Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
The FDA's Role in Product Liability Litigation
Aside from promulgating regulations, imposing rigorous standards on myriad product manufacturers, and conducting research and studies on all such products, the FDA also takes an active role in participating in an array of product liability litigations both on the state and federal levels. Often, the FDA's position and “expertise” on an issue carry great weight with the courts and consequently can affect the outcome of litigation. Thus, defense counsel involved in product liability matters in which the FDA historically has had an interest should keep abreast of the FDA's positions on the relevant issues.
Three areas of product liability litigation in which the FDA has involved itself are cases in which 1) the question was presented whether the Food, Drug, and Cosmetic Act, 21 U.S.C. '' 301 to 399 (2003), (FDCA) broadly preempts state common law tort claims; 2) there was an issue as to what deference courts should accord to the FDA's “expertise” in matters of drug labeling and advertising; and 3) the FDA brought matters regarding a party's compliance with federal law, or lack thereof, to the courts' attention. (These areas of the FDA's involvement in product liability litigation are by no means exhaustive. Therefore, the reader is encouraged to investigate further the FDA's evolving positions on other relevant issues.)
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?
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.
The DOJ's Corporate Enforcement Policy: One Year Later
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.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
Protecting Innovation in the Cyber World from Patent Trolls
With trillions of dollars to keep watch over, the last thing we need is the distraction of costly litigation brought on by patent assertion entities (PAEs or "patent trolls"), companies that don't make any products but instead seek royalties by asserting their patents against those who do make products.