Pharmaceutical Lawsuits

Pfizer Nigerian Lawsuit.

2007-11-06T16:04:00.000-08:00

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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Astellas Pharma, King Pharma settle lawsuits against Teva

2007-10-22T09:11:00.000-07:00

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

2007-10-22T09:02:00.000-07:00

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

2007-04-09T14:32:00.000-07:00

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

2007-02-15T14:46:00.001-08:00

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

2007-02-15T14:44:00.001-08:00

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.

In lawsuits, secrecy can have dangerous side effects

2007-02-12T15:54:00.000-08:00

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

2007-02-12T15:52:00.001-08:00

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

2007-02-10T16:29:00.001-08:00

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.

Viagra lawsuit looms over 'party drug' adverts

2007-02-10T16:24:00.000-08:00

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.

U.S. jury awards millions in Vioxx lawsuit

2005-09-02T18:34:00.000-07:00

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

SEC Asks Pfizer for Bextra, Celebrex Data

2005-09-02T18:25:00.000-07:00

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

2005-09-02T18:22:00.000-07:00

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

2005-09-02T18:20:00.000-07:00

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

2005-09-02T18:19:00.000-07:00

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?

2005-09-02T18:16:00.000-07:00

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

2005-09-01T12:13:00.000-07:00

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

2005-06-24T21:01:00.003-07:00

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.

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

2005-06-24T21:01:00.002-07:00

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

2005-06-24T21:01:00.001-07:00

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

2005-06-24T21:01:00.000-07:00

With Vioxx gone, pain drug prices jump - study

2005-06-09T20:12:00.000-07:00

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.

The good, the bad and the ugly

2005-05-25T14:38:00.000-07:00

The good, the bad and the ugly
May 26, 2005
Fiona Jones
Compliance Columnist
...back to list

Throughout the late 1980s and early 1990s, the public was very excited about the growing pharmaceutical industry with expectations of innovative drugs becoming available to cure every ill. It now seems as if pharmaceutical companies have lost all support and are labeled as the latest bad boys of industry. Even a quick glance at the news gives the impression of a lack of industry oversight and prompts rumors of drug side effects being brushed under the carpet to maintain healthy company profits. Is this a fair judgment? If so, then what are we doing in the compliance sector to correct these problems? Every day, throughout the world, every pharmaceutical and biotechnology company has staff eagerly working away to develop systems and procedures to introduce, maintain, and ensure strict compliance with regulatory agency guidelines and yet every day the news appears to run a story highlighting an error in the system. Is the coordination of introducing and monitoring quality in the pharmaceutical industry failing or is it just a case that the failures are more newsworthy than the successes?

I challenge you to enter “pharmaceutical” or “drug company” or any combination of similar words in to the news search engine of your choice and take a look at the results. I think you will see that there is a lot more happening in our industry than scandal and controversy. Below is a short summary of some of the news items – good, bad and ugly - that I pulled up.
The good

IBM Healthcare & Life Sciences has announced an initiative to support the pharmaceutical industry’s drive towards operational excellence, quality by design and risk-based compliance. IBM has teamed with leading technology providers to develop a solution aimed at enabling the transformation of pharmaceutical development and manufacturing capabilities of large pharmaceutical and biotechechnology companies. The company has developed a Proof of Concept (PoC) that demonstrates how the Food and Drug Administration’s (FDA) Science of Design and Manufacturing Science concepts can be enabled in a Service Oriented Architecture. IBM forecasts that by managing risk and applying scientific- and systems-based approaches throughout development and manufacturing, the top 30 pharmaceutical companies alone can protect up to $60 billion of future revenues, accelerate time to peak sales by two years or more, and reduce Cost of Goods Sold (COGS) by up to 16%. That must be good news.

In the area of clinical trials Genentech, Inc. announced that their phase III clinical study of Lucentis(TM) (ranibizumab) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration (AMD). Approximately 95 percent of patients maintained or improved vision at one year when treated with Lucentis(TM) injections compared to approximately 62 percent of those treated in the control arm (p<0.0001).

Alkermes Inc. has also announced positive results from a phase III, open-label, 12-month extension study of Vivitrex(R) (naltrexone long-acting injection) in alcohol-dependent patients. Findings from the study showed that Vivitrex(R) and counseling led to a sustained reduction in heavy drinking over an 18-month treatment period among patients who had completed the six-month Phase III efficacy trial ("main trial") and enrolled in an open-label 12-month extension study. Over eighty-five percent of patients who completed the main trial chose to participate in the extension study.

At the beginning of the month, Biovail Corporation announced that it has received an Approval Letter from the FDA for Tramadol ODT (tramadol hydrochloride), an orally disintegrating tablet version of the analgesic medication tramadol hydrochloride in 50mg dosage format, intended for the treatment of moderate to moderately severe pain in adults.

Alpharma Inc. also received approvable status on that its pending application for Kadian(R) 200mg a sustained release morphine sulfate product.

Boehringer Ingelheim Pharmaceuticals, Inc. was also the bearer of good news when they announced that the FDA Antiviral Drugs Advisory Committee recommended the approval of the investigational anti-HIV drug tipranavir.

So while the good news is there for those who look, it is perhaps not as exciting to the mainstream news media as some of the more scandalous events in our industry. Certainly, you can see why editors are not running these items on the front page of your local newspaper.
The bad

Unfortunately, the bad news items are around and are getting a lot of press. Able Laboratories, a small New Jersey-based generic drug manufacturer, was once a fast-growing star of the highly competitive $18billion generic drug industry. Then, on May 23, the company announced it was shutting down operations and ordered a nationwide recall of its products. The company, which employed 421 full-time employees, had an extensive range of 46 medications including prescription generic versions of Ritalin, Tylenol and Vicodin. So what went wrong? Able stated that the dramatic actions stemmed from an internal review of operating practices, which began after product recalls earlier in the year. Problems were apparently identified when working with outside consultants and the FDA. The company said in a statement the shutdown was prompted by "apparent departures from standard ... laboratory testing practices" and that the operations would halt "until such time as it can assure itself that its products are manufactured and tested in compliance with standard operating procedures and current good manufacturing practices." However, it appears that there has been a history of manufacturing problems dating back to 1992. The company signed a federal consent decree that called for a $450,000 fine, FDA supervision of its manufacturing facility and the forced resignation of two company executives. The court supervision ended in February 2002, but it doesn’t appear that the problems did. Last year the company received an FDA warning letter for failing to report serious side effects of some of its drugs. The letter stated:

“The specific violations noted in this letter are serious and may be symptomatic of serious underlying problems. You are responsible for investigating and determining the causes of the violations identified above and preventing recurrence of similar violations. You should take prompt action to correct these deficiencies. Failure to promptly correct these deviations may result in regulatory action without further notice. These actions may include, but are not limited to, seizure of your products and/or injunction. Federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts.”

It appears that the FDA’s concerns over “serious underlying problems” were well-founded. The series of events has thrown the immediate future of the company into doubt and it is exactly the news story that will have a ripple effect on the rest of the industry. With the FDA keeping a watchful eye on the company and the stringent procedures that are supposedly in place to protect the public health it seems inconceivable that so many problems can be coming out from just one company.
The ugly

Medical journalists are increasingly making their thoughts known regarding the pharmaceutical industry and transparency in clinical trial data is certainly one topic that seems to get editors hot under the collar.

Last week, Richard Smith, former editor of the British Medical Journal (BMJ) voiced his concerns about the power and influence of the industry and claimed that medical journals are nothing more than extensions of the marketing arm of pharmaceutical companies. Strong words, but are his comments justified? Smith, now chief executive of UnitedHealth Europe, published his forthright essay in the open access international health journal PloS Medicine. Smith is not alone in his condemnation of the industry. Last year Richard Horton, editor of the Lancet, wrote that "Journals have devolved into information laundering operations for the pharmaceutical industry" and Marcia Angell, former editor of the New England Journal of Medicine, also damned the industry for becoming "a marketing machine".

In his recent article, Richard Smith went as far as to suggest that the pharmaceutical industry employs a series of tricks to ensure good publicity for new products in prestigious journals. He said it was often impossible for editors to spot a rigged trial, despite the process of peer review and highlighted a "conflict of interest" because publishing trials by major drug companies would result in increased sales.

The Association of the British Pharmaceutical Industry was quick to deny the allegations, saying it would make no sense to manipulate trials because they would eventually be discovered. "There’s no future in twisting trials’ results because you’ll get found out long before you get to market, and with the costs of lawsuits and so on, it’s just not worth getting it wrong."

This month, the editor in chief of the New England Journal of Medicine accused three of the largest drug companies of "making a mockery" of efforts to create transparency in clinical trials. Editor, Jeffrey Drazen, said that Pfizer, GlaxoSmithKline and Merck are not providing enough useful information on clinical trials they register with the government. His comments were based on a review of the information drug companies posted on www.clinicaltrials.gov, which is run by the U.S. National Institutes of Health.
The errant underdog

So while the good news items are out there, they are perhaps not as interesting to the general public as the stories of rigged trials, over-priced drugs, deliberately withholding negative trial data, dodgy drug companies and counterfeit drugs flooding the market from overseas. As to whether all publicity really is good publicity? Luckily, the public always loves a good comeback story, and is usually willing to give an errant underdog a second chance if the problems have been handled correctly. So hopefully for the pharmaceutical industry, we will all get a second chance and in turn a media bonanza!

Merck Could Face 100K Vioxx Suits

2005-05-25T14:35:00.000-07:00

Merck Could Face 100K Vioxx Suits
New Orleans, May 24, 2005

A federal judge told dozens of lawyers crowded into a courtroom here Monday that there could ultimately be up to 100,000 cases filed against Merck over its now-withdrawn pain reliever Vioxx, and that he could hear a case as early as the fall.

There have been more than 2,000 cases filed against the New Jersey-based drugmaker so far. The pretrial issues for federal cases are being handled by U.S. District Court Judge Eldon Fallon, and lawyers from both sides met here for a monthly status conference.

Analysts have estimated that Merck's potential liability could reach $18 billion. Merck withdrew Vioxx from the market last September after a study showed it doubled patients' risk of heart attacks and stroke in people taking the drug longer than 18 months.

The plaintiff's attorneys are squabbling with Merck over records of thousands of company employees engaged in marketing the drug. A lawyer for Merck told the court Monday it would be "tremendously burdensome" to provide the information. The lead plaintiffs' lawyer, Russell Herman, countered afterward that Merck's sales representatives were "told to dodge" potentially awkward questions. Plaintiffs cite an internal Merck document with instructions to the representatives, referred to as "Dodge Ball Vioxx" in a court filing.

"All we want to do is spread some disinfectant," said Herman. The lead Merck lawyer, Phillip Wittmann, suggested it would be more reasonable to look at Merck employees on a case-by-case basis.

Meanwhile, the plaintiffs also are trying to extract information from the Food and Drug Administration, which regulated the drug and has been blamed for lax oversight. Plaintiff lawyers have complained the FDA has not been forthcoming with requested information. Meetings between lawyers for both sides and FDA officials are slated for this week, with additional meetings scheduled for next month.

Fallon told the lawyers Monday he wants the cases to move along, and suggested that trials in his court might be held by next fall. The drug company has vowed to defend every one, and has set aside hundreds of millions to defend itself.

Still, the first cases are set to be heard in state courts--Texas in July, and New Jersey in August. The delicate process of coordinating the federal suits with the state cases was underscored Monday by the presence in the courtroom of state court judges from those two states as well as Alabama, where one case already has been postponed.

"We intend to try to cooperate as much as possible," New Jersey Judge Carol Higbee told Fallon on Monday, adding that there would be no "friction" between the various jurisdictions.

E-mails Suggest Merck May Have Known of Vioxx's Risks: Report

2005-04-26T12:46:00.000-07:00

Did Merck officials know about the heart risks posed by its now-defunct painkilling drug Vioxx as far back as five years ago?

The New York Times reported Sunday that in 2000, Merck overruled one of its own scientists after he suggested that a 73-year-old female patient in a Vioxx clinical trial had probably died of a heart attack.

In an e-mail exchange concerning Vioxx, a top Merck scientist repeatedly encouraged the researcher to change his views about the death "so that we don't raise concerns." In later reports to the U.S. Food and Drug Administration and in a paper published in 2003, the company labeled the cause of death as "unknown," the newspaper said.

The discussion of the woman's death appears in several previously undisclosed Merck records, including e-mails from Dr. Edward M. Scolnick, Merck's senior scientist from 1985 to 2002, and Dr. Alise S. Reicin, a vice president for clinical research. The messages point to Merck's concerns about data contradicting its view that Vioxx was safe, the Times said.

When Vioxx was pulled from the market last September, Merck officials said they had only recently learned that the drug posed a risk of heart attack and stroke. At least 4,600 people or their survivors are suing the drug company, saying Vioxx — a member of a class of drugs called cox-2 inhibitors — caused their heart attacks or strokes. The e-mails and other internal Merck documents, including the report of the woman's death, were given to the Times by an unnamed source working with plaintiffs, the newspaper said.

A lawyer for Merck told the Times that the company had disclosed all information from clinical trials about Vioxx to the FDA. And Scolnick's e-mails "merely reflected his concern that the FDA weigh Vioxx's benefits and risks fairly. The e-mail discussion between the Merck scientists reflected an honest scientific debate over the cause of the woman's death," the newspaper reported, paraphrasing the lawyer.

Earlier this month, another cox-2 drug, Bextra, was withdrawn from the market for the same cardiovascular concerns. A third cox-2, Celebrex, remains available to U.S. consumers, but the FDA has mandated that it carry a strong "black box" warning label indicating the potential for long-term heart risks.