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GENERAL INFORMATION |
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Vioxx
Dangers, Vioxx Recall and Vioxx Suit Timeline
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- 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.
- August 2004: Vioxx Dangers Cause
Reconsideration
HMO Kaiser Permanente reconsiders use of 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.
- 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.
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- October 6, 2004: Editorials Question
Safety of All Arthritis Drugs; Call for
Investigation of Merck and Vioxx
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.
- November 5, 2004: Study in Britain's The
Lancet Concludes Vioxx Recall Should
Have Occurred in 2000
The British Medical Journal The Lancet published a study that
concluded Merck and Federal officials should have recalled 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.
- 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. Vioxx class action suit filed in many states in the United States.
- December 9, 2004: New FDA Warning Released
FDA warns that people who have recently had heart-bypass surgery should
not 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.
- 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 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.
- 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.
- August 19, 2005 - Merck Found Liable
in Vioxx Suit
In the first Vioxx
death trial, a Texas state court jury finds
Merck liable for the death of Robert Ernst,
who took Vioxx, awarding his widow, Carol
Ernst, $253.4 million in damages.
- 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.
- 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.
- 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.
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