Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Federal Preemption and Tort Claims
For medical device manufacturers, federal preemption can be a powerful defense to state tort claims. Although there is some split of authority, most federal courts of appeals that have addressed the issue have held that when a medical device reaches the market via the Food and Drug Administration's (FDA) rigorous “premarket approval” (PMA) process, many state common law claims are expressly preempted by the Medical Device Amendments (MDA) of 1976.
The emergence of new and innovative medical products that combine FDA-regulated devices with either a drug or biologic component, however, raises the question whether manufacturers will be able to successfully assert preemption as a defense to state tort claims arising from these “combination products.” See Laura Lewis Owens and Courtney Carter Fletcher: Combination Products: Is It a Drug, Medical Device, or Biologic? (unpublished manuscript, on file with Laura Lewis Owens, Alston & Bird, LLP). Although conventional wisdom would lead many to conclude that a preemption defense should be successful for many medical device combination products, at least one federal district court decision seems to conclude that the MDA's preemption provision never applies to “combination products.”
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- 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
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Bankruptcy Sales: Finding a Diamond In the Rough
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.
Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs
A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.
Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
Blockchain Domains: New Developments for Brand Owners
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.
Coverage Issues Stemming from Dry Cleaner Contamination Suits
In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.