Following Merck’s voluntary market withdrawal of its second biggest money maker, the arthritis painkiller Vioxx (rofecoxib), Merck faced mounting lawsuits involving claims of civil liability as well as charges of potential criminal wrongdoing.
Bob Ernst, a marathon runner and fitness fanatic, started taking Vioxx (rofecoxib) in November of 2000 for pain in his hands. Less than eight months later, the 59-year-old Texas man died in his sleep of a heart arrhythmia.
Ernst’s widow, Carol, was bereft and confused about her husband’s sudden death. The more she looked into it, the more she suspected the culprit was Vioxx, a nonsteroidal anti-inflammatory drug (NSAID) that had been heavily advertised for its easy-on-the-stomach pain relief.
Carol Ernst became the first of tens of thousands of consumers who sued Merck over allegations that the company had concealed information about the serious health risks of the popular arthritis drug — including the risk of fatal heart attacks and strokes — to protect sales.
Cardiovascular Risks Suspected for Years
Vioxx, which Merck pulled from the market in 2004, was what’s known as a COX-2 inhibitor. It works by selectively targeting a specific enzyme that causes inflammation and pain, but it leaves other enzymes that protect the stomach and intestinal lining untouched.
As a result, it causes less stomach upset than other NSAIDs, such as ibuprofen.
But Merck executives had become aware of potential cardiovascular risks associated with the drug as early as May 2000 and did little to pull back the reins on the drug’s development and marketing.
Clues about troubling side effects emerged in a large clinical trial launched in 1999 that compared the gastrointestinal side effects of Vioxx with side effects of an older painkiller, naproxen.
As Merck had hoped, results from the Vioxx Gastrointestinal Outcomes Research study (VIGOR) showed that patients taking Vioxx suffered fewer ulcers and bouts of gastrointestinal bleeding. But during the study, 79 of the 4,000 patients taking Vioxx suffered serious heart problems or died — a number twice as high as in the naproxen group.
Despite the red flags, marketers at Merck decided against a study aimed specifically at Vioxx’s effects on the heart. They feared it might send the wrong message and interfere with Merck’s competitive edge on the rival drug, Celebrex.
More Studies Reveal Risks, Recall Follows
More troubling information emerged in 2001, when Dr. Eric J. Topol and other cardiologists at Cleveland Clinic published a report in the Journal of the American Medical Association (JAMA) alleging that Cox-2 inhibitors such as Vioxx appeared to increase the risk of cardiovascular events.
Merck said the report was flawed and dismissed the call for a trial directed specifically at cardiovascular risks. Topol reported that, prior to the report’s publication, scientists from the billion-dollar drug company requested that the information be kept from the public.
Merck officials denied that claim but in 2002 changed their label to warn about higher risks of heart attack. The company finally decided to pull Vioxx from shelves in 2004, after additional studies revealed an increased risk of strokes and heart attacks among patients taking the drug for 18 months or longer.
Texas Jury Awards Ernst’s Widow $253 Million
Following the Vioxx recall, Merck was hit with a flood of lawsuits by patients and family members of patients who said they had suffered heart attacks and strokes because of the drug.
Ernst’s case was the first in the nation to be tried, and it ended with a $253 million award to his surviving spouse, Carol.
That award was reduced under Texas tort laws that impose caps on damages and later overturned altogether by a court of appeals that found that there was insufficient evidence to determine if Bob Ernst’s heart attack was directly caused by his use of Vioxx.
This was the first of several wins for Merck, which went on to successfully argue at least 10 more individual Vioxx lawsuits.
Other Notable Cases & Outcomes
- VIOXX Products Liability Litigation
- Begun in 2005, this MDL was transferred to the Eastern District of Louisiana in New Orleans and spanned eight years of litigation. Just in its first year, the court noticed 310 depositions relating to 168 witnesses and comprising over 35,000 pages of testimony. In total, the court conducted six Vioxx bellwether trials, with the first taking place in Houston, Texas.
Only one of the trials resulted in a verdict for the plaintiff, while one resulted in a hung jury. Four resulted in verdicts in favor of Merck. During the same time period, approximately 13 additional Vioxx-related cases were tried before juries in the state courts of Texas, New Jersey, California, Alabama, Illinois and Florida.
- Humeston, Et Al. V. Merck & Co., Inc.
- This trial ended in an immediate victory for Merck following a little more than a day of deliberations. The state court jury in Atlantic City, New Jersey, found Merck not liable for an Idaho man’s heart attack after taking Vioxx for a short time.
While the plaintiff’s attorney, Christopher Seeger, argued that Merck did not “win on science” but rather “by attacking the victim,” counsel for Merck, Kenneth Frazier, said the verdict was indicative of the company’s ability to defend the “insubstantial claims” being brought to court simply “to collect money from Merck.”
The win served to strengthen Merck’s bargaining power in future settlement discussions.
Merck Settles Vioxx Cases for $4.85 Billion
As time pressed on, approximately 60,000 personal injury cases were filed against the drug manufacturer for Vioxx injuries.
On February 16, 2005, the Judicial Panel on Multidistrict Litigation (JPML) conferred multidistrict litigation status on Vioxx lawsuits filed in various federal courts throughout the country. To be eligible for inclusion in the MDL, patients had to prove they had taken the drug for a month (30 pills), even though it took 18 months for increased cardiovascular problems to appear.
Despite the multiple individual wins, Merck eventually settled the cases, without admitting fault, in 2013, with a payout fund of $4.85 billion.
DOJ Investigations, Plea Deals and Settlements
Merck agreed to pay another $950 million to the DOJ in 2011 to resolve criminal charges and civil claims related to its alleged illegal promotion and marketing of Vioxx.
Under the terms of the settlement, Merck also agreed to plead guilty to a misdemeanor charge of a single violation of the Food Drug and Cosmetic Act (FDCA) for introducing a misbranded drug into interstate commerce and was ordered to pay a criminal fine of $321 million.
A secondary civil settlement required an additional payout from Merck of $628 million to resolve allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety. The payout was to be divided between the United States and participating Medicaid states, based on claims that Merck’s illegal marketing practices had influenced doctors to prescribe a drug they would not have otherwise prescribed.
The misbranding charge resulted from Merck promoting Vioxx as a drug for treating rheumatoid arthritis prior to that use being approved by the FDA.
Shareholder Lawsuits End in $830 Million Settlement
Over a decade after Vioxx went south and Merck withdrew it from the market, Merck agreed to pay yet another $830 million to settle a class action suit spurred by Merck’s disgruntled investors.
Shareholders claimed that Merck’s misleading statements regarding the arthritis painkiller, including the results of the VIGOR study, and the way the company downplayed the drug’s risks had influenced them to make a bad investment. This, they claimed, caused them to incur significant losses when the drug was pulled from the market.
Vioxx continues to haunt the drug-manufacturing giant as Merck will still have to battle out a few remaining individual securities lawsuits from investors who previously opted out of the class-action lawsuit certified by the judge in 2013.
Despite its decision to remove Vioxx from the health care market, Merck continues to deny any liability or wrongdoing for claims brought against it.
Please seek the advice of a medical professional before making health care decisions.