Monday, June 16, 2008

Vioxx Lawsuit

This article is from LegalNewsline.com...

Unions sue over Vioxx settlement
by Chris Rizo
NEW YORK (Legal Newsline) - Two of the nation's most powerful unions have sued six law firms for their handling of litigation against Vioxx maker Merck & Co. Inc.

The Service Employees International Union and the Teamsters Union filed the federal lawsuit in the Eastern District of Louisiana.

Vioxx was taken off the market in September 2004, after the once-popular pain medication was found to increase the risk of stroke and heart attack.

The unions claim the Nov. 2007 settlement of the liability class action suit, in which Merck was held harmless, failed to provide money for reimbursements to lien rights of Employee Retirement Income Security Act (ERISA) health plans.

ERISA, enacted in 1974, aimes to protect the interests of employee benefit plan participants and their beneficiaries by requiring the disclosure to them of financial and other information concerning the plan.

The complaint says that the $4.85 billion that Merck has agreed to place in a settlement account to pay claimants who say they were harmed by Vioxx will be distributed by a secret formula that violates the ERISA provisions.

If the court does not grant an injunction, the unions' lawsuit says the plaintiffs will be "irreparably harmed."

Defendants in the case are: BrownGreer PLC; Beasley, Allen, Crow, Methvin, Portis & Miles PC; Blizzard, McCarthy & Nabers LLP; Girardi and Keese; Herman, Herman, Katz & Cotlar LLP; and Levin, Fishbein, Sedran & Berman.

The lawsuit was filed last week on behalf of the unions by the New Orleans, La., law firm of King, Krebs & Jurgens.

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Tuesday, November 06, 2007

Pfizer Nigerian Lawsuit.

This has been borrowed from CNN Money.
Please go to their site for more informaion.


Pfizer court case adjourned again in Nigeria
November 06, 2007: 02:14 PM EST

KANO, Nigeria, Nov. 6, 2007 (Thomson Financial delivered by Newstex) -- A State High court in the Nigerian city of Kano has adjourned for the fourth time a hearing into a criminal suit filed by the Kano State authorities against US pharmaceutical giant Pfizer (NYSE:PFE) for an alleged unauthorized drug test 11 years ago.

'We have agreed to adjourn the case to December 20 because the judge is out of town and because six of the defendants who reside in the United States have not been served,' Aliyu Umar, Kano's justice commissioner told AFP outside the courtroom.

The Kano High Court II judge, Shehu Atiku, had on October 3 ordered the north Nigerian state's police commisioner to go to the United States and deliver court summonses to the defendants for them to appear Tuesday.

'We have not made the arrangements necessary to enable the commissioner to travel to the US to deliver the service to the defendants,' Umar said.

'We had an afterthought. We realised that it would be better for us to go through Interpol, with the Kano police legal department as a link. We will definitely do that before the adjourned date,' he said.

Kano state government filed a 2.75 bln usd civil suit and a criminal suit against Pfizer for allegedly using an untested meningitis drug, Trovan without authorisation on 200 children during a triple epidemic of meningitis, measles and cholera in which over 12,000 people died.

Kano says that the drug test led to 11 deaths and more than 180 cases of deformity including paralysis, deafness, blindness and brain damage.

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Monday, October 22, 2007

Astellas Pharma, King Pharma settle lawsuits against Teva

Another great article from Reuters

Astellas Pharma, King Pharma settle lawsuits against Teva
Mon Oct 22, 2007 8:08am EDT

Oct 22 (Reuters) - Astellas Pharma Inc said its U.S. units alongwith Item Development AB and King Pharmaceuticals Inc (KG.N: Quote, Profile, Research) had settled lawsuits against Teva Pharmaceutical related to Adenoscan, an agent used in heart stress study.

The lawsuits pertained to an abbreviated new drug application filed by a unit of Teva Pharmaceutical Industries Ltd (TEVA.O: Quote, Profile, Research) for a generic version of Adenoscan.

Under the settlement, Teva Pharmaceutical will be able to launch its generic for Adenoscan under a license in September 2012. (Reporting by Anant Vijay Kala in Bangalore)

Woman wins $43 million medical lawsuit

I found this great article b y Annie Flanzaraich for the North Lake Tahoe Bonanza.
I have included the text and a link to the original site.


Woman wins $43 million medical lawsuit

Annie Flanzraich
Bonanza Staff Writer
October 21, 2007

Leg cramps, breast pain and yeast infections.

Those were the side effects listed on Arlene Rowatt's bottle of Premarin, a drug she started using in 1991 to treat menopause symptoms.

But almost a decade later she developed breast cancer, and a chronic fear of doctors and pills.

"I don't have any faith in the medical profession at all," said Rowatt, 67, of Incline Village.

Two weeks ago a jury found in favor of Rowatt and two other Nevada women, and issued a $134 million judgment against pharmaceutical giant Wyeth. The $43 million in compensatory and punitive damages the jury awarded Rowatt can't bring back her health. But, she says it can send a message to any women who may still be on the combination estrogen progesterone pill, now called Prempro.

"What we really wanted to do is tell women if they are taking that drug to stop taking it immediately," Rowatt said.

From 1990 to 1995, Premarin was the most frequently dispensed prescription drug in the United States, according to court documents from Rowatt's trail. When it was prescribed to Rowatt, the drug already enjoyed a two-decade long marketing campaign. A key slogan was "start her on, keep her on."

So Rowatt stayed on the drugs for almost a decade, drugs meant to treat common symptoms of menopause like hot flashes or mood swings. Wyeth marketed the drug as a preventative measure against osteoporosis. It is a claim not backed by medicine, according to court documents.

Before moving to Incline Village from Oregon in 2000, she found a lump in her breast. Rowatt was worried, but didn't suspect cancer. She already had two cysts removed, and had no risk factors or family history of breast cancer.

The diagnosis was shocking.

"I was somewhat in denial, I could not believe it," Rowatt said.

She was alone in Incline Village after her moving from Oregon and retiring from 25 years of service in the Army Corps. Rowatt had the cancer removed and went through chemotherapy, but still didn't know what caused the cancer.

Then one night in 2002 she watched a newscast about a Women's Health Initiative study - a study that found hormone therapy increased a woman's risk for breast cancer by 26 percent.

"I learned about it from Tom Brokaw," Rowatt said. "I was furious that I had to hear it on television."

By 2004 when she saw an ad from the Las Vegas and Reno-based law firm of White, Meany & Wetherall looking for women who had breast cancer after hormone therapy, she was ready to take action.

The law firm previously won a $14 million lawsuit against the Dow Chemical Co. for faulty breast implants.

"We don't prosecute frivolous lawsuits, we don't have the time or inclination to do that," firm partner Geoffrey White said. "But we like going against large corporations that make bad and defective products that injure people."

The law firm interviewed more than 1,000 women state-wide who had breast cancer after taking hormone therapy. Rowatt and two other women, Jeraldine Scofield, 75, of Fallon, and Pamela Forrester, 64, of Yerington, were chosen because they were on the drug for a prolonged period of time and didn't exhibit any risk factors or family history of breast cancer.

The judgment levied against Wyeth on Oct. 11 for Rowatt and the other women is the largest award to date against the New Jersey-based company. It faces about 5,300 similar lawsuits across the country in state and federal courts.

"That's 5,300 women just like me," Rowatt said. "I would like to see them (Wyeth) get hurt bad enough that they have to do something about getting that drug off the market.

Wyeth said it would appeal the judgment because of jury confusion while awarding damages.

"This flawed verdict is the result of a trial riddled with errors," Lawrence V. Stein, Wyeth's Senior Vice President and General Counsel said in a statement. "The events of last week and the confusion surrounding the jury's deliberations only confirm our view that this verdict will not survive on appeal."

Still, White said the verdict was valid and felt it would stand up in the Nevada Supreme Court if it got there.

"All three of our clients would willingly happily give their checks back to Wyeth, every penny plus interest, if they could have their health back," White said.

Rowatt, who has severe heart problems including two replaced valves and aorta, said she will create a living trust with the money for her three children and eight grandchildren. She also would like to donate some of it to the Susan G. Komen foundation. She also said she would like to travel if her health was up to it.

Monday, April 09, 2007

Celebrex Commercial Draws Criticism

Celebrex Commercial Draws Criticism
NEW YORK TIMES

Article Tools Sponsored By
By STEPHANIE SAUL
Published: April 10, 2007

A new television advertisement for Pfizer’s painkiller Celebrex that has attracted attention for both its length and innovative marketing approach is now also the target of criticism for its message.

Public Citizen, a consumer group, asked the Food and Drug Administration this morning to ban the Celebrex television commercial, alleging that it gives consumers a false impression that the prescription drug has no more safety risk than some other painkillers.

Celebrex is in the same class of drugs as the Merck pill Vioxx, which was withdrawn in 2004 because of its link to cardiovascular problems. At that time, the F.D.A. also asked Pfizer to suspend its television advertising for Celebrex.

The new Celebrex ad, which is also viewable on a Pfizer Web site celebrex.com represents a return to television for the product following a hiatus of more than two years. It had its premier last Monday evening on “World News With Charles Gibson” on ABC.

It is unusual for its length — two-and-a-half minutes rather than the usual 30- to 60-second spots — and for the fact that it was the sole sponsor of the ABC newscast, meaning that there were fewer commercial interruptions and fewer minutes over all devoted to advertising. It was the only ad during last Monday’s program.

Mr. Gibson announced that the new format with less advertising would be repeated on several Mondays this month.

Pfizer has also bought tonight’s and next Monday’s “World News” broadcast, although it is not yet clear whether the Celebrex ad will be used in either case.

The ad uses animated line drawings rather than actors, with a voice-over narrator who spends much of the time comparing Celebrex with the safety of other painkillers and discusses the risks associated with it use.

A Pfizer executive today defended the advertisement. “We do feel that this ad is a very responsible approach to talking about a medicine, and clearly a medicine that is an important thing for many, many patients to be thinking about and talking to their doctors about,” said Dr. Gail Cawkwell, the senior medical director for Pfizer.

Dr. Cawkwell said the allegations by Dr. Sidney M. Wolfe, director of Public Citizen’s Health Research Group, were wrong in several respects.

She said that his letter suggested, for example, that the ad compared Celebrex to over-the-counter medications, but that it never did. She also said that the ad clearly stated the gastrointestinal risks of Celebrex, while Dr. Wolfe suggests that those risks are played down.

Dr. Wolfe, in his letter to the F.D.A. commissioner, Dr. Andrew C. von Eschenbach, said that the ad violated the law because it contained “false or misleading statements” that might lead consumers to underestimate the risks of Celebrex and use it instead of safer painkillers that are just as effective.

“The overall purpose of the ad is to make it appear, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than those of any of the other Nsaid painkillers,” the letter said, referring to nonsteroidal anti-inflammatory drugs. “Further, it asserts that certain gastrointestinal problems are, if anything, less frequent with Celebrex than with two popular over-the-counter (OTC) painkillers.”

In an interview, Dr. Wolfe said “the safest, in terms of cardiovascular risk, is naproxen” — a reference to an over-the-counter drug that is sold as Aleve, among other brand names, as well as by prescription.

“There’s no question that Celebrex has an increased cardiovascular risk,” Dr. Wolfe said. “It’s trying to bathe Celebrex in the same bath that these others are.”

Celebrex and Vioxx belong to a category that are a subset of Nsaids drugs — a category known as Cox-2 — originally intended to avoid some of the potential for stomach irritation and other gastrointestinal side effects common with Nsaids.

But clinical studies in patients did not ultimately show a protection against ulcers and bleeding with Celebrex. Dr. Wolfe’s letter contends that a thorough review of all randomized controlled trials indicates that the Cox-2 drugs, including Celebrex, do pose an increased risk of heart attacks and other cardiovascular problems. The American Heart Association recently concluded that important differences exists in the risks of the Nsaid drugs, although it said that all the drugs required more study.

Because of the differences, the heart association recommends a hierarchy for pain treatment of people with known cardiovascular disease or risk factors. Naproxen is the association’s preferred choice among Nsaids. The group recommends that the Cox-2 drugs be the last choice, and to be used for those people who fail to respond to the older Nsaids or other drugs.

Pfizer is currently running a large clinical trial comparing Celebrex, naproxen and ibuprofen in high-risk patients.

Dr. Steven E. Nissen, the lead investigator on that trial, said today that he did not approve of consumer advertising of pharmaceuticals. But Dr. Nissen, the chairman of cardiovascular medicine at Cleveland Clinic, said he believed that the Celebrex ad was presented in a responsible fashion.

Thursday, February 15, 2007

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.”

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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.

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Monday, February 12, 2007

In lawsuits, secrecy can have dangerous side effects

Citation at end of article.

In lawsuits, secrecy can have dangerous side effects
BY RICHARD ZITRIN

Drug giant Eli Lilly & Co. recently settled 18,000 lawsuits brought by people claiming they were injured by the side effects of its biggest-selling drug, Zyprexa, which is used to treat schizophrenia and bipolar disorder. But the $500 million in settlements says less about the dangers of the drug than the dangers of secrecy.

About 18 months earlier, Lilly had settled 8,000 other Zyprexa cases for $700 million. But those settlements required the plaintiffs to return all sensitive documents obtained through the legal discovery process to Lilly — a requirement that kept the strongest smoking-gun evidence out of public view. The plaintiffs also had to agree "not to communicate, publish or cause to be published, in any public or business forum or context, any statement, whether written or oral, concerning the specific events, facts or circumstances giving rise to (their) claims."

Lilly had strong motivation to settle. The documents contained evidence that Zyprexa caused large, often enormous, weight gain in many patients, significantly increasing the risk of dangerously high blood-sugar levels and diabetes. They also showed that Lilly knew about the problems in 1999, largely through its own research. Other documents outlined a marketing scheme to encourage physicians to prescribe Zyprexa for elderly patients with early signs of dementia. This strategy not only had no clinical evidence to support it, it promoted an "off-label" use not approved by the Food and Drug Administration, a violation of federal law.

Lilly gave the original 8,000 plaintiffs ample incentive to settle. Those plaintiffs received substantial compensation, and by agreeing to secrecy, they surely avoided years of scorched-earth litigation, extremely costly in terms of time, money and emotion.

When secrecy is the price of a legal settlement, wrongdoers hide their mistakes as if they never happened and continue with business as usual. That's what happened in the Lilly case. The thousands of plaintiffs and dozens of lawyers involved in the 2005 settlements kept their part of the bargain, while Lilly continued to sell Zyprexa in huge quantities — a reported $4.2 billion in sales in 2005 — without warning either patients or doctors about the drug's dangers.

Part of the problem was that those plaintiffs had little control over their cases. They were consolidated — as these matters often are — in one huge federal case in which a committee of plaintiffs' lawyers has much more say over a settlement than in typical civil suits. In exchange for access to key Zyprexa data in the Lilly case, the committee agreed to a "protective order" that kept the information secret. That may have expedited things for their clients, but it was a public disservice.

Courts have the power to grant protective orders only to limit the disclosure of highly personal information and legitimate trade secrets. But when all the lawyers in a case agree, judges often grant protection even if the trade secrets in question show how the product does not work, not how it does. Neither lawyers nor judges should ever be party to such agreements. It is simply unacceptable as a matter of public policy to permit secret deals that conceal evidence of dangers to the public.

In the Zyprexa cases, the documents eventually were exposed when Alaska attorney James B. Gottstein, working on an entirely unrelated case, subpoenaed the records of one of the plaintiffs' expert witnesses. Gottstein not only used the documents in his lawsuit but, to his great credit, disclosed them to the New York Times and several health care groups.

Gottstein was almost immediately ordered to return all the documents he had, but the train had left the station: The New York Times published articles about the dangers of Zyprexa, and excerpts from the documents began appearing on the Internet. Within two weeks, with much of the Zyprexa evidence now out in the open, Lilly settled the additional 18,000 cases. Negotiated secrecy, Lilly's primary goal, had become moot.

Some intrepid plaintiffs and their lawyers refuse to play the secrecy game. In Northern California, plaintiffs in dozens of Catholic Church sexual abuse cases have banded together and refused to keep the names and whereabouts of molesters secret. And recently, Eva Rowe, who lost her parents as the result of an explosion at a Texas oil refinery in 2005, refused to settle with BP unless the oil company agreed to release the millions of documents obtained as evidence. Rowe and her lawyer hope the documents, which they say show how BP's underfunding and lackadaisical attitude created significant safety problems, will serve as an industry blueprint on how refinery safety should, and shouldn't, be handled.

Unfortunately, disclosure is still the exception. But we should have learned our lesson by now. From Zomax and Halcion in the 1980s to shredding Firestone tires and GM gas-tank fires in the 1990s, to Vioxx and Zyprexa today, when lawyers cut secret deals behind the public's back, what we don't know can and does hurt us. The civil justice system belongs to all of us, and no one should be allowed to use it to keep the public in the dark.

Richard Zitrin practices law in San Francisco and teaches at the University of California, Hastings, College of the Law. He is also the founder of the Center for Applied Legal Ethics at the University of San Francisco. He wrote this piece for the Los Angeles Times.

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.

Saturday, February 10, 2007

Federal Court Tosses Vioxx Suit

THE HEARTLAND INSTITUTE
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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.

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.