Health Care Lawyers & Attorneys : Schottenstein Zox & Dunn Law Firm : Strategic Planning, Managed Care, Insurance : Columbus, Cleveland, Cincinnati, Central Ohio

A Philadelphia Common Pleas judge has ruled that the Vaccine Act, a federal law that governs the liability of pharmaceutical companies for drug vaccines, pre-empts state law tort claims that a vaccine design was defective or that there was a failure to warn the patient of risks associated with the vaccine.

In Wright v. Aventis Pasteur, Jared Wright, an eleven year-old boy with autism, was administered vaccines during his infancy that contained "thimerosal," a mercury-based preservative that Wright's parents contend was the cause of Wright's autism. 

Wright argued that Aventis Pasteur Inc., Merck & Co. Inc., and Wyeth were negligent because they failed to warn the medical community about the potential hazards of mercury in the vaccines, and also argued that the defendants failed to use ordinary cases in designing the vaccines because of the risks toxic mercury poses to infants and children.

Judge Arnold L. New, however, ruled that the Vaccine Act pre-empts Wright's state law tort claims. Specifically, Judge New discussed Congress' intent to avoid instability in the vaccine market that would result from state-law tort liability for vaccine injuries. Judge New also cited Congress's actions in creating the National Vaccine Injury Compensation Program as evidence that Congress intended the Vaccine Act to pre-empt state law tort claims.

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The FDA, as part of its Sentinel Initiative to better monitor FDA approved medical products, has announced its intention to create a national database of orthopedic implant registries. This database would track and monitor the progress of various orthopedic implants in an attempt to detect early troubles with the implants. The FDA proposes to create its database through the use of, and by querying, government databases, private and public medical claims databases, and electronic health record systems.

The following article provides a good summary of the FDA's proposed registry:

www.govhealthit.com/online/news/350502-1.html

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The FDA recently announced that it will begin posting a list of approved drugs that it is investigating due to safety concerns. The list will be available on the FDA's website, and the FDA will update it on a quarterly basis. 

The FDA receives, through its Adverse Event Reporting System, thousands of complaints each year about FDA approved drugs. The list that the FDA will post, however, will feature only those drugs that the FDA has chosen to investigate from the numerous complaints submitted.

While the FDA acknowledges that the list may create a type of false panic among consumers, the list may also serve to protect and inform conscientious consumers who are experiencing health complications from drugs that are on the FDA's quarterly list.

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This fall the United States Supreme Court will hear Wyeth v. Levine - a case that may close the loop on whether pharmaceutical manufacturers are immune from state law tort claims. The case is highly anticipated in the life sciences industry as it comes on the heels of two recent U.S. Supreme Court decisions regarding state law tort immunity for manufacturers in the industry.

In February, the Supreme Court heard Riegel v. Medtronic, Inc.  and determined that federal law preempts state law tort claims against medical device manufacturers. Just a few weeks after its decision in Medtronic, the U.S. Supreme Court heard Warner-Lambert, Co. v. Kent and, in a 4-4 deadlock, did not extend preemption immunity to pharmaceutical companies.

Based upon existing law in the medical device arena, the Court’s decision in Medtronic was not terribly unpredictable. The question of state law tort immunity for pharmaceutical companies, however, is a much more difficult issue as existing law in this arena is more ambiguous.
The life sciences industry will surely watch the Supreme Court this fall in anticipation of the Wyeth decision. 

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