Black Box Warning Too Little Too Late for Essure
After more than 5,000 women filed grievances with the FDA, complaining of unintended pregnancies, miscarriages, stillbirths, severe pain and bleeding, the FDA has finally woken up to the serious complications associated with Bayer’s Essure. The FDA said Essure is now required to have a black box warning label. This is one of the most serious
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Duodenoscope Manufacturer Knew It Could Kill and Did Nothing
This is Michael Brady Lynch, lead trial attorney for the Michael Brady Lynch Firm. Patients try to do their homework and make the best decisions when concerning their health; however, for many simple, routine medical procedures often skate by us without a second thought. How many times have you been warned of the risks associated with
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FDA Disregards Essure Hysterectomy Risk
It still shocks me how much the FDA shows a blatant disregard for public health. Essure manufacturer, Bayer and the FDA are fooling women into choosing a seemingly easier method of female sterilization, instead of the surgical alternative of tubal ligation. However, Essure hysterectomy risk and pregnancy risk is higher than tubal ligation. The FDA doesn’t
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Putting a Face to Invokana Dangerous Complications
At night while relaxing on the couch watching TV, we see advertisements for “miracle” or “life-changing” pharmaceutical drugs without giving it a second thought. Unfortunately, what manufacturers sell us as safe and effective ways to manage various medical conditions is anything but. For many consumers, these drugs induce life-threatening complications. One such drug I see advertised constantly and know first hand
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Transvaginal Mesh Officially a High-Risk Device
The FDA just announced that implanted mesh used for transvaginal repair of pelvic organ prolapse (POP) will now be classified as a high-risk (class III) device. This means that manufacturers will have 30 months to prove the safety and effectiveness of their products. Transvaginal mesh evolved from mesh used for hernia repair in the 1950s.
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Bayer May Have ‘Actively Concealed’ Negative Essure Reports
This is attorney Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm. The first Essure lawsuit was filed in Philadelphia against Bayer HealthCare. The suit accuses Bayer and original manufacturer Conceptus of intentionally misleading women implanted with Essure, which violates the conditions of premarket approval from the FDA. Approved in 2002 for
Read MoreFDA Requires New Ketoacidosis Warning for Invokana
This is Michael Brady Lynch, lead trial attorney for The Michel Brady Lynch Firm. Well, it is about time the FDA acted on the problem of ketoacidosis and the drug Invokana. December 4, 2015 Invokana and SGLT2 Inhibitors: Drug Safety Communication – Labels to Include Warnings About Too Much Acid in the Blood and Serious
Read MoreSupport An End to Big Pharma Direct to Consumer Advertising
AMA Calls for Ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices. This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm. In what is hopefully a precedent-setting stance on direct-to-consumer drug advertising to American consumers, the American Medical Association has taken a commendable stance to end this
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The Michael Brady Lynch Firm Files Invokana Ketoacidosis Case
October 29, 2015 For Immediate Release: The Michael Brady Lynch Firm files first Invokana case involving allegations of diabetic ketoacidosis. The case JENNIFER ANZO, Plaintiff, v. JANSSEN RESEARCH & DEVELOPMENT, LLC; JANSSEN PHARMACEUTICALS, INC.; JOHNSON & JOHNSON, was filed in the United States District Court of the Eastern District of California. Ms. Anzo has never explained
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3M Bair Hugger Linked to Life Threatening Infections
This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm. The Michel Brady Lynch Firm is investigating 3M Bair Hugger lawsuits on behalf of individuals who allegedly developed serious infections, including MRSA or sepsis, following hip or knee replacement surgery that involved the use of one of these forced air warmer
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