We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday dog-walker to keep the Drug and Device Law Little Shaggy Rescues indoors (lest they unwittingly look skyward), and we have a continuous loop of the Fifth Dimension’s “Age of Aquarius” going around in our head. (Parenthetically, we accidentally typed “Fifth Amendment” just then for the name of the band.) The song has nothing to do with the eclipse, but it talks about the moon. And about Jupiter aligning with Mars. Appropriately thematic, we thought.

And, while “love steering the stars” may be a little strong to describe recent activity in Risperdal litigation, we have been pleased by a recent spate of positive developments. Last week, Bexis reported on two favorable decisions out of federal courts, one a post-BMS personal jurisdiction denial and the second a refusal to consolidate dissimilar cases for trial. Today we round out the triumvirate with a nice summary judgment decision from Pennsylvania’s state court system.

In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia – excessive breast tissue – when he was prescribed Risperdal (beginning when he was eight years old). He sued, including claims for design defect, failure to warn, and fraud. The defendant won summary judgment. The published decision occurs in a peculiar posture that is a creature of the Pennsylvania Rules of Appellate Procedure. Under Pa. R.A.P. 1025, when a grant of summary judgment is appealed, the trial judge prepares a written opinion in support of affirmance, arguing that there were adequate grounds for the summary judgment decision.

Design Defect

First, the court addressed the plaintiff’s design defect claims sounding in both strict liability and negligence. Because there were unresolved choice-of-law issues, the court considered these claims under the laws of both North Carolina, where the plaintiff was prescribed Risperdal and developed gynecomastia, and Pennsylvania, the forum state. Both states prohibit strict liability design defect claims against pharmaceutical manufacturers. While Pennsylvania, since Lance v. Wyeth, permits claims for negligent design defect, “a drug manufacturer can shield itself from liability for the design of drugs by including appropriate warnings; however, when it becomes known that a drug should not be used in light of the relative risks, the manufacturer can only avoid liability by removing it from the market.” P.D., 2017 Phila. Ct. Com. Pl. LEXIS 231 at *8-9. Here, the plaintiff did not offer “any evidence that Risperdal was so dangerous no warning could mitigate the relative risk of gynecomastia.” To prevail on a negligent design defect claim under North Carolina law, the plaintiff was required to submit evidence of a safer alternative design, and he had not “even address[ed] this requirement . . . , let alone submit evidence of a safer alternative design for Risperdal.” Id., at *9. As such, the court held, the plaintiff’s negligent design defect claims also failed under either body of applicable law.

Failure to Warn

The court’s dismissal of the plaintiff’s warnings claims rested on a finding that the plaintiff had not met his burden, under either North Carolina law or Pennsylvania law, of proving “warnings causation;” in other words, he had not proven that any alleged inadequacy of the product’s warnings was causally related to the his injury. We love this doctrine, because a successful argument can turn on the opportunistic exploitation of a plaintiff’s lawyer’s failure to ask a single question when deposing the plaintiff’s prescribing physicians.

The plaintiff’s warnings expert opined that the 2006 Risperdal label, in effect when the drug was prescribed for the plaintiff, should have included: 1) a recommendation for physicians to monitor prolactin levels; and 2) an indication that there was a statistically significant association between Risperdal use and gynecomastia. Id. at *12. But, as the court explained, “[a]lthough the parties deposed Plaintiff’s prescribing physicians, neither party elicited any testimony from [the doctors] concerning whether [the expert’s] proposed warnings . . . would have affected their prescribing decision.” Id. And so, the court concluded, “In light of the dearth of testimony from his prescribing physicians that [the expert’s] proposed warnings would have changed their prescribing decision, Plaintiff failed to establish proximate causation.” Id. (citation omitted).

The plaintiff attempted to save his warnings claim by arguing that the defendant engaged in illegal off-label promotion. The court held that, because the plaintiff was in an indicated population and was prescribed the drug for an indicated use, any discussion of off-label promotion was irrelevant to the case.

Fraud

Finally, the plaintiff argued that the court erred in dismissing his fraud claim. Again the court considered this claim under both North Carolina law and Pennsylvania law. Federal courts have interpreted Pennsylvania law as ‘barring [fraud claims]against pharmaceutical manufacturers.” Id. at *18 (citations omitted). Pennsylvania appellate courts have not addressed this issue. North Carolina law permits such claims, but not “where the purported misrepresentation was made solely to a third party.” Id. (citations omitted). “Because . . . neither Plaintiff nor Plaintiff’s mother relied on any representation” from the defendant in deciding whether to use the drug, “Plaintiff’s fraud claim must fail under North Carolina law.” Id.

The parties agreed that, where a true conflict of law existed, North Carolina law would apply, as that state, where the Plaintiff ingested the drug and developed gynecomastia, had a greater interest in the application of its law than did Pennsylvania, the forum state. “Ultimately,” the court held,

[I]t is immaterial whether Pennsylvania law permits a fraud claim in pharmaceutical cases. Assuming, arguendo, that Pennsylvania permits [such a claim], then Pennsylvania law conflicts with North Carolina law and North Carolina law would apply. Conversely, if Pennsylvania law prohibits such a claim, then Pennsylvania law applies. In either scenario, Plaintiff’s fraud claims would be dismissed.

Id. at *19.

We love a good summary judgment decision.  P.D. is sound and well-supported, and we trust that it will be affirmed on appeal. We will keep you posted. In the meantime, the [very cool] eclipse has come and gone. In the words of the Fifth Dimension, “let the sun shine!”

 

 

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak.  We think design defect claims usually are clearly preempted in this context and warnings claims will often be preempted too, even with Levine’s high “clear evidence” hurdle.  Cases about thrombotic risks with hormonal contraceptives have featured prominently in such posts, like this opus, precisely because design is not the issue and FDA has long been intimately involved with labeling of these products.

Another obvious fertile ground for preemption has been with gastrointestinal bleeding with anticoagulants, something of the therapeutic flip side to the risk of thrombosis.  First, it is a well-known issue.  Our quick PubMed searches easily got us to articles about this from the 1950s.  Second, this risk has been described in drug labels for a long time.  We easily found this as the first warning in prescription labels as early as 1998, although we suspect they had been around for a few decades by that point.  Third, this risk has been seen with every anticoagulant since there have been anticoagulants.  We have no doubt that any anticoagulant drug coming to market gets a thorough review of its bleeding risk and its labeling about that risk by FDA.  This surely includes attention to any differences in the labeling of the different anticoagulants and whether any post-approval studies or adverse events merit changes.  These facts should make it hard to articulate, let alone prove, a design defect claim that gets by Bartlett or a warning claim that gets by Levine, unless Buckman gets ignored.

We say “should,” but, in all fairness, it certainly depends on where the case is and who is deciding it.  Even in the nascent era of drug and device product liability litigation where cases should pretty much be in federal court unless they are in state court in the defendant’s true home state, the court can be all but determinative of the decisions on litigation-altering issues.  The selection of court can, in turn, depend on the selection of the MDL’s home in litigations where the lawyer advertising drums up enough cases to get the JPML’s attention.  We were going to contrast cases decided by different MDL courts overseeing product liability litigation over the bleeding risk of relatively new prescription anticoagulants.  Instead, we will be discussing one decision addressing allegations we think are pretty typical of what is getting offered up elsewhere and our dear readers can draw their own conclusions.

Fortner v. Bristol-Myers Squibb Co., No. 17cv1562 (DLC), MDL No. 2754, 2017 U.S. Dist. LEXIS 117030 (S.D.N.Y. July 26, 2017), comes out of the Eliquis MDL.  Based on the JPML’s statistics, when decided, there were 23 pending cases out of a total of 69 ever-filed cases in this relatively young MDL.  The drug was approved in 2012 with extensive warnings about the risk of bleeding.  Plaintiffs in the MDL offered various allegations about how the drug was defectively designed because it had a clotting risk, was not accompanied by a drug-specific clotting test, was not accompanied by an “antidote,” and was to be taken twice a day.  These same criticisms were offered as warnings claims, but there were no allegations that the manufacturer had received post-approval safety information triggering some alleged duty to try to change any aspect of the label through the CBE process.  The manufacturers challenged whether these allegations stated any state law claim that was not preempted and, before there was even an MDL established, dismissed a number of cases without prejudice in Utts I, which we discussed here.  After the MDL was established, the plaintiffs got another shot with amended complaints and still came up short in Utts II, this time with prejudice.  The court, in an exercise of magnanimity, invited the remaining plaintiffs to see if they could come up with complaints that stated a non-preempted claim.  That is how we get to Fortner, who alleged a variety of claims under Tennessee law based on the same allegations about the drug, manufacturers, and FDA that most of the remaining plaintiffs apparently offered.

As is often the case with pleading around statutes of limitation—complaints with dates for everything but when plaintiff’s alleged injury occurred—it looks like the fourth attempt at a complaint was modified to be vague, repeating allegations “in less detail and without identifying or appending the specific studies from which these allegations are drawn.” Id. at *7.  The Fortner court saw through this “pleading tactic” of “masking the basis for her claim”:  The complaint’s “claims do not become more plausible simply because the plaintiff has omitted from the FAC the sources upon which her conclusory factual allegations are based.” Id. at **7-8.  Well stated and clearly correct, but many courts let uncertainty work to the plaintiff’s advantage in this posture, despite TwIqbal’s requirement of factual allegations that plausibly state a claim.

The critical aspect of Fortner’s approach is that the court required the plaintiff to plead a warning claim based on “sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.” Id. at *8.  This, in turn, flowed from the court’s prior decisions holding that “post-approval failure to warn claims are preempted unless the plaintiff can plausibly allege that there existed ‘newly acquired information’ such that, pursuant to the Changes Being Effected (‘CBE’) regulation, the defendants could independently have updated the Eliquis label to include such warnings.” Id. at *5.  There is no such thing as a pre-approval warning claim—absent an allegation that the launch label resulted from fraud-on-the-FDA that side-stepped Buckman—so this is a pretty good statement of what a non-preempted prescription drug warnings claim should allege.

By contrast, under the court’s prior analysis, there is no such thing as a non-preempted post-approval design defect claim because “FDA regulations prohibit a change of the type implicated by the claim.” Id. Here, the first urged defect was twice daily dosing—which is a design issue if the plaintiff alleges the product should have been designed to deliver the effective dose by taking it once a day, for instance, and something that clearly cannot be changed without a new NDA.  The other urged defects are things we see as more labeling than design issues—lack of a drug-specific clotting test or an “antidote” to the drug that could be recommended or sold with the drug.  Even if such a test or antidote existed, it could not be sold with the drug based on anything the manufacturer could have done independent of FDA action.  In reaffirming its prior decision on the preemption of pre-approval design defect claims, the Fortner court noted that Yates was the only appellate court to address the issue and no binding authority disagrees with its analysis.

Based on a trio of preemption rulings at the pleading stage, it looks like the Eliquis MDL will be short lived.  That is not always the case with MDL proceedings based on dubious claims, where the burden of one-sided discovery and the weight of the docket tend to dictate the result more than anything approaching the merits.  In terms of issues that seem as obvious to us as preemption of pre-market prescription drug design defect—we note that “duh” and “no duh” mean the same thing, like “regardless” and “irregardless” or “flammable” and “inflammable”—it will help to have more appellate courts follow Yates.

 

About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of Torts §402A, comment k (1965) was somehow limited to implantable – as opposed to non-implantable – medical devices.  While most medical device litigation has historically involved implants, in that post we saw nothing in comment k, or the broader concept that prescription-only products have inherent risks (why their availability requires a doctor’s prescription in the first pace), that is logically limited to implantable devices.

We pointed out in that post that this rather weird argument apparently originated in ill-considered dictum in Chandler v. Chiron Corp., 1997 WL 464827, at *4 (N.D. Cal. July 28, 1997), a case which ultimately dismissed the plaintiff’s design defect claim on causation grounds (and was affirmed on that basis, see 176 F.3d 481 (9th Cir. 1999)), and was directly refuted by controlling California appellate authority: Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), which applied the comment k unavoidably unsafe rationale to intraocular fluid, a non-implanted surgical aid.  As we put it then:

The issue is not whether the device is implanted, it is whether the device unavoidably poses risks even as it must be used by physicians to “save lives or reduce pain and suffering.”

Quoting Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988)).

We were recently contacted by fellow defense counsel about a similar argument being made by plaintiffs in a Pennsylvania case, since Pennsylvania, like California, also applies comment k across the board.  We took a look at the case law and let them know that Pennsylvania precedent likewise has not recognized any artificial distinction between implanted and non-implanted prescription medical devices.  Rather, in Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 315 (E.D. Pa. 2016), a Pennsylvania court applied comment k/the unavoidably unsafe doctrine to bar strict a liability claims involving a prescription device that wasn’t an implant. Wagner involved a temporary feeding tube used while the plaintiff was in intensive care, and the court dismissed strict liability design and warning defect claims, but not manufacturing defect claims, under Pennsylvania’s broad reading of comment k.  225 F. Supp.2d at 315 & n.4.  Indeed, Wagner essentially took the application of the unavoidably unsafe doctrine to design and warning claims as a given, as 9/10 of the opinion was about whether or not strict liability manufacturing defect claims could survive (which is a different issue we addressed here).  Id. at 316-18.

Maybe a feeding tube, although not technically an implant, still seems “close enough,” since such tubes do extend inside the body, albeit quite temporarily.  OK, but there’s plenty of precedent out there about devices that don’t even temporarily penetrate the body.

In Racer v. Utterman, 629 S.W.2d 387 (Mo. App. 1981), the plaintiff was injured when “a disposable drape manufactured by defendant . . . caught on fire resulting in serious burns.”  Id. at 391.  “The purpose of the surgical drape is to provide a sterile field and to serve as a barrier to prevent bacteria from reaching the operation site.”  Id. at 391-92.  The appellate court affirmed application of comment k to this product:

Comment k to the Restatement recognizes that “unavoidably unsafe” products achieve protection despite their danger “when accompanied by proper directions and warning”. . . .  On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product which affords substantially increased protection against infection during surgical procedures.  Its water-repellant attributes increase these protections.  In the state of knowledge at the time of the injury no method of making the product fire-resistant was available which did not adversely affect its barrier against infection or create potential injury to the patient from allergy or disease.

Id. at 393.  The defendant still lost, but on warnings, id. at 395, not because comment k didn’t apply to the drape because it wasn’t implanted.

The Illinois Supreme Court applied comment k’s unavoidably unsafe rationale to therapeutic x-ray radiation equipment in Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980).

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement. Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability. . . .  [C]omment k presume[s] in their treatments that the denomination “product” has already been applied to the matter in question.  Nevertheless, imposition of strict liability is a question of policy, and often the same policy concerns are involved in discussions which are ostensibly diverse, for example: the meaning to be given such terms as “product,” “defective,” “unreasonably dangerous,” and “business of selling.”  For the reasons stated we conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments by a hospital.

Id. at 394-95 (citations and quotation from Prosser’s On Torts omitted).

Two other cases have applied comment k’s analysis to external patches that release drugs that are absorbed through the skin.  In Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997), the court cited and quoted comment k (“the law regarding such products appears at Comment k”) in a case involving nicotine patches.  These were products “incapable of being made safe, but are of benefit to the public dispute the risk.  Id. at 300.  Likewise, in Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012), a fentanyl “pain patch” was considered to be within the scope of comment k.  The court refused to grant summary judgment, but only because it found “genuine issues of material fact . . . as to whether the patches at issue were incapable of being made safe,” not because comment k was categorically inapplicable to non-implanted products.  Id. at *7.

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court applied comment k to a surgical robot – a piece of equipment that assists in the conduct of surgery and is never implanted in the body.  The court applied comment k analysis to the liability questions.  Id. at 526-28.  As in Racer, Taylor found that the comment k exception did not apply on the facts of the case, because it could not be said that the product warnings were adequate as a matter of law.  Id. at 528 (“[e]xemption from strict liability under comment k is expressly limited to products accompanied by adequate warnings”).  Once again, there was not a hint in Taylor that the fact that the robot was not an implant made comment k ipso facto inapplicable.  Washington law “safeguard[ed] the public to the greatest extent possible without discouraging the development and marketing of unavoidably unsafe products.”  Id.

The great majority of product liability litigation involving prescription medical devices happens to involve implants.  However, that descriptive fact is of no legal consequence to the applicability, or not, of the comment k/unavoidably unsafe product doctrine.  That doctrine is interpreted in a variety of different ways – most notably case-by-case versus across-the-board application to prescription medical products.  But no matter which way the doctrine is interpreted, its application is not dependent upon whether or not a medical device is implanted in the body.  At least three state high courts, two state intermediate appellate courts, and a couple of federal district court agree.  There is no contrary precedent, only the aforementioned dictum in Chandler, a 20-year-old district court case, the reasoning of which has never been adopted by any subsequent decision, and (as we already discussed) is refuted by the Cal. App. Armstrong decision.

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue.

Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803 (Cal. App. June 30, 2017), and the result, particularly on the design side, was much more to our liking.

Indeed, there may well not have been post-BMS personal jurisdiction in Trejo either, since the plaintiffs were Hondurans injured in Honduras.  It’s not clear from the opinion where the drug at issue – an over-the-counter (“OTC”) ibuprofen-based pain relief medication – was purchased.  Somewhere in the United States, we gather, and it was then sent as a “care package” to the purchaser’s Honduran relatives.  Trejo, 2017 WL 2825803, at *2.

The drug was eventually taken, in Honduras, by someone other than its intended user, and that person, the eventual plaintiff, subsequently suffered Stevens-Johnson Syndrome (“SJS”), a nasty condition that we’ve encountered frequently on this blog.  This particular exercise in litigation tourism was quite initially successful.  A jury awarded over $50 million (including $15 million in punitive damages), finding for plaintiff on negligent failure to warn, negligent design, and strict liability design defect under the so-called “consumer expectation” test and the risk-benefit test.  The defendant “won” (if you could call it that) on strict liability warning defect and design defect under the “risk/utility” test. Id. at *5.  California not only allows plaintiffs two bites at the warning apple on separate negligence and strict liability theories, but three bites at the design apple under separate negligence, strict liability/consumer expectation design defect, and strict liability/risk/utility design defect theories.  No wonder plaintiffs flock to the state.

On appeal, however, the plaintiff in Trejo lost it all.

The design defect rulings are the most significant for the rest of us.

First, Trejo becomes the fourth appellate court to hold that the impossibility preemption rationale of Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), applies generally, and it not limited to generic drugs – the others being Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016) (airplanes); Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir., 2015) (branded drugs), and In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34, 41 (1st Cir. 2015) (branded drugs). Trejo joins Sikkelee and Yates in applying Mensing/Bartlett to design defects.  And Trejo is the first appellate decision to apply Mensing/Bartlett specifically to OTC drugs.

This is a good direction for the law to be moving. No appellate court has held that Mensing/Bartlett is limited to design defects in generic drugs.

Here’s what the unanimous Second District Cal. App. panel in Trejo had to say about preemption:

While the FDCA contains an express preemption provision concerning OTC drugs (21 U.S.C. §379r) – with a great big exception that exempts “product liability” claims from preemption – express and implied preemption operate independently.  Thus the savings clause for “product liability” doesn’t preclude implied preemption where product liability claims are in conflict with federal law.  Trejo, 2017 WL 2825803, at *23 (“[t]he savings clause does not foreclose the possibility that conflict preemption may arise from federal sources other than . . . §379r”).

Plaintiff’s design defect claim was that the defendant shouldn’t have used ibuprofen at all, but rather dexibuprofen, an isomer of the drug in question, “even though the FDA has not approved dexibuprofen for sale in the United States.” Id. at *5.  That’s right – plaintiff articulated a blatant stop-selling claim of the sort Bartlett had held preempted, and the Court of Appeal called “barnyard expletive” on plaintiff’s tortured argument otherwise:

[Plaintiff] asserts that he did not argue that defendants “should have withdrawn [the drug] from the marketplace, or should have never sold it in the first place.”  This argument is merely a matter of semantics. No matter how plaintiff words his argument, the claim that defendants failed to sell dexibuprofen instead of ibuprofen requires the claim that defendants should have withdrawn [the drug] from the market because defendants could not have changed the active ingredient of [the drug] without undergoing an entirely new FDA drug application process.

Trejo, 2017 WL 2825803, at *21 n.20 (emphasis added).

The Bartlettindependence principle” also required preemption.  It was impossible for the defendant to do what plaintiff contended state law required (materially change the drug’s design) immediately because material design changes to OTC (and all) drugs (and medical devices) require the prior review by and approval of the FDA.  “[F]ederal law prohibited the manufacturer from taking the remedial action required to avoid liability under [state] law.”  Trejo, 2017 WL 2825803, at *25 (quoting Bartlett, 133 S. Ct. at 2476).  That ruling applied to all drugs:

Consistent with our conclusion that the savings clause . . . does not prevent the applicability of ordinary preemption principles in the nonprescription drug context, we agree . . . that Bartlett’s holding is not limited to prescription drugs.

Trejo, 2017 WL 2825803, at *25 (emphasis added).  The FDCA did not permit the defendant to substitute freely one active ingredient for another.  “Dexibuprofen therefore would be a new drug, requiring a new drug application.”  Id.

[F]ederal law prohibited defendants from changing the design of [the drug] by selling dexibuprofen without prior FDA approval.  Defendants accordingly could not have avoided design defect liability without violating federal law.  “FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product.”

Id. (quoting and following Yates, 808 F.3d at 298).

Preemption applied because the defendant could not have acted “unilaterally” to make the design change purportedly required by state product liability law – whether design defect is measured by consumer expectation or risk/utility:

Thus, under federal law [citations omitted] defendants could not unilaterally change the chemical composition of [the drug] from ibuprofen to dexibuprofen in order to satisfy consumer expectations or to increase the benefits or decrease the risks of [the drug].  Nor could they be required to stop selling [the drug] in order to avoid state liability.  Plaintiff’s design defect claim accordingly is preempted.

Id. at *26 (Bartlett citations omitted) (after quoting from a half-dozen cases listed in our post-Levine drug preemption cheat sheet).

Moreover, after trying the case as a straight-forward “you should have designed the product differently” claim, plaintiff could not attempt to convert it to some kind of quasi-warning-based case.  Plaintiff had a real warning claim (which we’ll get to) and couldn’t convert one possible design related factor (presence of warnings) into the whole design ball of wax to avoid preemption after having tried a different case to the jury.  Id.

But there’s more on design first.

Second, as we mentioned, California allows plaintiffs generally to prosecute design defect claims on either a consumer expectation or risk/utility theory of liability.  Not anymore in prescription medical product cases after Trejo.  Trejo also held, quite apart from preemption, that the consumer expectation theory was inapplicable to complicated products such as OTC drugs – and thus, we would argue, a fortiori would be inapplicable to prescription medical products.

The consumer expectation test is only appropriate for products that “everyday experience” allows consumers generally to have safety expectations about:

[T]he consumer expectations test is reserved for cases in which the everyday experience of the product’s users permits a conclusion that the product’s design violated minimum safety assumptions, and is thus defective regardless of expert opinion about the merits of the design.

Trejo, 2017 WL 2825803, at *27 (quoting Soule v. General Motors Corp., 882 P.2d 298, 308 (Cal. 1994)) (emphasis original).  OTC drugs – let alone prescription products – aren’t that.  Plaintiff tried the case with expert witnesses, which is a no-no under the consumer expectation theory.  That plaintiff did so demonstrated the theory’s inapplicability.

The circumstances of [the drug’s] failure involve technical details and expert testimony regarding the effect of the product upon an individual plaintiff’s health, and the ultimate question of whether [the drug] was defectively designed calls for a careful assessment of feasibility, practicality, risk, and benefit.

Id. at *30 (citations and quotation marks omitted).  SJS was an “unusual reaction” to the drug, thus “expert testimony was required to explain plaintiff’s theory.”  Id.  “Accordingly, we conclude that the consumer expectation test should not have been applied.”  Id.

In light of this complexity, plaintiff’s excuse for consumer expectations fell in the same barnyard as his argument against stop selling preemption.  Simply testifying that “I didn’t expect to get hurt” didn’t cut it:

Plaintiff here contends that the consumer expectation test applies because the ordinary consumer does not expect to contract SJS/TEN from taking OTC [ibuprofen].  However, it could be said that any injury from the intended or foreseeable use of a product is not expected by the ordinary consumer.  If this were the end of the inquiry, the consumer expectation test always would apply and every product would be found to have a design defect.

Trejo, 2017 WL 2825803, at *29 (emphasis added).  A consumer cannot, by playing dumb, bootstrap himself into a consumer expectation claim.  “[T]he consumer expectation test does not apply merely because the consumer states that he or she did not expect to be injured by the product.”  Id. Admittedly, we haven’t seen that many California plaintiffs audacious (or desperate) enough to utilize consumer expectation theories against FDA-approved products; nonetheless we’re beyond pleased now to have explicit appellate authority precluding this theory of liability against our clients.

After Trejo, it becomes a lot harder for any plaintiff to pursue a design defect claim against a prescription medical product in California.  If the design considerations that go into OTC drugs are too complex and involved to allow use of the consumer expectation theory of liability, than that theory is even less available to more sophisticated prescription products whose risks and benefits are so esoteric that the FDA has concluded that they should be dispensed only after evaluation by medical doctors.  Likewise, the Mensing/Bartlett preemption rationale against design defects is equally applicable to all FDA regulated products.  Can a branded drug manufacturer change its product’s active ingredient – or any other aspect of the product that materially affects product safety?   No.  And neither can a medical device manufacturer.  Effectively, all design defect claims that could make a difference in a product liability action (that materially affect “safety”) require prior FDA review, and thus should be preempted under Trejo and the Mensing/Bartlett independence principle.

That’s still not all.  We still have Trejo’s disposition of the warning-related aspects of the verdict to discuss.

Third, the Court of Appeal unanimously held that the jury’s verdict for the defendant on strict liability warning defect was fatally inconsistent with its verdict for plaintiff on negligent failure to warn.  Trejo, 2017 WL 2825803, at *8-14.  From a national perspective, this result is less important than the design defect aspects we just finished with, because disposition of the warning claim has to do with the interaction of California’s peculiar warning-based legal doctrines, which still attempt to maintain a difference between negligence and strict liability in the warning context.  Most other states treat them interchangeably.

It’s still important in Trejo, however.  $50 million is $50 million.

Briefly – because the whole thing reeks of hair-splitting to us – “both the strict liability and negligence theories were premised on a single alleged defect.”  Id. at *8.  “[U]nder either a negligence or a strict liability theory of products liability, to recover from a manufacturer, a plaintiff must prove that a defect caused injury.”  Id. at *6.  However, “strict liability, which was developed to ease a claimant’s burden of proof, requires proof of fewer elements than negligence.”  Id.  Thus, negligence requires “an additional element, namely, that the defect in the product was due to negligence of the defendant.”  Id.  Where (as here) the claimed defect under both theories is the same, that means that strict liability simply eliminates an necessary element, so that “a positive verdict on the latter [negligence, is] difficult to explain if strict liability cannot be found.”  Id.

Exactly that happened in Trejo, and it cost plaintiff $50 million.  It wasn’t the first time, either.  A previous decision, Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr. 2d 252, 262-64 (Cal. App. 1999), was directly on point, forthrightly holding that “[a]s a practical matter then, the difference in the two concepts [negligence and strict liability] is so small as to make no difference.”  Id. at 263.  The jury’s finding for the defendant on the “easier” warning defect claim was necessarily inconsistent with its finding for plaintiff on the “harder to prove” negligent warning claim.  Trejo, 2017 WL 2825803, at *14 (“The jury’s special verdict on negligent failure to warn is fatally inconsistent with its verdict on strict liability failure to warn and must be reversed.”).

Who knows what would have happened if this plaintiff had not insisted on more than one bite at the apple?  That’s what we’ll find out on retrial.  We have no idea when that might be however, since further appellate review in Trejo is certainly possible.  In this respect, we are reminded that Bartlett, like Trejo, was also an SJS case.

It’s a fairly well known double standard. If you ask your child why he or she did that rotten, terrible, awful thing and he or she responds “just because” – that’s never good enough. When a parent is faced with the question “why,” however, “because I said so” is a fairly standard, albeit a bit of a crutch, response. If your child happens to have a litigator as a parent, the lesson that “just because” won’t cut it is learned very early. Litigators like to practice their cross-examination skills. Litigator-parents get that opportunity when faced with broken windows, missed curfews, and dented bumpers. DDL Blog litigator-parents not only cross-examine, we TwIqbal (actually seems to work well as a verb). We want supporting facts and they better be sufficient to “nudge” whatever explanation is being offered “across the line from conceivable to plausible.” Ashcroft v. Iqbal, 556 U.S. 662, 680 (2009).

That’s exactly what the judge was looking for in Staub v. Zimmer, Inc., 2017 U.S. Dist. LEXIS 89109 (W.D. Wash. Jun. 9, 2017). Try as he might, however, he couldn’t find it. Plaintiff filed suit in Washington state alleging injury from the implantation of a prosthetic hip. Id. at *1. Following removal to federal court, defendant moved to dismiss.

In Washington, all products liability claims are subsumed under the Washington Product Liability Act (“WPLA”). Id. at *4. The WPLA allows a plaintiff to seek recovery for defective design; failure to warn; defective manufacture; or breach of express or implied warranty. Id. at *4-5. While a plaintiff does not have to specify in the complaint which precise theories he or she is pursuing, the complaint has to “contain sufficient non-conclusory factual allegations to support at least one avenue of relief.” Id. at *5. So, the court combed the Staub complaint to see if it met that basic requirement.

First, the court could find no indication anywhere in the complaint that plaintiff was alleging either failure to warn or breach of warranty. Id. at *5-6. The court was unwilling to read into the complaint claims that plaintiff appears to have failed to assert. As an aside the court pointed out that should plaintiff wish to pursue a failure to warn claim, it may be barred by the learned intermediary doctrine. Id. at *6n3. Perhaps a little foreshadowing?

The WPLA recognizes both the risk utility test and the consumer expectations test as bases for a design defect claim. So plaintiff’s complaint better have support for at least one of these theories. Plaintiff Staub, however, failed to adequately plead either. On risk utility, plaintiff only alleged that the product was “not reasonably safe.” Id. at *7. On consumer expectations, plaintiff only alleged that the device “failed to meet consumer expectations of safety.” Id. at *8. These are the pleading equivalent of “just because.” Parroting back the words of the elements of the claim do not suffice. Nowhere did plaintiff allege how a design element led to his alleged injury, whether there was a feasible alternative design, or how the product didn’t meet expectations. Id. at *7-8.

On his manufacturing claim, plaintiff failed to allege any facts showing that the device at issue deviated in any way from the intended design. Id. at *9. Once again, a bare bones allegation that the product was “defective and unreasonably dangerous” was far from satisfactory. Id. Plaintiff apparently made some attempt to save his manufacturing defect claim by alluding to the fact that the product had been voluntarily recalled. But without any allegations connecting the recall to plaintiff’s alleged injuries, the recall alone offers no support. Id. at *10n5.

Plaintiff is getting a do-over; he has 20 days to file an amended complaint. It’s sort of like, go to your room and when you come back you better having something better than “just because.”

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the Spanish Riding School in Vienna, as we had wished for this since we were very small. And in the phrase “hold tickets” lies the rub.  Though our companion warned us, as we locked the door and departed for the airport, to be sure we had the tickets, we somehow arrived in Europe without them and descended into panic.  For, unlike virtually every other admission credential we had used in the past five years, these were not e-tickets or pdfs but were actual, cardboard tickets, mailed to us in a postal envelope.  And they were missing.  Luckily, in this age of e-mailed confirmations and of people everywhere speaking perfect English, we were able to secure duplicate tickets and to see the stunning white horses of our dreams.  But we were warned, so we would have had no one to blame if the outcome had been different.

As was the case in today’s decision. Ford v. Riina, et al., 2017 N.Y. Misc. LEXIS 1649 (N.Y. Sup. Ct. May 2, 2017), is an unpublished opinion out of the Supreme Court of New York County. The facts are quite tragic.  The plaintiff was being treated for a brain aneurysm by the physician defendant when “a coil escaped” and migrated further into the plaintiff’s brain. Ford, 2017 N.Y. Misc. LEXIS 1649 at *1.  The doctor attempted to retrieve the coil using the manufacturing defendant’s device after another method failed.  “Retrieval of foreign bodies misplaced during interventional radiologic procedures in the neuro . . . vasculature” was one of the indications in the device’s Instructions for Use (“IFU”), which contained warnings about, inter alia, using the proper size of the device (available in a range of sizes) and not performing more than six retrieval attempts in the same vessel using the device.   The IFU also reported that one fracture of the retriever had occurred during clinical trials and provided instructions for reducing the risk of fracture.

The doctor first tried one size of the retriever in the plaintiff. He captured the errant coil, but the retriever fractured when he attempted to retract it.  He tried a larger retriever, which also fractured.  Ultimately, the doctor was able to capture one of the fractured retrievers with a snare but was unable to capture the second retriever or the coil.  The plaintiff was taken for an emergency craniotomy and suffered a major stroke that left him severely brain-damaged.  He sued the doctor and the device manufacturer, and stipulated that claims against the manufacturer would be limited to design defect and failure to warn, and the manufacturer moved for summary judgment on both claims.

In support of its motion, the manufacturer submitted four affidavits.   The first was the affidavit of an engineer employed by the manufacturer’s successor.  The engineer stated that he was able to determine the lot number of each device opened by the doctor and that he was able to determine that there were no reported fractures of any devices in the relevant lots except the fractures to the devices used in the plaintiff.  The second affiant was a bioengineer, who stated that the retriever was the state-of-the-art medical device for foreign body removal from the time of the plaintiff’s procedure up to the present time.  He also stated that fracture was exceptionally rare in the device in question and that the benefits of the device outweighed the risk of fracture, which is inherent in all retrieval devices. The third affiant, a neurologist, opined that the retriever’s IFU expressly warned of the risk of fracture and of vessel damage, that the warnings – including the warning of the precise event that occurred in the plaintiff – were clear an adequate, and that the risks of fracture and vessel damage were “generally known and accepted in the relevant medical community.” Id. at *13-14.  Finally, a registered professional engineer opined that “no other commercial engineering or biomedical alloy can come close” to the elasticity and shape memory of the alloy used in the defendant’s device, id. at * 15-16, that there is no other material commercially available to manufacture the device for its intended use. Id. at *17.

In opposition, the plaintiff submitted the affidavits of two witnesses. The first, a materials scientist, claimed that he tested the retrieval device under a variety of conditions, that the testing confirmed that cracks and fractures could occur with much greater ease and frequency than the IFU suggested and under conditions of which the IFU did not warn, and that, as such, the IFU did not contain adequate warnings related to the potential for fracture. The second witness, a biomedical engineer, opined, inter alia, that the IFU did not adequately warn of the potential for the device to become entangled or stuck in a vessel and of the difficulty of disengaging it once it was stuck.  He also claimed that there were feasible alternative design features that would have prevented the plaintiff’s injury.

The court held that the manufacturer had “establishe[d] prima facie that the IFU conveyed to physician-users the most current knowledge concerning the potential risk of fracture associated with the [device], which is all the law requires.” Id. at *33 (citation omitted).  In addition, the IFU “set forth various steps which the physician-user could take to reduce that risk.” Id. Finally, the manufacturer “establishe[d] its prima facie entitlement to summary dismissal of plaintiff’s design defect claim by establishing that the [device] was state of the art for removing . . . foreign bodies from the neurovasculature, that the device was properly designed and manufactured . . . and . . . incorporated changes made to the [device’s predecessor] as well as other modifications that minimized the risk of fracture.” Id. at *34 (citations omitted).

Once the manufacturer made its prima facie showing, the burden was on the plaintiff to identify a triable issue of fact. And the court held that the plaintiff did not satisfy this burden.  The court stated, “An expert’s affidavit – offered as the only evidence to defeat summary judgment – must contain sufficient allegation to demonstrate that the conclusions it contains are more than mere speculation and would, if offered alone at trial, support a verdict in the proponent’s favor.” Id. at *35 (citations omitted).  In this case, the plaintiff’s experts made “repeated reference to various tests and experiments they performed which they contend[ed] replicated the foreseeable event of the [device] being ‘fully stuck’ within a patient’s cerebral vasculature.  However, noticeably absent . . . is any description . . . of the actual tests and experiments they performed or the conditions under which they performed them . . . [including whether] the tests and experiments . . . were based on accepted industry standards. Id. at *36 (citations omitted).  The court concluded, “Simply stated, there is nothing in the experts’ affidavits from which the validity of their ultimate conclusions about the design of the [device] and the adequacy of the IFU can be inferred. . . .In the absence of any reference to a foundational scientific basis for their conclusions, [the plaintiff’s experts’] opinions lack sufficient probative value to raise a triable issue of fact” as to design defect or the adequacy of the warnings.”  Claims dismissed, summary judgment for the manufacturer.

Ford is a well-reasoned and correct decision that fits nicely into our self-styled crusade against the opinions of experts who should never darken the courthouse steps.  We will keep our eyes open for similar holdings in published, precedential opinions, and we will keep you posted.

This post comes from the Cozen O’Connor side of the blog.

Plaintiffs and defendants have now completed briefing before the Fifth Circuit on defendants’ appeal of the $498 million verdict in the second bellwether trial of the Pinnacle hip implant MDL. Obviously, there is a lot riding on this appeal. In March, we laid out for you the manner in which defendants’ opening brief addressed certain key issues. Below, we discuss the defendants’ responses, in their reply brief, to the arguments that plaintiffs make on those key issues in their opening brief:

Design Defect Verdict: While defendants have offered a number of reasons to overturn the verdict on design defect, the survival of that portion of the verdict could very well turn on whether plaintiffs can convince the Fifth Circuit that an allegedly safer alternative design for DePuy’s metal-on-metal hip implant, a necessary element of a design defect claim, can be an entirely different product—a metal-on-polyethylene hip implant—one that is already marketed by DePuy. In our experience, an entirely different product cannot serve as an alternative design. Here is a portion of defendants’ discussion of this failing in their reply brief:

To prevail on their design-defect claims, plaintiffs were required to prove that a safer alternative design existed for the Pinnacle Ultamet. Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384 (Tex. 1995). Yet plaintiffs do not argue that the Ultamet should have been shaped differently, secured differently, made of a different metal alloy, or altered in some other way. Instead, plaintiffs argue that the safer alternative design is the Pinnacle AltrX, an existing metal-on-polyethylene hip implant. The question here is whether that metal-on-polyethylene hip implant—which already exists and, indeed, is manufactured and sold by DePuy—is an “alternative design” for the Pinnacle Ultamet, or is instead an “entirely different product.” Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 770 (Tex. App.—Houston [14th Dist.] 2009).

Brockert provides the answer. In Brockert, the plaintiff argued that an “alternative design” for a drug combining estrogen with progestin was a drug containing only estrogen. Id. at 769. There, like here, that proposed alternative already existed and, again like here, was manufactured by the defendant. Id. The Fourteenth Court of Appeals held that plaintiff’s claim failed because she did not show how the defendant’s drug “could have been modified or improved”; she instead argued that the drug should be an entirely different product—i.e., the one defendants already made. Id. at 770-71. . . .

Plaintiffs attempt to distinguish Brockert and Caterpillar by noting that the proposed alternatives in those cases “impaired the product’s utility.” But that is no distinction at all: plaintiffs’ proposed alternative design here would impair the Ultamet’s utility by eliminating precisely the feature that makes it distinctive and an arguable improvement over pre-existing products. Plaintiffs do not deny that metal is more durable than plastic, making metal-on-metal implants a more “attractive option for the younger, high-demand patient who was wearing out their plastic previously.” Nor do they dispute that metal-on-metal implants eliminate plastic debris. Texas law requires plaintiffs to propose an alternative design that replicates those benefits, not just any two benefits they can conjure up. In short, plaintiffs were required to propose a safer alternative design for a metal-on-metal hip implant, but they instead pointed to a different product altogether, which is precisely what Texas courts have held that plaintiffs may not do.

(Defendants’ Reply Br. at 3-6.)

Failure to Warn (Marketing Defect) Verdict: In their opening brief, defendants argued that their Instructions for Use sufficiently warned about the risks that form the basis of plaintiffs’ claims, while plaintiffs’ opening brief argues that those warnings needed to be more specific. While we believe that defendants have the better of that argument, they appear to have even stronger arguments as to plaintiffs’ failures to offer expert testimony on causation or prescriber testimony on how a different warning would have changed their decisions to use the Pinnacle metal-on-metal hip implant. Here are key excerpts from defendants’ reply brief on these issues:

[Lack of Expert Opinion]

Regardless, plaintiffs can prevail under Texas law only if they established with expert testimony that the warnings were inadequate, and they did not do so here. Plaintiffs do not dispute this requirement, instead contending that Dr. Matthew Morrey’s testimony satisfied their burden. But Dr. Morrey was never tendered or admitted as a warnings expert at trial. Plaintiffs attempt to dance around that problem by stating that they designated Dr. Morrey as a warnings expert before trial, but the district court never evaluated his qualifications to be a warnings expert or admitted him as a warnings expert, and his testimony therefore cannot carry plaintiffs’ burden.

[Lack of Prescriber Testimony]

Greer: Greer’s surgeon, Dr. Goletz, did not testify at trial. . . .

Peterson: Peterson’s surgeon, Dr. Schoch, also did not testify at trial. . . .

Christopher: Plaintiffs do not dispute that Christopher’s surgeon, Dr. Kearns, “never read an [IFU] on the Pinnacle Ultamet” and did not know what the IFU said “regarding risks for the implantation of these devices.” . . .

Klusmann: Plaintiffs assert that Klusmann’s surgeon, Dr. Heinrich, testified that additional information “would have changed how he treated Klusmann.” But Heinrich did not say he would have used a different hip implant; he said only that he would have evaluated Klusmann’s post-implant symptoms differently. Dr. Heinrich never testified that he would have used anything other than the Ultamet, and in fact testified that he was aware of the risk of metal ions attacking tissue, but used the Ultamet anyway.

Aoki: The only testimony plaintiffs cite about Aoki is her statement that Dr. Heinrich told her the Ultamet could last “up to 20 years and perhaps life.” But that testimony does not prove that Dr. Heinrich would have used a different implant if DePuy provided different warnings, especially in light of his testimony that he was aware of the Ultamet’s risks. . . . .

(Defendants’ Reply Br. at 10-14.)

Verdict against J&J: Defendants’ reply brief surgically attacks plaintiffs’ arguments on why the trial court could maintain personal jurisdiction over DePuy’s parent company, J&J, as well as plaintiffs’ theories for ultimately holding J&J liable. Plaintiffs’ personal jurisdiction arguments appear to be different from those raised at trial (and therefore waived) and to rely on exhibits that, in some cases, were not even admitted at trial and acts that were not committed by J&J itself, but instead by its subsidiaries. Plaintiffs’ opening brief also struggles to support the viability of their substantive claims against J&J, including how plaintiffs can turn an affirmative defense for a non-manufacturing seller into a cause of action. Here is how defendants sum up these problems in the introduction to their reply brief:

Plaintiffs’ efforts to justify J&J’s presence in this case are no more persuasive. They abandon their previous personal-jurisdiction arguments for new ones, asking this Court to adopt a stream-of-commerce theory so expansive it would bring every parent company into any litigation involving a subsidiary. They try to buttress that argument with lengthy footnotes full of string-cites to evidence either not in the trial record or not what they claim, but super-sized footnotes are no substitute for minimum contacts, which are plainly lacking. And even if they could establish jurisdiction, plaintiffs have no viable claims against J&J. They do not point to a single Texas case holding a defendant liable in tort for a “nonmanufacturing seller” claim or an aiding-and-abetting claim, and they fail to show that J&J undertook a duty for their protection or that they relied on its performance.

(Defendants’ Reply Br. at 1.)

Highly Inflammatory, Irrelevant and Unduly Prejudicial Evidence: This is the BIG issue, the one that raised so many eyebrows as the trial moved on. In their opening brief, plaintiffs try to calm those reactions by underplaying their use of this evidence at trial and its importance to the verdict. But the defendants reply brief reacts effectively to this tactic, providing detail on plaintiffs’ repeated, not limited, used of this evidence, so much so that it formed a central component of their presentation to the jury. Here is how defendants address this issue in, once again, the introduction to their reply brief:

Plaintiffs’ defense of the inflammatory evidence they introduced at trial is to assert that each transgression was not that inflammatory. After all, they referenced Saddam Hussein in only “a handful of exchanges,” linked defendants to tobacco and asbestos companies while questioning only “one defense expert,” invoked the threat of cancer for only “three-and-a-half pages of testimony,” implied just “twice” that the Ultamet could lead to suicide, told the jury that plaintiffs considered jumping off a bridge for a mere “five lines of argument,” mentioned the thousands of other lawsuits in the MDL only “on five occasions,” and discussed transvaginal mesh lawsuits brought by “45,000 women” for only “12 lines of testimony.” The suggestion that the combined effect of all this profoundly prejudicial evidence was marginal does not pass the straight-face test; indeed, the best indication of the importance of this evidence is that fact that plaintiffs’ counsel repeated all of it in his closing statement to the jury. Inflaming the jury’s passions through irrelevant evidence was not just a happenstance but a core component of plaintiffs’ trial strategy, and the gargantuan verdict shows the success of that strategy.

(Defendants’ Reply Br. at 2.)

Next comes oral argument and then the Fifth Circuit’s decision. And that decision will, quite obviously, have a major impact on the future of an MDL that without appellate intervention appears destined to produce more and more massive verdicts.

As our post-Levine preemption cheat sheet demonstrates, Mensing/Bartlett preemption is breathing down the necks of all prescription drug design defect claims.  Recent cases finding preemption of design defect claims due to the need for FDA pre-approval of “major” or “moderate” design changes (basically, anything that could be causal in a product liability lawsuit) include:  Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir. 2015); Young v. Bristol-Myers Squibb Co., 2017 WL 706320, at *5 (N.D. Miss. Feb. 22, 2017); Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449, at *12 (S.D.N.Y. Dec. 23, 2016); Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1364 (N.D. Ga. 2016); Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp.3d 826, 832-34 (W.D. Tenn. 2016); Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296, 320-22 (D. Conn. 2016) (OTC drug); Barcal v. EMD Serono, Inc., 2016 WL 1086028, at *4 (N.D. Ala. March 21, 2016); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035, 1040-41 (S.D. Ohio 2015); Trahan v. Sandoz, Inc., No. 3:13-CV-350-J-34MCR, 2015 WL 2365502, at *6 (M.D. Fla. March 26, 2015).

We don’t expect the other side just to sit idly by and watch their design defect claims get washed away by a preemptive deluge, and they haven’t. To counter preemptive FDA-pre approval design requirements, they’ve conjured up the idea of a “pre-approval” design defect.

What the heck is that, you ask?  Well, since preemption depends on the regulatory requirement to get FDA approval for any design change that could affect product safety, these cockamamie claims try to change the time-line – targeting the design as it stood before the drug was submitted to the FDA in the first place.  Since way back when, the prospective NDA holder could have chosen to submit some different molecule to the FDA, plaintiffs claim that the failure to do that was a “design defect.”  That is, they contend the drug was defectively designed before it could ever legally be produced commercially.

Got it?

Thankfully, this “pre-approval” defect concept hasn’t done all that well, even as a matter of preemption. In Yates the Sixth Circuit, the first appellate court to pass on such a claim, accurately rejected it as another variant of a preempted claim that the defendant should never have sold its product.

In contending that defendants’ pre-approval duty would have resulted in a [product] with a different formulation, [plaintiff] essentially argues that defendants should never have sold the FDA-approved formulation of [their drug] in the first place.  We reject this never-start selling rationale for the same reasons the Supreme Court in Bartlett rejected the stop-selling rationale of the First Circuit.

808 F.3d at 300; accord Utts, 2016 WL 7429449, at *11; Brazil, 196 F. Supp.3d at 1364 (subjecting pre-approval design defect claims for preemption for similar reasons).

However, a few recent cases from Fifth Circuit turf have let pre-approval design defect claims escape preemption.  See In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1395312, at *3 (E.D. La. Apr. 13, 2017) (“Louisiana law imposes a duty on all manufacturers to consider feasible, alternative designs. . . .  Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval.”) (following Guidry v. Janssen Pharmaceuticals, Inc., 206 F. Supp.3d 1187, 1206-97 (E.D. La. 2016)); see also Young v. Bristol-Myers Squibb Co., 2017 WL 706320, at *8 (N.D. Miss. Feb. 22, 2017) (“there is no conflict between [plaintiff’s] pre-approval theory and the defendants’ federal law duties”) (also following Guidry).

We, of course, think Yates nailed it on preemption – any common-law claim, the result of which would be a jury finding that an FDA-approved product design should never have been sold, is a stop-selling claim barred by Mensing/Bartlett.  The FDA determines what products may be marketed, not individual juries misled by reptile-minded plaintiffs’ lawyers.

But this post isn’t about that – it is not another defense of preemption.  Another thing Yates had to say about pre-approval design defect claims was:

[Plaintiff’s] argument regarding defendants’ pre-approval duty is too attenuated.  To imagine such a pre-approval duty exists, we would have to speculate that had defendants designed [the drug] differently, the FDA would have approved the alternate design.  Next, we would have to assume that [plaintiff] would have selected this [hypothetical product].  Further yet, we would have to suppose that this alternate design would not have caused [plaintiff’s injuries].  This is several steps too far.  Even if New York law requires defendants to produce and market a different design, the ultimate availability to [plaintiff] is contingent upon whether the FDA would approve the alternate design in the first place.

808 F.3d at 299.  Thus, the Sixth Circuit was “unable to conceive of any coherent pre-approval duty that defendants would have owed to [plaintiff] when it was developing” the product.  Id. at 300.  See also Young, 2017 WL 706320, at *8 (“the parties have not argued whether Mississippi law recognizes a pre-approval claim, and the Court does not reach the issue”).

The reason that Yates (and, apparently, Young) was “unable to conceive of” a state law pre-approval duty is because such duties do not exist.  Design defects under Restatement (Second) of Torts §402A (1965), do not suffer from the “attenuation”/”speculation” problem identified in Yates because §402A is limited to products that are defective at sale.  “The rule stated in this Section applies only where the product is, at the time it leaves the seller’s hands, in a condition . . . which will be unreasonably dangerous” to the ultimate consumer.  Restatement (Second) of Torts § 402A, comment g (1965).

In the Third Restatement, this time in the black letter, rather than the comments, all “categories of product defect” are likewise determined “at the time of sale or distribution.”  Restatement (Third) of Torts, Products Liability §2 (1998).  The comments reinforce this view.  “[F]or the liability system to be fair and efficient, the balancing of risks and benefits in judging product design and marketing must be done in light of the knowledge of risks and risk-avoidance techniques reasonably attainable at the time of distribution.”  Id., comment a.  “[T]he plaintiff must prove that such a reasonable alternative was, or reasonably could have been, available at time of sale or distribution.” Id. comment c.  Similarly the black letter of Restatement Third §6(b), specifically applicable to prescription medical products, expressly measured defectiveness – including design defect, to the extent allowed at all − “at the time of sale or other distribution.”

Statutory product liability schemes are generally similar to the common law stated in the Restatements with respect to when defectiveness is measured.  Since both Xarelto and Guidry (on which it almost exclusively relied) are from Louisiana, we looked up the equivalent provision of the Louisiana Product Liability Act, which for design defects provides:

A product is unreasonably dangerous in design if, at the time the product left its manufacturer’s control:  (1) There existed an alternative design for the product that was capable of preventing the claimant’s damage. . . .

La. Stat. Ann. §9:2800.56 (emphasis added).  Thus, under Louisiana law, an available alternative design must exist “at the time the product left its manufacturer’s control.”  E.g., Reynolds v. Bordelon, 172 So. 3d 607, 614 (La. 2015) (“the plaintiff was first required to show an alternative design for the [product] existed at the time it left [defendant’s] control”); Roman v. Western Manufacturing, Inc., 691 F.3d 686, 700–01 (5th Cir. 2012) (“the statute required [plaintiff] to prove (i) that an alternative design existed at the time [defendant] manufactured the [product]”)  (applying Louisiana law).

Thus, quite apart from preemption, there is no common-law claim for a product that became defective at some time – years, perhaps decades, before the product itself was sold – when the design was first submitted to a government regulator like the FDA.  This essentially universal common-law requirement exists, as the Restatement Third discussed, to ensure that defendants are judged by the state of the art existing at the time of manufacture, not some other time way later, or presumably way earlier (although we suspect that the Restatements’ drafters were, like the court in Yates, “unable to conceive of” something as bizarre as a purported duty to redesign a product years before it had ever been sold to anyone).

In order to avoid this result, Guidry was forced to ignore the express terms of the Louisiana statute – “at the time the product left its manufacturer’s control.”  Contrary to what the Louisiana legislature had mandated, Guidry replaced “product” with “design” – specifically “chemical composition”:

Defective design claims are supposedly preempted because the drug manufacturer loses control to alter the chemical composition of the drug once the FDA approves it.  Application of the defendants’ preemption theory necessarily entails that the drug “leaves the manufacturer’s control” when the FDA approves it, not when it is sold to consumers.  Consequently, the “unreasonably dangerous” analysis in the defective design context necessarily occurs pre-FDA approval (the only period in which the drug manufacturer has control over the drug’s design).

206 F. Supp.3d at 1208.  As a regulatory matter, that proposition is simply false.  A manufacturer still has “control” of product design.  It can file what’s called a “supplement” to its NDA at any time to change a design.  However, the FDA gets to evaluate the supplement first, before it can go into effect – and that triggers preemption.

But for present purposes, note how Guidry put the rabbit in the hat.  It truncated its quotation of the statute – starting just after the legislature’s operative term “the product.”  The LPLA even defines “product”:

(3) “Product” means a corporeal movable that is manufactured for placement into trade or commerce, including a product that forms a component part of or that is subsequently incorporated into another product or an immovable.

La. Stat. Ann. §9:2800.53(3).  A “product” is thus “corporeal” – it is not merely its “design,” nor is it just its “chemical composition.”  Guidry never acknowledges this statutory definition.  “Corporeal” nowhere appears in that extremely long opinion.

Thus Guidry conveniently omitted what the legislature in fact enacted.  Only by substituting “design”/“chemical composition” for “product” as defined by the LPLA could Guidry advance to its next remarkable proposition:  that in the case of all FDA-approved products, Louisiana’s (or presumably some other state’s) “’unreasonably dangerous’ analysis in the defective design context necessarily occurs pre-FDA approval.”  206 F. Supp.3d at 1208 (emphasis added).

“Necessarily”?  Come on, now.

What does Guidry cite for this remarkable proposition that juries must determine the defectiveness of an FDA-approved design at a point before it was ever approved by the FDA – that is, many years before it was ever used by any plaintiff?

Nothing at all.  Zilch.  Not a single statute.  Not a single case.  Guidry made it up.

As we have stated many times before, for a federal court to invent new state law, expanding liability where the state’s courts and lawmakers have not gone, is a serious violation of federalism under Erie v. Tompkins.  “As always, in conducting [an Erie] inquiry our task is ‘to predict state law, not to create or modify it’ − that is, we are ‘to apply existing Louisiana law, not to adopt innovative theories for the state.’”  Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002) (quoting United Parcel Service, Inc. v. Weben Industries, Inc., 794 F.2d 1005, 1008 (5th Cir. 1986)).  As the en banc Fifth Circuit explained thirty years ago:

As a federal court, it is not for us to adopt innovative theories of state law, but simply to apply that law as it currently exists. . . .  We are emphatically not permitted to do merely what we think best; we must do that which we think the [state’s] Supreme Court would deem best.  Finally, under Erie we cannot skirt the clear import of state decisional law solely because the result is harsh.

Jackson v. Johns-Manville Sales Corp., 781 F.2d 394, 397 (5th Cir. 1986) (en banc) (citations and quotation marks omitted), overruled in part on other grounds, Salve Regina College v. Russell, 499 U.S. 225 (1991) (rejecting appellate deference to in-state district court Erie predictions).

As Jackson “emphatically” held, “under Erie we cannot skirt the clear import of state decisional law solely because the result is harsh.”  That’s exactly where Guidry erred.  Before mangling Louisiana’s statutory defect-at-sale requirement, Guidry complained about a harsh result:

The Court first notes that, if it finds the plaintiff’s defective design claim is preempted, even under a pre-FDA approval theory, the result is that a Louisiana plaintiff can never bring a defective design claim against a drug manufacturer. . . .   And no federal remedy exists either. . . .  As a result, if the defendants’ preemption argument prevails, Louisiana plaintiffs will have no remedy against a drug manufacturer for a defect in a drug’s design.

206 F. Supp. at 1206-07 (Levine quotation omitted) (emphasis original).  Thus, the Erie error in Guidry is no accident.  The decision deliberately flouted the law to avoid a result it didn’t like.  For the hundredth time we’ll say, strange things happen in tort preemption cases.  In Guidry, that strangeness was the invention out of whole cloth of a novel “pre-approval” design defect that is flatly inconsistent with Louisiana’s defect-at-sale requirement for design defects.

Not only that, but the contortions that this novel idea of “pre-approval” design defects require of the well-established defect-at-sale requirement (both statutory and common-law) will have unintended consequences.  The LPLA, similarly to the common-law as stated in the Second and Third Restatements, imposes the exact same “at the time the product left its manufacturer’s control” limit on warning defects.  La. Stat. Ann. §9:280.57(A).  Warnings are FDA approved, too, so if defect analysis “necessarily occurs,” Guidry, 206 F. Supp.3d at 1208, prior to FDA approval, consider whether a plaintiff should be able to “claim[] that the defendants intentionally concealed or downplayed the seriousness and likelihood of these adverse side effects” during post-approval promotional activities.  Id. at 1199.  Guidry found nothing amiss with the warning claims, id., but unless we are dealing with a “heads plaintiffs win; tails defendants lose” situation, the defect at sale requirement – whether statutory or common-law – has to run from the same date for both warning and design claims.  And on warning claims, that absurdly early date favors defendants.

In sum – forgetting about preemption − the notion of a “pre-approval” design defect is a non-starter under state law, and rightly so. The legal requirement that a product be defective at the time of distribution is a bedrock product liability principle in all states, and as just discussed, that requirement is utterly incompatible with plaintiffs’ new defect theory that pushes the defect analysis earlier by years if not decades.  This novel theory is being asserted solely to avoid the FDA-pre-approval trigger for preemption first recognized in Wyeth v. Levine, 555 U.S. 555 (2009).  But federal courts under Erie are not supposed to make up new state law just because Levine’s preemption analysis happens to require broad preemption in design defect cases.

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing the Lipizzaner stallions perform at the Spanish Riding School in Vienna.  When we were eleven years old, we read “My Dancing White Horses” by Colonel Alois Podhajsky, director of the School.  This wonderful autobiography recounts Podhajsky’s extraordinary efforts to save the Lipizzaners during World War II.  It was (and is) a compelling read, and it led us to “My Horses, My Teachers,” Podhajsky’s homage to his stunning equine mentors.  Since that time, the Lipizzaners have occupied a permanent spot atop our bucket list, and we are beyond thrilled to hold tickets to one of their performances.  Beyond that, we had to start from scratch to plan this trip.  We Googled and researched, and our takeaway was how much we didn’t know about Budapest’s history and culture.

Perhaps the plaintiff’s would-be experts in today’s case should have engaged in similar assessments of their knowledge bases. Regular readers of this blog are familiar with our ongoing rant against “experts” who aren’t, and with the cases that nonetheless ride on the “experts’’ unqualified shoulders.  In this case, the Court agreed with us.

In Hale v. Bayer Corporation, 2017 WL 1425944 (S.D. Ill. Apr. 20, 2017), the plaintiff alleged that the defendant’s product, an over-the-counter (“OTC”) non-steroidal anti-inflammatory drug (“NSAID”) caused him to develop a permanent kidney injury known as “Minimal Change Disease” (“MCD”). He asserted the usual product liability claims sounding in strict liability and negligence, and identified three experts.  The defendant moved to exclude all three – the plaintiff’s primary care physician, the plaintiff’s treating nephrologist, and a pharmacist — under Daubert, arguing that none had rendered an opinion that was “properly founded in or based upon sufficiently reliable medical, scientific, or other specialized knowledge.” Hale, 2017 WL 1425944 at *1 (citation omitted).

Plaintiff’s Primary Care Physician

The plaintiff’s primary care physician testified that he referred all kidney patients to a nephrologist and that he had never studied whether NSAIDs may cause particular kidney injuries. Naturally, the defendants moved to exclude him because he was unqualified to offer causation opinions and because he relied on the plaintiff’s treating nephrologist’s opinions and diagnosis as the basis of his opinions.  In their response, the plaintiffs stated that they would not offer the expert to testify about causation,  but only to discuss his care and treatment of the plaintiff.  The Court agreed that the doctor would be permitted to testify about his treatment of the plaintiff but would not be permitted to offer causation opinions.

Plaintiff’s Treating Nephrologist

Next, the plaintiff offered his treating nephrologist, who diagnosed the plaintiff with NSAID-induced MCD.  The defendants argued that the nephrologist’s opinions were “insufficiently supported by medical science” and that he was “not able to definitively establish by any medical or laboratory test that the plaintiff’s consumption [of the NSAID] was the cause of his MCD.” Id. at *3.  They also argued that the nephrologist’s purported “differential diagnosis” was based on insufficient scientific data.  The plaintiffs argued that the doctor had 30 years of experience as a nephrologist, that he managed the plaintiff’s case, and that he relied on scientific literature in reaching his causation conclusion.

The court cited case law confirming that, while a properly-performed differential diagnosis can constitute a reliable methodology, such diagnosis must go “beyond the mere existence of a temporal relationship” between the plaintiff’s ingestion of the defendant’s product and the onset of his symptoms. Id. at *4.  Analyzing the doctor’s methodology, the court observed that the doctor had ruled out certain diseases that can cause MCD.  He also ruled our food poisoning and some infections.  But most MCD is idiopathic.  (Idiopathic means nobody knows what causes it.)  To rule out idiopathic MCD in the plaintiff’s case, the doctor testified that he relied on the temporal relationship and on scientific literature that had acknowledged “for the last 25 years that NSAIDs can cause renal injury or renal malfunctions.” But the data the doctor cited involved prescription-strength NSAIDs, and he testified that he did not know of studies involving lower-strength OTC NSAIDs and had never read an article linking the defendant’s specific NSAID to renal injury.  The court concluded that the doctor could not “provide any scientific and/or medical data with regard to the relationship of over-the-counter NSAIDs and kidney disease,” let alone any specific data related to the defendant’s product.  As such, the doctor’s opinions were “unreliable based on the lack of supporting medical science as required by” Fed. R. Evid. 702.  Moreover, though the doctor had general knowledge about the diagnosis and treatment of kidney disease, he lacked “expert knowledge with the specific subset of over-the-counter NSAIDs” and MCD.  And so, like the PCP, the nephrologist was permitted to testify about his care of the plaintiff but was precluded from offering causation testimony.

The Pharmacist

Finally, the plaintiff offered a pharmacist to testify, as an element of Illinois’s “consumer expectation test,” that the plaintiff’s particular kidney injury was foreseeable to the defendant and that the danger of this injury went beyond that which would be contemplated by the “ordinary patient with ordinary knowledge common to the community.” The pharmacist was qualified to offer this opinion, they argued, “based on many years of educating and working with healthcare providers and providing healthcare services to patients.” Id. at *6.  He said that he “regularly interacted with [patients] and understood their level of awareness regarding OTC . . . NSAIDs and kidney injury.” Id. at *7.

The court pointed out that the pharmacist was not a physician, had never participated in clinical trials involving any NSAID, and was not aware of any cases of MCD associated with OTC use of the defendant’s product. Though he had reviewed 203 case reports, none involved MCD, and, in any event, the court had previously rejected expert opinions based on case reports.  As the court emphasized, “Because of their limitations, case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation. Such case reports are not reliable scientific evidence of causation, because they simply describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group. . . [T]hey do not isolate and exclude potentially alternative causes . . . and do not investigate or explain the mechanism of causation.”  Id. at *8 (citation omitted).

Finally, the court held that the pharmacist “clearly [did] not have the necessary background to offer an opinion of whether the risk and danger of [the product] outweighed its benefits.”  His entire opinion was “based on the fact that there are alternative [products] that may achieve the same relief benefit.  That is like saying that an individual could safely ride the train to work and thus have avoided a car accident, [but] . . . there is no indication of a complete risk/benefit analysis being conducted by [the pharmacist] or that [he] relied on any studies” conducting such an analysis.  Id. at *7.  (We have posted on this issue before.  You can see some of the posts here.)  The court concluded that the pharmacist had “provided no support – other than his general experience – of the opinions” he had offered. As such, the court held that the pharmacist’s opinions were “unreliable based on the lack of supporting data as required by Federal Rule of Evidence 702.” Id. at *8.

And then there were none. And with no experts, the plaintiffs could not meet their burden of proof of causation.  Moreover, while the court acknowledged that Illinois had not decided whether the consumer expectation test required expert testimony, the plaintiff had not demonstrated that the defendant’s product was unsafe, because “every expert deposed stated that they believed [the product] to be safe when used as directed.” Id. at *11.  Check and mate – summary judgment granted for defendants.

Sometimes, when we write this stuff, we have trouble keeping a straight face because the plaintiffs’ arguments so lack merit as to verge on silliness. It continues to puzzle us that these experts – and these cases – even see the light of day.  But we are grateful for the sensible judges who extinguish them.

We’ll be back in a week or so, with pictures of beautiful white stallions (and one beautiful daughter) in hand. E-mail us – we’ll send you copies.

 

Just yesterday we made the following observation: a design defect claim is often a make-weight claim. How should the design have been improved? Not selling the product at all is hardly a design improvement. An entirely different product is not a safer alternative under the law of any enlightened state. Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).

And miss the point the court did in In re: Xarelto Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 56629 (E.D. La. Apr. 12, 2017). Plaintiffs in the Xarelto MDL allege that the anti-coagulant drug caused serious bleeding events and that the drug was unreasonably dangerous due to its defective design. Id. at *3. As we noted yesterday, true design claims, as opposed to failure to warn claims, aren’t the crux of most pharmaceutical drug cases. But the Xarelto plaintiffs went that route and so defendants raised preemption as a defense. Unfortunately, to no avail.

Xarelto is an anti-coagulant drug that is taken once a day and all patients are given the same dosage without the need for routine monitoring. Id. Plaintiffs argue that patients’ reactions to the drug vary causing some to experience bleeding complications. Id. at *3-4. It is undisputed that both the dosing and monitoring specifications were approved by the FDA. Id. at *4. So, if the FDA approved the design, what do plaintiffs say the manufacturer could have done differently? Essentially, plaintiffs’ position boils down to the manufacturer should not have sold Xarelto but should have developed and sought FDA approval of a different product. Wait. We’ve been down this road before and the Supreme Court found such claims preempted. Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).

Before we get to Bartlett, let’s look at the specific design defects plaintiffs alleged in this case. First, the manufacturer should have designed an assay to allow doctors to monitor the effects of the drug on each patient. Second, the manufacturer should also have designed and marketed an antidote to counteract a major bleeding event. Third, in the absence of the first two, the manufacturer should have warned about the availability of other tests to measure anticoagulation. Id. Putting aside failure to warn, a claim that the manufacturer should have submitted a different version of the drug to the FDA for approval is the functional equivalent of the “stop-selling” claim that the Court found preempted in Bartlett.

Now that we are back to Bartlett, we should point out that the Xarelto court wrongly discounts defendants’ reliance on it, saying that it relates to generic drug manufacturers, not name brand manufacturers. Id. at *7-8. While it is true that that drug at issue in Bartlett was a generic, the rulings are in Bartlett are not so limited, and certainly not on the very issue germane to this case. The Court in Bartlett went out of its way to state, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’” 133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added). Instead the Xarelto court, in its discussion of design defect, relies more on Wyeth v. Levine, using that decision on failure to warn claims to suggest that preemption is not as clear for brand manufacturers. But the distinction between Bartlett and Wyeth isn’t that one involved a generic and one involved a brand. It’s that Bartlett dealt with design defect and the court’s failure to follow the preemptive logic of Bartlett in this context is an error – at least in our books.

The way the court appears to get around Bartlett is by drawing an artificial distinction between “pre-approval” and “post-approval” design defect claims. Id. at *10. But, as noted above a pre-approval design defect claim is the same thing as saying the manufacturer should stop selling the current product – that it never should have been brought to market. But it was. And only after the FDA reviewed and approved it, including its dosage and monitoring specifications. A design defect claim is about whether the product at issue – the one that was sold and marketed and used by plaintiffs – was defectively designed and whether there is a feasible alternative design. By focusing on the “pre-approval” time period, the court is basically inviting the jury to second guess the FDA’s approval of the drug — a question clearly not meant for a jury. If the court had focused on the “post-approval” product, the actual product at issue, the design defect claims would fall squarely into Bartlett preemption.

But the court didn’t and so we add this to the list of cases that simply miss the point.