February 19, 2009
Florida Jury Awards $8,000,000 against Philip Morris USA
A Miami Herald article today by Patrick Danner notes that a Florida jury in the Hess case, part of a long-running series of product liability claims in that state against cigarette manufacturers, and noted on February 13 on this blog, awarded $8,000,000 to the widow and son of Stuart Hess, who died of lung cancer as a result of his smoking addition. The jury reached its verdict after about nine hours of deliberations over a two day period. The award includes $5,000,000 in punitive damages. Philip Morris USA will appeal.
February 18, 2009
Wisconsin Supreme Court Rules Product Liability Claim Against Device Manufacturer Preempted
The Wisconsin Supreme Court ruled yesterday that state law tort claims against the manufacturer of an FDA-approved medical device are preempted. In Blunt v. Medtronic, 2009 WL 367768 (Wis., 2-17-09), the Wisconsin court concluded that the U.S. Supreme Court's ruling last year in Riegel v. Medtronic, 128 S.Ct. 999 (2008) governed in this case as well. Joseph Blunt had a Medtronic pacemaker implanted in 2004 to keep his heart from failing. Based on its own laboratory testing, Medtronic warned the following year that the devices' batteries might fail in one out of 10,000 patients. Blunt then chose to have the device removed. Medtronic became aware of the problem two years before it issued the warning. The manufacturer submitted to the FDA a supplemental application reflecting design changes aimed at eliminating the battery problem. The FDA approved these changes but did not order the device with its original design recalled nor did it withdraw its 2002 approval of the original design. During all of this time, Medtronic continued to market and sell the device with its original design.
Riegel says that a device-specific pre-market approval of a Class III device by the Food & Drug Administration constitutes a federal requirement that preempts any different or additional state law requirements. The Wisconsin court concluded that the specific device implanted in Mr. Blunt, manufactured according to its original design, had been determined to be safe and effective after a rigourous pre-market review by the FDA. It is in precisely that situation that the federal agency's approval preempts state law, including common law, claims.
Two Justices concurred but criticized both Riegel and the FDA's process for assuring the safety of medical devices.
February 13, 2009
Florida Jury: Smoker Was Addicted
In the latest chapter in the long-running Engle tobacco litigation saga that began in 1994, a Florida jury has found that Stuart Hess, a 40-year chain smoker who died in 1997, was helplessly addicted to nicotine as a result of deceptive practices by Philip Morris that hid the dangers of smoking, including the danger of addiction. In Engle v. R.J. Reynolds Tobacco Co., a Miami jury found way back in 1999 that smoking caused 20 diseases and that five cigarette manufacturers, individually and in conspiracy with each other and two trade groups that they had established, committed a variety of torts including fraud and fraudulent concealment. This finding followed the trial court's class certification on behalf of all Florida smokers and their families. A $145 billion punitive damages award followed in 2000. In July 2006, the Florida Supreme Court ordered that the punitive damages award be vacated and the class de-certified but that members of the de-certified class members could file individual claims within one year of the de-certification. The court also ruled that several important findings from the first phase of litigation were entitled to "res judicata" effect, including the addiction, smoking-causes-cancer, and fraudulent concealment findings.
Hess's suit is the first of about 8000 pending cases to go to trial since those 2006 developments. The case was delayed once due to flooding last year at the Broward County courthouse and then again last December when a mistrial was declared after a witness used a racial epithet. But the trial finally got underway on February 4th, the addiction determination is now complete, and the fault and compensatory damages phase, in which Hess's lawyers will presumably ask for millions of dollars, has begun. A third, punitive damages, phase of the trial could follow.
February 5, 2009
CPSIA Activity for this week - it went from bad to worse
This was an active week regarding CPSIA implementation (or non-implementation). Last Friday, as my last blog summarized, the CPSC approved a stay of certain testing and certification requirements. Then on Tuesday, they issued a ballot for another stay, this time for the effective date of limits on lead content in accessible parts and components in children’s products. This was the stay requested by NAM in their January 28th letter to the CPSC (NAM-1-28-09.pdf). The CPSC didn't even bother to draft a stay, they just attached the letter.
Today, a federal judge in overturned a CPSC advisory opinion. On November 17, 2008, the CPSC issued an advisory opinion letter stating that products violative of Sections 108(a) and 108(b)(1) [phthalate ban] may continue to be sold and distributed in commerce after February 10, 2009, as long as these products were manufactured prior to February 10, 2009. This interpretation was challenged in a lawsuit by the Naturall Resources Defense Council and Public Citizen. (nrdc_complaint)
The judge issued a ruling today setting aside the advisory opinion. (phthalate_order) The judge said that the phthalate prohibitions unambiguously apply to existing inventory. Therefore, if this decision stands, affected products that violate the phthalate requirements cannot be sold or distributed after February 10, 2009. California already has banned products with phthalates and their ban was effective January 1, 2009. (CA_phthalate_letter)
In addition, Congresssmen Waxman and Rush and Senators Rockefeller and Pryor sent a letter to President Obama demanding that he ask CPSC Acting Commissioner Nancy Nord to step down. (waxman_to_obama)
And, Senator DeMint has drafted a bill to take care of all of the problems. (DeMintBill)
Stay tuned. Who knows what will happen next.
February 3, 2009
Criminalizing Products Liability
Professor Frank J. Vandall of Emory University School of Law has published an article entitled "The Criminalization of Products Liability: An Invitation to Political Abuse, Preemption, and Non-Enforcement," in 59 Cath. U.L. Rev. 341 (2008). The SSRN abstract reads as follows:
Senator Arlen Specter called a hearing in March 2006, on a proposal that urges the criminalization of products liability for the manufacture of intentionally lethal goods. The hearing before the Senate Judiciary Committee provided an opportunity to comment on the numerous issues raised in the far-reaching proposal. Responding to these issues requires revisiting the foundational question of whether the manufacture and sale of a defective product should be addressed by civil litigation or criminal prosecution. Understanding the issues will assist state legislatures and federal agencies in considering such a proposal. To plumb the issues raised by Senator Specter history, economics, and the system of product design and manufacture must be examined. Because Senator Specter argues for a federal act and federal enforcement, his proposal demands consideration of the concepts of preemption, political abuse, and nonenforcement. Fundamental concepts of cause-in-fact and proximate cause must also be considered. After examining these concepts, it should be clear that the criminalization of products liability is neither necessary, nor desirable.
Vandall, Frank J.,The Criminalization of Products Liability: An Invitation to Political Abuse, Preemption, and Non-Enforcement(January, 14 2009). Catholic University Law Review, Vol. 57, No. 1, 2008. Available at SSRN: http://ssrn.com/abstract=1327761