Product Liability

October 15, 2009

Deaths Linked To Yaz and Yasmin Birth Control Pill

It was August, 2008, when 24-year-old Tanya Hayes began to experience breathlessness and what her family described as a “nasty, hard cough.” Tanya ignored the symptoms until one afternoon when she collapsed in a car park in her hometown of Melbourne, Australia. Five hours later, she was pronounced dead of a pulmonary embolism.

According to the head of the emergency room that treated Ms. Hayes, her death was the result of “blood clotting caused by factors related to taking the oral contraceptive pill.”
What her family did not discover until later is that the fine print on the package of pills she was taking, known as Yasmin, lists “breathlessness” as a “very rare . . . very serious side effect.”

October 13, 2009

Glaxo Ordered to Pay $2.5 M for Paxil Birth Defect Lawsuit

by Dr. Shezad Malik

GlaxoSmithKline Plc must pay $2.5 M over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial.

Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

October 13, 2009

Glaxo Ignored Paxil’s Birth-Defect Risks, According to Lawyer

by Dr. Shezad Malik

GlaxoSmithKline Plc officials intentionally ignored the possibility that the Paxil antidepressant caused birth defects, a lawyer said in closing arguments of a trial over the drug. Glaxo researchers never followed up on studies showing Paxil posed a birth-defect risk for fear of harming sales,
The London-based drugmaker “made a concerted effort” not to study Paxil’s links to birth defects, Tracey said. Glaxo executives sought to “avoid doing studies that would have revealed the truth about their drugs,” he said.

The trial is the first of more than 600 cases alleging that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid those risks to increase profits.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about Paxil’s risks and failed to properly test the drug. Lyam’s mother, Michelle David, blames Paxil for causing her son’s life-threatening heart defects.

October 13, 2009

Yasmin and Yaz Side Effects Were Concealed to Boost Sales

by Dr. Shezad Malik

Two pension funds for firefighters and city employees in Pennsylvania have filed a lawsuit against Bayer, saying that the drug maker hid health risks and misrepresented the effectiveness of its popular birth control pills Yaz and Yasmin. The complaint joins hundreds of other lawsuits pending against the pharmaceutical company over problems with Yaz and Yasmin.

The Yaz / Yasmin lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania by the Philadelphia Firefighters Union Local No. 22 Health and Welfare Fund, and the American Federation of State, County and Municipal Employees, District Council 47 Health and Welfare Fund. The funds accuse Bayer of unlawfully promoting Yaz to mislead investors about the value of the company, concealing the drug’s increased risks of blood clots, strokes, heart attacks, gallbladder disease, pulmonary embolisms and deep vein thrombosis (DVT).

October 12, 2009

Chinese Drywall Personal Injury Cases Continue to Increase

by Dr. Shezad Malik

When Bill Morgan, moved into his newly built dream home in Williamsburg, Va., three years ago, his hopes were quickly dashed. As reported in the New Times. Read the complete story here

His wife and daughter suffered constant nosebleeds and headaches. A persistent foul odor filled the house. Every piece of metal indoors corroded or turned black.

Mr. Morgan moved out. The headaches and nosebleeds stopped, but the ensuing financial problems pushed him into personal bankruptcy.

Mr. Morgan, like many other American homebuyers who tell similar tales of woe, is blaming the drywall in his new home — specifically, drywall from China, imported during the housing boom to meet heavy demand — that he says is contaminated with various sulfur compounds.

October 8, 2009

Glaxo Claims to Have Complied With FDA Rules on Paxil

by Dr. Shezad Malik

GlaxoSmithKline Plc, the U.K.’s largest drugmaker, complied with all U.S. Food and Drug Administration regulations in testing and monitoring Paxil, according to a former employee for the agency.

Glaxo reported to the FDA on a regular basis and supplied animal toxicology studies that didn’t indicate the drug could cause birth defects, Judith Jones testified as an expert witness for the company. Jones spent eight years in the FDA’s post- marketing surveillance and drug safety group.

“The FDA was provided all of the reports that GlaxoSmithKline had received on a regular basis and they specifically did not identify a signal,” Jones told jurors in state court. “They provided all the necessary information to the FDA.”
Jones testified toward the end of the first trial over claims Paxil causes birth defects. Michelle David blames her Paxil use for her 3-year-old son’s life-threatening heart defects. She accuses the company of withholding information from consumers and regulators about the risk of birth defects and failing to properly test Paxil.

October 7, 2009

Bayer Sued Over Health Claims About Multivitamin for Men

by Dr. Shezad Malik

A nonprofit health advocacy group wants Bayer correct its marketing techniques — this one involving its Men’s One A Day multivitamin.

The Washington, D.C.-based Center for Science in the Public Interest (CSPI) is suing the German drug giant for allegedly claiming falsely that selenium in the men’s multivitamin might reduce the risk of prostate cancer.

The lawsuit, filed in San Francisco Superior Court, comes on the heels of several multimillion-dollar settlements that Bayer has paid out to resolve claims about misleading advertising. This year, Bayer agreed to run a $20 million corrective advertising campaign about its birth control pill Yaz.

In 2007, it paid a $3.2 million fine over weight loss claims involving its One A Day vitamin as part of a consent decree reached with the Federal Trade Commission and the U.S. Department of Justice and another $8 million to resolve allegations, raised by state attorneys general, that it hid safety issues surrounding its cholesterol-lowering drug Baycol.

October 7, 2009

Teen’s Fatal Overdose Blamed on Fentanyl Patch

by Dr. Shezad Malik

For a 15-year-old, or anybody else, Michael Blankenship had already been through a lot when he arrived at Seattle Children’s hospital for some routine dental work.

What left him dead, was the painkiller-laced patch — meant to ameliorate chronic pain in cancer patients and others — that was prescribed to Blankenship.

Discharged to his mother’s home the day of the March 9 tooth extraction, Blankenship was found dead in his bed the following morning. According to a civil suit filed earlier this month in King County Superior Court, a medical examiner found Blankenship had died from a drug overdose caused by the fentanyl patch.

October 6, 2009

Bayer Sued, Accused of Hiding Yaz Risk to Boost Sales

by Dr. Shezad Malik

Bayer AG, Germany’s largest drugmaker, was sued by two Pennsylvania pension funds and accused of misrepresenting the safety and effectiveness of the Yaz contraceptive to boost sales.

Bayer unlawfully promoted the drug from March 2006 to March 2009 by concealing side effects including blood clots, heart attacks and pulmonary embolisms, two health and welfare funds for firefighters and city employees said in a federal court complaint made public today in Philadelphia.

The Yasmin family of birth control pills, known as Yaz, Yasmin and Yasminelle, were Bayer’s top-selling drugs last year, bringing in about $1.8 billion, a 17 percent increase over 2007.

October 4, 2009

Yaz and Yasmin: Get the Medical Facts

by Dr. Shezad Malik

The New York Times reported September 25 on the controversy surrounding Yaz and Yasmin, two popular birth control pills (BCPs).

The controversy is a result of the marketing and manufacturing processes identified by the Food and Drug Administration. The major concern is whether these medications increase the risk of blood clots.

Yaz and Yasmin use both estrogens and progestins to prevent ovulation. Estimates are that at baseline about 1 women in 10,000 will have a blood clot this year; that number increases to about 3 women in 10,000 if they are taking BCPs.

Also the fact is that more than 50 women in 10,000 will get a blood clot due to pregnancy.