On January 29th, the FDA revised Penumbra’s Urgent Voluntary Recall of the Jet 7 Catheters with Distal Tip. The FDA has received over 200 reports of adverse reactions to their Medical Device Reporting system (MDRs) including death, serious injury and malfunctions. Serious injuries have been described as vessel damage, hemorrhage, and cerebral infarction. The Penumbra system is used in stroke patients to remove blood clots, during a bench test performed by the manufacturer, the distal tip was not able to withstand the same burst pressure as the other catheters manufactured by the same company.
‘Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.’
Over twenty-thousand devices have been recalled, Health Care officials were notified on December 15th, 2020, when the voluntary recall was initiated.
By Cindy L. Nations –
Drug company Mylan agreed to pay $465 million to quickly settle a Justice Department investigation into claims that it deliberately overcharged Medicaid for its EpiPen anti-allergy device. Why would a company agree so quickly to such a large settlement? Well, it might have something to do with this … The Department of Health and Human Services’ Office of Inspector General reports that the Medicaid misclassification of EpiPen may have cost taxpayers $1.27 billion from 2006 to 2016. Senator Richard Blumenthal and a group representing state Medicaid directors are now demanding that Mylan pay Medicaid the full amount up to $1.27 billion that it owes. Fortunately, the previous settlement agreement, which is a fraction of the true costs, has not yet been finalized.
Read more here: https://consumerist.com/2017/05/31/hhs-taxpayers-may-have-overpaid-1-27-billion-for-epipens/
By Buck Daniel –
Takeda Pharmaceuticals has agreed to pay $2.37 billion to settle the Actos bladder cancer lawsuits in a global settlement agreement. Takeda Pharmaceuticals, which manufactures the drug, and plaintiffs’ counsel reached an agreement that attempts to resolve all pending lawsuits in the United States as well as a number of not yet filed cases. In addition to cases filed in a federal court in Louisiana, those filed in Cook County and other state courts including several hundred cases consolidated in California state court, can be resolved through this settlement offer.
The Actos settlement will compensate plaintiffs who were diagnosed with bladder cancer as a result of their use of Actos.
As of today, a potential 12,000+ cases are eligible to participate in the settlement of $2.37 billion. The settlement agreement includes cases that have not yet been filed but involve an alleged injury of bladder cancer that occurred prior to April 28, 2015. The only cases that will qualify for this settlement must include Actos use followed by a confirmed diagnosis of bladder cancer.
By Buck Daniel –
In the most recent legal defeat for Johnson & Johnson, the South Carolina Supreme Court affirmed a verdict against J & J under the Attorney General’s Unfair Trade Practices Act for “willfully failing to disclose known risks and side effects associated with Risperdal.” Though the original award of $256 million was reduced by the South Carolina Supreme Court award to $136 million, the amount still marks a devastating blow to Johnson & Johnson’s legal team in their legal battle.
In one of the largest health-care fraud lawsuits in U.S. history, J & J paid $2.2 billion in November 2013 to settle a Risperdal lawsuit brought by the United States Department of Justice. The settlement included civil recoveries of $1.72 billion under the federal False Claims Act and criminal penalties and forfeitures totaling $485 million. These amounts were not recovered on behalf of injured plaintiffs, but affirmed the type of fraud in these cases.
By Buck Daniel –
A large number of Bard IVC filter lawsuits are expected to be filed within the next few months, each alleging that individuals suffered damage when the IVC filter implants tilted, fractured or migrated inside their bodies causing harm or requiring removal.
C.R. Bard has been unsuccessful in its efforts to settle a number of unfiled cases and as a result, a request has been made to the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the pretrial proceedings for the cases. These proceedings will take place July 30, 2015. If the request is granted, all Bard IVC Filter complaints filed in U.S. District Federal Courts across the country will likely be transferred to one judge, reducing duplicative discovery and making the proceedings more convenient for the parties, witnesses, and courts.
Posted by Buck Daniel
September 6, 2012 – Bayer recently informed its investors of the potential costs that will be necessary to settle outstanding lawsuits regarding its birth control medication, Yaz. The company admits it faces no fewer than 12,325 lawsuits regarding the higher risks associated with its product. Nearly half of the lawsuits considered by Bayer have been brought for blood clot injuries only, while the other half includes heart attacks, strokes and gallbladder issues. However, in official statements, Bayer defends its products as carrying no greater risk than any other oral contraceptives, despite what studies suggest. The FDA has continued to push Bayer to strengthen its label regarding the dangers of Yaz, but the company has no intention of taking the birth control medication off the market.