Lessons from Pharmaceutical Product Litigation: Merck and the Vioxx Withdrawal, Cona & McDarby vs. Merck

In 2004, pharmaceutical powerhouse Merck acknowledged potentially harmful side effects and withdrew one of its best selling drugs, Vioxx, an arthritis and pain relief drug, from the market. Withdrawing an FDA approved drug from the U.S. market due to newly-discovered side effects was not so uncommon. What was unusual, however, was that Merck’s withdrawal was a voluntary decision by the company after Vioxx had been taken by an estimated 80 million patients during four plus years on the market. While Merck’s decision was initially hailed as an example of Merck’s well known dedication to ethical business practices, some in the medical community instead accused Merck of intentionally keeping Vioxx on the market even though it was too dangerous. Critics claimed that Merck had put profits ahead of patients and Merck soon faced close to 30,000 product liability lawsuits.

This case package consists of a written case, supporting written materials, and an accompanying case video which takes place in the courtroom of a trial against Merck. Tom Cona and John McDarby sued Merck after experiencing heart attacks that they attributed to Vioxx. Using trial footage supplied by Courtroom View Network, this case explores the kinds of wrongful conduct alleged and how companies like Merck defend themselves against such claims. The witnesses testifying in this trial include the patients and their families who are suing, Merck’s CEO and senior management, the physicians who prescribed the drug, and those who were called to give expert testimony in support of and against Merck’s drug development, regulatory, and marketing activities.

This material is designed to be used in a one-day seminar or equivalent, with students having read the written case study and watched Disk 1 prior to class. This case is particularly well suited for business, medical, and law students. The written materials and video are sold as a package and are designed to be used together. Academic faculty may request a teaching note. Please contact cases_requests@gsb.stanford.edu for permissions to use the written case each time it is taught.

This package contains the following:

Disk 1: Introduction to the trial & Opening statements (TRT 53:26 min.)

Disk 2: Testimony in Plaintiffs’ Case (TRT 91:36 min.; Plaintiffs’ Witnesses 57:01, Plaintiffs 13:40, Plaintiffs’ Experts 20:55)

Disk 3: Testimony in Merck’s Defense (TRT 111:13 min.; Merck’s Witnesses 66:58, Merck’s Experts 44:15)

Disk 4: Closing Statements, Judge Instructions, Verdicts (TRT 46:47 min.; Closing Statements 42:07, Judge Instructions & Verdicts 4:40)

Disk 5: Review copy of case study, supplementary materials (Studies in Evidence and FDA Warning Letter) and slides from video presentation