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News Archive for February, 2012

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

Wednesday, February 29th, 2012

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 Illinois’s U.S. District Court. Bayer also manufactures Ocella, a generic form of Yasmin marketed and distributed by Teva Pharmaceuticals.

On Dec. 8, 2011, panelists at a joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee voted 21 to 5 that the current labeling of Yaz and other popular birth-control pills using the manmade hormone progesterone is inadequate in warning users of its potentially deadly side effects.

During the early part of the marathon meeting, panel members heard testimony from patients and their family members who say Yaz or Yasmin lead to deadly blood clots.

One of those individuals was a mother who talked about the last conversation she had with her daughter, who died on Christmas Eve of 2008 because of a blood clot that traveled to her lung.

The mother assured the panel of experts that if her daughter had been aware of the Yasmin’s risks, she would have opted to take a safer birth-control pill.

In October of 2011, the FDA issued a statement warning the general public that women taking Yaz or any contraceptive with drospirenone were 74 percent more likely to develop potentially fatal blood clots than those who used other contraceptives.

If you or someone you love developed a blood clot, stroke, or pulmonary embolism while taking Yaz, Yasmin, or Ocella, you may be eligible to recover damages. Please contact Lopez McHugh for a FREE consultation with a qualified and trusted attorney who can answer your questions and ensure your legal rights are protected. Call today because if you wait too long, you may be barred from recovering for your injuries by your state’s time limits.

See a transcript of the meeting here:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM288721.pdf

Birth Control Pills Recalled Over Packaging Error

Wednesday, February 29th, 2012

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 tablet orientation and making the lot number and expiry date visible only on the outer pouch. As a result, the daily regimen may be incorrect and could leave women without adequate contraception.

The FDA recommends that consumers exposed to the affected packaging should start using a non-hormonal form of contraception immediately. Patients who have the affected product should notify their physician and return the product to the pharmacy.

For a listing of affected lot numbers and expiration dates, go here:

http://www.fda.gov/Safety/Recalls/ucm293347.htm

Unsafe Artificial Hip Marketed after FDA Rejection

Wednesday, February 29th, 2012

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. 14, 2012, New York Times report, the DePuy division of Johnson & Johnson formally recalled the devices in August, 2010, amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.

But in a confidential letter from August of 2009, the F.D.A. informed Johnson & Johnson that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness.

In 2005, DePuy used a regulatory loophole to sell a version of the metal hip implant in the United States without clinical testing, based on the company’s assertion that the implant was similar to one already on the market.

Widespread complaints about the device include patients crippled by tiny particles of metallic debris.

If you received a DePuy Orthopaedics hip implant and are experiencing side-effects, contact Lopez McHugh for a free case evaluation.

See the New York Times report here:

http://www.nytimes.com/2012/02/15/business/hip-implant-the-fda-rejected-was-marketed-abroad.html?pagewanted=1&_r=1&hpw

BMJ Report: Replacement Hips Expose Patients to Potentially Toxic Metals

Tuesday, February 28th, 2012

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 times in the United States.

Multiple studies have warned about the potential of the implants to release toxic metal ions. The BMJ report cites an internal document from manufacturer DePuy dating from 2005, indicating the company’s awareness that the implants might be carcinogenic. Despite that, the company’s marketing materials made no mention of internal concerns, BMJ says. Instead, the internal document concludes that  “the ultimate test is the long term human experience.”

If you received a hip implant, contact Lopez McHugh for a free case evaluation.

See the BMJ report here: http://www.bmj.com/content/344/bmj.e1410

Bosch/Tassimo Coffee Makers Recalled for Causing Burns

Saturday, February 11th, 2012

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 models listed below, you should stop using it and contact BSH Home Appliances Corp., of Irvine, Calif. for a replacement part:

If, however, you were one of the unlucky people to suffer burns, you may be entitled to compensation. Contact Lopez McHugh for a free case evaluation, or call 877-703-7070. We may be able to recover compensation for you.

Models under recall: TAS100 FD 8806 through 9109, TAS200, TAS451, TAS46, TAS651, TAS6512CUL FD 8905 through 9109

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