In its November 2008 issue, the Harvard Law Review will publish "Preemption of State Common Law Claims," 122 Harv. L. Rev. 405, an article that discusses Riegel v. Medtronic, Inc., 128 S.Ct 999 (2008) and its impact on state law claims. Of note, the authors state: "Despite criticisms that it leaves tort victims uncompensated, preemption is … Continue Reading
In “Ex Parte Talks Allowed Under Georgia Law For Counsel, Doctors Preempted by HIPAA,” the United States Law Week discusses in detail Moreland v. Austin, Georgia Sup. Ct. No. S08G0498, a November 3, 2008 decision holding that defense attorneys who wish to engage in ex parte communications with plaintiffs’ treating physicians must comply with HIPAA … Continue Reading
In Carter v. Novartis Consumer Health, Inc., --- F. Supp. 2d --- , No. EDCV08-0334 MRP (JCRx) (C.D. Cal. Aug. 5, 2008) and its companion cases, the Central District of California addressed the express preemption clause of Section 379r of the Food, Drug and Cosmetic Act governing OTC drugs. Here, the parents of children younger than age 6 filed a complaint against manufacturers alleging that the OTC cough and cold medicines "d[id] not work" and were dangerous to their children. There were no requests for damages based on injuries, but rather for the economic harm of purchasing these products. Plaintiffs also sought injunctive relief, pursuant to various state consumer fraud statutes, and each case sought to certify a class on behalf of all others similarly situated.
The court granted the defendants' motion to dismiss based on federal preemption for all of the claims (unjust enrichment, false and misleading advertising, fraudulent concealment, unfair and deceptive business practices, and breach of express and implied warranties), noting that OTC cough and cold medicines are regulated by the FDA pursuant to the OTC monograph, generally described within 21 CFR part 341. Such OTC monographs set forth approved indications for use and age-dependent dosage instructions that must comply with all FDA regulations, and are therefore generally recognized as safe and effective. Claims attacking these federal "requirements" therefore preempted the state "requirements" established by the state law claims. Of particular note was the court's understanding that the state requirements were not defined by its label, but "its ultimate outcome: would a finding of liability impose requirements that are different from or in addition to FDA requirements?" p. 13. Because the claims were premised on attacks based upon FDA-approved statements in product labeling and advertising, such claims were preempted.… 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
In Parker v. Stryker Corp., 2008 WL 4457864 (D. Colo. Oct. 1, 2008), the District of Colorado addressed Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), and the applicability of the express preemption clause of the Medical Device Amendments in a case where the manufacturer sought a discovery stay pending resolution of its motion … Continue Reading
SCOTUSblog has its usual comprehensive coverage of the first Supreme Court case of this term, Altria Group v. Good, which involves questions of express and implied preemption in the context of tobacco. As Lyle Denniston explains, “More than four decades ago, the Federal Trade Commission – the federal government’s main regulator of business conduct – told … 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
The plaintiff in Hearn v. Advanced Bionics Corporation, No. 06cv114-KS-MTP, 2008 WL 3896431 (S.D. Miss. Aug. 19, 2008) attempted to win a do-over of a straightforward defense preemption win. The district court had granted in part and denied in part the defendant’s motion for summary judgment based on preemption as a result of the Class … Continue Reading
Earlier this week, in Uhm v. Humana, Inc., --- F.3d --- , 2008 WL 3891592, No. 06-35672 (9th Cir. Aug. 25, 2008), the Ninth Circuit upheld a lower court ruling that the express preemption provision of the Medicare Prescription Drug Improvement and Modernization Act preempted state law claims arising from the plaintiffs' prescription drug benefits provided by a Medicare supplement insurer.… Continue Reading
This case provides an interesting glimpse of what could happen if the plaintiffs are successful in persuading Congress to change the import of Riegel v. Medtronic, Inc.’s, (552 U.S. ___, 128 S.Ct. 999, (Feb. 20, 2008)) holding through legislation. In Lundeen v. Canadian Pacific Railway Company, 532 F.3d 682 (8th Cir. July 2, 2008), the Eighth Circuit addresses … Continue Reading
A recent Virginia federal court decision demonstrates the powerful effect of the Riegel v. Medtronic precedent in product liability cases where PMA-devices are subject to claims-sounding in negligence or breach of duty related to the design, manufacturing, and labeling of the device. According to this court, however, the preemption defense of Riegel reaches only those allegations … Continue Reading
Reed Smith partners James W. Wood and James C. Martin recently wrote an article regarding pharmaceutical and medical device preemption for the Washington Legal Foundation, discussing such cases as the Third Circuit’s Colacicco v. Apotex, Inc. case, as well as activity in the U.S. Supreme Court.… Continue Reading
This post was also written by Michael K. Brown. In This Issue… U.S. Supreme Court Activity in Medical Device and Drug Preemption Cases Express Preemption in the Lower Courts Preemption and Buckman Implied Preemption in the Lower Courts Recent Legislation Miscellaneous Cases Click here to read more.… Continue Reading