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Class I Recall of Medtronic Cardiac Guidewire After FDA Investigation Reveals Complaints

On November 15, 2013, Medtronic issued a press release announcing a recall of certain cardiac guidewires, which has been classified by the FDA as a Class I Recall.  A Class I Recall is defined as “a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause […]

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OxyElite Pro™ Dietary Supplements Recalled by Manufacturer After Reports of Liver Illnesses

The FDA reports that the manufacturer of OxyElite Pro™, USPLabs, issued a recall of the dietary supplement on November 9, 2013. The company decided to recall OxyElite Pro™ products “after receiving a letter from the U.S. Food and Drug Administration (FDA) stating that the products have been linked to liver illnesses and that there is […]

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Proposed FDA Rule Would Overturn Mensing Decision

The United States Food and Drug Administration (FDA) has proposed a new rule in the Federal Register regarding generic drug labeling. On November 13, 2013, the proposed rule appeared in the Federal Register entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” The proposed rule would permit manufacturers of generic drugs to […]

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C8 Lawsuit Update: More Lawsuits Filed in Federal MDL 2433 Against DuPont for C8 Water Contamination

Nine more people in Ohio and West Virginia have filed federal lawsuits against DuPont this month. Since last April, roughly 50 cases have been filed in federal court, including one wrongful death case. These lawsuits have been consolidated in the federal Multidistrict Litigation (MDL) entitled In Re: E.I. du Pont de Nemours and Company C-8 Personal […]

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FDA Requires Black Box Warning for GSK’s Anti-Seizure Drug Potiga® Due to Risks of Retinal Abnormalities

On October 31, 2013, the FDA issued a Drug Safety Communication informing the public that the FDA has “approved changes to the drug label of the anti-seizure drug Potiga® (ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent.” The FDA also […]

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First Topamax® Trial Resulted in $4 Million Jury Verdict for Plaintiff

A Philadelphia jury has awarded $4 million dollars against Johnson & Johnson’s Janssen Pharmaceutical unit and in favor of a plaintiff, a mother named April Czimmer who took the company’s drug Topamax® for six months before giving birth to a son with a cleft lip. April Czimmer took the drug from August 2006 through February […]

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