Drug Lawsuit news

Merck, Schering defend handling of Vytorin study

NEW YORK, Jan 25 (Reuters) - Merck & Co and Schering-Plough Corp on Friday defended their handling of a study of their shared cholesterol drug Vytorin amid criticism they lagged in releasing the study's results.

The mixed results of the "Enhance" trial, released Jan. 14, showed Vytorin failed to prevent buildup of fatty plaque in the carotid artery better than a widely used generic drug.

"While the Enhance trial was time consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial," Thomas Koestler, president of the Schering-Plough Research Institute, said in a statement.

Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke.

Merck Pays $4.85 Billion for Vioxx Settlement

NEW YORK (Reuters) - Merck & Co has agreed to pay $4.85 billion to settle claims that its painkiller Vioxx caused heart attacks and strokes in thousands of users, the drugmaker said on Friday.                                                 

The agreement covers lawsuits filed against the company in U.S. courts, resolving a major legal battle that has dogged the drugmaker since it pulled Vioxx off the market three years ago.

Merck recalled the popular painkiller, which had $2.5 billion in annual sales, in September 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

In the settlement, reached with representatives of plaintiffs in federal and state courts, Merck did not admit Vioxx caused patient injury and did not admit fault.

Avandia - increased risk of heart failure

The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial is a six year study that has been on-going since 2003. But due to the meta-analysis study that concluded recently that rosiglitazone (Avandia) may cause heart attacks and fatal cardiovascular conditions, the researchers for the RECORD trial decided to publish some results in the middle of the trial.

The researchers concluded,

"Our interim findings from this ongoing study were inconclusive regarding the effect of rosiglitazone on the overall risk of hospitalization or death from cardiovascular causes. There was no evidence of any increase in death from either cardiovascular causes or all causes. Rosiglitazone was associated with an increased risk of heart failure. The data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction."

Rosiglitazone does have a side effect of increased risk of heart failure, which appears as a "black box" warning from the FDA, on the medication. Although the data wasn't strong enough to prove that rosiglitazone does cause an increase in risk of heart attacks, it does seem to support the FDA warning of increased heart failure risk.

Reuters reports that two advisory separate panels of the FDA are scheduled to study the issue of Avandia's safety at a series of meetings starting July 30. The endocrine and metabolic drugs committee and the drug safety and risk management committee will meet simultaneously, an FDA agency notice said.

The advisory panel will discuss the cardiovascular risks of the class known as thiazolidinediones, "with a focus on rosiglitazone," said an FDA statement. Rosiglitazone is the generic name of Avandia.

Lexapro, Zoloft, Paxil & Prozac Warnings

Expectant women and those trying to become pregnant should avoid taking antidepressants because of a risk of birth defects, a group of U.S. obstetricians suggested Thursday.

The American College of Obstetricians issued the warning, which is published as an opinion in the December issue of the journal Obstetrics & Gynecology.

The obstetricians said exposure to selective serotonin re-uptake inhibitors or SSRIs, a class of antidepressants that includes Prozac, Zoloft, Lexapro and Paxil, during the later stages of pregnancy has been linked with short-term complications in newborns.

But the group acknowledged that reproductive-age women face a higher risk for depressive disorders. Accordingly, the college suggested that doctors should decide on a case-by-case basis if women should continue to take the antidepressants.

Prempro Drug Trial In Second Day of Deliberations

No verdict after a second full day of jury deliberations Wednesday in a Benton woman’s lawsuit alleging that Wyeth Pharmaceuticals’ hormone drugs caused her breast cancer.

U. S. District Judge Bill Wilson Jr. ordered jurors to return at 9 a. m. today to the federal courts building in Little Rock to resume deliberations.

Jurors are asked do decide if the hormone drugs Premarin and Prempro were safely made and adequately labeled at the time Linda Reeves took them from 1992 to 2000 to prevent osteoporosis and alleviate vaginal dryness.

Reeves’ case is the first of several bellwether cases across the country to go to a jury. There are roughly 5,000 similar cases pending against Wyeth across the country.

Eli Lily Sued over Zyprexa

A West Baton Rouge Parish woman has filed a federal lawsuit against Eli Lilly and Co., claiming her son developed diabetes after taking the drug Zyprexa for three months in 2003.

Catherine Harrison’s lawsuit, filed Tuesday in U.S. District Court in Baton Rouge, says her son developed severe stomach and bowel problems and diabetes.

The lawsuit also claims the child has suffered extreme pain and will have substantial medical bills all his life. It also contends Eli Lilly did not give proper warning that the drug could have severe side effects.

Continue reading "Eli Lily Sued over Zyprexa"

Prempro Trial Getting Under Way

Merck has been the drugmaker in the news the past couple of months. It's fighting off thousands of Vioxx lawsuits one by one. But another company is set to steal that unwelcome spotlight. Wyeth is defending about 4,500 suits over its hormone replacement, Prempro. Six million menopausal women in this country have taken it. But the drug has been linked to breast cancer. Jury selection in the first case to go to trial began in late August.

Merck Loses Vioxx Lawsuit

New Orleans jury ruled against Merck in the latest trial related to the pain reliever Vioxx. The jury ruled that Merck failed to warn doctors about the medical risks associated with the drug. The jury also ruled a that a patient who had a heart attack after taking the drug is entitled to 50 million dollars of compensatory damages.

The panel has not decided on punitive damages in the case. Merck pulled Vioxx off the market in 2004 after a study found the drug increased the risk of heart attacks and strokes.

Merck Found Liable in Vioxx Death

A state jury found Merck & Co. liable Friday for the death of a 71-year-old man who had a fatal heart attack within a month of taking its since-withdrawn painkiller Vioxx and ordered the company to pay $32 million. Merck said it would appeal.

The damage award will likely be reduced because of state caps on such awards.

The jury of 10 men and two women deliberated for about seven hours over two days before returning the verdict in favor of the family of Leonel Garza.

The company was ordered to pay $7 million in non-economic compensatory damages and $25 million in punitive damages.

But the punitive damage amount is likely to be reduced since state law caps punitive damages at twice the amount of economic damages, lost pay, and up to $750,000 on top of non-economic damages, which are comprised of mental anguish and loss of companionship.

Because Garza was retired, the jury awarded no economic damages. That means the most Garza's family could receive under state law is $7.75 million.

"Merck will appeal," spokesman Kent Jarrel said.

The case was the sixth of 11,500 lawsuits to reach a verdict and brings Merck's scorecard in the trials to three wins and three losses.

In the prior two losses, the New Jersey-based pharmaceutical company was ordered to pay one plaintiff $253.4 million, which will be reduced to $26 million under Texas caps on punitive damages; and the other $13.5 million.

Attorneys for Garza said that while Garza had a history of heart problems, his veins had been cleared and a stress test showed less than a 2 percent risk of heart attack within a year. They said he had taken the drug for almost a month before he died in April of 2001.

Jury finds Merck liable for $32 million

A Texas jury has found Merck & Co. liable in the heart attack death of a Vioxx user on Friday, awarding his widow a total of $32 million in damages and marking the second straight loss for the company in the courtroom.
According to Merck spokeswoman Casey Stavropoulos, the state jury found that Merck should pay $7 million in compensatory and $25 million in punitive damages to the family of 71-year-old Leonel Garza, who died of a heart attack in April 2001.
Garza reportedly suffered the fatal heart attack after taking Vioxx for about a month.
According to Merck, Garza was an obese, lifelong smoker who had undergone quadruple coronary-bypass surgery in 1985 and had suffered an earlier heart attack in 1981. Merck also claimed that medical records indicated Garza took Vioxx for only about a week.
In a statement released after the verdict, Merck said that Texas state law caps the punitive award at $750,000. Merck plans to appeal the verdict.