Essure Black Box Warning – A Roar without Any Bite

This post was inspired by a real-life hero, Dr. Julio Novoa. In fact, the title comes from a letter he wrote (reproduced in part and linked with his permission) regarding Bayer’s “permanent” birth control device, Essure. For those unfamiliar with Essure, there are numerous posts on this site about the device and the dangers thereof. For those unfamiliar with Dr. Novoa, he is an outspoken physician advocate of removing this dangerous product from the market. His is one of the strongest, loudest voices calling for its removal. He is also one of the most outspoken critics of the FDA’s handling of the issue. Case in point: the Essure black box warning – a roar without any bite.

Plaintiffs Want MDL Status for J&J Talc-Ovarian Cancer Suits

Earlier this month, plaintiffs firm Don Barret filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate the many suits against Johnson & Johnson regarding its talc-powder products. Plaintiffs want MDL status for J&J talc-ovarian cancer suits as an MDL would make pre-trial items, such as discovery, much easier and convenient. If approved, the MDL would be overseen by U.S. District Judge David Herndon in the Southern District of Illinois. The venue was chosen as it “would permit convenient travel for the parties and counsel as compared to the east or west coast,” according to the motion. Plaintiffs reside in multiple states.

First Benicar MDL Trials Won’t Happen Until 2017

Benicar, a popular blood pressure medication manufactured by Daiichi Sankyo and Forest Laboratories, has been the focus of a multidistrict litigation (MDL) for some time now. The Judicial Panel on Multi-district Litigation (JPML) issued the order granting multiple suits MDL status back in early 2015. However, it appears that the first Benicar MDL trials won’t happen until 2017. Daiichi is a Japanese company whose U.S. headquarters are located in Parsippany, NJ. Forest Labs was purchased in 2014 by Actavis.

Mirena Plaintiffs Prepare Response to Bayer’s Summary Judgment Motion

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.

Women’s Health Bills are now in Committee

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.

Study Shows FDA Used Flawed Data to Approve Devices

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. 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.

Representative Mike Fitzpatrick Announcing Medical Device and FDA Reform Bills

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.

Bayer Lost Bid to Remove Essure Suit to Federal Court

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.