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Vioxx Recall: The
international prescription drug company
Merck announced in September 2004 the worldwide
withdrawal of the arthritis medication Rofecoxib,
sold in most countries under the brand name
Vioxx, because a study showed an increased
risk of heart attack and stroke.
Vioxx
Trial: Patients
who have suffered injuries due to Vioxx
have filed litigation against Merck for
selling Vioxx even though Merck allegedly
was aware of Vioxx's dangerous
side effects. |
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Vioxx Dangers, Vioxx Recall
and Vioxx Suit Timeline
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- March 13, 2007 - Vioxx Jury Awards $47.5M to Idaho Couple
A jury in Atlantic City rules that Merck & Co.'s painkiller Vioxx contributed to an Idaho postal worker's heart attack, reversing the verdict in the man's first trial and hitting Merck with a total of $47.5 million in damages.
- April 5, 2006 - New Jersey Man Wins $4.5 Million Verdict Against Merck
A state jury finds Merck & Co. liable for one of two former Vioxx users’ heart attacks and orders $4.5 million in damages in a closely-watched trial involving two New Jersey men.
- February 17, 2006 - Merck Cleared of Responsibility in the Death of Florida Man
A federal jury clears Merck & Co. of any responsibility in the death of a 53-year-old Florida man who had a heart attack after taking Vioxx for less than a month.
- December 8, 2005 - Editorial Says Merck Concealed Heart Attacks in Clinical Study
An editorial in the New England Journal of Medicine said Merck concealed heart attacks suffered by three patients during a clinical study of Vioxx in a report on the study published in the Journal in 2000.
- August 19, 2005 - Merck Found Liable in Vioxx Death
In the first Vioxx product liability trial, a Texas state court jury finds Merck liable or the death of Robert Ernst, who took Vioxx, awarding his widow, Carol Ernst, $253.4 million in damages.
- April 7, 2005 - Bextra Withdrawn From Market
Pfizer Inc. agrees to voluntarily recall its painkiller Bextra at the request of the U.S. Food and Drug Administration due to the risk of heart attack and stroke. The FDA also asks Pfizer to include a black box warning on its painkiller Celebrex.
- December 21, 2004 - Naproxen | Aleve Problems Found
A government clinical trial showed an increased risk for heart attacks and strokes in patients taking Naproxen, sold by Bayer under the brand name Aleve. The FDA recommends consumers limit their use of naproxen to the amount suggested on the label and not take the pills for longer than ten days unless advised to do so by a doctor.
- December 17, 2004 - Celebrex Problems Found
Pfizer said a government-sponsored study of Celebrex in cancer prevention found a significant risk of cardiovascular problems. A second cancer study released simultaneously, though, showed no increased risk. Pfizer declined to recall Celebrex and advised patients using Celebrex to consult with their doctors.
- December 9, 2004: New FDA Warning Released
FDA warns that people who have recently had heart-bypass surgery shouldn't take Bextra, after a study showed patients who had just had cardiac surgery and were treated with Bextra were more likely to have heart and blood clotting problems than those who didn't receive the drug.
- November 2004: Vioxx Investigations Launched
The Justice Department and the Securities & Exchange Commission launch investigations into Merck's handling of Vioxx. U.S. Senate begins hearings on how Merck and the FDA responded to safety concerns about Vioxx.
- November 5, 2004: A study in Britain's The Lancet concludes Vioxx Should Have Been Pulled from Market in 2000
The British Medical Journal The Lancet published a study that concluded Merck and Federal officials should have withdrawn the painkiller Vioxx from the market as early as 2000 because studies of the drug had clearly shown that it doubled the risk of heart attack among users.
- October 6, 2004: Editorials Question Safety of All Arthritis Drugs; Call for Formal Investigation of Merck
The New England Journal of Medicine issues two editorials calling for renewed scrutiny into the entire class of arthritis drugs to see if other drugs in the category also cause heart problems. In one editorial, Cleveland Clinic cardiologist Eric Topol, who was the first to raise the alarm about Vioxx three years ago, calls for a formal government investigation into how Merck and the U.S. Food and Drug Administration left Vioxx on the market for so long after concerns about its possible heart risks had been raised.
- September 30, 2004: Vioxx Pulled from Market
Merck withdraws Vioxx from the market. The FDA issues a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.
- August 2004: Kaiser Reconsiders Vioxx
HMO Kaiser Permanente reconsiders Vioxx for its member patients after an FDA study finds that patients who had taken more than 25 mg a day were 3.15 times more likely to have a heart problem.
- Early 2004: Merck Faces Securities Litigation
A securities class action complaint is filed on behalf of several Merck investors alleging the company engaged in a marketing campaign that included false and misleading statements concerning the safety profile of Vioxx and that company insiders sold personally held shares of Merck for over $175 million in proceeds.
- October 2003: Merck Study Finds Increased Vioxx Risk
Merck-funded study finds patients taking Vioxx are at a 39% increased risk of heart attack within the first ninety days, compared with Celebrex.
- 2003: High Volume of Vioxx Sales
Worldwide sales of Vioxx reach $2.5 billion.
April 2002: FDA Approves New Vioxx Labeling - The FDA, following up on the advisory panel's advice from the year before, approves new labeling for Vioxx that points out the association with higher heart-attack and stroke risk.
- September 17, 2001: FDA Letter Warns Merck on Advertising and Vioxx Side Effects
In an eight-page letter to Merck Chief Executive Raymond Gilmartin, the FDA warns Merck for engaging "in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed" in a clinical trial comparing Vioxx to naproxen, a less-expensive painkiller. "Your promotional campaign discounts the fact" that in the trial, "patients on Vioxx were observed to have a four to five-fold increase" in heart attacks, compared with patients on naproxen, the letter said.
- August 2001: Further Examination of Vioxx Adverse Effects Published
Doctors at the Cleveland Clinic examine data from several trials of Vioxx patients and publish their findings in the Journal of the American Medical Association, claiming the “available data raise a cautionary flag about the risk of cardiovascular events" with Cox-2 inhibitors, especially Vioxx.
- February 2001: FDA Approves Vioxx Re-Labeling
FDA Approves Merck request to label Vioxx as safer on the stomach than older painkillers, giving the drug a slight but important edge over Celebrex.
- Early 2001: FDA Meets To Discuss Findings
At a meeting of an FDA advisory panel, Merck argues that the trial results might reflect the protective effects of naproxen and not danger from its drug. The committee ends up recommending that the issue be noted on Vioxx's label, and members call for follow-up research to clear up the questions.
- November 2000: Vioxx Trial Results Published, Vioxx Dangers Reported
The New England Journal of Medicine publishes the results of a Merck trial called Vigor. It showed that patients taking the drug were four times as likely -- 0.4% to 0.1% -- to have a heart attack or stroke as patients taking the over-the-counter pain reliever naproxen.
- 2000: Merck Spends Millions on Vioxx Marketing
Merck spends $161 million on Vioxx advertising (more than Pepsi or Budweiser spent on advertising that year).
- May 1999: Vioxx Introduced
Merck introduces Vioxx to the market with great fanfare. The FDA approves Vioxx for arthritis pain as well as other kinds of pain in adults. Vioxx is sold in over 80 countries.
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| Lieff Cabraser: Experienced Product Liability Lawyers |
| Founded in 1972, Lieff Cabraser Heimann & Bernstein,
LLP is an over fifty attorney law firm with offices in San Francisco, New
York and Nashville. For the last five years, the National Law Journal has
recognized Lieff Cabraser as one of the top plaintiffs law firms
in America. |
| For our personal injury cases, we bring a team of experienced lawyers. Each client is assigned a partner and an associate. In addition, we have on staff multiple nurses, legal assistants, scientific analysts and case clerks to assist the attorneys. |
| We have represented thousands of patients who ingested prescription drugs with dangerous undisclosed side effects, and patients who received defective medical devices in personal injury lawsuits across America, including residents of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming. |
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Lieff
Cabraser Heimann & Bernstein, LLP
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| Trademark Notice |
| "Vioxx" is
a registered trademark of Merck. Lieff Cabraser Heimann & Bernstein,
LLP is in no way affiliated with Merck, and the Vioxx
trademark is used solely for informational purposes. |
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Copyright © 2009 Lieff Cabraser Heimann & Bernstein, LLP |
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Merck
Agrees to Resolve U.S. VIOXX® Product
Liability Lawsuits
November 9, 2007
Merck & Co., Inc.
announced that
it has entered into
an agreement to resolve
state and federal myocardial
infarction (MI) and
ischemic stroke claims
already filed against
the Company in the
United States. More... |
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