New Medical Device Preemption Win

We’ve read Kaiser v. DePuy Spine, Inc., ___ F. Supp.2d ___, 2013 WL 2006122 (M.D. Fla. May 14, 2013), which granted a motion to dismiss with prejudice on grounds of PMA preemption.   Kaiser involves an artificial spinal disc; this was plaintiff’s second shot at pleading nonpreempted claims – the defendant’s first motion had been granted as unopposed but allowing an amended complaint.  So the plaintiff, when filing the amendment in Kaiser, did so knowing full well what would happen.

So do we all.   The plaintiff attempted to plead a "parallel" violation claim, and the defendant argued in return that he hadn’t done so.

The key allegation was that the "Defendant failed to design, test, manufacture, market, sell, promote, label, and/or distribute the [device] implanted in Plaintiff's spine in accordance with the PMA requirements determined by the FDA."   Id. at *1.  That didn’t work; it was TwIqballed, and rightly so, as being entirely generic and fact-free.   "Plaintiffs cannot simply incant the magic words."   Id. at *4.

Only in one place had the plaintiff done any better, alleging that the "PMA requires that the [device] be designed, tested, and manufactured with [components] that, when surgically implanted in a patient's spine, will provide natural motion in the lumbar spine."   Id. at *1.   Plaintiff advanced the providing of "natural motion" as some sort of FDA performance standard for the device, and claimed a violation in that the device eventually failed to do this.   Id. at *5.   There was only one problem with that – the plaintiff invented this purported FDA standard from whole cloth.   It didn’t exist.

 

Plaintiff does not allege that the FDA ever adopted formal performance standards and regulations requiring the [device] to "slide and otherwise restore natural motion." In fact, in its PMA memorandum, the FDA identified the specific performance standards that apply to the [device], and it specifically recognized that the [device] conformed to all of these standards. None of those standards identified in the PMA memorandum were alleged to have been violated in Plaintiff's amended complaint.

Kaiser, 2013 WL 2006122, at *5.  In helpful, but case specific, footnotes (that we’ve omitted), the court took judicial notice of the "performance standards" that the FDA’s "public records" stated were applicable.   Id. at *5 nn. 1-2.

We find Kaiser’s reliance on "performance standards" to be quite interesting.   Although Kaiser doesn’t cite Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012), Walker also limited the parallel violation exception to Riegel preemption to FDA performance standards applicable to the device.   Because plaintiffs can’t make up performance standards the way the plaintiff in Kaiser tried to do, it’s a firm, fixed standard that a complaint either satisfies or does not.  Because performance standards are bright lines, we’d like to see more courts adopt this boundary for the definition of parallel claims.

The plaintiff’s purported parallel claim also failed from the opposite direction – from the state law side. Kaiser alternatively held that the violation claims failed as a matter of Florida law, since that state does not allow a plaintiff to bring a private cause of action to enforce FDA regulations under the guise of negligence per se:

 

[D]istrict courts in this Circuit have consistently held that private actions like Plaintiff’s that seek to enforce violations of FDA regulations are barred because Florida does not recognize such causes of action.

2013 WL 2006122, at *5. So with respect to the "parallel" claim in Kaiser, one line wasn’t really parallel and the other line didn’t exist at all.

Finally, plaintiffs’ last ditch attempt to seek yet another amended complaint also failed.   Some states allow warranty claims in the absence of privity, and some states don’t.  Florida doesn’t.   Id. at *6. Kaiser thus got nowhere – time to abdicate and flee to the Netherlands.

Latest A-Z Motion In Limine Rulings Are Anything But Boring

We occasionally blog about motion in limine rulings, but not nearly as often as we read this type of decision.   Let’s face it, as blogging material (as opposed to their impact on a particular case) decisions on motions in limine can be pretty boring.   You can talk about this; you can’t talk about that.   In modern prescription medical product mass tort litigation, the plaintiff usually has about fifteen stock motions, whereas the defendant probably has between 35 and 50.   Motion in limine decisions are usually a matter of checking off this or that from a long list.   We read them – well at least Bexis does, because he has to update the evidentiary chapter for his book – but usually there’s not enough there there for a blogpost

Not so with Hill v Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2013 WL 1953753 (E.D. Cal. May 10, 2013), which decided a number of very interesting issues (including preemption) in the context of motions in limine filed in an Aredia/Zometa case.  In fact, Hill is so interesting that West has decided to publish it, a rarity with motion in limine rulings.

Here’s a rundown of the more important rulings.

(1) A batch of emails were excluded.   Normally this kind of thing is extremely case specific, and thus not of general interest. These emails, however, were between "members of a panel of physicians and oral surgeons" who were editing a document about the drug.   Hill, 2013 WL 1953753, at *1.   These doctors were on an outside "advisory panel" to the defendant manufacturer, but none were employees or otherwise formally affiliated with the defendant. The emails were excluded as hearsay. Id. at *1.   The plaintiffs argued that doctors on a "advisory panel" were "agents" of the company, and thus the emails were admissions by a "party opponent."   That’s an important issue, since many drug and device company have outside physician advisory groups.  The court rejected the agency argument:

 

Rule 801(d)(2)(D) requires .　.　. agency. An agency relationship arises when both the principal and the agent must manifest assent to the principal’s right to control the agent. Here, there is, at present, simply no evidence that would permit the Court to conclude that [panel physicians] were agents (or employees) of [defendant], let alone evidence to show that the emails related to matters within the scope of their purported agency.　.　.　. [W]hile it is true .　.　. that persons serving as "advisors" and "consultants" have sometimes been held to be agents, in none of these cases was it the fact of being an advisor or consultant that alone created the agency relationship.　.　.　. Where an advisor or a consultant is not subject to the control of the party opponent with respect to consultation he or she is hired to give, the consultant cannot be deemed an agent.

2013 WL 1953753, at *3 (citations and quotation marks omitted). Here, the emails themselves refuted agency, as they "criticized" what was being drafted (precisely why plaintiff wanted to use the emails).   Id.   That the physician advisors "could criticize the [document] and propose changes to it suggests that their role was to provide an independent assessment and that [defendant] did not have the right to control them."   Id. at *4.

Thus, if fighting claims that your client’s physician-advisors have somehow become "agents" of your client, Hill is definitely a decision of interest.

(2) The court threw out allegations of "ghostwriting."  This seems to be one of the other side's flavors du jour, as we see it asserted here, there, and everywhere.  We say, "big whoop" – as if it should surprise anybody that initial drafts of articles (or lawyers’ briefs) weren’t actually written by the ultimate author.  Lawyers do this all the time, as do other busy professionals.  As long as the information that’s presented is correct, we don’t see a problem.  It’s irrelevant to the merits of anything .　.　. and that’s more or less what the court found:

 

[T]he Court was concerned that Parisian’s [ghostwriting] opinion lacked a proper foundation. [Plaintiff] also represented to the Court .　.　. that Parisian would not be questioned about this issue. [Since] the only expert who offered an opinion .　.　. about ghostwriting and company-funded publications was Parisian, this prong of [defendant’s] omnibus motion is granted.

   Hill, 2013 WL 1953753, at *5. A Parisian opinion lacking proper foundation? No surprise there. And without the opinion – well, plainly, ghostwriting is of no inherent relevance to anything.

(3) The court allowed plaintiffs to argue that the duty to warn was not limited to the prescribing physician.  Before the A-Z litigation started, we’d thought, and Bexis had even written in his book, that limiting the duty to warn in this way was a loser.  But the defense has done a lot better than we thought on this issue, and has won it outright in several cases.   Not in Hill, however – although the ruling is phrased in a rather odd way:

 

[Plaintiff] would not be precluded under the learned intermediary doctrine from introducing such [inadequacy of warning] evidence and from arguing that [defendant’s] duty to warn ran to individuals other than her prescribing physicians. While [defendant] would then be entitled to a jury instruction directing the jury not to consider such a duty where the jury found that the warnings to the physician were inadequate, it could not preclude [plaintiff’s] counsel from introducing evidence and argument to the contrary.

Hill, 2013 WL 1953753, at *7. That’s not bad for a denial.   Instead of simply holding that non-prescribing treaters (usually dentists in A-Z) must be provided with adequate warnings, and leaving it at that, the court found that those physicians were part of the population against which the adequacy of warnings is to be judged.   Still the defendant was entitled to a jury instruction "not to consider such a duty" with respect to inadequate warnings, id., so it’s hardly a total loss.

(4) Several of the evidentiary rulings were grounded in preemption.   A-Z involves prescription drugs, so after Wyeth v. Levine, 555 U.S. 555 (2009), preemption arguments are swimming upstream.   The first motion concerned "black box" warnings, where (as we discussed here) a very good preemption argument exists because the FDA reserves to itself the decision whether to include boxed warnings and what they say. As is often the case with such allegations, the plaintiff backed down. Hill, 2013 WL 1953753, at *7 (plaintiff "represents she will not offer argument or evidence on black box warnings"). Too bad; that one’s a winner.

 

One that wasn’t a winner was defendant’s attempt to extend Mensing preemption to prescription drugs.   Not that PLIVA v. Mensing, 131 S. Ct. 2567 (2011), an implied preemption case, shouldn’t apply across the board, but because this particular aspect of the plaintiff’s warning claim – involving "a different dosing regimen" – unfortunately appears to fall on the bad side of the "changes being effected" ("CBE") divide that marks the boundary between the domains of Levine and Mensing:

 

Among other things, this "changes being effected" (CBE) regulation provides that if a manufacturer is changing a label to add or strengthen a contraindication, warning, precaution, or adverse reaction or to add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product, it may make the label change upon filing its supplemental application with the FDA; it need not wait for FDA approval.

Hill, 2013 WL 1953753, at *9 (citations and quotation marks omitted) (emphasis added). With "dosage" within the general scope of the CBE reg, the court wasn’t about to find preemption.

Not so, however, with respect to that aspect of a warning claim alleging that the defendant "should have formatted the [drug] labeling differently." Id. at *10.  The formatting of drug labels is minutely governed by the FDA’s regulations, and is not governed by CBE standards.   In what may be a ruling of first impression, Hill held that warning claims attacking how the warnings were formatted were preempted:

 

FDA regulations for prescription drug labeling extend not only to content but to formatting. While the case law is clear that manufacturers may modify the contents of a brand-name drug label without FDA approval by adding to or strengthening the warnings, [plaintiff] has provided no authority − and the Court’s research reveals no authority − to suggest manufacturers may do the same with the label’s formatting. Accordingly, [defendant’s] motion is hereby granted to the extent it seeks to preclude [defendant] from arguing that the [drug] labeling should have been formatted differently.

2013 WL 1953753, at *11. While the formatting claim is only a minor part of the A-Z litigation, we’ve seen warning claims based on allegations in other cases that this or that risk was insufficiently highlighted to make it stand out.  Preemption of formatting claims would kill off such claims.  To us, the finding of what we’ll call "formatting preemption" from here on out may well be the most important of all the Hill rulings. Defense counsel – make a note of it.

(5) Also of general interest is the ruling in Hill precluding the plaintiff from pursuing a "lost chance" case. "Lost chance" is a medical malpractice concept arising from failure-to-diagnose situations where a pre-existing disease (usually cancer) gets worse in the interim.   The theory seeks to recover for the "increased risk" that the plaintiff will die of the belatedly diagnosed condition, and utilizes negligent services sections of the Restatement (Restatement (Second) §§321 & 323) that excuse plaintiffs from having to prove "but for" causation.   In short, it’s not a product liability theory – since in product liability the product is alleged to be the cause of whatever injury is asserted

We’ve opposed plaintiffs trying to infiltrate "lost chance"/"increased risk" theories into product liability litigation in Pennsylvania:

 

The doctrine of increased risk of harm is inapplicable absent the undertaking of a service either gratuitously or for consideration. Appellants’ allegations of negligence did not assert that [defendant] undertook to "render services" to [plaintiff], therefore a charge on increased risk of harm was not appropriate. Additionally, the doctrine presupposes an outside injury or source of negligence not concurrent with any alleged negligence by a defendant.

 

Ettinger v. Triangle-Pacific Corp., 799 A.2d 95, 107-08 (Pa. Super. 2002).   Accord Steamfitters Local Union No. 420 Welfare Fund v. Philip Morris, Inc., 171 F.3d 912, 936 (3d Cir. 1999) ("Converting a company’s marketing into a special undertaking .　.　. would subject every manufacturer that advertises its products to liability for a ‘special duty’ created by such marketing.　.　.　.  We are unwilling to so dramatically extend the scope of liability for a state-law cause of action"); Lempke v. Osmose Utilities Services, 2012 WL 94497, at *4 (W.D. Pa. Jan. 11, 2012) (courts "have invoked Section 323 in a variety of factual settings, but never in the context of a negligence-based products liability case"); Lobianco v. Eckerd Corp., 2004 WL 3009005, at *4 n.23 (E.D. Pa. Dec. 29, 2004) (increased risk "theory is limited to medical malpractice cases [and] is inapplicable to this [product liability] case").

Thankfully, the court in Hill also rejected this misplaced theory:

 

[T]he lost chance doctrine, even when recognized, has been limited to medical malpractice cases.　.　.　.  [Plaintiff] has provided no authority − and the Court's research reveals no authority − to suggest that the doctrine could conceivably apply in a products liability case where, as here, the plaintiff alleges that a pharmaceutical manufacturer’s failure to warn of risks associated with a prescription drug caused the plaintiff to develop a condition she would not otherwise have developed had she not taken the drug.

2013 WL 1953753, at *13.   Thus, while ostensibly deciding a motion in limine, the ruling in Hill is a significant substantive legal decision with respect to the "lost chance"/"increased risk" issue.

(6) The defendant in Hill also sought to have everything that happened after the plaintiff last used the drug excluded, mostly as subsequent remedial measures.  The defendant lost – but won.  The most significant subsequent events – label changes – were excluded:

 

Evidence that a manufacturer changed a product’s warning label after a plaintiff was allegedly injured by the product is not admissible in a failure-to-warn case because such evidence could lead a jury to infer the manufacturer added the warning because it believed the product was unsafe without it.  This is precisely the type of inference that Rule 407 [pertaining to subsequent remedial measures] forecloses in order to avoid discouraging the taking of remedial measures.  [Plaintiff] argues that the changes [defendant] made to the [drug’s] label .　.　. involved nothing more than the inclusion of intentionally misleading [information] .　.　. and were therefore not subsequent remedial measures.　.　.　.   [A] manufacturers motive for making the change is irrelevant.

2013 WL 1953753, at *14 (citations and quotation marks omitted).   As to everything else, the court in Hill was unwilling to enter a "blanket" exclusion order against evidence based on one point in time.   Id. at *14-15. Defendant will have to "offer individualized objections to the introduction of [such] evidence at trial." Id. at *15.  Again, for a loss, that’s not bad – not bad at all.

(7) Finally, the defense came away with a win with respect to "evidence of medical expenses that were not actually paid" – that is, nominal charges for medical costs that far exceeded what the plaintiff (or her insurer) actually paid for the services.   This is another recurring issue, as so-called "chargemaster" prices for medical services bear no resemblance to reality, and are routinely reduced to pennies on the dollar by insurers (and the government).   We’ve seen this in Pennsylvania as well, where the rule is that the reasonable value of medical services cannot exceed the sum that a plaintiff's medical care providers accepted as payment in full.   Moorhead v. Crozer Chester Medical Center, 765 A.2d 786, 789-90 (Pa. 2001).

That’s the majority rule, and Hill followed it:

 

The Court concludes that because evidence of any amounts billed above the amounts paid are not of consequence in determining plaintiff’s damages claim .　.　., and because such evidence would be of only modest probative value for other purposes, such evidence would have extremely limited relevance under Rule 401 and its introduction would likely confuse and mislead the jury into considering collateral payments within their damages calculation if introduced at trial.  Consequently, the prejudice of introducing such evidence substantially outweighs its probative value.

2013 WL 1953753, at *17.

There are a number of other rulings in Hill – some that the defense won and others that it lost – but these are the ones that aren’t so fact-bound as to be of little interest outside of the A-Z litigation.  With preemption, lost chance, agency, post-sale warning changes, actually-paid medical costs, and ghostwriting on the table, this was an extraordinarily meaty set of in limine rulings.

Another Aredia-Zometa Win, Read Against That Institute You Can't Disparage

Marriage is a civil institution, so it's natural that there are so many laws respecting it. Marriage is also an emotional, fragile relationship, so it's also natural that many of the laws are a bit nutty.   For instance,  on Sundays in Hartford, Connecticut, it is illegal for a man to kiss his wife.  A married couple in a rented room in Massachusetts may not legally sleep in the nude.  In Vermont, a wife must have written permission from her husband to wear false dentures.  And marriage-law-madness is not confined to New England.  You might have heard of proxy weddings, where the marriage ceremony takes place without the presence of either the groom or the bride -- somebody else stands in for one of them.  There might be perfectly good reasons for that to happen.  But in Montana (and, as far as we can tell, only in Montana) there can be a proxy for both the groom and the bride.   We do not know whether the Big Sky state also countenances proxy honeymoons.  In Kentucky, a woman is not allowed to marry the same man more than 3 times.  Hmmm.  Maybe that’s not so strange.  Maybe that’s just common sense.

We’ve all likely heard the phrase that the “law is an ass.”  It comes from the Charles Dickens novel Oliver Twist, when a character is schooled on the fine points of the doctrine of coverture.  Specifically, Mr. Bumble is informed that “the law supposes that your wife acts under your direction”.  Mr. Bumble replies “If the law supposes that … the law is a ass – a idiot.  If that’s the eye of the law, the law is a bachelor; and the worst I wish the law is that his eye may be opened by experience.” 

Joe Hollingsworth recently sent us another defense win in the Aredia-Zometa litigation, and there are a number of aspects to it that will cheer and empower other defense practitioners.  But the case also reminded us of the way marriage sometimes sits rather oddly in the legal matrix.   In Wheeler v. Novartis Pharmaceuticals Corp., Case No. 1:11-cv-0021 (S.D. Ga. May 15, 2013), a husband brought suit both on behalf of the estate of his deceased wife and in his personal capacity for loss of consortium.  The claim was that his wife developed osteonecrosis of the jaw (“ONJ”) as a result of her use of Zometa.  The court granted summary judgment for the defendant on the claims of both the estate and the husband, but for different reasons.

The court had no problem holding that the underlying claim on behalf of the wife’s estate was barred by Georgia’s statute of limitations for personal injury actions.  Georgia law requires that “[a]ctions for injuries to the person shall be brought within two years after the right of action accrues…”O.C.G.A. §9-3-33.  The lawsuit was filed on December 28, 2011.  The court gave the plaintiff the benefit of the doubt by treating the prescription of the drug as a continuing tort (there were continual doses of Zometa), thus permitting the plaintiff to invoke the discovery rule.  But even the discovery rule could not save the underlying claims.

The wife arguably discovered her injury as early as July 14, 2009, when she underwent the extraction and grafting procedure of her jaw.  Less than a week after that extraction, her doctor told her that Zometa was a potential cause of her jaw injuries.  On October 8, 2009, another doctor told the wife that “she had evidence of osteonecrosis of the jaw and that continuing the Zometa would worsen the condition.”  Consequently, the wife knew the cause of her ONJ on or before October 8, 2009 at the latest.  That was more than two years before she filed suit, so the claims based upon her personal injury were untimely and barred by the statute of limitations.  On July 10, 2010, the wife passed away due to her metastatic breast cancer.

The husband’s loss of consortium claim was a different matter.  We usually think of a loss of consortium claim as being completely derivative of the underlying claim.  But the Wheeler court held that “[t]he running of limitation for a personal injury claim does not bar a derivative loss of consortium claim.”  The statute of limitations for a claim of loss of consortium is four years, and thus the husband’s loss of consortium claim was filed well within the limitation period. 

Thus we are presented with a case where the injured party might be out of court but the spouse could proceed with the loss of consortium claim.  Still, the court granted summary judgment on the loss of consortium claim as well, because all of the underlying claims failed on the merits.  First, there was “no probative evidence” to establish causation.  The plaintiff failed to designate any expert witness to opine on causation.  Slip Op. at 14-15.  The learned intermediary doctrine barred the failure-to-warn claim because the wife’s prescribing oncologist testified that he was aware of the risks associated with Zometa at the time he prescribed it, that such risks were well known in the medical community, and most significantly, that he continues to prescribe Zometa in the same manner today as he did for the wife.  Slip Op. at 16-18.  Finally, the warranty claim failed due to a lack of privity, as there was no evidence that the drug was purchased directly from the defendant.   

Maybe there are sound reasons why loss of consortium actions should enjoy a longer limitations period than the underlying action.  Maybe the theory is that the spouse is less in a position to know when an action accrues.  Here, the wife had died, so maybe there is some sense in giving the surviving spouse more time to figure out that there is a lawsuit.  But the rule would seem to apply whether or not the primarily injured party was alive or not, and one could envision a very odd case where the injured party would be reduced to being a spectator to the loss of consortium claim.  It would be just another case of marriage and the law making strange bedfellows.   

Plaintiff’s Second Try Still Preempted

           This one's from the Dechert side only. 

           We talk about a lot of motions to dismiss on this blog and being a defense blog, the overwhelming majority are successful.  Motions to dismiss being what they are – motions that examine only the pleadings and are generally brought early on in the life of a lawsuit – a fair number of the motions we bring to your attention are granted without prejudice.  In other words, courts frequently give plaintiffs another chance – a second bite at the apple.  And so many of our posts on these cases end with a caveat that the case could be resurrected or a prediction that plaintiff’s amended complaint will meet the same demise.  We also usually tell you we’ll report back with further developments. 

            Well, so you know we aren’t making hollow promises, we have just such an update today.  Back in October, we told you about McClelland v. Medtronic, Inc., (M.D. Fla. Sep. 27, 2012) (see post) in which the court dismissed plaintiff’s claims -- negligence per se and failure to warn -- arising from the implantation of a pacemaker on the grounds of no private right of action to enforce the FDCA and preemption.  Relying on   In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010), the McClelland court granted plaintiff leave to file an amended complaint, noting that “a narrow gap exists for a plaintiff’s state law claim if it is to avoid express or implied preemption....”  Slip op. at 13. 

            Last week, the court found that plaintiff’s amended allegations failed to fit in that “narrow gap.”  The claim that was previously dismissed was premised on defendant’s failure to report certain adverse events to the FDA.  Plaintiff’s amended complaint isn’t all that different:  “Plaintiff alleges that Defendant ‘fail[ed] to promptly and accurately report to the FDA incidents and problems with the [pacemaker] that occurred after the device received [PMA]’” in violation of FDA regulations.  McClelland v. Medtronic, Inc.__ F.Supp.2d __, 2013 WL 2109965, at *4 (M.D. Fla. May 16, 2013).  So, it isn’t surprising that the court this time found that to the extent plaintiff was alleging a breach of duty owed by defendant to the FDA, the claim was implied preempted pursuant to Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  McClelland, 2103 WL 2109965, *6.   The claim also failed because no private right of action exists under the FDCA.   Plaintiff cannot “recast a claim for violation of the FDCA as a state-law negligence claim” because “the United States rather than private litigants are authorized to file suit for noncompliance with the medical device provisions.”  Id. (quotation marks and citations omitted).

            But plaintiff also claimed that by alleging a duty to notify the FDA, she was actually contending that defendant breached a duty owed to plaintiff.  Plaintiff argued that

the essence of [her] claim is not that the defendant breached a duty to the FDA, but that it breached a duty to [the Decedent], who was in the foreseeable zone of risk created by [Defendant] – namely the duty to provide an adequate warning of the dangers of its product, which in this case paralleled its duty to comply with the conditions of its PMA.

 

Id. at *4.   Ah, the magic word “parallel.”   For plaintiff’s state law claims to parallel federal regulations, and thereby arguably fit in that “narrow gap” of claims that are not preempted, they must not impose any requirement different from or in addition to FDA requirements.  Id. at *5.  And while there is a comprehensive set of regulations governing a manufacturer’s duty to report adverse events to the FDA, “[p]laintiff has not pointed to any statute or regulation which imposes a duty on the manufacturer to inform patients about such incidents.”  Id.  So, the court quoted from its first decision dismissing plaintiff’s claims.  We quoted it in our prior post, but like the court, we think it’s worth a second mention:

Under Plaintiff’s theory of liability, Defendant would be required to provide information to ... patients beyond those on the device’s labeling. Accordingly, the state and federal requirements are not “genuinely equivalent” because Defendant could be held liable under the state law without having violated the federal law.

Id.  For the second time, plaintiff’s claims were held to be both expressly and impliedly preempted.  And this time, the court said two tries was enough.  So unless plaintiff appeals, we can now close the book on McClelland; satisfied that the story ended as well as it began.   

Plaintiffs Discover Risks of Refusing to Participate in Predictive Coding Discovery

 Let’s see whether it works: Discovery!  Are you excited?  How about this: Technology Assisted Review!!  Nothing yet?  How about: Predictive Coding!!!  We gave you three exclamation points for that one.  Are you pumped yet?

Yeah, neither are we.  But we're going to discuss these things anyway, in particular the way in which the court addressed them in a recent MDL decision in the hip implant litigation.  In re Biomet M2A Magnum Hip Implant Prods. Liab. Litig., 2013 WL 1729682 (N.D. Ind. Apr. 18, 2013).  Why?  Because it’s important for anyone whose practice involves discovery of massive amounts of electronically stored information (ESI) – and mass torts certainly qualify – to understand the potential cost savings for clients presented by technology assisted searches and the legal viability of implementing them. 

We’ve blogged about predictive coding before.  Look here.  In short, predictive coding software “learns” from the user’s selections or preferences and identifies – with greater accuracy as it learns – what the user wants to find.  It’s used for many things on the Internet, and it’s now being used to identify electronic documents for production in litigation.  The process involves an initial interaction between the software and reviewing attorneys, but at some point the software should be able to take it from there alone (for the most part).  Here’s how the MDL court described the process that Biomet used to conduct it review of the 2.5 million documents it selected for review:

Under predictive coding, the software “learns” a user’s preferences or goals; as it learns, the software identifies with greater accuracy just which items the user wants, whether it be a song, a product, or a search topic.  Biomet used a predictive coding service called Axelerate and eight contract attorneys to review a sampling of the 2 .5 million documents.  After one round of “find more like this” interaction between the attorneys and the software, the contract attorneys (together with other software recommended by Biomet’s e-discovery vendor) reviewed documents for relevancy, confidentiality, and privilege.

Id. at *1.  While it can reduce costs, things still aren’t cheap.  The review cost Biomet $1.07 million, and Biomet projected that its ultimate costs would total $3.25 million.  But a manual attorney review would have cost much more, and what plaintiffs were asking the court to order Biomet to do would have cost millions more.

You see, Biomet got to the 2.5 million documents by culling a total universe of 19.5 million documents using keyword searches and de-duplication.  Id.  Only then did Biomet apply predictive coding to search the 2.5 million documents.  Plaintiffs, however, claimed that keyword searching wasn’t accurate enough and wanted Biomet to use predictive coding on the entire universe of 19.5 million documents.  

They may or may not have had a point, but here’s where the plaintiffs found themselves in trouble with the court.  Biomet had asked plaintiffs’ steering committee to suggest additional keywords to use in the search of the 19.5 million documents and even to review the (non-privileged) documents that the  predictive coding search did not select from the 2.5 million documents – so that plaintiffs could assess the process.  Plaintiff refused both offers.  Why?  Well, plaintiffs believed that both these efforts, even with their participation, would not “assure proper document production.”  Id.  They believed that Biomet should have used predictive coding on all 19.5 million documents and that, regardless, Biomet should have waited until the MDL was formed and addressed discovery before reviewing and producing documents.  Id. 

So plaintiffs asked the court to order Biomet to start over and review the 19.5 million documents using predictive coding.  That’s where plaintiff’s lost the court. 

The court didn’t see the issue as one of whether predictive coding was a better review method than keyword searching.  The court was faced with the question of whether Biomet’s process met FRCP 26(b)(2)(C)’s proportionality test (burden and expense versus benefit) and whether Biomet should be required to start over and spend millions of dollars to do so.  The court came out on Biomet’s side: 

The issue before me today isn’t whether predictive coding is a better way of doing things than keyword searching prior to predictive coding.  I must decide whether Biomet’s procedure satisfies its discovery obligations and, if so, whether it must also do what the Steering Committee seeks. What Biomet has done complies fully with the requirements of Federal Rules of Civil Procedure 26(b) and 34(b)(2).

Id. at *2. 

Plaintiffs’ had a number of arguments on why they should have won.  While Biomet ran confidence tests suggesting that “a comparatively modest number of documents would be found” if it redid things using a predictive coding search on the 19.5 million documents, plaintiffs argued that keyword searches using Boolean methods generally identify less than 25% of relevant documents.  But the court found nothing in the record to equate the keyword searches done by Biomet to the type of Boolean search that plaintiffs used as the basis for their argument.  Id.  And the court was in no way sympathetic to the steering committee’s argument that Biomet should have waited to start its review until after the MDL was formed and addressed discovery.  Biomet had discovery obligations in the original district courts, and it was required to meet them:

It might be that the Steering Committee’s argument could carry the day in some cases, but this one doesn’t seem to be such a case.  The Steering Committee hasn’t argued (and I assume it can’t argue) that Biomet had no disclosure or document identification obligation in any of the cases that were awaiting a ruling on (or even the filing of) the centralization petition.  Until the MDL Panel enters a centralization order under 28 U.S.C. § 1407 (or transfers a tag along pursuant to an earlier centralization order), a transferee court is free to act on pending matters.  Indeed, through its conditional transfer orders, the Panel regularly encourages transferee courts to do so.  To hold that a party that behaves as the transferee court directs, or that follows the transferee court’s standing procedures, does so only by forfeiture of the proportionality provision of Rule 26(b)(2)(C), seems an uncongenial exercise of whatever discretion I have.  It also would seem inconsistent with the purposes of centralization under § 1407.

Id. at *3.

There can be little doubt that choosing to sit idly by while Biomet spent over a million reviewing documents hurt plaintiffs’ chances.  Under those circumstances, the court found ordering Biomet to redo its review to the tune of even more millions of dollars didn’t fit within FRCP 26(b)(2)(c)’s proportionality standard:

It might well be that predictive coding, instead of a keyword search, at Stage Two of the process would unearth additional relevant documents.  But it would cost Biomet a million, or millions, of dollars to test the Steering Committee’s theory that predictive coding would produce a significantly greater number of relevant documents.  Even in light of the needs of the hundreds of plaintiffs in this case, the very large amount in controversy, the parties’ resources, the importance of the issues at stake, and the importance of this discovery in resolving the issues, I can’t find that the likely benefits of the discovery proposed by the Steering Committee equals or outweighs its additional burden on, and additional expense to, Biomet.  Fed. R. Civ. P. 26(b)(2)(C).

Id. at *2.

Now, the plaintiffs’ steering committee will no doubt have more opportunities to address Biomet’s document review methods as the litigation moves forward.  But their decision to refuse Biomet’s invitation to participate from the start lost them an opportunity to have input into the original culling of the 19.5 million documents.  Plaintiffs may see a lesson in this: participate.

And we doubt that this will bring about a “be careful what you wish for” scenario.  Sure, plaintiffs’ participation in establishing the process for technology assisted review will be challenging, particularly as their approaches become more sophisticated.  But it’s necessary.  Courts have already started to signal that they want plaintiffs to participate, or at least be invited to participate.  If, in the meantime, we can move the battle from whether to use technology assisted research and predictive coding to negotiations on how they should be used, that’s a victory. 

A Not So Bad Blast from The Past

            We saw the news yesterday about DePuy discontinuing two of their lines of hip implants, which have been involved in some litigation.  While we are not ignorant of the impact of litigation on business or the impact of discontinuation/withdrawal/recall on litigation, we do hate to see situations where the availability of useful medical products can be affected by the number of lawsuits drummed up through waves of lawyer advertising.  We do not know the merits of the cases involving these products, except to the extent we have seen some decisions on pleading and preemption, but we do know we see ads to bring suit about these products everywhere we turn, even as annoying pop-ups on “free” apps.  We ran across a case approaching consideration of the merits on a case involving another one of DePuy’s hip implant products.  In Rydzewski v. DePuy Orthopedics, Inc., No. 11-80007-Civ-Williams, 2012 U.S. Dist. LEXIS 187963 (M.D. Fla. Aug. 14, 2012), most but not all of plaintiff’s claims were kicked on summary judgment.  (You ask why we post now on a decision from 9 months ago.  Well, first, we do what we want, and, second, it was just “published” by Lexis last week.)

            When we started reading the Rydzewski decision, we thought we were not going to like it.  As we have said before, the language the court uses to describe the plaintiff and his/her injury often foretells the result.  Here, the plaintiff was described as “6’1” in height and 230 pounds in weight, and [] a physically active police officer,” and his alleged injury was described as “when the femoral stem of the device fractured, disabling him and causing severe pain . . .  [and s]ince that time [plaintiff] has experienced constant pain and significant physical limitations.”  We say “alleged injury,” but the court did not use that qualifier.  Nor did it need to describe extent of plaintiff’s damages to rule on a fairly straightforward motion for summary judgment based on whether plaintiff had established a prima facie case for any of his asserted causes of action.

            When the court denied the motion as to design defect without any explanation of the proffered evidence, we thought we had read the omens correctly.  (We are not sure if  this process is more like reading entrails, tea leaves, bird flight patterns, thrown bones, or some other esteemed method of prognostication.)  The plaintiff alleged that the design defect related to the product’s “unacceptably low safety strength factor” and had two experts to say that “a design defect caused the device to undergo premature fatigue failure,” “that there was no practical justification for the defective design” and “that alternative safer designs were available.” Id. at **4 & 9.  The court did not mention the experts’ qualifications, basis, reasoning, or even whether the defect they opined on was that “unacceptably low safety strength factor” thing.  As we see later in the decision, the issue really seems to be whether the product was strong enough for someone with plaintiff’s size and activity level.  We cannot tell from the decision whether the plaintiff’s experts actually supported a defect along those lines, but the court said they did −  not only enough to create a genuine issue of material fact as to a design defect under the risk utility test, but also to overcome any presumption against defect from the Florida statutory Government Rules Defense.  Id.  The court did not decide whether that defense applied to the case.  Nor did it decide whether “the consumer expectation test is still an independent basis for finding a design defect under Florida law” given that the test was dropped in the Third Restatement—it merely “assume[d]’ that it was.  It did, however, conclude that the consumer expectation test did not apply for a complex implantable medical device, which may be helpful in other cases.  Id. at **8-9.

            After this shaky start, the court proceeded to knock out a manufacturing defect claim.  That was largely because the plaintiff did not try to justify the claim in his summary judgment response.  Then the court turned to claims for implied warranty.  Florida requires privity, which you typically do not have for medical devices.  Plaintiff tried to say that the privity requirement was satisfied because he was a third-party beneficiary of some sales contract, but the court pointed to Florida law requiring that “the parties to the contract clearly express . . . an intent to primarily and directly benefit the third party or a class of persons to which that party claims to belong.”  Id. at * 12.  Plaintiff—and, we suspect, the vast majority of device plaintiffs--could not satisfy that standard, so the implied warranty claims were gone.  The tea leaves for the remaining negligence claim were not looking so grim (or Grim).

            The main hurdle in evaluating the negligence claim seemed to be determining what negligence was being asserted, challenged by defendant, and argued by plaintiff.  The count seems to have been drafted like the typical kitchen sink negligence claim, with parts sounding in negligent design, negligent failure to test, negligent failure to warn, and negligent manufacturing.  Defendant said they were only moving on the warnings part and then plaintiff took the position that he had not asserted and did not really resist summary judgment on warnings.  The court proceeded to grant summary judgment on negligent failure to warn without addressing other negligence theories.  We do not quite get it, particularly how negligent manufacturing could survive where plaintiff did not even try on manufacturing defect, but that is what happened.  The warnings analysis was pretty solid.  Contrary to what we saw with the discussion of the expert evidence on design defect, the court did what it was supposed to and looked closely at the proffered evidence.  The same expert who helped carry design defect could not raise a genuine issue on the adequacy of warnings because his affidavit amounted to “unsupported factual assertions” due to lack of citations and detail.  Id. at *18.  The court even went to the expert’s report, maybe sua sponte, to spot inconsistencies with his affidavit.  In a clear statement of how warnings claims should be analyzed, the court found:

The warnings quoted above accurately, clearly, and unambiguously provide that excess body weight and activity level can adversely affect the device, and that the largest device possible should therefore be used.  The Plaintiffs offer no explanation as to how the warnings in this case were inaccurate, unclear, or ambiguous, and in this respect they correctly acknowledge that the adequacy of warnings can be a question of law.  Thus the Court finds that the Plaintiff have not produced sufficient evidence to create a genuine issue of material fact regarding the adequacy of the warnings provided to [the surgeon.]

Id. at **19-20 (citation omitted).

            Not surprisingly, the plaintiff also failed on proximate cause.  The experienced surgeon knew all the pertinent risks and never read the package insert, so there were two problems for plaintiff.  He did “not explain what additional warnings not within [the surgeon’s] independent knowledge should have been provided” and “it is unclear how the inclusion of additional warnings in the insert would have prevented the incident.”  Id. at *21.  We certainly appreciate it when courts take proximate cause seriously and do not let plaintiffs get by on speculation and assumption.  So, the negligent warnings claim was gone too.

            With a nod towards old SNL, now is the time on “Sprockets” when we second-guess.  We have not checked the briefs or docket here, so our three hindsight observations should be taken as such.  We are not sure why the attack on the negligence claim was not broader.  Plaintiff clearly did not have negligent manufacturing evidence, and the failure-to-test theories (even if cognizable) were going to run into the same proximate cause problems as the warnings claim, which was largely based on failure to test evidence anyway.  Also, we are not sure why some of this was not sorted out on a motion to dismiss.  Clearing out counts or portions of counts that were impermissibly vague or not allowed under Florida law might have narrowed the target for summary judgment.  And, lastly, this may be the only summary judgment decision we have read on an implantable surgical device that does not mention preemption.  We are not saying how that would have gone here—Class II, we think, in the Eleventh Circuit—but design defect under a risk utility test can smack up against preemption.  Anyway, not so bad as is.  And, no, you cannot touch our monkey.