Product Liability

September 16, 2009

Glaxo Withheld Paxil Birth-Defect Data, Witness Says

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, withheld birth-defect data tied to its antidepressant drug Paxil from physicians as the number of reports grew, a psychiatrist testified.

Doctors seeking information about birth defects linked to Paxil originally got the total numbers of side-effect reports about the issue from Glaxo, Dr. David Healy, a professor at Cardiff University in Wales, told a Pennsylvania jury today. He’s testifying on behalf of a family suing over a child born with heart defects allegedly caused by the drug.

September 15, 2009

Glaxo Executive’s Memo Suggested Burying Drug Studies

by Dr. Shezad Malik

An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

September 15, 2009

Glaxo E-Mails Over Paxil Study Must Be Turned Over

by Dr. Shezad Malik

GlaxoSmithKline Plc’s e-mail with researchers studying birth defects allegedly caused by the drugmaker’s antidepressant Paxil must be turned over to a family suing over the drug.

U.S. District Judge Nancy Gertner in Boston refused to block William Seale’s family from reviewing e-mails and other communications between Glaxo and Boston University researchers over Paxil’s birth-defect risks.

The 1-year-old, whose pregnant mother took the antidepressant, died in 2004 after three surgeries to address heart defects, according to court filings.

September 15, 2009

FDA Warns Bayer Maker of Yaz and Yasmin

by Dr. Shezad Malik

U.S. health regulators have warned drugmaker Bayer over quality control issues at a plant that makes the key ingredient in Yaz and other popular birth control drugs.

In a warning letter posted online Tuesday, the Food and Drug Administration said its inspectors uncovered testing problems at the company’s plant in Berghamen, Germany, during a March visit.

FDA inspectors said the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results.

September 13, 2009

Merck Lawsuit Over Fosamax ends in Mistrial

by Dr. Shezad Malik

A lawsuit alleging that Merck & Co’s osteoporosis drug Fosamax caused jaw damage ended in a mistrial on Friday .

U.S. District Judge John Keenan declared the mistrial two days giving the New York jury considering the case a “cooling off period” in light of supposed acrimony among jurors.

A Merck lawyer on Wednesday referred to an “unsubstantiated claim” of a chair being thrown in the jury room.

Merck faces lawsuits involving almost 900 cases by patients who say the use of Fosamax causes osteonecrosis of the jaw, or the death of jawbone tissue. The trial is Merck’s first over the drug

September 12, 2009

Kugel Mesh Patches and Hernia Surgery Side Effects

by Dr. Shezad Malik

The Kugel Mesh Patch, a medical device that was commonly used in surgeries to repair hernias, was recalled in 2005, 2006, and again in 2007 after patients suffered painful bowel perforations and other chronic injuries. The patch, placed inside the body following hernia-repair surgery to prevent tearing or the formation of scar tissue, had a tendency to break or move around inside the body, causing tears between the intestines and other digestie organs, such as the bladder and rectum.

The Kugel Mesh Patch injuries were caused when the “memory recoil ring,” which opened the oval patch so it could lay flat after it was inserted into the body through a narrow incision, broke.

September 11, 2009

Family of Texas Musician Who Died On Stop-Smoking Drug Chantix Sues Maker

by Dr. Shezad Malik

Relatives of a Texas musician who died in 2007 after acting bizarrely while taking the smoking-cessation drug Chantix have filed a lawsuit against the drug’s maker, Pfizer, accusing the company of failing to warn of suicidal thoughts and other dangerous psychiatric side effects associated with the medication.

The death of Carter Albrecht on September 3, 2007 became an example of reports of dangerous complications seen in people taking Chantix. Albrecht, a well-known Dallas musician and member of Edie Brickell & the New Bohemians, was fatally shot by a neighbor after the guitarist started banging on the windows of the neighbor’s house in the middle of the night.

Albrecht’s family claimed the strange and violent behavior was totally out of character for Albrecht and blamed his condition on Chantix, which caused severe hallucinations, vivid nightmares, and violent, unpredictable behavior.

September 11, 2009

Flip Over Handlebars Leads Bike Rider to File Product Liability Suit

by Dr. Shezad Malik

While riding his bicycle, Scott Warren says he was thrown over the handlebars and onto the pavement when the pedal suddenly broke.

Warren filed a product liability lawsuit against Pacific Cycle, Dorel Industries Inc, Catic Bicycle Co., and Whole Man Enterprise Co. on Dec. 15, 2008, in the 366th judicial district of Collin County. The defendants removed the case to the Sherman Division of the Eastern District of Texas on Sept. 2.

Warren was riding a Mongoose Placid bicycle that he purchased in November 2005.

He argues that the defendants were negligent in failing to design the bicycle so that the pedal crank would not break and negligent in the manufacture of the bicycle. Further, the plaintiff claims the defendants were negligent for not warning that the pedal might suddenly and unexpectedly break.

September 10, 2009

Merck Loses Bid to Dismiss 24 Fosamax Lawsuits

by Dr. Shezad Malik

Merck & Co. lost a legal bid to dismiss 24 lawsuits claiming its osteoporosis drug Fosamax causes ‘jaw death’ in patients who took the medicine for fewer than three years.

U.S. District Judge John Keenan in New York, in a ruling released today refused to dismiss the lawsuits, saying that whether there is a three- year threshold is a “genuine issue of fact for trial.” The plaintiffs claim Fosamax causes osteonecrosis of the jaw, or ONJ.

“This simply reflects what’s been known in the science for a while now, that there is no magic window where a patient can be automatically said to be safe from developing ONJ after beginning Fosamax,” Tim O’Brien, one of the plaintiffs’ lawyers, said of Keenan’s ruling.

September 10, 2009

Miss. Chinese Drywall Lawsuits Filed Post-Katrina

by Dr. Shezad Malik

Chinese drywall could become the new asbestos – a building substance that’s the target of a growing number of lawsuits.

About 150 lawsuits already have been filed over Chinese drywall, including about a dozen in Mississippi, and the number is growing almost daily, based upon federal court records. The cases will be consolidated into a class-action lawsuit in federal court in New Orleans.