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When Products Liability Intersects with Malpractice Strategy

By Lori G. Cohen and Sara K. Thompson

Manufacturers of implantable medical devices are likely to rely on prescribing medical providers to not only provide the patient with full and complete warnings and counseling on the risks and benefits of the product as part of obtaining informed consent, but also to transmit to the patient any manuals, product literature or other materials specifically intended for the patient which may be included in the device packaging. Product labeling and manuals are approved by the FDA along with the device's design and manufacturing specifications, and therefore failure-to-warn claims based upon the adequacy of the warnings contained in such literature are susceptible to federal preemption. See, e.g., Brooks v. Howmedica, 273 F.3d 785, 798 (8th Cir. 2001).

Some plaintiffs seek to obviate preemption by arguing not that the warnings were inadequate as approved by the FDA, but rather that the product literature containing such warnings simply was not passed on appropriately to physician or patient as part of the packaging of the device. Manufacturers will dispute the relevance of such argument in cases in which the learned intermediary rule applies, however, if the physician or hospital adequately documented the procedures for transmittal of such materials to the patient prior to or following prescription or implantation of the device. Such evidence may assist with defeating such an argument. In addition, where hospitals or physicians have practices regarding the handling of medical devices and their packaging within the practice or hospital, production of any records demonstrating the chain of custody will also be helpful to invalidate this argument by the plaintiff.

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