Based on a recently completed safety review, the FDA has concluded that birth control pills containing drospirenone (a synthetic version of the female hormone progesterone, also known as progestin) may be associated with a higher risk for blood clots than other progestin-containing pills. The FDA is adding information about the studies to the labels of…
DetailsU.S. District Judge Joseph R. Goodwin in Charleston, West Virginia has set a February 5, 2013 trial date for the first of approximately 600 cases against Bard arising out of injuries as a result of the Avaulta device. The Bard cases have been consolidated with cases filed across the U.S. against Bard, Johnson & Johnson…
DetailsA trial has been set in Nevada state court for December 3, 2012. The case involves three plaintiffs alleging their DePuy ASR hip implants were defective. The case was filed in state court in Nevada because the distributor, Precision Instruments Inc. distributed the hips in Nevada.
According to the FDA, there have been 26 incidents of accidental fentanyl exposure since 1997 resulting in ten deaths and twelve cases requiring hospitalization. Most of the cases invovled children. The FDA issued a consumer advisory Thursday reminding parents, caregivers and medical personnel of the deadly consequences posed to children from accidental contact with or…
DetailsOver the past several months we have passed along some very discouraging information about Metal-on-Metal hip prostheses. We are happy to have something positive to report: According to a published report in HealthDay News on April 3, 2012, “People with metal-on-metal hip replacements do not have an increased risk of cancer during the first seven…
DetailsA lawsuit filed by a physician who worked under contract for Takeda, the maunufacturer of Actos, a diabetes medication, alleges that the pharmaceutical company failed to accurately report cases of bladder cancer. The lawsuit was filed by Dr. Helen Ge who also asserts in the lawsuit that Takeda failed to report all cases of heart…
DetailsZofran has been connected to a wide range of birth defects. Prescription drugs are often at the center of legal action. In many of these cases, it is uncovered that the drugs were not properly evaluated before they were marketed to physicians to prescribe to their patients. In other cases, drugs were prescribed outside of…
DetailsThe U.K.’s Medicines and Healthcare products Regulatory Agency issued a statement urging surgeons to stop using a specific combination of Johnson & Johnson and Stryker metal hip devices due to unacceptably high rates of failure. The combination is Mitch TRH cup/heads and Accolade femoral stems.
The FDA has announced that it will hold an advisory panel on June 27-28 to gather input from scientists, researchers , patients and medical practitioners to help regulators decide whether to impose new testing standards and review requirements before a medical devide is sold in the U. S. This panel is in response to mounting…
DetailsThe Gynecare Prolift was introduced in March 2005 by J&J, however the U.S. FDA did not learn about the Prolift until 2007 when J&J was seeking approval for a related product. There are currently more than 550 lawsuits against J&J alleging injuries caused by vaginal mesh implants.