Vioxx®

Consult with your physician if you have questions concerning this medication.

On March 12, 2007, The Associated Press reported, “Painkiller Vioxx contributed to an Idaho postal worker’s heart attack, a jury in Atlantic City ruled Monday, reversing the verdict in the man’s first trial and hitting Merck with a total of $47.5 million in damages."

In one of Merck’s biggest losses over the drug so far, the jurors awarded the man and his wife $20 million in compensatory damages Monday morning, then later said Merck should pay $27.5 million in punitive damages.

Source: “Vioxx jury awards $47.5M to Idaho couple,” by Linda A. Johnson, AP Business Writer.

UPDATE 3:
On August 18, 2006, The Associated Press reported, “Merck & Co. suffered two major legal setbacks over the withdrawn painkiller Vioxx when a federal jury ordered the drug maker to pay $51 million to a heart attack victim, and a state judge in New Jersey overturned a November verdict favoring the company.”

In the $51 million verdict in New Orleans, the jury found that Merck “acted in wanton, malicious, willful or reckless disregard for the plaintiff’s rights.”

In New Jersey, state Superior Court Judge Carol Higbee ruled evidence uncovered since the November verdict showed that Merck withheld information showing heart attacks could come with use of Vioxx for less than 18 months.

Source: "Merck suffers 2 setbacks in Vioxx cases," by Mary Forster of The Associated Press.

UPDATE 2:
A jury awarded $9 million in punitive damages to a New Jersey man who suffered health complications after taking Vioxx®. The jury found that Merck & Co. knowingly withheld information about the risks of the arthritis drug. The state court jury said Merck’s conduct illustrated a “wanton and willful disregard of another’s rights.”

UPDATE:
In an unprecedented ruling on Friday, August 19, 2005, a Texas jury awarded $253.4 million to the widow of a man who died after taking Vioxx ®. The jury found that Mr. Ernst, 59, died of a Vioxx-induced heart attack which led to fatal arrhythmia.

Thousands more cases across the country are still pending. Analysts have speculated Merck’s liability could reach $18 billion (1).

If you or someone you know has suffered a heart attack or other cardiovascular problems after taking Vioxx, contact our law firm immediately.

Vioxx, or rofecoxib, is a non-steroidal anti-inflammatory drug (NSAID) approved by the Food and Drug Administration (FDA) in 1999 and prescribed to help ease acute pains associated with osteoarthritis, rheumatoid arthritis, menstrual cramps, migraines, and other painful conditions. Merck, its manufacturer, claimed the drug’s benefit over existing treatments was its ability to reduce pain without any gastrointestinal (GI) side effects, which are typical in other NSAIDs such as aspirin or ibuprofen.

The drug has been linked to several cardiovascular risks. On September 30, 2004, Merck announced the immediate voluntary worldwide withdrawal of Vioxx, a decision based on new data from a three-year Vioxx trial.

What are NSAIDs and what are their side effects?
NSAIDs, or Non-Steroidal Anti-Inflammatory Drugs, are very common to household medicine cabinets. Over-the-counter and prescription drugs like aspirin, ibuprofen, and naproxen are all NSAIDs. This class of drug works by blocking the COX-2 enzyme in the body, which reduces swelling; however, they also block the COX-1, which involves digestion in the GI tract. This often causes serious GI side effects, including ulcers, burns, and bleeding in the stomach lining.

Vioxx, and the Pfizer drug Celebrex®, belong to a special group of NSAIDs called COX-2 selective inhibitors. These drugs block the inflammation-causing COX-2 enzyme without blocking the COX-1, an action that, theoretically, should preserve all of the NSAID benefits while eliminating the gastrointestinal side effects.

What dangers are associated with Vioxx?
Concerns about Vioxx began to emerge with the release of data from the Merck-initiated Vioxx Gastrointestinal Outcomes Research (VIGOR) study in November 2000. The trial was designed to chart the difference in gastrointestinal effects between Vioxx and naproxen. However, the results also revealed a possible trend that suggested Vioxx—at the 50 mg. dose—may be responsible for an increased risk of adverse cardiovascular events, including:

Acute Myocardial Infarction (AMI), or heart attack
Sudden Cardiac Death (SCD)
Stroke

In August 2004, at the ISPE annual conference, an interdisciplinary forum to discuss various pharmaceutical issues, a study was presented, the results of which introduced distressing new figures about the relative safety of high doses of Vioxx. The study, funded by an FDA contract with HMO giant Kaiser Permanente, found that, “higher-dose [Vioxx] (>25 mg/d) conferred a 3.15-fold increased risk of AMI and SCD compared with remote use of any NSAID.” It further concluded that, even at a lower dose, “[Vioxx] 25 mg/d conferred an increased risk of AMI and SCD compared with [Celebrex]” (3).

On September 30, 2004, Merck announced the voluntary withdrawal of the drug, a decision based on early data from the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial. The trial, which is being stopped, was designed to evaluate the long-term effectiveness of Vioxx on preventing recurring colorectal polyps. However, the study also suggested an unforeseen result: “…an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo” (6).

What actions are being taken to protect consumers?
Since the possible adverse cardiovascular effects of COX-2 inhibitors revealed in the VIGOR study were published, researchers and experts have been pursuing the answer to the question of Vioxx’s safety. The FDA reviewed the issue in February 2001, and many of the present experts and committee members voiced their questions and concerns.

On September 17, 2001, the FDA sent Merck a warning letter stating their Vioxx campaign, “minimized the potentially serious cardiovascular findings that were observed in the [VIGOR] study, and thus, misrepresented the safety profile for Vioxx.” The FDA also reprimanded Merck for false or misleading statements made during promotional conferences, press releases and sales pitches, which misrepresented the safety of Vioxx and promoted it for unapproved uses; the FDA instructed Merck to cease promotional activities until the problem was corrected.

By April 11, 2002, the FDA required Merck to place cardiovascular warnings on Vioxx labels. In addition, they were required to include a new label warning that Vioxx at 50 mg. or more per day is not recommended for chronic use.

In September 2004, Merck made the decision to withdraw Vioxx from the market, citing the preliminary results of the APPROVe trial; executives decided that the action, “best serves the interests of patients” (7).

On August 19, 2005, a Texas jury awarded the widow of a man who died from a heart attack resulting from Vioxx use $253.4 million. The jury found that Mr. Ernst, 59, died of a Vioxx-induced heart attack which led to fatal arrhythmia.

What should I do if I took Vioxx?
Merck executives advise patients taking Vioxx to consult with their physician “to discuss discontinuing use of Vioxx” and to discuss the possibility of alternative treatments (6). If you or someone you know has suffered a heart attack or other cardiovascular problems after taking Vioxx, contact our law firm; we would like to help.

Sources:

“Jury Awards Widow $253.4M in Vioxx Trial” from the Associated Press, 08/19/05 accessed on 08/19/05.
FDA-CDER Arthritis Advisory Committee, 8 February 2001.
“Risk of Cardiovascular Events Associated With Selective Cox-2 Inhibitors,” Mukherjee, et al, Journal of the American Medical Association, Vol. 286 No. 8, August 2001.
“Risk of Acute Myocardial Infarction and Sudden Cardiac Death with Use of COX-2 Selective and Non-Selective NSAIDs,” Graham, et al, ISPE Conference on Pharmacoepidemiology, August 2004.
“Big HMO Reconsiders Vioxx After Study Points to Heart Risks,” The Wall Street Journal, 26 August 2004.
“Arthritis drug linked to heart deaths,” Reuters, MSNBC.com, 26 August 2004.
“Merck Announces Voluntary Worldwide Withdrawal of Vioxx,” Merck News Release, 30 September 2004.

Consult with your physician if you have questions concerning this medication. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Vioxx® is a registered trademark of Merck & Co., Inc. and is used here only for the purpose of identifying the product in question.

Celebrex® is a registered trademark of Pfizer Inc. and is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with Merck & Co., Inc., Pfizer Inc., the FDA, JAMA, IPSE, The Wall Street Journal, Reuters, or MSNBC.com.