Force-Placed Suit Against GMAC Will Proceed

As reported today in the American Banker (10/2, Cumming) a NY class action lawsuit brought by homeowners accusing GMAC Mortgage of “taking kickbacks and overcharging homeowners on force-placed insurance policies has survived a motion to dismiss.”  Specifically, Judge Alison Nathan refused to throw out a portion of the suit alleging violations of the Racketeer Influenced and Corrupt Organizations, or RICO, Act, and …

Deadline set for fungal meningitis claims against NECC

As described in the Tennessean (9/30, Roche), last week in Massachusetts, US Bankruptcy Judge Henry Boroff set a Jan. 15, 2014, deadline for victims of the nationwide fungal meningitis outbreak to file claims in the bankruptcy case of the company blamed for the deaths of 64 patients. NECC is the manufacturer of contaminated steroid shots that were distributed to medical …

Vaginal-mesh manufacturers in settlement talks

According to Bloomberg News (9/30, Feeley, Voreacos), C.R. Bard Inc., Endo Health Solutions Inc., Boston Scientific Corp., along with two other manufacturers of vaginal-mesh implants accused of injuring thousands of women are in settlement talks. According to the report, U.S. District Judge Joseph Goodwin in Charleston, West Virginia, who is overseeing the federal lawsuits targeting the implants has been asked to appoint a settlement …

FDA warns Pfizer’s drug Tygacil raises risk of death

Reuters (9/27, Clarke), the AP (9/27) and the Wall Street Journal (9/27) reported on Friday that the Food and Drug Administration issued a warning that tigecycline (Tygacil), Pfizer Inc’s antibacterial drug, can increase the risk of death when used as authorized by the FDA or for other non-approved conditions.  A boxed warning will be added to the drug’s label, and the FDA indicated …

FDA To Regulate Some Medical Device Apps

The U.S. Food and Drug Administration announced earlier this month that it would regulate small portions of the growing number of mobile health applications, which are popular on smartphones and tablets. FDA officials told the New York Times that their goal is to oversee apps that function like medical devices, which could potentially pose risks to patients. Many of the …

Severe Quality Violations at Factory Manufactoring Popular Generic Drug, Metoprolol

As reported today in Bloomberg News (9/27, Gokhale) “Urine Spills Staining Image of Wockhardt’s Generic Drugs,” the U.S. Food and Drug Administration inspected the generic drugmaker Wockhardt Ltd.’s factory in India and found serious quality violations including “urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area.”  This factory makes metoprolol, a generic version of the popular …

FDA strengthens HBV warning of two cancer drugs

As reported by Reuters (9/26, Clarke), the U.S. Food and Drug Administration has announced that GlaxoSmithKline Plc’s chronic lymphocytic leukemia (CLL) drug, Arzerra, and Roche Holding AG and Biogen Idec Inc’s drug, Rituxan, will now contain black box warnings on “the risk that they may reactivate the hepatitis B virus in patients previously infected with the disease.” Hepatitis B is a …

Overuse of Cardiac Stents Linked to Deaths

In a highly critical article titled “Deaths Linked To Cardiac Stents Rise As Overuse Seen,” Bloomberg News (9/26, Waldman, Armstrong, Freedberg) reports on “US medicine’s binge on cardiac stents.”  Cardiac stents are used to restore blood flow in patients, including 7 million Americans in the last decade at a cost of more than $110 billion. The article reports that in …

Five Women File Yaz Lawsuit After Suffering Pulmonary Embolisms

Five women have filed a lawsuit against Yaz manufacturer Bayer in the United States District Court for the Southern District of Illinois, claiming that they suffered pulmonary embolisms as a result of taking the contraceptive. The women filed their lawsuit on March 26—two of the plaintiffs live in California, one in Wisconsin, one in Texas and one in Florida. The …

Houston Woman Files Lawsuit After Daughter Dies From Alleged Pharmacy Error

According to ABC News, a Houston woman is suing a pharmacy claiming that a dosage error led to her daughter’s death. Simone Allen claims that her 6-year-old daughter Jadalyn died after taking a dose of morphine 10 times higher than her prescription called for in April 2012. “They gave me the medicine to help her with her pain, and it …