Defective Products and Devices: April 2010 Archives

April 28, 2010

$520 Million Pay Out for Off-Label Marketing

The New York Times reports that AstraZeneca has agreed to settle a federal investigation of its marketing practices for the drug, Seroquel.

The settlement requires the company to pay $520 million and was announced on Tuesday by Attorney General Eric Holder. AstraZeneca denies the allegations, but agreed to the payment to avoid what would be protracted litigation with the government.

The drug was originally developed to treat schizophrenia. However, the pharmaceutical company allegedly paid doctors to market drugs for unapproved uses including uses by kids, the elderly, veterans and others. With federal investigations and whistleblower suits lingering, the company's sales and marketing was front and center in this matter. This is the latest settlement in a line of federal investigations into the illegal marketing of antipsychotic drugs.

The claims center around the contention that the company misled doctors and their patients by failing to disclose studies that showed this drug increases diabetes risk. They also are alleged to have emphasized favorable research while also failing to disclose risks.

The uses for kids and others were not approved by the Food and Drug Administration and caused various side effects. Kids gained weight and other patients died as a result of the off-label uses.

The California Injury Attorney Blog has reported previously on the off-label marketing case against Pfizer and its settlement. Similar cases have been settled with Eli Lilly for Zyprexa and other pharmaceuticals.

Related Web Resources

Visit the Food and Drug Administration's site for more information on how drugs are approved for use.

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April 17, 2010

Auto Safety Woes Continue for Toyota


Last week, Toyota got more bad news and more bad press about the safety of its cars. Its the kind of bad press no car manufacturer would want, especially one that has been a headline news story for months.

What happened this time? Consumer Reports tested the Lexus GX 460. They reported that its tests revealed a dangerous problem in handling the car. This in turn led to a Don't Buy recommendation by the popular consumer hot spot.

What went wrong with this car? In the Consumer Reports testing, when pushed to its limit, the rear of the car swerved making rollover a major risk. The electronic stability system did not engage until after the rear of the car had already slid out nearly sideways. The driver was not able to regain control of the auto until it was close to a roll-over.

A bit of good news for Toyota: the other Toyota SUV's tested by Consumer Reports did not have this problem.

Under the safety and governmental microscope, Toyota took fast note and its engineers replicated the slide. Toyota agrees -- there is a safety issue with the vehicle. In an unprecedented move, sales of the Lexus GX 460 were halted.

Toyota also has a big decision to make about fines. They must inform the National Highway Traffic Safety Administration this week about whether the company will pay the proposed fine of $16.4 million for the alleged failure to disclose information regarding the "sticky pedal" issue that has been haunting the company for months now. Failure to pay this fine could result in court action against Toyota.

Related Web Resources

For more information on the Toyota recall visit the company's recall site. To read more about the halt of sales for the Lexus GX 460 visit the New York Times and Huffington Post.

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