Jury Awards Widow $253.4M in Vioxx Trial

This is the first case to reach a decision. There are 4,200 more court cases facing Merck. Analysts have speculated Merck's liability could reach $18 billion. Merck pulled Vioxx, a $2.5 billion seller, from the market in September 2004 when a long-term study showed it could double risk of heart attack or stroke if taken for 18 months or longer.

Although this case is not directly a GMP issue, it points out the impact trouble can have on a company.

Training Tip

During your GMP training sessions, have small groups of people discuss the impact news like this can have on a company. Answers will include things like:

• Stock price drops (causing stockholders to get cranky and put pressure on management to improve performance).
• Reputation of the company is affected, possibly resulting in decreased sales.
• The actual cost associated with the withdrawal of Vioxx.
• Lost revenue – Vioxx was a $2.5 billion seller for Merck.
• The costs associated with legal defense. (Most manufacturing people will quickly point out that lawyers tend to earn more than production operators.)
• Budget tightening at the company.
• More FDA scrutiny.
• Questioning of company officials by Congress.
• Morale could decrease within the company.

These same consequences that Merck is facing could come about by inattention to GMP. The shortage of flu vaccine last fall was a result of contaminated batches. This was certainly a GMP issue.

Click on http://www.gmptrainingsystems.com/ and go to Articles. You can download a News Article about Vioxx and Merck you can use in your training.

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We design and conduct GMP and related Training Programs for the Pharmaceutical and Medical Device industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.