Posts Tagged 'Legal Issues'

FDA Panel: Yaz/Yasmin Birth Control Labeling Should Reflect Risks

A Food and Drug Administration panel of experts ruled that the labeling of the popular birth-control pills Yaz and Beyaz should be updated to reflect recent data showing the drug poses a higher risk of causing blood clots than older contraceptives.

Already, 10,458 lawsuits have been filed in federal court against pharmaceutical giant Bayer AG, maker of the contraceptives Yaz, Beyaz, and Yasmin. Plaintiffs claim they weren’t warned of the drug’s harmful side effects, according to the Southern District of ...

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Birth Control Pills Recalled Over Packaging Error

The federal Food and Drug Administration has announced that a batch of birth control pills has been recalled because of a packaging error that may leave women at risk of unintended pregnancy.

On Feb. 24, Glenmark Generics Inc. USA – the domestic distributor for Glenmark Generics Ltd. India – issued the recall of seven lots of norgestimate and ethinyl estradiol tablets.

According to a release by Glenmark, select blisters on the packaging were rotated 180 degrees within the card, reversing the weekly ...

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Unsafe Artificial Hip Marketed after FDA Rejection

The New York Times has reported that Johnson & Johnson marketed an artificial hip overseas after the federal Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.

In addition, the company continued to sell a related model of artificial hip in the U.S. after the FDA rejection, which went on the market because the company used a regulatory loophole that enabled it to avoid a similar safety review

According to the Feb. ...

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BMJ Report: Replacement Hips Expose Patients to Potentially Toxic Metals

A report today in the British Medical Journal (BMJ) alleges that metal-on-metal hip replacement surgery has potentially exposed hundreds of thousands of patients around the world to toxic substances.

The report, dated Feb. 28, 2012, states that patients have been misled about their participation in “what has effectively been a large uncontrolled experiment.”

The hip replacement joints in question employ a cobalt-chromium alloy rather than ceramic or polyethylene. The BMJ report states that the procedure has been used close to a million ...

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Bosch/Tassimo Coffee Makers Recalled for Causing Burns

The U.S. Consumer Product Safety Commission announced today that several models of Bosch/Tassimo Coffee Makers are being  recalled because they have caused numerous burns. To date, 140 people have reported that the coffee disks have burst while they were making coffee. Boiling water is is then sprayed in front of the machine. Thirty-seven people suffered second degree burns, and a 10-year-old girl was hospitalized.

If you have any of the ...

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PA Supreme Court Refuses to Throw out Yaz Lawsuits

King’s Bench Petition Denied

Today the Pennsylvania Supreme Court denied Bayer’s King’s Bench Petition in the Yaz/Yasmin litigation. In plain English, this means that these lawsuits, many of which were pending since 2009, and which were put on hold late last year, can now go forward.

Some Background

Several thousand women from across the country have sued Bayer in state Court in Philadelphia. The basis of the lawsuit is that Bayer Corporation, and its subsidiaries, ...

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