A recent case in the Southern District of New York debunks two myths that we see all the time. Myth number one:  A medical device is defective if it fails.  Myth number two:  A plaintiff can prove causation on a failure-to-warn claim by asserting that he or she would not have consented to the procedure if his or her doctor had told her about some risk.  Plaintiffs often assert these positions.  Neither is true.  And the magistrate judge’s report and recommendation granting summary judgment in Tomaselli v. Zimmer Inc., No. 14-CV-04474, 2017 U.S. Dist. LEXIS 9874 (S.D.N.Y. Jan. 20, 2017), does a really nifty job explaining why.

In Tomaselli, the plaintiff was treated with a hip repair device—a Greater Trochanter Reattachment device, or GTR.  A GTR is not like the ball-and-socket total hip replacement devices that have generated so much litigation and with which so many of our readers are familiar.  A GTR consists of a plate and two 1.8 millimeter cables that are surgically implanted to reinforce the top of a patient’s femur—the trochanter—in the event of a fracture. Id. at **1-2.

The plaintiff later complained of hip pain, and imaging revealed that one of the cables broke. Id. at *5.  It is not clear whether the broken cable made any difference:  The cable stayed in place, and removing it would not have alleviated the pain. Id. The evidence also suggests that the pain was not substantial:  The plaintiff went for long periods of time between doctor’s appointments; she was able to exercise and engage in daily activities; and she testified that stretching and taking a few steps would relieve any pain. Id. at *6.  The plaintiff sued the device’s manufacturer and distributor anyway, alleging a variety of product liability claims.

The defendants moved for summary judgment under New York law, and the magistrate recommended granting their motion on every claim. The magistrate’s report and recommendation is particularly interesting on the two issues that we foreshadowed above—failure to warn and product defect.


Continue Reading