Analysis of the Bextra Whistleblower Case

Analysis of the Bextra Whistleblower Case

Penny August, Marilyn Ballester, Jeannie Tillery, Larry Williams, Elisa Young

LAW/531

April 9, 2012

Donna Ross

Abstract

Analysis of the Bextra Whistleblower Case

The article that will be analyzed is the "Bextra Whistleblower Case Started Investigation of Pfizer." The purpose of this paper is to determine how this article relates to regulatory agencies. The following paragraphs will discuss whistleblower laws and strict liability.

The Bextra case illustrates a whistleblower ("qui tam") lawsuit that occurred in Florida in 2003. This lawsuit was initiated by John Kopchinski, a pharmaceutical sales representative for Pfizer. Bextra was approved by the Federal Drug Administration (FDA) in 2001, however it was removed from the market in 2005. The reason the medication was removed from the market is that "Pfizer promoted Bextra for uses and in doses that far exceeded what the FDA had approved. This put patients at risk for serious health problems such as heart attack, stroke, and pulmonary embolism (blood clot in the lung)" (Bextra Whistleblower Case Started Investigation of Pfizer, 2009).

Kopchinski received a monetary reward for the work that his law firm did on this case because it was filed under the False Claim Act (FCA). He will also receive another monetary reward because he filed this as a qui tam claim. This means that he will receive a portion of the money that is recovered from the defendants.

Strict liability is applied to a product. In this case, the product is Bextra. "Strict liability wrongs do not depend on the degree of carefulness by the defendant. Simply stated, a defendant is liable when it is shown that the product is somehow defective and unreasonably dangerous. It is irrelevant whether the manufacturer or supplier exercised great care. If there is a defect in the product that causes harm, the manufacturer or seller of the product will be liable for it" (FreeAdvice Staff, n.d.).

There are several regulatory agencies that were involved with this case. The United States Department of Justice is the federal agency that fined Pfizer. This agency is also responsible for enforcing the False Claims Act. The United States Food and Drug Administration was also involved in this case because it was the agency that approved Bextra.

The other agency that was involved was the National Association of Medicaid Fraud Control Units. This team is "a single identifiable entity of state government, annually certified by the