Month: November 2013

FDA reviewing complaints about Essure

Jennifer is a mother of two. She lives in Glendale with her family, including two additional stepchildren. With a full house, she wanted permanent birth control.

She chose Essure. The device consists or two small metal coils which are placed inside each fallopian tube. Scar tissue grows to block conception.

But, even after doctors confirmed her fallopian tubes were fully blocked, Jennifer got pregnant.

“Essure just basically didn’t do its job. And because of that, we had to pay the price. Other women have to pay the price,” said Jennifer.

Jennifer is talking about a group of women sharing their experiences with Essure on Facebook .

Many describe the exact same symptoms like extreme bloating, skin rashes and headaches. They also post pictures, including photos of X-rays that show coils cutting through fallopian tubes and broken coils after they were removed.

There are more than 3,500 women in the group and the number keeps growing.

Patients and doctors also reported these same issues to the Food and Drug Administration. The federal government received a total of 943 adverse event reports about Essure.

Including the first reported death associated with Essure.

Now, a month after our initial investigation, the FDA responded to public pressure.

In a statement posted on their website , the agency states they “reviewed” the complaints and clinical trial documents.

They acknowledge some of the complaints are symptoms included in the Essure labeling, and some that are not.

The FDA states, at this point, its “found no evidence” of “more widespread complications” about Essure and said nothing about it’s status as a defective medical device.

J&J Pays $2.2 Billion in Risperdal Damages

In one of the country’s largest health care-related settlements, pharmaceutical giant Johnson & Johnson paid $2.2 billion to settle charges of false marketing, and paying doctors and nursing homes kickbacks for promoting drugs for unapproved uses.

Officials with the U.S. Department of Justice alleged that Johnson & Johnson promoted the use of Risperdal, a drug approved by the Food and Drug Administration only for the treatment of schizophrenia, for controlling symptoms of anxiety and aggression in elderly dementia patients, as well as in children and the mentally disabled with behavioral problems.

J&J to Pay $2.2 Billion in Risperdal Settlement

Johnson & Johnson has agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it improperly promoted the antipsychotic drug Risperdal to older adults, children and people with developmental disabilities, the Justice Department said on Monday.

The agreement is the third-largest pharmaceutical settlement in United States history and the largest in a string of recent cases involving the marketing of antipsychotic and anti-seizure drugs to older dementia patients. It is part of a decade-long effort by the federal government to hold the health care giant — and other pharmaceutical companies — accountable for illegally marketing the drugs as a way to control patients with dementia in nursing homes and children with certain behavioral disabilities, despite the health risks of the drugs.

The settlement, which requires the approval of a federal judge, will also resolve accusations that the company inappropriately promoted two other drugs, the heart-failure drug Natrecor and Invega, a newer antipsychotic drug.

Much of the conduct highlighted in the case, which for Risperdal extends from 1999 through 2005, occurred while Alex Gorsky was vice president for sales and marketing and later president of the company’s pharmaceutical unit, Janssen. Mr. Gorsky became chief executive of Johnson & Johnson last year. Risperdal, which has lost its patent protection, was once one of the company’s best-selling drugs.

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