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Unlike other countries, the United States has no way to monitor medical devices after they are approved and used or implanted in patients. It is sort of the Wild West out there. When a medical device is defective and injures a patient, the patient, her doctor or lawyer have the […]

It may sound good – bee pollen, green tea, all natural ingredients, but the U.S. Food and Drug Administration (FDA) is warning consumers that Fat Zero is anything but natural. Consumers are being warned not to purchase Fat Zero for weight loss or any other reason. It is sold on […]

It is still uncertain why and how many American Medical Systems (AMS) transvaginal mesh victims are affected, but Endo Health Solutions Inc, which bought the company, has agreed to settle a small number of AMS cases. Endo has agreed to pay $54.5 million to settle product liability or defective product […]

Statins are drugs that are commonly prescribed to lower cholesterol. It’s estimated about one-quarter of all Americans over the age of 45 with high cholesterol is prescribed a statin to avoid a heart attack or stroke. They are generally thought of as safe, but researchers have linked these drugs to […]

Cook Medical has just been added to the name of corporate defendants consolidated in Multidistrict Litigation (MDL) in Charleston, West Virginia. The Judicial Panel on Multidistrict Litigation (JPML) added Cook on July 11 and with it transferred 13 complaints from eight different districts. Cook joins five other major transvaginal mesh […]

It is unclear what caused the deaths of two patients injected with the anti-psychotic medication Zyprexa, but the U.S. Food and Drug Administration is investigating. According to the FDA, the two died a few days after being injected with Zyprexa Relprevv. The drug’s warning label contains information about delirium sedation […]

Consumers may not realize it, but the U.S. Food and Drug Administration (FDA) currently has no way to track problems with medical devices and drugs that go wrong other than voluntary reporting. Unlike other countries that have drug and device registries, the FDA has an absolute head-in-the sand approach to […]

The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]

FDA agents have discovered that employees at the Houston office of Cetero Research tampered with records and manipulated test data. This firm has conducted research for drug companies worldwide. Chinna Pamidi, the testing facility’s president, bluntly admitted that much of the lab’s work was fraudulent, saying “You got us” when […]

The Biomet MDL (multidistrict litigation) was established for the organization and litigation of individual personal injury lawsuits against Biomet in the fall of 2012. In February of this year, the MDL contained 132 individual lawsuits. The count now stands upwards of 180 individual lawsuits, and it is still growing every […]