Product News and Recalls

Number of Pradaxa Lawsuits Expected to Keep Growing

In October of 2010 the FDA approved Pradaxa for the prevention of blood clots and strokes in patients with atrial fibrillation (irregular heartbeat). It was marketed by its manufacturer, Boehringer Ingelheim, as an alternative to warfarin. Over the following year a number of cases of gastrointestinal bleeding were reported, some severe enough to cause death. According to the Cleveland Clinic, Pradaxa had a 33% increased risk of heart attack or heart disease over warfarin.

According to the Institute ...

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Cipro, Z-Pack Linked with Acute Kidney Injury In Adult Men

A new study links serious renal side effects in men to antibiotics recognized as fluoroquinolones – more commonly known as Levaquin, Cipro and Avelox.

The Canadian Medical Association (CMA) published an article in its June 2013 medical journal that warns patients of “the use of fluoroquinolones may lead to acute kidney injury.”

The study compiled men ranging from 40 to 85 years of age who were enrolled in the United States IMS Life Link Health Plan ...

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Johnson & Johnson recalls contraceptives

Johnson & Johnson has announced a voluntary recall of millions of oral contraceptive packages, after tests showed that one of the hormones in the pills was being released more slowly than it should.

A story in the Asbury Park Press notes that it’s the latest in a series of about 40 product recalls announced by Johnson & Johnson since 2009.

Among them is the 2010 recall of an all-metal hip implant manufactured ...

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The Public Dangers of Private Confidentiality Provisions and Gag Orders

It is common to find confidentiality provisions in settlement agreements, where a wrongdoer seeks to keep all harmful information from getting out to the public. Confidentiality provisions are often accepted because the risks of passing up a settlement (the proverbial bird in the hand) are too great to warrant being left without any compensation for one’s injuries.

Confidentiality provisions are especially common where a wrongdoer is alleged to have injured multiple victims, because if one person settles, any information they have ...

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More than 70,000 complaints about Mirena IUD

An investigation by WEWS-TV out of Cleveland uncovered more than 70,000 complaints about the Mirena intrauterine device filed with the U.S. Food and Drug Administration since 2000.

A number of women have filed lawsuits claiming the company overstated the device’s benefits in its advertising while trying to conceal some potentially dangerous side effects. Those side effects include the possibility that the device will ...

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FDA Announces Voluntary Recall of Nova Max Blood Glucose Test Strips

Last week, the U.S. Food and Drug Administration announced a voluntary recall of Nova Max Blood Glucose Test Strips that may report a false, abnormally high blood glucose result.

The FDA stated in a news release that “under certain conditions, a false, abnormally high blood glucose level could result in an insulin dosing error, requiring the user to seek immediate medical attention.”

It has been reported that nearly 62 million strips may be affected by this recall. ...

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