The Cost to Society of Pharmaceutical Mass Tort Litigation

Abstract

This lecture for the Foundation for Law, Justice and Society, at Wolfson College, University of Oxford, addresses the cost to society of pharmaceutical mass tort litigation, nearly 15 years after the withdrawal by Merck & Co., Inc. of Vioxx® (rofecoxib) from markets worldwide. When Merck withdrew Vioxx based on an increased relative risk of thrombotic cardiovascular events seen in the APPROVe study in “the interests of patients” and “as the responsible course to take,” the company’s stock dropped nearly 27%; it took a charge of more than USD 726 million to effect the withdrawal; physicians prescribed alternative pain relievers in the non-steroidal anti-inflammatory drug (NSAID) class such as celecoxib, diclofenac, ibuprofen, and naproxen that did not have rofecoxib’s gastrointestinal safety data; governments investigated the company; and lawyers launched more than 50,000 claims and class actions in the US and many jurisdictions across six continents. Although Merck won most of the cases heard in the United States and prevailed in jurisdictions around the world, the company spent more than USD 2 billion on its own legal defense and nearly USD 7 billion more for the resolution of Vioxx litigation and investigations through the end of 2016. When the interim results of APPROVe were received, “no other non-aspirin NSAIDs or selective COX-2 inhibitors had been studied in this large a patient group for this duration,” and no one knew whether a similar increased relative risk would be seen with other NSAIDs, such as diclofenac and ibuprofen. It now appears that all of the non-aspirin NSAIDs, with the possible exception of naproxen, have a similar cardiovascular safety profile to Vioxx. Merck spent approximately USD 10 billion in connection with withdrawing Vioxx and defending and resolving litigation and investigations. Those funds were not available to fund the discovery and development of up to four or more new breakthrough medications.