Drug and Medical Device Lawsuits

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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Journal says more women needed in medical testing

A recent opinion piece in the Journal of the American Medical Association faults the federal Food and Drug Administration for not adequately taking gender differences into account for medical device clinical trials.

Authors Sanket S. Dhruva, MD, and Rita F. Redberg, MD, MSc, note early on that women generally have higher bleeding rates and procedural death rates than men, meaning the risk/benefit assessments for implanted medical devices can be different for women.

The FDA is aware of this situation, and has put ...

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Pharmacy mixes up breast cancer drug, children’s fluoride

As many as 50 families may have been affected by a New Jersey CVS Pharmacy’s mixup of children’s fluoride prescriptions, and the breast cancer drug tamoxifen, the Chatham Courier reports.

According to the newspaper, parents who had their children’s fluoride prescriptions filled at the Chatham, N.J., location are between Dec. 20 and Feb. 20 are being asked to check that the pill bottles don’t contain tamoxifen.

The paper quotes a CVS spokesman as saying the company is “deeply sorry for the mistake.”

See ...

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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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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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