Another Win on Summary Judgment Based on the Learned Intermediary Doctrine

We routinely cover decisions addressing drug manufacturer’s reliance on the learned intermediary doctrine to obtain dismissals in failure to warn cases.  Last month, in In re Avandia Mktg., Sales Practices & Products Liab. Litig., No. 07-MD-01871, 2015 WL 1383070 (E.D. Pa. Mar. 24, 2015), the Eastern District of Pennsylvania emphasized that in order for plaintiff to establish proximate cause, the prescribing doctor must unambiguously testify that had he received a different warning, he would have changed his prescribing decision.  The District Court dismissed all claims against the drug manufacturer on the basis that Plaintiffs failed to prove proximate cause because at no point did the prescribing doctor testify that a different warning would have altered his prescribing habits.

In the case, Plaintiffs, Mr. and Mrs. Schatz commenced an action against GlaxoSmithKline (“GSK”) for numerous claims including negligence, negligent misrepresentation, strict liability, breach of warranty, fraud, and unjust enrichment.  In re Avandia, 2015 WL 1383070 at *1.  Specifically, Plaintiffs alleged that Mrs. Schatz suffered bone fractures in March 2007 as a result of her use of GSK’s diabetes medication, Avandia.  Id.  GSK moved for summary judgment on the basis that Plaintiffs failed to prove  GSK’s alleged failure to warn was the proximate cause of her injuries.  Id.

Before March 2007, the Avandia label did not include any warnings or precautions about the risk of bone fractures.  Id. at *2.  After a long-term study was published in the New England Journal of Medicine indicating that more female patients taking Avandia experienced fractures, GSK distributed a Dear Health Care Provider letter summarizing the study’s results.  Id.  Subsequently, in March 2007, the Avandia label was revised to include a precaution regarding the increased incidence of bone fracture in female patients taking Avandia in a long-term trial. Id.

The Court explained that under the learned intermediary doctrine, a manufacturer’s duty to warn is discharged where the patient’s doctor is adequately warned of the risks associated with use of the drug.  Id. at *3.  The District Court explained that to establish proximate cause, the prescribing doctor must testify that had he received a different warning, he would have altered his prescribing habits.  Id. Notably, the District Court emphasized that at his deposition, Plaintiff’s prescribing doctor testified that he would still prescribe Avandia to a patient with the same medical history presented by Plaintiff back in 2002.  Id.  Indeed, the Court stressed that “[a]t no point in his deposition [did] he testify that he would have made different medical decisions about Mrs. Schatz’s treatment if GSK had provided different or more prominent warnings about the risk of fractures.” Id.

In a failed attempt to create an issue of material fact, Plaintiffs pointed to evidence suggesting that had GSK included a black box warning regarding the risk of bone fractures, that warning would have “caught [the prescriber’s] eye.” Id. at *4.  The District Court rejected Plaintiffs’ effort to avoid summary judgment, explaining that the doctor’s testimony that he relied on “black box warnings to weigh risks and benefits, and that a black box warning would have been more salient, is not sufficient to establish a genuine issue of material fact as to whether such a warning would have deterred him from prescribing Avandia to Mrs. Schatz…”  Id. (emphasis added).  Furthermore, although the prescribing doctor did not recall whether he received the letter distributed in 2007, the record revealed that he continued to prescribe the drug to Plaintiff for approximately nine months following that letter.  Id.

In one last shot to create an issue of fact, Plaintiffs pointed to the fact that after learning that fractures could be a rare adverse reaction, Plaintiff’s doctor substituted a different medication.  Id.  The District Court found, however, that such a response was “simply insufficient” since it still did not raise a material fact as to whether the doctor would have changed Plaintiff’s medication when he learned of this association before she suffered the fractures in 2007.  Id.

Accordingly, the District Court held that Plaintiffs failed to establish an issue for trial with respect to whether GSK’s conduct was the proximate cause of her injuries.  Id. at *5.  And, despite alleging various claims other than negligence, including breach of warranty, fraudulent misrepresentation, unjust enrichment, and loss of consortium, the District Court dismissed the entire action with prejudice, emphasizing that the crux of the complaint was that GSK failed to adequately warn.  Id.

This decision emphasizes that without explicit and unambiguous testimony from the prescriber that a different warning would have actually changed his prescribing decision, plaintiffs will be unable to proceed with their failure to warn cases.  This is just one more win for the learned intermediary doctrine.