Today’s case was decided back on April 23rd, but just showed up on our radar.  That made us look back to see first what we were posting about on that date (answer:  Lone Pine) and second, what was the world talking about on that date (answer:  Chauvin guilty verdict, surging Covid-19 cases in India, vaccinations; the DC statehood bill; and hate crimes against Asian Americans).  Gutierrez v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 113262 (W.D. Tex Apr. 23, 2021) might not have made headlines like those other events/issues, but it’s a significant pelvic mesh win out of Texas and that warrants a little love from the DDL blog.

After voluntarily dropping some claims, plaintiff’s causes of action could basically be divided into claims based on a (1) failure to warn:  failure to warn, fraud, negligent misrepresentation, and violation of consumer protection laws and (2) design defect.  Defendant moved to dismiss all claims as barred by the statute of limitations which the court denied finding a genuine issue of material fact as to when plaintiff’s cause of action accrued.  Id. at *17-35.  As it’s a fact intensive discussion, we will not address it here.

Defendant also moved to dismiss both the failure to warn and the design defect claims on causation grounds.  On these arguments, the court agreed with defendant.  Texas has adopted the learned intermediary doctrine and in the case of a prescription pharmaceutical or medical device Texas has interpreted that to place two burdens on plaintiff.  First, plaintiff must demonstrate that the warnings were inadequate.  Second, plaintiff must show that had her physician received the alleged adequate warning, he would have changed his decision to use the device.  Id. at *38-39.  To establish the second prong, the causation prong, plaintiff in Gutierrez relied on the implanting surgeon’s testimony that had he been given additional information, he would have shared it with plaintiff as part of the informed consent process.  But under Texas law, that is a “legally irrelevant point.”  Id. at *47.  It does not matter whether the plaintiff would have changed her mind, only whether a different warning “would have changed the decision of the intermediary to prescribe the product.”  Id. at *48.  On that question, the evidence was clear.  Plaintiff’s surgeon testified that defendant’s device has fewer complications than other devices; that knowing what he knows today he would still prescribe the device; that he does not second guess his decision; that he would still present it as a viable option and would still do the procedure today; and that he has no reason to conclude the device is not the gold standard for treating plaintiff’s condition.  Id. at *47.

Plaintiff tried to get the court to follow the reasoning of the Fifth Circuit in McNeil v. Wyeth, 462 F.3d 364 (5th Cir. 2006) which allowed an informed consent-based way for plaintiff to prove warning causation (finding inadequate labeling could be a producing cause of injury if given more information the plaintiff would have rejected the drug).  But relying on McNeil’s prediction of Texas law overlooks that subsequent to that ruling, the Texas Supreme Court decided the issue and opted not to adopt the Fifth Circuit’s interpretation.  In fact, in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), the Texas Supreme Court cited McNeil as standing for a “different proposition” from Texas law.  Gutierrez, at *51.   As a court sitting in diversity, the Gutierrez court was obligated to follow the law as announced by the highest court in the state.  Therefore, plaintiff’s failure to warn claims were dismissed.  The same logic dictated dismissal of plaintiff’s fraud, misrepresentation, and consumer protection claims as they were all premised on defendant’s alleged failure to provide adequate and/or accurate information to the public.  Id. at *53-54.

Texas law forecloses the deployment of creative pleading to circumvent the learned intermediary doctrine. . . . Texas courts must discern the “gravamen” of claims to determine whether they, in truth, simply rehash failure-to-warn theories. Doing so is necessary because if the learned intermediary doctrine could be avoided by casting what is essentially a failure-to-warn claim under a different cause of action such as the DTPA [i.e., a consumer-protection law] or a claim for misrepresentation, then the doctrine would be rendered meaningless.

Id. at *54-55.  Therefore, because the “crux” of plaintiff’s fraud and misrepresentation claims “is really a failure-to-warn theory, the learned intermediary doctrine applies with equal force.”  Id. at *55.

That left plaintiff’s design defect claim.  To prove this claim under Texas law, plaintiff bears the burden of proving there was a safer alternative design and that the defect caused plaintiff’s injury.  Id. at *58.  Texas law further requires that plaintiff prove the safer alternative design reasonably would have “prevented or significantly reduced the risk of plaintiff’s injury and that it was economically and technologically feasible at the time the product left the control of the manufacturer.  Id. at *58-59.  Here, plaintiff lacked the necessary case-specific causation expert evidence that a safer alternative design, in reasonable probability, would have prevented plaintiff’s injuries.  Id. at *60.

Neither of plaintiff’s case-specific experts addressed the issue.  Id. at *61-64.  While the reports talked about plaintiff’s injuries, there was nothing to suggest that an alternative design would have prevented or lessened those injuries.  Evidence that the product injured plaintiff is not evidence that an alternative design would have prevented those injuries.  Plaintiff attempted to rely on her generic experts, but

[s]uch generalized opinions that apply to the entire MDL suit obviously do not suffice to show that alternative designs would have prevented specifically Mrs. Gutierrez’s injuries. Thus, the plaintiffs have failed to put forth evidence supporting the “necessary” showing that alternative designs could have prevented the harms to Mrs. Gutierrez.

Id. at *64.  In fact, plaintiff’s case-specific expert reports point to numerous comorbidities such as age, smoking, prior surgeries, and diabetes.  All factors that complicate her medical history, making proof that a different design would have led to a better outcome especially important in this case.  Id. at *65.

With the underlying claims gone, so too go loss of consortium and punitive damages.  Definitely a case worthy of the blog, even two months later.