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.

Advertisements
click here

“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

SEC Asks Pfizer for Bextra, Celebrex Data

SEC Asks Pfizer for Bextra, Celebrex Data
Staff and agencies
09 August, 2005

By MADLEN READ, AP Business Writer Tue Aug 9, 5:55 PM ET

NEW YORK - Pfizer Inc. is responding to a request from the Securities and Exchange Commission Securities and Exchange Commission for information and documents on its Bextra Bextra and Celebrex painkillers, the drugmaker said Tuesday in a filing.

New York-based Pfizer, the world‘s biggest drugmaker, had received similar requests for information and documents from the Department of Justice Department of Justice and a group of state attorneys general about Bextra and Celebrex, which along with Merck & Co.‘s painkiller, Vioxx Vioxx, are known as Cox-2 inhibitors.

In April, Pfizer‘s Bextra was pulled from the market because of safety risks. The U.S. Food and Drug Administration Food and Drug Administration also ordered Pfizer and 19 other popular prescription competitors to provide stronger warnings about possible cardiovascular risk in pain relievers.

Caris & Co. analyst Le Anne Zhao said Pfizer will likely keep working with government officials on the Celebrex label. Bextra probably won‘t return to the market "until more studies have been done to show risk factors," Zhao said.

Also in Pfizer‘s filing Tuesday, the company said the U.S. Environmental Protection Agency Environmental Protection Agency in July proposed a civil penalty of $275,000 to settle alleged violations of the Federal Clean Air Act at the company‘s Kalamazoo, Mich., facility.

Pfizer‘s filing also noted the Internal Revenue Service Internal Revenue Service has begun an audit of the company‘s returns for 2002 and 2003.

In midday trading, shares of Pfizer rose 49 cents to close at $26.70 Tuesday on the New York Stock Exchange New York Stock Exchange.

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