FDA Food Recall System is Broken

In June, 2016, the Inspector General, Daniel R. Levinson, notified Robert M. Califf, M.D., Commissioner of Food and Drugs, Food and Drug Administration, FDA, that, as a result of an ongoing audit his office was conducting, it was found that the method that the FDA used to initiate a food recall was inefficient and ineffective.


End of the Mirena MDL as Bayer Wins Summary Judgment

Back in March, I wrote about how Blocked Expert Testimony Isn’t Necessarily the End of Mirena MDL. Then, at the end of June, I wrote about how Mirena Plaintiffs Prepare Response to Bayer’s Summary Judgment Motion. Sadly today, I get to write about the end of the Mirena MDL as Bayer wins summary judgment.


UPDATED: Essure Plaintiffs Moved to Create a MDL in Pennsylvania

Essure plaintiffs moved to create a MDL in Pennsylvania on July 25. The “[p]laintiffs in all of the actions currently pending in the United States District Court for the Eastern District of Pennsylvania (except for Williams et al v. Bayer Corporation, Case No. 4:16-cv-01105)” joined in the motion to create a multi-district litigation regarding Bayer’s “permanent” torture birth control device.


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.