One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA’s regulations governing the content of labels for prescription drugs. Essentially, defense lawyers … Continue Reading
Washington Legal Foundation’s latest Legal Backgrounder, the "Logic of Michigan’s ‘FDA Defense’ Survives Recent Supreme Court Ruling", authored by Thomas J. Foley, explains why the Wyeth v. Levine, 129 S.Ct. 1187 (2009) ruling does not support a rationale to overturn Michigan law that provides a defense against drug product liability suits where the manufacturer obtained … Continue Reading
The Supreme Court had held action on a petition in Colacicco v. Apotex, Inc., No. 08-437, an implied preemption decision out of the Third Circuit involving an anti-depressant, pending the outcome of Wyeth. The docket now reflects that the case has been distributed for the Court’s March 6, 2009 conference. The most likely outcome is that … Continue Reading
As Point of Law pointed out on February 3, a move is afoot to “Revers[e] Preemption, One Bill At A Time,” starting with industries regulated by the FDA. Section 2 of the FDA Globalization Act OF 2009, H.R. 759, merits the attention of the life sciences industry. It provides: This Act and the amendments made … Continue Reading
Today's posts on lifescienceslegalupdate.com include "Gerald Masoudi at ACI" which includes some notes regarding the presentation by the FDA's Gerald Masoudi today at the ACI Drug and Device Conference, and "EPA Proposes Change in Regulations for Disposal of Unused Pharmaceuticals".
View the full blog at https://www.lifescienceslegalupdate.com.
View "EPA Proposes Change in Regulations for Disposal of Unused Pharmaceuticals": https://www.lifescienceslegalupdate.com/2008/12/articles/regulatory-developments/epa-proposes-change-in-regulations-for-disposal-of-unused-pharmaceuticals/… Continue Reading
Tomorrow's JAMA contains an editorial entitled, "Prescription Drugs, Products Liability, and Preemption of Tort Litigation" (subscription) by Catherine D. DeAngelis; Phil B. Fontanarosa (JAMA. 2008;300(16):1939-1941 (doi:10.1001/jama.2008.513)).
Suffice it to say, the premise that tort litigation safeguards patient health is faulty. Ensuring patient access to innovative and needed medical options is essential. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1009 (2009) (discussing the express preemption statute for medical devices and stating, "the text of the statute - suggests that the solicitude for those injured by FDA-approved devices, which the dissent finds controlling, was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.")… Continue Reading
Over at Drug and Device Law Beck and Herrmann muse on the possible impact of a win by Sen. Obama on drug and device law. This blog takes no sides on the election – and this may mean nothing for the future development of the law – but it is interesting to note that in the … Continue Reading
The California Court of Appeal reversed a lower court’s holding for a generic pharmaceutical manufacturer and distributor, and held that implied preemption principles did not preempt the state law claims challenging the labeling for a generic drug. In McKenney v. Purepac Pharms. Co., — Cal. Rptr. — , 2008 WL 4355425 (Cal. App. Sept. 25, … Continue Reading