Products Liability Prof Blog

Arkansas Supreme Court Reverses No Preemption Finding in Light of Riegel

In a February ruling, the Arkansas Supreme Court reversed a circuit court's grant of summary judgment in favor of a hearing device manufacturer holding that a design defect claim regarding the allegedly defective product, approved for marketing by the Food & Drug Administration, was not preempted by the Medical Device Amendments (MDA) under which such regulatory approvals are granted.  Less than two weeks later, the U.S. Supreme Court decided exactly the opposite in Riegel v. Medtronic, Inc., (169 L.Ed. 2d 892 (2008). When the defendant-manufacturer petitioined for reconsideration in light of Riegel, the Arkansas court reversed its earlier ruling in Despain v. Bradburn, (2008 Ark. LEXIS 233) and held that the state-law-based design defect claim was preempted.  A concurrence bemoaned the conclusion in Riegel that state common law claims are preempted by the MDA and expressed "dismay at the summary abandonment of venerable principles of state common law that have been developed over many generations."

JDP

U.S. Food & Drug Safety Officials Plan Office in China

The U.S. Food & Drug Administration is planning to open an office in China as early as May 2008 once final approval is given by the Chinese government.  The initiative is in response to the massive amount of Chinese goods imported into the U.S. and the impossibility of inspecting all such products for safety.  The goal is to improve product quality and safety at the point of origin.  Discussions of similar arrangements are underway with India and Mexico, also large importers of drugs or drug ingrediants.  See Gillian Wong's story for the Associated Press.

JDP

Restatement 3d, Products Liability - 10th Anniversary Symposium

The Brooklyn Law School is sponsoring a symposium on November 13 - 14, 2008, occasioned by the tenth anniversary of the Restatement (Third) of Torts - Products Liability.  The title of the symposium is "The Products Liability Restatement:  Was it a Success?"  A list of the distinguished speakers may be found on the law school's website at:  http://www.brooklaw.edu/news/Scheduled_Participants_Restatement.pdf.

JDP

New York Appellate Court Overturns Negligent-Design Verdict Against Tobacco Companies

A New York appellate court overturned a jury verdict in favor of a decades-long smoker who claimed that the tobacco company defendants negligently designed their products by continuing to produce cigarettes with higher levels of tar and nicotine than so-called "light" cigarettes.  A Manhattan jury had handed down a $3.4 million compensatory award to be evenly split between Philip Morris and Brown & Williamson, and a $7.1 million punitive award against Philip Morris.  The appellate court noted that New York law requires a plaintiff in a negligent design case to prove that the product created a substantial likelihood of harm and that it was feasible to design the product in a safer manner.  The majority held that, though it was technically feasible to manufacture "light" cigarettes, the plaintiff had failed to prove that regular cigarettes retained their "inherent usefulness" to consumers.  Unless the plaintiffs proved such "consumer acceptability" of light cigarettes with their different tastes and psychological effects due to lower tar and nicotine levels, they could not show that the alternative design was "feasible" and thus failed to make out a prima facie case of negligent design. See Noeleen Walder's story for the New York Law Journal.

JDP

FDA Drug Regulation Preempts Failure-to-Warn Claim

The U.S. Court of Appeals for the Third Circuit ruled that the Food & Drug Administration's long history of regulating anti-depressants and its explicit rejection of a suicidality warning for the drugs Paxil and Zoloft preempts state-law based failure-to-warn claims.  The divided and narrowly-tailored opinion is limited to circumstances in which the FDA has actively monitored the drug's risk and publicly rejected the need for the warning that plaintiffs argue state law requires.  The court did not decide whether preemption would be appropriate in other circumstances such as where the FDA had not rejected the substance of the warning sought or where the FDA had only stated its legal postition after the litigation had begun.  See Shannon Duffy's article for The Legal Intelligencer.

JDP