Law

In O'Bryan v. Synthes, Inc., 2015 U.S. Dist. LEXIS 32361 (S.D.W.Va. Mar. 17, 2015), the plaintiff alleged that Synthes was liable for failure to warn her that the metallic fixation plate implanted to repair her fractured fibula could fail if subjected to full weight-bearing before the bone had healed.  Synthes moved for summary judgment on the plaintiff’s warnings claims.  As the Court discussed, the plate’s package insert contained detailed warnings to exactly this effect in both the “Warnings” and “Precautions” sections.  Nevertheless, plaintiff argued that her doctor did not provide her with the package insert, and that she would not have undergone her implant surgery if she had known the device could fracture in less than four weeks.  O'Bryan, 2015 U.S. Dist. LEXIS 32361 at *12. 

The Court gave Plaintiff’s argument the back of its hand.  Citing Tyree, the Court held, “Because Defendant Synthes is a ‘manufacturer of medical devices,’ the learned intermediary doctrine applies to the Plaintiff’s failure to warn claims.”  Id. at *17 (citation to Tyree omitted).   The Court emphasized that Tyree limited the application of State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (2007), the West Virginia Supreme Court’s decision rejecting the learned intermediary doctrine, to cases involving “prescription drug manufacturers and manufacturers engaged in direct-to-consumer (“DTC”) advertising.”  Id (more on this later).  Granting summary judgment for Synthes on plaintiff’s warnings claims, the Court held, “This Court finds the analysis and reasoning in Tyree particularly persuasive in this case involving implantation of a plate or medical device with no evidence of direct to consumer advertising.  The learned intermediary doctrine requires Synthes to warn only the plaintiff’s treating physician about the Synthes plate.”   Id. (internal punctuation and citation omitted).   Synthes, of course, had done just that.  And plaintiff’s warnings claim was dispatched to an appropriate learned intermediary graveyard.

We remain troubled by a window the Tyree opinion left open.  The O'Bryan court’s proclamation that the learned intermediary doctrine applied because Synthes was “a manufacturer of medical devices” buys into Tyree’s insistence that there is a distinction, for learned intermediary purposes, between prescription drugs and prescription medical devices, rendering device manufacturers more deserving of the doctrine’s constraints.  There is no such distinction (99.9% of all cases treat them identically), and, ever optimistic, we await such a proclamation in a West Virginia prescription drug case.  In the meantime, O'Bryan is another positive link in the jurisprudential chain.