US high court to decide on allowing Vioxx suits

From the AP:

US Supreme Court to consider allowing shareholder lawsuits over failure of Vioxx painkiller

Linda A. Johnson, AP Business Writer

TRENTON, New Jersey (AP) -- The U.S. Supreme Court will decide whether shareholders can sue Merck & Co. over whether the drugmaker provided adequate information about the risks of its former blockbuster painkiller Vioxx before it was pulled from the market.

The high court agreed Tuesday to review Merck's challenge to a federal appeals court's reinstatement of a class-action securities lawsuit.

Investors had accused Merck of providing misleading information or omitting information about the risks of Vioxx. A U.S. district judge dismissed the November 2003 lawsuit on grounds of a statute of limitations.

The 3rd U.S. Circuit Court of Appeals decided to allow the lawsuits and Merck appealed to the Supreme Court.

Vioxx was pulled from the market on Sept. 30, 2004, because it doubled risks of heart attack, stroke and death.

In a statement, Merck said the company is pleased the Supreme Court agreed to hear its appeal and to resolve the split among the circuit courts in their rulings on what constitutes proper notice to investors under securities laws.

"We believe that the District Court in this case correctly held that the intense public discussion of data surrounding Vioxx" had put investors on notice of the relevant issues long before Merck announced new scientific information and voluntarily withdrew Vioxx from the market, the statement said.

"The evidence shows that Merck properly informed the (U.S. Food and Drug Administration) and the scientific community about scientific data as it emerged," Merck wrote.

After it pulled Vioxx from the market, Whitehouse Station, New Jersey-based Merck was hit with a deluge of lawsuits from shareholders, patients and their survivors claiming Vioxx caused heart attacks and strokes, and from insurance plans seeking reimbursement for their costs for covering Vioxx prescriptions.

Merck is currently making payments to patients and survivors under a $4.85 billion settlement that ends lawsuits on behalf of roughly 50,000 patients who claimed Vioxx harmed them.

Lawyers for the shareholders did not immediately return a call seeking comment.

New FDA labeling rule could be lawsuit shield

This article comes from CNN

New FDA labeling rule could be lawsuit shield
FDA rule on drug labeling attracts praise from drugmakers, ire from lawyers
August 22, 2008: 05:04 PM EST

NEW YORK (Associated Press) - Government regulators have issued new rules designed to keep drug warning labels clear and concise, though some say the new guidelines would also shield drugmakers from lawsuits.

The regulations from the Food and Drug Administration, which were released Thursday and take effect next month, explain when drug and medical device companies are responsible for rushing out safety updates on their products.

The Pharmaceutical Research and Manufacturers of America welcomed the announcement, saying it provides much-needed clarity. But trial lawyers who represent consumers said it will provide legal protection to companies that withhold information on their products' risks.

In recent years, drugmakers have added warning information to their labeling more quickly, even when the scope of the risks was unclear. This strategy helped protect companies from allegations that they didn't act quickly enough to inform patients, according to Dan Kracov, an attorney with Arnold and Porter.

"The thinking was 'We need to get this information on the warning label now otherwise we're going to get hit over the head with product liability suits,'" said Kracov, who represents pharmaceutical companies.

The new FDA rule should protect companies from such lawsuits. It states that companies are only obligated to rush out warnings when they have clear evidence of a serious risk that hasn't been reviewed by FDA. In all other cases, the rules state that FDA will review the information and consider a new label at its own pace.

FDA officials said the changes would help ensure that companies are not haphazardly adding warning information to their products.

"The key point is this rule offers doctors and patients clarity and confidence that labels mean something and can be relied on," said Randall Lutter, FDA deputy commissioner for policy.

However, trial court attorneys said the rule lets companies off the hook on alerting consumers to the risks of their products.

The American Association of Justice, a professional group for attorneys, argues the new rule requires an excessive standard of scientific evidence before companies are required to update their labels. The group's lawyers say the new rule will make it easier for companies to claim they were not obligated to alert consumers.

"When consumers are harmed they will have no way to get recourse from manufacturers," said Gerie Voss, a director with the American Association of Justice. "This rule is going to be a total shield against all 'failure to warn' claims."

Voss said many of the recent lawsuits against drugmakers, such as the Vioxx case involving Merck & Co. Inc., would not be possible under the new rules. The company has agreed to pay $4.85 billion to settle with patients who suffered heart attack or stroke and alleged the company failed to warn them about those risks.

Voss said the new FDA rule is part of a larger effort across the Bush administration to shield companies from lawsuit.

Since 2005, the administration has proposed dozens of regulations that limit lawsuits against pharmaceutical makers, automakers and other companies by ruling that federal regulations trump state laws.

Product liability lawsuits are usually filed in state courts, where juries often are more receptive to claims against corporations.

The Supreme Court is scheduled to wade into the issue later this year. Top of page

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.

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.

tf.TFN-Europe_newsdesk@thomson.com
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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.

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.

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.