The drive from our home to the Delaware courthouse takes no more time than the drive to the Philly courthouse. But those two courthouses are worlds apart. The Philadelphia Court of Common Pleas is plaintiffs' heaven. Most judges there think everything should go to a jury, and most jurors there think heaps of money should go to plaintiffs. Forget about any sort of hometown advantage. Philly jurors feel no compunction about picking the pockets of local companies. It is all very ... interesting.
Delaware is altogether different. Dare we say it? We think we usually get a fair shake in the New Castle County Courthouse. Even when we lose, the judges supply explanations and case citations. But let's be candid: this love letter to Delaware would not be written if the judges there made a habit of blithely waving cases on to the twelve-headed monster. Delaware judges actually dismiss cases that should be dismissed.
All of which brings us to Camejo v. Angelina Pharma et al., 2021 WL 141338 (Del. Super. Ct. Jan. 15, 2021). The plaintiff claimed that a generic antidepressant drug caused him to suffer from priapism. Before you are tempted to make a joke quarreling with our use of the word "suffer," you should know that the plaintiff also claimed that because he had no knowledge of the risks, he delayed treatment and ultimately became impotent at the age of 50. The plaintiff sued both the manufacturer of the generic drug he took as well as the manufacturer of the brand name drug he did not take.
The labels for both the brand and generic drugs contained warnings about priapism and impotence. The labels were identical at first, but later the generic label was altered somewhat. The court actually uses the word "diminished" in describing how the generic label moved to slightly different language and ceased prominent capitalization. The priapism warning became "indistinguishable" from other warnings in the generic label.
Both manufacturers moved to dismiss the complaint. The brand manufacturer resisted the claim of innovator liability, while the generic manufacturer pointed to preemption and deference to the FDA. Because the plaintiff was prescribed the drug and ingested it in Los Angeles, the Camejo court decided that California law governed the case. At this point, any defense hack might worry that such choice of law might make the motions unwinnable. No need to worry. Forget about it; it's Wilmington.
The brand manufacturer had an easier time of it. The plaintiff had never consumed its product. Even California does not impose strict liability against a manufacturer who did not manufacture the allegedly defective product that allegedly caused injury. And while California's wretched T.H. v. Novartis case permitted innovator liability, the generic and brand labels in that case were identical. In Camejo, the labels were different. There was no way in Camejo that the brand label misled the plaintiff or played any role in his injury. Accordingly, the innovator liability, negligence, and warranty claims against the brand manufacturer were also dismissed.
The different label might seem to create a stiff problem for the generic manufacturer, but the Delaware court still held that Pliva v. Mensing preemption applied. The plaintiff did not contend that the generic manufacturer changed the label without FDA approval. (From the court's opinion we do not know what happened or why the generic manufacturer thought it a good idea to write a different label.) Moreover, even if the generic label was "diminished," it was still plainly adequate. It stated the risk of priapism in detail, explaining the condition and possible consequences. The Camejo court concluded that the "diminished warning" claim "provides no reasonably conceivable basis for a finding of liability" against the generic manufacturer under California law.
The plaintiff wasn't quite out of bullets yet. He invited the Delaware court "to be the first in the country to impose an affirmative duty on generic manufacturers to send 'Dear Doctor' letters ... that reiterate certain warnings in the FDA-approved drug." The court declined the invitation. Delaware calls itself The First State (because it was the first to ratify the U.S. Constitution), not the first stupid state. In Pliva, SCOTUS actually addressed Dear Doctor letters from generic manufacturers. Such letters must contain the same language as the label, without any adornment. The Camejo court reasoned that even a California court would see no sense in imposing a duty on a drug company "to pick out one of the myriad side-effect warnings (whether inadequately penned or not) from its product's packaging, [and] draft and distribute a single side-effect-targeted letter to health care providers with just that exact warning language (again, whether inadequately penned or not)." Hard cases might make bad law, but this one was not hard.
For some reason, the Delaware court's optimistic reading of California law makes us think of the ending of The Sun Also Rises. A woman tells her former lover that they could have had "a damned good time together." The man, rendered impotent by the war, not a pharmaceutical, replies, "Isn't it pretty to think so?"
In any event, we hope this summary of an eminently sensible Delaware court opinion gave you pleasure. But if you are still feeling this pleasure in four hours, definitely call a doctor.
This article is presented for informational purposes only and is not intended to constitute legal advice.