To us, sometimes plaintiffs’ lawyers sound like Cary Grant. You know, “Duty, Duty, Duty.” (By the way, “Judy, Judy, Judy” is a famous misquote. Cary Grant never once said it in a movie. But he did say it here – at the 0:50 and 1:30 marks.) Plaintiffs’ lawyers are often looking for new duties and how companies failed to satisfy them. When a traditional duty, such as failure to warn of a risk, doesn’t work, new alleged duties seem to crop up. Susan Burnett of Bowman & Brooke kindly sent us a recent pain pump decision that’s a good example of this – Todd v. Stryker Corp., 2012 U.S. Dist. LEXIS 60953 (E.D. Cal. May 1, 2012). And the court was having none of it.
In Todd, the traditional claim that the defendant company failed to warn of a risk of which it knew or should have known didn’t work. The state of the science at the time that the pain pump was used in the plaintiff didn’t support the risk. There had only been a tiny number of adverse events, a discussion of them at a medical conference, and a fairly weak set of medical literature. Id. at *13-15 & *20-12. And, worse for plaintiff, the company seemed to react responsibly to that information, conducting investigations of its files and the medical literature, reporting events to the FDA and seeking advice from outside experts. Id. at *15-16.
So what’s a plaintiff to do? Well . . . create a new duty. While the FDA had cleared the pain pump’s 510(k) application and thereby allowed it to be marketed, it had denied another 510(k) application (apparently more than once) that sought to market it for the particular indication for which the pain pump was used in plaintiff. Aha! While maybe there was insufficient scientific evidence of an actual risk, the company should have warned doctors about this regulatory history. Then maybe doctors would have some basis to speculate about a risk.
This is just what it sounds like: an attempt to sidestep the science. But in a failure to warn case the science is not something to be worked around. It defines the very duty that the defendant is supposed to satisfy. Regulatory history adds nothing. There’s a reason that labels include sections for indications, warnings, precautions, and adverse events, and not for regulatory history. As the Todd court put it, regulatory history is simply not a risk about which a warning should be given:
There is no duty to warn the patient’s physician of a prescription product’s regulatory history, because the history is not a "dangerous propensity" about which an adequate warning must be given . . . . .
Id. at *9-10.
That makes sense. As we all know, the FDA denies clearance of 510(k) applications for many reasons. Maybe the FDA decided that there was no substantially equivalent predicate device on the market, or that additional information was needed to clear the new indication.
Putting regulatory history in a label would simply invite doctors to speculate on what it means. That’s the opposite of what labels are for. Doctors are experts in medicine, not regulation. And, so, labels are places for scientific and medical information, not regulatory dockets. (For this reason, the rule in informed-consent cases is that doctors need only inform patients of a drug's benefits and risks, not regulatory status. See our post on this here.) If the particular regulatory history in which plaintiff was interested was the result of science that supported the presence of a risk (which apparently was not the case), the science, not the regulatory history, should have been put in the label. The court properly rejected this new duty.
Plaintiff didn’t abandon regulatory history so easily, though. She also argued that the mere fact that the FDA denied clearance for the indication signaled the need to warn of a risk. But this thinking has the same deficiency as plaintiff’s “regulatory history” argument. The FDA denies clearance for many reasons. The denial isn’t what matters. It’s the science. And, the science didn’t support the risk.
Undaunted, the plaintiff tried yet another new duty, one that we've seen tried before: the duty to test. We already deconstructed here plaintiffs’ past attempts to create a claim out of the amorphous and open-ended concept of duty to test. We even created a cheat sheet of plaintiffs’ many failed attempts. Suffice it to say that the Todd court wasn’t buying it either. It found, as have many other courts, that there is no such thing as an independent tort for failure to test:
When the warnings accompanying a prescription product adequately inform the prescribing physician of dangers inherent in its use, the manufacturer's alleged failure to test that product cannot, by itself, either cause injury or be a source of liability for the manufacturer.
Id. at *10.
Now, the Todd plaintiff’s claims had other, more ordinary deficiencies, including a proximate cause problem because the treating doctor decided to use the pain pump and medication on the basis of his own training and judgment, not any alleged influence by the company. Todd, 2012 U.S. Dist. LEXIS 60953, at *23-25. But what makes Todd most interesting, at least to us, was the court’s treatment of plaintiff’s less ordinary claims – the new duties, duties, duties. The court wasn’t having any of it.