Plaintiff Runs out of Time in Prosthetic Hip Lawsuit

Device makers know all too well they can be hit with a Warning Letter for failure to file a medical device report (MDR) when they reasonably should have known the device was associated with an adverse event, but a plaintiff in a lawsuit over a hip implant recently received the same message. The plaintiff had attempted to argue that the clock for the statute of limitations for a liability claim had not commenced until the implant was removed, but the judge who heard the case said no reasonable juror would have entertained any misgivings about the origins of the symptoms for that long a time.

The implant of the Zimmer hip took place in early 2011, and the plaintiff is said to have “suffered pain and complications as early as September 2012, when she returned to her surgeon due to recurrent pain in the hip. The surgeon initially treated the plaintiff for bursitis, but began to check for evidence of problems directly associated with the device in January 2013. Although imaging scans ruled out any loosening or fracture of the device and joint, there was evidence that metal ion levels were outside the normal range. The plaintiff experienced a dislocation of the hip in November 2014, however, and the physician advised the patient in January 2015 that a revision procedure might be necessary to address the problem.

The plaintiff agreed to undergo revision surgery in January 2015, and the procedure took place the following month. The plaintiff filed suit in February 2017 for strict liability, negligence and  three counts for breach of warranty, and toward the end of May 2018, Zimmer petitioned for summary judgment based on the two-year statute of limitations for such claims under Pennsylvania state law. The plaintiff argued that she could not have been clear on the precise origin of the problems until the device had been removed, but the judge in this case said the plaintiff’s acknowledgment in January 2015 that the device “had to come out” was a clear indication that the patient either already understood – or at least should have recognized – that the device was at the root of the problem.

At the very latest, the plaintiff’s signature on a consent form dated Feb. 9, 2015, which authorized the revision procedure, suggested that the plaintiff ought to have recognized “through the exercise of reasonable diligence,” that the hip implant was the root cause of the difficulties, wrote Judge Edward Smith of the U.S. District Court for the Eastern District of Pennsylvania. The suit was filed two years and one day after that consent form was signed, and Smith said no reasonable juror would have concluded that the plaintiff “was unaware, or should not have been aware” of a connection between the hip dislocation and device until after the revision surgery. While the surgeon confirmed after the revision that the device was, indeed, the cause of her injuries, Smith said that knowledge of precise medical cause is not required to start the clock on the two-year limitations period.

Apple Scores Quick De Novo

The pilot program for the FDA precert framework for software medical devices is still in development, but Apple Inc. scored a win with two apps for its Apple Watch 4 in a remarkably short amount of time. Other companies in the device business, even tech companies toiling in the digital space, might find the quick turn-around time for the de novo applications conspicuous, but the timing of the grant of the de novos was unusual as well.

The FDA posted the granted de novo petitions (here and here) to the agency’s website Sept. 12, the day after the date the petitions were granted. The interesting part of this discussion is that neither premarket filing took more than 33 days, a far shorter amount of time than the average turn-around of 150 days called for under the fourth device user fee agreement.

More conspicuous to some observers, however, was that the agency had posted those de novos on the same day that Apple unveiled the Apple Watch 4, the platform for the two software devices. Regardless of whether one sees the rapid review as more conspicuous than the synchronized announcements, the combination of the two makes it difficult to ignore the possibility that the entire affair was worked out well in advance.

There are clear indications that the de novos had been in the works for some time prior to the nominal filing dates – indeed, FDA Commissioner Scott Gottlieb tweeted that the agency had “worked closely” with Apple during the two software devices’ developmental phases – but Apple had the smarts to hire a consultant with the regulatory chops to help the company avoid choppy regulatory waters. Donna-Bea Tillman, who at one time was the director of the Office of Device Evaluation at the FDA, served as the lead consultant for these projects on behalf of Biologics Consulting Group in Alexandria, Va.

Conspiracy theorists may ultimately have nothing to dissuade them from their suspicions about the timing of all this, but device makers who hope that this signals a new era of cooperation may be likewise disappointed if they are hoping that this is the new normal at the FDA. There are far too many product releases to allow the agency to regularly coordinate with device makers in this manner, but one of the Apple apps is designed to detect atrial fibrillation, which is strongly associated with sudden cardiac death. The agency’s Sept. 12 announcement not only emphasized the need to encourage development in the digital space, but also to “help millions of users identify health concerns more quickly,” thus suggesting the FDA saw a considerable public health benefit in connection with the grant of these de novos.