We begin with a cautionary tale (with a happy ending) about life with an aging dog. Our vet estimates that one of our treasured Drug and Device Law Little Rescue Dogs is approaching 14. (We can't know for sure, because she was found as a stray and dumped in a shelter.) She remains happy and funny, always excited to chase balled-up socks and beg for treats. But she is slipping. Over the past year, she has begun stealing down to the kitchen in the middle of the night and barking at nonexistent noises. And barking some more. Until we give in and let her out. One night last week, we found ourselves at the door at 3 a.m. waiting for her to come back in and not seeing her anywhere in our fenced yard. We called and called, searched every corner of the yard, walked around the entire perimeter of the house in case she had somehow escaped the yard, and checked inside the house in case it was our mind that was going. And then we panicked, sure she was dead or stolen. Finally, a good thirty minutes later, we crawled under a big shrub in the back of the yard and found her, sound asleep. Amid the indescribable relief, we made a mental note: we'd seen the warning with our own eyes.
Not so the plaintiff's doctor in today's case. Fitzsimmons v. Biomet Orthopedics, Inc., et al., 2021 WL 211267 (M.D. Fla. Jan. 21, 2021), comes from the Biomet hip implant MDL. The plaintiff underwent hip-replacement surgery with the defendant's metal-on-metal artificial hip. Before the plaintiff's surgery, his surgeon discussed the risks of the procedure but did not warn of the risk of metal wear or of metallosis, a blood condition caused by high levels of toxic metals in the blood. The plaintiff's hip implant failed, and he was diagnosed with significant metallosis. He asserted the usual litany of product liability claims, including claims for design defect and failure to warn. Though the defendant moved for summary judgment on all of the plaintiff's claims, we focus, in this post, on the court's decision on the warnings claim, which turned on our favorite doctrine, so-called "warnings causation." To wit, a plaintiff asserting a failure-to-warn claim bears the burden of proving that both that the defendant's warnings were inadequate and that the inadequate warnings proximately caused his injuries. Under the learned intermediary doctrine, as all of you know, the manufacturer of a prescription drug or medical device has a duty to warn only the prescribing physician, not the patient. To defeat summary judgment on warnings causation in a drug or device case, the plaintiff must adduce evidence that a different or stronger warning would have altered the doctor's decision to prescribe the drug or device.
The defendant in Fitzsimmons argued that the warnings on the hip implant were adequate, and that, in any event, the plaintiff "could not establish that any alleged failure to warn proximately caused his injuries." 2021 WL 211267 at *4. Because the court "grant[ed] summary judgment . . . based on [the plaintiff's] failure to show causation, [it did not need to] consider" whether the warnings were adequate. Id.
And here's the fun part. As the court emphasized, the plaintiff was required "to show that the physician would not have used the device in question if [he] had been warned by the manufacturer of the risks. However, where a physician fails to review the warnings issued by the manufacturer, proximate caused cannot be established." Id. at *5 (internal punctuation and citations omitted). It's simple: if the doctor didn't read the warnings, what they said or didn't say could not have affected his prescribing decision, and nothing that might have been added to the warnings could have changed the decision. In this case, "it [was] undisputed [that there was] no evidence plaintiff's implanting surgeon ever read the instructions for use provided by" the defendant. Id. To the contrary, the surgeon testified that he selected the implant "based solely on his professional and clinical experience," not based on any materials provided by the defendant or anything he heard from the defendant's sales representatives." Id. The court concluded that, whether or not the warnings were adequate, the plaintiff could not prove that the warnings proximately caused his injuries. Summary judgment for defendant on the failure-to-warn claims sounding in both strict liability and negligence. We love failure-to-read cases. Hard to imagine anything cleaner, though we still see courts get these wrong. (You can find our 50-state failure-to-read survey here.) This court got it right.
We close with belated "happy 65th birthday" wishes to Bexis. Bexis is a regular-looking gray-haired guy with glasses, and you are familiar with his command of all things "drug and device." But that's not the whole picture. Bexis is a tireless advocate for rights and equality for people society tends to brush aside. Bexis works hard to make the world a better place. For his birthday, we hope the world returns the favor.
Originally Published by Reed Smith, January 2021
This article is presented for informational purposes only and is not intended to constitute legal advice.
