Study Links Certain Painkillers to High Cholesterol Levels

Study Links Certain Painkillers to High Cholesterol Levels
Date Published: Tuesday, February 13th, 2007

A new study published last month in the journal Arthritis Research & Therapy sheds new light on why the class of painkillers known as COX-2 inhibitors may lead to an increased incidence of heart attacks. Researchers at Winthrop-University Hospital in Long Island have determined that controversial drugs such as Vioxx and Bextra may impede the body’s ability to purge excess cholesterol.

“To our knowledge, this is the first study that describes the effects of COX inhibition on reverse cholesterol transport proteins,” the authors wrote. “Our results suggest that the cardiovascular hazard observed with COX inhibitors may result not only from enhanced platelet aggregation [blood clots], but also from interference with cholesterol outflow.”

Drugs such as Vioxx and Bextra were commonly prescribed in the treatment of arthritis pain before they were each removed from the market by the FDA due to safety concerns. The new research suggests that these medications block the patient’s ability to process lipid loads, allowing cholesterol to build up. To this point, researchers have focused on the risk of blood clotting as the leading cause of cardiovascular problems in these patients. “Increased cardiovascular risk with COX inhibition may be ascribed at least in part to altered cholesterol metabolism,” they claim.

“Selective COX-2 inhibitors reduce pain, stiffness, and inflammation with efficacy equivalent to non-selective NSAIDs, but with reduced gastrotoxicity,” the researchers note. “Unfortunately, adverse effects on coronary heart disease risk with prolonged use of COX-2s may offset any gastrointestinal benefit.”

Vioxx whistle-blower weighs in on demoted antibiotic Ketek

By Rita Rubin, USA TODAY
More than two years after David Graham told a Senate panel that the Food and Drug Administration was "incapable of protecting America against another Vioxx," the FDA scientist was back on Capitol Hill on Tuesday to tell a House panel that "nothing has really changed."
The nearly five-hour hearing before the House Subcommittee on Oversight and Investigations was only the first in what chairman Bart Stupak, D-Mich., says will be a series to "evaluate the Food and Drug Administration's ability to safely approve new drugs and provide post-marketing surveillance."

No FDA or drug company representatives were asked to speak at Tuesday's hearing, a decision that drew criticism from some committee members. "I'm disappointed that neither the FDA nor the manufacturer of Ketek … were invited to tell their side," said Rep. Michael Burgess, R-Texas, who is a physician. "We must be cautious not to come to conclusions today."

Much of the testimony centered on the antibiotic Ketek, which has been linked to liver failure and other adverse side effects.

On Monday, the FDA announced that Ketek was no longer approved to treat sinusitis or bronchitis, because its potential risks outweigh any benefits for these fairly benign conditions. Ketek, approved in April 2004, remains on the market only to treat pneumonia acquired outside a hospital or nursing home.

"FDA approved Ketek, despite knowing that it could kill people from liver damage and that tens of millions of people would be exposed to it," physician David Ross, who had worked on the pre-approval side of FDA's Center for Drug Evaluation and Research (CDER) for a decade, told the panel. Ross said his superiors forced him to soften his unflattering review of the drug.

Lisa Kennedy, of Ketek maker Sanofi Aventis, told USA TODAY that Ketek can't be compared with Vioxx, the blockbuster arthritis drug pulled off the market in September 2004, because an FDA advisory panel in December supported the antibiotic's continued use for pneumonia.

Graham told panel members that CDER "regards industry as the agency's main client." Asked if he had concerns about other drugs, Graham said off-label use of atypical anti-psychotic medications to sedate nursing home residents kills roughly 15,000 people a year.

He also cited Zyprexa, used to treat schizophrenia and bipolar disorder, because, he said, maker Eli Lilly has known for years that the drug causes weight gain that leads to diabetes.

Lilly said in a statement that ever since Zyprexa was approved in 1996, its label has noted that weight gain and diabetes were observed in clinical trials.

Panel members asked Graham to submit the names of other potentially dangerous drugs. In an interview afterward, Graham declined to name the drugs before alerting the panel. He said he plans to submit his list next week after canvassing his colleagues to see if any drugs are "bugging" them.

Doctors warned: take care with freebies

February 13, 2007 - 9:49AM

Samples of prescription drugs given out as freebies by doctors are often used incorrectly by patients confused by poor labelling, an independent review has found.

The review's report has cautioned that the "starter packs" of new medications handed out by pharmaceutical marketers can be responsible for delays in vital treatment.

It outlines a series of complaints of "medicine misadventure" made to the adverse medicines events hot line over a two-year period.

"The most commonly reported problems were drug samples being supplied to patients with inadequate information regarding dosage, administration, storage and possible adverse effects," the report, published in the industry bulletin Australian Prescriber, says.

"In addition, some patients were given excessive quantities of a drug."

In one of 13 cases outlined, a 50-year-old woman took home an unlabelled sample of the anti-psychotic drug, Seroquel, prescribed for schizophrenia, believing it was pain relief to be taken "as required".

A 32-year-old women was given samples of the same drug, another antidepressant Fluoxetine and the anti-anxiety drug Rivotril and took all three at once.

"Patient took the drugs for three weeks concurrently before questioning how best to take them and what the potential adverse effects were," the report states.

A 28-year-old male patient was given four starter packs of the anti-depressant Luvox to "take the edge off" but he didn't take the drugs because he had inadequate product information.

At least two complaints related to the controversial anti-arthritis drug Vioxx, which was withdrawn worldwide in 2004, after it was linked to increased risk of heart problems.

Drug samples were not regulated at the time the complaints were laid, but a Medicines Australia spokeswoman said a new code of practice had been introduced in December.

"Starter packs supplied from then should include that information," she said.

Drug samples are big business, with US statistics showing manufacturers spent $US10.5 billion ($A13.55 billion) on the marketing strategy in 2001.

© 2007 AAP

Merck Pharmaceutical Drug War Comes to Heartland -- First Vioxx Trial in Midwest Announced

The upcoming wrongful death lawsuit, Schwaller vs. Merck & Co, will be the first Vioxx case to be tried in the Illinois Circuit Court in Madison County and the first anywhere in the Midwest. It is possible that this case will set the tone for how Merck will handle cases in the future.

St. Louis, MO (PRWeb) February 12, 2007 -- The legal war between drug manufacturers and people who use the drugs has now moved into the heartland of America. The law firm of Brown & Crouppen www.BrownandCrouppen.com along with lawyers from the Watts Law Firm www.Wattslawfirm.com and Beasley Allen www.BeasleyAllen.com will begin the first Vioxx case to be tried in the Midwest beginning Tuesday, February 20th. . Until now most Vioxx cases filed against the giant drug maker Merck & Co. have been tried on the east and west coasts and New Orleans.

The Role of Litigation in Defining Drug Risks
"This is the first time that this war has been fought in the heart of America and it's possible that this case will set the tone for how Merck will handle cases in the future," said Andy Crouppen, attorney for Brown & Crouppen, the law firm representing the case of Schwaller vs. Merck & Co.

The upcoming wrongful death lawsuit, Schwaller vs. Merck & Co, Madison County ILL Case No. 05-L-687,will be the first Vioxx case to be tried in the Illinois Circuit Court in Madison County and the first anywhere in the Midwest. Brown & Crouppen has a long history in standing up for the consumer in drug litigation.

The case of Patricia Schwaller, a 52-year-old mother of two adult children, who died suddenly of a heart attack on August 8, 2003, will be tried by a trial team assembled by Brown and Crouppen consisting of Mikal Watts of The Watts Law Firm, Andy Birchfield of Beasley Allen and John Driscoll of Brown & Crouppen. She had been taking the drug Vioxx for just over 20 months. Schwaller was a long-time resident of Granite City, Ill in Madison County. Frank Schwaller, her spouse, is the plaintiff.

Merck, the number four (4) U.S. drug maker, withdrew Vioxx in 2004 when a study showed it raised the risk of heart attacks and strokes. Merck faces a reported 27,000 Vioxx lawsuits. So far Merck & Co. has gone to court with 13 plaintiffs.

"One must understand the importance of this type of litigation," said Crouppen, attorney for Brown & Crouppen. "The money awarded to the plaintiff might be a better 'headline,' but it is secondary to the thousands of lives it saves a year by ensuring that dangerous drugs are detected and either labeled or pulled."

A report by the Journal of American Medical Association (JAMA) January 17, 2007 titled "The Role of Litigation in Defining Drug Risks" seems to support this statement. A summary statement says "…limiting legal involvement in the prescription drug arena is likely to increase the nation's problem of poorly defined or inadequately presented drug risk information. These case studies indicate that clinical trials and routine regulatory oversight as currently practiced often fail to uncover important adverse effects for widely marketed products. In each instance, the litigation process revealed new data on the incidence of adverse events, enabled reassessments of drug risks through better evaluation of data, and influenced corporate and regulatory behavior. In performing these tasks, lawyers and their clients often find themselves serving as the drug safety researchers of last resort."

A love story-that has died- Patricia Schwaller graduated from Granite City High School in June 1969 and married Frank, her high school sweetheart, that same year. After discharge from the service, Frank often worked the night shift. Patricia would stay up to wake Frank in time for work and make his lunch - Patricia lovingly put mustard "hearts" on his sandwiches. During the last year or so of Patricia's life, her interests included her family, going to the theater with friends, relaxing in the pool, and enjoying a comfortable life-style with Frank. They had two children, Melissa and Jonathon, now grown. Frank has never recovered from Patricia's sudden death and the loss of the times they shared. He does not know what to do with his life. Patricia will be missed by many.

Other Vioxx lawsuits have alleged that Merck & Co. failed to heed warning signs about the cardiovascular risks of its painkiller before rushing it to market, alleging the drug maker failed to warn doctors and patients of the medicines harmful effects. Also, alleging that the popular pain-relieving drug Vioxx caused heart attacks.

Brown and Crouppen has a successful track record in Madison County, with a 19 million dollar verdict in a trial just two years ago. For more information about the firm and for daily updates on the progress of Schwaller vs. Merck & Co, please visit www.brownandcrouppen.com.

Merck Pharmaceutical Drug War Comes to Heartland -- First Vioxx Trial in Midwest Announced

The upcoming wrongful death lawsuit, Schwaller vs. Merck & Co, will be the first Vioxx case to be tried in the Illinois Circuit Court in Madison County and the first anywhere in the Midwest. It is possible that this case will set the tone for how Merck will handle cases in the future.

St. Louis, MO (PRWeb) February 12, 2007 -- The legal war between drug manufacturers and people who use the drugs has now moved into the heartland of America. The law firm of Brown & Crouppen www.BrownandCrouppen.com along with lawyers from the Watts Law Firm www.Wattslawfirm.com and Beasley Allen www.BeasleyAllen.com will begin the first Vioxx case to be tried in the Midwest beginning Tuesday, February 20th. . Until now most Vioxx cases filed against the giant drug maker Merck & Co. have been tried on the east and west coasts and New Orleans.

The Role of Litigation in Defining Drug Risks
"This is the first time that this war has been fought in the heart of America and it's possible that this case will set the tone for how Merck will handle cases in the future," said Andy Crouppen, attorney for Brown & Crouppen, the law firm representing the case of Schwaller vs. Merck & Co.

The upcoming wrongful death lawsuit, Schwaller vs. Merck & Co, Madison County ILL Case No. 05-L-687,will be the first Vioxx case to be tried in the Illinois Circuit Court in Madison County and the first anywhere in the Midwest. Brown & Crouppen has a long history in standing up for the consumer in drug litigation.

The case of Patricia Schwaller, a 52-year-old mother of two adult children, who died suddenly of a heart attack on August 8, 2003, will be tried by a trial team assembled by Brown and Crouppen consisting of Mikal Watts of The Watts Law Firm, Andy Birchfield of Beasley Allen and John Driscoll of Brown & Crouppen. She had been taking the drug Vioxx for just over 20 months. Schwaller was a long-time resident of Granite City, Ill in Madison County. Frank Schwaller, her spouse, is the plaintiff.

Merck, the number four (4) U.S. drug maker, withdrew Vioxx in 2004 when a study showed it raised the risk of heart attacks and strokes. Merck faces a reported 27,000 Vioxx lawsuits. So far Merck & Co. has gone to court with 13 plaintiffs.

"One must understand the importance of this type of litigation," said Crouppen, attorney for Brown & Crouppen. "The money awarded to the plaintiff might be a better 'headline,' but it is secondary to the thousands of lives it saves a year by ensuring that dangerous drugs are detected and either labeled or pulled."

A report by the Journal of American Medical Association (JAMA) January 17, 2007 titled "The Role of Litigation in Defining Drug Risks" seems to support this statement. A summary statement says "…limiting legal involvement in the prescription drug arena is likely to increase the nation's problem of poorly defined or inadequately presented drug risk information. These case studies indicate that clinical trials and routine regulatory oversight as currently practiced often fail to uncover important adverse effects for widely marketed products. In each instance, the litigation process revealed new data on the incidence of adverse events, enabled reassessments of drug risks through better evaluation of data, and influenced corporate and regulatory behavior. In performing these tasks, lawyers and their clients often find themselves serving as the drug safety researchers of last resort."

A love story-that has died- Patricia Schwaller graduated from Granite City High School in June 1969 and married Frank, her high school sweetheart, that same year. After discharge from the service, Frank often worked the night shift. Patricia would stay up to wake Frank in time for work and make his lunch - Patricia lovingly put mustard "hearts" on his sandwiches. During the last year or so of Patricia's life, her interests included her family, going to the theater with friends, relaxing in the pool, and enjoying a comfortable life-style with Frank. They had two children, Melissa and Jonathon, now grown. Frank has never recovered from Patricia's sudden death and the loss of the times they shared. He does not know what to do with his life. Patricia will be missed by many.

Other Vioxx lawsuits have alleged that Merck & Co. failed to heed warning signs about the cardiovascular risks of its painkiller before rushing it to market, alleging the drug maker failed to warn doctors and patients of the medicines harmful effects. Also, alleging that the popular pain-relieving drug Vioxx caused heart attacks.

Brown and Crouppen has a successful track record in Madison County, with a 19 million dollar verdict in a trial just two years ago. For more information about the firm and for daily updates on the progress of Schwaller vs. Merck & Co, please visit www.brownandcrouppen.com.

Federal Court Tosses Vioxx Suit

THE HEARTLAND INSTITUTE
19 South LaSalle Street #903
Chicago, IL 60603
phone 312/377-4000 · fax 312/377-5000
http://www.heartland.org


Federal Court Tosses Vioxx Suit

Author: John Dale Dunn, M.D., J.D.
Published by: The Heartland Institute
Published in: Health Care News
Publication date: February 2007

On November 22, a federal judge refused to certify a national class-action lawsuit filed on behalf of thousands of plaintiffs from various states. The suit claimed the plaintiffs had been injured by the arthritis drug Vioxx, manufactured by Merck.

Judge Eldon Fallon of the U.S. District Court in New Orleans instructed the plaintiffs to file lawsuits in their various home states, refusing in his 26-page ruling their request to try all the cases in one class action under New Jersey law. Merck is headquartered in New Jersey.

Critics say class-action lawsuits are a strategy of intimidation and extortion, and a way to shop for a favorable forum. Federal courts have become increasingly strict in applying class-action criteria, requiring plaintiffs to have a predominant, common claim and pattern of injury.


Unique Claims

In his ruling, Fallon pointed out that each individual's claim is unique. Therefore, he noted, one court would be forced to try thousands of cases where injuries, damages, and claims of negligence or liability would hinge on individual issues of fact.

"[E]ven if New Jersey law could be applied to the entire class," Fallon wrote, "individualized factual issues concerning specific causation and damages dominate this litigation and create independent hurdles to certification."

Though Fallon said he did not doubt there were common issues, it did not change the fact that claims would be unique depending on the damage suffered and how that damage related to the allegations of failure to warn, and whether the risks known by the defendant and the prescribing physician pertained to the damages suffered.


Slight Risk

The Vioxx claims arose from a long-term study showing the drug suppressed colon polyps but slightly increased the study subjects' risk of suffering heart attacks and other cardiovascular events.

The slight increase of cardiovascular problems identified in the research caused public anxiety, and Merck withdrew Vioxx from the market in September 2004. Merck is now facing more than 27,000 claims of injury from former Vioxx users.

Vioxx was found to be a beneficial drug for arthritis eight years ago, causing less intestinal irritation and bleeding than other drugs of its type. Millions of patients used Vioxx continuously or intermittently for their arthritis.

In 2003, Vioxx generated $2.5 billion in revenue for the company--11 percent of its $22.49 billion in annual revenue at that time.


Rational Decisions

Gil Ross, M.D., medical and executive director of the American Council on Science and Health--a public health advocacy group based in New York City--has been watching the Vioxx case closely.

Though he declined comment on its legal subtleties, Ross pointed out, "since the news of the drug's cardiovascular risks broke, other studies have shown increased cardiovascular risk for the entire Cox-1 class of drugs" marketed under the trade names Motrin, Naproxen, and Aleve, to name just a few.

"Are the lawyers going to go after those drugs on the same theory applied to Vioxx litigation?" Ross asked.

Ross added that he supports Pfizer's decision not to withdraw Celebrex--a similar, popular drug that has the same cardiovascular risks as those associated with Vioxx. Ross pointed out every drug, and most therapies, have risks and benefits.

"The Vioxx story is unfortunate," Ross said, "because it sacrificed rational medical decision-making to a litigation agenda and created public panic."

Dr. John Dale Dunn (jddmdjd@web-access.net), an inactive attorney, teaches emergency medicine at Fort Hood, Texas and is a member of the Science and Policy Advisory Board of the American Council on Science and Health.

For more information ...

Judge Eldon Fallon's decision for the United States District Court for the Eastern District of Louisiana, In Re: Vioxx Products Liability Litigation, issued November 22, 2006, is available through PolicyBot™, The Heartland Institute's free online research database. Point your Web browser to http://www.policybot.org and search for document #20367.

Vioxx set to take center stage in Madison County

Vioxx set to take center stage in Madison County

Thursday, February 08, 2007

By Steve Gonzalez

Madison County Circuit Judge Daniel J. Stack


Attorney John Driscoll


Attorney Dan Ball
Plaintiff's attorney John Driscoll of Brown & Crouppen will try to convince a jury that Vioxx caused or significantly contributed to the death of Frank Schwaller's wife in Madison County's first trial against Merck over the recalled arthritis pain reliever.

The high stakes trial, likely to capture national attention, will last at least six weeks. The court's most experienced handler of complex litigation Circuit Judge Daniel Stack will preside over the dramatic stage, set to open Feb. 20.

Jurors will report to the courthouse that day and will have a week to fill out jury questioners. They will return Feb. 26, when voir dire -- juror interviews -- begins.

Vioxx was pulled from the market in September 2004 because studies indicated it could contribute to heart ailments. Since then it has been targeted in thousands of lawsuits across the country.

While the pharmaceutical is under siege in court, a recent study by the Competitive Enterprise Institute offered moral support for Merck by reporting that an overwhelming majority of orthopedic surgeons surveyed believe Vioxx should still be on the market. (See related story).

Vioxx is the brand name of rofecoxib, one of a class of drugs called prostaglandins which work to reduce inflammation and pain by providing analgesic and anti-inflammatory benefits to people who suffer from arthritis and muscle pain.

Vioxx was introduced in the United States in 1999. Vioxx is a Cyclo-Oxygenase-2 (cox2) inhibitor and was used to treat arthritis and is in the class of drugs called NSAIDs (non-steroidal anti-inflammatory). Other NSAID drugs include Ibuprofen, Celebrex and Aleve.

In the upcoming Madison County trial, Schwaller claims Merck failed to effectively warn users and doctors that numerous other methods of pain relievers, including Ibuprofen, Naproxen and Mobic were safer.

He claims Vioxx was defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings, which subjected users to risks of heart attacks, strokes and other illnesses.

Schwaller is seeking at least $250,000 for Merck's alleged violations of Illinois Consumer Fraud Act, product liability, negligent design and negligent failure to warn.

He claims his wife was unaware of the "dangerous propensities" of the product until well after her use and medical conditions requiring hospitalization.

Schwaller also claims that Merck did not accurately reflect the symptoms, type, scope, or severity of the side effects and also claims Merck failed to perform adequate testing prior to marketing Vioxx.

"Merck also failed to act properly on adverse reports it received about Vioxx, and failed to properly study pre-market as well as post-market studies," Schwaller's complaint notes.

Trial outcomes have so far produced mixed results.

On Aug. 19, 2005, a jury awarded Texas widow $253.4 million in damages in the first Vioxx trial.

In November 2005, Merck won the second case that went to trial in New Jersey. The jury ruled that Merck had adequately warned doctors and patients of the drug's risk.

In January 2006, a Texas jury awarded a 71-year-old smoker with heart disease $7 million compensatory and $25 million punitive damages. The plaintiff in that case had a fatal heart attack three weeks after finishing a one-week sample of Vioxx.

In a federal trial in February 2006, a jury found Merck not liable after the case was first tried in a Houston court, but resulted in a hung jury.

Merck has reserved $970 million to pay for its Vioxx-related legal expenses through the end of this year.

They will be represented by Dan Ball, Dan Nester and Stephen Strauss of Bryan Cave in St. Louis.

George Tsougarakis of Hughes, Hubbard & Reed in New York will also represent Merck.

Driscoll will have help from Andy D. Birchfield, Jr., and Patricia Leigh O'Dell of Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Ala.

U.S. jury awards millions in Vioxx lawsuit

U.S. jury awards millions in Vioxx lawsuit

By LEONARD ZEHR

Saturday, August 20, 2005 Updated at 2:03 AM EDTKey

From Saturday's Globe and Mail

Drug giant Merck & Co. Inc. has suffered a severe setback in the first of thousands of lawsuits in the United States and Canada as a Texas jury awarded more than $253-million (U.S.) to the family of a man who died after taking the company's Vioxx painkiller.

In a groundbreaking decision, the seven-man, five-woman jury found Merck liable in the death of 59-year-old Robert Ernst. They rejected Merck's argument that Mr. Ernst died of clogged arteries rather than a Vioxx-induced heart attack that led to his fatal arrhythmia, or irregular heart beat.

Merck yanked Vioxx, a $2.5-billion a year blockbuster, from markets worldwide in the fall of 2004, after a long-term study showed it could double the risk of heart attack or stroke if taken for 18 months or longer.

“This loss means that this particular jury believed the plaintiff's story about the company's wrongful conduct, which we believe will carry into the future,” said Windsor, Ont. lawyer Greg Monforton, whose firm has some 200 Vioxx clients across Canada.

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“The verdict against Merck is very encouraging news for all Canadians who have suffered heart attacks or strokes while taking Vioxx,” he added.

Some four dozen claims have been filed in Canada against Merck by a consortium of law firms. The cases, however, have not yet been consolidated into a single class action. Mr. Monforton said his clients may proceed individually or join a class action.

Merck put a great deal of energy into its defence in Texas on the grounds that a victory would have discouraged lawsuits in the future. “However, the net result is the opposite,” Mr. Monforton said. “Now that we have a jury verdict, it will embolden a lot of individuals to come forward with their claims.”

That prospect prompted investors to dump shares of Merck on the New York Stock Exchange yesterday. The stock price sank $1.16, or 4 per cent, to $29.25.

Robert's widow, Carol Ernst, began to cry when the verdict was read while her attorneys jumped up and shouted, “Amen!”

Mr. Ernst was a produce manager at Wal-Mart and a marathon runner who died in May, 2001 after taking Vioxx for eight months to alleviate pain in his hands. The couple had been married for less than a year.

Merck has vowed to fight each case individually, claiming that adverse cardiac events were caused by a patient's pre-existing condition and not by Vioxx. It said it plans to appeal the Texas ruling.

“There is no reliable scientific evidence that shows Vioxx causes cardiac arrhythmias, which an autopsy showed was the cause of Mr. Ernst's death, along with coronary atherosclerosis,” said Jonathan Skidmore, a member of Merck's defence team.

The jury award consisted of $24.4-million in actual damages and $229-million in punitive damages.

“This case did not call for punitive damages,” Mr. Skidmore said. “Merck acted responsibly and in the best interest of patients, from researching Vioxx prior to approval in clinical trials involving almost 10,000 patients, to monitoring the medicine while it was on the market, and to voluntarily withdrawing the medicine when it did.”

Legal experts suggest the jury award was excessive and will probably be reduced on appeal. They said Texas law caps punitive damages to twice actual damages. The U.S. Supreme Court has ruled punitive damages should usually be limited to nine times actual damages.

Vioxx was used by more than 20 million people. It and Pfizer Inc.'s Celebrex commanded the lion's share of the pain reliever market in the past five years. Pfizer has rejected studies linking high doses of Celebrex with an increased risk of stroke or coronary disease.

Legal experts said the Texas decision is especially damaging because Merck initially had been expected to win what was considered a weak case linking Vioxx to arrhythmia. And the next two cases Merck faces appear somewhat stronger, they say. A trial begins next month in Atlantic City, N.J., over a former U.S. Marine's claims that Vioxx caused his heart attack.

In November, the first of 1,800 federal cases will be heard in New Orleans. It revolves around Richard Irvin, a Florida man who was taking Vioxx for a month before his 2001 death from a blood clot in his heart. Scientists have speculated that Vioxx causes cardiovascular problems because it blocks a substance that keeps blood from clotting.

With a report from Associated Press

Moran sets trial date in Vioxx, but Walgreens wants out

Moran sets trial date in Vioxx, but Walgreens wants out

Thursday, September 01, 2005

By Steve Gonzalez - Edwardsville Bureau

Circuit Judge George Moran
While it doesn't appear that a Vioxx trial will get under way any time soon in Madison County, a frequent Merck co-defendant, Walgreens, is asking Circuit Court Judge George Moran to be dismissed from a suit scheduled for trial in 2007.

Dick Donohoo of East Alton filed an 11-count suit Feb. 4, claiming his use of the arthritis pain reliever Vioxx caused him to suffer heart damage. Merck pulled the drug from the market almost a year ago and ever since, the pharmaceutical has been the target of thousands of lawsuits across the country.

In the nation's first Vioxx trial, a Texas jury recently awarded more than $250 million to a consumer's widow, but the whopping judgment was whittled down because of the state's cap on damages law.

According to Donohoo's suit, he claims he suffered a heart attack and stroke at age 67.

"His heart attack and stroke were caused or significantly contributed to be caused by Vioxx." He states the Vioxx was purchased from a Madison County Walgreen's.

Walgreens, according to Donohoo, was negligent because it sold a defective product and was in breach of warranty.

In its April 15 motion to dismiss, which will finally be heard Sept. 8, Walgreens claims Donohoo does not allege when Vioxx was sold to him, when he ingested the medication, or where he suffered his heart attack or strokes.

“Donohoo’s complaint fails to allege the date which he last received a prescription for Vioxx, however, based on the natural inferences of his allegations, Donohoo’s claim for breach of warranty is barred as he does not allege the Vioxx in question was purchased within two years of the alleged injuries,” the motion states.

Walgreens also claims that both state and federal courts in Illinois have held that pharmacists and pharmacies are not strictly liable under product liability theories of failure to warn or the “unreasonably dangerous” condition of prescription medication, if the medicine in question is dispensed as ordered by the prescribing physician.

“Donohoo does not allege that Walgreens filled the Vioxx prescriptions in question in any other way other than was ordered by the prescribing physician.”

Walgreens also claims that Donohoo fails to state a proper claim for breach of express warranty because he does not allege that the medication was not effective in treating the medical condition for which it was purchased.

Walgreens is represented by John Cunningham of Brown & James of Belleville.

Donohoo is represented by Jeffrey Lowe of St. Louis, Joseph Danis of St. Louis, Evan Buxner of Walther Glenn in St. Louis and Evan Schaeffer and Andrea Lamere of Godfrey.

Filipino Witness Doomed Vioxx

Filipino Witness Doomed Vioxx

News Report,
Filipino Reporter, Sep 01, 2005
The crucial testimony of Dr. Maria Araneta, the Filipino coroner who conducted the autopsy on a Texas man who died while taking Vioxx, helped convince a Texas jury last Aug. 20 to return a stunning $254.4 million verdict against pharmaceutical giant Merck & Co. in the first trial involving health risks from the popular pain reliever.

The jury award to the man’s widow, Carol Ernst, is the largest ever against the New Jersey-based drugmaker, which faces more than 4,000 other Vioxx-related suits in state and federal courts. It is also one of the largest damage awards ever to a single plaintiff.

The Manila-born Araneta testified on video that Robert Ernst, who died from an irregular heartbeat in 2001, more likely died from arrhythmia caused by a heart attack while taking Vioxx for eight years.

At the time of Ernst’s death, Araneta was assistant coroner with the Johnson County Medical Examiner’s Office and performed autopsies at Walls Regional Hospital in Cleburne near Fort Worth, Texas, where she worked from 1994 to 2002.

A graduate of the University of the Philippines-Philippine General Hospital (UP-PGH), Araneta moved to Abu Dhabi in the Middle East, and was only flown by the plaintiff’s legal team to Angleton, Texas — 40 miles south of Houston — to testify.

Plaintiff’s lawyer Mark Lanier hired a private investigator to find Araneta. Lanier then persuaded the Filipina doctor to return to Texas, telling her she’s “going to make such a good witness.”

Two days later, Araneta gave a videotaped deposition in which she said she believed that Ernst had actually died of a heart attack, despite her autopsy finding, which was devastating to Merck’s defense. Araneta’s testimony also helped cement Lanier’s place as one of the top civil trial lawyers in America.

Merck pulled Vioxx from the market in September last year when a study showed it doubled risk of heart attack or stroke if taken 18 months or longer. But Merck contends no studies link Vioxx to arrhythmia based on Araneta’s testimony, and therefore the drug couldn’t have caused Ernst’s death.

In the private deposition last July 26, Araneta testified that arrhythmia, the clinical term for an irregular heartbeat, “does not spontaneously occur.” She testified that “something must trigger it.” Her opinion counters Vioxx maker Merck & Co.’s reliance on her report to bolster its position that Ernst didn’t have a heart attack.

Araneta’s opinion supports plaintiff’s lawyer Mark Lanier’s contention that Ernst suffered a heart attack that killed him too fast to leave evidence of heart damage. He also has drawn jurors’ attention to Merck’s medical manual for doctors, which says arrhythmia in some form occurs in more than 90 percent of heart attack patients.

She said Ernst probably had a heart attack because a blood clot blocked blood in an artery already clogged with plaque. However, vigorous CPR conducted on Ernst — including pounding on his chest that fractured some of his ribs — probably dislodged the clot and his sudden death left no time for his heart to show damage, she said.

“Vigorous CPR could dislodge a clot. Also, the clot may be small. It doesn’t have to be a big clot to cause a myocardial infarction,” she said, using the medical term for heart attack.

Araneta also conceded that sudden cardiac death with clogged arteries can occur without a heart attack.

Ernst, a 59-year-old marathoner, was taking Vioxx for eight months to ease pain in his hands before he died in his bed on May 6, 2001.

Merck’s lawyers have relied heavily on Araneta’s autopsy, which attributed Ernst’s death to arrhythmia secondary to blocked arteries and doesn’t mention heart attack as a cause.

However, Lanier, the plaintiff’s lawyer, didn’t identify Araneta by name as a witness by the pretrial deadline, so Merck’s team balked at what they called her surprise appearance.

Merck’s former marketing director also testified — saying the drug was never tested for its effects on the heart before going on the market

Merck said it would appeal the decision, citing several grounds for reversal, such as the plaintiff’s use of a surprise witness, referring to Araneta.

The jury said Carol Ernst should be awarded $229 million in punitive damages and $24.5 million for mental anguish and economic losses. Because punitive damages are capped at $1.6 million in Texas, Ernst would receive no more than $26.1 million total.

Jurors said they voted to hold Merck liable in part because of videotaped testimony from Araneta. They said they were also influenced by internal documents that showed the company “seemed to care more about profits from the drug than the public’s welfare.”

More lawyers are expected to queue up cases against Merck.

One trial is scheduled to begin this September in Atlantic City, and the first federal case will begin in New Orleans in November.

Reports said some 20 million people used Vioxx for chronic pain after it was approved in 1999. It brought in $2.5 billion in sales a year.

News of the verdict sent the company’s stock price down 7 percent to $28.06 at the close of regular trading, a loss of $5 billion in market value.

Poles sue Vioxx makers

Poles sue Vioxx makers

Fifty thousand Poles have taken Vioxx, the painkiller that, as a Texas court has proved, leads to heart attacks and strokes. Four of those who have taken the life-threatening painkiller have decided to sue the American pharmaceutical company for compensation in the USA.

Already four Poles are determined to fight for compensations in American courts after they got serious heart failures. The internationally known medicine called Vioxx was meant to be a highly effective painkiller. However, instead of healing their painful backbones the patients almost killed their hearts. Many of them used vioxx until it was finally withdrawn from the market in October last year.

Out of the 50 thousands Poles who have taken the medicine or rather poison – one would say- 81 have reported suffering harm on their health caused by the medicine.

An American law firm which have already won an exceptionally high compensation of 253mln US dollars for an American widow of a vioxx victim, is ready to represent the Polish sufferers in court promising not lower compensations than those of 75thousand US dollars, says Lawrence Landskroner of Lawrence Landskroner and Associates in Ohio, the USA:

Patients have to collect a very detailed documentation of their treatment process and prove that the medicine was taken for at least 18 months . Then, as the damage on health is significant, the chances to win the case seem to be very high.

Even though the issue of vioxx is not the first one, and trials connected with similar pharmaceutical affairs haven’t finished up yet in Polish courts, Poles seem to be unable to stop just gobbling tons of drugs.

Statistics say that about 40% of Polish people visit a pharmacy once a month. While 80% of Poles suffer from headaches, 79% of them get themselves any painkiller without prescription.

The pharmaceutical business seems to be flourish in Poland no matter what.. But is it at least properly controlled? Jarosław Pinkas of the Kardiological Institut in Warsaw:

American courts have to deal now with some 4 thousand cases from the whole world concerning Vioxx , as the medicine was distributed in 80 countries. (pg)

Vioxx surprise settlements?

Vioxx surprise settlements?
Fri 02 Sep 2005 06:53 am CST
WASHINGTON (myDNA News)

To learn more visit myDNA's News Center Read More

In a surprise move, giant pharmaceutical manufacturer Merck is considering settling some of the Vioxx claims. The admission, reported in last Friday's Wall Street Journal, would pertain to individuals without risk factors for heart attack or stroke and who took Vioxx for more than eighteen months. The revelation appears counter to the company's previous position of fighting each of the Vioxx lawsuits.

Although the new position was communicated by a Merck spokesperson, the company's chief counsel has stated that Merck's strategy of fighting every claim has not changed. Other legal experts believe the decision to settle at least some of the claims will actually be a cost-saving measure for Merck over the long-run.

The apparent decision to settle cases among individuals who used Vioxx for more than a year and a half, and who were absent cardiovascular risk factors, will involve an undetermined number of claims. Risk factors are conditions that have been found to be associated with increases in heart disease. Major risk factors include heredity, age, smoking, high cholesterol, high blood pressure and physical inactivity.

It is estimated that more than 20 million people took Vioxx in the United States alone, before the drug was pulled from the marketplace last September. Merck withdrew Vioxx after a company sponsored clinical trial found an increased risk of heart attacks and strokes in people who took the drug for more than 18 months.

On August 19th, a Texas jury found Merck liable for the death of a 59-year old man who took Vioxx for eight months. The jury awarded his widow $253 million in damages although the award is likely to be capped to about $26 million under Texas law.
To learn more visit myDNA's News Center Read More
Reviewed: September 02, 2005 Rick Nauert PhD
Source:

myDNA.com

VIOXX: ITALIAN CONSUMERS START CLASS ACTION AGAINST MERCK

VIOXX: ITALIAN CONSUMERS START CLASS ACTION AGAINST MERCK
(AGI) - Rome, Italy, Sep 1 - Italian customers having been prescribed Vioxx produced by pharmaceutical company Merck can contact Italian consumer association Codacons if they wish to partake in the class-action in US courts. The case is being brought to bear after the drug was found to have damaging side-effects. Choosing US courts de facto sets a limit to the time available to submit for damages. "According to Food and Drug Administration reports Vioxx has been deemed responsible for the death of some 27 thousand persons due to sudden heart attack", reads a Codacons communique'. Codacons also specifies that the interests of some 100 Italian citizens have been brought to bear. "The pharmaceutical company has been forced by Illinois judge - says Chicago based Codancons lawyer Kenneth Moll - to pay 250 million dollars to the families of the victims for having deliberately covered up the nature of the drug's negative side-effects". In the US alone some 240 thousand citizens are claiming damages. The courts are yet to designate eligibility criteria. According to Codacons as many as 3.5 million Italians may have taken Vioxx at some stage. Codacons has also drawn up a blacklist of dangerous drugs: 28 drugs in all, 15 active ingredients; top of the list are Bextra (valdecobix) and celebrex (celecobix) leading to requests by consumers and the Italian drug agency AIFA for them to be banned. (AGI) -
011751 SET 05

Merck Voluntary Recalls Vioxx® After Experts Claim it Can Cause Serious Injury

Merck Voluntary Recalls Vioxx® After Experts Claim it Can Cause Serious Injury

Merck & Co Inc. voluntarily recalled the widely prescribed arthritis drug Vioxx® on September 30, 2004, amidst evidence that it drastically increased users' risk of heart attack and stroke. This Vioxx® recall is believed to be the most expensive drug recall in the history of the pharmaceutical industry.

The Vioxx® recall is so large that Merck suffered a 27 percent decrease (nearly $25 billion) in stock value the same day, thereby prompting a full 0.6 percent drop in the Dow Jones industrial average. According to financial reports, the makers of Vioxx® claim that the drug accounted for at least 10 percent of Merck's revenue in 2003.

A three-year study of 1,300 Vioxx® users found 15 cases of heart attack, stroke, and blood clots; this was three times the number reported among participants taking a placebo. Merck maintains this risk was relatively low, but it nonetheless was enough to warrant a Vioxx® recall to prevent further injury.

It is important to the note that the U.S. Food and Drug Administration didn't order the Vioxx® recall, although it did issue a public health advisory to all Vioxx® users about the recall and how Vioxx® can cause injury: anyone who uses Vioxx® should stop taking it immediately and talk to a doctor about an alternative medication.

Vioxx® is dangerous. If you have taken Vioxx®, you may be able to file pharmaceutical litigation claim today, as you may be eligible for compensation. Contact a personal injury attorney who specializes in pharmaceutical litigation today to find out more about Vioxx®, Vioxx®-related injury, the Vioxx® recall, and how to file a Vioxx® claim.

With Vioxx gone, pain drug prices jump - study

With Vioxx gone, pain drug prices jump - study

June 09, 2005 10:44:49 (ET)

In June 2 WASHINGTON story headlined "With Vioxx gone, pain drug prices jump - study," please read date as June 2 ... instead of ... June 1 ... (Corrects date of release of report).

In 7th paragraph, please read "... prescription-strength Motrin, the ibuprofen marketed by Pfizer..." instead of "...prescription-strength Motrin, the ibuprofen marketed by Johnson & Johnson's unit McNeil-PPC..."(Corrects the maker of prescription-strength Motrin).

A corrected version follows:

By Susan Heavey

WASHINGTON, June 2 (Reuters) - Prices for dozens of prescription painkillers have jumped by as much as 15 percent since Merck & Co. Inc. (MRK,Trade) pulled its once-popular arthritis drug Vioxx from the market last year, a report released on Thursday found.

Thirty-six pain medicines, including Mobic, Motrin and Relafen, saw price increases after studies linked Vioxx to heart problems and led to its withdrawal in September, according to the Consumers Union publication, "Consumer Reports Best Buy Drugs."

The number of prescriptions for many of the non-steroidal anti-inflammatory drugs, or NSAIDs, also increased, the consumer group said.

Consumer Union's findings come weeks after the U.S. Food and Drug Administration called on Pfizer Inc. (PFE,Trade) to pull its rival drug Bextra over similar heart problems and the added risk of a fatal skin condition. The agency also ordered stronger warnings on all pain medicines.

Vioxx, Bextra and Pfizer's other pain drug Celebrex are a type of NSAID known as Cox-2 drugs that are thought to be easier on the stomach than older counterparts like naproxen or ibuprofen.

The report, which analyzed data from health care information firm NDCIHealth, also found 17 drugs dropped in price while 10 remained flat. It did not evaluate over-the-counter pain medicines.

Since Vioxx's withdrawal, prices for prescription-strength Motrin, the ibuprofen marketed by Pfizer, rose 13.3 percent from $30 to $34.

Higher doses of privately-held Boehringer Ingelheim Pharmaceuticals's Mobic, which is distributed in the United States by Abbott Laboratories Inc. (ABT,Trade), jumped 10.6 percent while lower doses were up 6.7 percent.

Prescriptions for the highly-marketed drug also jumped in the wake of Vioxx's demise, doubling from 314,000 to 742,000 since September, the report said.

Consumer Union's Steven Findlay, who wrote the analysis, said Boehringer's advertising showed the power of marketing and its impact on drug prices.

"Doctors and consumers are unquestionably swayed by the ads and promotions for costly new medicines, even when lower-cost options that are just as effective are available," he said.

Boehringer officials have said Mobic was their second-best selling drug last year, up 44 percent.

Wyeth's (WYE,Trade) Lodinem cost $150 in September and now costs $170, or 13.3 percent, more. GlaxoSmithKline Plc's ((GSK.L)) (GSK,Trade) Relafen also jumped 10.6 percent,

Costs for lower doses of Celebrex rose 1.5 percent, while higher doses rose 0.9 percent.

FDA officials have said data does not show if some patients benefit more from certain painkillers, and have called on companies for more studies

Still, Consumer's Union said most studies show NSAIDs "are equally effective," adding that patients do not need more expensive prescriptions unless they do not respond to other, cheaper versions.

Instead, the group said consumers should stick to generic ibuprofen, naproxen and salsalate. While some of their prices also rose, they were still cheaper.

The cost of a 400 milligram version of generic ibuprofen rose from $24 to $26 since September as did generic salsalate, 3M Co. (MMM,Trade) unit 3M Pharmaceutical's brand name salsalate, called Disalicid, dropped 1.5 percent in price at $74.