A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act.  It contained a provision providing the manufacturers of FDA-approved drugs with immunity from product liability absent the application of two narrow exceptions.  A challenge to the constitutionality of the provision soon followed and the Michigan Supreme Court, in Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003), basically said the legislature can enact a law like that and the immunity on drug manufacturers was as broad as it seemed.  (This guest post provides a nice history.)  Other decisions followed, like Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), and Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), coming down on opposite sides of the issue of whether the first exception—the defendant “before the event that allegedly caused the injury . . . intentionally withholds from or misrepresents to [FDA] information concerning the drug that is required to be submitted” under the FDCA that would have prevented original or continued approval—runs into Buckman preemption.  What also followed was that Michiganders who wanted to sue over alleged drug started to go elsewhere.  (Not to galaxies several parsecs—a unit of distance, not time—away, but just to other states.)  They did so because they hoped that the immunity in § 600.2946(5) would not follow them.

We have called this phenomenon the Michigan diaspora, and, while the dispersal of the Michigan litigation tourists is merely temporary, their cases do keep popping up in some likely spots.  Just last month, we discussed how West Virginia state courts have applied Michigan law to the claims of Michiganders hoping to find more plaintiff-friendly law.  We have also discussed how the claims of Michiganians claiming gynecomastia from Risperdal have fared in the Philadelphia Court of Common Pleas, a jurisdiction that has seen plenty of action in that particular litigation.  We praised the court’s application of the Michigan statute to bar the claims.  The plaintiffs in that case appealed to the Superior Court of Pennsylvania, which has reversed more than a few defense rulings we have liked.  Instead In re Risperdal Litig., __ A.3d __, 2017 WL 5712521 (Pa. Super. Nov. 28, 2017), respected the force of the Michigan Legislature’s clear enactment and affirmed.

On appeal, the plaintiffs agreed that Michigan law applied, but argued that the statute provided no protection where the use was off-label.  When the plaintiffs (actually all but one of them) were prescribed the drug it had been approved but did not yet have an indication for use in juveniles, which they were at the time.  The statute, however, hinged on whether “the drug was approved for safety and efficacy,” not whether the particular indication had been approved.  Federal courts had followed “the plain language of the statute” and found off-label use was irrelevant to the application of immunity as long as the drug was approved.  2017 WL 5712521, **5-6.  “Thus, we conclude that as long s a drug has received approval, and its label is compliant with FDA regulations, the MPLA applies to bar any product liability claim, despite the drug’s indicated uses.” Id. at *6.

Next, plaintiffs argued that they had enough evidence to raise a genuine issue as to the statutory exception based on a fraud on the FDA.  Defendants claimed that any attempt to meet the exception would be preempted because the FDA had never found such a fraud.  The Superior Court did not take the opportunity to add to either side of the preemption ledger because plaintiffs did not have the evidence they needed anyway. Id. at *7.  The statute did not just require any fraud on FDA, but a withholding of information such that its proper submission would have meant “the drug would not have been approved” or FDA “would have withdrawn approval for the drug.”  Plaintiffs argued that their evidence of purported fraud was relevant to the approval of the additional indication for juvenile use, but they never contended that the drug would not have been approved or would have been withdrawn.  “[T]he proof of fraud a plaintiff is required to present in order to receive the benefit of the fraud exception must relate to the initial FDA approval.” Id. at *8.  Given that FDA had denied a citizen’s petition in 2014 that requested the drug be withdrawn, it was clear that any purported fraud related to the application to add the juvenile use indication almost a decade earlier was insufficient to trigger the exception. Id. We all know Yoda famously said “Do or do not.  There is no try.”  Here, plaintiffs tried and tried again, but they did not get around the statutory immunity despite their sojourn to Pennsylvania.

 

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog.  Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals.  As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame.  Take it away Kevin.

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SCOTUS Calls For Solicitor General’s Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog’s previous lambasting of the Third Circuit’s unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)?  Now, there is positive news to report. The Supreme Court has invited the Solicitor General “to file a brief in this case expressing the views of the United States.” Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog’s description:

“CVSG” stands for “call for the views of the Solicitor General.”  In most cases in which someone is seeking review of the lower courts’ decision, the Court will issue a straightforward grant or denial.  But sometimes the Court will want the government’s views on what it should do in a case in which the government isn’t a party but may still have an interest — for example, because the interpretation of a federal statute is involved.  So the Court will issue an order in which it “invites the Solicitor General to file a brief expressing the views of the United States.”  It isn’t an “invitation” in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file.  There is no deadline by which the government is required to file the brief, however.  And the government’s recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted.  Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, “An Empirical Analysis of Supreme Court Certiorari Petition Procedures:  The Call for Response and the Call for the Views of the Solicitor General,” 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG.  For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added).  If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the “clear evidence” preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer’s compliance with federal and state law is impossible, and thereby preempted, already an exacting defense.  As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without “clear and convincing” evidence that the FDA would have rejected a proposed warning.  Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended.  The Blog also discussed the Product Liability Advisory Council’s amicus brief in support of the petition here, which explained that the Third Circuit’s decision invites further lower court confusion, obliterates the district court’s ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases.  As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted “The Crookedest Street In The World,” with its eight hairpin turns and switchbacks that span the 600 feet of the street’s natural 27° grade.  In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin.   Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year.  This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results.  The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement.  As already discussed at length, the Appellate Division reversed the trial court’s decision that excluded plaintiffs’ expert causation testimony, reviving more than 2000 lawsuits.  Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey’s largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law.  When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a “relaxed” standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard.  Under Rubanick, expert testimony may be admitted “even though it is controversial and its acceptance is not widespread,” only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines “whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 426 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued the state’s unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to “demonstrate[] a statistically significant increased risk of developing Crohn’s disease.”  In re Accutane Litigation, 451 N.J. Super. 153, 168  (App. Div. July 28, 2017).  Nonetheless, the Appellate Division allowed the plaintiffs’ experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data.  Id. at 165-166.  Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications.  Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals.  The amici implored the New Jersey Supreme Court to adopt Daubert’s methodology to reaffirm the trial court’s role as a gatekeeper to ensure that only reliable scientific evidence informs the jury’s decision.  Again, the industry can take heart in the court’s order granting review of the Appellate Division’s abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony.  If that occurs, no doubt will the New Jersey high court reinstate the trial court’s ruling, and order dismissal of the more than 2000 cases for lack of  causation evidence.

The defendants in the Eliquis MDL have turned somewhat of a preemption hat trick. The latest order is In re Eliquis (Apixaban) Prods. Liab. Litig., No 17-md-2754 (S.D.N.Y. Nov. 29, 2017), where the district court dismissed twenty-four cases newly transferred into that MDL.  We will explain why in a moment, but first a little background.  The defendants scored their first goal in a case called Utts—which resulted in pair of orders (one before the MDL was formed and one after) ruling that federal law impliedly preempted the plaintiffs’ failure-to-warn and design defect claims.  These were important orders.  As we explained in detail here, the district court very clearly explicated the three Supreme Court opinions that mainly shape implied preemption in the prescription drug space—Wyeth v. Levine, Mensing, and Bartlett.

We all understand that Wyeth v. Levine opened the anti-preemption door by recognizing that an innovator drug manufacturer could sometimes change its label without the FDA’s pre-approval through the Changed Being Effected (or “CBE”) process.  Because that allowed the manufacturer, under some circumstances, to change its label to accommodate state law without running afoul of federal law, implied preemption did not necessarily apply.  Then came Mensing, which held that federal law impliedly preempted failure-to-warn claims against generic drug manufactures because generic manufacturers cannot use the CBE process, and therefore cannot change their labels without pre-approval.  That leaves generic manufacturers between a federal rock and a state-law hard place, which equals preemption.

Finally, Bartlett.  There, the Supreme Court held that federal law impliedly preempted state-law design defect claims for similar reasons, i.e., a generic drug manufacturer cannot change a drug’s design without pre-approval either, thus again triggering implied preemption.  We have said multiple times in this space that Bartlett’s rationale is not limited to generic manufacturers because an innovator drug manufacturer also cannot change its product’s design without pre-approval.

That is where Utts came in.  Although dealing with an innovator drug, the district court applied Bartlett to dismiss the design defect claims.  In the part that we like the most, the court also applied Wyeth and Mensing to dismiss the warnings claims because the plaintiffs did not present any “newly acquired information.”  Because “newly acquired information” is required to invoke the CBE process, the defendants could not change the Eliquis label without federal pre-approval.  Under those circumstances, a state-law tort claim would conflict with federal law, thus preemption.  The district court granted the plaintiffs leave to amend, but they again failed to plead any “newly acquired information.”  Moreover, because the labeling already warned stridently about the risk at issue (bleeding) the warnings were adequate as a matter of law, too.  Case dismissed without leave, as we explained here.

The defendants scored their second goal when the district court applied Utts to other cases in the MDL.  The order that caught our eye was Fortner, which we covered here.  In Fortner, other plaintiffs attempted to plead state-law claims that were not preempted.  But try as they might, these plaintiffs also could not plead any “newly acquired information.”  The CBE process there was still unavailable; the defendants still could not alter the labeling without pre-approval; and federal law still preempted their claims.  And, by the way, the warnings were still adequate as a matter of state law.  (Careful readers have figured out by now that we have oversimplified these orders for brevity, but you get the idea.  You can read our prior posts here, here, and here to get the gory details.)

Which brings us to the defendants’ third goal scored—application of Utts to cases newly transferred into the Eliquis MDL.  To start, we admire the district court’s process.  The district court used Utts as a vehicle to decide preemption in the first instance, and once it set the rules, it ordered any plaintiff assigned or transferred to the MDL to show cause within 14 days why his or her case should not be dismissed.  Slip op. at 2.

These twenty-four plaintiffs, newly transferred from the District of Delaware, complied with the court’s order and made three arguments, none of them successful. They argued first that Utts did not apply because they omitted from their amended complaints some of the material that appeared in the Utts amended complaint.  Slip op. at 4.  In other words, their claims should survive because they were more vague and less complete in asserting their claims.

The plaintiffs in Fortner tried this tactic too—we’ll call it pleading by obfuscation.  But it did not work there, and it did not work here either:  “Even without reference to the documents on which the amended complaint in Utts relied, the complaints ‘simply do[ ] not provide 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.’”  Slip op. at 5 (quoting Fortner).

Plaintiffs also argued that the warnings were inadequate under their various states’ laws, but they did not explain why. Nor did they “even cite the statutes or case law that pertain to the adequacy of a label’s warnings for any jurisdiction.”  Slip op. at 5.  Thus, “[i]n the absence of citation to any authority, it is unnecessary to address the argument further.”  Slip op at 5.  Finally, the plaintiffs asked to be remanded to the District of Delaware.  That’s right.  If you can’t win, get out of Dodge.  But they again failed to “explain a basis” for granting that relief.

We mused in our last post on Eliquis that this MDL may not last long, and we seem to have been correct. Moreover, given the sound basis for the district court’s preemption rulings, we doubt the plaintiffs will do any better elsewhere.

Today is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio.  That is fitting, given our postscript.

 

December 1 is also the birthday of Sarah Silverman and Bette Midler, two women who consistently bring smiles, so we’ll discuss a good case out of the Eleventh Circuit, though probably not good enough to crack our upcoming top ten list.  In Tsavaris v. Pfizer, Inc., 2017 WL 5593488 (11th Cir. Nov. 21, 2017), the plaintiff claimed that she developed breast cancer after ingesting a generic version of a hormone replacement drug.  She sued both the brand and generic manufacturers.  We don’t know what happened regarding the brand manufacturer (they should certainly have secured a dismissal), but we know that the district court dismissed the claims against the generic manufacturer on preemption grounds well-established in the Mensing and Bartlett SCOTUS decisions and the Guarino Eleventh Circuit decision.  The district court entered final judgment for the defendant.

 

The plaintiff filed an amended complaint against the generic manufacturer, asserting that she would not have been harmed had the manufacturer not “failed in its federally mandated duty” under 21 U.S.C. section 355 to notify the FDA of certain scientific studies relevant to the cancer risk.  The district court denied the amendment on both procedural and substantive grounds, and the Eleventh Circuit affirmed, holding that the district court had not abused its discretion.  The procedural grounds were enough to bar the amendment: the plaintiff identified no newly-discovered evidence or manifest error of law, as required by Federal Rule of Civil Procedure 59(e).  That is all well and good.

 

But it is the substantive decision that is more interesting to us.  The plaintiff was complaining of a violation of a federal reporting duty owed to a federal agency, not to her.  More specifically, she premised her complaint on a provision of the federal Drug Price Competition and Patent Term Restoration Act that requires companies to submit “data relating to clinical experience and other data or information … about the safety, effectiveness, or labeling of its drug” to the FDA.  Because the plaintiff was seeking “to enforce a duty owed to a federal agency and her cause of action would not exist in the absence of that duty, her proposed second amended complaint is preempted.”

 

The Tsavaris decision was not selected by the Eleventh Circuit for publication in the Federal Reporter, perhaps because this was a pro se appeal.  But the proposed amended complaint was drafted “with the assistance of counsel,” and is fairly typical of the way some plaintiff lawyers seek to evade preemption.  Thus, the Eleventh Circuit’s finding that the amendment would have been futile provides some comfort to practitioners on the right side of the v.

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We mourn the passing earlier this week of beloved Reed Smith colleague Chuck Pagliotti.  Chuck was what all of us in the legal profession should aspire to be – a problem solver.  Chuck was a genius when it came to fixing messes we made on our computers, iPhones, or anything else that could occasionally baffle us.  He always did so with patience and a smile.  We shared a love for anything relating to Star Wars.  Chuck was a sweet, gentle soul. Our grief exceeds our poor power of expression.

 

 

We can be inundated with news.  Old news.  New news.  Fake news.  Breaking news.  News that makes you want to break something.  News that makes you want to go back to bed.  In trying to be discerning consumers of the news, it is useful to do not just a reality check but a date check.  Stories on a social media stream come with a presumption of newness, but the date of the release of the story—once you find it—may make you stop reading because it is not news any more.  You may even have read the old news when it was new and just got suckered back by the misimpression of novelty.  A story about a new species of dinosaur, or even beetle, being discovered?  We are clicking.  Einstein’s prediction of gravitational waves verified?  Click—wait, we saw that way back in early 2016, and a Nobel Prize was awarded for that last month.

Generic drug preemption may not be as clickworthy as a “new” ankylosaur, but these decisions do still catch our attention.  After Mensing, Bartlett and scores of published decisions preempting the vast majority of conceivable claims—or holding that state law does not recognize the claim the plaintiff would need to sidestep preemption—you might think that plaintiffs would stop pursuing these claims.  Well, the nonsense that is innovator liability has not provided a viable alternative—although the plaintiffs keep trying (like here and here)—and courts have not yet resorted to Rule 11 for pursuing obviously preempted claims, so the plaintiffs keep trying.  When Kious v. Teva Pharmaceuticals USA, Inc., No. 16-990-R, 2016 WL 9559038 (W.D. Okla. Dec. 8, 2016), popped up in our searches, we thought it might be new and newsworthy.  It really was old news made to seem new because it had taken eleven months to get on Westlaw.  The generic manufacturer defendant secured dismissal of the claims against it on preemption, but was there anything new, different or interesting about it?  We think it is pretty much old hat, but that may be the point.

Kious involves a plaintiff who claims to have developed Stevens-Johnson Syndrome as the result of the use of a generic antibiotic, the label for which apparently matched that of the reference drug.  The plaintiff sued the generic manufacturer, asserting standard state law claims, and a motion to dismiss the amended complaint followed.  (He also sued the branded manufacturer, but that is not discussed in the opinion.)  The court walked through each asserted claim, starting with design defect.  Preemption of such claims is not really a question post-Bartlett, but the Tenth Circuit’s decision in Schrock, discussed here, left no doubt that strict liability and negligence design claims fail.  Id. at *2.  Next up was the claim for manufacturing defect, which was really just a re-packaged claim for design defect.  Plaintiff claimed “that every dose of azithromycin was defective because of its design and/or lack of adequate warnings,” so he did not plead a manufacturing defect claim under Oklahoma law (and the design claim under a different label was still preempted). Id.

Next up were the warnings claims.  Plaintiff did not allege a failure to update the generic label to mirror the reference drug’s label, so Mensing’s application should have been straightforward.  Not so, claimed the plaintiff, because Mensing involved prescriptions written before the Food and Drug Administration Amendments Act of 2007, which established a procedure under which FDA could ask for a new label from a generic manufacturer if the reference drug was no marketed and there is new safety information.  Even this argument, however, was not new, as courts like the Seventh Circuit had already rejected it.  The Wagner decision (a lofty fifth place on last’s year’s best list) made clear that the FDAAA did not remove the prohibition against a generic drug manufacturer changing its label unilaterally.  2016 WL 9559038, *4. Kious went a step further—and we think this was actually novel—and noted that the FDA’s proposed rule from 2013 to allow generic manufacturers to change their labels unilaterally in some situations supports preemption.  “The proposed rule would be unnecessary if, as Plaintiff urges, the 2007 Amendments permitted unilateral labeling changes by generic manufacturer.” Id. No news is good news, at least here, so warnings claims are still preempted.

The remaining claims were also dismissed.  Express warranty claims are really preempted warnings claims and implied warranty claims were really preempted design claims or preempted warnings claims, depending on how construed.  Again, the Schrock decision, also under Oklahoma law, determined the result. Id. at *5.  For the claims of fraud, negligent misrepresentation, and negligent concealment, the court looked to the Eleventh Circuit’s decision in Guarino for clear authority that these were simply another version of preempted warnings claims. Id. at **5-6.  That was it for every claim plaintiff offered and, plaintiff did not get to amend again.  Judgment for the defendant after only two strikes.  Could it be that sanctions for asserting frivolous claims are next in such suits?  That would be news, no matter when it happens.

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in a barrel, as our generic preemption scorecard documents.  Still, that’s no reason not to praise good results.  Recently, the manufacturers of generic amiodarone scored two big wins on the same day.  Moore v. Zydus Pharmaceuticals (USA), Inc., ___ F. Supp.3d ___, 2017 WL 4365162 (E.D. Ky. Sept. 29, 2017); Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330 (D.S.C. Sept. 29, 2017).  Moore, which is headed for F. Supp. publication, is the more comprehensive case, so we’ll start with it.

The plaintiffs’ pitch, such as it is, in these cases is that the generic defendants either piggybacked on the branded manufacturer’s earlier off-label promotion or else engaged in such promotion themselves.  Secondarily, they claim that they didn’t receive the medication guide that the FDA requires manufacturers of this product to provide to prescribing physicians.  Somehow, the failure of the prescriber to pass along this pamphlet is the manufacturer’s fault.

Didn’t work (mostly) in Moore.  As for the off-label promotion allegations, they were barred – as other information-related claims involving generic products are barred – because “the generic drug manufacturer could not change its labeling without violating FDA regulations.”  Moore, 2017 WL 4365162, at *3 (citing Mensing).  Further, the entire concept of “off-label” is derived from the FDA-approved label, and thus from the Food, Drug & Cosmetic Act (“FDCA”).  Id. at*7.  Plaintiff’s attempt to gin up a state-law negligence claim based on this alleged conduct ran straight into a quirk of Kentucky law that we’ve blogged about before:  Kentucky, by statute, prohibits negligence per se claims based on violations of federal law.

The Kentucky Supreme Court’s holding in T & M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530 (Ky. 2006) offers binding and unequivocal precedent concerning the scope of KRS 446.070 and demonstrates that [plaintiff] does not have a state based right to sue for negligence in this matter.

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Under Kentucky law and the Kentucky Supreme Court’s analysis of KRS 446.070, which codifies the doctrine of negligence per se, . . . the statute “did not intend for KRS 446.070 to … confer a private civil remedy for” violations of federal law.

Moore, 2017 WL 4365162, at *7-8.  Aside from the off-label aspect, all warning claims were preempted under Mensing.  Id. at *8-9.  Plaintiff did not allege design- or manufacturing-related claims.  Id. at *8.

As for the purported failure to supply the FDA-mandated medication guide, that was something that the plaintiff simply made up.  Kentucky, like every other state, follows the learned intermediary rule.  Id. at *6.  The manufacturer thus has no obligation, “non-delegable” or otherwise, to communicate warnings directly to a patient who has been prescribed a drug.  Id.  Because there is no such state-law duty, any obligation to supply medication guides was imposed solely by the FDCA.  The FDCA, however, “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.”  Id. at *5 (quoting Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001)).

Since [plaintiff’s] claim concerning receipt of the medication guide exists exclusively due to the federal regulatory scheme, her claim must fail as the cause of action is merely based upon alleged violation of the FDCA and it is the FDA, not [plaintiff], that “has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration.”

Id. (again quoting Buckman, 531 U.S. at 349).

Implied warranty claims were preempted for the same reasons as negligence and strict liability claims.  Id. at *9.  Express warranty claims failed because there was nothing the “explicitly warranted” the drug’s safety for the off-label use in question.  Id. at *10.  Without any express language, the warranty claim was simply a doomed repackaging of plaintiff’s preempted warning claim.  Id. at *11.

The only claim that could conceivably survive preemption in Moore was a fraud claim based on false off-label promotion.  As we’ve seen numerous times in PMA preemption, while every other aspect of off-label promotion was protected by preemption, an allegation that was both false and an FDCA violation could survive – if a plaintiff ever properly pleaded it.  The plaintiff in Moore didn’t come close:

The majority of the complaint fails to specify actions undertaken by [defendant] and instead conflates accusations of wrongdoing against the two originally named “Defendants.”  Instead of providing specific details concerning when the wrongful conduct took place, the Complaint alleges that the “Defendants’ scheme in the past involved and continues to involve a calculated and deceitful sales campaign. . . .”

Id. at 12.  The complaint was such a mess that “it is unclear whether providing [plaintiff] with an opportunity to amend her complaint would be futile.”  Id.  The court decided to give her one more shot.  Id.

The second preemption win, Bean, 2017 WL 4348330, was mostly along the same lines, except that, being from South Carolina, the Kentucky quirk on negligence per se wasn’t at issue.  The plaintiff made same the allegations about off-label promotion and medication guides.  Id. at *1-4.  The court was even firmer about preemption, not allowing any loophole for “fraudulent” off-label promotion:

Plaintiff’s “off-label” promotion claims are due to be dismissed as preempted under Mensing and Bartlett. . . .   The basis for Plaintiff’s “off-label” marketing claim is that Defendants, by virtue of their marketing of [the drug off-label], rendered the manufacturer’s warning inadequate.  Defendants are prohibited by the FDCA and FDA regulations from adding or strengthening any warnings for [the drug] to address any risks associated with off-label use.  If successful, Plaintiff’s “off-label” promotion claims would necessarily require Defendants to either: 1) change the warning label or disseminate additional warnings to reflect the alleged additional dangers associated with the “off-label” use of amiodarone for atrial fibrillation; 2) accept state tort liability; or 3) exit the market place. . . .  [S]uch a result requires preemption under Mensing and Bartlett.  Plaintiff’s “off-label” promotion claims, whether sounding in fraud or negligence, are preempted by the FDCA.

Id. at *5.

Also, as in Moore, the medication guide allegations were preempted as private FDCA enforcement under Buckman.  2017 WL 4348330, at *6-7.  Plaintiff didn’t even respond to Buckman, which the court found particularly “telling. Id.; see id. at *7 (“the requirement to provide a Medication Guide to distributors is based solely in the requirements of the FDCA and related regulations”).  The learned intermediary rule, which South Carolina follows, precluded any state-law liability for failing to provide warnings directly to a patient . Id. at *8.  Buckman also did in the off-label promotion claims, because the court found no state-law obligation to avoid off-label promotion.  “[T]he duties Plaintiff alleges Defendants breached regarding ‘off-label’ promotion exist solely under the FDCA.”  Id. at *7.

The court in Bean was particularly unhappy with both plaintiffs’ allegations and with her counsel.  The allegations were inherently inconsistent, because by alleging that the medication guide contained “adequate and sufficient” warnings, the plaintiff necessarily defeated her own allegations.  “Plaintiff does not allege that the prescribing physician did not receive the Medication Guide, was unaware of its contents, or the risk [the guide discussed].”  Id. at *8.  These allegations weren’t “plausible on [their] face” under TwIqbal, because the prescriber received “adequate” warnings.  Id.  As for counsel:

Plaintiff’s failure to respond to the learned intermediary argument is striking because Plaintiff’s counsel has been involved in several other amiodarone cases that were dismissed in part pursuant to the learned intermediary doctrine.

Id. at *7 n.4 (string citation omitted).  Thus, the plaintiff in Bean, unlike the plaintiff in Moore, didn’t deserve – and didn’t get – any chance  to replead.  Id. at *8.

One thing that Moore and Bean exemplify to us is how preemption principles cut across product lines.  As we’ve chronicled, much of the favorable law as to off-label promotion was developed in the context of PMA preemption.  Buckman, of course, was an implied preemption case involving a 510(k) medical device.  Both Moore and Bean employed this precedent to dismiss claims involving generic drugs.  In view of this cross-pollination of defense arguments in preemption cases, we offer one final opportunity for improvement.  As we blogged about at length here, there is an additional Mensing/Bartlett preemption argument whenever off-label warning claims are asserted.  Only the FDA can require warnings about off-label uses.

A specific warning relating to a use not provided for under the “Indications and Usage” section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.

21 C.F.R. §201.57(c)(6)(i) (emphasis added).  See also 21 C.F.R. §201.80(e).   Thus, regardless of anything else, a manufacturer cannot add or alter warnings related to off-label uses without first getting the go ahead from the FDA.  In and of itself, that requires preemption of off-label warning claims under Mensing/Bartlett.  For more details, see the other post.

A defense win anywhere helps defendants everywhere.  Keep winning.

Implied Preemption.  Off-label promotion. TwIqbal.  They make up a core of our posts, yet we never seem to tire of them.  Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires a rant.  Today’s case falls into the praiseworthy category, as the court dismissed a complaint predicated on violations of the FDCA in spite of sympathetic allegations that might have carried the day with some other courts. Markland v. Insys Therapeutics, Inc., — F. Supp. 3d –, 2017 WL 4102300 (M.D. Fla. Sept. 15, 2017), involved the alleged death of a patient as a result of respiratory distress from the defendant’s sublingual spray prescription painkiller drug, which she had started the day before.  Rather than offer the typical product liability claims under Florida law, perhaps because the labeling had extensive warnings on respiratory distress, plaintiff asserted only a claim for negligent marketing.  Calling it “negligent marketing” does not really identify what duty was allegedly breached, whether state law recognizes a claim for such a breach, and such a claim would be preempted.  The allegedly actionable conduct in Markland was promoting the drug for off-label use, like the chronic back pain of plaintiff’s decedent, as opposed to the approved indication for breakthrough pain with cancer.  While we do not know the merits, there were many allegations about off-label promotion, which seem to tie to the conduct at issue in well-publicized federal and state investigations.

Defendants moved to dismiss on various grounds, the most relevant of which (for our purposes) were that there was no claim under Florida law for this conduct and it would be impliedly preempted under Buckman anyway.  These had been hot topics recently in some Florida state and federal cases we have discussed, like Mink (here and here) and Wolicki-Gables, but those dealt with PMA devices and the additional issue of express preemption.  Here, with a prescription drug marketed under an NDA approval, there is no express preemption to navigate, but the plaintiff still had to walk a narrow path to state a claim that would not be impliedly preempted.  As we have said before, we think the appropriate order of analysis here would be the determine if there was a cognizable state law claim asserted and then determine if it was preempted, but the Markland court did not separate out its analysis.  It also did not weigh in on whether the allegations here were of truthful off-label promotion that might implicate First Amendment protection.  Instead, it assumed that the off-label promotion alleged violated the FDCA’s prohibition on misbranding.  2017 WL 4102300, *6 & n.4.

The court could take this approach because the plaintiff’s claim was so squarely focused on alleged violations of the FDCA.  Since Buckman, plaintiffs tend to be a bit cagier in making it look like their claims were not predicated on violations of the FDCA or fraud on the FDA.  The Markland plaintiff, however, labeled the defendant’s alleged conduct as violating the FDCA, “federal law,” and “requirements imposed by the FDA regarding the condition that this drug should be utilized to treat cancer patients with breakthrough cancer pain.” Id. at *9.  “Hence, [the claim], while framed in the language of negligence, appears to derive from [defendant’s] alleged off-label promotion of [the drug]” and “the very concepts of off-label use and off-label marketing are born out of the FDCA.” Id.   This was well phrased, as was the later statement that “it is only because of the existence of the FDCA’s restrictions on off-label marketing that Mr. Markland claims [defendant’s] actions were improper or otherwise violated a duty.” Id.

This is the recipe for implied preemption under Buckman.  It also means there is no negligence claim under Florida law, “which bars plaintiffs from using state negligence actions to seek recovery for FDCA violations.” Id. at 10 (citing negligence per se cases).  Of course, Buckman recognized that the FDCA does not provide for a private right of action, and preempts claims with FDCA violations as “critical element[s],” which should prevent such piggybacking.  So, plaintiff’s case was done and could not be revived by amending the complaint.  In other words, there was no need for a second and third strike before judgment could be entered.  This was so despite the Court’s expression of compassion:

The Court does not question for a moment the grievous nature of Carolyn Markland’s death, nor the deep sadness Mr. Markland must face on a daily basis as a result of his wife’s untimely passing. Nonetheless, the Court must act within the bounds of the law.

Id. at *11.  This a good lesson, especially for courts sitting in diversity, that the law should not be expanded to allow for recovery by sympathetic who cannot make their case under accepted tort theories.

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

In our post earlier this week “No Causation, No ‘Parallel Claim’” we examined the enormous causation hurdle plaintiffs face in trying to prove a Stengel or Hughes type failure to warn claim in those jurisdictions where such a claim has been found not to be preempted. In that post, we commented that we “would have preferred an order finding the failure-to-warn claims preempted.” Well today, we bring you two that do just that. The first a complete preemption win, the other only a partial, but we’ll start with the good news.

Both Golden v. Brown, Case # 17CV30568, slip op. (Colo. Dist. Ct. Sep. 24, 2017) and Norabuena v. Medtronic, Inc., 2017 Ill. App. LEXIS 593 (Ill. App. Sep. 20, 2017) refused to recognize a failure to warn claim premised on a failure to report adverse events to the FDA – a Stengel claim if you’re in the Ninth Circuit and a Hughes claim if you’re in the Fifth. Now neither Colorado nor Illinois is in those circuits, but we’d like to think that regardless these state courts would have reached the same conclusion they did – neither Colorado nor Illinois law recognizes a claim for failure to warn the FDA. So, plaintiff can allege defendant violated a federal regulation by failing provide information to the FDA – but it isn’t “parallel” to any state law claim because there is no such state law claim. The Illinois appellate court summed it up nicely:

[A]lthough plaintiffs have identified a federal requirement that their complaint alleges Medtronic violated, there is no Illinois requirement that parallels it. Plaintiffs asserted claims for failure to warn. Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug’s known dangerous propensities” under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.

Norabuena, 2017 Ill. App. LEXIS 593 at **14. The Colorado court not only found that allegations of failure to report adverse events to the FDA don’t state a parallel claim, but also concluded that Stengel and Hughes “cannot be reconciled with 21 U.S.C. §360k(a) as interpreted in Riegel or 21 U.S.C. §337(a) as interpreted in Buckman.” Golden, slip op. at 3. In other words, failure to warn a learned intermediary is different from and in addition to federal requirements regarding reporting of adverse events and a claim for failure to provide information to the FDA is an improper attempt at private enforcement of the FDCA. Just what we’ve been saying since these two awful decisions came down.

Both decisions have a little more to discuss.

In Golden, plaintiff also attempted to base a parallel claim on alleged violations of Current Good Manufacturing Processes (“CGMPs”). Noting that it was joining the majority of courts to have considered the issue, the court ruled that the CGMPs are too “vague” and “open-ended” to serve as a basis for a parallel claim. Id. at 2. The court also found plaintiff’s breach of implied warranty of merchantability claim preempted as essentially an allegation that the device was not safe and effective which would directly contradict the FDA’s PMA decision that “there is a reasonable assurance of . . . safety and effectiveness” and therefore expressly preempted. Id. at 3. And finally, the court found plaintiff’s claims impliedly preempted because plaintiff failed to explain “how Defendant’s conduct violated state law duties absent the FDCA.” Id. Simply stating that her claims were premised on Colorado common law was insufficient – “true merely in title, not substance.” Id. Instead, plaintiff’s claim exist solely under the FDCA which is not allowed.

The Golden case also suffered from some pleadings defects, such as failure to allege facts to support either a defect or causation. Id. at 2. But even if those pleading deficiencies could be cured, none of plaintiff’s claims survived preemption, so the case was dismissed in its entirety.

Switching gears to Illinois – unfortunately the court ruled that one of the bases for plaintiff’s failure to warn claim was not preempted. The FDCA contains regulations against device misbranding, which includes advertising that is false and misleading. Norabuena, 2017 Ill. App. LEXIS 593 at **15. Plaintiff alleged that defendant’s advertising was false and misleading in that it concealed known risks of using the device in an off-label manner. Id. at **16. In reaching its conclusion, the court distinguished plaintiff’s claim as not an attack on the device’s label which would be preempted as having been specifically approved by the FDA during the PMA process. But rather, plaintiff was challenging allegedly deceptive marketing practices post pre-market approval. Id. at **17. But that is a distinction without a difference where plaintiff’s allegation is that in its advertising defendant should have included a warning different from or in addition to the warning the FDA approved. The FDA-approved warning is what must accompany product advertising. Think about what the court is saying – if the warning is in the product label it must adhere to the FDA-approved language. If the warning accompanies an advertisement for the product it does not. We do not believe that is something the FDA would allow. While we can understand how a court can find that a false statement made in product promotion may be both a violation of state law and FDCA misbranding regulations, where that falsity is alleged to be a failure to include a warning not approved by the FDA, we respectfully disagree.

But, all is not lost in Norabuena. The appellate court found that plaintiff’s claims were properly dismissed on another ground – failure to plead causation. The complaint apparently was replete with allegations of “omitted” risks, “[h]owever, there are no specific factual allegations in the complaint asserting that [plaintiff’s] surgeon encountered or relied on any of the asserted promotional marketing.” Id. at **21. If a tree falls in the woods. . . . It’s not enough to plead the act or omission, the complaint was also allege facts supporting proximate cause. This pleading deficiency wasn’t enough for a dismissal with prejudice, so the case is heading back to the trial court and plaintiff will have to re-plead her remaining failure to warn claim.

 

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.