August 10, 2015

The Learned Intermediary Doctrine Gains Another Foothold in West Virginia

Jennifer A. Foster – August 10, 2015

In January, this author lauded a West Virginia federal court's recognition of the learned intermediary doctrine in Tyree v. Boston Scientific Corp., 56 F. Supp. 3d 826 (S.D. W. Va. 2014) (Goodwin, J.). See Jennifer A. Foster, "A Surprising Win for the Learned Intermediary Doctrine in West Virginia," Products Liability Litig. (ABA Section of Litig.), Jan. 6, 2015. Just five short months after the Tyree ruling, another West Virginia federal judge rallied additional support for the learned intermediary doctrine in the state in O'Bryan v. Synthes, Inc., No. 5:13-cv-25981, 2015 U.S. Dist. LEXIS 32361 (S.D. W. Va. Mar. 17, 2015) (Berger, J.). This trend creates a welcome boon for medical device manufacturers facing products liability litigation in the courts of West Virginia.

As in Tyree, O'Bryan involved product defect claims against the manufacturer of an FDA-approved medical device, including a warnings defect claim. The particular medical device at issue was a Synthes plate—a metallic internal fixation device—that had been surgically implanted in the plaintiff's fibula, which she had fractured approximately six months before the plate was implanted. At the time of the surgery, the package insert for the metal plate warned that "these devices are not designed to withstand the unsupported stress of full weight-bearing" and that they might "break when subjected to the increased loading associated with delay" in the healing and union of the bone fragments they are designed to join. In addition, the "precautions" section of the package insert informed physicians that they should instruct patients about "the limitations of the implant and that physical activity and full weight bearing or load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices." Physicians were also instructed to inform patients that the "metallic implant is not as strong as a normal, healthy bone and will fracture under normal weight bearing or load-bearing in the absence of complete bone healing."

Despite these instructions, the plaintiff in O'Bryan claimed that her surgeon told her she could bear weight on her fractured leg following surgery, but that she should wear a boot brace during the day. The plaintiff claimed that she followed these instructions, but approximately three or four days after the surgery, felt a "pop" and experienced severe pain while trying to lift her leg out of bed. When the plaintiff went back to her surgeon for a follow-up appointment a couple of weeks later, he took an x-ray of her leg, which revealed that the plate had fractured. This necessitated a second surgery to remove the first Synthes plate and implant another, thicker plate.

Following the plaintiff's second fibula surgery—which was successful—she sued the manufacturer of the metal plate, asserting various product defect and warranty claims, in West Virginia federal court. The device manufacturer, Synthes Inc., moved for summary judgment on all claims. With respect to the failure-to-warn claim, Synthes argued that it fulfilled any duty to warn by including specific provisions in the package insert that internal fixation devices are susceptible to breaking, especially with weight bearing, and that patients should be advised that physical activity and full weight bearing may result in loosening, bending, or fracture. Judge Irene Berger agreed, finding that "[b]ecause Defendant Synthes is a 'manufacturer of medical devices,' the learned intermediary doctrine applies to the Plaintiff's failure to warn claims." O'Bryan, 2015 U.S. Dist. LEXIS 32361, at *17 (citing Tyree, 56 F. Supp. 3d at 828). As in Tyree, the judge was persuaded that the learned intermediary doctrine was applicable because (1) the case involved a medical device, rather than a prescription medication; and (2) there was no evidence that the defendant had engaged in direct-to-consumer advertising. O'Bryan, 2015 U.S. Dist. LEXIS 32361, at *18. Continuing the trend started with Tyree, Judge Berger determined that, absent proof of direct-to-consumer advertising, Synthes had no duty to warn patients directly about the risks of its metal fixation plates and that Synthes's warnings and precautions in the package insert were sufficient to defeat the plaintiff's negligence and strict liability warnings claims as a matter of law.

Although Tyree and O'Bryan certainly are positive developments for the learned intermediary doctrine in West Virginia, an open question remains as to why the same rationale should not apply to pharmaceutical manufacturers. In both cases, the courts emphasized that their recognition of the learned intermediary doctrine in West Virginia was based heavily on the fact that medical devices, rather than pharmaceutical products, were the alleged source of injury. See O'Bryan, 2015 U.S. Dist. LEXIS 32361, at *17–18; Tyree, 56 F. Supp. 3d at 833. Almost certainly, this is because the West Virginia high court refused to apply the learned intermediary doctrine to absolve a pharmaceutical manufacturer of liability for failure-to-warn claims in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007). But many of the considerations that led the court to apply the learned intermediary doctrine in the O'Bryan case apply equally to pharmaceuticals.

First, regardless of whether a drug or device is at issue, physicians ultimately are the ones who have the medical training needed to understand the various warnings and precautions that need to be explained to a patient, and the ones who make the decision as to whether a prescription should be written or a surgery scheduled. Regardless of whether a physician physically implants a medical device, as opposed to prescribing a medication, the physician stands in the best position to educate the patient as to the risks and benefits of whatever the product may be. Thus, this difference does not warrant the disparate treatment that the West Virginia courts historically have given pharmaceutical companies who are sued in the state.

Second, by its very nature, prescription medication cannot be obtained without a doctor's prescription. The Tyree court's suggestionthat there should be some meaningful difference between the legal treatment of medical device manufacturers and pharmaceutical companies because patients might be able to obtain prescription medications without a prescription is, at best, speculation. See, e.g., Tyree, 56 F. Supp. 3d at 833. If that factual scenario, in fact, played out, the case would present entirely different legal issues regarding liability of pharmaceutical manufacturers where a medicine is illegally obtained and no learned intermediary is present. In short, this has nothing to do with whether, in the normal course of patients seeking medical treatment from physicians, medical device manufacturers should be treated any differently from pharmaceutical manufacturers when it comes to application of the learned intermediary doctrine. As such, it likewise provides no reasoned explanation for why the learned intermediary doctrine should apply to medical device manufacturers but not pharmaceutical companies faced with litigation in West Virginia.

Finally, in Tyree, Judge Goodwin suggested that physicians have more control over recommendations regarding implantation of medical devices, as opposed to use of prescription medications, because patients generally are not as informed about medical devices, and thus rely more heavily on their doctors' judgment. 56 F. Supp. 3d at 832. But this overlooks the fact that, whether or not a medical device or prescription drug is at issue, the doctor—not the patient—makes the ultimate determination and judgment as to whether a particular medical intervention is in the best interest of the patient. It also suggests that a doctor's medical judgment is somehow less important when prescription drugs, as opposed to medical devices, are at issue. Regardless of whether a patient comes in with a preconceived notion of the type of treatment he or she wants, or relies exclusively on the doctor's judgment in recommending a course of treatment, the doctor ultimately is the one who stands in the best position to understand the warnings and precautions that accompany a prescription drug or a medical device, and thus the one to whom those warnings should run. As such, there is at least some limited reason to hope that, as time goes on, the West Virginia high court may come around to the idea that pharmaceutical companies (at least those that do not directly advertise to patients) should benefit from the same learned intermediary protections as medical device manufacturers.

Keywords: litigation, products liability, internal fixation device, learned intermediary doctrine, duty to warn, medical device manufacturers, pharmaceutical manufacturers

Jennifer A. Foster – August 10, 2015