It's all too much. Mass torts, especially those involving drugs or devices, suffer from a severe case of too-muchness. Too much of what? Cases, defendants, prevaricating experts, documents taken out of context, appeals to outrage, eye-watering verdicts, etc. In the good old days when people got together physically, not virtually, for parties (especially this time of year), there would always come a point when someone would corner us and question how we could sleep at night after representing Fortune 100 companies that harmed Just Plain Folks. Goodbye conviviality, hello misery.

See this tall glass of vodka? It's a pretty decent sleep aid (though, admittedly, it will wear off at 3 am and send us downstairs to watch ConAir for the hundredth time), so never you mind about us. Then we'd point out to our interrogator that while there were plenty of cases in which people deserved compensation, the problem was there were plenty more with opportunistic plaintiff lawyers transmogrifying the meritless into the money-making. You know what? That argument usually worked well enough. We could at least change the subject to something less incendiary, such as the latest imbecilities in the political arena or Philadelphia sports team front offices. People know that there is too much litigation. Too many defendants are hauled into court for no good reason.

We've written often about cases in which the plaintiff lawyers sue not only the company that made the product, but also corporate parents and affiliates that didn't. It's a form of litigation promiscuity. Whether it arises from sloppiness, complaint fever, or a misguided attempt to secure leverage, it is pernicious. Lately, personal jurisdiction arguments offer an escape route for many extraneous defendants. Bauman and BMS really are gifts that keep on giving.

Castle v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 6712428 (Conn. Super. Ct. Sept. 11, 2020), was a case of too many defendants. The plaintiff alleged that he contracted gangrene from a diabetes drug. He also alleged that the drug should have been accompanied by a label that set out the gangrene risk. That sounds like a standard failure to warn claim, right?

There was a wrinkle. The drug had been developed by a joint venture between two pharmaceutical companies. One of the drug companies held the NDA for the drug. One did not. The plaintiff sued both. Of course. The non-NDA holder argued that the failure to warn claim against it was preempted because it could not make unilateral changes to the label. This argument was styled as a motion to strike portions of the complaint. (The court had earlier denied a motion to strike filed by both companies premised, presumably, on a broader impossibility preemption argument.)

The Castle court begins by observing that FDA regulations "nowhere contemplate a distributor of a brand drug, albeit a distributor closely affiliated with the NDA holder, initiating changes to an approved NDA." The plaintiff's argument came close to being 'regulations-shmegulations.' According to the plaintiff, the NDA holder and non-holder were so intertwined that either could submit a Changes Being Effected for the drug label. As the kids say so often these days, 'Yeah. No.' It helped the defendant that there were a couple of federal court precedents in its favor, including one involving the same drug.

The plaintiff seized upon a subsequent Indiana state court decision that denied a motion to dismiss in a "factually indistinguishable case." Maybe it was factually indistinguishable, but it was certainly legally indistinguishable. The Indiana state court decision was premised on that court's belief that, unlike with those prior federal decisions on impossibility preemption, motions to dismiss are "disfavored under Indiana law because they undermine the policy of determining causes of actions on their merits."

First, remember how in the last couple of weeks we've been showering praise on the Indiana judiciary? Well, we take it back. Or maybe that particular Indiana judge got it wrong. After all, if a motion to dismiss shows that, even accepting the complaint's allegations as true, the claim is preempted, then the case lacks merit. Is it part of Indiana policy to permit doomed cases to linger, extracting discovery costs from the parties and administrative costs from the state?

Second, as unfortunate as the Indiana judge's formulation might have been, it ended up being fortunate for the non-NDA holder in Castle, because it enabled the Connecticut court to discount the Indiana decision as turning "on a principle of Indiana law that is inapplicable here."

For the Connecticut court, "[g]iven the clarity of the law" on the inability of a non-NDA holder to make a unilateral label change, it was not only easy to strike the offending allegations, it was also easy to deny the plaintiff's request for discovery "as to the details of the joint venture." There was too much law and logic on the side of the non-NDA holder. Enough was enough.

Sent from my iPad

Originally Published by Reed Smith, December 2020

This article is presented for informational purposes only and is not intended to constitute legal advice.