Drug and Device Law

Good Ideas From Our Readership

2009-12-10T15:05:00.000-05:00

We love it when our readers share good ideas with us. For one thing, it saves us the trouble of having to think up ideas ourselves. Today we’re sharing a couple of those with you.

Ted Heise, who’s at Cook Medical, was reading our post on methods of proving up FDA-related evidence. He took the time to let us know that, if the fact of FDA pre-market approval is what’s at issue, there’s another avenue of judicial notice that we hadn’t considered. He tells us that the FDA issues quarterly lists of its premarket approvals, and that these lists are published in the Federal Register.

That’s interesting, because anything published in the Federal Register is subject to mandatory judicial notice by statute. See 44 U.S.C. §1507 (“[t]he contents of the Federal Register shall be judicially noticed”).

Ted even sent us a link to one of these quarterly reports through the Government Printing Office – but us Luddites couldn’t get it to work. Maybe it’s necessary to have a GPO account or something.

Anyway…. We do have a Westlaw account, and Westlaw includes everything that appears in the Federal Register (since 1981, for stuff that’s searchable, and even further back for non-searchable PDFs). So we ran a simple search: “pre-market approval” and “quarterly.”

Sure enough, Ted is right on the money. The second document (of 3070) is “Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,” 74 Fed. Reg. 53270 (FDA Oct. 16, 2009). It’s a list of every medical device approval that the FDA granted for the third quarter of 2009. There were six of them.

As Ted pointed out when he tipped us off, these lists don’t include supplements – only the initial PMA for the device.

We could have left it at that, but we’re pretty compulsive about evidentiary matters.

That quarterly report mentions that “[t]he regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals.” 74 Fed. Reg. at 53270. So we went looking for the relevant regulation. We found this:

Upon issuance of an order approving. . .any PMA, FDA will make available to the public the fact of the existence of the PMA and a detailed summary of information submitted to FDA respecting the safety and effectiveness of the device that is the subject of the PMA and that is the basis for the order.

21 C.F.R. §814.9(e). It doesn’t say anything about “quarterly” reporting, though, so we kept looking. Then we found 21 C.F.R. §814.44(d)(1), and there it was:

The notice of approval will be placed on FDA’s home page on the Internet (http://www.fda.gov/), and it will state that a detailed summary of information respecting the safety and effectiveness of the device, which was the basis for the order approving the PMA, including information about any adverse effects of the device on health, is available on the Internet and has been placed on public display, and that copies are available upon request. FDA will publish in the Federal Register after each quarter a list of the approvals announced in that quarter. When a notice of approval is published, data and information in the PMA file will be available for public disclosure in accordance with §814.9.

(Emphasis added). So, for anybody who needs to authenticate an initial PMA, that’s the complete regulatory paper trail for doing it.

But we didn’t stop there, either. At the very end of the document was the statement: “Persons with access to the Internet may obtain the documents at http:// www.fda.gov/cdrh/pmapage.html.” Since the regs also mention the FDA’s website, we took a peek there, too.

If you’ve never been to the FDA’s website, you really should give it a shot – there's a wealth of information on all sorts of things, and the courts generally (as we discussed in our prior post) seem inclined to judicially notice it.

We weren’t disappointed this time, either. Check out this link. The FDA’s website does better than just quarterly. It lists all PMA approvals by month, under the relevant year. The online PMA information goes back to 1994.

Not only that, the on-line information includes supplemental PMA approvals, too. We clicked on “January 2009," and in addition to one PMA, there was information about the approval of 54 PMA supplements.

So if you know the month and year that a relevant PMA supplement was approved, you can look it up that way, without having to go through all of the rigmarole that we went through earlier about creating permanent FDA device history links. That’s not to say that the link creation technique isn’t valuable – it’s the only way to gather the entire device history in one place. But if all you need is the fact of FDA approval of a particular PMA or PMA supplement, you can get it easier here.

One last cautionary note: the monthly PMA supplement material starts with 1995. The 1994 link has only initial PMAs.

So that’s one helpful tip. Thanks, Ted.

We got a second one, in response to the off-label use part of our “This and That” post, from a reader who wishes to remain nameless, letting us know that Medicare in some cases knowingly and willingly pays for unapproved uses. This tip included a link to this recent New York Times article, R. Abelson & A. Pollock, “Medicare Widens Drugs It Accepts for Cancer,” (N.Y.T. Jan. 26, 2009), discussing Medicare’s decision to broaden the range of off-label cancer treatments it will reimburse.

The Times article notes “a 1993 federal law gave Medicare specific authorization to cover some unapproved uses of cancer drugs,” and states:

The new rules expand the number of reference guides — or compendiums — that Medicare relies on for determining which off-label uses of cancer drugs to cover. The writers and editors of these compendiums, who work completely outside the federal government, scan the medical literature and evaluate the evidence in making their recommendations.

In 1993, Congress had authorized three compendiums for Medicare, all published by not-for-profit organizations. But by 2007 two had stopped publishing, leaving Medicare with a single compendium. Having selected three additional guides last year, the agency plans to review its choice of guides every year.

We’d known a little bit about this before. The amicus brief that Bexis filed for the WLF in the Caputo case looked into Medicare reimbursement of off-label uses as one example of the government’s Dr. Jekyll/Mr. Hyde approach to off-label uses:

Medicare pays for many off-label uses, 42 U.S.C. §1396r-8(k)(6) (criteria for off-label use as a “medically accepted indication”), and sometimes mandates payment. Id. at §1395x(t)(2)(B)(ii) (cancer treatment).

WLF Caputo br. at 8. But plainly there’s more here than we’ve thought about before.

The Times article, being for non-lawyers, doesn’t cite any of the material it mentions, so we went looking. First we dug up the relevant Medicare document. It’s called “Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen,” and it’s first listed as an available Medicare document in 73 Fed. Reg. 36596, 36599 (HHS, Ctrs Med. & Med. Svcs. June 27, 2008). This “process” document is available on-line from numerous sources, including this one.

The “process” document explains the history of medical compendia as a recognized basis for Medicare off-label use reimbursement. Congress designated the original compendia here 42 U.S.C. §42 U.S.C.A. §1395x(t)(2)(B)(ii)(I). But provided that this list could supplemented with “other authoritative compendia as identified by the Secretary.” Id. So that’s exactly how the government came to pay for a large number of off-label uses.

We dug a little further, and found the Medicare Notice that actually added the new compendia to the prior list of resources for off-label compensation.

Finally, we went looking for the four compendia themselves. We found them – sort of. The fly in the ointment is that each of these are commercial sources, and you’ll have to pay to look at them. In any event, here’s where the four current Medicare-accepted, off-label use compendia can be found, if you’re ready to shell out the cash:

• National Comprehensive Cancer Network, Clinical recommendations, accessible on-line, here (paid subscription only).

• American Hospital Formulary Service-Drug Information (AHFS-DI), accessible on-line here (paid subscription only).

• Thomson Micromedex DrugDex, accessible here (paid subscription only).

• Clinical Pharmacology, accessible on-line here (paid subscription only).

Finally, for sake of thoroughness, we’ll include a link to the FDA’s most recent authoritative statement on off-label use generally. This is the “Good Reprint Practices” guidance, that we discussed in greater detail here, shortly after it issued.

Once again, thanks to our readers for their useful tips. Keep them coming. We appreciate suggestions for topics like these that you think would be of interest to you.

Been Around This Block Before - Removal Before Service

2009-12-09T08:05:00.134-05:00

By now, everyone but the newest of our readers knows this drill. The client gets sued in state court. The action would be removable, because there's diversity of citizenship between plaintiff and defendants (that is, they live in different states) except there's an "in-state" defendant that prevents removal because the plaintiff sued that defendant in that defendant's own state's courts. The in-state defendant (which may or may not be the client) hasn't been served yet.

Remove to federal court before the in-state defendant is served, and what happens?

You may or may not get remanded, depending primarily on who the assigned federal judge is. We've posted about this a lot, most comprehensively here.

The latest entry is Wallace v. Tindall, 2009 WL 4432030 (W.D. Mo. Nov. 30, 2009), which denied remand. So what are the quirks in Wallace? For one thing, it was an amended complaint - and the in-state defendant was actually served, but only the first time around.

What happened is this. There was an auto accident; out of state plaintiff sues in-state defendant, the other driver in that driver's home (Missouri) court. And served him right - literally. Proper service on the in-state defendant under Missouri law. Wallace, 2009 WL 4432030, at *1.

But, oops.... What if the other driver doesn't have deep enough pockets?

Thus, a couple of weeks after completing service, the plaintiff files an amended complaint naming two additional out-of-state defendants: the other driver's employer and an insurance company. There's still diversity between the plaintiff (not sure where he's from, but not Missouri). Id.

But while plaintiff serves the new defendants with the amended complaint, he doesn't serve the original, in-state defendant. Id.

Double oops.

The additional defendants remove the case to federal court. Not only that, but the original defendant (the one not served with the amended complaint) didn't consent to the removal.

Thus the question presented: Is removal before service proper under the "properly joined and served" language of 28 U.S.C. §1441(b) where the in-state defendant was properly served with the original complaint that didn't name the removing defendants, but not with the amended complaint that did name those defendants. (There's also a secondary question about consent to removal, but that turns on the same issue.)

Answer, according to Wallace: Yes!

Here's why. Missouri state practice requires that, "Each affected party shall be served with. . .[e]very pleading subsequent to the original petition." Missouri Rule 43.01(1)(1). But that rule doesn't apply to defendants "in default." Id. 43.01(a)(3) (inapplicable exception omitted).

Plaintiff might have gotten away with the amendment, but didn't wait long enough. For a defendant to be "in default" under Missouri law, 30 days had to pass without the defendant answering (or otherwise pleading to) the complaint. Because the amended complaint came only a couple of weeks after sefvice of the first complaint, the defendant wasn't in default when the second one was served. Thus, under Missouri rules, plaintiff was obligated to serve him. Wallace, 2009 WL 4432030, at *3.

A couple of things might be going on here. It could just be a sloppy plaintiff's counsel. That would follow Occam's Razor, which in this context means "don't ascribe to malevolence, what can be explained by incompetence." Or it could be that the original defendant was just a sham to keep the case in state court (and the first service was to prevent resort to §1441(b)). Or it could be that the plaintiff, regardless of intent, couldn't wait any longer - maybe plaintiff simply couldn't wait any longer to sue the additional defendants. The opinion doesn't give the accident date, so there could be a statute of limitations looming out there.

In any event, the original, in-state defendant wasn't properly served with the amended complaint when the new defendants removed it. That also did away with the plaintiff's "consent to removal" argument, since the need to obtain consent likewise applied only to "properly served" defendants. Wallace, 2009 WL 4432030, at *4.

So on the main question, whether removal before service of an in-state defendant is proper, the court came down squarely on the side of those courts interpreting §1441(b) as meaning what it says:

The issue of service however is the pivotal issue in this case. Courts have held that even though a Missouri defendant is named in a Complaint, if that defendant is not served at the time of removal, the forum defendant rule does not apply. . . . As held by the ‘majority’ of federal courts, this Court must apply the statute as written and determine that Defendants properly removed this action.

Wallace, 2009 WL 4432030, at *3. The court followed two previous Missouri district court cases, Brake and Taylor - both of which we're glad to see were includded in our prior attempt at comprehensively addressing (our side of) this issue.

So chalk up another one for the side of truth, justice, and an infinite number of peculiar fact patterns.

Thanks to reader Roshan D. Shah at Baker, Sterchi for the tip....

Twombly/Iqbal - The Beat Goes On

2009-12-09T07:34:00.000-05:00

As we mentioned last week, we were invited to participate in a debate about whether Congress should act to overrule the pleading standard enunciated in Twombly and Iqbal. That debate's being hosted by the University of Pennsylvania Law Review's online supplement, PENNumbra.

We, predictably, thought Congress should stay out of this.

Our opponent in this debate is (drum roll please) Penn's own David Berger Professor for the Administration of Justice, Stephen Burbank. That alone probably explains why PENNumbra was only able to scrape up a couple of bloggers to take the other side.

Anyway, to read Professor Burbank's contrary take on Twombly/Iqbal go here. Those of our readers who like to call us the "Voldemorts" should expect to to have some fun, because he says we're not to be "taken seriously." But then, you already knew that.

Enjoy it while you can.

Our rejoinder to Professor Burbank will be available on PENNumbra in about a week.

Scorecard: Non-Manufacturer, Name-Brand Defendants In Generic Drug Cases

2009-11-12T12:17:00.001-05:00

Regular blog readers know how we feel about Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), review denied (Cal. Jan. 21, 2009) – the case that held a brand-name drug manufacturer potentially liable for “misrepresentations” even though it did not manufacture the drug that allegedly harmed the plaintiff. We criticized virtually every aspect of Conte here, here, here, and here. We gave Conte our nod as the worst judicial decision of 2008 in our field. Bexis wrote an amicus brief in support of the ultimately unsuccessful effort to get the California Supreme Court to review the Conte decision. In short, we thought Conte was bad news all around.

Last week we put up a guest post with some good news about Conte – in the year since it had been decided, no other court had found its reasoning to be persuasive. Our guest posters observed:

For those keeping score, this makes 31 courts in 19 states that have refused to impose liability on a brand name drug manufacturer for injuries caused by its competitors’ generic drugs.

We took that as a very subtle rebuke. It had to be subtle – it’s our blog, after all.

But they have a point. After all, isn’t keeping score one of the things we do? We maintain current scorecards on drug/vaccine preemption, medical device preemption, cross-jurisdictional class-action tolling (if you don't know, don't ask), and no present injury plaintiffs.

Well guys, it worked – you got us off our duffs. We haven’t put together a scorecard on a new topic in over a year, so that sounded like a good idea. What follows is a chronological list of every judicial decision we know of that addresses the issue of whether a name brand (also known as “pioneer” or “listed”) drug manufacturer can be liable in a suit where the plaintiff only took a generic version of that drug, which was manufactured and marketed by somebody else.

Foster v. American Home Products Corp., 29 F.3d 165, 168, 171 (4th Cir. July 14, 1994) (applying Maryland law). Promethazine (Phenergan) case. Name brand manufacturer not liable under negligent misrepresentation theory.
Flynn v. American Home Products Corp., 627 N.W.2d 342, 350-52 (Minn. App. May 15, 2001). Fenfluramine (Pondimin) case. Name brand manufacturer not liable under fraudulent misrepresentation, negligent misrepresentation, or consumer fraud theories.
Beutella v. A.H. Robins Co., 2001 WL 35669202, at *2 (Utah Dist. Dec. 10, 2001). Metoclopramide (Reglan) case. Name brand manufacturer not liable under any (unspecified) theory.
DaCosta v. Novartis AG, 2002 WL 31957424, at *8-9 (D. Or. March 1, 2002). Ergot alkaloid (Migranal) case. Name brand manufacturer not liable under strict liability, or fraud theories.
Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003). Metoclopramide (Reglan) case. Name brand manufacturer not liable under negligence, negligent misrepresentation, fraud, conspiracy, or malice theories.
Sloan v. Wyeth, 2004 Extra Lexis 202, at *3-12 (N.J. Super L.D. Oct. 13, 2004). Metoclopramide (Reglan) case. Name brand manufacturer not liable under fraud, negligent misrepresentation, fraudulent concealment, or consumer fraud theories.
Sheeks v. American Home Products Corp., 2004 WL 4056060, at *1-2 (Colo. Dist. Oct. 15, 2004). Metoclopramide (Reglan) case. Name brand manufacturer not liable under negligent misrepresentation or statutory products liability theories.
Reynolds v. Anton, 2004 WL 5000272, at *?? [towards end of opinion] (Ga. Super. Oct. 28, 2004) (Westlaw doesn’t provide jump cites to state trial orders anymore, which ticks us off). Methylphenidate (Ritalin) case. Name brand manufacturer not liable under overpromotion or any other theory for failure of proximate causation.
Kelly v. Wyeth-Ayerst Laboratories Co., 2005 WL 4056740, at *2-5 (Mass. Super. May 6, 2005). Metoclopramide (Reglan) case. Name brand manufacturer not liable under products liability, negligence, Restatement (Second) of Torts §323 (1965), negligent misrepresentation, breach of warranty, or consumer fraud.
Tarver v. Wyeth, Inc., 2005 WL 4052382, at *2 (Mag. W.D. La. June 7, 2005), adopted, 2006 WL 1517546, at *2-3 (W.D. La. Jan. 26, 2006) Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability or negligent misrepresentation theories.
Sharp v. Leichus, 2006 WL 515532, at *2-6 (Fla. Cir. Feb. 17, 2006), aff’d per curiam, 952 So.2d 555 (Fla. App. Jan 22, 2007). Metoclopramide (Reglan) case. Name brand manufacturer not liable under fraud, negligent misrepresentation, fraudulent concealment, or market share theories.
Possa v. Eli Lilly & Co., 2006 WL 6393160, at *1, slip op. at 2-3 (M.D. La. May 10, 2006). Fluoxetine (Prozac) case. Name brand manufacturer not liable under statutory product liability theory.
Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 539-43 (E.D. Pa. May 25, 2006), aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 129 S. Ct. 1578 (2009). Paroxetine (Paxil) case. Name brand manufacturer not liable under all (negligence, negligence per se, negligent misrepresentation, fraud, consumer fraud, infliction of emotional distress, or implied warranty) theories for lack of duty or causation.
Goldych v. Eli Lilly & Co., 66 Fed. R. Serv.3d 799, 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006). Fluoxetine (Prozac) case. Name brand manufacturer not liable under negligence, negligent misrepresentation, fraud, fraudulent concealment, or consumer fraud theories.
LeBlanc v. Wyeth, Inc., 2006 WL 2883030, at *5-6 (W.D. La. Oct. 5, 2006). Amiodarone (Cordarone) case. Name brand manufacturer not liable under statutory product liability theory.
Adamson v. Ortho-McNeil Pharmaceutical, Inc., 463 F. Supp.2d 496, 505 (D.N.J. Nov. 16, 2006), reconsideration denied, 2007 WL 604790 (D.N.J. Feb. 20, 2007). TriNessa (Tri-Cyclen) non-personal injury case. Name brand manufacturer not liable under consumer fraud theory for not advertising that generic drug was available more cheaply.
Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 WL 5787186, at *2-3 (S.D. Ala. April 24, 2007). Cephalexin (Keflex) case. Name brand manufacturer not liable under Restatement (Second) of Torts §402B (1965), strict liability, negligence, failure to test, failure to train physicians, express warranty, or implied warranty theories.
Green v. Wyeth Pharmaceuticals, Inc., 2007 WL 6428717, at *1 (Ala. Cir. May 14, 2007). Metoclopramide (Reglan) case. Name brand manufacturer not liable under any (unspecified) theory.
Clark v. Pfizer, Inc., 2008 Phila. Ct. Com. Pl. Lexis 74, at *20-32 (Pa. C.P. March 14, 2008). Gabapentin (Neurontin) non-personal injury case. Name brand manufacturer not liable under warranty theory. Name brand manufacturer could be liable under negligent misrepresentation or intentional misrepresentation theories for sums paid to generic manufacturers for off-label uses.
Swicegood v. Pliva, Inc., 543 F. Supp.2d 1351, 1354-59 (N.D. Ga. April 2, 2008). Metoclopramide (Reglan) case. Name brand manufacturer not liable under strict liability, negligence, fraudulent misrepresentation, negligent misrepresentation, Restatement (Second) of Torts §324A (1965), concealment, or implied warranty theories.
Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008). Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability, negligence, fraud, or misrepresentation theories.
Stanley v. Wyeth, Inc., 991 So.2d 31, 33-35 (La. App. May 2, 2008). Amiodarone (Cordarone) case. Name brand manufacturer not liable under statutory product liability or negligent misrepresentation theories.
Wilson v. Wyeth, Inc., 2008 WL 2677049, at *3-4 (W.D. Ky. June 30, 2008). Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability or negligent misrepresentation theories.
Morris v. Wyeth, Inc., 2008 WL 2677048, at *3-4 (W.D. Ky. June 30, 2008). Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability or negligent misrepresentation theories.
Smith v. Wyeth, Inc., 2008 WL 2677051, at *3-4 (W.D. Ky. June 30, 2008). Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability or negligent misrepresentation theories.
Westerlund v. Wyeth, Inc., 2008 WL 5592753, at *?? (N.J. Super. Law Div. Oct. 20, 2008). Amiodarone (Cordarone) case. Name brand manufacturer not liable under statutory product liability or any other theory.
Mensing v. Wyeth, Inc., 2008 WL 4724286, at *5 (D. Minn. Oct. 27, 2008). Metoclopramide (Reglan) case. Name brand manufacturer not liable under negligent misrepresentation, misrepresentation by omission, fraudulent concealment, or constructive fraud theories.
Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299, 309-311 (Cal. App. Nov. 7, 2008), review denied (Cal. Jan. 21, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under strict liability theory. Name brand manufacturer may be liable under negligent misrepresentation or fraudulent misrepresentation theories.
Huck v. Trimark Physicians Group, 2009 WL 3760458, slip op. at 1-2 (Iowa Dist. Feb. 27, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under any (unspecified) theories.
Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under any (unspecified) theories for lack of duty.
Schrock v. Wyeth, Inc., 601 F. Supp.2d 1262, 1266- (W.D. Okla. March 11, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under any (unspecified) theory for failure of causation.
Moretti v. Wyeth, Inc., 2009 WL 749532, at *3-4 (D. Nev. March 20, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under Restatement (Second) of Torts §§310, 311, 323 (1965), misrepresentation by omission, constructive fraud, negligent misrepresentation, or fraudulent concealment theories. Conte rejected as contrary to law and policy.
Fields v. Wyeth, Inc., 613 F. Supp.2d 1056, 1060-61 (W.D. Ark. May 11, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability, strict liability, negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, or implied warranty theories.
Stoddard v. Wyeth, Inc., 630 F. Supp.2d 631, 633-34 (E.D.N.C. June 24, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under express warranty, implied warranty, negligence, negligent omission, negligent misrepresentation, negligent undertaking, fraud, intentional infliction of emotional distress, negligent infliction of emotional distress, or consumer fraud theories.
Bartlett v. Mutual Pharmaceutical Co., ___ F. Supp.2d ___, 2009 WL 3126305, at *25 n.40 (D.N.H. Sept. 30, 2009). Sulindac case. Dictum recognizing "widespread rejection" of theories of "innovator liability."
Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability, negligence, strict liability, implied warranty, misrepresentation, fraudulent concealment, consumer fraud, or gross negligence. Conte rejected as anomalous and contrary to law.
Meade v. Parsley, 2009 WL 3806716, at *2-3 (slip op.) (S.D.W. Va. Nov. 13, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under unspecified "many theories of liability." Conte is considered and rejected.
Morris v. Wyeth, Inc., 2009 WL 4064103, at *4-6 (slip op.) (W.D. La. Nov. 23, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable under statutory product liability theory (within which all other causes of action are subsumed).
Mensing v. Wyeth, Inc., ___ F.3d ___, 2009 WL 4111209, slip op. at 16-18 (8th Cir. Nov. 27, 2009). Metoclopramide (Reglan) case. Name brand manufacturer not liable for various common law torts including negligent representation and fraud.

Preemption Scholarship

2009-12-08T08:00:00.000-05:00

We were accused -- okay, okay; we were guilty -- of being an "all preemption, all the time" blog in the days leading up to the Supreme Court's decision in Wyeth v. Levine.

But those halcyon days are behind us.

We're now half preemption, half the time.

It's that time!

Here are two recent articles wrestling with preemption law as it stands today.

First, Richard Cupp, Jr., (Pepperdine) has posted to SSRN "Preemption's Rise (and Bit of a Fall) as Products Liability Reform: Wyeth, Riegel, Altria, and the Restatement (Third)'s Prescription Product Design Defect Standard." In the words of the abstract:

"This Article compares and contrasts the rocky reception the Restatement (Third) of Torts section 6(c)’s restrictive prescription product design standard has endured with the rise of an increasingly active judicial approach to preemption from the 1990s through the late 2000s. Preemption’s rise may have to some extent crested (at least for now) with Riegel v. Medtronic in 2008, and it showed signs of possible contraction (again, at least for now) with Wyeth v. Levine in 2009. The Article analyzes the effect of preemption’s rise in the 1990s and pre-Wyeth 2000s on developing a generally more restrictive approach to prescription product design defect claims, along with other prescription product defect claims. The article suggests that the restrictive tone of section 6(c) may have to some extent caught the 'mood' of courts regarding prescription product design liability, even if the specific details of the unfamiliar standard have not found much traction. Indeed, some of the rationales provided for section 6(c) overlap with some of the rationales the Supreme Court employed in the 1990s and 2000s to support its increasingly aggressive use of preemption analysis in prescription products cases. Thus, the article concludes that the currents underlying section 6(c)’s restrictive tone for prescription product design liability may have found a “back door” in Supreme Court rulings such as Daubert and Riegel, despite most courts’ and commentators’ refusal to provide “front door” acceptance of the Restatement (Third)’s prescription product design defect standard. Further, the article contemplates whether Wyeth may represent the start of a contraction in preemption doctrine or whether its significance will be more limited. "

Second, Sandra Zellmer (Nebraska) has published "Preemption By Stealth" in the Houston Law Review. But a miracle of modern technology makes that puppy available for you at SSRN here. Zellmer accuses the Roberts Court of a pro-business bent, but she published her article before Wyeth v. Levine came down. In any event, here's the key snippet from her abstract:

"By focusing specifically on cases involving statutory savings clauses, this Article attempts to identify preemption patterns and principles from a discrete set of opinions issued by the Rehnquist and Roberts Courts through 2008. It undertakes a comparative analysis of case law in four areas: (1) the environment; (2) labor and employment; (3) products liability; and (4) agricultural practices. These four were chosen both because of the tremendous activity in these areas by all three branches of the federal government since the 1980s and because of their importance to federal–state relations. The analysis of key cases in these four areas indicates that, where Congress has included a savings clause in the allegedly preemptive federal statute, the Rehnquist Court was willing to allow some redress to injured persons, yet at the same time it paid little attention to savings clauses when it came to the preemption of protective state or local regulations. Where state or local regulations were challenged on preemption grounds, neither the statutory language nor the overarching congressional goals seemed to carry much weight. If we narrow the focus even further, and consider only the Roberts Court, a nascent trend in favor of business and against both state interests and injured persons alike is discernible in both tort and regulatory cases. The most significant tort case issued by the Roberts Court to date, Riegel v. Medtronic, Inc., indicates that the Court is taking an especially broad view of preemption clauses and a correspondingly dim view of savings clauses. It is too early to tell whether we might expect it to find preemption whenever business interests are affected, regardless of the context, but Riegel may be indicative of the future direction of the Roberts Court."

Now that we've done our preemption duty, maybe we can go back to some unusual topics -- like, say, Daubert or the learned intermediary doctrine.

(We're just full of surprises.)

New Drug/Vaccine Preemption Scorecard

2009-03-26T08:00:00.001-04:00

It was inevitable, we guess. Just as we ended up creating a new express preemption scorecard for medical devices after Riegel, we've decided to do the same with the drug/vaccine preemption after Wyeth v. Levine (yes, we know Levine doesn't address vaccines, but since we have to change one, we'll change them both).

It's basically the same as our other scorecards. It will be in chronological order after Levine, and we'll mention the drug, the basic result, pro or con, as well as the nature of the claims involved, to the extent they differ from Levine.

Smith v. Wyeth, 2009 WL 736208 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4697002, reconsideration denied, 2009 WL 425032) (see prior scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5460) is pending in the Sixth Circuit.
Morris v. Wyeth, 2009 WL 736200 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (582 F.Supp.2d 861, reconsideration denied, 642 F. Supp.2d 677) (see prior scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5509) is pending in the Sixth Circuit
Wilson v. Wyeth, Inc., 2009 WL 736198 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4696995, reconsideration denied, 2009 WL 425027) (see prior scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5466) is pending in the Sixth Circuit
Schrock v. Wyeth Inc., 601 F. Supp.2d 1262 (W.D. Okla. March 11, 2009), reconsideration denied (May 22, 2009), finding no preemption of warning claims in case involving generic Reglan. Considering defendant's arguments "similar, if not identical," to those rejected in Levine.
Stacel v. Teva Pharmaceuticals, USA, 620 F. Supp.2d 899 (N.D. Ill. March 16, 2009), finding no preemption of warning claims in case involving generic Minocin. While generics are distinguishable, the court rejects the FDA's position that generic manufacturers could not modify warnings via CBE process.
Longs v. Wyeth, 621 F. Supp.2d 504 (N.D. Ohio March 20, 2009), preemption recognized upon reconsideration (see prior scorecard) in fen-phen case of claim that the drug "was an ‘unreasonably dangerous’ drug for which no warning would have been adequate. This is a final order. An appeal (No. 09-3380) is pending in the Sixth Circuit.
Bruesewitz v. Wyeth, 561 F.3d 233 (3d Cir. March 27, 2009), express preemption affirmed (see prior scorecard) under Vaccine Act of design and warning claims in case involving DTP vaccine to infant.
Kellogg v. Wyeth, 612 F. Supp.2d 437 (D. Vt. April 10, 2009), denying motion for interlocutory appeal of pre-Levine ruling finding (see prior scorecard) no preemption of warning claims in case involving generic Reglan. While generics are distinguishable, the court concludes that Levine supports its prior ruling.
Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.3d 760 (Tex. App. April 14, 2009), reversing pre-Levine preemption ruling (see prior scorecard) in HRT litigation after the defendant withdrew its preemption argument in light of Levine. Plaintiff argued for warnings that the FDA later adopted.
Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009), no obstacle preemption of refund claim where FDA recalled drug on wholesale level but not retail level. There was no FDA conclusion that the recalled drug was actually safe.
Forst v. SmithKline Beecham Corp., 2009 WL 2256232, slip op. (E.D. Wisc. July 29, 2009), no obstacle or impossibility preemption in SSRI (Paxil) adult suicide case.
Bartlett v. Mutual Pharmaceutical Co., ___ F. Supp.2d ___, 2009 WL 3126305, slip op. (D.N.H. Sept. 30, 2009), finding no preemption of warning claims in case involving generic Sulindac. The generic preemption argument has no effect upon non-warning claims. Nothing in the FDCA prohibits generic manufacturers from post-approval modifications of their warnings, through the CBE process or otherwise. No deference granted to various FDA statements. Even if dissimilar labeling were a violation, the FDA has never taken enforcement action in such circumstances. There is no evidence of congressional intent to preempt state tort law as a means of lowering the cost of generic drugs.
Munroe v. Barr Laboratories, Inc., ___ F. Supp.2d ___, 2009 WL 4047949 (N.D. Fla. Oct. 15, 2009), finding no preemption of warning claims in case involving generic Adderall. Generic manufacturers may use the CBE process. Generic manufacturers are subject to the same liability as pioneer manufacturers.
In re: Aredia And Zometa Products Liability Litigation, ___ Fed. Appx. ___, 2009 WL 4072074 (6th Cir. Nov. 24, 2009), affirming preemption (see prior scorecard) of fraud-on-the-FDA exception to Michigan tort reform statute. Preemption applies to all claims alleging fraud on the FDA, including post-approval fraud and fraud asserted against an affirmative defense.
Gaeta v. Perrigo Pharmaceuticals Co., 2009 WL 4250690, slip op. (N.D. Cal. Nov. 24, 2009), refusing reconsideration of order (562 F. Supp.2d 1091, see prior scorecard) holding that implied preemption bars warning claims in case involving generic ibuprofen. Levine did not address generic drug preemption and the requirement that generic drug warnings be the "same" precludes resort to the CBE process that was dispositive in Levine. This is a final judgment and there will be an appeal.
Mensing v. Wyeth, Inc., ___ F.3d ___, 2009 WL 4111209, slip op. (8th Cir. Nov. 27, 2009), finding no preemption of warning claims in case involving generic metoclopramide. Regardless of CBE requirements the common law could impose a duty upon generic drug manufacturers to alert the FDA and to seek a stronger warning for both generic and brand name labeling or to have the agency issue a "Dear Doctor" letter, in light of evolving knowledge. Nothing in Hatch-Waxman evinces a congressional intent to preempt state law.
Couick v. Wyeth, Inc., 3:09-cv-RJC-DSC, slip op. (W.D.N.C. Dec. 7, 2009), finding no preemption of warning claims in case involving generic metoclopramide. Following analysis in Mensing; not deciding whether generic manufacturers could utilize CBE procedure. There was no conflict preemption because a generic manufacturer could have proposed a label change through the prior approval process. Fraud claims involving misrepresentations to doctors or patients are not based solely upon FDCA violations and thus are not barred under Buckman.

A Little Iqbal Win

2009-12-07T08:00:00.000-05:00

We just stumbled across Mohr v. Targeted Genetics, No. 09-3170, 2009 LEXIS 107761 (C.D. Ill. Nov. 18, 2009), and thought we'd share that small Iqbal win.

Jolee Mohr was enrolled in a clinical trial for an investigational gene therapy for rheumatoid arthritis. While Mohr was in the trial, her treating physician prescribed Abbott's rheumatoid arthritis drug, Humira, for her. Mohr died on July 24, 2007. The complaint pled that physicians should have known that it was dangerous to prescribe the investigational gene therapy and Humira simultaneously. The complaint named the manufacturer of the investigational therapy, Abbott, and an institutional review board as defendants.

But the complaint pled no specifics about Abbott's alleged misconduct. Abbott neither contributed to the design or manufacture of the investigational therapy nor was involved in any way in the clinical trial. All it did was lawfully distribute Humira.

The complaint pled strict liability and wrongful death claims against Abbott, but the complaint did not identify any tortious conduct by Abbott. Even if it were true that Mohr was prescribed and ingested Humira, those facts don't state a claim against Abbott. And, under Iqbal, plaintiffs must do more than plead "the 'magic words' which are typically used to support a product liability claim." Id. at *8. The court thus granted Abbott's motion to dismiss, although it gave plaintiff the right to replead.

Perhaps we'll have more to report if the plaintiff chooses to file an amended complaint.

(New) Medical Device Preemption Scorecard

2008-08-21T07:00:00.000-04:00

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:

Strini v. Edwards Lifesciences Corp., 2008 WL 820192 (Mag. N.D.N.Y. March 26, 2008). Preemption issues cannot be decided in context of a discovery motion. “Parallel” violation claims might escape preemption.
Stevens v. Pacesetter, Inc., 2008 WL 2637417 (D.S.C. April 1, 2008). No “parallel” violation claims pleaded; action preempted in its entirety.
Despain v. Bradburn, 282 S.W.3d 814 (Ark. April 10, 2008). Plaintiff’s claims preempted. No manufacturing defect claim pleaded.
O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008). 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.
Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008). Express warranty and failure to test claims are preempted under Riegel. Allegations amounting to fraud on the FDA are preempted by Buckman. Plaintiff has appealed this case.
McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008). Express warranty and failure to test claims are preempted under Riegel. Allegations amounting to fraud on the FDA are preempted by Buckman. Plaintiff has appealed this case.
Troutman v. Curtis, 185 P.3d 930 (Kan. June 20, 2008). Plaintiff barely pleaded, and entirely failed to prove, any unpreempted “parallel” violation claims.
Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008). A claim based on the activities of defendant’s on-site representative escapes preemption as not regulated by the FDA.
Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008). Taking judicial notice of FDA PMA. 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.
Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 31, 2008). Plaintiff failed to prove any unpreempted “parallel” violation claims. Negligent failure to train claims are preempted as “in addition to” the FDA’s requirements imposed upon the device.
McCutcheon v. Zimmer Holdings, Inc., 586 F. Supp.2d 917 (N.D. Ill. Aug. 6, 2008). Violation claims involving information the defendant 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.
Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008). FDA filed suit against manufacturer for violating Good Manufacturing Practices requirements. Plaintiff's strict liability and implied warranty claims that manufacturer sold adulterated product not preempted under Riegel.
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, including consumer protection, and breach of unspecified warranties, are preempted.
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 products in question had PMA approval.
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.
Carson v. Depuy Spine, Inc., CV 06‐7430‐VBF(PLAx), order (C.D. Cal. Sept. 17, 2009). 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. An appeal is pending (08-56698) in the Ninth Circuit.
Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. Oct. 22, 2008). Motion to dismiss on preemption grounds granted. 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.
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.
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).
Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008), reconsideration denied, 2009 U.S. Dist. Lexis 77572 (Aug. 31, 2009). Motion to dismiss granted ageinst all claims concerning total hip replacement prosthesis. Subsequent recall does not revoke PMA. Tort claims to not become parallel claims escaping preemption simply by adding allegations that FDCA violations were collaterally violated. Parallel claims limited to "a state regulatory enactment that provides damages remedies for violations of FDA regulations."
Robinson v. Endovascular Technologies, Inc., 2008 WL 5267874 (Cal. Super. Santa Clara Co. Dec. 17, 2008). Summary judgment granted against all claims concerning Ancure endograft system, an investigational device. Riegel applies to IDE devices.
Norks v. Endovascular Technologies, Inc., 2008 WL 5267875 (Cal. Super. Santa Clara Co. Dec. 17, 2008). Summary judgment granted against all claims concerning Ancure endograft system, an investigational device. Riegel applies to IDE devices. This case was appealed to the 6th Division of the California Court of Appeals on March 5, 2009).
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.
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 has been certified to the Third Circuit. Huber v. Howmedica Osteonics Corp., 2009 WL 2998160 (D.N.J. March 10, 2009).
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 parellel. 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.
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.
Means v. Howmedica Osteonics Corp., 2009 WL 347407 (S.D. Ind. Feb. 11, 2009), minute order following Hofts in hip replacement prosthesis case.
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.
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.
Shertzer v. Howmedica Osteonics Corp., 2009 WL 535997 (S.D. Ind. March 3, 2009), minute order following Hofts in hip replacement prosthesis case.
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.
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.
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.
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.
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.
Mullin v. Guidant Corp., 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.
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. 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 currently on appeal in the Eighth Circuit at No. 09-2870.
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.
Colombini v. Westchester County Health Care Corp., 24 Misc.3d 1222(A), ___ N.Y.S.2d ___, 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.
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.
Weston v. Kim's Dollar Store, ___ S.E.2d ___, 2009 WL 2136707 (S.C. App. July 15, 2009). All claims properly held preempted in litigation concerning colored contact lenses. The lenses were regulated by the FDA and were not purely cosmetic. Although a "misbranding" claim was alleged, it was not separately discussed.
Wolicki-Gables v. Arrow International, Inc., 641 F. Supp. 2d 1270 (M.D. Fla. July 22, 2009). Summary judgment granted against all claims against the manufacturer and distributor of a pain pump. No parallel claims were alleged.
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.
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.
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.
Williams v. Cyberonics, Inc., ___ F. Supp.2d ___, 2009 WL 2914414 (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.
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 preemtion, since essentially the same device was approved. A non-waiver clause in an informed consent form does not override preemption.
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.
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.
Hughes v. Boston Scientific Corp., ___ F. Supp.2d ___, 2009 WL 3817586 (S.D. Miss. Nov. 12, 2009). Summary judgment granted against all claims in HydroTherm Ablator case. Negligence per se claim based on post-market reporting procedures allegedly violating the FDCA is preempted under Buckman. Alleged negligent misrepresentation to the FDA is barred for the same reason as fraud on the FDA, because it would second guess FDA reporting requirements. Calling such claims "parallel violation" claims under Riegel is a distinction without a difference. Negligence per se based on FDCA violations does not state a common-law cause of action.
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.
Funk v. Stryker Corp., C.A. No. H:09-00733, slip op. (S.D. Tex. Dec. 1, 2009). Motion to dismiss granted against all claims in ceramic total hip replacement case. PMA approval is a matter of public record subject to judicial notice. Preemption bars implied warranty, most negligence claims, product liability, and consumer fraud claims. Res ipsa cannot be employed to establish an FDCA violation in a complex medical device. One may not infer a defect or a violation from a negative side effect.

Off-Label Promotion and False Claims

2009-12-05T06:21:00.001-05:00

We don't routinely follow qui tam litigation involving our clients. It's not something that we, personally, defend against. It's not our sandbox; qui tam trolls are the responsibility of other defense counsel.

But we are interested in off-label use. Thus Hopper v. Solvay Pharmaceuticals, No. 08-15810, slip op. (11th Cir. Dec. 4, 2009), caught our eye. It's one of these cases where a supposed relator (almost invariably a disgruntled sales rep) tries to turn allegations of off-label promotion into a false claims case. The district court recognized the difference between off-label promotion (which is illegal under the FDCA) and the submission of false claims to the government. The district court held that government payment for off-label uses does not, in and of itself, equal a recoupable "false claim" and the 11th Circuit affirmed yesterday.

Two theories of false claim recovery were at issue. The first, under 31 U.S.C. §3729(a)(1), requires "presentment" - which is a term of art, that as we understand it from reading the opinion, requires proof that someone (usually a doctor) "knowingly" sent the government a false claim. Off-label promotion, followed by the government paying for such off label uses (it's a weird statute - nobody seems to care whether the off-label use was medically effective or not) wasn't enough. They had to allege that some presenter knew that the claim itself was dodgy:

The Complaint also includes what the relators describe as “a highly-compelling statistical analysis". . .[showing off-label promotion followed by more claims submitted for off-label use]. But, the Complaint does not allegethe existence of a single actual false claim. . . . [T]he relators’ Complaint does not identify a single physician who wrote a prescription with such knowledge, does not identify a single pharmacist who filled such a prescription, and does not identify a single state healthcare program that submitted a claim for reimbursement to the federal government.

Hopper, slip op. at 12-13 (emphasis added). In other words, there has to be intent to submit a false claim. It's just possible for doctors to submit claims for off-label prescriptions that aren't false ("the horror, the horror"). We're glad to see that the False Claims Act recognizes that off-label use is legal - even if it doesn't seem to recognize that it's often clinically effective and within the medical standard of care. Without proof of anybody's intent, the complaint simply "pile[d] inference upon inference to suggest that [defendant's] marketing campaign influenced some unknown third parties to file false claims." Slip op. at 13.

That's the "presentment"-based claim.

There was a second claim, under 31 U.S.C. §3729(a)(2), that didn't require presentment of actual false claims to the government. That, in and of itself, seems Orwellian to us, but there doesn't seem to be any dispute about the statutory elements. It does, however, require specific fraudulent intent on behalf of the defendant and causation:

[A] plaintiff must show that (1) the defendant made a false record or statement for the purpose of getting a false claim paid or approved by the government; and (2) the defendant’s false record or statement caused the government to actually pay a false claim, either to the defendant itself, or to a third party.

Slip op. at 16 (emphasis added). And so, mere illegal off-label promotion isn't enough to state a claim under this section either. The protion must be intentionally directed at inducing a false claim and there must be reliance down the chain. There still must be a false claim. Id. (the section "demands proof that the government paid a false claim"). Off-label promotion (an "improper practice") isn't enough:

Improper practices standing alone are insufficient to state a claim. . .absent allegations that a specific fraudulent claim was in fact submitted to the government. . . . Congress intended this subsection to impose liability for false statements that actually cause the government to pay amounts it does not owe. . . .[T]he relators must show that the government paid a false claim. . . . Subsection (a)(2) is not, as the relators contend, a separate “attempt” provision.

Slip op. at 17-18 (emphasis added). Causation requires actual reliance upon bad faith statements:

[T]he Complaint remains deficient because it fails to allege that the defendants intended for the government to rely on their false statements in deciding whether to pay a false claim. . . . It is insufficient for a plaintiff to show merely that a false statement resulted in the use of government funds to pay a false or fraudulent
claim. . . . [T]heir complaint does not link the alleged false statements to the government’s decision to pay false claims. It fails to allege that the defendants intended for the government to rely on the substance of their off-label marketing campaign to decide to pay a claim. . . .

Slip op. at 21-22 (emphasis original). Thus - and to us it's the important point - good faith off-label use by physicians who believe the use to be beneficial to their patients severs the causal chain, no matter how illegal the promotion itself may have been.

We cannot infer that because [defendant] allegedly intended its marketing campaign to convince physicians to write off-label prescriptions, [it] intended for that campaign to influence the government’s decision to pay for those prescriptions.

Slip op. at 22. There's no "direct link" as long as the defendant isn't intending for the government itself to rely on the off-label promotion. It's not enough to allege that the off-label promotion was intended "to be material to physicians’ decisions to write off-label prescriptions." There must be allegations that the defendant "intended its false statements to play a[] role in the government’s decision to reimburse." Id. at 23.

We sure hope that Hopper is the law in this area. Off-label promotion is illegal, but off-label use isn't. Off-label use in most cases is beneficial to patients, or otherwise physicians wouldn't prescribe off-label so often. If off-label use is medically beneficial, then as far as we're concerned it should be covered by governmental programs.

To equate off-label use with a false claim would inevitably deter provision of medically beneficial treatment simply because it's off-label. If that happened, people could die. We care about that, even if qui tam relators don't.

This And That

2009-12-04T08:00:00.000-05:00

We tried to think of a great issue to explore today – and struck out. So instead we’ll discuss this and that – various things that we’re aware of, but that we haven’t gotten around to mentioning.

Pigs Get Fat, Mississippi Got Slaughtered

The top of the agenda, of course, is a review of Judge Weinstein’s Zyprexa decision (now online at 2009 WL 4260857) that we threw up a post about the other day (so we could say we were first on the web) and promised our readers our thoughts later. Our thanks to the folks at Pepper Hamilton for forwarding it.

Well, now is later.

Our first thought is that the opinion sounded unusually like a valedictory. Not only does it contain an extensive recounting of all the things that Judge Weinstein’s done in the Zyprexa MDL, slip op. at 10-11, 12-16 (something that’s not unusual in his recent opinions), but it takes an almost fond look back over the court’s prior views on the use of statistical evidence to facilitate mass adjudication of claims that (in Judge Weinstein’s view, unfortunately) aren’t capable of mass adjudication under the substantive law. Slip op. at 65.

Judge Weinstein may be waxing nostalgic because, in the opinion, as a proper district court judge should, he acknowledges that his liberal view of statistical evidence is not shared by a large majority of courts - particularly appellate courts, and especially his own appellate court - which instead follow an “individualized proof rule.” Slip op. at 66-84. He recognizes that “the Fifth Circuit Court of Appeals [including Mississippi] is inclined to be at least as restrictive in its approach to aggregate proof in mass tort cases as is the Second Circuit [the circuit in which Judge Weinstein sits].” Id. at 78. The Second Circuit in McLaughlin v. American Tobacco Co., 552 F.3d 215 (2d Cir. 2008) (our post about it here), and other cases has “rejected any fluid recovery theory.” Slip op. at 83. These decisions led to the rejection of the same evidence by the same expert that Mississippi used in the Zyprexa litigation. Id. at 84 (discussing In re Neurontin Marketing, Sales Practices, and Liability Litigation, 257 F.R.D. 315, 327-33 (D. Mass. 2009) (our post about it here)).

Judge Weinstein found only one exception to the individualized proof rule – the recent decision in In re Pharmaceutical Industry Average Wholesale Price Litigation, 582 F.3d 156 (1st Cir. 2009) (“AWP”). Judge Weinstein thoroughly and sympatheticly discussed the rationale in AWP, observing that it “seems so persuasive” to him. Slip op. at 84-89. The court yearned for something to fill “the continuing need to find a procedurally convenient and fair way to try these kinds of mass product liability cases." Id. at 90.

However, the court was constrained to agree that AWP wasn’t a product liability mass tort, and indeed wasn't a tort case of any sort (which is why we didn't blog about it). AWP involved causes of action entirely different from Mississippi’s claims, which implicated not only the learned intermediary rule, but also state-law issues of reliance and causation.

Through its PLA [product liability] CPA [consumer fraud], fraud, and negligence claims, Mississippi seeks recovery of other damages, such as amounts paid to treat diseases caused by Zyprexa. These theories do not fall within [any] exception to the Individualized Proof Rule. Because the State relies on aggregate proof to establish these claims, they are barred.

Slip op. at 97. Specifically:

As to product liability, (1) the claims were subject to the economic loss rule, and (2) the individual claims were highly variable. Id. at 98. Allegations of injuries that would not have been sustained “but for” supposed illegal promotion were not subject to any statistical means of proving reliance by prescribing physicians as required by the learned intermediary rule. Id. at 99-100. “[E]ach prescribing decision and each patient’s injuries would have to be considered individually." Id. at 101.

We might also add, that because Mississippi was seeking reimbursement for its own increased medical treatment costs for patients allegedly suffering Zyprexa-caused adverse reactions, recovery of these purely governmental expenses would also be barred by the municipal cost recovery rule that we discussed earlier, here. But that only makes the rubble bounce.

As to Medicaid fraud, and so-called “unjust enrichment,” allegations of submission of reimbursement claims for off-label use involve “the reliance of prescribing physicians on the absence of proper warnings.” Slip op. at 102. Reliance is individualized. The notion of off-label prescriptions as “not medically necessary” wasn't persuasive in the face of evidence that Zyprexa provided benefit to many patients in off-label situations. Id. at 103-04. “Medical necessity” “must take into account all the information available to the prescribing physician about the risks and benefits with respect to the individual patient in question and the myriad factors affecting [that patient], his family, and his associates. Id. at 103-04.

As to consumer fraud, the state would have to prove “ascertainable loss.” Depending on what that meant (which the state never made clear) it could fail for the same reasons (or not) as the other claims. Id. at 106.

As to common-law fraud and negligence, they “both require a showing of causation by reliance of prescribing physicians." Id. at 108. The fraud claim also looped back to the concept of medical necessity. Id. All such claims would require examining the reactions to the defendant’s alleged actions of a “heterogeneous population of. . .patients and physicians.” Id. at 109.

The Court’s decision was, at times, visibly reluctant. It concluded that the claims brought by Mississippi couldn’t be adjudicated on a mass basis and – since the state was unable or unwilling to prove them one-by-one – there was no evidence on critical causation, reliance, and injury points, which required entry of summary judgment.

Despite this court’s view to the contrary, appellate decisions have held that issues of reliance, loss causation, and injury are inappropriate for aggregation, due to the need to prove these elements on an individualized basis for each victim or injured party.

Slip op. at 65 (collecting cases).

One claim survived summary judgment – based upon a “theory that patients who were given [the drug] for unapproved uses received less benefit. . .and therefore the difference for those patients from the market price. . .and value received was greater.” Slip op. at 94. However, a major (if not sole) reason that this theory survived was because the court had already decided that exact issue in an earlier class action ruling and it was already on appeal from a prior Zyprexa decision. Id. at 95-96 (see our post about that, here). The value difference liability claims were stayed pending the outcome of that appeal. Slip op. at 108-09. Everything else went down to defeat.

There’s another thread, too. Judge Weinstein discusses at some length how all of the other states who brought similar claims in the Zyprexa MDL had the good sense to settle them for what he called “rough[ly] equivalen[t]” amounts “relative to the size of each state.” Slip op. at 20; see generally id. at 17-20 (discussing state and federal government settlements). Mississippi was – again unable or unwilling – to come to such a settlement, so its claims, which were legally meritless in any event, come to naught. At one point, late in the opinion, the court characterized Mississippi’s stance as “slash and burn” litigation. Slip op. at 116. The state was demanding billions (fines of up to $10,000 dollars for “almost one million” prescriptions, regardless of benefit or harm to any patient, id. at 97).

The court firmly rejected the notion of multiplied statutory penalties, and stated, in dictum, that such penalties were probably unconstitutional as “excessive fines.” Slip op. at 114-16. Assessing a penalty was in the “discretion” of the court, and that discretion turned on many factors: off-label use, medical necessity, benefit to the patient, harm to the patient, what the medical community knew at the time, and particular allegations of misconduct. Id. at 107. The court wasn’t about to undertake such an exercise:

Regardless of the lack of individualized evidence, imposition of civil penalties on a per-violation basis would entail separate examination of each of hundreds of thousands of claimed violations for purposes of determining the appropriate fine. Such an inquiry is impractical and beyond the resources of any court.

Slip op. at 107-08.

So by taking and sticking with an extreme position, Mississippi ended up getting essentially nothing. The court pointed out that the only money Mississippi received was less than several hundred thousand dollars in “holdbacks” from individual settlements that included Medicaid reimbursements. Slip op. at 20-21.

Here’s also where “other considerations” came into play. For one thing, the state knew full well that for years Zyprexa (and other similar drugs) was widely prescribed off label. Even if the state could take advantage of its governmental status to avoid the statute of limitations, slip op. at 62, it plainly sat on known information – just like (Judge Weinstein pointed out) Alabama had. See AstraZeneca LP v. State of Alabama, 2009 WL 3335904 (Ala. Oct. 16, 2009) (see our discussion here). While the court did not “rely" on this basis, it correctly chastised the state for its opportunism. Slip op. at 113 (“the State has. . .a special obligation to understand the benefits and dangers of widely prescribed drugs” used in its programs).

For another thing, the court didn’t share the state’s attitude towards the drug in question. A significant source of the court’s irritation with Mississippi (and presumably any other state, had any been so foolish not to settle claims that would have suffered similar fates) is the simple fact that Zyprexa (and other similar drugs) works – it brings about favorable outcomes – for both on-label and off-label uses. Judge Weinstein spends a great deal of time describing the benefits of the drug in the opinion. Slip op. at 6, 21-30, 31-33, 45-47, 113-14. Just a little of the flavor:

Numerous articles in medical journals and periodicals have reported off-label uses of atypical antipsychotics; some have endorsed such uses. Slip op. at 32.

An extensive list of the uses (on- and off-label) for which atypical antipsychotics have become “first line agents.” Id.

"Atypical antipsychotics are routinely prescribed off-label." Id. at 33.

"Even for those medications associated with an increased risk of metabolic side effects the benefit to specific patients could outweigh the potential risks. For example [a drug] has unique benefits for treatment refractory patients and those at significant risk for suicidal behavior." Id. at 6 (quoting ADA consensus statement).

"[Defendant]. . .has created a product with substantial benefits that even now – after many years of litigation, research, testing, and controversy – is still favored by many physicians and patients. . .for some of the most serious psychological conditions that afflict millions of people worldwide. Courts cannot ignore the substantial benefits accruing. . .from use of [the drug]. . .[which] [p]revent[s] users with serious mental problems from requiring hospitalization. . .and allow[s] them to become productive taxpayers and participants in the economy." Id. at 113.

Even the court’s discussion of the defendant’s off-label promotion is loaded with laudatory descriptions of clinical benefits, slip op. at 35-42 – comments that the opinion implicitly endorses as a matter of substantive medical (as opposed to legal) judgment. “Viva Zyprexa” (id. at 37), indeed.

Beyond all that, the court concluded as a matter of law that the “various deleterious metabolic effects,” which are primarily what's at issue in the litigation, slip op. at 47, were commonly known risks by the medical community since March 1, 2004. Id. at 48-49. And “the facts in many individual cases indicate a much earlier date of discovery." Id. at 49.

Query: Would it be off-label promotion for drug companies to distribute these parts of Judge Weinstein’s opinion? Just kidding – don’t try it, folks, even though it would almost surely be First Amendment protected speech (see below, at part 4).

Finally there’s more grist for the mill of aggregate litigation theorizing. Judge Weinstein, who has probably thought about mass tort issues as much or more than any other sitting judge, coins another new term to describe claims like Mississippi’s – “a structural class action.” Slip op. at 65. These are cases that:

Conceptually and structurally. . .[are] predicated on numerous acts. . .alleged to have affected a statewide population. . . . In effect Mississippi’s individual claim is structured on the foundation of many thousands of conceptually separate claims, coordinated and aggregated by the State for purposes of recovering a portion of its overall [drug]-related costs through its Medicaid reimbursement program.

Slip op. at 64-65. In “structural class actions” the law developed in the Rule 23 context “regarding the uses and limitations of aggregate evidendce” is so analogous as to be binding. Id. at 65.

We don’t know how much longer Judge Weinstein intends to remain on the bench, but with this latest Zyprexa opinion, he’s surely given everyone – the plaintiffs’ side, the defense side, industry, other courts, the academy, and folks like us – something to talk about for a long time to come.

Preemption and Twombly/Iqbal – Funkadelic Together

We could just say “get the Funk out my face” (but we’d be dating ourselves). Thanks to Scott Michelman over at Shook Hardy, we put Funk v. Stryker Corp., 2009 WL 4281389, slip op. (S.D. Tex. Dec. 1, 2009), in our medical device preemption scorecard the other day. But Funk deserves better than that.

Funk is yet another post-Riegel PMA device preemption case, but with a three twists that defense counsel can use. Only one of them directly concerns preemption. The first point of interest involves judicial notice. Funk was decided on motion to dismiss, and since plaintiffs rarely allege PMA approval themselves (they're smarter than that), there’s always the procedural issue of getting the fact of PMA before the court. This proved especially difficult in Funk because the plaintiff resisted, “express[ing] uncertainty as to the type of FDA approval.” Slip op. at 11. The court found the type of PMA approval to be a matter of “public record” subject to judicial notice and went on to apply PMA preemption:

First, such a conclusion is consistent with both parties’ pleadings. [Plaintiff] states that the [device] underwent either the §510(k) or the PMA approval process. In stating the device received PMA approval, [defendant] does not dispute Funk’s contention but rather confirms its accuracy and specifies which of the alternatives is correct. Second, in support of its motion to dismiss, [defendant] has attached a letter from the FDA to [it] indicating that the [device] underwent the PMA process. In his response to the motion to dismiss, Funk seemed to object to [defendant’s] attachment of the letter; however, he did not question the letter’s validity.

Id. at 12. We’ve dedicated an entire post just to use of judicial notice to prove FDA regulatory matters, so readers should add Funk to that list. We’d also like to remind everyone that in that prior post, we detailed how to create lasting URLs to device approval information on the FDA’s website - so there’s a way for defendants to present this kind of approval information directly from the FDA to the court electronically.

The second interesting point about Funk has to do with pleading and Twombly/Iqbal. Maybe it’s come up before, but this is the first time we’ve noticed it in drugs/devices. This has to do with pleading by “information and belief.” Does information-and-belief pleading survive Twombly/Iqbal? The Funk court suggests that it does not, at least in the context of things like FDA approval:

Whether an allegation based solely on information and belief is sufficient, after Twombly, to survive a motion to dismiss is unclear. . . . Prior to Twombly, the Fifth Circuit held that “‘information and belief’ pleadings are generally deemed permissible. . . . However, in Twombly, the plaintiffs based one of their allegations. . .“upon information and belief,” and the Supreme Court held that this allegation, without more, failed to provide sufficient facts “to state a claim to relief that is plausible on its face.” 550 U.S. at 551. Moreover, the court notes that allegations based upon information and belief are particularly inappropriate in cases where the allegations are based on matters of public record.

Funk, slip op. at 3-4 (citations we don't care about omitted). Defense counsel should keep in mind, in filing post-Twombly/Iqbal motions to dismiss, that “information and belief” pleading is now of questionable validity.

Third, and finally, since the plaintiff in Funk had absolutely nothing, not even a warning letter, on which to base an arguably unpreempted “parallel violation” claim, he resorted to “res ipsa loquitur” – that simply from the device’s claimed failure, he was permitted to infer a regulatory violation. No way, José. That doctrine is “soundly refuted by Riegel." Funk, slip op. at 14.

As the Supreme Court recognized, the PMA process does not demand that an innovation be risk free; instead, the law amounts to a federal declaration that the product, if manufactured according to specifications, is not unreasonably dangerous in light of its potential benefits. Riegel, 128 S. Ct. at 1004. It would follow that one may not infer a defect in the product simply because a patient encountered negative side effects in using it.

Id. Thus the res ipsa loquitur argument was “circular” and its “reasoning is contrary to the holding in Riegel.” Funk, slip op. at 15.

Three useful holdings in the same opinion – that’s some funky music to our ears.

More on Twombly/Iqbal

While on the subject of Twombly/Iqbal, we’re aware the Senate Judiciary Committee hearing that took place yesterday. Like the prior congressional hearing on preemption (oh-so neutrally entitled “Protecting Patients from Defective Medical Devices”), this one was rather much of a kangaroo court. For the general tenor, check out the Legal Times Blog and AMLaw. The Lawprofessors have more links here.

As per usual the kangaroos only allowed our side one witness while the other side got more. Our side’s Daniel in this lion’s den was Gregory Garre, who, as Solicitor General, won Iqbal. We wouldn’t think of stealing his thunder, but we don’t mind borrowing a bit of it. For anybody who’s interested, here’s a copy of Mr. Garre’s prepared testimony before the Committee. It’s as fine a defense of Twombly/Iqbal as we’ve seen, so we recommend it.

All of the testimony before the committee is available here. Note that Penn’s Professor Burbank testified for the other side. So remember, when we face off with Prof. Burbank on PENNumbra over the coming month, it’s a couple of bloggers against a guy who was preparing congressional testimony at the same time.

We think we’ll hold our own, though.

And Finally, the First Amendment

We posted not too long ago about Allergan's suit against the FDA that contends that the Agency's restrictions on off-label promotion violate the First Amendment. We’re pleased, but not at all surprised, that the Washington Legal Foundation (and some others) has jumped into that fray with an excellent amicus brief. We’re not so pleased that WLF didn’t let us know about that brief, which they filed two weeks ago.

Anyway, for anybody interested in pursuing the First Amendment argument in the off-label context, give this thing a read. The first fifteen pages of the WLF brief are all policy, which we think (having some experience in the area) is harder to put together than the actual constitutional arguments. We've seen the constitutional arguments before, and posted about them several times, here, here, here, and here. We’d just be wasting our (and your) time going over them again. We’ll simply note that on page 19 of its brief, WLF quotes one of Bexis’ articles on the subject.

Just to be sure we weren’t missing anything else in the Allergan case, we checked PACER. We weren’t.

Suffice it to say that this is one that definitely warrants watching.

Why Big Firms Don't Blog Well

2009-12-03T09:36:00.000-05:00

Herrmann's off on a solo lark again.

He looked at the ABA Journal's list of the "Top 100" legal blogs of 2009 to see how many blogs affiliated with big firms -- the AmLaw 200 -- were on the list.

How many do you suppose there were?

Two.

The first is SCOTUS Blog -- but Tom Goldstein launched that when he was a solo practitioner and presented the blog as an established institution to Akin Gump. That doesn't count.

And us.

How can that be?

The absence of big firm blogs from the list is not for want of choices. Fully 41% of the AmLaw 200 are now blogging, to the tune of 227 blogs. But the ABA isn't impressed. Why not?

We (or, at least, Herrmann) thinks there's one reason: lack of voice.

There are three main ways to make a legal blog succeed:

1. Be a first source of news.

The Wall Street Journal Law Blog can do that; Ashby Jones is paid to monitor the news. Lawyers at big firms can't compete.

2. Be extremely smart.

With all respect to -- well, ourselves -- we can't compete on this score either. The guys at Volokh Conspiracy, Concurring Opinions, Prawfs Blawg, and the like are not just smart, but -- because they're academics -- are also paid to sit around thinking great thoughts. Lawyers at big firms are paid to pursue clients' interests; it's hard to compete on your nights and weekends with the thoughts of the full-time thinkers.

3. Have an engaging voice.

Be funny! Be provocative! Do something that will draw readers in.

That's the key for many successful blogs, such as Simple Justice. It's not a first source of news. It's not breathtakingly intelligent (although it's not bad on that score -- don't take offense, Scott). But it has a voice. It's funny, and it can be thought-provoking.

We suspect that our limited success at blogging is due in large part to our voice. We're rarely a first source of news. We're not that smart. But there are apparently a fair number of lawyers who appreciate sophomoric humor -- so we're golden!

But why aren't other big firm blogs having the same success? Why doesn't the ABA Journal appreciate them? Why can't big firm blogs succeed by virtue of voice?

We propose three hypotheses:

1. Most lawyers at big firms are not funny.

That may be true of many lawyers at big firms (although it hasn't stopped us). But it's surely not true of all. So some lawyers at big firms could write blogs in an engaging voice.

2. Lawyers at big firms are trained not to be funny in writing.

Now we're on to something. Opinion letters are not funny. They may do a fine job of analyzing issues and protecting the firm from allegations of malpractice, but they're not funny.

And briefs are generally not funny. (At least not intentionally so.) Briefs present the legal issues in a persuasive and intelligent way, and they give proper dignity to the occasion of a legal dispute. They're written in formal prose, with no room for contractions, the first person, or colloquialisms.

Briefs also avoid humor, and for good reason: Humor runs a risk. If you say something cute in a brief and the judge appreciates it, you might earn yourself a smile. And maybe some good will. But you're unlikely to win the motion on the basis of personality.

On the other hand, if you say something cute and the judge finds it to be offensive, you may have done your client a world of harm. So most lawyers appropriately use humor only very sparingly in briefs.

Perhaps years of brief-writing beats the humor out of lawyers.

3. Writing in a distinctive voice is risky.

We think this is the real explanation for why most big firm blogs don't draw large readerships (or accolades from the ABA).

Just as it's risky to be provocative in a brief -- because the benefits are so small, but the costs so potentially large -- it's risky to be provocative in a blog.

If we write something funny here, you might smile. But you'd never send an e-mail to our colleagues praising us for being a laugh riot.

On the other hand, if you read our attempted humor and are offended, you might not be so constrained. You might write directly to us (and some of you have) or you might write to others in our firm to complain about us (and some of you have done that, too).

Solo practitioners don't have to worry about that risk: If Scott Greenfield embarrasses himself at Simple Justice, no one can complain to his colleagues. Not so for those of us in the AmLaw 200.

Why should lawyers at big firms run that risk?

The benefits of blogging are awfully intangible (Kevin O'Keefe's protestations notwithstanding), while the risk that a complaint will resonate, and cause you trouble, is real. Even if you can convince yourself to spend nights and weekends reading and writing about the law (and thus to fuel a blog), there's no reason to run the risk that you'll be criticized (and pay a price) for all your efforts. So you strip all humor and provocation out of your posts.

You lose your voice.

The posts are good. They're informative. They're lawyerly.

But they're boring; no one's drawn to them.

So that's our best guess: Crafting a distinctive on-line voice entails risk; most lawyers at big firms (perhaps intelligently) choose to avoid that risk; and so most big firm blogs just dangle out there, twisting slowly in the wind.

Mississippi State AG Zyprexa Action Decimated

2009-12-01T14:42:00.000-05:00

This just in - Eli Lilly has received summary judgment against the Mississippi Attorney General's consumer fraud lawsuit in all respects - except one. The court left the state's claim based on the difference between the price paid for Zyprexa and the value received by the State alive, but largely because that issue is currently before the Second Circuit in the TPP class action appeal.

It's Judge Weinstein, so you know it's long - 117 pages - so right now we'll simply post the opinion. On page 10 the court states that summary judgment is granted "because the use of aggregate proof to establish essential elements of Mississippi's theories of recovery is barred by applicable case law."

When we've read it, we'll probably have more to say about it.

The ABA Still Loves Us!

2009-12-01T13:29:00.000-05:00

We're pleased to report that the ABA Journal has once again chosen our humble Drug and Device Law Blog as one of the "top 100" legal blogs of the year.

Here's a link to the cover story of the Journal that announces the list.

We are again flattered by the company that we're keeping. Other blogs that made the ABA Journal's cut include the Wall Street Journal Law Blog, the Volokh Conspiracy, and the Blog of Legal Times, all of which are mighty impressive enterprises.

The ABA Journal is again asking readers to vote for the best blog in each of several categories. If you think that our little experiment is the best blog in the category of "Practice Specific," you can show your support (by casting a vote) here.

Accolades are nice, but readers make blogging worthwhile. Thanks for joining us.

Let The Iqbal Debate Begin

2009-12-01T12:56:00.000-05:00

As we told you this morning, we were invited to participate in a debate hosted by the University of Pennsylvania Law Review's online supplement, PENNumbra.

The debate is about whether Congress should act to overrule the pleading standard set forth in Twombly and Iqbal.

We think not; Professor Stephen Burbank of the University of Pennsylvania feels otherwise.

Our Opening Statement has now been posted online at PENNumbra here.

One week from today, and then two weeks and three weeks, you'll see the series of essays that we and Professor Burbank have written on the subject.

Enjoy!

An All Iqbal Day

2009-12-01T08:00:00.000-05:00

We were recently invited to participate in an online debate with Professor Stephen Burbank (Univeristy of Pennsylvania) about whether Congress should act to overrule the pleading standard articulated by the Supreme Court in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009). (Yeah, yeah: We had the negative.)

That debate will be published online in four parts at the University of Pennsylvania Law Review's online supplement, PENNumbra. Our Opening Statement will be published later this morning. (We'll publish a post, and give you a link, as soon as it's up.) Professor Burbank's Opening Statement will be published one week from today, on December 8. Our Closing Statement will appear one week later (December 15), and Burbank closes on December 22. Burbank's a smart guy, and the project was a lot of fun (in the same odd way that many of our extracurricular writing adventures could be said to be fun). Stay tuned.

In the meantime, here's other Iqbal news:

First, Russell Jackson reports on a proposed bill that would statutorily overrule Twombly and Iqbal and write the result of Conley v. Gibson, 355 U.S. 41 (1957), into law. In addition to overruling Twombly and Iqbal, that bill would displace the heightened pleading standard created by the Private Securities Litigation Reform Act and do other damage. Read all about it here.

Second, an article in the November 9, 2009 issue of Business Insurance quotes John Rabiej, chief of the support office for the Rules Committee of the Judicial Conference of the United States, as saying that the Towmbly and Iqbal standard "has had 'little or no impact,' and that the Committee is 'very skeptical at this point' that a problem exists."

Third, on the other side of the coin, Professor Patricia Hatamyar (St. Thomas, Florida) posts at SSRN "The Tao of Pleadings," which suggests that Twombly and Iqbal may in fact have increased the percentage of motions to dismiss granted by trial courts.

Finally, the Penn State Law Review is hosting a symposium on Twombly and Iqbal in March 2010 and has issued a call for papers. Details are posted here at the Civil Procedure & Federal Courts Blog.

You'll surely be reading more on this subject in the coming months.

(In fact, in the coming hours. Look for our Opening Statement in PENNumbra before you head out to lunch.)

Generic Preemption - Still Kicking

2009-11-30T08:15:00.000-05:00

There's life in generic preemption yet. The court in Gaeta v. Perringo Pharmaceuticals, slip op. (N.D. Cal. Nov. 24, 2009), has denied reconsideration of the preemption summary judgment entered last year pre-Levine. The court holds that Levine's impossibility analysis did not consider the FDCA's requirement that generic labeling be the "same" as name-brand labeling, and that because of this "sameness" issue it was impossible for a generic manufacturer to utilize the changes being effected (CBE) procedure that had defeated preemption in Levine. Slip op. at 6-7. Thus, Levine was not dispositive, and the plaintiff was not entitled to reversal on reconsideration:

The Court finds that Levine did not address a dispositive issue in this case, namely, whether a generic drug manufacturer may use the CBE process to make warning-label changes without prior FDA approval, and thus Levine does not govern whether the Court may grant summary judgment on Plaintiff’s state tort claims based on the defense of impossibility pre-emption.

Slip op. at 7. It appears that the plaintiff did not raise in Gaeta the non-CBE arguments that we've seen in Mensing and Bartlett. If that happened, there's no hint of it in the opinion.

Tip of the cyberhat to Kelly Savage Day at Sedgwick Detert for sending the win along. Good luck on appeal.

Opposing MDL Common Benefit Funds

2009-11-30T08:00:00.000-05:00

In multidistrict litigation, the MDL transferee judge typically appoints a plaintiffs steering committee to manage the litigation for all plaintiffs. And the lawyers on that committee often say that the cost of work done for the "common benefit" of all plaintiffs should be borne by all plaintiffs, not just the clients of the lawyers on the steering committee.

MDL transferee judges thus frequently enter orders creating "common benefit funds" to pay the members of the steering committee for work performed for the good of all MDL plaintiffs. Those orders impose a tax on all settlements (or judgments) obtained by MDL plaintiffs -- some portion of each individual plaintiff's recovery is taken away from the plaintiff (or that plaintiff's counsel) and paid to the members of the steering committee.

(Here's a link to a recent, and helpful, article by William Rubenstein (of Harvard) discussing some procedural issues related to the entry of those orders and collecting in one place the amounts of the common benefit taxes imposed in an assortment of MDLs.)

In one -- wrong -- sense, defendants have no interest in whether an MDL judge imposes a tax on plaintiffs' settlements. After all, they're plaintiffs' settlements -- why should a defendant care whether a plaintiff's settlement is reduced?

But in another -- right -- sense, defendants are deeply interested in the imposition of a tax on plaintiffs' settlements. After all, if a settlement will be taxed, say, five percent, then the cost of a typical settlement will increase by roughly five percent.

That's surely ample interest to give defendants a right to speak when a plaintiffs steering committee files a motion seeking to create a common benefit fund.

What might the defendant say in such a brief?

A recent article gives food for thought.

In "The Quasi-Class Action Method of Managing Multidistrict Litigations: Problems and a Proposal," Charles Silver and Geoffrey P. Miller really mean to suggest a new way for steering committees to perform common benefit work. And the article is worth a read on that score.

But, at the top of page 3, Silver and Miller write these words:

"Compensation of Lead Attorneys. Over the long history of MDLs, judges have awarded lead attorneys billions of dollars in fees and cost reimbursements. The practice supposedly rests on the common fund doctrine, a creature of the law of restitution which undergirds fee awards in class actions. Yet, the U.S. Supreme Court has never said the doctrine applies in MDLs, which are consolidations not class suits, and the American Law Institute’s Restatement (Third) of the Law of Restitution and Unjust Enrichment says it does not: 'By comparison with class actions, court-imposed fees to appointed counsel in consolidated litigation frequently appear inconsistent with restitution principles.'"

This recent scholarship thus proposes certain wholesale attacks on the very notion of creating common benefit funds.

We could say more, but we won't.

Defense lawyers reading this post will surely find plenty to think about even if we stop here.

Happy thinking!

Mensing - Brand Name Wins, Generics Lose

2009-11-28T10:11:00.000-05:00

The Eighth Circuit gave brand name drug manufacturers cause to give thanks yesterday, but for generics, is was Black Friday. In Mensing v. Wyeth, Inc., No. 08-3850, slip op. (8th Cir. Nov. 27, 2009), the court answered two questions: (1) can a brand name manufacturer be liable for an alleged inadequate warning on a generic drug, where the plaintiff never used the brand name product, and (2) are warning claims against generic manufacturers preempted by the FDCA requirement that generic drugs have the "same" labeling as their brand name bioequivalents.

The court in Mensing said "no" to the first question and "no" again to the second.

Mensing, like almost all the recent branded/generic cases, involves Wyeth's drug Reglan - also sold generically as metoclopramide. The plaintiff used the drug a long time and suffered tardive dyskinesia. Her lawsuit attacking the warnings for this condition named both the generic and brand name manufacturers. The district court entered summary judgment - for non-use of the product (no duty of care) for the brand name and on preemption because the generic warnings would no longer be "the same" for the generic manufacturerer.

The preemption ruling, frankly, doesn't surprise us. Like the "impossibility" argument in Levine, the "sameness" argument in generic drug preemption depends upon Bush-era FDA statements in the Federal Register. The beating that the FDA's 2006 preemption preamble took in Levine pretty much presaged the same treatment for these other FDA statements about "sameness" and the ability of generic manufacturers to alter their warnings. See Mensing, slip op. at 9 n.4. Significantly, the first case that the Eighth Circuit cites is Bartlett v. Mutual Pharmaceutical Co., ___ F. Supp.2d ___, 2009 WL 3126305 (D.N.H. Sept. 30, 2009). Mensing, slip op. at 4. The moment we saw Bartlett, we thought "the generics better have better preemption arguments than they showed here." We remember feeling that way once before - when we first saw the Vaccine Act-based, anti-preemption arguments in the DTP litigation almost 20 years ago. We didn't have a good answer then, and we lost. We have yet to see a good answer from the generics to the arguments raised in Bartlett.

The Eighth Circuit accepts in Mensing essentially the same simplistic argument that the Supreme Court bought in Levine - that because there's no express preemption in Hatch-Waxman (the FDCA amendments that authorized generic drugs), it presumably was content to leave FDA-regulated generic warnings subject to tort attack. Mensing, slip op. at 7.

As far as unilateral label changes are concerned, the court held that generics may maintain "sameness" by simultaneously seeking changes in both generic and brand name labeling for the same compound - completely separate from the "changes being effected" (CBE) process. Id. at 8-9 ("generic defendants could have at least proposed a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved"). That's the Bartlett argument for which we haven't seen the generics offer a good answer. In other words, "§201.57(e) does not permit generic manufacturers passively to accept the inadequacy of their drug's label as they market and profit from it." Mensing, slip op. at 9.

Implicit in these comments is the FDA's expectation that generic manufacturers will initiate label changes other than those made to mirror changes to the name brand label and that the agency will attempt to approve such proposals quickly. The availability of one particular procedure (the CBE process, on which the district court expended the majority of its discussion) is immaterial to the preemption analysis in light of this clear directive to generic manufacturers and the availability of the prior approval process.

Mensing, slip op. at 10-11. On more or less the same rationale, the court also held that nothing in federal law prohibits generics from requesting the FDA to send out "Dear Doctor" letters about risks beyond those that appear on a drug's labeling. Id. at 11-12.

The court in Mensing then holds that there's no "obstacle" preemption because strengthening warnings does not necessarily require the sorts of expensive clinical trials that Hatch-Waxman did a way with for generic drugs. In this particular case, the preemption defense was undercut by the FDA, after the fact, requiring a stronger warning about the risk in question:

[T]he FDA did not conduct its own studies when it mandated an enhanced warning for metoclopramide. It simply referenced studies published elsewhere. Requests for label changes must be supported by scientific substantiation, but there is nothing to indicate that the information must be acquired through a manufacturer's own clinical tests.

Mensing, slip op. at 14. Imposing the same requirements to monitor ongoing clinical and research experience that pioneer manufacturers must undertake, the court held, did not present any preemptive "obstacle." Id. at 15.

That's the bad news for generics. The good news for brand name manufacturers is in the second half (third?) of the opinion. The court followed the "ovewhelming majority" of courts (including the Minnesota court of appeals - see our branded/generic scorecard) in rejecting an duty of care owed by a brand name manufacturer to any plaintiff that did not consume the branded product. Mensing, slip op. at 16-17. The court rejected the "determinative" weight given to supposed prescriber reliance in the (grotesque) Conte case from California. Mensing, slip op. at 17. Tort law ain't estoppel - it requires a duty:

"[C]entral" to a fraudulent misrepresentation claim under Minnesota law is "a suppression of facts which one party is under a legal or equitable obligation to communicate to the other, and which the other party is entitled to have communicated to him." In other words, regardless of whether her doctor relied upon the [branded] label, [plaintiff] must show that the name brand manufacturers owed her a duty of care. Duty is a threshold requirement for all of the tort claims [plaintiff] asserts.

Mensing, slip op. at 17 (citation and quotation marks omitted). There was no case plaintiff could cite that imposed liability on a defendant that had not, at least, "intended" to communicate with the plaintiff. Id. at 17 n.9. Unlike Conte bare "foreseeability" isn't enough. To extend a duty to warn about a competing product would "stretch[] the concept of foreseeability too far." Mensing, slip op. at 18. In short, good-bye Conte.

Unless the generics can show us a whole lot better preemption argument than we've seen to date, in the post-Levine era, we think they're unlikely to prevail on this ground. Conversely, with the generics likely to be subject to suit for their own labeling defects, the pressure that motivated the judicial tort activism seen in Conte is unlikely to recur. Thus, Mensing is probably the shape of things to come.

Belated tip of the cyberhat to Jeff Pilkington of Davis Graham for letting us know about Mensing.

Free Case Law On-Line From Google

2009-11-24T08:00:00.000-05:00

We're delighted that many of our readers are, like us, Luddites.

We know that some of you folks don't understand the meaning of complicated words like "RSS feed," "gigabyte," and "computer."

So we're betting that a few of you aren't yet aware that Google announced last week that Google Scholar now makes available on-line, and free of charge, a broad range of case law and law review articles. Here's the obligatory link.

This puppy is pretty stripped down. It doesn't have headnotes to cases, has issues with sorting results, and doesn't permit searches of, for example, one word "within X words" of another, which are important features.

Over at the Volokh Conspiracy, the head conspirator ran some searches and complained about what came up.

The Wall Street Journal Law Blog quotes folks from Lexis and Westlaw explaining that the availability of cases on-line and free doesn't worry them at all.

Information Today spent a fair amount of time experimenting with the product and posted a pretty favorable review.

Finally, the Supreme Court of Texas Blog walks you through the entire search process.

So, take a look.

Experiment.

See what you think.

And remember: A "computer" is that thing on your desk that you're staring at as you read this post.

Check That - Let's Look At Something Else (Vioxx and Fosamax)

2009-11-24T07:50:00.000-05:00

Yesterday we mentioned that Merck had won summary judgment in a consumer protection-type suit brought by the Texas Attorney General concerning Vioxx. We hoped for an "interesting opinion." Well, check that. We've now seen the order - and that's all there is (at least for now) - an order. Here it is, but it doesn't say much beyond the relief granted.

We couldn't have done much with it any way, given Bexis' involvement in (other) Vioxx litigation, so lets move on to something more interesting.

Yesterday was a good day for Merck (unlike ... umm ... well, just insert an appropriate W.C. Fields reference). The company also won summary judgment in another test case in the Fosamax MDL in New York federal court (If you can make it there, you can make it anywhere). Here's a copy of that opinion - which actually is interesting.

The first thing we have to say, just reading the facts, is where do they get these plaintiffs? If this is a test case, we'd hate to see (actually as defense lawyers, we'd love to see), the cases that even the plaintiffs think are weak. This plaintiff - old, disabled from what the opinion describes as smoking-related lung disease, skin cancer and abcesses in the mouth area, severe osteoporosis, and most importantly for a Fosamax case - a lifetime of miserable dental hygene. Slip op. at 3-4. On top of that, this plaintiff didn't even have a permanent injury, but rather healed up after she finally got dental care (or after stopping the drug, which is one of the issues the opinion addresses). Id.

In short, a wonderful combination of weak liability and low damages. But that's modern mass tort practice, for you.

This plaintiff was treated by two dentists. Neither of the treaters was willing to offer much of an opinion that the injury (which we will assume, for purposes of this post, was osteonecrosis - what the Fosamax litigation is mostly about) was caused by the plaintiff's use of Fosamax. Slip op. at 4-7.

The case is under Mississippi law (you know what I mean! - sorry, that's the best we could do for a Mississippi reference off the top of our heads). Plaintiff gives up on three of her four causes of action (design defect, manufacturing defect, negligence per se) right out of the box - and this is a test case - so we're left with a warning claim. Slip op. at 9.

But it wouldn't really have mattered what theory the plaintiff pursued, becuase she couldn't prove causation. Those treating doctor's "opinions" were all plaintiff had to offer on whether Fosamax caused her an injury. Trouble was, one treater didn't have any opinion at all. See Slip op. at 13 ("Plaintiff cannot establish specific causation through the opinion of [the first treater] because, in short, he does not have an opinion").

Fault.

The other treater admitted that he didn't know squat about Fosamax. Slip op. at 16 (the second treater "instead repeatedly qualified his diagnosis by admitting that 'he knows little' regarding the topic"). His methodology, if it can be called that (the court expressed doubts) "reveals no other reasoning for his diagnosis other than the temporal relationship" and vague rumors ("a little hum") in the medical community. Slip op. at 19.

Double fault. And this is an MDL test case? We have to wonder what exactly is being tested.

So this test plaintiff loses because, with all the resources of a big-deal MDL behind her, she can't come up with an expert witness on causation other than these two treaters, one without any opinion and the other unfamiliar with the drug and incapable of even performing a differential diagnosis:

It is undisputed that [plaintiff] has smoked since childhood and has poor dental hygiene. . . . [A]t his deposition, [the second treater] did not rule out or otherwise address other possible causes for the injury to Plaintiff’s jaw, such as trauma or infection. In fact, he suggested a plausible alternative explanation for [Plaintiff's] injury: “[I]t could have healed up, I guess, either from stopping the Fosamax or it could have healed up on its own if it was just an -- just a horrible looking abscess.”

Slip op. at 20. And the coup de grâce: this supposed "expert" "when pressed at his deposition regarding his opinion, stated that he 'could not say' whether Fosamax was a cause or contributing factor of Plaintiff's injury." Id. at 22.

At the risk of repeating ourselves - this is an MDL test case? Unless the defendant got to pick this case (and defense picks, when permitted, usually end up being voluntarily dismissed by the plaintiffs), we have to doubt (yeah, we're defense counsel, that's what we do) whether there's any "there there" (apologies to Oakland) in the Fosamax MDL.

And congrats to Merck and its lawyers for yesterday's one-two punch.

Merck Wins Vioxx AG Case In Texas

2009-11-23T15:11:00.001-05:00

Bexis can't say much anyway, since his firm's involved in Vioxx, and neither of us have seen the opinion, but Merck announced today that it was granted summary judgment today in the Texas state AG consumer protection litigation. Here's a link to Merck's press release. When we get a copy of what promises to be an interesting opinion, we'll pass it along.

If any of our readers have the opinion, we'd appreciate you favoring us with a copy.

Zipursky On Preemption "In The Spirit Of Conversation"

2009-11-23T10:13:00.000-05:00

Professor Ben Zipursky (Fordham) just published a guest post over at Torts Prof Blog ruminating about why the Supreme Court found preemption in the context of medical devices that had undergone premarket approval in Riegel v. Medtronic, but did not find preemption in the context of prescription drugs on the facts of Wyeth v. Levine. That's an interesting post, and we commend it to you.

We have a couple of reactions to the post, one general and one specific.

First, the general: As you know, we're big believers in preemption at this blog, and we think the Supreme Court should have found preemption in both Riegel and Levine. And we're still optimistic that courts will find preemption in the context of drugs that have regulatory histories more compelling than the Phenergan involved in Levine.

But, in the spirit of conversation, let's think for a minute about whether Congress could reasonably have wanted to create a world in which preemption existed for certain medical devices, but not for drugs. We think it could have, for three reasons.

The first reason is historical accident. States were not regulating drugs very much in 1962, when Congress revamped the drug laws. But by 1976 that had changed, and states were regulating medical devices at the time Congress revamped the device laws - most notably California, which in 1970 enacted a law requiring its own premarket approval of medical devices. The Medical Device Amendments followed close on the heels of the Dalkon Shield controversy, which prompted states to act. With state regulation in the offing, Congress could reasonably have focused on the need for preemption in 1976 in a way that never occurred to it in 1962. This is particularly true with the most cutting edge, and highest risk/highest benefit devices, which after 1976 has to be premarket approved - the type of device at issue in Riegel. Had this been on Congress' radar screen in 1962, it might have done the same thing with PMA drugs.

The second reason for Congress to have distinguished between drugs and devices is grounded in policy. Historically, drug companies have been large. Bringing a new drug to market can take ten years and cost a billion dollars; drug companies have to be big. But historically, device companies were smaller. An orthopedic surgeon could step out into his garage, gin up a valuable implant with the tools he had on hand, and then start a small device company. These smaller companies have fewer resources to withstand the double jeopardy of first running the gauntlet of the FDA's approval maze, and then being second-guessed under the disparate laws of the 50 states. Don't get us wrong - we think such double jeopardy shouldn't be tolerated in either case, but we're not Congress. Perhaps Congress thought that large drug companies did not need the protection of preemption as much as small device companies did. In fact, the Senate said as much back in 1976, mentioning that its consideration was informed by the importance of the small innovative manufacturer in the invention and development of new medical devices.

The third reason is also grounded in policy. The useful life of a drug can be very long. Penicillin was discovered decades ago, but still serves a purpose, and thus is regularly prescribed. And, back in 1962, before Hatch-Waxman, drugs received patent protection for a long time, so drug companies could sell drugs profitably for many years. The useful lives of medical devices are frequently much shorter. It would be uncommon for a medical device invented today to remain state-of-the-art a decade from now. Perhaps Congress thought that drug companies, which could earn profits on their products for a long time, needed the protection of preemption less than device companies, whose products are not profitable for as long.

That's our general reaction to Zipursky; here's the specific.

We don't think that the difference between Levine and Riegel can be explained by calling Levine a "warning" case and Riegel a "design" case. For one thing, Levine did not say anywhere that design defect claims involving prescription drugs would be preempted. And we're not as confident as Prof. Zipursky that Levine should be considered a true "warning" case. After all, plaintiff never did offer an alternative warning in Levine and argued primarily that the drug should not have been used at all for that particular indication. 129 S. Ct. at 1194. Nor did Riegel hold that warning claims involving PMA medical devices escaped preemption - quite the contrary. Riegel specifically held warning claims were preempted. 128 S. Ct. at 1011 ("the MDA would pre-empt a jury determination that the FDA-approved labeling for a [device] violated a state common-law requirement for additional warnings").

Having litigated a lot of device cases in our lives, we don't agree with Prof. Zipurski that "most" device cases involve design defects. Certainly more do than in the drug area, since it's hard to conceptualize how in most drug cases one would change the "design" of a product and still have the same drug. But let's face it, design defect cases are hard - in most places a plaintiff has to have an alternative design that arguably works better, or at least more safely. That's expensive evidence to obtain, if it can be done at all. Warning claims are much easier to bring, since it's easy and cheap to second-guess a label. Thus, even in the device area, we'd say that there are still substantially more warning than design defect cases.

As litigators, we tend to take what courts say at face value. Since Levine and Riegel don 't purport to draw distinctions between warning and design claims, we're not prepared to read in such a distinction. But if we were inclined to psychoanalyze the Court, we would look more to Riegel as involving an off-label use, and Levine involving a labeled use. We could see the Court (although, of course, neither opinion says so) being less inclined to permit liability where a defendant's product caused injury while being used in a way inconsistent with its FDA-approved labeling, and more inclined to permit liability where the product was being used for an intended purpose, but nevertheless resulted in injury. But again, that's only rank speculation unsupported by anything in either opinion - and we think there should be preemption in either case, as long as the FDA considered the risk in question and made a decision about what the label should say about that risk.

But then again, maybe the most relevant distinction is between law professors, who are paid to think about such things, and us practicing lawyers, who aren't.

Today's Minnesota Supreme Court Decision In Fleeger -- Minnesota Is Still The Ellis Island For Old, Tired Products Liability Suits ... But Not Forever

2009-09-03T12:41:00.000-04:00

This guest post was written by Sean P. Costello http://www.jonesday.com/scostello/. Mr. Costello is an associate resident in the Atlanta office of Jones Day http://www.jonesday.com/Home.aspx. This post is entirely his work. It, of course, represents only his views, and not the views of his clients or firm:

At 10:00 a.m. (Central Standard Time) today, the Minnesota Supreme Court handed down its highly anticipated decision in Fleeger v. Wyeth. Here’s a link to the decision, hot off the presses http://www.mncourts.gov/opinions/sc/current/OPA082124-0903.pdf. The decision is good news for some in the Minnesota plaintiffs’ bar, but it is a disappointment for non-Minnesota companies who find themselves the target of products liability suits and the lawyers who represent those companies.

Herrmann and Beck gave this blog’s readers a head’s up about the Fleeger decision a couple of days ago and summarized the history and posture of the case in that post http://druganddevicelaw.blogspot.com/2009/09/fleeger-will-be-handed-down-on-thursday.html. And I have guest-posted about positive signs that Minnesota’s courts might soon abandon their practice of applying Minnesota'a ultra-liberal statute of limitations to products liability claims having nothing to do with the state or its residents http://druganddevicelaw.blogspot.com/2007/06/minnesota-on-road-to-recovery.html.

In Fleeger the Minnesota Supreme Court was asked to answer the following certified question from a federal district court overseeing an MDL proceeding involving products liability claims against a variety of drug manufacturers: “In a case commenced in Minnesota, does the Minnesota statute of limitations apply to the personal injury claims of a non-Minnesota resident against a defendant not a resident of Minnesota, where the events giving rise to the claims did not occur in Minnesota and took place before August 1, 2004?”

As framed, the question looked to be both loaded and leading. Indeed, it was almost rhetorical. No way the Minnesota statute of limitations would apply to personal injury claims brought by a Pennsylvania resident (Fleeger), who used the product in Pennsylvania (also Fleeger), and claims to have been injured in Pennsylvania (this, too, describes Fleeger), against non-Minnesota defendants. That “no way” earned an exclamation mark when you added in the fact the statute of limitations had run on the claim in the state where the plaintiff lives and where everything that matters in the case actually happened. Filing in Minnesota was obviously a transparent means of avoiding a claim-dispositive defense, because Minnesota has a generous statute of limitations for personal injury claims. That’s forum shopping, and most folks think that is a bad thing. Thus, a rule that encourages forum shopping would be, well, a bad rule. (In fact, in Fleeger, the plaintiff conceded that her claim would be barred by her home state’s statute of limitations, so even she made no effort to hide her motives.) “No way,” after all, is how the courts in virtually every other state in the country would come down on the question.

But not the Minnesota Supreme Court. It answered “yes” to the certified question. And it did so without breaking a sweat. According to the court, the rule of stare decisis made the question an easy one to answer: “The common law is clear. When directly faced with the issue, we have considered statutes of limitations to be procedural without exception.” Slip op. at 8. Consequently, the court wrote, “we have applied the Minnesota statute of limitations to cases properly commenced here [in Minnesota] regardless of whether those cases have any connection to this state.” Id. at 9 (emphasis added).

As shockingly candid as that assertion is, it is the law in Minnesota for pre-August 1, 2004 claims. (In Fleeger, the parties agreed that the Minnesota Supreme Court could assume that the plaintiff’s claims arose in 2002.) The tyranny of lex fori continues. Despite the fact that other state courts have abandoned lex fori – which the court acknowledged – and the fact that “a great deal of legal commentary” (id. at 9) supports departing from that rule, the court would not budge.

So, it seems that Minnesota will remain the Ellis Island for tired, old personal injury lawsuits that have no other place to go. But only to a point and not for long. Thanks to Minnesota’s Conflict of Laws-Limitations Act, Minn. Stat. Sec. 541.31 (2008), Minnesota will not long remain a beacon for "huddled masses" of plaintiffs’ lawyers with time-barred claims. That statute replaces lex fori with the more modern choice-of-law analysis when it comes to the statute of limitations for "claims arising from incidents occurring on or after August 1, 2004." (Hence the date in the certified question.) As we head into 2010 and beyond, fewer and fewer claims will escape the statute’s reach. This, perhaps ironically, was part of the reason the Minnesota Supreme Court was unwilling to abandon lex fori (slip op. at 10):

A prospective change . . . would apply only to cases commenced between the date
of this decision and August 1, 2010. And a retroactive change would only
affect cases that arose before August 1, 2004, which have not yet been
finally resolved. Such a limited effect does not present the compelling
reason necessary to overrule our precedent.

In other words, "why bother?" I don't quite see it that way. For defendants currently in such lawsuits and with the threat of such lawsuits looming for nearly another year, the effect is far from limited. That a statute will eventually eliminate the problem is no reason to forgo the opportunity to fix the problem now.

Questioning McQuiston

2009-11-23T08:00:00.000-05:00

Here's today's question: What do we think of McQuiston v. Boston Scientific Corp., No. 5:07-cv-01723-TS-MLH, slip op. (W.D. La. Nov. 19, 2009) (link here)?

Here's today's answer: We love it!

But not for the reasons you'd think.

Here's the deal: On September 1, 2006, Dr. Thomas Brown performed an angioplasty and stent procedure on James McQuiston. Boston Scientific manufactured the stent. McQuiston said his condition deteriorated after the stent was placed, and he filed a typical product liability complaint against Boston Scientific. (There are actually two plaintiffs, because McQuiston's spouse made a claim for loss of consortium.)

The stent was a Class III medical device that had been approved through the premarket approval process. Judge Stagg thus trots through the holding of Riegel v. Medtronic, 552 U.S. 312 (2008), and routinely applies that holding to find McQuiston's claims of design defect, inadequate testing, failure to warn, breach of express and implied warranties, and manufacturing defect to be preempted. McQuiston, slip op. at 13-16.

What's noteworthy there?

Not much. Although Riegel did not involve warranty claims, an earlier Fifth Circuit case did, so Judge Stagg found the warranty claims preempted. Id. at 15-16. Maybe that's worth mentioning.

McQuiston also pleaded state law negligence and fraud claims. The court dismissed those because they were displaced by the Louisiana Product Liability Act, which provides the exclusive theories of liability against product manufacturers in Louisiana. Id. at 16-17.

But that's still pretty routine. Where's the good stuff?

Our reader who sent us the copy of McQuiston liked the fact that the court refused to allow McQuiston to raise at the eleventh hour a "parallel requirements" claim -- a claim that preemption doesn't apply because Boston Scientific had allegedly violated requirements imposed by the FDA. The court rejected that attempt because there were no corresponding allegations in the complaint and McQuiston had known for over a year that Boston Scientific intended to raise preemption as an affirmative defense. Id. at 18-19.

We like that, too, and we're delighted that you shared the opinion with us. (Thanks!)

But we noticed two other things about this opinion that we liked even more:

At footnote 1 on page 4 of the opinion, the court recites the regulatory status of the Boston Scientific stent -- and it's not purely a Class III device. Rather, it's a "combination device," which involves both drug and device elements. (It was a paclitaxel-eluting stent.) For this stent, the Secretary of Health and Human Services decided that the "primary mode of action" of this combination product was to fulfill a "device function."

We really like that. Cases involving combination devices are hard to come by, and we're delighted to have another precedent to add to that relatively short list. (Riley v. Cordis Corp., ___ F. Supp. 2d ___, 2009 WL 1606650 (D. Minn. June 5, 2009), is another combination device case. It's right there on our (New) Medical Device Preemption Scorecard.)

Also, at footnote 5 on page 17, the court notes that the state law fraud claim may include an imbedded claim of fraud on the FDA -- the implication that Boston Scientific misled the FDA about some aspect of the device. The court properly finds that implied claim to be preempted under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001).

So we really like McQuiston, although for reasons that some might think obscure.

Latest Class Action Decision Shows That The Battles Were Important

2009-11-19T13:51:00.000-05:00

We aren’t the first to note the latest class action denial in the prescription medical product liability field, In re Panacryl Sutures Products Liability Cases, No. 5:08-MD-1959-BO, slip op. (E.D.N.C. Nov. 13, 2009). 360 (subscription only) beat us to the punch the other day. But just because we aren’t first, doesn’t mean there’s nothing in Panacryl worth blogging about.

We view decisions like Panacryl as vindication of all the fuss we made for more than two years about the ALI’s Principles of Aggregate Litigation project.

We’ve pointed out before – and consider it a significant legal accomplishment – that class certification in personal injury actions involving prescription medical products are routinely denied these days. Earlier this year, we gave the defense bar its highest grade – an “A” – for largely eliminating this sort of class action. We said then:

[I]n the late 1980s, we had to take class actions in product liability litigation very seriously. While there were never a lot of certifications, there were enough of them that – during the Bone Screw litigation, for example – plaintiffs would argue that there was some sort of “modern trend” favoring certification of personal injury class actions. . . .

Then our side prevailed in [Amchem and Ortiz]. After that – with a lot of blood, sweat, and good legal argument from our side – class actions (at least successful ones) largely disappeared from mass torts. . . . The few courts willing to certify class actions in drug and medical device cases have so far gotten shot down on appeal. . . . And with the enactment of CAFA, most class action decisions going forward, and essentially everything in mass torts, will be made by federal courts applying post Amchem/Ortiz law. . . .

As a measure of how far out of the mainstream tort class actions have become over the last couple of decades, the ALI’s Aggregate Litigation principles project, for all its pro-plaintiff leanings in other areas of the law, states quite clearly that personal injury class actions are disfavored for a variety of reasons.

“Taking Stock” post.

More or less removing the threat of class actions in mass tort litigation involving prescription drugs and medical devices has gone a long way to making the risks of this type of litigation manageable – as opposed to the existential threat pharmaceutical mass torts posed back in the days of Bone Screw and Fen-Phen. With the class action threat gone, the likelihood of a mass tort settlement gone wild has become quite remote.

Cases like Panacryl remind us why that is. In Panacryl, the plaintiffs claimed that the defendant’s synthetic surgical stitches (a medical device) were defective and caused or facilitated various types of post-surgical infections. Mass tort litigation followed an FDA Class II recall (It seems like every recall of a drug or medical device turns into a mass tort these days, doesn’t it?), and in the inevitable MDL, plaintiffs sought a nationwide class action that would have joined together more than 2 million users of these stitches – the vast majority of whom suffered no complications from using this product.

Because it was a nationwide class action, the first and foremost question raised was whether the law of all fifty states would apply. If it did, then there’s lots of law holding that the multiplicity of jurisdictions makes renders the class action uncertifiable. What did plaintiffs argue? Why, that the defendant’s principal place of business should apply to all claims, of course. Slip op. at 4. Last refuge of a scoundrel and all that.

Fortunately, the Panacryl court rejected that argument:

First, the court had no trouble finding that the states’ approach to products liability created numerous conflicts. Slip op. at 4-5. Well . . . duh. You've got a court in California, but nobody else, allowing "misrepresentation" liability for a brand-name company in a generic drug case. Then you've got West Virginia, but nobody else, rejecting the learned intermediary rule. Could anybody really deny the conflict question with a straight face?

So what does a court do with that conflict? Before ending up in the MDL, these plaintiffs filed in New Jersey, a state known both for having a lot of drug and device companies headquartered there, and for having relatively (not as much as before, though) pro-plaintiff substantive law. That meant that New Jersey choice of laws principles applied.

That means the court had to decide whether principal place of business could trump the place of injury as a choice of laws principle. Well, that’s one of the main issues that had to be fought out in the ALI’s Principles of Aggregate Litigation project. In fact, one of the three floor motions at the ALI annual meeting last May, was on that precise subject. We – and a lot of other folks – fought long and hard to keep principal place of business as a choice of laws rule out of the final Principles. In that, we were successful. The result, as we reported shortly after the meeting, was:

Principal place of business and choice of law – The reference is still there, but the next sentence now reads: “At the present time, choice-of-law principles that point towards application of the law of the defendant’s principal place of business remain quite rare across the various states.” This position is also now described as an “outlier” in the Reporters' Notes. The Schwartz amendment will add language to the effect that whatever choice of law principles are applicable to litigation generally apply equally to aggregated litigation. We’d rather not see principal place of business mentioned at all, but short of that, it’s essentially a complete fix.

Final report on ALI Principles of the law of Aggregate Litigation, available here.

The defendant in Panacryl succeeded, too. Relying on a recent and directly on point case out of the New Jersey Supreme Court, Rowe v. Hoffman LaRoche, Inc., 917 A.2d 767 (N.J. 2007) (which we reviewed here), the court held that in personal injury actions, the individual plaintiff’s home state/place where the injury occurred should control:

[H]aving considered the contacts relevant to the competing interests of the states in light of Rowe, this Court concludes that the competing interests of the states, the most important factor, weighs in favor of applying the law of each plaintiff’s home jurisdiction.

Panacryl, slip op. at 10.

That’s one – and it’s the big one. Once the court concluded that the plaintiffs’ nationwide class action had to be governed by the law of all 50 states, denial of class certification occurred pretty much as a matter of course.

Except. . . .

Plaintiffs argued that, if the court couldn’t certify the whole class, it should still give them half a loaf and certify an single-issue class action under Fed. R. Civ. P. 23(c)(4). Slip op. at 18-19.

That’s another biggie – the misuse of “single-issue” certifications where the litigation as a whole is too diverse to be certified. This issue, as well, was a major bone of contention in the ALI’s consideration of the Principles of Aggregate litigation. Making sure that single-issue classes stayed rare was the subject of another of the floor amendments offered last May at ALI. Again, we think we got most of what we wanted:

Broad Use of Single Issue Classes – this is the subject of the Beisner amendment that the Reporters largely agreed to. We expect it to end up some neutral language and a statement regarding the law being divided on the point. We expect a substantial, if not complete, fix.

Final report on ALI Principles of the law of Aggregate Litigation, available here.

We pointed out back then that the bulk of precedent rejected the use of Rule 23(c)(4) as a way to break up inherently individualized litigation into bite-sized, certifiable bits. The leading case is Castano v. American Tobacco Co., 84 F.3d 734 (5th Cir. 1996), which flatly held that a “district court cannot manufacture predominance through the nimble use of [bifurcation],” because “a cause of action, as a whole, must satisfy the predominance requirement of (b)(3).” Id. at 745 n.21. Rule 23(c)(4) isn’t a way to make the predominance requirement of Rule 23(b)(3) disappear:

Reading Rule 23(c)(4) as allowing a court to sever issues until the remaining common issue predominates over the remaining individual issues would eviscerate the predominance requirement of Rule 23(b)(3); the result would be automatic certification in every case where there is a common issue, a result that could not have been intended.

84 F.3d at 745. The problem with broad use of single-issue certifications is that it invites courts to ignore what’s left over – which is entirely improper. Cf. McLaughlin v. American Tobacco Co., 522 F.3d 215, 234 (2d Cir. 2008) (rejecting piecemeal certification; “given the number of questions that would remain for individual adjudication, issue certification would not ‘reduce the range of issues in dispute and promote judicial economy”); In re St. Jude Medical, Inc., 522 F.3d 836, 841-42 (8th Cir. 2008) (Rule 23(c)(4) certification improper where “trials will still be required” for remaining individualized issues).

And beyond Castano, a raft of federal district court decisions have reached the same conclusion – a lawsuit that’s individualized and not certifiable as a whole can’t be broken down into smaller, certifiable parts by the use of Rule 23(c)(4). We start with Blain v. Smithkline Beecham Corp., 240 F.R.D. 179 (E.D. Pa. 2007), one of Bexis’ cases that we discussed here. Blain rejected Rule 23(c)(4) single-issue certification, holding that “only after the court has found that the cause of action satisfies the predominance requirements of Rule 23(b)(3) may it certify common issues pursuant to Rule 23(c)(4).” Id. at 190. See also Rowe v. E.I. duPont de Nemours & Co., 2009 WL 2424086, at *2 (D.N.J. July 29, 2009) (“Because the medical monitoring . . . is not applicable to the “class as a whole” . . . [it has] not met the 23(b)(2) requirement and, thus, certification under 23(c)(4) would be improper”); Henry v. St. Croix Alumina, LLC, 2008 WL 2329223, at *4-5 (D.V.I. June 3, 2008) (“a claim for relief taken in its entirety must satisfy the predominance requirement of Rule 23(b)(3) before the court may select certain issues for piecemeal certification”); In re Welding Fume Products Liability Litigation, 245 F.R.D. 279, 312 (N.D. Ohio 2007) (“a court must not manufacture adherence to the requirements of Rule 23 through the nimble use of subdivision (c)(4)”); In re General Motors Corp. Dex-Cool Products Liability Litigation, 241 F.R.D. 305, 314 (S.D. Ill. 2007) (same); Taylor v. CSX Transportation, Inc., 2007 WL 2891085, at *14 (N.D. Ohio Sept. 28, 2007) (“Plaintiffs must still satisfy that the issues to be determined by class adjudication predominate over the claims as a whole, including the claims in the separate individual issue trials.”); In re Katrina Canal Breaches Consolidated Litigation, 2007 WL 2363135, at *1 (E.D. La. Aug. 16, 2007) (“Rule 23(c)(4) issue certification is allowed only if the Rule 23(b) requirements are first met as to the claim”); O’Neill v. The Home Depot U.S.A., Inc., 243 F.R.D. 469, 481 (S.D. Fla. 2006) (“[n]or may the Court certify a single issue when the case as a whole fails to meet the requirements of Rule 23”); Fisher v. Ciba Specialty Chemicals Corp., 238 F.R.D. 273, 316 (S.D. Ala. 2006) (“courts have emphatically rejected attempts to use the (c)(4) process for certifying individual issues as a means for achieving an end run around the (b)(3) predominance requirement”); Hyderi v. Washington Mutual Bank, FA, 235 F.R.D. 390, 398-99 (N.D. Ill. 2006) (quoting and following Castano); Hamilton v. O’Connor Chevrolet, Inc., 2006 WL 1697171, at *6 (N.D. Ill. June 12, 2006) (“a class action movant cannot gerrymander predominance by suggesting that only a single issue be certified for class treatment . . . when other individualized issues will dominate or be meaningfully material to the resolution of the absent class members’ claims”); Snow v. Atofina Chemicals, Inc., 2006 WL 1008002, at *9 (E.D. Mich. March 31, 2006) (“Rule 23(c)(4) may not be used to circumvent the predominance requirement”); Perez v. Metabolife International, Inc., 218 F.R.D. 262, 273 (S.D. Fla. 2003) (“sub-issues cannot be separated out from those that require individualized treatment unless the common issues in the action as a whole predominate”); Rink v. Cheminova, Inc., 203 F.R.D. 648, 651 (M.D. Fla. 2001) (finding Castano analysis of Rule 23(c)(4) “persuasive”); Robertson v. Sikorsky Aircraft Corp., 2000 WL 33381019, at *19 (D. Conn. July 5, 2001) (“[a]n action must be considered as a whole in order to determine whether or not the predominance requirement has been satisfied”); Neely v. Ethicon Inc., 2001 WL 1090204, at *5 (E.D. Tex. Aug. 15, 2001) (Rule 23(c)(4) “does not operate independently from the rule of predominance found in 23(b)(3)”; predominance inquiry cannot be limited to “common issues” alone); In re Jackson National Life Insurance Co. Premium Litigation, 183 F.R.D. 217, 225 (W.D. Mich. 1998) (“certification of the question . . . is inappropriate, for the cause of action as a whole certainly does not satisfy the predominance requirement of Rule 23(b)(3)); Arch v. American Tobacco Co., 175 F.R.D. 469, 496 (E.D. Pa. 1997) (“Plaintiffs cannot read the predominance requirement out of (b)(3) by using (c)(4) to sever issues until the common issues predominate over the individual issues”), aff’d, 161 F.3d 127 (3d Cir. 1998).

To this line of cases can now be added the Panacryl decision. The court held, as to Rule 23(c)(4):

But Rule 23(c)(4) may not be used to manufacture predominance for purposes of Rule 23(b)(3). Plaintiff’s trial plan does not eliminate the necessity of applying the laws of several jurisdictions or the individualized inquiry into whether [the product] caused each plaintiff’s injuries.

Slip op. at 19 (Castano quote omitted).

Panacryl thus demonstrates why engaging on the ALI’s Principles Project for Aggregate Litigation was both a good and necessary thing to do. In Panacryl, as in many class actions involving prescription drugs and medical devices, the key certification questions are those that were most controversial in the ALI – strained choice of law arguments to get around the importance of the plaintiff’s residence in personal injury actions, and slicing, dicing, and pureeing causes of action to avoid the predominance requirement for damages class actions. Of the three main issues that we took to the floor of the ALI, only medical monitoring didn’t raise its ugly head in Panacryl.

There's always good reason to fight the good fight.