A post-sale duty to warn is almost oxymoronic. If you think about a typical warnings case, the focus is on whether the manufacturer/seller had notice of a potential risk before the product left its control (or prescribed to the plaintiff), and if so, whether that risk was adequately conveyed to the plaintiff. The question we routinely ask in drug and device warnings cases is whether additional or different information would have made a difference to the prescribing physician in choosing a course of treatment. So, when a manufacturer acquires information after a medical device has been implanted, for instance, causation for a post-sale duty to warn seems tenuous at best. And that single, flimsy strand should snap completely in a case where the device is already explanted.
Those were the facts in Hix v. Zimmer Biomet Holdings, Inc., 2022 U.S. Dist. LEXIS 56749 (D. Nev. Mar. 29, 2022). The case was filed originally in 2014 in the Biomet M2a Magnum Hip Implants Products Liability MDL pending in the Northern District of Indiana. After the MDL pre-trial proceedings, it was transferred in 2018 to the District of Nevada. Id. at *2-3.
Plaintiff had a total hip replacement in 2010 and a little over two years later had a revision surgery during which the original metal-on-metal artificial hip device was explanted and a metal-on-polyethylene device was implanted. Id. at *3-4. The original device, the one at issue in the suit, was manufactured by Biomet. Three years after it was explanted and one year after plaintiff filed his lawsuit, Zimmer Holdings, Inc. acquired Biomet and changed its name to Zimmer Biomet Holdings, Inc. Id. at *4. In 2020 plaintiff filed an amended complaint adding Zimmer Biomet Holdings as a Defendant.
Since it was not disputed that the new parent holding company, Zimmer Biomet, did not design, manufacture, label, or sell the device implanted in plaintiff in 2010, plaintiff had to come up with both a basis for personal jurisdiction against the new parent company and a theory of liability. Id. at *9. As to personal jurisdiction, the specific jurisdiction the court exercised over the subsidiary was not enough to confer specific jurisdiction over the parent because “corporate entities are presumed separate.” Id. at *8. Thus, plaintiff’s two-pronged argument was that the new parent company assumed Biomet’s debts or the new company was the result of a merger. Plaintiff had proof of neither. The discussion is case specific to the terms of the deal between the two companies, but the bottom line was that plaintiff could “not raise an inference that the subsidiaries lack a separate and distinct corporate form, or that Zimmer Biomet Holdings is merely an alter ego for any of its subsidiaries.” Id. at *12.
Plaintiff’s second argument was that the new parent company was liable for a post June 2015 failure to warn claim. It had to be post June 2015 because the company did not exist before then. Nevada has not ruled on whether it would recognize a claim for post-sale duty to warn. But, in this case the court presumed that such a duty existed for defects that the manufacturer learns about after the manufacture and sale of the device. Id. at *13. The court also had to assume that such a duty would extend to the manufacturer’s parent company. But even under this make-believe version of Nevada law, the court knew where to draw the line:
Such a duty, however, does not and cannot extend to a person who is no longer the consumer of the medical device at issue.
Id. at *14. So simple, so obvious. A post-sale duty to warn, where it exists, cannot be the basis for a cause of action where plaintiff has stopped using the product. In this case, that was at the time of explant. However, it should apply equally to drug cases where plaintiff had stopped using the medication. If the product is no longer in use, any additional warning would have made no difference to plaintiff’s treatment or outcome. While this makes logical sense for products liability cases generally, it makes even more sense in drug and device cases where there is rarely a direct relationship between the manufacturer and the patient. Even factoring in the learned intermediary does not solve the problem. Patients switch doctors because they move, because they change health insurance, or just because they want to try someone new. To whom is the post-sale duty to warn owed – the original prescribing or implanting physician? Much like Hix who was an ex-consumer of the product, the link to an ex-patient is weak.
Without personal jurisdiction or a cognizable legal theory, the claims against the new parent company were dismissed on summary judgment.