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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.

Failure to warn. We like Tomaselli for its faithful application of New York’s learned intermediary rule, under which the only relevant inquiries are whether (1) a medical device manufacturer failed to warn the prescribing physician of known or reasonably knowable potential dangers and (2) that failure proximately caused the plaintiff’s injuries. Id. at *10 (citing Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75 (2d Cir. 1993), Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993), and other cases).  A warning is adequate as a matter of law if it is “accurate, clear, consistent on its face, and . . . portrays with sufficient intensity the risk involved.” Id. at **11-12.

The plaintiff’s claim failed on all counts. The device’s Instructions for Use informed the prescribing physician about potential cable loosening or breaking not once, not twice, but three times. Id. at **2-3.  Because the product labeling clearly warned of the exact risk that allegedly befell this plaintiff, the court ruled correctly that the “IFU warning is therefore adequate as a matter of law.” Id. at *13.

The court also rejected the failure-to-warn claim on causation. The implanting surgeon had not reviewed the IFU until his deposition [id. at *4], which means that additional or different information in the IFU would not have altered his treating decisions.  (See our 50-state survey on physician failure-to-read cases here.)  The court, however, emphasized the reason why the surgeon here did not read the IFU—the surgeon was already aware that the device had the potential to break as a result of his training and 30 years of experience. Id. **13-14.  As the court put it, “If the treating physician is aware of the risks of a medical device, independent of any warning by the manufacturer, such knowledge constitutes an intervening event relieving the manufacturer of any liability to a patient under a failure to warn theory.” Id. at *13 (internal quotations omitted).

Critically, it also did not matter whether he failed to advise the patient of the potential risk of breakage because the manufacturer’s duty ran to him alone.  Here is the relevant quote:

[The plaintiff’s] affirmation that she would not have consented to the surgery had [her doctor] advised her of the cable fracture risk is irrelevant to her claims against the defendant manufacturer and distributor of the GTR device. . . .  A failure to obtain informed consent might be a viable theory of liability against the physician or the hospital where the operation was performed.  But [the physician] is not a party to this lawsuit, and the plaintiffs’ claims against the [hospital] were dismissed.

Id. at *15 (emphasis added). This quote gets to the heart of the matter.  It is irrelevant to a product liability failure-to-warn claim whether the physician warned the patient of any particular risk.  That is because the manufacturer owes the patient no duty to warn, and it should not and does not help plaintiffs to say, even in 20/20 hindsight, that they would not have consented to their procedures had they known of certain risks.  Myth number one busted.

Product defect. The second interesting point is that this device broke, but it was not defective as a matter of law.  Under New York law, plaintiffs have to prove that the product, as designed, feasibly could have been designed more safely; and they have to prove it through expert evidence. Id. at *16.  The plaintiff offered none.  For their part, the defendants offered expert opinion that there was “absolutely no clinical evidence of defect” in the device and that “product defect cannot be demonstrated to be the cause of the . . . cable fracture in [the plaintiff’s] hip, to the exclusion of other, more likely patient-specific and surgical risk factors.” Id. at *7.  Plaintiff failed to introduce, or even attempt to introduce, expert testimony to contest these opinions, even though it was undisputed that the cable fractured.  No defect as a matter of law.  Myth number two busted.

The court also dismissed the plaintiff’s warranty claims and made some rulings on evidence and procedure, but the points above are the interesting ones. The plaintiff could challenge the report and recommendation with the district judge, but the report is so solid, we’re not sure what she would say.  We’re also not sure how committed she is to her case.  Recall that she did not retain an expert to oppose summary judgment, and even though she filed a cross-motion for summary judgment, she did not file a separate statement of undisputed material facts, which the local rules require.  We would say this case is more or less dead on the vine.