VIOXX & BEXTRA Information
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General Information about Vioxx

Merck's Vioxx is a cox-2 inhibitor drug, which was approved by the Food and Drugs Administration in May 1999 following various trials and tests. Upon its approval, Vioxx was hailed a miracle drug, as it could provide the effects of a non-steroidal anti-inflammatory drug without causing the gastric problems that commonly came with traditional NSAIDs. This was due to the fact that traditional NSAIDs inhibited the cox-1 enzyme as well as the cox-2 enzyme. Since the cox-q1 enzyme is essential in the protection of the stomach lining, this resulted in a variety of gastric issues for patients. Vioxx, however, was able to isolate and inhibit just the cox-2 enzyme, giving it a huge advantage over standard NSAIDs.

Five years on, in September 2004, this wonder drug came crashing down to earth with a bang, as continued testing indicated that, although it reduced the risk of stomach problems in patients, it also significantly increased the risk of heart attacks and strokes. Upon hearing of this evidence, the manufacturer of Vioxx, Merck, made arrangements for the drug to be immediately recalled from the US market. However, the circumstances surrounding the approval of Vioxx back in 1999 is now shrouded in controversy, with questions being raised about how long Merck had already known about these potentially fatal side effects, and how such a drug managed to slip through the net and gain approval with the FDA.

Merck's legal battle began after Sept. 30, 2004, when the company pulled Vioxx, an arthritis painkiller worth $2.5 billion in annual sales and about one-tenth of total company revenue, triggering a one-third slide in the company's stock value. Merck pulled the drug after participants in a Vioxx study experienced "adverse cardiovascular events" compared to those taking a placebo. Nonetheless, Merck never actually conceded there were health risks. Some 20 million people have used Vioxx. Since the recall, about 4,200 product liability lawsuits representing about 7,500 plaintiff groups have been filed against Merck.

On August 19, 2005, a Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country. A seven-man, five-woman jury deliberated for 10½ hours over two days before returning the verdict.

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WHAT IS VIOXX?

VIOXX is a non-steriodal anti-inflammatory drug (NSAID) intended primarily to treat the symptoms of osteoarthristis, rheumatoid arthritis, acute short-term pain and severe menstrual cramps. VIOXX, chemical name “roecoxib,” is a Cox-2 selective inhibitor “designer drug” with anti-inflammatory, analgesic and antipyretic properties. It was available in liquid and pill form.

DID MERCK KNOW VIOXX WAS DANGEROUS?

YES!! Acording to Merck’s own internal emails, it knew VIOXX was a dangerous drug, but its CEOs buried the information due to potential profit. One email, authored by Merck’s Chief of Research says that cardiovascular risks, “…are clearly there.” Several of these emails were published in the Wall Street Journal which wrote: “Merck’s first worry, in the mid-to-late 1990s, was that its drug would show greater heart risk than cheaper painkillers…company officials discussed in emails how to design a study that would minimize the unflattering comparison, even while admitting to themselves that it would be different to conceal.”

Vioxx Timeline

Key events involving the safety of Vioxx and other painkillers:

• Dec. 12, 2005: A judge in Houston declares a mistrial in the federal lawsuit over Vioxx. The jury failed, in about 18 hours of deliberations over three days, to side with the drug maker or Irvin's widow.
• Dec. 8, 2005: The New England Journal of Medicine publishes an editorial that says Merck concealed heart attacks suffered by three patients in the VIGOR study published in the New England Journal in 2000. The editorial, written by the journal's editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and a third doctor, also alleges the study's authors deleted other relevant data before submitting their article for publication and said, "Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article."
• Nov. 29, 2005: The third Vioxx trial and the first in federal court begins in Houston rather than its original venue of New Orleans because of damage wrought by Hurricane Katrina. The plaintiff, Evelyn Irvin Plunkett, alleges her husband, Richard "Dicky" Irvin, a wholesale seafood company manager in St. Augustine, Fla., died in May 2001 after taking Vioxx for about a month to ease back pain because the drug caused a blood clot to form in one of his arteries that led to a fatal heart attack. Merck counters that no studies show Vioxx to be dangerous with such short-term use. By this time Merck faces about 7,000 state and federal Vioxx lawsuits.
• Nov. 28, 2005: Squeezed by Vioxx lawsuits, tumbling revenues and other troubles, Merck announces it will eliminate 7,000 jobs and five production plants and revamp manufacturing in the first phase of an anticipated global reorganization.
• Nov. 3, 2005: Atlantic County Superior Court jury rules Merck was not responsible for Humeston's heart attack.
• Oct. 24, 2005: In its quarterly earnings report, Merck says that as of Sept. 30, it has been named as a defendant in about 6,400 lawsuits over Vioxx — about 160 of them potential class-action suits — and has signed agreements with about 3,000 other claimants temporarily suspending the clock on their states' time limit to file suit. At least several hundred additional lawsuits are filed in October.
• Sept. 14, 2005: The second Vioxx trial begins with opening arguments in New Jersey Superior Court in Atlantic City, as lawyers for Boise, Idaho postal worker Frederick "Mike" Humeston argue his Sept. 18, 2001, heart attack was caused by Vioxx, which he had been taking for about two months.
• Aug. 19, 2005: Texas jury finds Merck liable for the death of Robert Ernst, awarding his widow $253.4 million in damages. That will be reduced to about $26 million under Texas caps on punitive damages; Merck plans to appeal.
• July 19, 2005: U.S. District Judge Eldon Fallon schedules the first federal Vioxx trial for Nov. 28, later pushed to Nov. 29.
• July 13, 2005: A jury of seven men and five women is seated to hear the Ernst Vioxx lawsuit in semi-rural Brazoria County, south of Houston.
• April 7, 2005: Pfizer withdraws Bextra from the market at request of the FDA, which said it carries additional risks of serious, sometimes fatal skin reactions. The FDA also says not just Cox-2 inhibitors, but all prescription NSAID drugs, should carry a black-box warning label about cardiovascular risks.
• February 2005: FDA panel concludes Vioxx, Celebrex and Bextra all pose heart risks, but should be available to consumers.
• September 2004: Merck voluntarily withdraws Vioxx from the market after halting a long-term study that it said showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer. The study, called APPROVe, had focused on whether Vioxx could prevent reoccurrence of colon polyps, and on cardiovascular effects.
• May 2002: Carol Ernst sues Merck, alleging Vioxx triggered the May 2001 death of her husband, Robert Ernst, a 59-year-old Wal-Mart produce manager who ran marathons.
• April 2002: FDA changes warning label on Vioxx to reflect VIGOR study results showing increased risk of heart attacks and strokes.
• November 2001: Pfizer's Bextra, also a Cox-2 inhibitor, approved by FDA.
• September 2001: Merck receives a warning letter from the FDA about the company's post-VIGOR Vioxx promotional campaign "that minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."
• June 2000: Merck gives FDA results of VIGOR study, which shows Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's cardioprotective qualities rather than a defect in Vioxx, but was rebuked by the FDA for making that assertion without scientific proof.
• May 1999: FDA approves Merck & Co.'s Vioxx, another Cox-2 inhibitor, for treatment of arthritis and acute pain in adults.
• December 1998: Food and Drug Administration approves Pfizer Inc.'s Celebrex, the first Cox-2 inhibitor, to treat arthritis. Cox-2 drugs, part of the nonsteroidal anti-inflammatory drug (NSAID) class, inhibit the Cox-2 enzyme, which promotes inflammation, but protect users against stomach bleeds and ulcers, unlike other NSAIDs.

***Parts of timeline courtesy of Chron.com and taken from an Associated Press article from Dec. 12, 2005***

General Information about Bextra

In November 2004, the American Heart Association Conference presented preliminary results of a study linking Pfizer's painkiller BEXTRA® to an increased risk of heart attack and stroke.

At the American Heart Association Conference on November 9, 2004, Dr. Garret A. Fitzgerald, a cardiologist and pharmacologist at the University of Pennsylvania, presented preliminary results of a study linking Pfizer's painkiller BEXTRA® to an increased risk of heart attack and stroke.

The study, which pooled data from 5,930 patients taking part in 12 trials, found that patients who took BEXTRA® were more than two times likely to suffer a heart attack or stroke than those patients who were given a placebo (sugar pill). Speaking of the results, Dr. Fitzgerald said "This is a time bomb waiting to go off."

On November 10, 2004, the New York Times reported that a new safety study has established a link between BEXTRA® and serious side effects, including heart attack and stroke. BEXTRA® is a COX-2 inhibitor prescribed to treat those suffering from osteoarthritis, rheumatoid arthritis, and menstrual cramping. Pfizer Inc. manufactures the drug, BEXTRA®.

Pfizer Inc. on October 15, 2004, said two small clinical trials showed heart bypass surgery patients taking BEXTRA®, an anti-inflammatory in the same class as the recently withdrawn drug VIOXX, had a higher risk of stroke and heart attack.

The FDA approved BEXTRA® to treat arthritis pain, but surprisingly, BEXTRA® has not been proven to alleviate pain any better than older, cheaper medicines like ibuprofen or naproxen. Nor has BEXTRA® been proven to be any safer on the stomach than those drugs.

Currently, The Kahn Law Firm is actively investigating injury claims on behalf of injured BEXTRA® users. If you or a loved one has suffered damaging side effects as a result of taking BEXTRA® contact The Kahn Law Firm immediately to discuss your legal rights.