This blog is no stranger to the In re Smith & Nephew Birmingham HIP Resurfacing (BBR) HIP Implant Products Liability Litigation, MDL 2775, pending in the District of Maryland. Nor have we hidden our disregard for several of its decisions, going back to its preemption ruling on defendant’s motion to dismiss which made our bottom ten worst cases for 2018. So, no we were not surprised when it handed down another disappointing preemption decision earlier this summer. And if its decision in Albritton v. Smith & Nephew, Inc., 2021 U.S. Dist. LEXIS 153866 (D. Md. Aug. 13, 2021) (part of MDL 2775), had turned on preemption we are certain we would be sharing our further frustration. Instead, what the court allowed to escape preemption previously, it could not save on summary judgment because plaintiff failed on causation across the board.
Plaintiff, a Florida resident, suffered hip pain because of avascular necrosis (“AVN”), a condition where the bone weakens due to a lack of blood supply. Id. at *86-87. Plaintiff’s surgeon discussed the treatment options with him, including undergoing a hip resurfacing using defendant’s device. Id. at *88-89. Plaintiff underwent the surgery in 2009. In 2015, due to pain, he underwent a revision surgery during which it was discovered that the femoral neck of the device had fractured and loosened. Id. *91. Plaintiff alleges that prior to his surgery he was provided a patient guide that discussed using the device for treating AVN but did not include the increased risks and contraindications in such situations which were discussed in the device’s Instructions for Use (“IFU”). Id. at *89-90. Plaintiff also claimed that he relied on his surgeon in deciding to have the surgery and to select the device to use; that his surgeon told him the device would last the rest of his life, something his surgeon denies; and that he did not rely on any advertising in deciding whether to undergo the procedure with the defendant’s device. Id. The implanting surgeon testified that he was familiar with the device’s IFU and that he was aware, prior to plaintiff’s surgery, that AVN patients were at an increased risk for needing revision surgery, but that defendant’s device was the best option for plaintiff. Id. at *92-93.
Plaintiff’s causes of action were for negligent failure to warn, negligent misrepresentation, negligence per se, breach of express warranties, and negligent training. The court addressed each in turn. The court declined to determine whether Florida law would recognize a failure to warn claim based on an alleged failure to report adverse events to the FDA. That’s fine with us because based on precedent, it would likely have ignored Florida law anyway. But, if you want to know the answer, it is – Florida does not – as we discuss here. Instead, the court focused on causation. Plaintiff had no evidence that any information defendant was required to report to the FDA would have been made public in such a way as to have reached plaintiff’s implanting surgeon in time to alter his decision regarding using the device. Id. at *97-98. We’ve been talking about the causation problems with failure to report claims since Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) was decided. So, that the claim was ultimately dismissed is not surprising. That it should have dismissed because its not a claim under Florida law is disconcerting, but we’ll take the win.
On negligent misrepresentation, plaintiff also had a causation problem. First, his experts opined that that defendant did not make any misrepresentations regarding the risk of revision and the particular device used in plaintiff’s surgery. Id. at *99-100. Second, although plaintiff attempts to point out omissions in the patient guide, the record evidence is that plaintiff did not rely on the patient guide in deciding to have the surgery. Id. at *100-101. Third, plaintiff could not prove that his implanting surgeon relied on any misrepresentation by defendant. The surgeon testified that he read the IFU and was aware of the risk of revision prior to performing the procedure. Plaintiff argued that there were ad hoc reports of adverse events that were not in the materials provided to his surgeon. One such report which may have been available prior to plaintiff’s surgery purportedly showed a revision rate for AVN patients closer to 9.8% as opposed to the 7.9% revision rate in the IFU. Id. at *103-104. But there is no testimony from the implanter that such information would have changed his decision. The remaining ad hoc reports plaintiff relies on post-date his surgery and therefore “do not assist the factfinder in identifying what [defendant] knew before [plaintiff] had the [device] implanted.” Id. at *104. Without reliance by himself or his doctor, plaintiff failed to establish any alleged misrepresentation was a cause of his injury.
Plaintiff’s breach of express warranty claim failed for the same lack of causation. The patient guide was the only direct communication between the defendant and the plaintiff and plaintiff disavowed any reliance on it. Id. at *107-108. To the extent plaintiff tried to rely on his surgeon alleging telling him the device would last his lifetime, plaintiff cannot attribute that statement to the defendant. His surgeon denies making the representation, but regardless plaintiff has no proof defendant was the source. Id. at *108.
On failure to train, the court adopted its earlier ruling finding the claim preempted because attempts to add training requirements not imposed by the FDA violated the FDCA’s “different from or in addition to” language. Id. at *109.
Finally, plaintiff attempted a negligence per se claim based on Florida’s “Little FDCA” statute which prohibits misbranding. But such a claim would require plaintiff to challenge the adequacy of the FDA-approved label and therefore, it was preempted. Id. at *109-110.