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Sort by date 572 pages found matching <script>alert('What_Security?')</script>- Government Agencies Release Recommended Warning for Labeling Drug Products Associated with Stevens-Johnson Syndrome
Feb-19-17 Silver Spring, MD: Three US government agencies in January released finalized guidance on warning label wording for over-the-counter drugs that contain acetaminophen and labels regarding serious skin conditions such as Stevens-Johnson Syndrome (SJS) . Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statem... - Despite $1B Penalty by the Feds, It’s Not Over Yet for Takata: Airbag Injuries
Feb-1-17 Washington, DC: The massive $1 Billion criminal penalty announced by the US Department of Justice earlier this month surrounding defective Takata airbags is not, in reality, an end to the troubles for the beleaguered Japanese manufacturer. Just one day after the Christmas holiday this past December, German automotive manufacturer BMW announced a recall of... - Healthcare Whistleblowers Protect Patients' Rights
Jan-20-17 Marion, NC: Patients rely on doctors, medical centers, and healthcare companies to ensure the treatment they receive is safe and lives up to strict regulations. But sometimes healthcare companies attempt to get around the rules, putting the health and lives of their patients at risk. In those cases, healthcare whistleblowers —the people who know o... - California Supreme Court Weighs In on Intent of Rest Period
Jan-14-17 Los Angeles, CA: A revealing opinion issued at the end of last year by The California Supreme Court addressed, and clarified a heretofore murky area of California labor law , notably just what constitutes a true rest period, and what doesn’t. Specifically, the difference between rest periods whereby employees are relieved of all work tasks and... - Updated FDA Review Suggests Link Between Actos and Bladder Cancer
Dec-13-16 Santa Clara, CA: Findings from an updated review by the US Food and Drug Administration (FDA) on the use of type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) suggests there may be an increased risk for bladder cancer associated with drug. The FDA has issued an alert based on their findings. Additionally,... - Transvaginal Mesh Deaths Reported as Injuries?
Nov-25-16 York, PA: “A good number of attorneys have reported transvaginal mesh adverse events to the FDA on behalf of their clients/patients, but over 23,000 reports are from physicians,” says Madris Tomes, founder of Device Events and former FDA Program Manager. “Physicians are not great at reporting— this is a HUGE number.” Du... - Bair Hugger Lawsuits Continue to Climb
Nov-14-16 St. Paul, MN: In a little over a month the number of Bair Hugger warming blanket lawsuits have increased by over 100. According to court filings, there were 693 federal cases housed in multidistrict litigation on September 15 of this year. That number had increased to 809 cases by October 17, the most recent information available. With three days to go... - Patient With IVC Filter Gets Good News
Nov-7-16 Ottawa, ON: A Canadian patient who had an IVC filter implanted and was told it could not be removed has reportedly had surgery to have the device taken out. The patient received the inferior vena cava filter to prevent a blood clot from making its way to his heart or lungs, but was told by doctors the device had migrated, making it too risky to move. A... - Health Canada Recalls Certain Stryker Hip Lots
Nov-1-16 Ottawa, ON: Health Canada has stepped ahead of the US Food and Drug Administration (FDA), in announcing a recall of certain lots of components associated with the Stryker Accolade hip replacement devices. Specifically, the agency recalled units of the LFIT Anatomic COCR V40TM and COCR LFIT femoral heads, manufactured before 2011. The recall was ann... - Prescription Testosterone Products Get New FDA Health Warnings
Oct-26-16 Santa Clara, CA: All prescription testosterone products will now carry class-wide labeling changes introduced by The U.S. Food and Drug Administration (FDA) to warn of the health risks associated with testosterone abuse and dependence. The revised safety information is taken from published literature and case reports regarding the abuse and depende... - Canadian Study: Surgical Warming Blankets and Link to Infection
Oct-21-16 Kingston, ON: It’s been a little over a year since a landmark study in Canada revealed the striking number of door openings and closings that occur in an operating theatre during surgery. This potential for entry, migration and movement of pathogens and various bacteria may be exacerbated by the common practice of using warming blankets fed with warm... - Attorney: Stryker LFIT V40 Femoral Head "Prone to Catastrophic Dislocation"
Oct-13-16 Dallas, TX: Lawsuits have been filed against the maker of the Stryker LFIT V40 femoral head, alleging patients were harmed by use of the hip implant component. Issues associated with the Stryker LFIT V40 femoral head reportedly result in failure of the device, requiring patients to undergo revision surgery to fix the problem. Dr. Shezad Malik, founder... - Health Canada Issues IVC Filter Warnings
Aug-13-16 Ottawa, Canada : Health Canada has issued its own safety warning concerning inferior vena cava filters , following in the footsteps of the US Food and Drug Administration. The Canadian agency issued its warning on July 25, 2016, and noted there were serious complications associated with the IVC filters. As with the United States, IVC lawsuits have been f... - Proposed Government Bill Aims to Increase Reporting of Defective Medical Devices
Aug-9-16 Washington, DC: It was two years ago, in 2014 that the US Food and Drug Administration (FDA) issued its safety alert with regard to power morcellators, the medical devices once employed quite frequently for Laparoscopic Uterine Surgery for women. In the face of reports linking use of the device with cancer, the FDA took as its official position, discou... - Health Canada Updates Invokana Warning Ahead of the FDA
Aug-1-16 Ottawa, ON: While the US Food and Drug Administration (FDA) came out with a health and safety warning about invokana side effects pertaining to kidney injury, the Canadian equivalent to the FDA appears to have headed off the FDA at the pass by jumping the gun by a month and posting its own safety warning about Invokana and other drugs in the SGLT2 clas... - FDA Strengthens Invokana Warnings
Jul-7-16 Washington, DC: The US Food and Drug Administration (FDA) has strengthened its warnings about Invokana , following reports about the increased risk of acute kidney injury linked to the diabetes medication. In addition to Invokana, the warnings for Farxiga were also strengthened. Invokana lawsuits have been filed against Janssen Pharmaceuticals (maker of... - Medtronic MiniMed Insulin Pump: “MaxiRisk”
Jun-9-16 Washington, DC: While most Americans with type 1 or type 2 diabetes can control their condition with medication, those with more serious and debilitating forms of diabetes require constant monitoring, together with regular infusions of insulin to not only keep their blood glucose at appropriate levels, but to also keep them alive. Such functions, in recent... - The Curious FDA Reversal over Allegedly Flawed Endoscope Washers
Jun-5-16 Washington, DC: The curious about-face by the US Food and Drug Administration (FDA) over its position on an allegedly flawed endoscope cleaning machine has roots in a back-and-forth relationship between the federal regulator and Custom Ultrasonics Inc. (Custom) dating back to 1991. The history between the two parties, together with recent links to hospital... - Invokana Floats Like a Butterfly, Stings Like a Bee
Jun-5-16 Scarborough, ON: As the world continues to mourn the loss of boxing icon and humanitarian Mohammed Ali, a phrase oft-times used by Ali to describe his boxing style and prowess, “float like a butterfly, sting like a bee,” can also be brought to the fore to describe the type 2 diabetes drug Invokana. Some doctors - including one in Halifax, locat... - Some Plaintiffs Develop DKA Mere Months after Starting Invokana
May-31-16 Mobile, AL: As Invokana lawsuits continue to be filed in both the United States and Canada, pundits continue to wonder if the inmates are running the insane asylum given the reality that two years after approval by the US Food and Drug Administration (FDA) came reports of Invokana Linked with Cardiovascular Injuries and Kidney Failure , as were other dr...