Merck's Vioxx recall is taught as a model. The record says otherwise.
The FDA warned Merck about Vioxx in September 2001. Merck added a label warning and kept selling until September 30, 2004. Documented legal costs passed $6.6 billion.
Transcript
Merck's Vioxx recall is taught as a model of corporate responsibility. The paper trail tells a different story.
In September 2001, three years before the withdrawal, the FDA sent Merck a warning letter. Its promotion discounted a finding from the VIGOR study: patients on Vioxx had a four- to five-fold increase in heart attacks compared with naproxen.
The FDA called Merck's claims of a favorable cardiovascular safety profile simply incomprehensible.
Merck could pull the drug, or add a warning to the label and keep selling. It did not pull the drug. The label changed on April 11, 2002, and Merck kept selling.
Merck withdrew Vioxx worldwide on September 30, 2004, when a fresh trial made the danger impossible to sell around. More than 80 million people had taken it. Then came $4.85 billion for U.S. claims in 2007, with no admission of fault, $950 million to the Justice Department in 2011, and $830 million to investors in 2016.
Merck's documented Vioxx legal costs passed $6.6 billion. One case cannot show what an early withdrawal would have cost. But it shows that the decision that defines a crisis is often made years before the headline.
The records behind this video
Every figure in the video comes from this Decision Record, each with its sources.
Run this decision
The Crisis Response Strategy Pack. “What is one more quarter of not acting worth?” The framework, a model, a deck and the sourced cases, for running the same call on your own business. See the pack, $499 → Or start with the free guide to this decision →
