In re Rofecoxib (Vioxx) Products Liability Litigation Lawsuit

In re Rofecoxib (Vioxx) Products Liability Litigation

Rofecoxib was a selective COX-2 inhibitor, a type of nonsteroidal anti-inflammatory drug (NSAID) engineered to suppress the COX-2 enzyme involved in pain and inflammation while largely sparing the COX-1 pathway, which helps protect the stomach lining. Merck & Co. developed and sold the drug. It received FDA approval in May 1999 and was marketed in the United States under the brand name Vioxx (and, in some markets, as Ceoxx or Ceeoxx), in tablet and oral-suspension forms. Approved for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain, migraine, and dysmenorrhea, it became one of the most widely prescribed pain relievers of its era.

The cardiovascular concern

The dispute at the center of the litigation was whether Vioxx raised the risk of heart attack and stroke, and what Merck knew, and when. The VIGOR study, which compared rofecoxib with naproxen in arthritis patients, reported a markedly higher rate of heart attacks among rofecoxib users. FDA sent Merck's chief executive a warning letter in 2001 concerning promotional materials that downplayed those findings, and the product labeling was revised in 2002 to add cardiovascular warnings. The decisive evidence came from APPROVe, a long-term trial that examined whether rofecoxib could reduce the recurrence of colorectal polyps. It was halted early after interim results showed that patients taking rofecoxib faced roughly a doubled risk of heart attack or stroke after about 18 months of use. On the strength of those results, Merck withdrew Vioxx from the market worldwide in September 2004.

The mass tort

Following the withdrawal, tens of thousands of product-liability suits were filed in state and federal courts across the country. The federal cases were centralized as In re Rofecoxib (Vioxx) Products Liability Litigation, MDL No. 2:05-md-1657, in the United States District Court for the Eastern District of Louisiana (New Orleans), before Judge Eldon E. Fallon. The consolidated docket grew into one of the largest pharmaceutical mass torts in U.S. history. Plaintiffs generally alleged that Vioxx caused a heart attack, stroke, or death, and that Merck failed to adequately warn prescribers and patients of the cardiovascular risks.

The litigation was resolved without class certification or a trial on the consolidated claims. In late 2007, Merck and the plaintiffs' bar reached a global settlement covering the consolidated cases on an individual-case basis, with no admission of liability. After the deal was approved, the court intervened to resolve a dispute among plaintiffs' counsel over the allocation of attorneys' fees (per the Reuters blog post covering the Vioxx docket).

Parallel regulatory and enforcement proceedings

Several non-judicial tracks ran alongside the MDL. The Senate Finance Committee questioned Merck executives about the company's communications with FDA concerning Vioxx's risks (per the committee's October 2004 statements). A 2005 FDA advisory committee, after weighing the data, voted in favor of allowing the drug back on the market for some patients, though Merck never did (per the FDA committee briefing and minutes). Merck also commissioned an internal review of its handling of the safety data — the "Martin Report" — which concluded that senior management had acted in good faith. Separately, per a Reuters report, in November 2011 Merck resolved civil claims with the U.S. Attorney's Office and with a large number of states and the District of Columbia, and in a distinct criminal proceeding it pleaded guilty to a federal misdemeanor relating to the interstate marketing of the drug.

Aftermath

The MDL is terminated, and this entry is an archived record of the litigation. The scientific discussion continued afterward: FDA later concluded, in memoranda, that the cardiovascular risk associated with NSAIDs — both COX-2 selective and nonselective — depends on dose and duration. The molecule also did not entirely disappear: in 2017, Tremeau Pharmaceuticals announced a plan to develop rofecoxib for hemophilic arthropathy, a degenerative joint disease affecting people with hemophilia, for which FDA granted orphan-drug designation.