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.