Product Liability

September 28, 2009

FDA Seeks Outside Review of Medical Device Approvals

The Institute of Medicine will study a U.S. Food and Drug administration program that gives fast-track approval to certain medical devices.

Consumer watchdog groups, lawmakers and others have criticized the FDA for using the accelerated approval process for more products than Congress originally intended, leading to problems with devices after they are sold.

Expedited reviews of devices shown to be similar to existing products allow companies to get products to market more quickly and with less expense.

The study of the program by the institute, part of the National Academies, was required by a 2007 law, but the FDA said on Wednesday that the results would not come until March of 2011.

September 27, 2009

Merck Paying More Than 3,100 Death Claims in Vioxx Settlement

by Dr. Shezad Malik

Merck & Co. is paying claims by the families of more than 3,100 users of its Vioxx painkiller who died of heart attacks or strokes blamed on the drug, according to a law firm administering a $4.85 billion settlement fund.

The fund will pay about 3,000 claims for heart attack deaths and at least 122 strokes, according to BrownGreer LLP, a claims administrator appointed by both sides. Merck introduced Vioxx in 1999 and withdrew it in 2004 when a study showed the drug doubled the risk of heart attacks and strokes. Merck set up the fund, which covers claims of death and lesser injuries, in 2007 after reserving $1.9 billion to fight 26,600 Vioxx suits.

September 27, 2009

Paxil and Heart and Lung Birth Defects

by Dr. Shezad Malik

New studies point to an increased risk of Paxil birth defects in babies whose mothers use the antidepressant during pregnancy.

According to the findings of two studies, women who were taking Paxil during their first trimester were one and a half to two times more likely to have a baby with a heart defect than women who were taking other antidepressants or women of the general population.

A later study found that women who took Paxil at 20 weeks or later were six times more likely to have a baby with a rare birth defect known as persistent pulmonary hypertension, or PPHN.

September 26, 2009

Bayer Yaz Death Probed By Swiss Agency

by Dr. Shezad Malik

Bayer AG, Germany’s largest drugmaker, said its Yaz contraceptive is part of an investigation by a Swiss health regulator into the death of a young woman who took the pill.

The Swissmedic agency and an investigative judge are looking into the case of the woman, who died from the effects of pulmonary embolism, Bayer’s Swiss health unit said in a statement posted on its Web site yesterday. Bayer is cooperating with the authorities, the company said.

September 26, 2009

Bayer and Lawsuits Involving Yaz and Yasmin

by Dr. Shezad Malik

As Reported in the NY Times. Read the full article here.

The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention.

Yaz, in particular, the top-selling birth control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression.

September 25, 2009

Update: Paxil Heart Birth Defects and PPHN Lawsuits

by Dr. Shezad Malik

In 2003, GSK initiated a retrospective analysis of women, dating back to 1995, who had taken antidepressants in the first trimester of their pregnancies and had given birth to children with major congenital malformations. The study found an association between Paxil and congenital malformations in mothers taking Paxil in the first trimester.

Another study conducted by researchers in Denmark and published in Pharmacoepidemology and Drug Safety in 2005 showed a more than 2-fold increase for congenital malformations in women taking Paxil compared to other antidepressants.

In September 2005, GSK sent out a “Dear Doctor” letter informing physicians throughout the United States that the results of its analysis showed a higher rate of “congenital malformations associated with the use of Paxil as compared to other antidepressants” in infants born to women taking antidepressants during the first trimester of pregnancy.

The FDA has issued three Public Health Advisories since December 2005 concerning the risk of congenital heart defects and has changed Paxil’s pregnancy category from C to D, which indicates that “[t]here is positive evidence of fetal risk.”

September 25, 2009

Yaz Birth Control Link to Embolism Investigated

by Dr. Shezad Malik

Switzerland’s medicines supervisor has said it will investigate allegations an oral contraceptive contributed to a fatal lung embolism in a woman.

The embolism occurred ten months after the woman starting taking Yaz birth control pills produced by German firm Bayer. She died in mid-September. Swissmedic announced on Friday it would look into suspicions of a possible link.

Bayer could not comment on the case but said it would take any possible link seriously. It expressed sympathy with the woman’s family, saying her death was tragic regardless of whether there was a connection to its contraceptive pill.

September 25, 2009

Overuse of Denture Cream with Zinc Leads to Lawsuits

by Dr. Shezad Malik

When he began getting weak, 61-year-old Ronald Beaver figured he might just be feeling his age. Eventually his problem was traced to a serious blood disorder caused by low levels of copper.

It wasn’t until several weeks later — after the man from Tamarac, Fla., started getting daily doses of copper — that Beaver’s doctor mentioned that getting too much zinc can trigger loss of copper.

The only source of that much zinc they surmised was the tubes of PoliGrip denture cream he had been overusing for a decade.

September 23, 2009

AstraZeneca Denied Seroquel’s Diabetes Link Years After Warning

by Dr. Shezad Malik

An AstraZeneca Plc saleswoman told a U.S. doctor the antipsychotic Seroquel didn’t cause diabetes almost four years after the company warned Japanese physicians about the drug’s links to the disease, internal documents show.

Nancy White, the saleswoman, and a colleague met with an unidentified doctor in July 2006 who reported “getting a lot of flak” from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit.

AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel “where causality with the drug could not be ruled out.”

September 23, 2009

Texas Yaz, Yasmin and Ocella Birth Control Lawsuit Update

by Dr. Shezad Malik

Yasmin (also known as Yaz/drospirenone/ethinyl Estradiol. Generic : Ocella) is a birth control pill developed and manufactured by Bayer, AG. The medicine works by disrupting a woman’s natural menstrual cycle and providing a daily dose of hormones to regulate a new menstrual cycle.

Bayer AG has been involved in a few discussions with the Food and Drug Administration over questionable advertising campaigns seeming to suggest that Yasmin/Yaz has less side effects than other contraceptive medications.

Recent reports indicate that dangerous side effects could occur in women with preexisting conditions such as high blood pressure, diabetes, or obesity.