Impossibility Preemption Is Possible In 510(k) Device Cases

Published on Law360on October 9th, 2015 The implied impossibility preemption argument against design defect claims involving Section 510(k) medical devices has only rarely been made in any form and has yet to succeed in the 501(k) context. But James Beck at Reed Smith LLP firmly believes that the impossibility preemption argument is right and should win under current U.S. Supreme Court precedent. [ Read More ]

Related Event 

Drug and Med Banner

Join over 400 peers in analyzing how to prepare for increased litigation and knockout discovery battles based on the experiences of sophisticated trial counsel from around the country.  The 20th Anniversary event features panels including:

Preserving the Medical Device Preemption Defense in Light of Contrary Court Decisions and a Resurgence of Off-Label Attacks

Max C. Heerman, Principal Litigation Counsel Medtronic, (Minneapolis, MN) John P. Lavelle, Jr., Partner, Morgan Lewis & Bockius LLP (Philadelphia, PA) James F. Murdica, Partner, Patterson Belknap Webb & Tyler LLP (New York, NY)

• Updates on the status of FDA’s proposed generic labeling and preemption rule: deep-dive into the practical implications for both branded, generics, and biosimilars

– Branded liability based on their ability to unilaterally change the label: which state Courts are rejecting and accepting Conte? – Utilizing an innovator liability theory when arguing for generic preemption

• Survey of the new preemption landscape: Overview of the new Federal Court and lower Court decisions and pending significant appeals

– Dissecting plaintiffs’ best arguments for pleading around preemption – Overview of successful defense strategies in recent cases regarding parallel claims – Forecasting the resurgence of the impossibility preemption defense in light of recent case law – Update on the status of the infamous “Footnote 4” exception cases winding their way through the Courts

• Putting a defense strategy in place in spite of the current subtle contradiction in case law surrounding state-law parallel claims: what is the state of play with the Circuit splits?

– Understanding the significance of the Supreme Court’s denial of Cert in Stengel with respect to parallel state failure-to-warn claims – Avoiding express and implied preemption in cases regarding Class III medical devices – What are plaintiffs pleading to state their claims around preemption? – Which Courts are adopting or accepting the Solicitor General’s opinion?

• Insights into recent allegations of off-label promotion on medical device manufacturers

– Understanding how expressed and implied preemption will be affected – Special considerations surrounding preemption for PMA devices with combination or multiple parts including bone and hip grafts and infused products: what is the scope of pre-market approval? – Exploring the rise of FDA’s use of human factors experts and analysis

• Insights from real arguments to best respond to the concerns on Judges’ minds surrounding preemption going forward


More information about this event, including a full agenda, faculty list, and brochure can be accessed at