Products Liability Prof Blog

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.
MKS

Oregon Supreme Court Reaffirms $79.5 Punitive Damages Award in Williams

In an opinion issued today the Oregon Supreme Court reaffirmed a $79.5 million punitive damages award in  Williams v. Philip Morris Inc., following remand by the Supreme Court in Philip Morris USA v. Williams, 127 S.Ct. 1057 (2007).  This is what the Supreme Court of the United States said in its remand order:

As the preceding discussion makes clear, we believe that the Oregon Supreme Court applied the wrong constitutional standard when considering Philip Morris' appeal. We remand this case so that the Oregon Supreme Court can apply the standard we have set forth. Because the application of this standard may lead to the need for a new trial, or a change in the level of the punitive damages award, we shall not consider whether the award is constitutionally “grossly excessive.” We vacate the Oregon Supreme Court's judgment and remand the case for further proceedings not inconsistent with this opinion.

This is what the Oregon Supreme Court said in its opinion:

On remand, we are called upon to reconsider and reassess our earlier holding, which arose in the context of the trial court's refusal to give a particular proposed jury instruction that defendant had requested. Having reconsidered and reassessed the issue, we now conclude that the proposed jury instruction at issue here also was flawed for other reasons that we did not identify in our former opinion. We therefore reaffirm this court's prior conclusion that the trial court did not err in refusing to give the instruction. We otherwise reaffirm our prior opinion in all respects.

MKS

Gail Charnley's Qualifications for the Consumer Product Safety Commission

Dr. Gail Charnley is being considered as a potential replacement for Consumer Product Safety Commission chairman Nancy A. Nord, as noted in an earlier post.  A short post doesn't give a full sense  of qualifications.  A full cv is attached if you're interested in a more detailed look at her background and qualifications.

MKS

Preemption of Prescription Drug Failure to Warn Claim Adds Emphasis to Supreme Court Term

A federal trial court in Okalahoma has concluded that a the claim of a widow, whose husband committed suicide while taking an anti-depressant medication, is preempted by federal law, Dobbs v. Wyeth Pharmaceuticals, 2008 WL 169021 (W.D. Okla.).  Annabel Dobbs alleges that the drug maker Wyeth failed to warn adequately about the increased risk of suicide in patients like her husband taking its drug Effexor.  The court ruled, however, that the Food & Drug Administration (FDA) had considered and rejected a warning about suicidality at the time Dobbs' husband used the drug.  The court, citing the FDA's rule governing prescription drug labelling and its preamble in which the agency says that its rules are preemptive on the question of drug labelling content, said that the agency's position on preemption was entitled to considerable deference.

On the day following this decision, the U.S. Supreme Court agreed to hear Wyeth v. Levine, 2006 WL 3041078 (Vt. 2006, cert. granted 1/18/08, U.S. No. 06-1249), in which the Vermont Supreme Court ruled that federal law did not preempt a claim that a drug manufacturer should have warned about a particular method of administering a prescription drug for which the FDA had approved the label without such warning.

JDP

New York Court to Decide Defendant's Burden of Proof for Summary Judgment on "Defect" Question

The New York Court of Appeals will hear arguments in February in Ramos v. Howard Industries, Inc., to consider a manufacturer's burden of proof to establish in a motion for summary judgment that its product was not flawed or defectively designed in a case where the allegedly defective product was not available for examination.  The plaintiff in the case, a lineman for Niagara Mohawk Power Corp., allegedly sustained injuries when a transformer the defendant designed and manufactured exploded.  The plaintiff initially claimed that his injuries occurred when he reached out of an aerial bucket while installing the transformer on a utility pole, but later alleged that his injuries were the result of a transformer explosion.  The transformer could not be located for inspecting or testing to determine the cause of its failure.  The supreme court denied the defendant's motion for summary judgment and the appellate division affirmed.  831 N.Y.S.2d 615 (App. Div. 2007). In affirming the court noted that the defendant had "the burden of establishing as a matter of law that there was no defect in the design or manufacture  of the transformer," and that the defendant cannot meet that burden simply by pointing to gaps in the plaintiff's proof.  The defendant submitted evidence establishing that its transformers were designed according to Niagara Mohawk's specifications and under state of the art conditions, and that the transformer in question would have been individually tested to determine if it complied with customer specifications and industry standards.  The court concluded that the evidence did "not establish as a matter of law that the transformer was not defective and that a manufacturing defect therefore did not cause the explosion."  Judge Peradotto dissented, concluding that the defendant's evidence was sufficient to support its motion.  In his view, "a defendant in a manufacturing defect case in which the product is unavailable for inspection and testing must establish as a matter of law that it may be inferred from the evidence that the product was not defective when it left the defendant's control and that there are other possible causes of the accident not attributable to the defendant."  He thought the standard was met, given the defendant's evidence of quality control and of other potential causes, including rewiring of the transformer after it left the defendant's hands, and the possibility that the transformer had been rebuilt.  That evidence, coupled with a lack of rebuttal evidence by the plaintiff, justified granting the motion, according to Judge Peradotto.

MKS

White House Considering Consumer Product Safety Commission Candidates

Annys Shin reported in the Washington Post Saturday that the White House is considering Gail Charnley to replace Nancy A. Nord as chairman of the Consumer Product Safety Commission.  Charnley, who has a doctorate in toxicology from MIT, has a consulting firm, HealthRisk Strategies.  She has been been a member of several high-level government advisory panels and was the director of an NAS toxicology program in the mid-1990s. 

MKS