There are some basic rules for medical product liability litigation, at least as we—and the vast majority of courts—see it. One is that the manufacturer of the medical product that the plaintiff used and allegedly injured her is typically the right defendant. Part of what a potential plaintiff is supposed to do during the statute of limitations period after her alleged injury is figure out who made the product she took. For a drug, for example, it is pretty easy to figure out whether the plaintiff took the branded or generic version and, if the latter, who made the particular generic. Another rule is that you are not supposed to pursue multiple lawsuits in different courts over the same alleged injury. This applies whether or not you lump your claims with those of other plaintiffs into a single case. Another composite rule is that the claims asserted in a court filing should attempt to follow the law, reflect factual investigation, and not be frivolous. Putting these together, alleged claims against a generic drug manufacturer should be asserted in a single suit by someone who contends to have been injured by the defendant’s drug, should include allegations about the defendant and the plaintiff, and should try to plead cognizable state law claims. We could add more, like addressing FDA regulation and history accurately, not pursuing preempted claims, and not suing in inappropriate courts, but we would be straying beyond the “basic” rules.
The decision in Walsh v. Upsher-Smith Labs., Inc., No. 27-CV-20-6531, 2021 Minn. Dist. LEXIS 8 (Minn. Dist. Ct. Jan. 5, 2021)—which showed up in our searches recently and is probably already a step or two behind what is going on in the actual case—stood out to us more for the overall context of the litigation than for the actual rulings on preemption and pleadings in a motion to dismiss addressed by a state trial court. What do we mean? Well, this is a case with 70 different plaintiffs in interest (and 31 consortium plaintiffs) against a single manufacturer of a generic drug. Presumably, these plaintiffs had no connection to each other except that they wanted to sue the manufacturer in its home court. The motion dismiss was on plaintiffs’ 241 page first amended complaint. But, in reality, the plaintiffs had already tried elsewhere—or were still trying elsewhere. With no apparent recognition of how messed up this all is, the court led off its procedural history with this:
Most Plaintiffs made similar claims against Upsher-Smith in a California state-court case, but were dismissed for lack of personal jurisdiction. Some Plaintiffs made similar claims against another Amiodarone manufacturer, but those claims were dismissed on grounds of preemption and insufficient pleading. Most Plaintiffs have other cases pending around the country against other generic Amiodarone manufacturers.
Id. at *6. Trust us, this is very messed up, even if a federal court of appeals had not recently affirmed the dismissal of a similarly motley crew of amiodarone plaintiffs. Compounding the wackiness here—for the benefit of the double- and triple-dipping plaintiffs—was that the very long complaint was full of “overlapping allegations—the elements of causes of action are repeated in other counts, which makes it difficult to cabin Plaintiffs’ claims,” mostly focused on alleged federal obligations although only state claims were asserted, and include a bunch of allegations about the actions and inactions of the non-party branded manufacturer and other generic manufacturers. Id. at **4, 5 & 30. What a mess.
Rather than requiring the plaintiffs to pursue individual cases with factual allegations focused on themselves and the defendant they were suing, the court considered the motion to dismiss on the long and confusing complaint—not by any means a first try by novices, but an effort by lawyers/plaintiffs who had “litigated preemption claims [defenses?] around the country.” Id. at *9 (incredulous query added). Minnesota has lenient pleading standards and some pretty plaintiff-friendly law, including on issues of preemption in the context of generic drug claims, so it was clear that the plaintiffs were going to emerge with claims to pursue and probably yet another chance to re-plead any claims that were dismissed. That is what happened and, by now, a second amended complaint has surely been filed and maybe another motion to dismiss teed up. This is terribly inefficient and the burdens on the court systems around the country stem, in our not-so-humble opinion, from the flouting of the basic rules above by the plaintiffs and their counsel. Are some of these plaintiffs suing the manufacturer of a drug they did not take? Are some of these plaintiffs re-asserting the same claims based on the same allegations against a second manufacturer after another court found their claims preempted against the first manufacturer defendant? Do some of these plaintiffs have more than one case pending over the same injuries, including two cases against the same manufacturer? Clearly, “yes” to all of these questions. Our federal system allows this sort of gaming when courts are not vigorous in policing such abuses.
The rulings in the case? There were a bunch on preemption and pleadings, always with preemption first, even when the state claim was unsupported by sufficient pleading. As we have said many times before, we think that is not how the order of analysis should go. With that in mind and our overall gripe spelled out above, here are the rulings:
- Plaintiffs claimed defendant did not fulfill its federal obligation to provide Medication Guides to distributors and dispensers. The court found this was not preempted under Buckman based on the dissent from a Sixth Circuit case called McDaniel (discussed here) and a liberal reading of a dubious Minnesota cases called Angeles that this somehow was also an obligation under state law. at **12-21. On pleadings, the court excused the lack of detail about the impact of this alleged failure on their individual claims as something for discovery (“they will have to promptly disclose in discovery the names of the pharmacies”) and blew by the requirement of proximate cause for failure to warn in a convoluted discussion of the “learned intermediary defense.” Id. at **21-27.
- Plaintiffs asserted a classic, for a generic drug, claim based on failure to have the same label as the branded manufacturer. Even though there is a robust body of law on such “failure to update” claims (like here and here), the court rejected preemption with the statement that “Failing to communicate warnings to doctors is barred by both federal and state law.” Id. at **27-28.
- A claim expressly based on reporting adverse events to FDA was held not to be preempted based on that Angeles case, which held this to be a matter of “traditional state tort law” even though it is not. Id. at *28. Not even close. Nonetheless, plaintiffs had failed to plead facts linking such an allegedly reporting problem to their injuries, so it was dismissed on pleading grounds. Id. at *29.
- Plaintiffs also claimed that defendant should be liable because it and other manufacturers allegedly promoted off-label. The court bought that they “pled around” a ruling from Angeles that this sort of claim was preempted because they characterized off-label use as “unreasonably dangerous.” Id. at **30-32. Again, this was an unnecessary ruling, because plaintiffs’ pleading on this alleged claim was woefully insufficient in terms both in terms of attempting to saddle this manufacturer with liability for the conduct of others and case-specific details about their own physicians. We give the court credit for rejecting the plaintiffs’ attempts to offer “merely conclusory pleading an element of fraud, not facts supporting that element” and their excuse that they need discovery to plead a contrived claim about fraud. Id. at **35-36.
- Challenges to negligence per se were rejected based on referring to earlier rulings, without ever addressing how most courts reject FDCA violations as a basis for state law negligence per se (discussed here and here).
- Something the plaintiffs called a “manufacturing defect” claim was dismissed because it had nothing to do with whether “the Amiodarone tablets that Plaintiffs ingested deviated from the intended formula.” Id. at *39. The court offered four more reasons why a theory about FDA’s Good Manufacturing Practices and distributing Medication Guides was not cognizable under Minnesota law. Id. at **39-40. Overkill in a good way this time.
- Lastly, as alluded to above, the plaintiffs were permitted “as opportunity to amend the FAC to cure any deficiencies Plaintiffs reasonably believe can and should be cured.” Id. at *42. We get that this is within the court’s discretion, but there are times where enough is enough.
All told, Walsh let more claims survive dismissal than we think should have. This results in the real possibility that the liability of a defendant generic drug manufacturer on between one and seventy plaintiffs’ claims will hinge on a state jury’s evaluation of compliance with FDA obligations, something FDA has the sole responsibility to police. If the plaintiffs do not win here, then perhaps some other court will let them try again. That is not how it is supposed to work.