http://www.yourlawyer.com/topics/overview/rezulin Sat, 21 Nov 2009 20:19:40 -0800 pixel-app en http://www.yourlawyer.com/articles/read/13989 Wed, 05 Mar 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13989 Rezulin lawsuit will proceed in Michigan, after the US Supreme Court deadlocked over a case regarding patients' rights to sue over injuries they receive from drugs that are approved by the Food & Drug Administration (FDA).  Pfizer, Inc., the maker of Rezulin, was trying to convince the Court to overturn a Michigan law that allows plaintiffs to sue drug and device makers when there is evidence that manufacturers defrauded the FDA.

Rezulin was withdrawn from the market  at the request of the FDA in March 2000.  Rezulin was prescribed to diabetics who took insulin but whose blood sugar was not well controlled. It was designed to help insulin (either the body's own or injected) work better, by drawing the sugar from the blood into the cells.  On March 21, 2000 the head of the FDA's center for Drug evaluation and Research stated that the "Continued use of Rezulin" posed an "unacceptable risk" to diabetes patients. The FDA said at least 63 Rezulin users have died of liver failure. However, some patient advocates believe the total number of Rezulin deaths to be as much as ten times higher than the reported 63 cases.

Rezulin was banned in England in December 1997, following the death of an American who took the drug. The drug's manufacturer, Warner-Lambert successfully fought a ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug. Before the ban, sales of Rezulin generated Warner-Lambert $1.8 billion in revenues. At its peak, the drug was prescribed 488,000 times in January of 1999. Warner-Lambert was acquired by Pfizer in 2000.

Pfizer was hoping to expand a 2001 Supreme Court ruling that said patients can't sue companies for defrauding the FDA.  Unfortunately for Pfizer, Supreme Court Chief Justice John Roberts removed himself from the case because he is a Pfizer stock-holder, setting up a scenario for a potential deadlock.  In the end, the Court voted 4-4 in the a case.  The ruling sets no nationwide precedent while upholding a lower court decision favoring the patients. The court issued only a one-sentence order and didn't specify on which side of the case justices voted.

The Michigan law at issue shields drug makers from product-liability suits over approved treatments. But the  measure makes an exception for companies that withhold information or deceive the FDA. In addition to allowing the Michigan law to stand, the Court's deadlock also keeps in place similar laws in six other states, including Texas.

The Supreme Court's ruling allows 27 plaintiffs in Michigan to move ahead with their Rezulin lawsuit.  All of the plaintiffs either used Rezulin, or had a loved one who did and died as a result.  

]]> http://www.yourlawyer.com/articles/read/12168 Thu, 05 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12168
In a ruling issued late Thursday, the 2nd Circuit Court of Appeals vacated a lower court's ruling that tossed out the case last year.

In February 2005, U.S. District Judge Lewis A. Kaplan in Manhattan threw out the lawsuit by the Michigan plaintiffs, citing a Michigan law that shields pharmaceutical companies from product liability claims unless there is evidence that the drug company misrepresented or withheld material information in obtaining approval for the drug from the U.S. Food and Drug Administration.

At the time, the judge found that the Michigan claims couldn't be distinguished from other state "fraud-on-the-FDA" claims that have previously found to be preempted by federal law.

On Thursday, the appellate court disagreed and remanded the case to the district court for further proceedings.
Warner-Lambert, which was acquired by Pfizer Inc. (PFE) in June 2000, pulled Rezulin from the market in March 2000 at the FDA's request. The FDA initially approved the drug in 1997.

A Pfizer spokesman didn't immediately have a comment late Thursday.
]]> http://www.yourlawyer.com/articles/read/9119 Tue, 28 Dec 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9119
Recently, withdrawals of the diabetes drug Rezulin and the antidepressant Serzone have been related to liver toxicity. Other substances, including herbal drugs and weight loss agents, also can damage the liver.

The study, called the Drug-Induced Liver Injury Network or DILIN, will enroll people over the age of 2 years who have recently developed liver problems after taking any drug or herbal therapy. Patients who have suffered liver damage because of an overdose of acetaminophen, a painkiller often sold under the brand name Tylenol, are not eligible. They will give blood and urine samples for diagnostic and genetic analyses, have an ultrasound scan of their liver, and complete health questionnaires. Participants will be evaluated again six months later, to see if their liver damage is persistent, and if so they'll be contacted annually for follow-up.

The study also is looking for people who in the past 10 years have suffered liver damage from four drugs: the anti-tuberculosis drug isoniazid; the anti-seizure drug Dilantin; the antibiotic Augmentin , and the migraine and epilepsy drug Depakote. They will have blood drawn and will be interviewed about their experience with the drug they took. Their medical records also will be examined. Information will be given to a registry for the study.

Six other hospitals in southeast Michigan will help U-M recruit patients: Arbor VA Healthcare System, Oakwood Hospital in Dearborn, St. Joseph Mercy Hospital in Ypsilanti, Beaumont Hospital in Royal Oak, Henry Ford Hospital in Detroit and Providence Hospital in Southfield. U-M is one of five national sites for the study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases. ]]> http://www.yourlawyer.com/articles/read/8923 Sun, 28 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8923
According to the Senate testimony by Dr. David Graham, associate director for science and medicine in the Food and Drug Administration's Office of Drug Safety, as many as 55,000 patients may have died as a result of taking Vioxx. Shocking. But not to Merck.

The most loathsome aspect of the Vioxx affair is the way Merck used a $500 million marketing campaign to persuade more than 20 million Americans to pop its noxious little pill before it withdrew the painkiller from the shelves in September. Company executives continued to run these ads long after they knew that there was big trouble brewing. There ought to be a special place in hell for corporations that show such a wanton disregard for human life.

How many times do we have to travel down this deadly path?

The Vioxx affair is certainly giving me a profound sense of drug company dj vu, with the tragic stories of Baycol, Rezulin and Duract still fresh in my mind. After each case come the inevitable calls for accountability and promises to reform the system promises that are then forgotten until the next killer drug hits the headlines.

During the hearings on the Vioxx scandal, Graham, while citing an additional five drugs that he feels pose a danger to the public, said that the nation's compromised drug oversight system had left Americans "virtually defenseless" against killer drugs and warned that we are facing "the single greatest drug safety catastrophe in the history of this country or the history of the world."

And you thought our biggest problem with pharmaceuticals was President Bush refusing to allow us to get cheap drugs from Canada, which he justifies because of concerns about the safety of Canadian drugs.

So why don't things ever change, even as the death toll mounts? As always, the answer can be found by following the money. The big pharmaceutical companies continue to be the 800-pound gorillas of American politics their power stemming from a muscular combination of lobbying ($150 million a year), campaign contributions (close to $50 million doled out to federal candidates over the past four years) and powerful friends in very high places (Don Rumsfeld was formerly CEO of drug industry powerhouse G.D. Searle, and Mitch Daniels, the former White House budget director and now governor-elect of Indiana, was a senior vice president at Eli Lilly).

In a 2000 E-mail, Merck's chief of research called Vioxx's propensity to cause heart attacks and strokes "a shame." Something his company clearly lacks. Of course, the real shame is that we continue to have a regulatory system in which corporate greed, political timidity and a culture of cronyism have rendered the public good a quaint afterthought. ]]> http://www.yourlawyer.com/articles/read/8202 Sat, 03 Jul 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8202
The two-year-old lawsuit accused the Warner-Lambert Co., which Pfizer bought in June 2000, of misrepresenting Rezulin's safety between 1996 and March 2000 when it stopped selling Rezulin, the St. Louis Post-Dispatch reported Saturday.

The suit alleged the drug caused liver problems in 5 percent of the people who used it, contradicting advertising about Rezulin's "unparalleled safety."

The preliminary settlement, under which Pfizer did not admit wrongdoing, was approved in May, but sealed until Friday.

The settlement calls for all current Illinois residents who bought Rezulin to recoup up to 85 percent of their out-of-pocket costs for the drug. Class members must prove they were prescribed Rezulin and provide documentation of how much they spent for the drug.]]> http://www.yourlawyer.com/articles/read/6347 Thu, 03 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6347
The court reversed a decision by Raleigh County Circuit Judge John A. Hutchison, who denied the plaintiffs' class-action request in 2001 and ruled that tests did not conclusively prove the drug caused liver damage.

Hutchison will now hear the case brought on behalf of up to 5,000 West Virginians to recover the costs of medical monitoring to determine whether they have been injured by the drug.

Rezulin, made by Warner-Lambert Co., won Food and Drug Administration approval in 1997 and generated $2.1 billion in revenue before it was banned in March 2000. FDA research linked the drug to 63 deaths from liver failure.

The Supreme Court concluded that Hutchison was mistaken in considering the merits of the claims at this early stage and said the judge also erred in denying the class certification.

During oral arguments before the court, Warner-Lambert attorney Michael J. Farrell argued that no diagnostic test could prove that a person's liver damage was caused by Rezulin.

Warner-Lambert was bought by Pfizer Inc. in 2000.

More than 2 million people took Rezulin before it was pulled from the market, and Pfizer has said it faces hundreds of lawsuits and claims over the drug.]]> http://www.yourlawyer.com/articles/read/4984 Fri, 07 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4984
The company hired Rep. Aaron Pena, D-Edinburg, to represent it, but some have criticized Pena for taking the job. They say Pfizer hired Pena as a way to postpone the case until after the legislative session.

A state provision allows a lawyer-legislator to delay a trial as long as they file a legislative continuance 10 days before the start of the trial.

Pfizer was sued by Maria Garcia of Alice. In her lawsuit, she alleges that she has end-stage liver disease caused by Rezulin, which the company manufactures.

Garcia's trial was scheduled for Feb. 13. Pena was hired by Pfizer on Feb. 2, and he filed a legislative continuance on Feb. 3.

The case was settled out of court last week, said Garcia's attorney, John Thomas of Houston.

"We're very pleased with the results and the Garcia family is happy to have this matter behind them," Thomas said in today's editions of The (McAllen) Monitor. "They can start focusing on hopefully getting Mrs. Garcia a new liver."

The terms of the settlement are confidential, Thomas said.

Thomas had pushed for the trial, arguing that Pena was hired by Pfizer to delay the trial.

Pena said he sought the blessing of all plaintiff attorneys before agreeing to take the case for Pfizer, but Thomas said Pena never contacted him.

Last month, state Sen. Juan "Chuy" Hinojosa, D-McAllen, filed a bill that would require attorney-legislators to file for legislative continuances at least 30 days for the start of a trial. Hinojosa said it would prevent either party from ambush.

Thomas said the bill is a good idea. "Ten days is tough," he said. "We were right down to flying in experts to testify and paying for hotel rooms. Thirty days would probably be better." ]]> http://www.yourlawyer.com/articles/read/4985 Wed, 19 Feb 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4985
Suspicious that Rezulin (pronounced REZ-uh-lun) might have caused her death, the Brown family was outraged when the drug was yanked from the market about a year later when the federal government said it had been linked to about 60 deaths.

Carroll Brown and his family are now suing the drug company for millions of dollars in one of the biggest product liability lawsuits in Tarrant County and only the seventh trial in the nation concerning Rezulin.

"I feel like they killed my wife," said Carroll Brown, Doris Brown's high school sweetheart and husband for 45 years. "And the way they did it, a few deaths didn't matter to them. They were driven by profit."

The jury began deliberations Tuesday after a six-week trial that turned Judge Dana Womack's sixth-floor courtroom into a storage room for documents, poster boards and high-tech slide shows.

The testimony in person and on video resembled biology lessons on enzymes, cell damage and tissue death with terms such as mitochondrial damage, necrosis and cholestic injury.

"We want to send a message that this type of conduct will not be tolerated in Fort Worth, Texas," said Zoe Littlepage, a Houston lawyer who is one of the attorneys representing the Brown family.

About 8,000 Rezulin users have filed lawsuits against the drug manufacturer in state and federal courts across the country. In June 2000, Pfizer Inc. bought Warner-Lambert, the pharmaceutical company that originally produced Rezulin.

Attorneys for Pfizer have argued that Rezulin was carefully studied before and after it went on the market and repeatedly won approval from the Food and Drug Administration.

Pfizer's attorneys presented evidence that the drug was effective in controlling patients' blood sugar, and say only a fraction of the nearly 2 million people who took the drug were harmed by it.

They've also questioned whether Doris Brown's doctors carefully read the warning labels that came with Rezulin before prescribing the drug to the Hurst woman.

"We believe that the threats of Rezulin's toxicity are extremely rare and unpredictable," said Jack Urquhart, lead attorney for Pfizer in the Brown trial.

Diabetes is a difficult disease to treat and is a leading cause of death, blindness, heart disease, nerve disease, stroke and amputation.

Dr. Eric Orzeck, a Houston diabetes specialist hired by Pfizer, said that before Rezulin became available in 1997, doctors had been "twisting in the wind" to treat the disease.

"Rezulin was an absolute godsend to physicians," Orzeck said. "A lot of patients heard about it, they took it, and they liked it. I really feel it was the right drug at the right time."

A wife and friend

When the Browns retired in 1995, they planned to see the world.

It seemed a fitting and typical reward for a couple who had been together for nearly half a century and who had known each other since they were teen-agers in Lake Worth in the 1940s.

"We had a great life," said Carroll Brown, a former Bell Helicopter employee. "She was not only my wife but my best friend."

But in 1998, as Carroll and Doris Brown were planning a trip to Alaska, problems with her diabetes flared.

Doris Brown, a former day-care worker and floral designer, had Type 2, or adult-onset, diabetes. Short and overweight, Doris Brown's blood sugar levels were fluctuating when her Fort Worth doctor prescribed Rezulin, Carroll Brown said.

On the market for about a year, Rezulin had been introduced with great fanfare as the new hope for diabetes patients who feared other treatments. Rezulin helped the body use its own insulin.

In a recent interview with the Star-Telegram, Carroll Brown said his wife began feeling nauseated and fatigued within two weeks of starting the medicine.

By the end of June, she had dementia because her liver was unable to filter the ammonia in her blood, Carroll Brown said.

In and out of hospitals and specialists' offices after that, Doris Brown was sent home each time. She stopped taking Rezulin in June of that year, and by August a CT scan revealed that her liver was shrinking.

Eventually, a gastroenterologist discovered that she had "acute cirrhosis of the liver," a disease that typically plagues alcoholics. Doris Brown did not drink.

She died less than a week later.

"She suffered," said her daughter, Janice Daniel, who lives in Hurst. "She died at the hospital saying she didn't understand why this happened."

Carroll Brown, 71, said he immediately suspected Rezulin contributed to his wife's death.

Last year, the Los Angeles Times reported that internal documents indicated Warner-Lambert masked early indications of the drug's danger to the liver and its lethal toxicity in information provided to the FDA and to doctors.

"I believe that the FDA was misled," Carroll Brown said. "They were not furnished all of the information or they never would have approved that drug."

Pfizer revealed in recent annual reports that it is cooperating in a federal grand jury investigation in Maryland concerning Rezulin.

Questions raised

The FDA approved Rezulin for U.S. patients in early 1997, giving it a "priority review" because it was viewed as the first in a new class of drugs believed to be a significant improvement to the treatment of diabetes.

Warner-Lambert said the drug was thoroughly tested under strict medical protocols monitored by the federal government.

No cases of liver failure occurred in clinical trials involving 2,500 patients, Pfizer's attorneys said. Roughly 2 percent experienced some difficulties, but the problems were resolved without permanent injury, they said.

"The FDA knew there was a potential problem with liver damage, and they approved it," Urquhart said. "We feel very confident the information was provided and understood by the FDA and its advisory committee."

Six months after Rezulin went on the market, after reports of patients developing liver problems, the first of several revised FDA-sanctioned warning labels were issued, Pfizer attorneys said. Doctors also got warning letters.

Mounting evidence that Rezulin could injure a patient's liver, and the availability of two newer drugs that were not as risky, led Warner-Lambert and the FDA to discontinue Rezulin's distribution.

But before Rezulin was voluntarily taken off the market in March 2000, it had provided Warner-Lambert nearly $2.1 billion in sales.

"They were celebrating making a billion dollars as she [Doris Brown] laid in the hospital here, dying," said Rainey C. Booth, a Florida lawyer who also is representing the Brown family. "They called it their 'billion dollar bash.' "

In the Brown lawsuit and in others, Pfizer has vigorously argued that the drug helped thousands of people afflicted with diabetes.

"We don't deny it's tragic that [Doris] Brown died," said Robert Fauteux, a spokesman for Pfizer. "It's just not Rezulin-induced."

Doris Brown's medical records indicate that she was clinically obese, had a history of hypothyroidism and an irregular heartbeat, and had apparently been exposed to something toxic in the 1980s that caused her to develop a liver condition.

She also had developed NASH non alcoholic steato-hepatitis or a cirrhosis of the liver whose cause was unknown, Urquhart said.

"Everyone agrees there was liver trouble," Urquhart said. "They [the Browns] say Rezulin did it. But they don't present any evidence to support that."

Urquhart said the pharmaceutical industry, which is among the most regulated in the nation, is targeted for such lawsuits because the companies are big, wealthy and impersonal.

Pfizer fights each case. It has lost a few, including a $43 million verdict in a Corpus Christi case that led to an undisclosed out-of-court settlement.

Judges in California, New York and West Virginia, however, have refused to grant class-action status in Rezulin lawsuits, in some cases questioning whether Rezulin could be linked to the injuries.

Ultimately, Pfizer attorneys say, such lawsuits could inhibit pharmaceutical companies from testing new drugs.

"Rezulin clearly saved many more lives and the patients lived better lives than if it was not available," said Orzeck, a physician paid by Pfizer to talk to the media about Rezulin. "It was a huge plus for me."

But Doris Brown's daughter Janice Daniel says the case has made her question the safety of the nation's drug supply.

"I am terrified now when I take my 6-year-old to get a prescription," Daniel said. "I wonder what I'm putting into that child's mouth."]]> http://www.yourlawyer.com/articles/read/460 Tue, 30 Apr 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/460
But then came problems, and now a Worcester man is fighting for his life, and what he calls justice.

NewsCenter 5's Liz Brunner reported that just four years ago, Richard Robichaud said, he was a happy, energetic man. But now, at age 49, he has been told he has only a short time to live.

"All of a sudden I blew up with fluid. They said 'You've got cirrosis of the liver.' And I said, 'No, I don't have that. I don't drink,'" Robichaud said.

While he never drank, he did take Rezulin just after it came on the market, for about eight months. It was sold as a drug to help those with type 2 diabetes, an illness Robichaud had been managing for 20 years. Now, however, he's worse off.

"It's like a slow death. That's just what it's like, having this liver disease. Rezulin has poisoned Rich's liver, so it's like a slow death," said his wife, Barbara Robichaud.

Rezulin was approved for use January of 1997, the first in a new class of drugs shown in studies to help people with Type 2 diabetes better respond to their own insulin.

But the drug quickly came under fire. By October 1997, one liver-related death had been reported. In the months that followed, the company, working with the U.S. Food and Drug Administration (news - web sites), issued four separate letters to doctors, warning of risks, and requiring regular tests be performed on patients who use the drug.

In December of that year, the drug was removed from shelves in Britian for safety reasons. But it took 26 months before it would be taken off the market in the United States. By that time, 63 patients had died of liver disesae.

"They sold a product that they knew would kill people, they knew would seriously injure people and they counted the beans and knew they would make billions of dollars even after they paid the lawsuits," said attorney Robert Bonsignore.

A spokesman for the Pfizer company, which now owns Warner Lambert, says the approval process is different in Britain and it maintains that the drug was safe when used appropriately.

"The FDA was completely aware of the United Kingdom's decision. The benefits of Rezulin clearly outweighed the risks," said Bob Fauteux, a Pfizer spokesman

At the Joslin Center for Diabetes, the head of adult diabetes clinic agrees. Dr. Martin Abrahamson says Rezulin was an important advancement for many patients who were not being helped by other drugs. In the past, he has received money from Pfizer for unrelated work.

"If people followed the guidelines for liver testing, a 1-in-100,000 risk of developing a serious liver event is in fact extremely low and lower than many other drugs being used in widespread clinical practice," said Abrahamson.

But Robichaud believes it was this drug that has brought his life to its final days. He is one of more than 5,600 people suing the makers of Rezulin. It could take three years before his case is heard, and given his condition, his attorney has filed for a speedy trial.

"I'd like to wake up one day and feel good. I don't know what that's like anymore. One day. Without being sick, without needing help out of bed," said Richard Robichaud.

So far, four cases have been heard nationally. In two of them, the patients won. The drug maker prevailed in one and in the fourth, a settlement was reached. ]]> http://www.yourlawyer.com/articles/read/5475 Tue, 19 Mar 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/5475
The drugs belong to a class of drugs called glitazones and are sold under brand names Avandia and Actos. These drugs are used to treat type 2 or adult onset diabetes, which is the most rapidly increasing type of diabetes. A third glitazone, Rezulin, was withdrawn from the market two years ago because of severe liver toxicity side effects.

Thomas Delea, a researcher with Policy Analysis Inc. in Brookline, Mass., analyzed records of claims from 35 health insurers covering 1.7 million Americans. He identified 8,288 diabetics taking glitazones and 41,440 who did not take the drugs and then compared claims over a 36-month period from the time of the first prescription for a glitazone.

Diabetes itself is a risk factor for heart disease, including heart failure, which causes fluid retention and extreme breathlessness as the heart struggles to pump blood to vital organs.

After 36 months, patients taking glitazones faced a "4.5 percent risk of developing heart failure," said Delea. "Diabetics who didn't take glitazones had 2.6 percent risk."

After he controlled for other risk factors, such as obesity, high blood pressure and smoking, glitazone remained an independent predictor for heart failure and compared to non-users "there was still a 50 percent increase in risk for heart failure," he said.

Delea did caution the findings are based on "observational data and need to be confirmed in a clinical trial."

Dr. John Buse, who heads a special committee on heart disease at the American Diabetes Association, said the oral drugs, used to control sugar levels in the blood, are useful medications but need to be carefully monitored.

He said package inserts included with the drugs warn they can cause fluid retention as well as plasma volume expansion, both factors associated with heart failure.

"The problem is that the people who need these drugs are the people who are already at the highest risk for heart failure," Buse said.

Adult onset diabetes can be controlled by diet, exercise and strict blood pressure control. But in some patients, these lifestyle changes do not reduce blood sugar to normal levels and medications are needed.

Delea agreed with this assessment, noting glitazone users in his study were "older and were more likely have other risk factors for heart failure."

He added these patients also were likely to have a history of higher health costs, suggesting they were generally sicker than diabetics who did not use glitazone.]]> http://www.yourlawyer.com/articles/read/5290 Tue, 01 Jan 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/5290
Throughout the nation, lawsuits filed at the district court level by former Rezulin users and their families have become so prevalent that a seven-member judicial panel designated by the chief justice of the U.S. Supreme Court has been assigned to coordinate the legal proceedings arising from the district court cases. Initial meetings of the panel are planned for this May in Washington, D.C. A June 2002 Los Angeles Times article reported more than 2,000 Rezulin lawsuits had been filed.

Some Rezulin cases have already gone through district courts. The first six civil trials were completed during the first half of last year and resulted in two juries deciding in favor of the drug company and four others ending in multi-million-dollar verdicts or settlements for the plaintiffs.

A $24.9 million verdict in a Rezulin case in Texas in January 2002 ranked as the 91st largest monetary verdict in the country in 2002, according to The National Law Journal. That case involved an 80-year-old woman who allegedly died after taking Rezulin. The jury deliberated for only an hour before announcing its verdict.

Like other Rezulin lawsuits nationwide, the suit filed last week in Raton district court by Emily Krulyac accuses pharmaceutical company Warner-Lambert, the manufacturer of Rezulin, of conducting insufficient studies of the drug before seeking federal approval of the drug, as well as failing to inform the public, doctors, hospital, clinics and pharmacists of the dangerous side effects associated with the drug even after the company allegedly knew of potential dangers.

Also named in the Krulyac suit is drug maker Pfizer, Inc., which inherited the mounting litigation connected with Rezulin when Pfizer acquired Warner-Lambert in mid-2000, shortly after Rezulin had been pulled from the market. The suit, which seeks unspecified monetary damages under New Mexico's "Wrongful Death Act," also names other subsidiary drug companies as defendants.

The suit also names Raton physician Dr. Hugh Naylor as a defendant. Naylor prescribed Rezulin for George Krulyac, according to the suit, which alleges that the doctor failed to inform his patient of risks that could be associated with the use of Rezulin. Naylor did not return a Range phone call seeking comment.

Rezulin was approved by the U.S. Food and Drug Administration in January 1997. Not long after the agency gave the drug "fast-track" approval, allowing it to be prescribed by doctors for patients in the general public, reports of liver-related deaths began to be connected to the drug.

Rezulin was promoted by its makers as a "once-a-day" pill that would allow some people with adult-onset Type II diabetes to stop taking insulin injections, according to the Krulyac suit. George Krulyac was diagnosed as diabetic prior to his taking Rezulin, the suit says, and he died while taking Rezulin.

The suit lists several health side effects that allegedly have been linked to Rezulin. The list includes heart disease, hepatitis, jaundice, liver failure and death. Liver failure appears to be the most commonly mentioned hazard that has been associated with Rezulin.

The Krulyac suit alleges the Rezulin makers "consciously ignored and understated the health risks associated with Rezulin" and that the companies used "manipulation of statistics to suggest acceptability in the medical and lay community." The June 2002 Los Angeles Times article reported that although a panel of experts at the National Institutes of Health found that Rezulin "probably" caused the death of a woman in a NIH study and the coroner's death certificate listed the "underlying cause" of death as Rezulin. However, the Times report said, Warner-Lambert issued a news release that blamed the death on factors "unrelated" to Rezulin.

The Krulyac suit claims some scientists who participated in the NIH study of Rezulin were also consultants for Warner-Lambert and were receiving grants from the company.

The Krulyac suit claims that between March 1997 and March 1999, the two years immediately after Rezulin was approved for use, 53 deaths were associated with Rezulin, and 21 were linked to liver failure.

Emily Krulyac is being represented by a Gallup attorney, as well as a Houston law firm that has handled other Rezulin cases, including the Texas case that won the $24.9 million verdict last year.

George Krulyac was married to Emily 53 years. He was the father of one son and three daughters. He was a World War II veteran and retired miner who was living at Miners' Colfax Medical Center Long-term Care facility when he died.]]> http://www.yourlawyer.com/articles/read/35 Sat, 22 Dec 2001 00:00:00 -0800 http://www.yourlawyer.com/articles/read/35
The amount of the settlement was not disclosed, but Pfizer general counsel Paul Miller said it was ``substantially lower'' than the $43 million in compensatory damages awarded by the state court jury. The company did not admit liability.

Margarita Sanchez' case was the second to go to trial involving Rezulin, which has been linked to 63 deaths from liver failure. On Monday, a Houston jury found the company not liable for a 58-year-old woman's death.

The settlement, which would erase the compensatory damages verdict, was announced as the jury considered whether to add punitive damages against Pfizer's Warner-Lambert unit.

``The very tough truth is that taking Rezulin was a death sentence for Margie Sanchez,'' said Mikal Watts, lead trial attorney for 63-year-old Sanchez and her family. ``Now she and her family face the frightening prospects of a liver transplant and a long and very tough battle as a result of the damage this drug caused her.''

During the two-week trial, Sanchez's lawyers said Warner-Lambert lied to the U.S. Food and Drug Administration about Rezulin's dangers.

FDA research has linked the drug to 63 deaths from liver failure. According to company documents, Pfizer faces more than 4,200 claims and lawsuits over Rezulin.

Pfizer, which acquired Warner-Lambert last year, had argued Sanchez's liver condition was caused by hepatitis. Company lawyers said they would have appealed if the settlement hadn't been reached.

Miller said the judge improperly limited Pfizer's ability to question witnesses and allowed jurors to hear prejudicial and hearsay evidence.

"In reaching settlement, the plaintiffs recognized that a second and fair trial was likely to lead to a very different outcome," he said.

The FDA approved Rezulin in 1997 to treat type II diabetes. The drug was taken by nearly 2 million people before it was removed from the market last year.]]> http://www.yourlawyer.com/articles/read/38 Fri, 21 Dec 2001 00:00:00 -0800 http://www.yourlawyer.com/articles/read/38
The amount of the settlement was not disclosed. The deal, eliminating the possibility of an appeal by the drug maker, was announced as the state court jury considered whether to add punitive damages against Pfizer's Warner-Lambert unit.

``The two parties said, 'Let's settle.' It was settled to everybody's mutual satisfaction. Everybody is happy,'' said Mike Papantonio, one of the lawyers who represented 63-year-old Margarita Sanchez.

Pfizer spokesman Bob Fauteux said the settlement should be finalized next week.

During a two-week trial, Sanchez's lawyers said Warner-Lambert lied to the U.S. Food and Drug Administration about Rezulin's dangers.

FDA research has linked the drug to 63 deaths from liver failure. According to company documents, Pfizer faces more than 4,200 claims and lawsuits over Rezulin.

``I think it should be a very clear signal to people who own stock in this company that there's more to come,'' Papantonio said after the jury verdict on compensatory damages.

Pfizer, which acquired Warner-Lambert last year, had argued that Sanchez's liver condition was caused by hepatitis and vowed to appeal.

``With a fair presentation of the evidence, we believe that our defenses would have prevailed, just as they did in Houston earlier this week,'' said Pfizer general counsel Paul S. Miller.

On Monday, a Houston jury found the company not liable for a 58-year-old woman's death. It was the first verdict in a Rezulin-related litigation.

The FDA approved Rezulin in 1997 to treat type II diabetes. The drug was taken by nearly 2 million people before it was removed from the market last year.

Warner-Lambert made $1.6 billion on the drug, Papantonio said.
]]> http://www.yourlawyer.com/articles/read/1092 Tue, 06 Nov 2001 00:00:00 -0800 http://www.yourlawyer.com/articles/read/1092
Details of the settlement, reached Monday in Hinds County Circuit Court in Raymond, were sealed.

As part of the settlement, the drug's manufacturer, Parke-Davis/Warner-Lambert, which last year voluntarily stopped selling the drug in the United States, denied any wrongdoing.

Jury selection had been planned for today, before the settlement was reached in Ouida Cunningham's wrongful death lawsuit on behalf of her husband, Orville Cunningham, 61.

He died in December 1999 of liver disease, six months after a liver transplant.

Orville Cunningham, who taught sociology at Jackson State University for 13 years, had taken Rezulin in 1997 and 1998 to treat his diabetes.

"Mrs. Cunningham is extremely pleased with the settlement," said her attorney, Roe Frazer. "She can put this disaster behind her and get on with her life. She can take some consolation in that she was one of the leaders in getting Rezulin pulled off the market."

Ouida Cunningham said she feels she accomplished what she wanted in filing the lawsuit, though no settlement can make up for the loss of her husband.

"Justice has been served," Cunningham said. "I feel a little numb."

Rezulin, released to the public in March 1997, has been linked to at least 63 deaths nationwide, some involving liver damage.

Parke-Davis/Warner-Lambert pulled the drug off the market after the Food and Drug Administration requested in March 2000 that it no longer be sold.

Frank Wood Jr. of Jackson, one of the attorneys for the drug maker, told Circuit Judge L. Breland Hilburn that both the plaintiffs and the defense agreed the settlement was not an admission of guilt on the part of the company.

"Parke-Davis/Warner Lambert denies all the material facts in the complaint," Wood said.

Everything the company did in marketing the prescription drug was legal and proper, he said.

Frazer told the judge he was confident in the plaintiff's ability to prove the case had it gone to trial.

The lawsuit claimed Rezulin was defective and unreasonably dangerous because of inadequate testing.

Bob Fauteux, a spokesman for Pfizer in New York City, has said, "We do not believe Rezulin had anything to do with Dr. Cunningham's condition."

Pfizer bought Warner-Lambert and its subsidiary, Parke-Davis, in November 1999, almost two years after the drug was first marketed in the United States.

Rezulin was a once-a-day pill that replaced or helped diabetics cut back on insulin injections. It was prescribed for Type 2 diabetes, the most common form, which usually starts in adulthood.

Fauteux said of the 1.9 million patients prescribed the drug, fewer than 100 reported acute liver failures leading to death or transplant.

Fauteux said Monday the terms of the settlement couldn't be discussed. He said he couldn't comment on whether the state's perception by some as a mecca for high-dollar jury verdicts played any part in settling the case.

Recently, a Holmes County Circuit Court jury awarded $150 million in compensatory damages to six laborers from Attala and Holmes counties in an asbestos case.

In another case, a jury in Claiborne County awarded 10 plaintiffs $100 million in a lawsuit against the makers of the heartburn drug Propulsid. ]]> http://www.yourlawyer.com/topics/overview/rezulin Tue, 06 Nov 2001 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/rezulin At this time, we are not accepting new Rezulin case inquiries. On March 21, 2000 head of the FDA's center for Drug evaluation and Research stated that the "Continued use of Rezulin" posed an "unacceptable risk " to diabetes patients. At least 63 Rezulin users have died of liver failure. The total number of deaths is estimated to be as many as ten times higher than the reported 63 cases.

Doctors prescribed Rezulin to diabetics who took insulin but whose blood sugar was not well controlled. It was designed to help insulin (either your own or injected) work better, by drawing the sugar from your blood into the cells to supply energy. Rezulin was approved for diabetics who used insulin and took certain types of oral antihyperglycemic medications or fodiabetics. The patient’s diabetes could not be controlled by diet and exercise alone.

Rezulin was banned in England in December 1997, following the death of an American who took the drug. The drug manufacturer, Warner-Lambert successfully fought a ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug on March 21, 2000. Before the ban, sales of Rezulin generated Warner-Lambert $1.8 billion in revenues. At its peak, the drug was prescribed 488,000 times in January of 1999. 63 Rezulin users have reportedly died from use of the drug.

The deaths were caused by liver failure. The total number of deaths is likely to exceed 63 by many times according to experts.]]>