There is a new $64,000 question in legal circles this summer. It involves a wildly popular form of birth control and an incredibly awful potential side effect. What is that question? Simply put, does Bayer’s Mirena® cause pseudotumor cerebri?
Health & Medicine
Justice was done the Friday before Independence Day in a courtroom in Philadelphia. Janssen, on trial for failure to properly warn of side effects caused by one of its popular antipsychotic drugs, was given no cause to celebrate the long weekend when the jury awarded plaintiff $70M Risperdal verdict.
Bayer is still trying to shake liability for the thousands of injuries its Mirena Intrauterine Device (IUD) has caused. Back in March, they convinced U.S. District Judge Cathy Seibel to bar certain of plaintiffs’ expert witnesses from offering testimony, figuring that without expert testimony on causation, plaintiffs would lose. However, the case hasn’t been dismissed. Yet. Bayer filed a motion for summary judgment – legalese for a judgment in one party’s favor based on the entire case’s merits or on certain issues – on May 4, 2016. Now, Mirena plaintiffs prepare response to Bayer’s summary judgment motion.
Three important pieces of legislation, one introduced last year and two introduced this month, could change the way certain women’s health issues are handled. These women’s health bills are now in Committee. The bills were introduced by Rep. Mike Fitzpatrick (R-PA), a long-time supporter of women’s health causes and champion of the move to reform the FDA’s broken processes for medical device approval.
As this was being written, Reps. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) were introducing a package of bills aimed at fixing the FDA’s flawed medical device approval process. WRIC.com 8News in Richmond, Virginia reports the recent release of a study that shows this proposed legislation is crucial to patient safety, especially in the area of women’s health. The study shows FDA used flawed data to approve devices, including Essure.
On Wednesday, June 8, Representative Mike Fitzpatrick announcing medical device and FDA reform bills. The Congressman from Pennsylvania has been a consistent supporter of women’s health issues, especially as pertains to dangerous medical devices. Once again, Rep. Fitzpatrick (R-PA) is headed to DC to fight, not only for those injured women, but for reforming the FDA’s medical device approval process.
On May 20, Big Pharma/Life Sciences giant Bayer filed a motion in federal court in the Eastern District of Missouri. Its goal? Removal of a pending suit filed in state court in St. Louis over its “permanent” birth control device, Essure. Six days later, Judge Carol E. Jackson of the Eastern District of Missouri handed down her decision on the removal request. Bayer lost bid to remove Essure suit to federal court. The judge, in effect, said that the suit was perfectly situated in the state court.
Bayer, owner of the “permanent” birth control device Essure, knew of the risk of unwanted pregnancies after implantation of its device. That the Big Pharma giant knew is not shocking; that someone was able to uncover the information is the shocker. As many of us who advocate for the removal of this dangerous product have long believed, Bayer lied about Essure pregnancy risks.
Women injured by pelvic mesh implants have found a new way to fight back. This is the shot heard ‘round the world, mesh community hits social media! The Mesh Awareness Movement (MAM) currently hosts parties every Friday night on Twitter, as well as keeping an active Facebook page.
The most touching thing one can do is to put a human face on what Bayer and the FDA see as statistics only. Guess what, folks? Brianne has gone and done such an amazing job of it that I had to share. Thank you, Brianne! Here is “Dear Bayer – Do you care? A letter about Essure and doing the right thing.”