Letter, Opinion Piece Address Supreme Court Case Regarding Drug Safety, Federal Pre-Emption

Main Category: Pharma Industry / Biotech Industry
Also Included In: Litigation / Medical Malpractice;  Public Health
Article Date: 06 Nov 2008 - 10:00 PDT

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The U.S. Supreme Court on Monday heard opening arguments in Wyeth v. Levine, a case that could determine whether patients have the ability to file product liability lawsuits against pharmaceutical companies in state courts (Kaiser Daily Health Policy Report, 11/4). Summaries of a letter to the editor and an opinion piece about the case appear below.

Letter to the Editor
Attorney David Ferrera in a Boston Globe opinion piece published on Friday "purports to dispel myths surrounding Wyeth v. Levine," but what he "really does is perpetuate them," Nan Aron, president of the Alliance for Justice, writes in a Globe letter to the editor. According to Aron, the "ability to hold drug manufacturers accountable and demand the safest possible products is in jeopardy," adding, "There is no effective federal system in place to force companies to recall a product if dangers emerge after it goes to market." He continues, "Without legal liability, there is little incentive for companies to remove a drug from the marketplace." Aron writes, "While Ferrera would have us believe that [FDA] is more than capable of ensuring the safety of products, history has proved otherwise." If the Supreme Court rules in favor of Wyeth, "the civil justice system will no longer be able to serve as a critical layer of consumer protection," he writes (Aron, Boston Globe, 11/5).

Opinion Piece
"If the judgment against Wyeth stands, it will open the floodgates for lawsuits challenging the authority of the FDA to evaluate drugs and their labels" and the "impact will be devastating," Lawrence McQuillan, director of business and economic studies at the Pacific Research Institute for Public Policy and co-author of the 2008 U.S. Tort Liability Index, writes in a Washington Times opinion piece. "If the FDA is found not to have the last word in drug approval, we will see a chaotic patchwork of state- and jury-written warning labels," McQuillan writes, adding, "Faced with 50 different state standards and an avalanche of state lawsuits, drug manufacturers will simply stay away from developing new, lifesaving drugs because they deem them too costly and risky to pursue," or "they might pull existing drugs off the market."

He writes, "In an attempt to head off costly litigation, warning labels will expand, attempting to cover every imaginable use or misuse of a given drug," which could "lead to the phenomenon known as 'overwarning,' where vital and relevant warnings are buried in a sea of outlandish and unnecessary warnings, diminishing the impact of the real safety information, or scaring patients from using drugs they need and costing lives." The "goal of tort law is to deter wrongdoers efficiently and compensate unjustly injured victims," McQuillan writes. He continues, "When implemented fairly, the system works" and "[w]hen corrupted, the system produces frivolous lawsuits and mind-boggling monetary awards that have a chilling effect on the economy and damage our quality of life." If the Supreme Court "allows a jury to supplant FDA scientists, we will be taking a major step backwards in the struggle for common-sense tort reform and better health care," he writes (McQuillan, Washington Times, 11/5).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation.  All rights reserved.

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