Product Liability

Frequent, long-term monitoring recommended for hip implants

According to an article in the New York Times, British health regulators are recommending that patients who received a certain type of metal-on-metal hip implant get annual examinations for as long as they have the devices, because of concerns that the implants will shed pieces of metallic debris as they wear.

Previously, the health regulators had recommended that the patients be monitored for five years. But recent data show the hip implants in question – consisting of both a ball and ...

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Bayer suing over controversial birth control

Bloomberg reports that a unit of Bayer is suing generic drug manufacturer Watson Pharmaceuticals Inc. over allegations that Watson has violated a patent for Beyaz birth control pills.

A spokesman for New Jersey-based Watson said the company intends to contest Bayer’s claims.

Bayer has requested that a judge ban the sale of birth control pills based on the patent.

Beyaz and other birth control pills containing the compound drospirenone has served as the basis of read more.... --> continue reading...

Another delay in Yasmin case

For the second time in three months, the U.S. District Court has delayed trial deadlines in the cases over Yaz/Yasmin/Beyaz birth control for 60 days.

Chief Judge David R. Herndon of the Southern District of Illinois announced the delay on Feb. 29. The delay will allow the parties in the case more time to negotiate.

Lopez McHugh is representing multiple plaintiffs against Bayer Healthcare, manufacturer of the birth control pills Yasmin, Yaz, Beyaz, and Ocella. Lopez McHugh’s claim, supported by a ...

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Coalition demands more rigorous FDA screening

A coalition of patient, consumer, and public health groups urged the federal Food and Drug Administration to require more rigorous testing before a medical device used for addressing complications from aneurysm treatments can be sold.

“This decision by FDA sets a bad precedent for approving new devices,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “Medical devices intended to save lives should require the FDA’s most rigorous safety testing. Bypassing such testing up front can put hundreds of thousands ...

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Members of Congress: Close FDA loophole

Four Democratic U.S. Representatives have introduced legislation designed to close a major loophole in the process by which the federal Food and Drug Administration approves medical devices. The legislation’s sponsors specifically cite vaginal mesh implants and metal-on-metal hip implants as dangerous and defective devices that have made it onto the market as a result of that loophole.

A news release from ...

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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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