motion to dismiss granted against all product liability claims involving Synvisc-One but denies as to parallel claim, allegations of adulteration, supported by immediate injury were sufficiently specific to state an unpreempted claim.  Plaintiff did not have to state specifically how FDA regulations were violated.
  133. Weston v. Kim's Dollar Store, 399 S.C. 303, 731 S.E.2d 864 (S.C. Aug. 8, 2012), grant of partial summary judgment affirmed in litigation concerning colored contact lenses.  Express preemption provisions should be construed broadly.  Colored contact lenses are PMA medical devices.   All claims based on warning, labeling, design, marketing, or misbranding were properly dismissed as preempted.  Defendant conceded that a negligent manufacturing claim may survive preemption as a parallel claim.  Affirming as modified 684 S.E.2d 769 (S.C. App. July 15, 2009).
  134. Cornett v. Johnson & Johnson, 211 N.J. 362, 48 A.3d 1041 (N.J. Aug. 9, 2012), grant of motion to dismiss affirmed against most, but not all, claims involving a drug eluting stent.  Failure to warn claims are preempted.  Fraud on the FDA claims concerning the approval process are preempted, as are claims that require proof of fraud on the agency.  Off-label use did not go through the FDA's regulatory process, therefore failure to warn claims not involving agency fraud that pertain to off-label uses are not preempted.  Warning claims based on legal (safe harbor) off-label promotion are preempted.  Express warranty claims survive preemption to the extent based on statements not subject to FDA approval.  All other express warranty claims are preempted.  Affirming as modified, 998 A.2d 543 (N.J. Super. A.D. July 23, 2010).
  135. Mayen v. Tigges, 2012 WL 3553378 (N.Y. Sup. Aug. 17, 2012) (in table at 36 Misc.3d 1231(A), 959 N.Y.S.2d 90), motion to dismiss granted against all claims involving knee implant, including express and implied warranty.  Request for discovery denied.
  136. Ali v. Allergan United States, 2012 WL 3692396 (E.D. Va. Aug. 23, 2012), motion to dismiss granted against all claims involving stomach band, including express and implied warranty.  Plaintiff must allege what federal regulations were violated, and how the violation caused injury.  Plaintiff must allege Initial failure of PMA did not establish anything.  Recall was non-causal unless the device in question was recalled due to the risk at issue.  Disagrees with Hofts.  Request for discovery denied.  Currently on apeal.
  137. Hawkins v. Medtronic, Inc., 909 F. Supp.2d 901 (S.D. Ohio Sept. 24, 2012), motion to dismiss granted in part and denied in part in case involving implantable pulse generator.  Vague allegations of FDCA violations in design, warning, manufacturing, and implied warranty cannot be held entirely preempted on motion to dismiss.  Ignoring TwIqbal pleading standards in favor or earlier "precise contours" language in Lohr.  Negligent handling claims have no FDCA equivalent and are dismissed as preempted.  Express warranty not preempted because it does not require finding that any FDA-approved statements are untrue.  Fraud claims would require finding FDA-approved statements are untrue and are preempted.  Failure to report claims are preempted by Buckman. Interlocutory certification denied, 2012 WL 6059361 (S.D. Ohio Dec. 6, 2012),
  138. McClelland v. Medtronic, Inc., 2012 WL 5077401, slip op. (M.D. Fla. Sept. 27, 2012), motion to dismiss granted against all claims involving an implanted pacemaker.  Documents in the FDA public record are judicially noticeable.  Under Florida law, the violation of a statute can only give rise to civil liability if the statute indicates an intention to create a private cause of action.  The FDCA explicitly bars private rights of action.  All non-parallel violation claims are preempted under Riegel.  There is no FDCA requirement that a manufacturer contact doctors or patients directly, without FDA involvement, concerning alleged device defects.  There is no parallel in Florida common law to an FDCA violation claim, so parallel violation claims do not state a claim under state law.  Claims based onf FDCA disclosure requirements are impliedly preempted.  Renewed motion granted (see below).
  139. Killen v. Stryker Spine2012 WL 4482371 (Mag. E.D. Pa. Sept. 28, 2012), motion to dismiss granted in part and denied in part in case involving an investigational cervical intervertebral device.  Preemption under Riegel applies to IDE devices.  Plaintiff pleaded parallel violation claims as well as could be expected without discovery.  The express warranty claim is preempted as pleaded but may be amended to specify any non-FDA-approved statement upon which the claim is based.  Fraud claims are preempted to the extent they involve FDA-approved statements, but not as to follow-up medical care.  Adopted 2012 WL 4498865 (W.D. Pa. Sept. 28, 2012).
  140. Tillman v. Smith & Nephew, Inc., 2012 WL 6681698 (N.D. Ill. Nov. 1, 2012).  Taking judicial notice of FDA PMA for defendant's hip resurfacing system.  Plaintiff did not plead any parallel claims, only preempted claims concerning "defects."  Plaintiff must replead facts establishing a parallel claim or suffer dismissal.
  141. Cline v. Advanced Neuromodulation Systems, 921 F. Supp.2d 1374, 2012 WL 7009687 (N.D. Ga. Nov. 7, 2012), motion to amend complaint to add parallel claim granted in case involving spial cord stimulator.  Warning letter provided specific regulatory violations and causation was adequately pled.  Unidentified regulations or vague GMPS would not have been sufficient.  The claim is not impliedly preempted because it parallels a manufacturing defect claim.  Most claims preempted, 2014 U.S. Dist. Lexis 56669 (N.D. Ga. March 31, 2014) see below.
  142. Raborn v. Albea, 2012 WL 6600475 (La. Dist. Dec. 7, 2012), exception of no cause of action (motion to dismiss?) granted against all claims involving bone growth stimulator.  Claims involving alleged off-label use are preempted as imposing different requirements than the FDA.  Claims involving off-label promotion are also preempted as private enforcement under Buckman.
  143. Littlebear v. Advanced Bionics, 896 F. Supp.2d 1085 (N.D. Okla. Dec. 19, 2012), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Claims that defendant did not meet a specific moisture level are preempted because the PMA did not impose such a requirement.  A GMP regulation to evaluate suppliers is too vague to suppport a parallel claim.  Fraud and consumer protection claims are preempted; there is no FDA regulation requiring disclosure.  Failure to obtain supplemental PMA claims are impliedly preempted under Buckman.  This is not a safety requirement and there is no private right to enforce the FDCA.  Claims alleging deviation from PMA requirements are not preempted.  Negligence per se claims are attempts to enforce the FDCA and are preempted.
  144. Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Jan. 10, 2013) (en banc),  motion to dismiss affirmed in part and reversed in part in case involving PMA pain pump.  All claims not involving "parallel" violations of the FDCA were properly held preempted.  Presumption against preemption applies.  A claim for failure to warn a third party (the FDA) about reportable adverse events is an unpreempted parallel claim under Riegel. Since the claim does not involve the FDA's pre-market approval process it is preempted under BuckmanReversing 2010 WL 4483970 (N.D. Ariz. Nov. 9, 2010).
  145. Sons v. Medtronic Inc., 915 F. Supp.2d 776 (W.D. La. Jan. 14, 2013),  motion to dismiss granted against all claims in case involving pacemaker.   Claims for design defect, manufacturing defect, failure to warn, negligence, and strict liability are preempted.  No parallel claim alleged.  Even if a claim for failure to train isn't preempted, it does not state a claim because the manufacturer is not responsible for the practice of medicine.
  146. Desai v. Sorin CRM USA, Inc., 2013 WL 163298 (D.N.J. Jan. 15, 2013), motion to dismiss granted against all claims in case involving cardiac defibrillator.  Judicial notice may be taken of the FDA website's list of PMA approvals.  Claims for negligence, defective design, and failure to warn are preempted.  Allegations of deviations from FDA standards for design and manufacture are conclusory.  A failure does not establish an FDCA violation.  Discovery may not be based on vague allegations.
  147. Kallal v. Ciba Vision Corp., 2013 WL 328985 (N.D. Ill. Jan. 28, 2013), summary judgment granted in case involving contact lenses.  Lenses were not subject to recall.  Fact of adverse reaction does not establish a defect or an FDCA violation.  Plaintiff failed to establish a violation of an FDA requirement, as opposed to an internal corporate specification.
  148. Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206 (W.D. Okla. Feb. 6, 2013), motion to dismiss granted against all claims in case involving bone growth stimulator.  Off-label use does not limit express preemption under Riegel.  Alleged illegal promotion does not make all the plaintiff's claims "parallel."  Fraudulent inducement, misrepresentation, constructive fraud, and negligence claims are expressly preempted to the extent they seek changes to device labeling, marketing, design, or manufacturing.  These claims are impliedly preempted under Buckman to the extent they depend on alleged off-label promotion.  Off-label use and promotion are inherently FDCA-based concepts, thus tort claims based thereon are in substance claims violating the FDCA, which the statute forbids.  Allegations of false statements to physicians, whether or not involving off-label promotion, are inadequately pleaded.  Failure to warn, design defect, and negligence claims are preempted.  Warranty claims involving journal articles and opinion leaders allege that the product was not safe or effective, and are preempted.  Discovery is unnecessary.  On appeal to 10th Circuit.
  149. Gale v. Smith & Nephew, 989 F. Supp.2d 243 (S.D.N.Y. Feb. 13, 2013), motion to dismiss granted in part and denied in part in case involving hip resurfacing system.  Design, warning and manufacturing defect claims preempted.  Express and implied warranty claims preempted.  Fraud on the FDA claims brought as a consumer fraud claim are probably preempted, but are not pleaded sufficiently to state a claim.  Post sale duty to warn claim preempted.  Negligent coduct of recall claim not preempted.  Failure to comply with PMA reporting requirements not preempted.  Ruling on amended complaint, see below.
  150. Lamere v. St. Jude Medical, Inc., 827 N.W.2d 782 (Minn. App. Feb 19, 2013), summary judgment affirmed in case involving mechanical heart valve.  Allegedly violated GMPs were too vague to support a parallel manufacturing defect claim.  Plaintiff did not indicate how alleged violations were causal.  A manufacturing defect claim unrelated to any alleged FDCA violation was preempted.  Affirming, 2012 WL 3635953, slip op. (Minn. Dist. Jan. 18, 2012) and 2011 WL 10550518 (Minn. Dist. Feb. 7, 2011).
  151. Anderson v. Boston Scientific Corp., 2013 WL 632379 (S.D. Ohio Feb. 20, 2013), motion to dismiss granted in case involving spinal cord stimulator.  All claims are based on state law defects, not any violation of the FDCA.  Negligence claim concerning actios of sales representative fails to plausibly allege causation.
  152. Gray v. Stryker Corp., 2013 WL 633120 (S.D. Ind. Feb. 20, 2013), motion to dismiss denied in case involving hip implant.  Judicial notice may be taken of the FDA approvals on the agency's website.  Manufacturing defect claims are only preempted if the defendant complied with FDA requirements.  Plaintiff is suing about the same recalled device as in Bausch and has adequately pleaded violation claims of a similar nature.  Pleading the specific regulations violated is not required.
  153. Burgos v. Satiety, Inc., 2013 WL 801729 (E.D.N.Y. March 5, 2013), motion for summary judgment granted against remaining manufacturing defect claim in case involving investigational stomach stapling system. Plaintiff lacked any evidence of how the device violated FDA regulations.  In the absence of any evidence of a violation, plaintiff could not create a question of fact from a spoliation inference, even if such an inference were proper.  A settlement offer is not evidence of a violation.  A product-related injury does not support an inference of a violation.
  154. Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670 (W.D. Ky. March 8, 2013), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Failure to obtain PMA supplement did not render either the device or the component unapproved.  Negligence per se failed on state law grounds.  Fraud, fraudulent omission, and misrepresentation either sought preempted label changes or involved the FDA and were preempeted under Buckman. A design claim based on deviation from the relevant supplemental PMA survived preemption, but other design claims were preempted.  Failure to obtain supplemental PMA claims are impliedly preempted under Buckman.  A GMP regulation requiring testing under actual or simulated use conditions was sufficiently specific to survive preemption as a parallel claim; all other GMPs were too vague.  Claims that defendant should have conducted life cycle testing are preempted because the PMA did not impose such a requirement.  Other Negligence claims follow the strict liability analysis.
  155. Smith v. St. Jude Medical Cardiac Rhythm Management Division, 2013 WL 1104427 (D. Md. March 13, 2013), motion to dismiss granted in case involving pacemaker.  All claims, including express and implied warranties, were preempted or inadequately pleaded.  Parallel claims were inadequately pleaded and unlike Bausch did not allege any action taken by the FDA.
  156. Smith v. Depuy Orthopaedics, Inc., 2013 WL 1108555, slip op. (D.N.J. March 18, 2013), summary judgment granted against all claims in case involving PMA knee implant.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Parallel violation claim not pleaded with requisite particularity.  Preemption requires specific requirements and cannot be defeated with vague allegations of FDCA violations.  Express warranty preempted because it involves FDA-approved statements.  Fraud is subsumed by state product liability statute.  Affirmed 2014 U.S. App. Lexis 718 (see below).
  157. Lasalle v. Pappas, 2013 WL 1130726 (E.D. La. March 18, 2013), motion to dismiss granted in case involving unidentified device.  All of plaintiff's claims are not only preempted, but also fail under TwIqbal.  Plaintiff is not entitled to discovery to look for possible "parallel" claims.
  158. Kubicki v. Medtronic, Inc., 2013 WL 1739580 (D.D.C. March 21, 2013), motion to dismiss granted in part and denied in part in case involving insulin pain pump.  Fraud, consumer fraud, and misrepresentation claims are insufficiently pleaded.  Mixed in with preempted claims are various allegations of FDCA violations.  Because these claims may reasonably be understood to assert violations, they survive preemption.  Nothing more is required at the pleading stage.  Express warranty claims may also survive preemption to the extent they are based on advertising or some other non-FDA-approved communication.
  159. Simmons v. Boston Scientific Corp., 2013 WL 1207421, slip op. (C.D. Cal. Mar. 25, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator.  All non-parallel claims preempted.  Parallel claims were inadequately pleaded.  Plaintiff pleaded no facts supporting a Stengel failure to warn the FDA claim.  No deviations from FDA-approved design were pleaded.  GMPs were too generic to support manufacturing-related violation claims.  A product recall does not establish a violation.  Since this was plaintiff's third amendment, no further leave to amend was appropriate.  Defendant was awarded costs.
  160. Stokes v. I-Flow Corp., 2013 WL 1715427 (M.D. Fla. April 8, 2013), motion to dismiss granted against all claims in case involving pain pump.  A claim that a defendant failed to comply with the FDA's rejection of a marketing use is an attempted private FDCA cause of action under Buckman.  Design and warning claims differ from FDA requirements and are preempted.  Plaintiff's negligence claim does not parallel any FDA regulation.  Reporting obligations are owed to the FDA, not to the medical community.
  161. Messner v. Medtronic, Inc., 2013 WL 1655218 (N.Y. Sup. April 9, 2013) (in table at 39 Misc.3d 1213(A), 975 N.Y.S.2d 367), motion to dismiss granted in part and denied in part in case involving porcine heart valve.  Claims based on defective design, negligence, implied warranty improper labeling preempted.  Parallel claims based on improper manufacturing, including related warning and express warranty claims, not preempted.
  162. Elmore v. Smith & Nephew Inc., 2013 WL 1707956 (N.D. Ill. April 19, 2013), motion to dismiss denied in case involving hip implant.  Only parallel claims were pleaded.  Defect claims based on failure to follow GMPs are parallel.  Common-law claims based on FDA violations are not preempted so long as the same conduct would result in independent liability.  Reconsideration denied, 2013 U.S. Dist. Lexis 101085 (N.D. Ill. July 1, 2013)
  163. Knoppel v. St. Jude Medical, Inc., 2013 WL 3803612 (C.D. Cal. May 7, 2013), motion to dismiss granted against all claims, predominantly design claims, in case involving cardiac defibrillator.  All claims that require a different design or manufacturing process than what the FDA approved are preempted.  No parallel claims alleged.
  164. Kaiser v. Depuy Spine, Inc., 944 F. Supp.2d 1187 (M.D. Fla. May 14, 2013), motion to dismiss granted against all claims in case involving artificial spinal disc.  Allegations that the defendant failed to design, test, manufacture, market, sell, promote, label, and/or distribute the device in accordance with FDA requirements failed under TwIqbal.  Plaintiff failed to allege that the defendant violated any applicable FDA performance standard; the violation plaintiff claimed was not an FDA performance standard.  State law does not allow pursuit of parallel claims based on FDA violations.
  165. McClelland v. Medtronic, Inc., 944 F. Supp.2d 1193 (M.D. Fla. May 16, 2013), motion to dismiss granted against the only remaining claim in case involving an implanted pacemaker. Failure to report adverse event claims are preempted. To the extent the alleged duty is owed to the device user, it is expressly preempted. There is no FDCA duty to inform patients of adverse events. To the extent the alleged duty is owed to the FDA, it is preempted as private FDCA enforcement. Prior decision discussed above.
  166. Pinsonneault v. St. Jude Medical, Inc., 953 F. Supp.2d 1006 (D. Minn. June 18, 2013), motion to amend denied in large part in case involving pacemaker leads.  Failure to report adverse event claims are preempted.  A state law post-sale duty to warn product users is not the same as a duty to report adverse events to the FDA.  FDA adverse event reports are not necessarily public and available to users.  No state recognizes a tort cause of action for failure to report to a federal agency.  Because there is no recognized state-law parallel, the reporting claims are also preempted under Buckman as improper private FDCA causes of action.  An express warranty of "safety" is preempted because no non-FDA-approved labeling statements are specified.  Certain factual amendments may not be futile because their causal relevance to the plaintiffs' injuries cannot be determined on the pleadings.
  167. Lederman v. Howmedica Osteonics Corp., 950 F. Supp.2d 1246 (M.D. Fla. June 19, 2013), motion to dismiss granted against against all claims in case involving hip implant.  Manufacturing defect claims are preempted unless alleged as parallel claims.  Plaintiff's parallel claim pleading is insufficient.  He fails to explain how FDA warning letters relate to his device, manufactured three years before the letter.  Plaintiff must specify how the device violated a particular FDA regulation.  Plaintiff has leave to amend.
  168. Wendt v. Bernstein, 2013 WL 3199361 (Ill. Cir. June 24, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator. Allegations concerning off-label promotion and use are not parallel to any FDA regulation, but rather are improper private attempts to enforce the FDCA.  Plaintiff given leave to amend.
  169. Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592 (D. Vt. June 25, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  All non-FDA-related claims are preempted.  Allegations that fail to identify the alleged regulatory violations cannot defeat preemption.  Allegations solely concerning off-label promotion and use are not parallel claims because there is no FDA regulation barring such activity.
  170. McBride v. Medtronic, Inc., 2013 WL 3491085 (W.D. La. July 10, 2013), motion to dismiss granted against against all claims in case involving an infusion pump.  Taking judicial notice of FDA PMA.  A manufacturing defect claim asserting deviation from the manufacturer's specifications is not a parallel claim and is preempted.  Under the exclusive state statute, claims for negligence per se are subsumed.  Therefore, there is no state-law basis for asserting parallel claims.  All failure to warn claims are preempted.
  171. Gavin v. Medtronic, Inc., 2013 WL 3791612, slip op. (E.D. La. July 19, 2013),  motion to dismiss granted in part and denied in part in case involving an infusion pump.  Preemption applies to off-label uses.  Preemption depends on FDA approval, not how the device was ultimately used.  PMA preemption applies to off-label use of a component of a product system separately from the rest of the system.  The component remains PMA approved.  Claims that defendant should have warned about off-label uses vary from FDA approved warnings and are preempted.  A claim based on failure to report adverse events survives express preemption.  Various causes of action dismissed under exclusive state statute.  Express warranty claims attacking FDA-approved labeling are preempted, and nothing else is pleaded.  Implied warranty claims are preempted.  State law does not recognize claims based on violations of federal regulations.  Off-label use and promotion are purely FDA-related concepts, so claims based on such allegations are impliedly preempted under Buckman.
  172. Eggerling v. Advanced Bionics, L.L.C., 958 F. Supp.2d 1029 (N.D. Iowa July 24, 2013), summary judgment granted in part and denied in part in case involving cochlear ear device.  Preemption is not an appropriate subject for collateral estoppel.  Failure to obtain PMA supplement did not render either the device or the component unapproved.  Parallel claims based on broad administrative GMPs are preempted.  Design and manufacturing claims based on deviation from the relevant supplemental PMA is not preempted.  A GMP regulation requiring testing under actual or simulated use conditions was sufficiently specific to survive preemption as a parallel claim.  Claims that defendant should have conducted life cycle testing are preempted because the PMA did not impose such a requirement.
  173. Houston v. Medtronic, Inc., 957 F. Supp.2d 1166 (C.D. Cal. July 30, 2013), motion to dismiss granted against against all claims in case involving an infusion pump.  Taking judicial notice of FDA PMA.  PMA preemption applies to off-label use of a component of a product system separately from the rest of the system. The component remains PMA approved.   Off-label use occurs "with respect to" a device, so claims concerning such use are within the scope of express preemption.  Claims concerning warnings, including post-sale warnings, about off-label use are preempted as in addition to the warnings the FDA requires.  What the FDA merely permits, state law cannot make mandatory.  Design defect claims are preempted.  Off-label use claims exist solely because of the FDA's labeling requirements, and are therefore impliedly preempted as attempts to enforce the FDCA.  All other parallel claims do not state what was violated, and are inadequately pleaded.  Allegations of false off-label promotion would state an unpreempted parallel claim, however the claims are not pleaded with particularity under Rule 9(b).  An express waranty claim alleging false statements not constituting labeling would not be preempted, but is inadequately pleaded.  Renewed motion to dismiss granted in part and denied in part - see below.
  174. Harris v. Medtronic, Inc., 2013 WL 4011624 (Cal. Super. Aug. 1, 2013), demurrer with leave to amend granted against all claims in case involving a bone growth stimulator.  The fraud claim must be repleaded to avoid fraud on the FDA and product labeling.  Warning claims cannot be based on FDA-approved labeling.  Design defect claims cannot be based on off-label use.  PMA covers devices, not uses.
  175. Lawrence v. Medtronic, Inc., 2013 WL 4008821 (Minn. Dist. Aug. 7, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  Claims requiring labeling about off-label use are expressly preempted.  Claims, including consumer fraud, are impliedly preempted under Buckman to the extent they depend on alleged illegal off-label promotion.  The label is an FDA concept.  All non-off-label claims would require changes to FDA-approved aspects and are expressly preempted.  Fraudulent off-label promotion claims are not preempted, but are not pleaded with particularity.
  176. Dawson v. Medtronic, Inc., 2013 WL 4048850 (D.S.C. Aug. 8, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  There is no state claim for off-label promotion.  Off-label promotion is not necessarily illegal; the only statutory prohibition has ceased to be effective.  Claims are impliedly preempted under Buckman to the extent they depend on alleged illegal off-label promotion.  Failure to warn, design defect, negligence, strict liability, warranty, fraud, negligence per se, and misrepresentation claims that would require changes to FDA-approved warnings or labelsare expressly preempted.  Violation claims cannot be based on information provided to the FDA.
  177. Scianneaux v. St. Jude Medical, S.C., 961 F. Supp.2d 808 (E.D. La. Aug. 19, 2013), motion to dismiss granted against against all claims in case involving an implantable cardiac defibrillator.  Taking judicial notice of documents on FDA website.  Plaintiff failed to plead an unpreempted violation claim.  A recall does not defeat preemption.
  178. Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. Aug. 21, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator.  Taking judicial notice of device labeling.  While off-label use claims can be expressly preempted, off-label promotion claims are not.  The FDA does not review off-label promotion; it is essentially unregulated.  Applying presumption against preemption.  Claims based on the fact of off-label promotion would be impliedly preempted.  Parallel claim analysis is not necessary for claims involving off-label promotion.  Negligence per se claims are preempted under Buckman.  Tort claims not concerning off-label promotion are preempted under Riegel, except for failure to report adverse events, which are not preempted.
  179. McDonald-Lerner v. Neurocare Associates, P.A., 2013 WL 7394926 (Md. Dist. Aug. 29, 2013), motion to dismiss denied in case involving a bone growth stimulator.  The FDA does not review off-label uses or statements, therefore there is no preemption of claims alleging off-label promotion.  All claims are parallel.  Truthful off-label promotion should be illegal.  Overruled by McCormick, see below.
  180. Alton v. Medtronic, Inc., 970 F. Supp.2d 1069 (D. Or. Sept. 6, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator.  Judicial notice taken of adjudicative facts in documents, including FDA documents.  Off-label promotion does not necessarily violate the FDCA, but is only evidence; disagreeing with Ramirez.  Off-label promotion does not eliminate preemption.  Fraud, negligence, and strict liability claims based on introduction of a misbranded device by virtue of off-label promotion survive both express and implied preemption.  Other warning claims that would impose additional labeling obligations are preempted.  Design defect claims are preempted.  Express warranty claims are preempted to the extent based on FDA-approved statements, but not where based on off-label statements.
  181. Gale v. Smith & Nephew, Inc., 2013 U.S. Dist. Lexis 188812 (S.D.N.Y. Sept. 13, 2013), motion to dismiss amended complaint granted in part and denied in part in action involving hip prosthesis.  Manufacturing defect claim based on vague FDA GMPs preempted.  Claims that device was labeled for the wrong size parallel FDA regulations and survive.  Failure to warn physicians about adverse events is preempted, since the FDCA does not require such warnings.  Allegations of failure to report adverse events are not preempted.  See above for prior ruling.
  182. Suckow v. Medtronic, Inc., 971 F. Supp.2d 1042 (D. Nev. Sept. 20, 2013), motion to dismiss granted against against all claims in case involving implantable cardiac defibrillator.  Plaintiff failed to plead a parallel violation claim.  Supplemental PMA is preemptive.  Strict liability and express warranty claims are preempted. 
  183. McPhee v DePuy Orthopedics, Inc., 2013 WL 5462762, slip op. (W.D. Pa. Sept. 30, 2013), motion to dismiss granted against against all claims in case involving knee implant.  Plaintiffs fail to plead a parallel claim alleging manufacturing violations.  Plaintiffs fail to plead how regulations were violated.  The cited GMP regulations are too general to form the basis of a violation claim.  Implied warranty claims are preempted.  Express warranty claims are not preempted, but are insufficiently pleaded.
  184. Eidson v. Medtronic, Inc., 981 F. Supp.2d 868 (N.D. Cal. Oct. 3, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator. Judicial notice taken of documents on FDA website.  All claims challenging labeling are preempted.  Use of fewer than all components of device system did not defeat preemption.  Fraud and negligence claims based on alleged untruthful off-label promotion survive both express and implied preemption.  Warnng claim based on failure to report adverse events is not preempted, but claim is dismissed with leave to amend for failure to plead causation.  Neglligence claim alleging illegal off-label promotion is impliedly preempted as an FDCA violation claim.  See below for decision on amended claims
  185. Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. App. Oct. 11, 2013), affirming denial of summary judgment in case involving implantable cardiac defibrillator.  Plaintiff's sole remaining claim, concerning statements made by a company technician during surgery were not preempted because it did not involve FDA-approved statements on labeling.
  186. Bradley v. Baxter Healthcare Corp., 2013 WL 5952060 (Mag. W.D.N.C. Oct. 18, 2013), adopted without separate opinion, 2013 WL 5952060 (W.D.N.C. Nov. 6, 2013) motion to dismiss granted against against all claims in case involving gelfoam.  All claims seek to change or add to federal requirements.  A general allegation of violating "good manufacturing practices" was insufficient to state a parallel claim.
  187. Chao v. Smith & Nephew, Inc., 2013 WL 6157587, slip op. (S.D. Cal. Oct. 22, 2013), summary judgment granted in part and denied in part in case brought by physician involving total hip replacement.  Design defect claim preempted.  Claim of violation of FDA training requirements for physicians is a parallel claim and not preempted, but a violation may not have occurred.
  188. Brown v. DePuy Orthopaedics, Inc., 978 F. Supp.2d 1266 (M.D. Fla. Oct. 24, 2013), motion to dismiss granted against all claims in case involving knee implant.  Warning and design claims are preempted.  A parallel claim based on an FDA warning letter fails because for lack of causal nexis, given an unexplained two-year gap between the time of the FDA inspection and the manufacture of plaintiff's device.   The parellel claim is also impliedly preempted, as it amounts to an attempted FDCA private right of action.  There is no analogous state law action because Florida law does not permit actions to enforce FDA requirements.
  189. Cook v. Coe, 2013 WL 6154562, slip op. (Cal. Super. Nov. 18, 2013), demurrer (motion to dismiss) granted against all claims in case involving a bone growth stimulator.  Preemption is not defeated by a presumption.  Any claims that would change the FDA-approved warnings are preempted.  Claims alleging promotion of off-label uses and failure to seek a supplemental PMA are preempted as attempts to enforce the FDCA.  Misrepresentation about off-label use would not be preempted, but are inadequately pleaded.
  190. Kashani-Matts v. Medtronic, Inc., 2013 WL 6172234, slip op. (C.D. Cal. Nov. 22, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator.  All warning claims preempted.  Design defect claims preempted.  Fraud claims based on FDA-approved warnings are preempted.  Fraudulent misrepresentations in the context of off-label promotion would not be preempted, but are inadequately pleaded.  Amended complaint dismissed see below.
  191. Simon v. Smith & Nephew, Inc., 2013 WL 6244525, slip op. (S.D.N.Y. Dec. 3, 2013), motion to dismiss granted against all claims in case involving a hip replacement system.  Taking judicial notice of FDA website documents.  Claims based on a physician's mixing components of different PMA-approved systems are preempted.  A voluntary recall does not establish a parallel violation claim.  A different product is not an alternative design.  Preemption extends to all components of a PMA system.  Implied warranty claims preempted for similar reasons.  Reconsideration  denied, 2014 WL 1257780 (March 26, 2014).
  192. Frederick v. Smith & Nephew, Inc., 2013 WL 6275644 (N.D. Ohio Dec. 4, 2013), motion to dismiss denied in case involving a hip replacement system.  The complaint does not clearly establish the PMA status of all the components allegedly used, so preemption cannot be determined at this time.
  193. Comella v. Smith & Nephew Inc., 2013 WL 6504427, slip op. (N.D. Ill. Dec. 11, 2013), motion to dismiss granted in part and denied in part in case involving a hip replacement system.  Claims that the defendant failed to advise the FDA after approval about product dangers is an unpreempted parallel claim.  Claims that the defendant failed to warn the public are preempted.  Failure to report adverse event claims are not agency fraud claims preempted under Buckman.  The claims are sufficiently pleaded under Bausch.
  194. Ledet v. Medtronic, Inc., 2013 WL 6858858, slip op. (S.D. Miss. Dec. 30, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator.  Off-label use does not affect PMA preemption because the analysis does not depend on use of the device.  Fraud claims based on labeling are expressly preempted.  Fraud and negligence claims based on off-label promotion are impliedly preempted as attempts to enforce the FDCA.  Warning, design, warranty, and negligent misrepresentation claims are expressly preempted.
  195. McDonald v. Lester E. Cox Medical Centers, 2014 WL 58773slip op. (Mo. Cir. Jan. 2, 2014), summary judgment granted against all claims in case involving a implantable cardiac defibrillator.  All claims are preempted.  Plaintiff failed to establish any facts providing a basis of liability on the conduct of the defendant's sales representative.  There is no proof of any representations that would qualify as express warranties.
  196. Wells v. Allergan, Inc., 2014 WL 117773, slip op. (D.S.C. Jan. 13, 2014), motion to dismiss granted against all claims in case involving injectable gel dermal fillers.  During PMA, the FDA evaluates everything about the device, from labeling to safety, preempting all claims except "parallel" violations.  Plaintiff failed to plead defect, violation, or causation as to any violation claim.  Plaintiff is not entitled to discovery.
  197. Smith v. Depuy Orthopaedics, Inc., 552 F. Appx. 192 (3d Cir. Jan. 14, 2014), summary judgment affirmed against all claims in case involving PMA knee implant.  PMA supplements are equally preemptive.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Plaintiff does not need discovery to know that all the components were incorporated into a PMA.  Affirming 2013 WL 1108555.
  198. Poll v. Stryker Sustainability Solutions, Inc., 2014 WL 199150 (D. Ariz. Jan. 17, 2014), motion to dismiss granted in part and denied in part in case involving hip imiplant.  Judicial notice taken of documents on FDA website.  Failure to submit adverse event reports can be the basis of a warning claim surviving preemption, however the claim is inadequately pleaded.  Strict liability and warranty claims based on FDA-approved labeling are preempted.
  199. [adverse case we know about but has not appeared on Lexis or WL, so why tell the other side?]
  200. Coleman v. Medtronic, Inc., 223 Cal. App.4th 413, 167 Cal. Rptr.3d 300 (Cal. App. Jan. 27, 2014), review accepted by the California Supreme Court - opinion vacated and uncitable.
  201. Bohnenstiehl v. Wright Medical Group, Inc., 2014 WL 319652 (E.D. Mo. Jan. 29, 2014),  motion to dismiss granted in case involving femoral implant against express and implied warranty claims.  Preemption not mentioned with respect to other claims.
  202. Hawkins v. Medtronic, Inc., 2014 WL 346622, slip  op. (E.D. Cal. Jan. 30, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Off-label use does not trump PMA preemption.  All PMA components are protected by preemption.  Off-label promotion does not trump PMA preemption.  Defective warning claims preempted.  A new "intended use" would require changes to PMA labeling.  Off-label promotion can be the basis of a parallel claim.  Failure to report claims are insufficiently pleaded.  Claims affecting the PMA label are preempted.  Fraud and misrepresentation claims concerning off-label promotion are not preempted, but are insufficiently pleaded.  Off-label promotion is a disguised FDCA claim, whereas negligent failure to warn is a traditional state law claim.  Negligent warning claims that would alter PMA warnings are preempted.
  203. Rodriguez v. American Medical Systems, 2014 WL 429431 (S.D. Tex. Feb. 4, 2014), summary judgment against all claims in penile prosthesis case.  Preemption under Riegel applies to devices approved under a product development protocol.  A parallel claim cannot be assumed from the fact that plf was injured.
  204. Scovil v. Medtronic, Inc., 995 F. Supp.2d 1082 (D. Ariz. Feb. 7, 2014), motion to dismiss granted against most claims in action involving bone growth device.  Off-label promotion claims preempted because only the FDA can enforce its prohibition.  Design and manufacturing claims based on risks of off-label use are preempted.  Any warning claim concerning off-label uses is in addition to the label and therefore preempted.  Disagreeing with Ramirez.  All negligence claims are preempted except marketing involving off-label promotion.  Fraud and consumer fraud claims involving off-label promotion are not preempted.  Warranties were disclaimed.
  205. Kashani-Matts v. Medtronic, Inc., 2014 WL 819392 (C.D. Cal. Feb. 14, 2014), motion to dismiss amended complaint granted in action involving bone growth device.  Vague statements that the device's labeling did not meet FDA requirements were insufficient to state parallel claims.  "Magic words" are not enough.
  206. Starks v. Coloplast Corp., 2014 WL 617130, slip op. (E.D. Pa. Feb. 18, 2014),  motion to dismiss granted against all claims, including implied warranty, in action involving penile implant.  Judicial notice taken of FDA documents.  A subsequent PMA takes precedence over an earlier 510k approval of some components for preemption purposes.  Parallel claims cannot be boilerplate.  Express warranty claims are inadequately pleaded.
  207. Kitchen v. Biomet, Inc.,  2014 WL 694226 (E.D. Ky. Feb. 21, 2014), motion to dismiss granted against all claims, in action involving knee implant.  All non-parallel claims, including express and implied warranty, are preempted.  Parallel claim allegations are insufficiently pleaded.
  208. Harris v. Medtronic, Inc., 2014 WL 866063 (Cal. Super. Feb. 27, 2014).  Demurrer granted in part and denied in part in action involving bone growth device.  Failure to report adverse event claims are not preempted.  Failure to warn and fraud claims based on off-label promotion are preempted.  FDA regulations about off-label promotion are not genuinely equivalent to any state-law claim.  Negligence per se claims concerning off-label promotion are not preempted.  Fraud claims concerning statements made to the FDA are fraud on the FDA claims and are preempted.  Fraud claims based on  affirmatively false off-label promotion are not preempted.  Genuine equivalence not present liability could exist under the state law without a violation of federal law.
  209. Marse v. Medtronic, Inc., 2014 WL 987829 (Minn. Dist. March 12, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption.
  210. Schuler v. Medtronic, Inc., 2014 WL 988516, slip op. (C.D. Cal. March 12, 2014), motion to dismiss granted against all claims in action involving bone growth device.  All claims would require additional disclosure.  Off-label promotion is not barred by federal law and cannot give rise to a parallel claim.
  211. Seeberg v. Medtronic, Inc., 2014 WL 1102740 (Minn. Dist. March 12, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption. Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  212. Younkin v. Medtronic, Inc., 2014 WL 1102738 (Minn. Dist. March 12, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption. Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  213. Swisher v. Stryker Corp., 2014 WL 1153716 (W.D. Okla. March 14, 2014), motion to dismiss granted against negligence per se claims in action involving hip resurfacing system.  Conclusory statements that the defendant violated multiple regulations are not sufficient to plead a parallel claim.  Causation and the nature of the violation are required.
  214. Bertini v. Smith & Nephew, Inc.8 F. Supp.3d 246 (E.D.N.Y. March 17, 2014), motion to dismiss granted against all claims in action involving hip replacement system.  Judicial notice taken of FDA approval/clearance documents.  Where components of a PMA approved device and a 510k cleared device are mixed, preemption could be complex.  Focusing on the system as a whole, the only defects that could be causal are those relating to the PMA components.  While mixing components was off-label, preemption is not concerned with how devices are used.  Off-label use is not a defect.  Failure to warn is not parallel to claims about violating reporting requirements.  FDA reporting requirements do not require warnings directly to doctors or patients.  No reliance was alleged with respect to off-label promotion.  Consumer expectation-based implied warranty claims are preempted.
  215. Mead v. Medtronic, Inc., 2014 WL 1102737 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device.  Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption.
  216. Davenport v. Medtronic, Inc., 2014 WL 1102736 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption.
  217. Starovasnik v. Medtronic, Inc., 2014 WL 1102742 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out fraudulent off-label promotion or agency claims that survive preemption.
  218. Beaudry v. Medtronic, Inc., 2014 WL 1102741 (Minn. Dist. March 19, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device.   Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption.  Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  219. Herron v. Smith & Nephew, Inc., 7 F. Supp.2d 1043 (E.D. Cal. March 21, 2014), motion to dismiss granted in part and denied in part in action involving hip resurfacing system.  Allegations of a mislabeled component adequately state a parallel claim.  Other undefined or jargon-filled allegations are dismissed.  Claims asserting that the FDA did not do its job are preempted.  Much of the complaint is too vague to determine if parallel claims are being made, and must be repleaded.
  220. Schouest v. Medtronic, Inc.13 F. Supp.3d 692 (S.D. Tex. March 24, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption extends to all components of a device system, whether or not used together.  All claims that seek to have the defendant do more than the FDA has required are preempted.   The FDA does not define nor explicitly ban, off-label promotion.  Claims including express warranty based on false off-label promotion are not preempted.  Warning and implied warranty claims about off-label use are preempted.  Design claims are preempted.  Mere off-label promotion claims are preempted by Buckman.  If plaintiff can identify a state law duty to report adverse events, such a claim would not be preempted.
  221. McConologue v. Smith & Nephew, Inc.8 F. Supp.3d 93 (D. Conn. March 24, 2014), motion to dismiss granted in part and denied in part in action involving hip replacement system. Blanket preemption rejected in light of parallel claim exception.  A device not manufactured in accordance with a PMA remains a "device intended for human use," and preemption applies.  A manufacturing defect claim predicated on failure to follow PMA standards survives preemption as does misrepresentation and implied warranty claims predicated on the manufacturing defect.  Independent state law claims are not parallel and are preempted.  Warning and design claims preempted.  Testing claims TwIqballed.
  222. Blankenship v. Medtronic, Inc.6 F. Supp.3d 979 (E.D. Mo. March 25, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Taking judicial notice of FDA approvals and supplements.  Making what is permissive into something mandatory is preempted.  General references to violating GMPs fail to establish a parallel claim.  Violations of the PMA would state a parallel claim.  Off-label promotion is prohibited by federal law but not unlawful under traditional state law.  Manufacturing defect and negligence claims based on off-label promotion are preempted as imposing different requirements.  Demands for warnings about off-label uses are preempted.  Failure to file adverse event report claims are preempted.  Design defect claims seeking anything other than what the FDA required are preempted.  Off-label promotion only exists by virtue of the FDCA.  Negligence per se is not based independently tortious conduct.  Non-disclosure of facts about FDA approval is not a state-law tort.  A claim of fraudulent off-label promotion would not be preempted, but is inadequately pleaded.
  223. Burkett v. Smith & Nephew, 2014 WL 1315315slip op. (E.D.N.Y. March 31, 2014), motion to dismiss granted against all claims in action involving hip replacement system. A PMA supplement supports preemption.  Violation allegations involving vague GMPs do not support preemption.  Nor was causation pleaded between the alleged violation and the plaintiff's injury.  Design and warning claims preempted, in negligence as well as strict liability.  Fraud express/implied warranty, and consumer protection claims inadequately pleaded to escape preemption.
  224. Simoneau v. Stryker Corp., 2014 WL 1289426, slip op. (D. Conn. March 31, 2014), motion to dismiss granted in part and denied in part in action involving hip replacement system.  In light of FDA warning letters and product recalls, claims alleging manufacturing defects are parallel and not preempted.  Allowing reliance at pleading stage on general GMPs.  Recalls were pleaded to involve components implanted specifically in plaintiff.  Warning and design based claims are preempted.  Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA.  Express warranty claims inadequately pleaded.
  225. Cline v. Advanced Neuromodulation Systems, ___ F. Supp.2d ___, 2014 WL 1624084 (N.D. Ga. March 31, 2014), motion to dismiss granted in part and denied in part in action involving a spinal cord stimulator.  Strict liability claims are preempted because, whether or not a "duty" is involved, they would require changes in the device triggering the express preemption clause.  The battery life claim is preempted because there is no FDA performance standard to that effect.  A design validation claim is preempted because there is no showing that the defendant's validation was contrary to FDA regulations.  Several FDA violation claims fail because they lack any causal connection to the failure plaintiff alleged.  One parallel claim based on a recall has a sufficient causal relationship and thus survives preemption as a parallel claim.
  226. Houston v. Medtronic, Inc., 2014 WL 1364455, slip op. (C.D. Cal. April 2, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption applies to devices, not uses of devices or promotion of uses of devices.  FDA requirements extend to off-label use and promotion.  Ramirez is wrongly decided.  Failure to report claims to the FDA are not preempted. Fraudlulent promotion of off-label use can escape preemption.  Plaintiff pleaded his physician's exposure to fraudulent promotion with sufficient particularity.  Express warranty is not preempted and is adequately pleaded.
  227. Brady v. Medtronic, Inc., 2014 WL 1377830, slip op. (S.D. Fla. April 8, 2014), motion to dismiss granted in action involving bone growth device.  Preemption does not turn on how a device is marketed.  Fraud claims against FDA-approved labeling are preempted.  Fraud claims involving off-label promotion are not preempted, but not pleaded with particularity.  Negligent warning and design claims are preempted.  Negligence claims based on illegal promotion are preempted as attempts to enforce the FDCA.  Express warranty claims not involving FDA labeling may not be preempted, but are not properly pleaded.
  228. Beavers-Gabriel v. Medtronic, Inc., 2014 WL 1396582, slip op. (D. Haw. April 10, 2014), motion to dismiss granted in action involving bone growth device.  Documents on FDA website judicially noticed.  All claims challenging contents of FDA-approved label are preempted.  Off-label promotion claims can be preempted (rejecting Ramirez).  Design and off-label promotion claims preempted, except fraud.  Fraud, concealment, and misrepresentation claims not preempted, but inadequately pleaded.  Failure to report claims inadequately pleaded.  Express warranty claims outside the label not preempted but inadequately pleaded.
  229. Eidson v. Medtronic, Inc., ___ F. Supp.2d ___, 2014 WL 1996024 (N.D. Cal. May 13, 2013).  Renewed motion to dismiss granted in part and denied in part.   Claims alleging affirmatively fraudulent off-label promotion are not preempted.  Failure to warn claims based on overpromotion and deceptive off-label promotion are expressly preempted, but claims alleging failure to report adverse events to the FDA are not.
  230. Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014), motion to dismiss granted in action involving implantable cardiac defibrillator.  Parallel claims not pleaded where the violation of allegedly parallel regulations did not articulate a defect with any specificity. Nor was causation alleged.  Nor was the nature of the allegedly parallel state-law cause of action.
  231. Reed v. Medtronic, Inc., 2014 WL 1930221 (Cal. App. May 15, 2014) (unpublished), summary judgment reversed because plaintiff should have been allowed to amend complaint.  Plaintiff did not appeal entry of summary judgment against all prior product liability claims.  A claim that an employee of the defendant negligently programmed a device is not a requirement "with respect to a device," as it does not challenge any aspect of the device.  Such a claim is not a parallel claim because no violation is involved.
  232. Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235 (N.D. Cal. May 28, 2014), motion to dismiss granted in action involving breast implants.   Plaintiff concedes that all her pleaded claims were preempted, but failed to allege an adequate parellel claim.  Failure to report adverse events alleged only an FDCA violation.
  233. Hornbeck v. Medtronic, Inc.,  2014 WL 2510817 (N.D. Ill. June 2, 2014), motion for judgment on the pleadings denied in action involving bone growth device.  All plaintiffs' claims involve FDCA violations, so they are parallel claims.  By promoting off-label use the defendant removed itself from the protection of preemption.  Because the FDA only approved the components for use together, preemption cannot apply to components used separately.
  234. Johnson v. Hologic, Inc., 2014 WL 2581421, slip op. (E.D. Cal. June 6, 2014), judgment on the pleadings granted against all claims in action involving a mammography machine.  Documents on FDA website judicially noticed.  No parallel claims were pleaded.
  235. Franzese v. St. Jude Medical, Inc., 2014 WL 2863087 (E.D.N.Y. June 23, 2014), motion to dismiss granted in action involving implantable cardiac defibrillator.  PMA documents judicially noticed.  Parallel claims alleging violations of vague GMPs are preempted.  Nonspecific adulteration claims are preempted.  Design defect claims are preempted.  A warning letter issued three years after manufacture does not establish causation.  Express and implied warranty claims based on FDA-approved labeling are preempted.  Negligence claims preempted for same reasons as strict liability.  Negligent misrepresentation claims inadequately pleaded.
  236. Pinsonneault v. St. Jude Medical, Inc., 2014 WL 2879754 (D. Minn. June 24, 2014), summary judgment granted in large part in action involving implantable cardiac defibrillator.  A manufacturer's purely internal manufacturing specifications do not become FDCA requirements simply because the FDCA requires manufacturers to have such specifications.  None of plaintiff's alleged manufacturing defects violate any actual FDCA requirement so plaintiffs have no parallel unpreempted claims.
  237. Dunbar v. Medtronic, Inc., 2014 WL 3056026, slip op. (C.D. Cal. June 25, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device. Warning and design claims expressly preempted.  There is no traditional tort claim for off-label preemption, so negligence and negligence per se claims based on such allegations are impliedly preempted.  Express warranty claims are not preempted, but are inadequately pleaded on basis of the bargain and notice grounds.
  238. Edwards v. Ethicon, Inc., 2014 WL 3361920 (S.D.W. Va. July 8, 2014), summary judgment denied in action involving vaginal mesh.  That a device system had one component that was PMA approved did not support preemption where the system as a whole was cleared as substantially equivalent under §510k.
  239. Huskey v. Ethicon, Inc., 2014 WL 3362287 (S.D.W. Va. July 8, 2014), summary judgment denied in action involving vaginal mesh. That a device system had one component that was PMA approved did not support preemption where the system as a whole was cleared as substantially equivalent under §510k.
  240. Highfield v. Perard, 2014 WL 3773976, slip op. (Pa. C.P. Clarion Co. July 16, 2014), preliminary objections granted against third-party complaint in action involving thermal ablation device.  A failure to maintain/inspect claim would impose extra requirements to the PMA process and is preempted.  There is no private right to enforce the FDCA.  Alleging violation of non-device-specific GMPs is insufficient to state a parallel violation claim.  General violation claims do not provide a causal nexus between the violation and the alleged injury.
  241. Waltenburg v. St. Jude Medical, Inc., 2014 WL 3586471 (W.D. Ky. July 21, 2014), motion to dismiss granted in part and denied in part in action involving implantable cardiac defibrillator.  Specifically pleaded manufacturing defects in violation of GMPs are not preempted.  FDA requirements are in both PMA and supplemental PMAs.  Failure to report to FDA warning claim not preempted.
  242. Martin v. Medtronic, Inc., ___ F. Supp.2d ___, 2014 WL 3635292 (D. Ariz. July 23, 2014), motion to dismiss granted in action involving bone growth device.  Judicial notice taken of FDA approvals. Preemption applies to off-label uses, rejecting Ramirez.  Misrepresentation can be a parallel state duty in cases of untruthful off-label promotion.  Fraud claims based on FDA-approved labeling are preempted.  Fraud claims based on untruthful off-label promotion are not preempted but are inadequately pleaded.  Warning claims based on off-label promotion are preempted.  Failure to report adverse events to the FDA is not preempted, but plaintiffs fail to allege how such a failure caused them injury.  Design defect claims preempted.  Negligence claim based on off-label promotion impliedly preempted.  Express warranty claim based on untruthful off-label promotion not preempted but warranty must be pleaded.  Second complaint dismissed, see below.
  243. Thibodeau v. Cochlear Ltd., 2014 WL 3700868 (D. Ariz. July 25, 2014), motion to dismiss granted in part and denied in part in action involving cochlear implant.  An unexplained list of 30 allegedly violated regulations is conclusory and cannot defeat preemption.  Negligence per se is impliedly preempted as directly based on an FDCA violation.  All warning-based claims, including express warranties, are preempted.  Allegations of failure to warn the FDA are not preempted.
  244. Scanlon v. Medtronic, Inc., ___ F. Supp.2d ___, 2014 WL 3737501, slip op. (D. Del. July 28, 2014), motion to dismiss granted in action involving bone growth device. Judicial notice taken of FDA approvals and other documents.  Motion for discovery denied.  Off-label promotion claims preempted, and are not parallel claims.  Warning and negligence prempted as adding requirements.  No federal requirement to seek label change.  Misrepresentation claim prempted where label complied with FDCA.  False promotion and failure to report would not exist apart from FDCA and are implied preempted.
  245. Huggins v. Medtronic, Inc., 2014 WL 4262211 (Colo. Dist. July 28, 2014), motion to dismiss denied in action involving bone growth device.  Everything is a parallel claim.
  246. Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014), partial motion to dismiss (all but manufacturing claims) granted in action involving hip implant.  Warning, design, and implied warranty claims are preempted.  Express warranty based on manufacturing defect would not be preempted, but is inadequately pleaded.
  247. Blankenship v. Medtronic, Inc., 2014 WL 3818485 (E.D. Mo. Aug. 4, 2014), motion to dismiss denied in action involving bone growth device against repleaded fraud claims concerning off-label promotion.  Fraud claims adequately pleaded.
  248. Zaccarello v. Medtronic, Inc., 2014 WL 3866607 (W.D. Mo. Aug. 6, 2014), motion to dismiss granted in part and denied in part in action involving in action involving bone growth device.  Design, manufacture, and warning claims preempted.  Express warranty, fraud, and consumer fraud escape preemption to the extent based on false off-label promotion, but express warranty and fraud are inadequately pleaded.  Improper promotion and negligence per se impliedly preempted as disguised FDCA causes of action.
  249. Vitale v. Medtronic, Inc., 2014 WL 3893294, slip op. (C.D. Cal. Aug. 8, 2014), motion to dismiss granted in action involving bone growth device.  All claims are expressly or impliedly preempted.
  250. Arthur v. Medtronic, Inc., 2014 WL 3894365, slip op. (E.D. Mo. Aug. 11, 2014), motion to dismiss granted in part and denied in part in action involving in action involving bone growth device.  Judicial notice given to FDA documents.  Off-label promotion is subject to misbranding, which is an FDA requirement.  Design, warning, and warranty claims expressly preempted.  Negligence claims based on off-label promotion impliedly preempted as private FDCA actions.  The concept of "off-label" is a creature of the FDCA.  Fraudulent misrepresentation and express warranty claims involving false off-label promotion are not preempted, but inadequately pleaded.
  251. Tansey v. Cochlear Ltd., 2014 WL 4829453 (E.D.N.Y. Sept. 26, 2014),  motion to dismiss granted in part and denied in part in action involving cochlear implant.  Manufacturing defect claims are parellel and not preempted.  Design defect claims are preempted. Warning claims rely on an FDA recall occurring more than a year later, which fails to plead causation.  Failure to inspect claims are TwIbaled.  Related negligence claims follow the defect allegations.
  252. McCormick v. Medtronic, Inc., ___ A.3d ___, 2014 WL 4976616, slip op. (Md. App. Oct. 7. 2014), dismissal of all claims affirmed in part and reversed in part.  Allegations of misrepresentations (fraud, misrepresentation, consumer fraud, express warranty) made in the context of off-label promotion are neither expressly or impliedly preempted.  Rejects Ramirez.  All claims that challenge the FDA-approved warnings or design of a PMA device are preempted.  Failure to disclose information in the course of the approval process are impliedly preempted.  Pure off-label promotion claims, not depending on falsity are impliedly preempted.  Both are seeking to enforce the FDCA.  Strict liability is preempted.  Breach of warranty is preempted to the extent based on FDA labeling, otherwise it is not.  Plaintiffs failed to plead fraud with particularity.
  253. Sluss v. Medtronic Sofamor Danek USA, Inc., No. BC 496524, slip op. (Cal. Super. Oct. 15, 2014), demurrer granted in part and overruled in part in action involving in action involving bone growth device.  All claims preempted except for those relating to negligent off-label promotion and failure to report adverse events.  Strict liability off-label promotion is preempted as are all design claims and warnings not concerning off-label promotion.
  254. Anderson v. Medtronic, Inc., 2014 WL 5528664, slip op. (Minn Dist. Oct. 16, 2014), motion to dismiss granted in action involving bone growth device.  Fraud and constructive fraud based on false off-label promotion are inadequately pleaded because they rely on generalized fraud on the market allegations.  All other claims are preempted, including negligence, strict liability, express and implied warranty, several consumer fraud/trade practices statutes, and unjust enrichment.
  255. Lindler v. Mentor Worldwide LLC, 2014 WL 6390307 (D.S.C. Oct. 23, 2014), motion to dismiss granted against all claims in action involving breast implants.  All claims preempted, except express warranty, whidh is inadequately pleaded.
  256. Hesik v. Boston Scientific Corp., 2014 WL 5644699 (D.S.C. Nov. 4, 2014), summary judgment granted in part and denied in part in action involving defibrillator.  All claims dismissed except for alleged 5-year express warranty., which is arguably beyond anything required by the FDA.  Violations of vague FDA regulations cannot escape preemption as parallel claims.  Implied warranty claims are preempted.
  257. Stanifer v. Corin USA Ltd., 2014 WL 5823319 (M.D. Fla. Nov. 10, 2014), motion to dismiss granted against all claims in action involving hip resurfacing device.  Only parallel claims escape preemption and plaintiff did not plead any.  Judicial notice of FDA approval is proper.  Request for pre-complaint discovery is denied.
  258. Cales v. Medtronic, Inc., 2014 WL 6600018 (Ky. Cir. Nov 21, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Off-label use does not oust preemption.  Preemption does not depend on using all of the approved components.  The FDA approves devices, not uses.  Parallel claims must involve a substantially equivalent state-law theory.  Neither off-label promotion nor failure to report are parallel claims.  They have no equivalent state liability theories.  Private enforcement of the FDCA is impliedly preempted.  Fraud is not properly pleaded.  Without pleading physician-specific reliance, plaintiff is alleging improper fraud on the market.  All claims attacking FDA-approved labels and design are preempted.  Without pleading phisician-specific cauasation, failure to report claims do not allege any state law claim, and are dismissed.  Any warranty created by off-label promotion must become part of the basis of the bargain to avoid preemption.
  259. Martin v. Medtronic, Inc., No. 2:14-cv-0385-HRH, slip op. (D. Ariz. Nov. 24, 2014), motion to dismiss granted against all claims in action involving bone growth device.  All claims previously dismissed as preempted are again dismissed.  Failure to report claims dismissed for failing to plead causation.  Fraud is sufficiently pleaded, with reliance on a specified article and the author's agency by specified financial ties.  Other promotional allegations insufficiently pleaded.  Allegations of reliance upon unspecified medical literature are not enough.  General allegations about product safety dismissed as fraud on the market.  Express warranty inadequately pleaded.  Entire complaint dismissed as prolix and redundant with leave to amend.
  260. Herrnandez v. Stryker Corp., 2014 U.S. Dist. Lexis 171697, slip op. (W.D. Wash. Dec. 11, 2014), motion to dismiss granted against all claims in action involving total hip implant.   Vague references to "adulteration" and FDA warning letters do not plead sufficient facts to establish a parallel claim.  Causation fails because plaintiff fails to link letters to her claim.  The allegedly violated GMPs do not specify any steps that the defendant was required to take.  Express warranty claims based on FDA-approved labeling are preempted.
  261. Brooks v. Sanofi Aventis LLC, 2014 U.S. Dist. Lexis 174842 (S.D. Ohio Dec. 18, 2014),  motion to dismiss denied in action involving cosmetic injection.  Citing Bausch, the court refuses to decide any preemption issue without discovery into whether a parallel claim exists.