News Update: Jury Awards Widow of Vioxx User $253 Million in Damages In First Vioxx Trial.
A Texas jury found Merck & Co. liable for the death of a man who took the painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country. The jury awarded $450,000 in economic damages, $24 million for mental anguish and loss of companionship, and $229 million in punitive damages.
Robert Ernst, 59, died of fatal arrhythmia after taking Vioxx. Ernst, ran marathons and taught aerobics classes on the side. The jury rejected Merck's argument that Ernst died of clogged arteries rather than a Vioxx-induced heart attack. The case presented a particular challenge in that unlike many other pending lawsuits involving heart attacks, the Ernst case centered on an autopsy that attributed his death to an arrhythmia secondary to clogged arteries. That coroner's autopsy and testimony proved critical to the trial's outcome.
There are more than 4,200 state and federal Vioxx-related lawsuits pending across the country. Legal experts note that the damage award will likely to be drastically cut because Texas law caps the punitive damages that made up the bulk of the total. Merck said it plans to appeal.
February 2005 Vioxx News: Federal Judges Consolidate Vioxx Lawsuits.
Hundreds of lawsuits filed against Merck, blaming its painkiller Vioxx for deaths and injuries, will be consolidated in a federal court in New Orleans. The Vioxx lawsuits will be transferred to a Louisiana judge experienced in major pharmaceutical litigation for coordinated handling of discovery and other pretrial proceedings.
On February 16, 2005, the Judicial Panel on Multi-District Litigation (MDL) composed of federal judges assigned all pending Vioxx product liability suits against Merck & Co. Inc. to Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana in New Orleans.
In January, the MDL panel of judges met in Fort Myers, Florida and heard arguments from Merck and from plaintiffs' attorneys on possible locations to handle pretrial steps in the massive litigation. Those steps include overseeing depositions of witnesses, document collection and deciding on pretrial motions filed by either side.
Vioxx Judge Fallon has been handling pretrial proceedings since 2000 in thousands of lawsuits involving the former ulcer drug Propulsid, withdrawn from the market by Janssen Pharmaceutica Inc., a subsidiary of Johnson & Johnson. The Vioxx judge is expected to soon issue orders setting dates for meetings with attorneys to schedule the steps in the cases.
January 2005 Vioxx News.
On January 24, 2005, the medical journal The Lancet published on its website a report on Vioxx risks that was previously blocked by the FDA. The study found that Vioxx may have caused as many as 140,000 cases of heart disease in the United States and as many as 56,000 deaths during the five years that it was on the market. The newly published study of 1.4 million patients shows that that low doses of Vioxx increased the risk of heart disease by about 50%, and higher doses increased it by 358%.
The report was sponsored by the FDA and originally scheduled to be published in November 2004 in the Lancet medical journal. However, the FDA scientist who authored the article, David Graham, was ordered by the FDA to withdraw the paper. "On Nov. 16, I was ordered to withdraw the paper or 'face severe consequences' - which I interpreted to mean that I would be fired." Graham stated. "With a gun to my head, I called Lancet and withdrew the article."
Graham, an outspoken critic of the FDA's policies on new drugs testified before a Senate Committee last year about the danger of Vioxx and other drugs. Based on the study, Graham and his colleagues estimate that Vioxx is responsible for 88,000 to 140,000 cases of heart disease nationwide.
December 2004 Vioxx News.
According to the drug maker, Vioxx had 20 million users. U.S. Food and Drug Administration scientist David Graham estimated during U.S. Senate hearings on Nov. 18 that the drug hurt or killed between 88,000 and 139,000 people. Graham links the drug to 27,785 heart attacks and deaths. Merck has been named in numerous consumer lawsuits throughout the United States, and the State of New York sued the company on December 1, 2004.
Merck has said in court papers filed in defense of the suits that no drug is completely safe, that the FDA got all of the company's safety data on Vioxx and that clinical trials failed to prove it harmed patients. In a news conference, Merck General Counsel Kenneth Frazier said there was no ''reliable way'' to estimate actual Vioxx use in the population and the actual number of cardiovascular problems caused by Vioxx. Frazier stated, ''Because heart attacks and strokes occur in the general population, in any particular case, one cannot say that if one had a cardiovascular event while taking Vioxx that Vioxx caused it.'' In defending against injury cases, Merck argues that every plaintiff must prove that the drug, not something else, caused the alleged injury or death. Superior Court Judge Carol Higbee of New Jersey has ruled that Vioxx victims ''have to present expert testimony of causation of injury to prove their allegations in each case.''
Vioxx users or their survivors are suing Merck asserting the drug maker knew of the risks of Vioxx before its May 1999 launch and concealed potentially fatal side effects to maintain sales revenue and increase profits.
Following the Vioxx recall, CBS MarketWatch stated "the recent fiasco over the Vioxx recall has exposed the U.S. Food and Drug Administration to broad-based charges that the agency is less an independent regulatory body than an old-guard bureaucracy where senior officials snuff out dissenting voices among its scientific staff members."
On September 30, 2004, Merck & company, the manufacturer of the blockbuster arthritis drug Vioxx, announced the worldwide recall of Vioxx after a recent clinical trial confirmed previous studies linking Vioxx to serious cardiovascular problems, including heart attack and stroke. The three year trial was originally aimed to show that Vioxx could prevent the recurrence of polyps in the rectum (thereby reducing the risk of cancer). However, the trial showed an increased risk of heart attack and other cardiovascular problems. Merck stopped the study after it discovered that participants had twice the risk of heart attack than other participants taking placebos. The study showed the increased risk of heart attack began 18 months after patients started taking Vioxx. Medical experts advise patients to consult their doctor about alternatives.
Vioxx belongs to a class of drugs known as COX-2 inhibitors. When the drugs were introduced a few years ago, COX-2 inhibitors were thought to be safer and more effective than other drugs such as Aspirin and Ibuprofen. However, several studies have questioned the cardiovascular safety of Vioxx. In a study of more than 8,000 patients comparing Vioxx and traditional NSAID (non-steroidal anti-inflammatory drug) naproxen, the risk of cardiovascular problems, including heart attack, chest pain, stroke, blood clots and sudden death, was more than two times higher in the Vioxx group than in the control group.
In May 2002, the U.S. Food and Drug Administration (FDA) published a Talk Paper about new label warnings for the popular arthritis and pain drug know as Vioxx (rofecoxib). The new label warnings are based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR). According to the FDA, recent studies demonstrate that Vioxx is associated with a higher rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris, and peripheral vascular events). Based on the recent study, the FDA agreed with the Arthritis Advisory Committee recommendations February 8, 2001 that the label for Vioxx include gastrointestinal and cardiovascular warning information. Serious side effects attributed to Vioxx are heart attacks, seizures, strokes, blood clots, or liver/kidney problems.