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.

 

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.

We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot of thought into it.  From time to time, however, we see an opinion that is just plain wrong, and we have to call it out.  That is the case today with Mink v. Smith & Nephew, Inc., No. 16-11646, 2017 WL 2723913 (11th Cir. June 26, 2017).  The plaintiff sued the manufacturer of a metal-on-metal hip replacement device for negligence and strict product liability, among other claims, alleging that the manufacturer did not meet federal requirements in the manufacture of the device, that it improperly trained surgeons, and that it failed to report adverse events. Id. at **6-8.

The device is a Class III device approved through the FDA’s rigorous premarket approval process. That means express preemption applies, and because the plaintiff was suing to enforce federal requirements on the manufacturing of a device, implied preemption applies, too.  The district court so ruled and dismissed the plaintiff’s claims. Id. at *2.  But the Eleventh Circuit came to the opposite conclusion, and the opinion caught our eye for two reasons.  First, the Eleventh Circuit professes to know more about Florida law than the Florida courts.  What do we mean by that?  Well, the Medical Device Amendments state that federal law preempts all state law requirements “different from or in addition to” federal requirements.  Under the widely misunderstood “parallel claim” exception, plaintiffs can sometimes pursue state law claims that “parallel” federal claims, but this requires that state law actually recognize such a cause of action.

Here, the Eleventh Circuit allowed the plaintiff’s manufacturing defect claims to proceed as “parallel claims” because Florida recognizes a strict product liability claim based on a manufacturing defect and the plaintiff alleged that the defendant “violated the Florida common law duty to use due care in manufacturing a medical device.” Id. at *7.  This is okay as far as it goes, but what was the basis for the manufacturing defect and the alleged breach of duty?  The manufacturer did not comply with the FDA’s requirements. Id. at *8.  The plaintiff was suing because the manufacturer allegedly violated federal requirements.

That is federal preemption. Moreover, a Florida court recently held in the context of MDA express preemption that neither federal law nor Florida state law creates a private right of action to enforce federal medical device requirements. Id. at *5 (discussing Wolicki-Gables v. Doctors Same Day Surgery Ctr., Ltd., 216 So. 3d 665 (Fla. Dist. Ct. App. 2017)).  To make matters worse, the Florida Supreme Court held more than twenty years ago that penal and regulatory laws do not create a private right of action under Florida law absent a clear legislative intent to do so. See Murthy v. N. Sinha Corp., 644 So. 2d 983, 986 (Fla. 1994).  Congress has expressly said that the FDCA and the Medical Device Amendments do not create a private right of action, and the Florida legislature has never created such a right of action either.  The Eleventh Circuit apparently knows better.

The second reason this opinion caught our eye is the Eleventh’s Circuit’s apparent motivation—that unless it reversed the district court’s order dismissing the plaintiff’s claims, the plaintiff would not be allowed to proceed. Id. at *5.  We sometimes characterize opinions as “result oriented,” but rarely are circuit courts so blunt.  This court took umbrage with the idea that a plaintiff would not be able to pursue product liability claims against the manufacturer of a premarket approved device.  The Supreme Court thought differently in Riegel.

The court did hold that claims based on inadequate training were expressly preempted because no such claim exists under Florida law (i.e., there is no “parallel”), and the claim based on the failure to report adverse events was impliedly preempted because it was similar to a “fraud on the FDA” theory, per Buckman. The district court, however, came to correct result for the correct reasons when it dismissed the plaintiff’s claims.  The Eleventh Circuit should have affirmed it.

Here’s the crux of today’s case, In re Trader Joe’s Tuna Litig., 2017 WL 2408117, at *1 (C.D. Cal. Jun. 2, 2017):

Plaintiffs determined that the Trader Joe’s tuna cans were underfilled and underweight by commissioning testing with the U.S. National Oceanic and Atmospheric Administration (“NOAA”) on December 1, 2015. NOAA tested several varieties of Trader Joe’s tuna according to the FDA’s standards for canned tuna, pursuant to 21 C.F.R. § 161.190. This statute determines the standard fill of tuna within a container based on its pressed cake weight.

Even though there’s more, we cut this block quote short because we saw the word “cake.” It’s distracting. Cake has always distracted us. It’s a minor miracle that it didn’t cause us to simply insert a post-ending ellipsis and begin a blurry daydream about cake, like a daydreaming scene in a movie. The only thing that stopped us was that the block quote also said “tuna.” We like tuna just fine. But tuna cake? That’s not so enticing.

Unless—apparently—you’re a class action plaintiffs’ lawyer. Ever in search of financial damages and the type of factual and legal sameness that leads to class certification, pressed cakes of tuna had the plaintiffs’ lawyers daydreaming. They dreamed of financial damages for underweighted tuna cans and the necessary sameness created by an FDA regulation that set the standard for weighing them. And so they gathered putative class representatives and filed claims ranging from breach of implied warranty of merchantability, unjust enrichment and fraud to violations of New York General Business Law §§ 349, 350 and violations of the ever-present California Consumer Legal Remedies Act, Unfair Competition Law, and False Advertising Law. Id.

And, while many of these claims are not typical in product liability litigation, they certainly do implicate defenses that are. The claims are—explicitly—premised on alleged violations of FDA regulations. And that allowed defendants to bring a motion to dismiss asserting a number of very familiar defenses, including implied preemption, conflict preemption, and primary jurisdiction. Id. at *2. For instance, primary jurisdiction was in play because, according to defendants (id. at *1), the FDA was actively considering revising its weight regulation that relied on pressed cake. . . . . . .

. . . Yum, there it is again. Cake. We’re imagining it as chocolate cake—with chocolate icing. Better yet, chocolate ganache. That’s probably the same as chocolate icing, but it sounds so much tastier. And no “erries”—that means, no blueberries, strawberries, raspberries, or anything like them. They get in the way of the chocolate without being nearly as good. It’s fine to include vanilla, preferably as ice cream. But that’s it. No other additions. That is, unless we make it a chocolate soufflé—or bread pudding. Or how about a three-course meal of chocolate cake, soufflé and bread pudding . . . . .

Oh, sorry. Back to the law. . . . . .

It wasn’t primary jurisdiction that won dismissal. It was implied preemption under Buckman. A reminder on the standard:

The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013) (quoting In re Medtronic, 623 F.3d 1200, 1204 (8th Cir. 2010) (emphasis in original)). Thus, “under principles of implied preemption … private litigants may not bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA.” Loreto v. Procter & Gamble Co., 515 F. App’x 576, 579 (6th Cir. 2013)

Id. at *2.

And there simply was no way for the plaintiffs to get around the fact that they were absolutely suing “because” the underweighting of the tuna cases allegedly violated the FDA regulated testing standard. And so the court dismissed the claims:

In sum, Plaintiffs’ claims would not exist without the FDCA. Plaintiffs allege that Trader Joe’s misrepresented that its cans contained an adequate amount of tuna . . . . Plaintiffs also maintain that the reason the amount in the tuna cans was inadequate is because it failed to meet the pressed cake weight standard under 21 C.F.R. § 161.190. Consequently, the theory underlying Plaintiffs’ state-law claims depends entirely on an FDA regulation. Plaintiffs’ state law claims are in reality claimed violations of an FDA regulation, and therefore, the FDCA prohibits Plaintiffs from bringing them. On this basis, the Court GRANTS Defendants’ Motion to Dismiss.

Id. at *4.

Piece of cake.

Put a New Yorker and a Californian in a room together and the debate will begin almost immediately. Hollywood v. Broadway. Atlantic v. Pacific. Dodgers v. Yankees or Giants v. Forty-Niners. Shake Shack v. In-N-Out (or is Five Guys overtaking both?). And more generally speaking that east coast/west coast divide extends beyond those two urban hubs. Laid back v. fast-paced lifestyle. Deserts v. low country. Golden Gate v. Sunshine Skyway. Disneyland v. Disney World. And let’s not forget – the west coast may be synonymous with California sunshine, but the east coast gives you actual seasons.

While failure to report adverse event claims are not limited to the west coast, we think of them as Stengel claims. In case you need reminding, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA. Since Stengel is a Ninth Circuit case and the Ninth Circuit includes the entire west coast – we’re going to saddle the west coast with that one. And we’re going to praise an east coast court for saying, thanks but no thanks.

We’ve talked about Burrell v. Bayer Corporation before when earlier this year the court ruled that allegations of parallel claims in plaintiff’s complaint conferred federal question jurisdiction. After winning on removal, the defendants next moved to dismiss the entire case on preemption. Round 2 goes to defendants as well.

The product at issue is the Essure birth control medical device. It is a pre-market approved device so preemption shouldn’t be a big surprise. Burrell v. Bayer Corp., 2017 WL 1955333, *1 (W.D.N.C. May 10, 2017). As is true of the vast majority of drug and medical device products cases, failure to warn is at the heart of the case. But as we already know, traditional failure to warn claims are preempted in PMA device cases. So, plaintiffs pushed for a Stengel-claim. Plaintiff’s argument is failure to warn premised on failure to provide adverse event reports to the FDA is a non-preempted parallel claim. Unpersuaded by the reasoning of that west coast court, Burrell found that the requirement to report adverse events exists under the FDCA rather than state law and therefore, plaintiff’s failure to warn claim is “being brought because the [] defendants allegedly failed to meet these reporting requirements.” Burrell, at *5 (emphasis added). And where a claim is being brought solely based on a violation of the FDCA – that’s Buckman implied preemption. Traditional failure to warn is expressly preempted, failure to report to the FDA is impliedly preempted. Score one for the east coast for getting this.

But the court didn’t stop there. Analyzing the claim under state law, it still didn’t hold up because plaintiff’s allegations didn’t support a finding of causation. This is where most Stengel claims. By the time the device was implanted in plaintiff, the FDA had received and analyzed the adverse event reports and the subsequent warning did not contain any new information. Id. at *5 (although a black box warning was required, that was a new “type” of warning, the substance of the warning was unchanged). So there was no causal nexus between the alleged failure to report and plaintiff’s injury.

None of plaintiff’s remaining claims fared any better. On failure to train, the claim only survives preemption if premised on allegations that defendant failed to train in accordance with federal requirements. Plaintiff made no such allegations. Id. at *6. Moreover, plaintiff again failed to allege any facts to support a causal connection between the failure to train and her injury. Id. Plaintiff’s negligent manufacturing claim suffered the same fate – no alleged violation of federal requirements and no facts to support causation. Id. Plaintiff’s design defect claim was dismissed as expressly preempted. As a PMA device, the “FDA made its determination of this products safety and effectiveness for its given use. As the plaintiff cannot allege that [defendant] departed from its FDA-approved design of this product, these design defect claims are preempted.” Id. at *7. Even if not preempted, North Carolina does not recognize strict liability claims for products liability. Id.

            Moving on to warranty claims, plaintiff alleged that defendant expressly warranted the product was safe. To find that defendant breached that warranty, a jury would have to conclude that the product was unsafe – which is contrary to the FDA’s conclusion in its pre-market approval that the device was in fact safe and effective. So, express warranty is expressly preempted. Id. Since plaintiff’s implied warranty claim also turned on whether the product was reasonably safe, it too was expressly preempted. “The FDA, under the FDCA and the MDA, has the express authority to make such determinations as to the safety and effectiveness of Class III medical devices.” Id.

Plaintiff’s final claims against the manufacturer were for fraud and unfair trade practices. The court first noted that most of the allegations on these claims were just a re-packaging of the allegations pleaded with plaintiff’s other claims. Since the allege misrepresentations were largely “indistinguishable from FDA-approved labeling statements” – they too were preempted. Id. at *8.

Nice job North Carolina. In the east coast v. west coast debate, we’ll side with an anti-Stengel jurisdiction every time.

This post originates from the non-Reed Smith side of the blog.

A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex May 11, 2017). That seems pretty straightforward to us. Plaintiffs typically use negligence per se to try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim.  State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman.  That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that. Monk doesn’t say all of that explicitly, but it relies on cases that do. That’s good enough for us.

Plaintiff based her negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions.  The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at *3, *6 (citing 21 C.F.R. § 208.24(b)).

And this is where things get confusing, because while the court dismissed plaintiff’s negligence per se claim based on violation of this regulation, the court reached the opposite conclusion regarding plaintiff’s negligent failure to warn claim based on exactly the same thing.  A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the court concluded that this very federal-sounding claim was actually a parallel state law failure to warn claim. But wait. Isn’t plaintiff suing because the defendant allegedly violated the FDCA.  That’s Buckman implied preemption. As many courts have noted, plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging they are suing for conduct that violated the FDCA, but not because the conduct violated the FDCA. But the only allegation here is that defendants did not provide the medication guides as required by federal regulations.

The court’s reasoning is based entirely on dicta in the Fifth Circuit’s decision in Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 679 (5th Cir. 2014) that “failing to provide FDA-approved warnings would be a violation of both state and federal law, this is a parallel claim that is not preempted.” Id. But the claim that defendants provided no warnings was not alleged in the complaint and so was not allowed by the court. There is no information in Eckhardt regarding the basis for plaintiff’s claim that defendant failed to provide any warnings and so it is unknown if it was “because” defendant’s violated a federal regulation.

In Monk, the court knew precisely the basis for plaintiff’s failure to warn claim – 21 C.F.R. § 208.24(b); the same basis as plaintiff’s negligence per se claim. That the result is different on both claims is really difficult to reconcile. So we won’t try. We’ll instead reiterate – no negligence per se based on FDCA in Texas.

 

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug (Eliquis) were preempted under the impossibility preemption reasoning in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  However, as we noted in that post, dismissal of the non-design aspects of complaint was with “leave to amend.” See also Utts, 2016 WL 7429449, at *1.

Of course, plaintiffs amended.

Now, they probably wish they hadn’t.

In a second opinion, issued earlier this month, the Utts litigation was dismissed a second time, this time with prejudice. Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2017 WL 1906875 (S.D.N.Y. May 8, 2017) (“Utts II”).  Preemption was once again front and center, but this time an excellent preemption result was accompanied by a variety of equally pleasing common-law – California law – rulings.

Impossibility Preemption

First, preemption. Design defect claims had already been preempted under Mensing/Bartlett, as plaintiffs were reminded whenever they crossed the line into design-type claims. Id. at *1, 9, 10 n.10, 13 n.15, 16, 19.  But the major preemption issue this time around involved warnings – and whether any of the information that plaintiffs claimed required some kind of “better” warnings involved “newly acquired information” of the sort that a defendant could unilaterally add given the scope of the FDA’s “changes being effected” exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the “CBE” regulation for drugs – note, there are similar CBE regulations for devices and biologics; we’ve discussed the device regulation here).

For a more detailed discussion of the “newly acquired information” aspect of preemption, see our post here about In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), which was the first appellate decision finding preemption where plaintiffs failed to come forward with any “new” information to support their warning claims. Utts II explained that, in the preemption context, “if the plaintiff can point to the existence of ‘newly acquired information’ to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling change made on the basis of this newly acquired information.”  2017 WL 1906875, at *9.

Plaintiffs threw a lot of mud at the drug and its manufacturer, but nothing they heaved against the wall stuck – everything plaintiffs cited all old information that did not go beyond what the FDA had before it when it approved the drug in the first place.

Why is that?

Basically, Eliquis is a next-generation anticoagulant, very effective at what it does, and not requiring the kind of dietary restrictions and constant blood testing that older blood thinners such as warfarin – originally sold as rat poison – do.  Utts II, 2017 WL 1906875, at *2 & n.4.  Unfortunately, the plaintiffs’ bar has decided that anybody needing anticoagulation therapy should be should only have such older drugs available, and has launched an ongoing litigation assault at practically every next generation anticoagulant (others include Xarelto and Pradaxa) – because of risks of serious and sometimes fatal bleeding inherent in what these drugs are supposed to do.

The FDA was well aware of the risks that Eliquis, like any other anticoagulant, could cause uncontrollable bleeding when it approved it. Indeed, the “label warns about the risk of serious bleeding no less than five times.” Id. at *3.  It “specifically warns about the risk of bleeding” during concomitant therapy “in conjunction with antiplatelet agents, such as aspirin.”  Id. at *4.  The labeling also “twice warns about the fact that there is no specific antidote” should serious bleeding occur.  Id.

That’s why plaintiffs lost in Utts II.

Basically, the well-known fact that anticoagulants carry with them serious bleeding risks is why none of the information that the plaintiffs in Utts II brought forward qualified as “new.”  “New” is defined in the FDA’s CBE regulation as “studies, events, or analyses [that] reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.  21 C.F.R. §314.3(b) (quoted at 2017 WL 1906875, at *8).  In the preemption context, “

  • “The table and the description from the ISMP report do not suggest − nor do the plaintiffs allege − that the real-world signal data for [the drug] shows a greater severity or frequency of bleeding events or deaths than previously disclosed in [defendant’s] submissions to the FDA. Accordingly, the information contained in this table does not constitute newly acquired information. Utts II, 2017 WL 1906875, at *13.
  • Plaintiffs argue “that the guidance regarding concomitant use of antiplatelet agents is inadequate because the label does not advise how or when to use combination therapy . . . or how commonly bleeding events will occur. This omission . . . was evident to the FDA when it approved the label and the plaintiffs have not identified any newly acquired information.” Id. (quotation marks and footnote omitted).
  • This observation does not constitute newly acquired information, as it simply speculates whether [drug] safety could be further improved. Id. at *14 (as to “improved dosage guidance”).
  • [E]mbolic-thrombotic events are . . . not bleeding events. Nor do the plaintiffs argue that any of this data comparing the incidence of embolic-thrombotic events . . . constitutes newly acquired information. Id. (footnote omitted).
  • [T]he findings directed towards the risk of ischemic stroke for [the drug] users do not constitute newly acquired information. Id. at *15.
  • [P]laintiffs do not allege, however, that this expert guidance contains, or is founded upon, any newly acquired information regarding reversal agents or the treatment of excessive bleeding.” Id.
  • “[P]laintiffs do not allege that this statement contains newly acquired information about what constitutes a safe residual drug level.” Id. at *16.
  • “[T]his article does not refer to any new information that would have permitted the defendants to amend the [drug’s] label. And, in their opposition to this motion, the plaintiffs do not argue that it does.” Id.
  • “[P]laintiffs do not contend that any of the five remaining documents . . . contains newly acquired information regarding an undisclosed risk of bleeding. Several of these articles merely express a desire for further investigation. Id.

Thus, although plaintiffs loaded up their amended complaint with no fewer than “34 warnings that the defendants allegedly failed to provide,” 2017 WL 1906875, at *11, there was no safety in numbers. None of their supposedly missing warnings was based on “newly acquired information” as defined and required by the FDA’s CBE regulation.

Because, plaintiffs could not point to any “newly acquired information” to support their warning-related allegations, those allegations fell outside the scope of the Levine CBE exception and were preempted, because under Mensing/Bartlett such warnings could not be added without prior FDA approval.  2017 WL 1906875, at *9.

Next, in accordance with practically all law, Utts II held that preemption could be decided on a motion to dismiss.  A “determination regarding preemption is a conclusion of law.” Id. at *19 (pointing out that Mensing had been decided on a motion to dismiss).  To the extent that the Third Circuit’s aberrant Fosamax decision was pertinent, it was distinguishable.  Fosamax was limited to “clear evidence” determinations, and in Utts II, because plaintiffs offered no “new” information, clear evidence was never at issue.  Id. at *19-20.  Finally, plaintiffs were “not entitled to discovery on preempted claims.”  Id. at *20 (discussing TwIqbal).

In a way, the new evidence requirement discussed in Utts II resembles the so called “public disclosure” requirement that is a defense to False Claims Act claims (see here for more discussion), except that the “newness” of the information in preemption of state-law warning claims is measured against the evidence presented to the FDA, as opposed to the public.

Buckman Preemption

Utts II also found fraud-on-the-FDA preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Plaintiffs ran from their blatant fraud-on-the-FDA allegations, asking that they “be read merely as evidentiary background.”  2017 WL 1906875, at *26.  The court read them as they were written (and no doubt intended), and found preemption:

Each of the statements on which the fraud claim is premised depends on statements made to and approved by the FDA. There is no newly acquired information that required or suggested that the allegedly fraudulent statements should be altered to remain truthful and non-fraudulent.  Accordingly, the fraud claims are preempted.

Id.

Other FDCA-Related Issues

On other FDCA-related issues, Utts II ends up on our Adverse Drug/Device Event cheat sheet because of its discussion of how voluntarily reported adverse events aren’t legitimate proof of causation:

Federal regulations advise that a report submitted by a manufacturer “does not necessarily reflect a conclusion by the [manufacturer] or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse effect.” 21 C.F.R. § 314.80(l).  As the FDA Website explains:

FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

The Supreme Court has similarly warned that “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.” Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011). I n sum, “the mere existence of reports of adverse events . . . says nothing in and of itself about whether the drug is causing the adverse events.” Id.

Utts II, 2017 WL 1906875, at *12.

In addition, Utts II contains an excellent discussion of the harmful effects of overwarning.  The need to prevent overwarning is the reason that the CBE regulation does not apply to all information, new or old, that could in some way “strengthen” existing warnings:

The FDA has recognized that “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it.” Indeed, “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.” For this reason, the CBE regulation requires that there be sufficient evidence of a causal association between the drug and the information sought to be added.

Utts II, 2017 WL 1906875, at *8 (all quotes from “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices,” 73 Fed. Reg. 2848 (FDA Jan. 16, 2008).

Another notable FDA-related aspect of Utts II has to do with so-called “comparative claims” – claims that one medication is better than another in some respect.  Plaintiffs often claim (as they did in Utts II) that there is some sort of duty to warn that ones product is less safe than its competition.  However, Utts II points out that the FDA does not permit such claims except when supported by specific types and amounts of scientific evidence.  “[A]ny claim comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”  2017 WL 1906875, at *7 (citing 21 C.F.R. §201.57(c)(7)(iii)).  Further, “federal regulations do not require a manufacturer to include information about a competitor’s product or progress.” Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, 201.80).

State-Law Warning Issues

Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful holdings, mostly about California law.  The decision contains an excellent discussion of the state of the art defense.  2017 WL 1906875, at *10.  It also points out that, the California Supreme Court’s holding – quite apart from preemption – that as a matter of federal/state comity, warning liability does not exist as a matter of state law where the purported duty flies in the face of FDA regulation:

Even where a risk is “known” or “knowable” at the time of distribution, under California law, a manufacturer “may not be held liable for failing to give a warning it has been expressly precluded by the FDA from giving.” Thus, if the manufacturer disclosed to the FDA “state-of-the-art scientific data concerning the alleged risk” and the FDA determined, after its review, “that the pharmaceutical manufacturer was not permitted to warn − e.g., because the data was inconclusive or the risk was too speculative to justify a warning,” then the manufacturer could not be held strictly liable for failure to warn. “[T]he FDA’s conclusion that there was, in effect, no ‘known risk’ is controlling.”

2017 WL 1906875, at *11 (all quotations from Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996)).  Thus, the same grounds that support preemption as a matter of federal law – where, as here, the FDA says “no” – also preclude liability as a matter of state law.

In tandem with preemption, Utts II also holds that the defendant’s drug labeling was adequate as a matter of California law on the bleeding issues raised by plaintiffs – just as our prior post thought it should.  In general, the label “clearly discloses that there is a risk of excessive bleeding and that there is no known antidote if that occurs.”  2017 WL 1906875, at *21.  Nor could plaintiffs prevail with any of the usual nitpicking that goes on in this type of litigation.

  • Monitoring – “The label provides, in unambiguous terms, all of the scientifically reliable information that physicians may need to determine how to monitor their patients.” Id.
  • Bleeding Reversal – A “recommendation is to discontinue [the drug] and apply ‘standard supportive treatment and other local measures’ . . . does not supply a basis for a plausible claim that the label needed to add further guidance.” Id. at *22 (quoting medical article).
  • Dosage – Plaintiffs do “not identify any research or data that undermines or contradicts the dosing guidance” and “speculation about information that the defendants may possess is insufficient to plausibly plead a claim.” Id. (citing TwIqbal).

Similarly, plaintiffs other warning-based claims failed due to the adequacy of the warning.  Id. at *24 (implied warranty), *26-27 (fraud); *29 (consumer fraud)

Finally, here are some other California warning-related nuggets we can use:  (1) Under the learned intermediary rule, “a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient.”  2017 WL 1906875, at *11. (2) “[P]harmaceutical manufacturer[s] may not be required to provide warning of a risk known to the medical community.” Id. (quoting Carlin).  (3) “[W]arnings relevant to any breach of warranty claim are those directed to the physician rather than the patient.” Id. at *22 (quoting Carlin) (emphasis original).  (4) The opinion notes that the learned intermediary rule applies to California consumer fraud claims.  Id. at *28 n.32.

Looking Forward

Utts II contains by far the most detailed discussion to date of the interplay between preemption and the “newly acquired evidence” requirement of the FDA’s CBE regulation.  It would be notable for that reason alone.  However, it also finds the labeling adequate as a matter of law, which is second highly significant ruling in any prescription medical product litigation.  What’s more, since the entire Utts amended complaint is now dismissed with prejudice, not only Utts II, but also the original Utts design defect preemption ruling, is now appealable.

Any appeal would be interesting.  Every ruling in Utts II is double-breasted, in that preemption is bolstered by independent state law grounds.  That is not the case with design defect preemption in the original Utts decision, where preemption is the sole basis for dismissal.  Utts, 2016 WL 7429449, at *12.  So, if plaintiffs were to appeal, their only clean shot at preemption would involve their design claim.  In any event, the preemption rulings in both Utts (Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015)), and Utts II (Celexa, 779 F.3d 34) are supported by court of appeals decisions, as our preemption cheat sheet demonstrates.  At best, in a hypothetical appeal, we would get an affirmance and reinforcing appellate precedent supporting preemption in innovator drug cases.  At worst, there would be a circuit split, which would offer the further (double-hypothetical) possibility of additional Supreme Court review of what Utts II called the Levine “trilogy.”  2017 WL 1906875, at *9.  While we always prefer to win, whenever, however, and as quickly and as thoroughly as possible, we certainly would find another shot at innovator drug preemption in the Supreme Court an interesting proposition.

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.

Today, the Tenth Circuit affirmed in part, reversed in part, and remanded the post-Levine branded drug preemption decision in Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017).  You can read our discussion of the district court opinion in Cerveny here.

While any decision with a description of “affirmed in part, reversed in part, and remanded” is necessarily something of a mixed bag, we’re pleased to report that the defense side won the two most important preemption issues presented in Cerveny (preemptive effect of FDA citizen’s petition denials and of FDA “no evidence” determinations, the court dodged the third (the judge/jury issue from Fosamax), and did its reversing and remanding on issues that could still eventually be preempted, but that it thought the district court had paid insufficient attention.

Cerveny was a birth defect case, and the plaintiff’s major claim was that she took the drug before becoming pregnant.  Slip op. at 2, 13 (all “parties agree that [plaintiff mother] took [the drug] before she became pregnant, but not afterward”).  Plaintiff made a secondary claim – about warnings of risks that the plaintiff did not actually encounter – that if a warning the FDA had actually proposed, concerning the possibility of birth defects during pregnancy, had been included, she wouldn’t ever have taken the drug, even though she never actually took it during pregnancy.  Id. at 3-4.  As we recently discussed in our Smoke Screens & Side Shows post, the law overwhelmingly rejects warning claims based on risks that the plaintiff never actually encountered.

The first theory was the important one, and the Tenth Circuit affirmed preemption:

The ruling was correct on [plaintiffs’] first theory, for the undisputed evidence shows that the FDA would not have approved a warning about taking [the drug] before pregnancy.

Slip op. at 4. As for the second, stay tuned, we’ll discuss it in the order the opinion addressed the claims.

The “clear evidence” required by Wyeth v. Levine, 555 U.S. 555 (2009), existed as to plaintiffs’ before-pregnancy theory because that issue was directly presented to the FDA prior to the injuries claimed in Cerveny by a citizen’s petition that the FDA rejected for lack of evidence.  Thus Cerveny presented the same “changes being effected” exception to FDA pre-approval of warning changes situation as had Levine.  However, “even when this exception applies, the FDA will ultimately approve the label change only if it is based on reasonable evidence of an association.”  Cerveny, slip op. at 7-8 (regulatory citation omitted).

Plaintiffs first tried to argue that there could never be preemption in branded drug warning cases, claiming that Levine’s “discussion of the “clear evidence” standard [w]as dicta.”  Id. at 11.  That Hail Mary pass went nowhere:

[O]ur court has relied on Levine in holding that a state tort claim is preempted if a pharmaceutical company presents clear evidence that the FDA would have rejected an effort to strengthen the label’s warnings.  Thus, we must apply the “clear evidence” test.

Id. at 11-12 (citing Dobbs v. Wyeth Pharmaceuticals, 606 F.3d 1269 (10th Cir. 2010)).

Next, as this blog has discussed, while Cerveny was pending, the Third Circuit decided In re Fosamax Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), including its precedent-shattering holding that the “what the FDA might have done” question posed by Levine “clear evidence” preemption wasn’t a question of law after all.  Id. at 286-89.  Plaintiffs in Cerveny had not argued that proposition, but once Fosamax was decided, they belatedly tried to raise it.  The Tenth Circuit was not inclined to go there.

[Plaintiffs] insist that we should adopt the Third Circuit’s approach and deny summary judgment if “no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected” the proposed label.  We are reticent to take this approach, for the parties’ appeal briefs do not address this issue.

Cerveny, slip op. at 11-12.  Ultimately, though, Fosamax didn’t matter because even assuming that its standard applied, preemption barred plaintiffs’ before-pregnancy warning claim.

The court first looked at the direct regulatory history of the drug, and FDA consideration of teratologically-related warnings.  Not enough, the court held:

[The drug’s] regulatory history is similar to Phenergan’s [the drug in Levine].  Like Phenergan, [this drug] had appeared on the market for decades before [plaintiff mother] took [it].  And [defendant] has intermittently corresponded with the FDA about [the drug’s] labels. . . .  Likewise, the FDA’s approval of [the drug’s] labels suggests only that the FDA knew about potential issues involving pre-pregnancy use . . . not that the FDA would have rejected a stronger warning if one had been proposed.

Cerveny, slip op. at 17.  So, if that was all the regulatory history, the defendant would have lost. – but it wasn’t.

Enter the citizen’s petition.

A plaintiff’s lawyer brought a citizen’s petition seeking to force the FDA to add a pre-pregnancy birth defect warning to the drug after the use at issue in Cerveny.  Id. at 14 & n.8, 18-19.  That petition was denied in 2009 (the use in Cerveny occurred in 1992).  Id. at 19.  Critically, the FDA denied that petition for lack of scientific basis – using the same regulatory standard of proof applicable if the manufacturer had sought the same change.

The FDA concluded that . . . “the scientific literature [did] not justify ordering changes to the labeling that warn of such risks beyond those presently included in labeling”. . . .  [Petitioner] sought reconsideration, which he twice supplemented with more information.  The FDA declined to reconsider, explaining that the original denial had “appropriately applied the standards in the [FDCA].

Cerveny, slip op. at 19.

The petition denial satisfied Levine’s “clear evidence” standard.  Plaintiffs’ “failure-to-warn claims are based on the same theories and scientific evidence presented in [the] citizen petition.”  Id.

Cerveny rejected plaintiffs’ argument that citizen’s petitions shouldn’t count.  First, label changes are serious business.  “[T]he FDA views overwarnings as problematic because they can render the warnings useless and discourage use of beneficial medications.” Id. at 20.  Second, “the FDA standard for revising a warning label does not discriminate between proposals submitted by manufacturers and proposals submitted by citizens.” Id. at 21 (regulatory citation omitted).  Arguments that the FDA nonetheless differentiated between manufacturers and independent petitioners didn’t hold water:

[Plaintiffs] suggest that the FDA disobeys its own regulations to apply different standards depending on the source of the proposed change. But we do not presume that the FDA deviates from regulatory requirements.

*          *          *          *

[plaintiffs] hypothesize that the FDA would be more receptive to a manufacturer’s request to strengthen a warning than to a citizen’s effort to compel a stronger warning.  But a factual dispute cannot be based on speculation that the FDA would jettison its legal requirements and rubber-stamp [defendant’s] hypothetical proposal notwithstanding the risk of overwarning.

Under the same standard for manufacturer-initiated changes, the FDA rejected a citizen petition containing arguments virtually identical to [plaintiffs’].  We will not assume that the FDA would have scuttled its own regulatory standard if [defendant] had requested the new warning.  Thus, we reject [plaintiff’s] challenge to [defendant’s] reliance on [the] citizen petition.

Id. at 21, 23 (citations and alternative explanations for FDA conduct omitted).  Third, even under a Fosamax standard, the FDA’s rejection of the citizen’s petition was a “smoking gun” that “foreclose[d] any reasonable juror from finding that the FDA would have approved” the label change advocated by plaintiffs.  Id. at 23 n.11.

Thus a no-evidence rejection of a comparable warning change was preemptive.  There was no “bright-line rule” that such a rejection was insufficient to constitute “clear evidence” satisfying Levine.  Thus, Cerveny rejected contrary cases, including one that we have criticized – slip op. at 25-27 (rejecting Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015), Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F. Supp.2d 1125, 1133 (D. Minn. 2011), and Forst v. Smithkline Beecham Corp., 639 F. Supp.2d 948, 954 (E.D. Wis. 2009)) − and distinguished others.  Slip op. at 24-25, 27 (distinguishing Mason v. SmithKline Beecham Corp., 596 F.3d 387, 396 (7th Cir. 2010), Koho v. Forest Laboratories, Inc., 17 F. Supp.3d 1109, 1117 (W.D. Wash. 2014), Dorsett v. Sandoz, Inc., 699 F. Supp.2d 1142, 1158-59 (C.D. Cal. 2010), and Hunt v. McNeil Consumer Healthcare, 6 F. Supp.3d 694, 700-01 (E.D. La. 2014)).  Critically, Cerveny distinguished Mason because there, the petition “had been rejected before the plaintiff’s injury.”  Cerveny, slip op. at 24 (emphasis original).  The “bright line” were interested in – that an FDA insufficient-evidence rejection after a plaintiff’s injury is necessarily preemptive, since even less evidence would have existed at any earlier time – remains intact in Cerveny.

Finally, some clarity for the “clear evidence” standard.

However, the court reversed dismissal of the plaintiffs’ weaker claim, that if they had received a stronger warning about a birth-defect risk existing only during pregnancy, they wouldn’t have taken the drug at all (even before pregnancy) and thus the injury wouldn’t have occurred.  As to that risk, they could point to a label change proposed (but not required) by the FDA.  Slip op. at 28-29.  That proposal “d[id] not suggest that the FDA would have approved a warning about taking [the drug] prior to pregnancy,” id. at 29, and thus did not affect preemption of plaintiff’s pre-pregnancy claims.  Id.

Plaintiffs’ pre-pregnancy claim is exactly the sort of attenuated allegation that we addressed at length in our Smoke Screens & Side Shows post – that the plaintiff mother “would not have taken [the drug], even pre-pregnancy, if [defendant] had used the FDA’s proposed wording” about post-pregnancy risks.  Id. at 32.  The problem on appeal in Cerveny was that dismissal had been sought from, and granted by, the trial court solely on preemption grounds, whereas (as our post demonstrates) the best defense was that remote causation claims did not exist under state law.  Id. at 34.

The Tenth Circuit cut plaintiffs a break. Even though the district court had pointed out that it “would be a nonsensical result if a plaintiff could avoid a preemption defense by arguing that a drug label could have been strengthened in any form, regardless of its relevance to the plaintiff’s case,” id. at 34 (quoting Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203, 1220 (D. Utah 2016)), the appellate court decided that wasn’t enough to affirm dismissal on non-preemption grounds.

In sum, the district court did not consider whether it could rest on Utah law when deciding a summary judgment motion that had relied solely on federal preemption.  Because the district court did not consider this question and it has not been fully briefed on appeal, we leave this question for the district court to address on remand.

Cerveny, slip op. at 36.  So much for affirming on any ground.  Strange things happen in tort preemption cases.  At least the blog’s already done some of the defendant’s research (although we didn’t find any Utah cases, unfortunately).

The last bit was the disposition of plaintiffs’ fraud, misrepresentation, and implied warranty claims. The district court had dismissed them as just preempted warning claims under different names.  Id. at 37.  Again the court cut the plaintiffs a break, holding that any preemption dismissal needed to address those claims separately:

[W]e reverse and remand the award of summary judgment on the claims of fraud, negligent misrepresentation, and breach of an implied warranty.  We do not foreclose the possibility that these claims might be preempted.  But on remand, the district court should explain the effect of preemption on th[os]e claims.

Id. at 38.  Finally, the Tenth Circuit held that plaintiffs were not entitled to additional discovery before preemption was decided.  Id. at 38-41.  At least, on remand, the defendant won’t be forced to incur additional discovery costs before teeing up preemption again.

Although not every claim was held preempted on appeal, in our books Cerveny is a significant defense win.  It finds “clear evidence” as a matter of law to preempt the plaintiffs’ main claim.  It holds that citizen’s petition denials are as preemptive as any other form of FDA decisionmaking.  It affirms the importance of overwarning, and thus that an inadequate-information FDA label change preempts all prior claims where there can be no claim of additional information being discovered in the interim.

We wonder whether plaintiffs will appeal.  There is now a direct conflict between Cerveny (a court of appeals) and Reckis (a state high court) on FDA citizen’s petition denials being “clear evidence” under Levine.  We’ve thought from day one that Levine was appallingly reasoned and should be reconsidered, and maybe this is the vehicle.  We also think that Justice Gorsuch, a textualist, won’t put much stock in the Reckis (and plaintiffs’ in Cerveny) rationale that the identical FDA standard doesn’t mean the same thing depending on who is submitting a proposed label change.

Do plaintiffs roll the dice?

 

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn.  Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff of evidence that anything went wrong on the production line?  Seldom do we see the pharma equivalent of a mouse in the Coke bottle or, thinking of a more recent case, a bat in the salad.  Similarly, 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).  No, failure to warn is where the action is.  In the wake of Wyeth v. Levine, it seemed that preemption would be a tough row to hoe in such cases, but keep hoeing that row because the preemption defense might still be available – as a motion to dismiss, summary judgment motion, directed verdict, or argument to the jury.

 

The recent case of Amos v. Biogen Idec, Inc. et al., 2017 WL 1316968 (W.D.N.Y. April 10, 2017), makes every one of these points for us.  The court granted summary judgment to the defendants in that case, holding that all of the claims were fundamentally about failure to warn, the warning was adequate as a matter of law, and the FDA’s earlier rejection of proposed warnings meant that the plaintiff’s claims were preempted.  The facts of Amos present the sort of situation defendants encounter all too often, but which make for a hard sell to a jury: something very sad happened to an innocent patient, but it was nobody’s fault.  The patient had Multiple Sclerosis too severe to respond well to the usual treatments.  Her doctor recommended Tysabri.  That medicine came with a black box warning that it might increase the risk of Progressive Multifocal Leukoencephalopathy (“PML”), a viral infection of the brain that is as incurable as MS is.  The patient eventually contracted PML and died.  Her estate filed a lawsuit that included claims for negligence, negligent misrepresentation, strict liability, and breach of implied warranty. 

 

From the recital of facts in the Amos case, it appears that the manufacturer of Tysabri was quite diligent and proactive.  It also appears that the defense attorneys did an excellent job of mining the administrative record.  The manufacturer continued to perform clinical trials after initial approval, and promptly alerted the FDA of whatever risks it observed.  Among other things, the company asked the FDA to add information in the label about screening for certain virus antibodies that might increase the risk of PML.  The FDA rejected this proposal a couple of times, finding insufficient evidence at those times to support the label change.  The FDA ultimately relented and approved a label change in 2012 – after the plaintiff’s decedent died.

 

In considering the defense motion for summary judgment, the court concluded that all of the plaintiff’s claims turned on the sufficiency of the warnings.  New York law applied, and there was ample precedent under New York law that adequate warnings precluded claims for negligence, strict liability, breach of warranties, or fraud.  What’s more, the learned intermediary applied to claims regarding prescription drug warnings, and the record was replete with evidence that the prescribing doctor was well aware of the increased risk of  PMI.  It certainly helped the defense that the defendant, in collaboration with the FDA, had created a program called Tysabri Outreach: Unified Commitment to Health (“TOUCH”), which required that, prior to prescribing Tysabri, a physician had to acknowledge in writing that he/she understood the risks of PML and obtained a written acknowledgment from the patient that the patient understands the PML risk. The existence of the TOUCH program was one of several facts that made Amos a hard case for the plaintiff to win.

 

Even so, we all know that no matter how comprehensive and informative a warning label is, a good plaintiff lawyer can flyspeck it and find, or make up, some gaps.  The plaintiff lawyers in the Amos case are well known to us, and are very, very good.  They argued that the Tysabri warnings were inadequate because they failed to include information regarding the correlation between the virus antibodies and PML, and failed to inform doctors of the risks associated with duration of treatment and prior treatment with an immunosuppressant.  To our eyes, the plaintiff lawyers made the best arguments they could.  In too many courts, such an argument would furnish enough of a crutch for a plaintiff-leaning (or lazy-leaning) judge to mutter ‘factual dispute’ and deny the motion in a post-card ruling.  But not this court.  The judge analyzed New York law and held that even without the details regarding specific risk factors, “when read as a whole, the warnings unmistakably conveyed the seriousness of PML and its association with Tysabri treatment.”  That “read as a whole” point is important.  Do not let a court tell you that it is the jury’s duty to read the warnings as a whole.  It is the court’s job to assess whether the warning is adequate as a matter of law, and plaintiff post hoc fly-specking should not be enough to plant a case in front of twelve citizens good and true (and half-asleep and inflamed with sympathy and anti-corporate hatred).    

 

Even aside from the conclusion that the Tysabri warnings were adequate as a matter of law, the court offered an alternative basis for dismissing the case:  the claims were preempted as a matter of law.  Wyeth v. Levine ruled against preemption on the (at least partially specious) ground that drug companies can unilaterally ramp up warnings through the Changes Being Effected (“CBE”) process.  But the Amos court accurately observed that CBE is not available in all situations, and definitely is not available to add or change a black box warning, which is what was at issue in this Tysabri case.  Moreover, “the evidence of record leads inescapably to the conclusion that the FDA would not have approved a change to Tysabri’s label prior to 2012.”  With respect to Tysabri, there were two “smoking gun” rejections from the FDA. 

 

Also notable in Amos:  a second defendant in the case, a distributor of Tysabri, received summary judgment on preemption grounds.  The distributor did not own the drug’s New Drug Application, and thus had no power under the FDA scheme to alter warnings in any way.  The distributor’s inability to act independently to change warnings meant that, under the Mensing and Bartlett decisions, all claims against it were preempted.

 

There have been other cases around the country where courts arrived at similar rulings that Tysabri warnings were adequate as a matter of law and that failure to warn claims were preempted.  Perhaps plaintiff lawyers will do their best to distinguish these cases on their facts.  We will, doubtless, hear that “smoking gun” has become the standard for the Wyeth v. Levine “clear evidence” standard. We heard something nearly as silly from our home appellate court recently.  But reading the Amos case in the same way that the Amos court read the Tysabri label – as a whole – there is an awful lot of comfort in that case for drug and device defendants.