After getting off to a rocky start a few years ago on preemption, cases in the Birmingham hip MDL are falling like dominoes.  And just like last week’s case, the decision in Sedgwick v. Smith & Nephew, Inc., 2021 U.S. Dist. LEXIS 157412 (D. Md. Aug. 19, 2021) falls apart at the summary judgment stage on causation.

Plaintiff underwent surgery with implant of the BHR resurfacing device in September 2007.  Seven years later, pain and related complications led to revision surgery.  Id. at *66.  As in the other BHR cases, plaintiff’s primary allegations are that defendant’s marketing was misleading regarding the success and revision rates for the device.  Id. at *63.  Plaintiff focuses on ad hoc reports from outside the US, and that post-date plaintiff’s surgery, showing higher revision rates for smaller sizes of the device.  Id. at *71.

Having dismissed strict liability failure to warn at the motion to dismiss stage, only a negligent warning claim was at issue.  Any such claim based on an alleged failure to warn plaintiff’s implanting surgeon was dismissed as preempted, leaving only failure to report to the FDA.  Id. at *79.  Opting again to forego the question of whether Maryland would recognize such a claim, the court dismissed the failure to report claim because plaintiff had no evidence that any information that defendant was required to disclose to the FDA would have reached his surgeon in time to alter his decision to use defendant’s device.  Id. at *81-82.  In other words, no causation.

Moving on to negligent misrepresentation – that claim would be preempted if based on FDA approved statements or information.  But, where plaintiff alleges the misleading information was in “voluntary statements” that were not FDA-approved, the claim survives preemption only to fail on causation.  As to the Patient Guide which plaintiff believes he may have reviewed, whether that contained any misrepresentation is irrelevant where plaintiff’s testimony is that he could not recall its contents and that he relied on his surgeon, not the guide in deciding to undergo surgery with the device.  Id. at *84-85.

As to statements made to plaintiff’s surgeon, the court would not consider a Dear Doctor letter that was sent after plaintiff’s surgery.  Id. at *86.  With respect to statements made to plaintiff’s surgeon, pre-surgery, regarding the revision rates for the device, the information plaintiff takes issue with is consistent with information contained in defendant’s FDA-approved label at the time.  Id. at *86-88.  In fact, certain of the information plaintiff points to as showing higher revision rates pre-dates the FDA’s Pre-Market approval of the device.  The fact that the “voluntary information” being provided to the medical community was the same as what the FDA approved for the device’s label was enough for the court to find preemption:

This strikes the court as a preempted attempt to undermine the FDA’s PMA approval process and the FDA-approved BHR label which contained and “blessed” those revision rates.

Id. at *88.

Defendant also made statements regarding the benefits of the metallurgy of its device which plaintiff contends were contradicted by ad hoc reports of higher revision rates from Australia and the UK.  But those reports also post-dated plaintiff’s surgery.  Id. at *89.  So plaintiff focused instead on an allegation that defendant had reason to know there was additional information it could have requested and because it did not, it cannot vouch for the veracity of the statements it made based on the information it had available.  Id. at *88-89.  Plaintiff was attempting to graft onto Maryland’s negligent misrepresentation law a duty that defendant must seek out and disclose additional information.

But the court has held that any claim that [defendant] had a duty to warn the medical community is preempted.  And the duty to make “truthful, accurate, and not misleading” statements, requires only that [defendant] not create a misleading impression by failing to disclose other known information. The record is clear that the information provided to [plaintiff’s surgeon] during his 2006 training was consistent with [defendant’s] knowledge at the time the statements were made. Thus, those representations cannot support a negligent misrepresentation claim.

Id. at *91-92 (citations omitted).  Simply, the statements were not misrepresentations.  Moreover, these claims would have failed for lack of reliance.  Plaintiff claims to have relied exclusively on his surgeon and his surgeon’s testimony is that even if presented with the information plaintiff wanted disclosed, it would not have altered his decision.  Id. at *93-94.

Plaintiff brought a breach of express warranty claim alleging that defendant warranted the device would last for a specific period of time, “about fifteen years.”  Id. at *95.  But that information seems to have come from comments his surgeon made that were not even specific to the BHR device.  Because there is no evidence that defendant was the source of the claim, there is no express warranty.  Id. at *95-96.

Finally, plaintiff’s negligent training and misbranding claims were preempted for the same reasons the court found in its prior decisions.  Id. at *97-99 (a conclusion that the training program had to change would impose new or different requirements on defendant; and any claim that defendant had to change its labeling is preempted).

Based on these first decisions, it looks like plaintiffs have an uphill battle on causation in the individual cases.