Saturday, February 10, 2007

Federal Court Tosses Vioxx Suit

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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.

Viagra lawsuit looms over 'party drug' adverts

Viagra lawsuit looms over 'party drug' adverts
By Stephen Foley
Published: 23 January 2007
Pfizer's marketing campaign for Viagra has turned the impotence pill into a "party drug" whose use is fuelling the Aids epidemic, according to a campaign group that is suing the pharmaceuticals giant.

The Aids Healthcare Foundation, which runs HIV clinics in the US and overseas and campaigns against the pharmaceuticals industry, has launched a lawsuit accusing Pfizer of reckless advertising. The organisation points to several recent Viagra promotions, including a 2005 newspaper ad that featured a smiling man asking, "What are you doing on New Year's Eve?"

Michael Weinstein, AHF president, said: "I've never before heard of a drug being marketed as a party favour. Viagra was approved to treat erectile dysfunction. The way they advertised this drug in the beginning was with [the former Senator] Bob Dole, who was a prostate cancer survivor, but now Pfizer is advertising it as a drug to improve your sex life. Erectile dysfunction is a medical condition; performance anxiety is not."

Pfizer has been in trouble with regulators over this issue, and two years ago it was ordered to pull Viagra ads set in a lingerie shop, where a man in devil horns said: "Remember that guy who used to be called 'Wild Thing'? He's back."

The AHF said that Viagra sales have been inflated by a black market in the pills. It said that users of crystal meth are combining it with Viagra to bolster their sexual performance, and are failing to take precautions against sexually transmitted diseases, leading to the spread of HIV.

The company said it does not promote Viagra for recreational use. "We have always been committed to safe and appropriate use of Viagra for the treatment of erectile dysfunction," a spokesman said.

Worldwide sales of Viagra were $450m in the final three months of 2006, compared with $430m for the same period in 2005.