Personal Injury

September 18, 2009

GlaxoSmithKline to Defend Paxil in Birth-Defect Case

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.

Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.

September 17, 2009

FDA Requires Strong Amputation Warning on Promethazine

by Dr. Shezad Malik

Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday.

The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.

Wyeth had appealed the case up to the Supreme Court after a Vermont woman named Diana Levine, who once played the guitar and piano professionally, sued because she had to have her right arm amputated after being injected with Phenergan. Levine’s lawsuit, which claimed she wasn’t sufficiently warned of the risks of using Phenergan, won her a $6.7 million jury award.

September 16, 2009

Glaxo Withheld Paxil Birth-Defect Data, Witness Says

by Dr. Shezad Malik

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 14, 2009

Utah Supreme Court Says Insurer Has to Pay Malpractice Policy

by Dr. Shezad Malik

After years of legal wrangling, a 12-year-old Eureka, Utah boy who suffered brain damage at birth is a step closer to getting money to help compensate for his injuries.

The Utah Supreme Court on Tuesday ruled an insurance company cannot invalidate the medical malpractice policy of the obstetrician who made a failed attempt to deliver the boy with forceps. Under that decision, The Doctors’ Company (TDC), an insurance company based in Napa, Calif., remains responsible for an almost $1.3 million jury verdict in favor of Athan Montgomery. With interest, the total could top $2 million.

The insurer has argued for years that it should be excused from defending the doctor or paying any judgment on his behalf.

David Biggs, an attorney who represents Athan and his family, said: “We are pleased beyond measure that finally, this young child, now a young man, might be compensated for the medical malpractice that took place so many years ago.”

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.