We greeted the result in Bartlett v. Mutual – that a generic manufacturer could be tagged for $21 million in a product liability case, despite Mensing, on the theory that the manufacturer had the option not to sell the product at all – with derision and dismay. The decision was wrong, even subversive. It stuck a thumb in the eye of the Supreme Court’s Mensing analysis and adopted a rationale that no other court has been silly enough to embrace. See our Mensing scorecard. We make no bones about our preference for touting good defense decisions, but we certainly never pretended that Bartlett was not important. It is important. So is the Ebola virus. And the Dallas Cowboys.
The plaintiff and her lawyer trumpeted the significance of the Bartlett case. Here is what the plaintiff said after learning of the $21 million verdict: “That was my biggest thing – getting the word out. Before this happened to me, I never knew something like this could happen just from taking medication.” Bartlett’s attorneys said it was the largest award in a New Hampshire product liability case. The largest previous award was $13 million in a construction site accident. After the First Circuit affirmed the verdict, the plaintiff lawyer called the ruling “potentially huge.” He said it established “that Mensing only affects failure to warn claims. ‘Impossibility preemption’ – where a generic company cannot simultaneously be held liable for failure to change a label when it has no ability to change a label – has no relation to a product defect case.”
Now get a load of a couple of the headings in the Opposition to Certiorari:
- “The petition does not present a question of recurring national importance.”
- “Sulindac is not an essential drug, and petitioner presented no contrary evidence.”
Turns out the Bartlett case was not so important after all. Nothing to see here, Justices, move along.
Let’s face it, if the Supreme Court takes a look at the Bartlett decision, there will be a reversal. In fact, summary reversal is appropriate. The plaintiff lawyer knows that. Consequently, the Opposition to Certiorari suggests that the case is so insignificant and eccentric as to be beneath the Supreme Court’s attention.
According to the plaintiff, Bartlett is unusual because it was a product liability case with no failure to warn claim at all. That supposedly makes it different from Mensing and every other case under the sun. The luckiest thing that ever happened to the plaintiff in Bartlett was when the trial court dismissed the failure to warn claim. Even so, under New Hampshire law, the warning would have been relevant in a design defect claim insofar as a comment k analysis was in play, because the issue of whether a product was “unavoidably unsafe” takes into account the warnings. But the defendant in Bartlett explicitly waived its comment k defense before trial, apparently because the defendant wanted to make sure the jury would not work up prejudice over the warning issue. The plaintiff argues that all Mensing did was preempt failure to warn claims against generics. The plaintiff also argues that while a generic manufacturer cannot simultaneously comply with a state duty to slap a better warning on a drug whilst also complying with federal law that prevents generics from changing the label, it is possible for a generic to comply with both federal law and the state law not to sell an unreasonably dangerous product by simply not selling the product at all.
The Opposition is desperation wrapped in modesty bundled in sophistry. We cannot improve on the Petition for Certiorari, which made several points that thoroughly puncture the plaintiff’s effort to hang onto the $21 million:
- The federal duty of “sameness” for generics applies to design as much as to the warning.
- After the Supreme Court’s Mensing decision, the Eighth Circuit in Mensing vacated its pre-remand opinion despite the plaintiff’s post-Mensing assertion that “there is nothing inconsistent with the Supreme Court’s decision about holding defendants liable for their failure to suspend sales.”
- The Sixth Circuit, in Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), affirmed judgment for generic manufacturers despite plaintiffs’ post-Mensing claim that the defendants’ “decision not to suspend sales and to continue selling their [generic product] is [both] actionable [and] wholly consistent with Mensing” because “no federal statute or regulation prohibited them from ‘independently’ suspending sales of their product.”
- Bartlett’s reasoning “blasts a gaping hole in Mensing.” Put simply, the Bartlett rationale would have produced a different result in Mensing.
- The First Circuit itself in Bartlett acknowledged “tension” between its reasoning and Mensing, and practically begged the Supreme Court to take a look.
We would add two more points about what’s wrong with Bartlett and why the Supreme Court needs to administer a fix:
- Bartlett is perversely reasoned. It begins its preemption analysis, not with Mensing, but with Wyeth v. Levine. The First Circuit concludes that Wyeth v. Levine established a general no-preemption rule. Only then does the First Circuit mention Mensing, and construes it as a narrow exception that does not apply here because Mensing was a failure to warn case, not a product defect case. Here is what is so weird about that bit of terpsichorean jurisprudence: Wyeth v. Mensing, too, was a failure to warn case, not a design defect case. Moreover, Mensing, like Bartlett, involved a generic manufacturer. Wyeth v. Levine did not. Bartlett takes preemption through the looking glass. Pernicious nonsense reigns.
- As we discussed in one of our many earlier posts about Bartlett, the defendant got mightily hosed because, even after winning dismissal of the failure to warn case, and even after deciding to waive its comment k defense just to make sure failure to warn would not sneak into the case, the plaintiff still managed to parade the warning before the jury, despite the usual, feckless limiting instruction. A little truth please: Bartlett might have been dressed as a design defect case, but like most DDL cases it centered on failure to warn.
We do not agree with plaintiff attorneys or Dallas Cowboy fans often, but this time we agree with the Fort Worth plaintiff lawyer who said that his win in Bartlett was “huge.” No need for modesty. Now let’s get a huge reversal.