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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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- 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.
- 2000:
Merck Spends Millions on Vioxx Marketing
Merck spends $161 million on Vioxx advertising
(more than Pepsi or Budweiser spent on advertising
that year).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2003:
High Volume of Vioxx Sales
Worldwide sales of Vioxx reach $2.5 billion.
- 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.
- 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: 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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.
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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 © 2007 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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