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Merck Agrees To Settle Multistate Vioxx Lawsuit
Nevada Shares Over $1.2 Million
Merck has agreed to a $58 million settlement with 29 states and the District of Columbia to end investigations over allegations that it downplayed cardiovascular risks caused by the COX-2 inhibitor Vioxx in direct-to-consumer (DTC) advertisements dating back to 1999.
Merck withdrew the painkiller from the market in 2004 after research found it doubled the risk of heart attack and stroke.
“This is the largest money settlement a consumer protection multi-state group has ever received in a pharmaceutical case,” said Nevada General Catherine Cortez Masto. “In addition, the comprehensive injunctive relief addresses all concerns identified over the last three years of investigation.”
Nevada's share of the $58 million payment to the participating states totals $1,252,469. The judgment filed in Clark County District Court will also largely restrict Merck's ability to deceptively promote any Merck product.
The judgment requires Merck to submit all DTC television drug advertisements to the Food and Drug Administration (FDA), wait for approval, and comply with FDA comments before running the advertisement. Merck must also comply with any recommendation by the FDA to delay DTC advertising for new Merck pain-relieving drugs. The states' Attorneys General expressed concerns regarding the negative effect of DTC advertising that commences immediately with the release of a new drug, before doctors have a chance to gain experience with the drug, and understand its potential side effects.
“Because of Merck's aggressive promotion of Vioxx to consumers, hundreds of thousands of consumers sought out Vioxx prescriptions before all the risks of taking the drug were known,” Masto said. “Today's action gives the FDA discretion and authority to assess all new Merck pain drugs, and require Merck to submit television ads to the FDA for suggested revisions, and acceptance of the final product before running the ads.”
Medical Ghostwriting
In the settlement, Merck also agreed to end its practice of so-called "medical ghostwriting." The American Medical Association in April published a report that alleged Merck employees or paid consultants -- rather than the physicians listed as lead authors -- wrote several published studies on Vioxx. The report found 16 of 20 early studies of Vioxx listed the lead author as an academic researcher, although internal documents listed a Merck employee as the author of the first draft.
Other Concerns Addressed:
- Deceptive use of scientific data when marketing to doctors;
- Failing to adequately disclose the conflict of interest of Merck promotional speakers when these speakers present in supposedly “independent” Continuing Medical Education;
- Conflicts of interest in Data Safety Monitoring Boards sponsored by Merck
State appeals courts in New Jersey and Texas have reversed two jury verdicts and a judgment on payment of legal fees in lawsuits related to Vioxx that would have required Merck pay about $37 million.
In the New Jersey lawsuit, the state Superior Court Appellate Division reversed part of a 2006 jury verdict that would have awarded $9 million in punitive damages to plaintiff John McDarby, who experienced a heart attack after he took Vioxx for four years reports the Associated Press. The court ruled that the plaintiffs did not prove that Merck violated state consumer fraud laws. The court also reversed a judgment that awarded $2.27 million in legal fees to attorneys for McDarby and a second plaintiff, Thomas Cona, who experienced a heart attack after he took Vioxx for 22 months. However, the court upheld part of the jury verdict that awarded $4.5 million in compensatory damages to the estate of McDarby, who died last year.
In the Texas lawsuit, the state 14th Court of Appeals reversed a 2005 jury verdict that would have required Merck to pay $26.1 million in damages to plaintiff Carol Ernst, whose husband Robert died of arrhythmia after he took Vioxx for eight months. A lower court previously reduced the jury verdict from $253 million to $26.1 million because of a state cap on damages. The appeals court ruled that the plaintiffs had not provided adequate evidence to prove that Vioxx caused the blood clot that led to the death of Ernst.