February 20, 2008
Supreme Court Upholds Preemption Claim Under Medical Device Amendments
The Supreme Court made it harder for consumers to sue manufacturers of federally-approved medical devices when it ruled in Riegel v. Medtronic that many state common law claims are preempted by federal law. Riegel was injured when a balloon catheter burst during a medical procedure. He sued claiming that the device was defectively designed and that the manufacturer failed to warn of this risk. Medtronic argued that the Food & Drug Administration's approval of this device, and its inability to change either the design or warnings without the agency's approval, put it in an untenable position if it was also subject to state-law-based product defect claims. The federal district court ruled that these claims were preempted by section 360K of the Medical Device Amendments to the federal Food, Drug & Cosmetics Act, a result upheld on appeal by U.S. Court of Appeals for the Second Circuit. The Supreme Court accepted the case for review and heard argument on it in early December 2007. See Pete Yost's article for The Associated Press.
February 7, 2008
Third Circuit Certifies Strict Liability Bystander Recovery Case to Pennsylvania Supreme Court
Berrier v. Simplicity Manufacturing, Inc., No: 05-3621 (3d Cir. Jan. 17, 2008), arose out of injuries sustained by a four-year-old Ashley Berrier when her grandfather inadvertently backed over her foot while mowing his lawn with a riding mower manufactured by the defendant. Her foot was ultimately amputated as a result of the accident. Her parents sued Simplicity on their own behalf and as her parents and guardians, alleging strict liability and negligence claims based design defect and inadequate warning theories. The case was filed in the Pennsylvania Court of Common Pleas and removed to the United States District Court for the Eastern District of Pennsylvania. Simplicity moved for summary judgment on both claims. In granting the defendant’s motion for summary judgment, the trial court in the case expressed “grave doubts as to the logic of preventing an innocent bystander from recovering for injuries caused by an allegedly defective product, particularly when the American Law Institute, through the Restatement (Third) of Torts: Product liability, has retreated from the very genesis of the ‘intended user’ doctrine.” The court nontheless felt constrained to follow Pennsylvania law in Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003) (holding that a child who started a house fire with a butane lighter was not an intended user), which limits liability under a strict liability theory to intended users of a product. Berrier v. Simplicity Corp., 413 F.Supp.2d 431, 432 (E.D. Pa. 2005).
In its review of Pennsylvania law the Third circuit was “persuaded that the proper scope of strict liability remains unresolved where a bystander, who is neither a ‘user’ nor a ‘consumer’ of an allegedly defective product, is injured when that product is being used as intended.” The court certified the following question to the Pennsylvania Supreme Court:
Whether, under Pennsylvania law a plaintiff minor child may pursue a strict liability claim for injuries caused by a riding lawnmower, where that child is neither an intended user nor consumer of the mower. See Pennsylvania Department of General Services v. United States mineral Products Co., 899 A.2d 590 (Pa. 2006); Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003); Riley v. Warren Manufacturing, 688 A.2d 221 (Pa. Super. 1997).
February 5, 2008
Tobacco Control Legal Consortium Newsletter Overview of Light Cigarette Lawsuits
The latest issue of Legal Update, the Tobacco Control Legal Consortium newsletter, is now available at www.tclconline.org. The issue includes the Legal Consortium’s most recent law synopsis, Light Cigarette Lawsuits in the United States: 2007, an overview of light cigarette litigation and its mixed record in state and federal courts to date. The synopsis was written by attorneys at the Consortium's Massachusetts affiliate, the Public Health Advocacy Institute at Northeastern University School of Law.
February 4, 2008
Teflon Paste Failure-to-Warn Claim Preempted by Medical Device Amendments
In yet another case, a court has ruled that a failure to warn claim regarding a Class III medical device is preempted by the FDA's approval of the product for sale. In Mathis v. E.I. dupont De Nemours & Co., W.D. La., No. 06-0825 (1/16/08), the plaintiff claimed that she was injured by a Teflon paste used to treat her vocal chords paralyzed because of earlier thyroid surgery. The product manufacturer moved for summary judgment arguing that Mathis' failure to warn claim was preempted. In granting the defendant's motion, the court noted that the FDA had imposed device-specific requirements on the product, including requirements for the information to be included in the product's labeling and warnings, and that the warnings could not be modified without FDA approval. To say that the warnings were inadequate or that additional or different warnings were required under state law would be imposing state requirements "different from or in addition to" those imposed by the FDA and thus, the court concluded, were preempted under 21 U.S.C. section 360k(a) of the Medical Device Amendments to the Food, Drug & Cosmetics Act.
February 1, 2008
Chinese Manufacturer of Tainted Cancer Drugs at Center of Nationwide Drug Scandal
A New York Times article by Jake Hooker and Walt Bogdanich Shanghai Hualian, a large Chinese state-owned pharmaceutical company that exported drugs to dozens of countries, including the U.S., has been the subject of a national drug scandal in China because of harm, including paralysis, to nearly 200 Chinese cancer patients. The factory that produced the drugs has been shut down by drug regulators and the head of the plant and another official have been detained by the Shanghai police in connection with their criminal investigation of the problem. Shanghai Hualian is the sole supplier to the U.S. of mifepristone, the abortion pill known as RU-486, although that drug was made at a different factory. The U.S. FDA has indicated that there is no link between the two drug producing facilities. These problems have arisen in the wake of continuing concerns about the safety of Chinese-manufactured products.