October 2010 Archives

October 27, 2010

Bitter Pill: GlaxoSmithKline Pays $750M Over Defective Drugs

Drug maker GlaxoSmithKline will pay a $750 fine to settle allegations that the company manufactured defective drugs -- including the antidepressant Paxil -- at a GSK facility in Puerto Rico.

Certain batches of drugs manufactured at the Puerto Rico plant were misidentified and were inconsistent in terms of their active ingredient levels and their purity -- in some cases falling "materially below, the strength, purity or quality specified in the drugs' FDA applications," the U.S. Department of Justice says. It's important to note that there were no reports of patients being harmed by the defective drugs; the penalty against GSK is for the company's ongoing violation of laws meant to ensure the drugs' quality and safety.

In addition to Paxil, other drugs that were allegedly manufactured with defects include Kytril (an anti-nausea drug), Bactroban (used to treat skin infections), and Avandamet (for treatment of Type II diabetes).

Under the deal, SB Pharmco Puerto Rico Inc. (a subsidiary of GSK) has agreed to plead guilty to charges related to the selling of the defective drugs. SB Pharmco will pay a criminal fine and forfeiture of $150 million, and another $600 million to settle allegations under the federal False Claims Act and related state claims.

Here's some related news, and it should serve as incentive for corporate mischief-spotters everywhere to grab their whistles and blow like Dizzy Gillespie. Cheryl Eckard is the ex-quality assurance manager at GSK who filed the whistleblower suit against the company in 2004, shining a spotlight on the questionable manufacturing practices at the Puerto Rico facility. Eckard will receive a lottery jackpot-like $96 million as compensation for coming forward and exposing GSK's wrongdoing.

Learn more about defective drugs and the legal issues they raise in Nolo's Dangerous Products & Drugs section.

October 25, 2010

Halloween Safety Tips for Kids and Parents

If there's one thing that's less exciting to get on Halloween than pennies and raisins, it's tips on keeping things safe. But October 31 is right around the corner, and for kids there's the good kind of scared (ghoulish costumes and haunted houses) while parents and homeowners get the bad kind -- the dangers posed by certain costumes, questionable candy, dark streets, and unsafe property.

So at the risk of donning a Debbie Downer costume this year, here's an old pillowcase full of safety tips for trick-or-treaters, parents and caregivers, and homeowners who are getting ready for Halloween.

Costumes: Make sure costumes and accessories are flame-resistant. Avoid really baggy costumes that can pose a tripping hazard. For greater visibility -- especially since it gets darker earlier this time of year -- use flashlights and apply reflective tape to darker costumes.

Candy and Treats: Parents and caregivers should always inspect their young trick-or-treaters' haul of candy for evidence of tampering or anything that looks suspicious. One good rule of thumb is to avoid any treats that don't appear to be factory-wrapped.

For Homeowners: Keep all walkways, stairs, lawns, and driveways well-lit and free of obstacles. Also, make sure any candle-lit jack-o-lanterns and all other open flames are attended at all times and out of reach of young kids. Otherwise you could be starring in your own personal horror film: The Attack of the Premises Liability Lawsuit.

For Pedestrians and Drivers: Trick-or-treaters and other pedestrians should stay on sidewalks and other designated walkways at all times, and only go up to homes that are well-lit or show other signs that trick-or-treaters are welcome. Drivers should use extra caution and drive slowly in any neighborhood where kids might be out trick-or-treating, and be especially vigilant for pedestrians crossing the street outside of the usual crossing areas.

Get more Halloween safety tips from the Centers for Disease Control and Prevention and the U.S. Consumer Product Safety Commission.

Related information from Nolo:

October 21, 2010

Meridia Recalled Over Heart Risks

Meridia manufacturer Abbott Laboratories has agreed to stop marketing the popular weight loss drug in the U.S., after a study raised serious concerns over a link between Meridia use and heart problems.

The announcement of the Meridia recall came on October 8, 2010. The main impetus for Abbott's action (with a strong nudge from the FDA) was a recently concluded study that showed an increased risk of heart attack and stroke in patients that were taking Meridia, and minimal weight loss benefits in light of those health risks. The 60-month study (called the Sibutramine Cardiovascular Outcomes, or "SCOUT" trial) followed 10,000 men and women who were given Meridia or a placebo. Development of cardiovascular problems was closely monitored in these patients, while progress in their weight loss was also tracked.

According to the FDA, results of the study showed a 16 percent increase in the risk of serious (sometimes even fatal) heart events like heart attacks and strokes in patients who were given Meridia, compared with patients who took the placebo. At the same time, there was only a slight difference in weight loss progress when the Meridia group and the placebo group were compared.

A day after the Meridia recall announcement, this Washington Post article labeled the weight loss pill's withdrawal "the latest setback in the long, frustrating quest for a pharmaceutical solution to the nation's obesity epidemic."

Meridia (sibutramine) was approved by the FDA in 1997, as a prescription weight loss medication intended for use by patients who were considered obese under the body mass index (BMI) measurement standard.

Related information from Nolo: