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On
September 30, 2004, the international prescription
drug company Merck announced 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. Patients who have suffered
injuries due to Vioxx have filed litigation
against Merck for failing to recall the drug
when it first learned of Vioxx's dangerous side
effects.
To contact in confidence an experienced personal
injury attorney at Lieff Cabraser working on
the Vioxx lawsuit, click
here. |
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The
painkiller Vioxx was marketed throughout the
world, sold in many countries under the name
Vioxx and in others as Ceoxx. Lieff Cabraser
is working with attorneys and solicitors in:
Argentina
Austria
Canada
Ireland
Italy
South Africa
United
Kingdom
and other countries to bring litigation against
Merck in U.S. courts for patients suffering
heart attacks and strokes from Vioxx. If you
are visiting this website from outside the U.S.,
please click here
to contact an attorney regarding your experiences
with Vioxx or Ceoxx. |
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| Below
are summaries of press articles on the Vioxx case.
For a concise review of the Vioxx controversy
and how injured Vioxx and Ceoxx users may obtain
compensation, please visit
our main page. |
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| December
3, 2004 |
Forbes,
"Merck's Vioxx Liability Could Reach $38 Billion"
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The
legal liability to Merck for the withdrawn arthritis
drug Vioxx could be huge, according to Richard Evans,
an analyst at Sanford C. Bernstein. If all the patients
who had heart attacks as a result of taking Vioxx were
to receive an average-sized legal settlement, Evans
wrote in a research report, Merck's liability could
reach $38 billion. That assumes that 58,000 heart attacks
could be linked to the drug, and that the average settlement
would be $650,000. At current prices, Evans wrote, the
company's share price assumes about $25 billion in risk.
Evans, who rates Merck at "market perform,"
cautions that it's not yet clear whether trial lawyers
can win settlements or at jury, but if they do the liability
is likely to far exceed his previous estimates.
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| November
18, 2004 |
The
New York Times, "Earlier Merck Study
Indicated Risks of Vioxx"
|
Nearly
a year before Merck received results from the clinical
trial that prompted the company to withdraw its painkiller
Vioxx from the market, the company received preliminary
results from a separate study of patient records that
also apparently indicated that the drug posed cardiovascular
risks.
Merck
has not publicly disclosed that separate study's results
or referred to it in any of its statements about Vioxx's
safety record since announcing in late September that
it would stop selling the drug. But a company spokeswoman,
in response to a reporter's questions yesterday, confirmed
the study's existence and said that Merck, which paid
for the research, received its preliminary results last
November - and was given a final report 10 days before
the company announced it would stop selling Vioxx.
When
it withdrew the drug from the market, Merck cited a
long-term trial showing that some patients, after taking
Vioxx for 18 months, developed serious cardiovascular
problems. But Merck's critics continue to say that the
company should have heeded signals years earlier that
Vioxx might pose dangers. Today in Washington, the company's
chief executive, Raymond V. Gilmartin, is expected to
be questioned on the matter in a hearing by the Senate
Finance Committee, which will also be examining the
Food and Drug Administration's handling of Vioxx and
other drug safety issues.
The
study report that Merck received on Sept. 20 was an
analysis of patient records from the UnitedHealth Group,
one of the nation's biggest plans. It compared the relative
rates of heart attack and stroke in people taking Vioxx;
a similar drug, Celebrex; and traditional over-the-counter
painkillers.
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| November
18, 2004 |
Associated
Press, "FDA Called 'Defenseless' Against
Bad Drugs"
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The
American public is "virtually defenseless"
if another medication such as Vioxx proves to be unsafe
after it is approved for sale, a government drug safety
reviewer told a congressional committee Thursday. "I
would argue that the FDA as currently configured is
incapable of protecting America against another Vioxx,"
said David Graham, who warned that the arthritis drug
had been linked to an increased risk of heart attack
and stroke.
Raymond
V. Gilmartin, the company president, said in prepared
testimony that Merck acted within four days of learning
about the risk. The Food and Drug Administration has
defended its actions regarding Vioxx. In a statement
issued late Wednesday, the agency cited its "well-documented
and long-standing commitment toess and transparency
in its review of marketed drugs." Graham told the
committee that research indicated that Vioxx caused
up to 160,000 heart attacks and strokes.
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| November
14, 2004 |
60
Minutes, "Prescription For Trouble"
|
When
the pharmaceutical giant Merck pulled its blockbuster
pain medication Vioxx off the market in late September,
it became the largest prescription drug recall in history.
The company says it took immediate action after a new
study showed that Vioxx doubled the risk of heart attacks
and strokes in some patients.
However,
according to internal Merck documents 60 Minutes
has seen, and interviews with outside scientists, Merck
had concerns that Vioxx could possibly cause cardiovascular
risks long before it was pulled off the market. Some
20 million Americans took Vioxx in the five-and-a-half
years it was being sold. It may have contributed to
thousands of heart attacks and sudden deaths.
To read the complete 60 Minutes Report, click
here.
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| November
14, 2004 |
The
New York Times, "In Face of Warnings,
Drug Giant Took Long Path to Vioxx Recall"
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In
May 2000, executives at Merck, the pharmaceutical giant
under siege for its handling of the multibillion-dollar
drug Vioxx, made a fateful decision. The company's top
research and marketing executives met that month to
consider whether to develop a study to directly test
a disturbing possibility: that Vioxx, a painkiller,
might pose a heart risk. Two months earlier, results
from a clinical trial conducted for other reasons had
suggested such concerns.
Merck
decided not to conduct a study solely to determine whether
Vioxx might cause heart attacks and strokes - the type
of study that outside scientists would repeatedly call
for as clinical evidence continued to show cardiovascular
risks from the drug. Instead, Merck officials decided
to monitor clinical trials, already under way or planned,
that were to test Vioxx for other uses, to see if any
additional signs of cardiovascular problems emerged.
It
was a recurring theme for the company over the next
few years - that Vioxx was safe unless proved otherwise.
As recently as Friday, in newspaper advertisements,
Merck has argued that it took "prompt and decisive
action'' as soon as it knew that Vioxx was dangerous.
But a detailed reconstruction of Merck's handling of
Vioxx, based on interviews and internal company documents,
suggests that actions the company took - and did not
take - soon after the drug's safety was questioned may
have affected the health of potentially thousands of
patients, as well as the company's financial health
and reputation.
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| November
12, 2004 |
Forbes,
"The Vioxx Safety Study Merck Didn't Do"
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On
Sunday, 60 Minutes will run a story asking if
Merck knew about the dangers of Vioxx, the arthritis
drug that was pulled from the market because it doubled
the risk of heart attack and stroke. Did Merck do enough
to study Vioxx's effect on the heart?
At
a December 2001 meeting with financial analysts, Merck
promised to study the safety of Vioxx and a follow-up
drug, Arcoxia. To help prove the heart safety of Arcoxia,
Merck announced a 23,542-patient trial called MEDAL
in September 2002. Yet no similar study was conducted
for Vioxx.
Certainly,
such cancer studies can turn up cardiovascular risk.
In fact, it was one of the placebo-controlled studies,
begun in 1999, that resulted in Vioxx being pulled from
the market. There's only one problem: Cancer studies
are not what others heard Merck promise at its meeting
with the financial community in 2001. News sources,
including Dow Jones and Reuters, reported at the time
of the 2001 meeting that big cardiovascular trials were
expected for both Vioxx and Arcoxia.
In
a letter to the public published in newspapers this
morning, Merck Chief Executive Raymond Gilmartin defended
his company's "consistent and rigorous adherence
to scientific investigation, transparency and integrity."
Moreover, Gilmartin wrote, "When questions arose,
we took additional steps, including conducting further
prospective, controlled studies to gain more clinical
information about the medicine." It's certainly
true that Merck studied its drug. But did it really
do every study it said it would?
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| November
12, 2004 |
Crain's
New York Business, "Merck CEO defends
handling of Vioxx"
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In
full-page newspaper ads today, Merck & Co. Chief
Executive Raymond Gilmartin defended his company's research
on Vioxx as well as its handling of the drug once health
concerns emerged. Mr. Gilmartin said in ads that in
the weeks since Merck voluntarily recalled the drug
because of cardiovascular risks, "incomplete and
sometimes inaccurate information has been presented
by others about Merck's scientific integrity and [its]
commitment to ensuring patient safety."
Merck
has received a subpoena from the U.S. Justice Department
requesting information about its research, marketing
and selling activities related to Vioxx. The Securities
and Exchange Commission has also begun an informal inquiry.
The Senate Finance Committee has requested testimony
from Mr. Gilmartin at a hearing this month on the Vioxx
withdrawal, and lawyers for ex-Vioxx users who are suing
Merck are reportedly seeking to depose him.
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| November
7, 2004 |
Newhouse
News Service, "Vioxx recall may cost
$18 billion"
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A
Wall Street analysis suggests the Vioxx recall may cost
the pharmaceutical firm Merck as much as $18 billion
over the next decade. The staggering sum reflects the
possibility that more than 50,000 Vioxx users suffered
heart attacks or strokes, and that each patient will
file a successful lawsuit against the beleaguered drug
maker, according to the report by Merrill Lynch.
The
popular painkiller was withdrawn Sept. 30 after being
linked to cardiovascular problems. Since then, anxious
investors have driven Merck shares down about 40 percent
over fears that litigation costs will skyrocket. Those
fears rose further after recent reports suggested Merck
attempted to downplay the cardiovascular risks before
Vioxx was launched in 1999, and continued to do so even
after researchers and physicians questioned the drug's
safety.
About
300 lawsuits have been filed against Merck and hundreds
more are expected. Some lawsuits seek damages, while
others want the company to pay for medical monitoring
in the event a heart attack or stroke occurs later.
Merck spokeswoman Anita Larsen said the Whitehouse Station,
N.J., company will vigorously defend against the lawsuits
but can't predict the outcome or reasonably estimate
the possible loss.
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| November
5, 2004 |
The
New York Times, "Merck lawsuits on tap?
Attorneys representing people alleging harm from Vioxx
set meetings to fix game plan"
|
Drugmaker
Merck & Co., which pulled its blockbuster painkiller
Vioxx from shelves in September, is about to become
the target of hundreds of lawsuits, according to a published
report Friday. Attorneys, representing people who claim
injury or death because of the use of Vioxx, plan to
meet next week to lay the foundations for a nationwide
blitz against Merck.
Merck
(Research) has been buffeted since the company pulled
Vioxx after it was shown to increase the risk of heart
attack and strokes.
The
specter of litigation against Merck has increased since
the recall was issued in late September. On Thursday,
Swiss scientists writing in a report for British medical
journal The Lancet said that the company should
have pulled Vioxx four years ago because of data showing
an elevated risk of a cardivascular event.
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| November
5, 2004 |
The
New York Times, "Lawyers Organizing
for Mass Suits Over Vioxx"
|
Hundreds
of plaintiffs' lawyers who claim that people were injured
or killed by the painkiller Vioxx plan to meet next
week to lay the groundwork for a nationwide legal assault
against the drug's maker, Merck.
The
lawyers expect the discussions to begin informally on
Tuesday in Pasadena, Calif., in the hallways of a conference
on Vioxx litigation that will also beto defense
lawyers.
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| November
5, 2004 |
The
New York Times, "Study Says Drug's Dangers
Were Apparent Years Ago"
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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 attacks among users, according to a study released
yesterday by The Lancet, a British medical journal.
Authors
of the study pooled data from 25,273 patients who participated
in 18 clinical trials conducted before 2001. They
found that patients given Vioxx had 2.3 times the risk
of heart attacks as those given placebos or other pain
medications. Merck withdrew Vioxx on Sept. 30 of this
year after a company-sponsored trial found a doubling
of the risks for heart attack or stroke among those
who took the medicine for 18 months or more.
An
editorial accompanying the study criticized both Merck
and the Food and Drug Administration, and described
Vioxx's approval and its popularity as "public
health catastrophes" that led to over 27,000 heart
attacks and sudden deaths.
"For
with Vioxx, Merck and the F.D.A. acted out of ruthless,
short-sighted and irresponsible self-interest,"
wrote Richard Horton, editor of The Lancet.
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| November
1, 2004 |
MSNBC.com,
"Report: Merck tried to bury Vioxx concerns; E-mails
suggest drug firm knew of problems for years"
|
Internal
e-mails and other documents from Merck & Co. show
the company fought for years to keep safety concerns
from undermining the drug's commercial prospects, the
Wall Street Journal reported on Monday [November
1, 2004].
Vioxx,
a drug known as a COX-2 inhibitor, was withdrawn from
the market after it was shown to double the risk of
heart attack and stroke in patients who had been taking
it for at least 18 months. Vioxx generated some $2.5
billion in annual sales, and its withdrawal pummeled
Merck's shares.
On
Monday [November 1, 2004], the Journal reported
that an e-mail dated March 9, 2000, suggested Merck
recognized that something in Vioxx was linked to increased
heart risk.
Edward
Scolnick, Merck research chief at the time, wrote in
the e-mail that cardiovascular events "are clearly
there" and called it a "shame."
Although
Scolnick compared Vioxx with other drugs with known
side effects and wrote, "there is always a hazard,"
the company's public statements continued to reject
the link between Vioxx and increased intrinsic risk.
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| October
22, 2004 |
New
Jersey Star-Ledger, "Vioxx recall continues
to shake Merck"
|
The fallout from the Vioxx recall became crystal clear
yesterday as Merck reported third-quarter earnings plunged
29 percent, more cost-cutting is planned and hundreds
of additional lawsuits have been filed by health plans
and consumers. The profit picture for next year appeared
equally sobering: The Whitehouse Station-based drug
maker estimated 2005 earnings will drop as much as 11
percent thanks to lost Vioxx revenue and costs associated
with the Sept. 30 product withdrawal.
The difficulties created by Vioxx are only beginning.
As of Oct. 15, Merck faces about 300 lawsuits filed
by health plans and individuals alleging consumer fraud.
Other lawsuits seek class-action status and allege personal
injury, such as gastrointestinal bleeding and heart
attacks. Some demand medical monitoring.
The episode may resemble the diet-pill litigation. Since
Wyeth withdrew two drugs in 1997, the company has taken
$16.6 billion in charges and reached settlements with
thousands of consumers. Nonetheless, lawsuits remain
outstanding and more charges are expected. At last count,
about 20 million Americans have taken Vioxx since it
was launched in the United States in 1999, with about
105 million prescriptions written. The number of patients
outside the United States who have taken Vioxx is not
known, according to Merck.
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| October
18, 2004 |
The
Washington Post, "Painful Withdrawal for Makers
of Vioxx; Pulling of Arthritis Drug Raises Questions
on Marketing, Safety Risks"
|
Backed by a $195 million ad campaign, featuring testimonials
from former skater Dorothy Hamill and music by the Rascals
to appeal to aging baby boomers, Merck had sold Vioxx
to more than 20 million Americans since its approval
in 1999 and millions more worldwide.
An examination of how and why Merck reacted offers an
unusual look at how safety issues are handled in clinical
trials once a drug is on the market and the complex
business of weighing risks against benefits.With Vioxx,
researchers had been warning about the drug's possible
cardiovascular risks since 2000, only a year after it
was approved by the FDA. Data from a company study found
then that users had four times as many heart attacks
and strokes as those who used another painkiller.
When the recall occurred, it came about because of a
major clinical study sponsored by Merck that tracked
2,600 patients for almost three years to find out if
Vioxx helped prevent colon polyps. Merck launched the
effort hoping to create new markets for Vioxx, while
also laying to rest questions about the drug's connection
to heart attacks and strokes.
Far from it, the trial confirmed the predictions of
Merck's harshest critics, who had long complained that
the New Jersey manufacturer was closing its eyes to
Vioxx's problems and improperly pushing a dangerous
drug onto consumers with aggressive ads. Vioxx and other
Cox-2 inhibitors like Celebrex had been promoted as
wonder drugs, since they provided pain relief to arthritis
sufferers without causing stomach problems, but now
Vioxx is off the market and the others are under a cloud.
Cleveland Clinic cardiologist Eric J. Topol, an early
critic of the drug, estimates Vioxx may have caused
30,000 to 100,000 heart attacks and strokes, many of
them "preventable" because patients could
have taken other drugs.
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| October
10, 2004 |
Forbes,
"Top Doctor Calls For Vioxx Investigation"
|
The New England Journal of Medicine issued
two editorials today 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. He blasts them for not doing bigger,
better studies that might have teased out Vioxx's
effect on the arteries.
Merck pulled Vioxx last week after a big study found
long-term use of the drug nearly doubled the risk
of heart attacks and strokes. The second editorial,
by University of Pennsylvania cardiovascular researcher
Garret FitzGerald, warns that it is very possible
that other similar drugs, such as Pfizer's Celebrex
and Bextra, may also increase the risk of heart problems.
He says the burden of proof is now on Pfizer and Novartis
-- and other drugmakers that sell or hope to sell
so-called cox-2 inhibitors -- to prove that their
drugs are safe on the heart.
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| October
6, 2004 |
MSNBC.com,
"Vioxx linked to thousands of deaths; Newspaper
cites government study on recalled pain drug"
|
Merck
& Co.s arthritis drug Vioxx may have led to
more than 27,000 heart attacks and sudden cardiac deaths
before it was pulled from the market last week, the
Wall Street Journal reported Wednesday, citing
an unreleased study by government regulators.
Last
week, Merck abruptly recalled Vioxx, an arthritis treatment
and one of the companys top-selling drugs, after
an internal study showed that patients taking the drug
were more likely to suffer a cardiac event than those
taking a placebo.
The
Journals report, citing a study by the
Food and Drug Administration, said that from Vioxxs
approval in 1999 through 2003, an estimated 27,785 heart
attacks and sudden cardiac deaths would have been avoided
if Celebrex, a competing drug made by Pfizer Inc., had
been used instead of Vioxx.
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| October
5, 2004 |
Irish
Times, "Arthritis Drug Concerns Raised
Some Time Ago"
|
The
potential for cardiac side-effects with the arthritis
drug Rofecoxib, which was withdrawn from use last week,
has been known for some time, it was claimed yesterday.
A
number of doctors have contacted The Irish Times to
express their concern that the drug, which is marketed
here as Vioxx, was not withdrawn earlier. They said
they have been concerned about its safety and that of
other Cox II inhibitors for some time.
Vioxx
was withdrawn from use last Thursday after research
had shown that taking the drug long-term could increase
the risk of heart attack or stroke between three and
fourfold compared to patients taking a dummy pill. The
drug is one of the latest generation of non-steroidal
anti-inflammatory drugs.
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| October
2, 2004 |
Washington
Post, "Lawsuits for Vioxx use begin
to emerge"
|
The abrupt withdrawal last week of the best-selling
painkiller Vioxx is an event rich in ironies and lessons
that may ultimately lead to a rethinking of the way
drug safety is evaluated in the United States.
Drugs whose stated advantage is that they are safer
than their competitors -- which was Vioxx's claim --
are likely to get much closer scrutiny. The Food and
Drug Administration in the future may force companies
to run new, definitive clinical studies specifically
to address safety issues even after a drug is on the
market and in widespread use.
Vioxx, taken by 1.3 million Americans, was removed from
sale worldwide on Thursday because it raised the risk
of cardiovascular disease, the nation's leading cause
of death. Proof of that hazard did not come until five
years after the drug was licensed and three years after
the first hints of a problem.
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| October
1, 2004 |
The
Wall Street Journal, " Merck Pulls Vioxx
From Market After Link To Heart Problems"
|
On the morning of Sept. 24, Raymond Gilmartin, chief
executive of Merck & Co., got the call every pharmaceutical
executive dreads. Peter Kim, Merck's research chief,
told him an outside panel overseeing a clinical trial
of the company's painkiller Vioxx had urged Merck the
night before to halt the trial and immediately stop
patients from taking the drug.
The reason: Patients on the drug were twice as likely
to have a heart attack or stroke as those on a placebo.
Six days after that call, Merck announced that it is
withdrawing Vioxx from the world-wide market.
The drug had global sales of $2.5 billion in 2003 and
more than 100 million prescriptions have been written
for it since it went on the market in 1999, according
to Merck. But it had been dogged for several years by
suggestions that it led to heart problems. Until yesterday,
Merck vehemently denied there was a connection.
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| October
1, 2004 |
Newsday,
"Concerns over Vioxx raised in '01"
|
In February 2001, Dr. Steven Nissen of the Cleveland
Clinic was part of an advisory panel put together by
the Food and Drug Administration to address mounting
evidence suggesting the popular COX-2 inhibitor Vioxx
could increase risk of heart disease and stroke.
The drug had been approved two years earlier and millions
throughout the world were taking daily pills to reduce
the pain and inflammation of arthritis and other conditions.
Nissen told his colleague and chairman of cardiovascular
medicine, Dr. Eric Topol, that he was not satisfied
with the explanation put forth by Merck officials, who
said Vioxx wasn't harmful to the cardiovascular system.
According to Merck, comparison studies of Vioxx versus
naproxen, sold as Aleve, were actually picking up on
Aleve's protective effects on the heart, rather than
alleged harmful effects from Vioxx.
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| October
1, 2004 |
CNN.com,
"Merck faces lawsuit after Vioxx pulled"
|
An
Oklahoma lawsuit filed on Thursday charges that Merck
& Co. misled patients about the safety of its arthritis
drug. The case may signal many more such lawsuits against
the drugmaker, following its withdrawal of Vioxx, legal
experts said.
The
company said earlier on Thursday that the drug, used
by 2 million people worldwide, doubled the risk of heart
attack and stroke in a recent clinical trial.
The
suit, filed on behalf of an Oklahoma County resident
but likely to become a class-action effort, alleges
Vioxx raises the risk of heart attack, blood clots and
other serious cardiovascular events, which can lead
to injuries and death.
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| October
1, 2004 |
San
Francisco Chronicle, "Arthritis drug
Vioxx yanked off market"
|
Pharmaceutical
giant Merck & Co. abruptly ordered a worldwide recall
of its premier arthritis drug Vioxx on Thursday after
a company-run study confirmed that long-term use of
the pills increased risk of heart attack and stroke.
Vioxx
is taken by more than 2 million arthritis patients around
the world for the treatment of joint pain. It's one
of a new family of anti-inflammatory drugs known as
COX-2 inhibitors, which grew in popularity because they
cause fewer stomach problems than competing nonprescription
medicines such as naproxen or ibuprofen.
The
reason Vioxx causes a higher risk of heart problems
remains a mystery. However, one theory holds that such
drugs can disable a protective mechanism that keeps
blood cells from clumping together. A number of smaller
clinical studies have also detected increased rates
of high blood pressure among patients taking Vioxx compared
to those on Celebrex.
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| October
1, 2004 |
Forbes,
"Merck's Legal Nightmare"
|
Merck's
recall of its popular painkiller Vioxx after a big study
found it increased the risk of heart attacks and strokes
could set off the next big class-action feeding frenzy.
Virtually
every time a drug has been recalled because of side-effect
problems in recent years, the companies have faced legal
liability. The question for Merck and its investors
now is, How big will its legal bill be? The answer is
unknown but could potentially be huge, because Vioxx
was a popular drug used by millions of consumers. Overall,
84 million people worldwide have taken Vioxx worldwide
since it was approved in 1999.
"This
is going to be a nightmare of unbelievable proportions
in terms of legal liability" for Merck, says independent
analyst Hemant Shah of Warren, N.J., who was one of
the first to predict that Wyeth would face enormous
legal liability from its recall of the diet drugs fenfluramine
(part of the fen-phen combo) and Redux in 1997.
|
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| October
1, 2004 |
Associated
Press, "Merck Raises Vioxx Prescription
Estimate"
|
Merck & Co. on Friday raised its estimate of the
number of prescriptions written in the United States
for its recently recalled heart disease treatment Vioxx.
Merck said about 105 million U.S. prescriptions were
written for the drug from May 1999 through August 2004.
The drug giant said it has not determined the number
of prescriptions written outside of the United States.
Previously, Merck said the drug had been prescribed
about 84 million times since 1999. Merck recalled Vioxx
Thursday after a study showed it doubled the risk of
heart attacks and strokes.
|
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| October
1, 2004 |
Atlanta
Journal-Constitution, "Vioxx Users Can
Find Safe Alternatives"
|
A day after one of the largest drug recalls in history,
America's two million Vioxx users are left wondering
what's next in terms of relieving their arthritis pain.
Fortunately, a wide range of safe, effective treatment
alternatives are waiting on drugstore shelves, experts
say.
"There are several anti-inflammatory medicines
that have the same effect as Vioxx, and several in the
same class of cox-2 inhibitors," said Dr. Michael
Fleming, president of the American Academy of Family
Physicians.
|
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| September
30, 2004 |
Bloomberg.com,
"Merck to Withdraw Vioxx Because
of Heart Risks"
|
Merck
& Co. withdrew its Vioxx painkiller, which generated
$2.5 billion in sales last year, because of a link to
heart attacks and strokes. The company's shares slid
as much as 28 percent, wiping out $28 billion in market
value.
New three-year data from Merck suggested that patients
taking Vioxx for more than 18 months faced twice the
risk of a heart attack compared with those taking a
placebo. The Whitehouse Station, New Jersey-based company
retracted its third-quarter profit forecast and cut
its full-year estimate by 50 cents to 60 cents a share,
spokesman Tony Plohoros said.
The U.S. Food and Drug Administration issued an advisory,
urging Vioxx users to consult with a doctor about alternative
medications.
|
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|
September
25, 2001
|
USA
Today, "FDA sends warning letter to Vioxx
maker"
|
The
Food and Drug Administration has ordered Merck, maker
of the blockbuster painkiller Vioxx, to issue a letter
to doctors "to correct false or misleading impressions
and information" stemming from the drug's promotional
campaign.
Merck's
marketing efforts, aimed mainly at doctors, have minimized
Vioxx's known and potential cardiovascular risks,
the FDA wrote in an eight-page "warning letter" faxed
Sept. 17 to Raymond Gil- martin, president and chief
executive officer. The letter, signed by Thomas Abrams,
head of the FDA's Division of Drug Marketing, Advertising
and Communications, was posted Friday on the FDA Web
site.
So far this year, the FDA has sent drug companies
fewer than a dozen warning letters, which the agency
reserves for activities that raise significant public
health concerns.
According to the Sept. 17 warning letter, a doctor
under contract with Merck to present talks to other
physicians, company sales representatives and a press
release have minimized the possibility that Vioxx
could increase users' risk of heart attacks or strokes.
|
|
|
| September
3, 2004 |
Atlanta
Journal-Constitution, "FDA Nod Won't
Guarantee Drug Safety"
|
A
60-year-old woman with degenerative disk disease recently
came into Dr. Allen Lebovits' Manhattan office with
a complaint. This time, the grievance wasn't about the
pain but about news reports linking Vioxx, her pain
reliever, with an increased risk of heart attacks and
sudden cardiac deaths.
Lebovits
expects to see more reactions just like this in the
wake of new reports that heart attack rates and sudden
cardiac deaths were tripled in patients taking Vioxx
vs. those taking a similar drug, Celebrex. Both are
in the class of medications known as cox-2 inhibitors.
But
Vioxx was not the only drug to get bad press this week.
A study released early from the Sept. 15 issue of the
Journal of the American Medical Association reported
that people who took a high dose (80 milligrams daily)
of Zocor, a cholesterol-lowering statin, had an increased
risk of muscle-related complications without any increased
benefit.
Both
Vioxx and Zocor are U.S. Food and Drug Admininstration-approved
blockbuster drugs.
|
| |
| August
27, 2004 |
Forbes,
"Vioxx Safety Debate Renewed After FDA Report"
|
A new study linking high doses of Vioxx to an increased
risk of heart attacks and sudden cardiac deaths has
re-ignited a running debate about the safety of the
arthritis drug.
The study of 40,500 people enrolled in Kaiser Permanente,
the nation's largest health management organization,
found that heart attack rates and sudden cardiac deaths
were tripled in patients taking Vioxx in doses higher
than 25 milligrams a day compared to those taking a
competing drug, Celebrex.
The study was done by personnel at the U.S. Food and
Drug Administration, who said that "this and other
studies cast serious doubt on the safety" of Vioxx
and that Celebrex "may be safer."
Merck & Co., which markets Vioxx, "strongly
disagrees" with the findings of the new study,
according to a statement by Peter S. Kim, president
of Merck Research Laboratories. He faulted the study
as being merely observational, looking back at medical
records, rather than a randomized, controlled clinical
trial, "the gold standard to evaluate safety and
efficacy."
|
| |
| August
27, 2004 |
San
Jose Mercury News, "Arthritis drug linked
to higher heart risks"
|
California health care giant Kaiser Permanente is likely
to advise its doctors not to prescribe the popular arthritis
drug Vioxx after a medical study of Kaiser members found
the medicine may increase the risk of life-threatening
heart problems.
The study, led by the federal Food and Drug Administration,
found that people taking higher doses of Vioxx had more
than triple the risk of heart attack or sudden cardiac
death when compared with people who had not recently
used the prescription medicine or similar painkillers.
Some researchers have questioned the safety of Vioxx
before, but the findings from this new study are likely
to broaden those concerns. Given the study's size --
almost 1.4 million Kaiser patients in California, with
more than 26,700 taking Vioxx -- other insurers are
likely to join Kaiser in reconsidering their position
of the drug. Doctors and federal regulators said they
might re-examine the drug.
|
| |
| August
27, 2004 |
NBC
10 (Philadelphia, Pennsylvania), "Vioxx
Linked To Increased Cardiac Deaths"
|
A new study shows that the prescription drug Vioxx can
drastically increase a person's risk of sudden cardiac
death, and that risk is greater if you take a higher
dose, or if you take it for a long time.
The Food and Drug Administration funded the study. The
study looked at medical records of 1.4 million people.
People taking low doses of Vioxx, less than 25 milligrams
daily, had a 50 percent higher risk of heart attack
and sudden cardiac death, compared to those taking Celebrex.
Both drugs are COX-2 inhibitors, which reduce inflammation
in arthritic joints.
"All medications are poisons, and they should be
taken for the shortest period of time that you can,"
said Dr. Vincent Zarro, a rheumatologist at Drexel University
College of Medicine.
Zarro says elderly patients, especially those taking
diuretics or anti-hypertensive medication, are at the
highest risk.
"At this point, I would advise my patients to avoid
taking Vioxx or other nonsteroidal anti-inflammatory
drugs," Zarro said.
|
| |
|
July
14, 2004
|
WebMD
News, "Painkiller Vioxx Often Taken
at Too High Dose"
|
Evidence
continues to grow that the popular pain reliever Vioxx
may cause high blood pressure, swelling, and other
health problems. And with the latest study, there's
a new concern: High rates of misuse of the popular
arthritis remedy, with many patients taking daily
doses at twice the usual recommended level.
And
it's not that they are necessarily "doubling
up" their prescribed doses for better pain relief.
Researchers at Vanderbilt University Medical Center
say that patients are often being prescribed the highest
50 milligram dose by their doctors for daily pain
relief.
|
|
|
| Lieff
Cabraser: Experienced Product Liability Lawyers |
| Founded
in 1972, Lieff Cabraser Heimann & Bernstein, LLP is
a nearly sixty attorney law firm with offices in San Francisco,
New York, Washington, D.C., Beverly Hills, and Nashville.
In 2003 and 2004, the National Law Journal recognized
Lieff Cabraser as one of the top 20 plaintiffs law
firms in America. |
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In addition, we have on staff multiple nurses, legal assistants,
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Cabraser Heimann & Bernstein, LLP
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© 2004-2005 Lieff Cabraser Heimann & Bernstein,
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|
"Researcher
says 139,000 harmed by Vioxx," Reuters,
Jan. 3, 2005
Just weeks after Forbes announced Merck's
Vioxx liability could reach US$38 billion,
the U.S. drug safety officer who warned months
ago about risks from Merck & Co. Inc.s
painkiller Vioxx has won clearance to publish
a study arguing the now-recalled drug may have
caused up to 139,000 excess cases of heart attacks
and strokes. More...
To read more press articles on the Vioxx recall
and Vioxx class action lawsuit, click
here. |
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Cabraser has participated in twenty-three $100
million-plus settlements and verdicts. To read
a summary, click here. |
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