July 13, 2007
Seventh Circuit Upholds Exclusion of Expert Evidence in Remicade Case
In Ervin v. J ohnson & Johnson, Inc. , 2007 WL 1966796 (7th Cir. July 9, 2007), the Seventh Circuit affirmed the trial court's grant of Johnson & Johnson's motion in limine to exclude testimony from the plaintiff's expert and motion for summary judgment in a products liability failure to warn case based on allegations that the defendant's prescription drug, Remicade, used in treating the plaintiff for Crohn's disease, caused a blood clot that required the partial amputation of his leg. The plaintiff relied on a single expert, a physician, to establish causation. The expert took the position in his deposition that "to a reasonable medical certainty" Remicade was the major contributing factor to the plaintiff's thrombotic arterial occlusion and a subsequent amputation of his leg below the knee. He used the process of differential diagnosis in "ruling in" Remicade as a possible cause of the plaintiff's arterial thrombosis, relying on various factors, including "the temporal proximity between the drug infusion and the development of the clot and an Internet Google search that revealed one case report of an arterial clot following Remicade infusion," along with "a handful of 'line entries' from FDA printouts" containing basic information that did not include the patient histories, treatment descriptions, and analysis. He acknowledged that those line entries did not account for other potential causes of the patients' problems and he did not rely any other source indicating an association of Remicade with increased risk of thrombosis. That, along with other problems with the support on which the opinion was based, prompted the district court to conclude that the expert had no reliable basis for his opinion under Daubert. The lack of any epidemiological data supporting his opinion and his inability to articulate "any scientifically physiological explanation as to how Remicade would cause arterial thrombosis" did not establish a sufficient causal relationship between the use of Remicade and arterial thrombosis. The mere existence of a temporal relationship between administration of the medication and the onset of symptoms was insufficient to establish a sufficient causal relationship. The court of appeals held that the district court did not abuse its discretion in concluding that the expert's testimony was unreliable. Absent any other evidence on causation, the court of appeals held that the district court properly granted summary judgment to the defendant.
July 12, 2007
Jury Awards $5.5 Million to Victim of Defective Pain Patch
A federal jury in West Palm Beach, FL, awarded $5.5 million to the estate of a man who died of an overdose due to a malfunction of a prescription pain patch manufactured by two subsidiaries of Johnson & Johnson. The transdermal patch called Duragesic is designed to administer a powerful pain killer through the skin over a three-day period. The plaintiff's death resulted from a defectively manufactured patch. The jury also found that the companies had failed to warn adequately about this risk but rejected the plaintiff's design defect claim and a claim of failing to warn about the risks of the patch's interactions with other drugs. See Billy Shields story for Daily Business Review.
Consumer Class Actions Usurping Personal Injury Claims
Plaintiffs' lawyers are filing an increasing number of class actions under state consumer protection laws in conjunction with, or in place of, traditional personal injury class actions. Personal injury class actions are difficult to certify because the facts and circumstances surrounding each individual's injury are typically too dissimilar to allow the claims to be decided on a class-wide basis. However, the consumer protection law class actions typically seek reimbursements not for physical injury but for those who claim that they would not have purchased a product had they known that it created a risk of physical harm. For example, two multidistrict litigation actions pending in California seek reimbursement for purchases of iPod and Motorola Bluetooth headsets, alleging that the products displayed inadequate warnings of the risk of noise-induced hearing loss. No plaintiff in either case has suffered a hearing loss. See Amanda Bronstad's story for The National Law Journal.
July 11, 2007
China Imposes Ultimate Liability for Defective Products
The former head of China's food and drug regulatory agency has been executed for taking bribes from companies to register their products for sale without making them undergo the necessary safety checks. As a consequence, several tainted medicines and other products ended up in the hands of consumers resulting in several deaths. See the BBC News story.
July 6, 2007
Strong World Smoking Standards Set Pursant to WHO Framework Convention on Tobacco Control
As part of the implementation of the world tobacco control treaty, the Framework Convention on Tobacco Control, 146 countries today adopted strong world standards to guide the regulation of smoking. Tobacco Law Center
July 2, 2007
West Virginia Rejects Learned Intermediary Doctrine
In Johnson & Johnson v. Karl, the West VIrginia Supreme Court upheld a trial court's refusal to recognize the learned intermediary doctrine in West Virginia law. Citing the vast sums spent by prescription drug manufacturers on direct-to-consumer adverstising and reports that patients increasingly pressure doctors to prescribe drugs that they have seen advertised, a 3-2 majority of the Court found the learned intermediary doctrine "outdated and unpersuasive," at least in failure to warn cases involving prescription drugs. The Court held that "under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers." The Court also noted the existing duties of physicians toward their patients and observed that, under West Virginia's law of comparative contribution, liability may be allocated between drug manufacturers and prescribing physicians. The dissent called the majority opinion "exceptionally shortsighted" and argued that the majority attached undue importance to advertising and downplayed the role of the physician. See Steve Korris' story in The West Virginia Record.