Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Medical Malpractice Law & StrategyLJN NewslettersNewsSections

When Products Liability Intersects with Malpractice Strategy

By Lori G. Cohen and Sara K. Thompson
September 27, 2007

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.

This premium content is locked for LJN Newsletters subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
The DOJ's Corporate Enforcement Policy: One Year Later Image

The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.

The DOJ's New Parameters for Evaluating Corporate Compliance Programs Image

The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.

Use of Deferred Prosecution Agreements In White Collar Investigations Image

This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.

Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability Image

This article explores legal developments over the past year that may impact compliance officer personal liability.