We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes). We’ve said before (e.g., https://www.druganddevicelawblog.com/2008/10/everything-you-need-to-know-about-wyeth.html) that both Levine and Riegel were really med-mal cases. That search for a deeper pocket is undertaken by the lawyer, not the client. We say this because we can use up all the fingers on one hand counting cases over the last year or so where it became clear that the product liability plaintiffs were certain that it was actually their doctors who erred. The plaintiffs said so themselves. They said so in their testimony. They said so in contemporaneous diaries. This evidence was hard to align with the lawyers’ strategy of making the case all about the manufacturer and its documents. But why let reality get in the way of a game plan? The plaintiffs’ discovery, motions, and rhetoric pretty much ignored whether the doctor met the standard of care. Indeed, the doctors often got dropped just before trial. Sometimes, we are sorry to say, our cynical eyes espied a shady quid pro quo, as the same doctors show up as witnesses for the plaintiffs.

Why does a med-mal case turn into a product liability case? Perhaps we should add a qualifier here. It is product liability lawyers, not all lawyers, who contrive to turn med-mal cases into product liability cases. There are plenty of superb med-mal plaintiff lawyers out there who are perfectly happy to practice their craft, and would sooner set their hair on fire before steering a case into comment K, the learned intermediary doctrine, or an MDL. But product liability lawyers are at home with these lovely little bits of business. It’s like that old saw about how a hammer sees nails everywhere. We had lunch earlier this week with a friend who formerly worked with us at a defense firm, but who has now become a plaintiff med-mal lawyer and is doing terrifically well. He wracks up big verdicts all the time. His name on a complaint must up the settlement value of a case by 20%. But he acknowledges that suing doctors isn’t easy. He estimated that 90-95% of med-mal trials in Pennsylvania end with a defense verdict. Of course he files his cases in Philadelphia whenever possible, but even in that benighted jurisdiction the defense win rate hovers in the 80s. We were astonished to hear this. We were less astonished after our friend explained that the slam-dunk med-mal cases invariably settle. The ones that go to trial tend to be a bit on the flimsy side, or at least there is a yawning weakness somewhere in the case. And then there is the fact that most people are willing to give the benefit of the doubt to doctors. Unless you get the kind of stunning insider testimony that dealt Paul Newman a winning hand in The Verdict, doctors win most med-mal cases. In addition, there are often procedural hurdles or damages caps unique to med-mal cases. It is a different playing field from a mass torts case. Doctors get treated like the home team. Drug or device companies get treated like a criminal syndicate – even when the trial really is on their home turf.

How does a med-mal case morph into a product liability case? Failure to warn and failure to train are usually the operative theories. Mind you, we don’t think failure to train is a legitimate theory at all. We have a whole topic thread devoted to that issue. https://www.druganddevicelawblog.com/tag/duty-to-train/ If there isn’t some specific law that requires such training, or that such training be carried out in a particular way, and if the company is going above and beyond what is legally required, it seems stupid and unfair to pin additional liability on a company for a voluntary undertaking or through some other specious legal theory. In any event, at the doctor’s deposition the plaintiff’s lawyer will play the game of “wouldn’t you have liked to know x,” and whatever the x is, such as adverse event data, a footnote in a study, or the surprise ending of the new Harry Potter play, the doctor will likely say yes, because … well, because nobody with an advanced degree wants to come across as stubbornly ignorant. Moreover, a plaintiff’s product liability case acquires enhanced sex appeal if it turns out that a company sales representative was in the operating room. The plaintiff attorney will argue that the sales rep’s action or inaction was somehow a huge factor as to why the patient sustained the alleged injury. Once or twice we have met sales reps who bragged about how they would use a laser pointer during an operation to ‘help’ the doctor, but most acknowledge that they would never render such ‘advice.’ Sales reps cannot and do not practice medicine. More importantly, we have never met a doctor who said that a sales rep superseded seven-plus years of medical education. Turning a med-mal case into a product liability case presupposes a willing suspension of disbelief, but upon that suspension of disbelief rests a huge chunk of the American tort industry.

But here is a nifty New York County (that’s Manhattan) decision upholding the proposition that medical device manufacturers, even if they have representatives in attendance during the use of their products, are not liable for how the physician chooses to use them. Gregory v. Tehrani, et al., 2017 N.Y. Misc. LEXIS 3491, 2017 N.Y. Slip. Op. 31963(U) (Supreme Ct. N.Y. County Sept. 15, 2017). The Gregory case sheds light on the med-mal vs. product liability distinctions in an odd and unexpected way: the plaintiff tried to make the manufacturer a defendant in a med-mal case. The case wasn’t restyled as a product liability case – it was still travelling under a med-mal theory. And therein lies the problem for the plaintiff.

The plaintiff had undergone plastic surgery on his face. The doctor used a facial filler during the procedure. Representatives of the facial filler manufacturer were allegedly present during some of the treatments rendered by the doctor to the plaintiff. Something apparently went wrong and the plaintiff sued the doctor, the facility, and the manufacturer of the facial filler for medical malpractice and lack of informed consent. The manufacturer filed a motion to dismiss the claims against it. The manufacturer won.

The medical malpractice claims simply did not fit against the manufacturer. The court considered the second theory (lack of informed consent) first. The plaintiff’s claim that the facial filler manufacturer failed to inform the patient was foreclosed by the learned intermediary rule. The manufacturer had a duty to warn the doctor, not the manufacturer. Put simply, informed consent is not a theory that lies against a manufacturer. The medical malpractice claim made even less sense. Rather than allege the classic product defect claim against the manufacturer, the plaintiff alleged that the manufacturer failed to ensure that the doctor used the device in “a safe, indicated manner … and according to their own product guidelines and the guidelines of administrative agencies and bodies including but not limited to the Food and Drug Administration.” Gregory, 2017 N.Y. Misc. LEXIS 3491 at *5. It sounds almost as if the plaintiff was complaining that the manufacturer had failed to practice medicine. That is a weird theory. It is also rare. (Though it was alleged all the time in Bone Screw litigation.) We have blogged about something like this before: see https://www.druganddevicelawblog.com/2013/12/drugdevice-labels-are-not-required-to.html. There’s a reason why the theory is rarely seen: it is fundamentally wrong. It conflates product liability and med-mal law. The Gregory court proceeds to un-conflate them: “[W]hile the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.” Id. Further, the plaintiff didn’t allege anything wrong with the warnings themselves. Further further, the plaintiff’s allegations did not connect any of the manufacturer’s actions or omissions to the alleged injuries. In short, there was no reason for the manufacturer to be a defendant in this med-mal case, and after the court granted the motion to dismiss, it wasn’t.