Before becoming LegalReader's Editor-in-Chief, Jay W. Belle Isle worked as a freelance copywriter with clients on four continents. Jay has a degree in Business Administration from Cleary University and a Juris Doctor from Thomas M. Cooley Law School. Jay has also worked as a contracts administrator for a DOD contractor specializing in vehicle armor.
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.”
A recent letter to Congressman Jason Chaffetz, written by Holly Ennis of Ennis Law and various administrators of Essure Problems, contains an Essure investigation and congressional hearing request. The request is backed by a great deal of sound reasoning and good evidence. It is a long piece, compared to our usual stories on LegalReader, but it is an important piece and, therefore, is reproduced in its entirety below.
There have been some unique and inexplicable changes in adverse event reporting regarding Bayer’s “permanent” birth control device, Essure. The changes began July 17, 2015 after the agency announced its review of Essure’s safety and efficacy. In a recent letter, Congressman Mike Fitzpatrick questions FDA about Essure reporting changes.
Those who suffer from chronic heartburn may have to add an additional heartburn concern to their list. Chronic heartburn drug use linked to kidney disease risk, according to a recently published study in the Journal of the American Society of Nephrology.
Boston Scientific is finally facing greater heat over allegations that it used substandard material in its vaginal mesh implants. Federal prosecutors have impaneled a grand jury in Charleston, West Virginia as Boston Scientific faces criminal investigation over counterfeit mesh. It’s about time! The affected mesh has been implanted into thousands of women across the U.S.
Sad news from Fort Bend County, Texas as Honda and NHTSA announce one more U.S. Takata airbag death. This is the tenth death in the U.S. caused by the defective Takata airbag inflators and the eleventh worldwide. Of the ten U.S. fatalities, nine were in Honda vehicles and one was in a Ford vehicle. The non-U.S. death occurred in July 2014 in Malaysia. The victim in that incident was a pregnant woman driving a 2003 Honda City.
According to NHTSA data, automakers are running behind on Takata airbag replacements. Of the total estimated 29M vehicles recalled for defective Takata Corp. airbag inflators, only about one-quarter have been replaced or repaired. Some automakers are doing better than others, but only one so far has managed to fix more than half of the vehicles it recalled.
According to Rob Davis of the Oregonian, health officials in Oregon claim a cancer cluster found near Oregon glassmaker. The “small, statistically significant cluster of bladder cancer diagnoses in two North Portland neighborhoods” is the first of its kind discovered.
Congressman Mike Fitzpatrick (R-PA) is an outspoken opponent of Bayer’s “permanent” birth control device, Essure. He has made and continues to make efforts on behalf of women seriously injured by this product. His goal, as evidenced in the E-Free Act, which he introduced in November 2014, is to revoke the FDA’s pre-market approval of Essure and remove the product from the market. His latest action on behalf of women’s health took the form of a letter to Department of Veterans Affairs and the Department of Defense. Congressman Fitzpatrick to VA: stop buying Essure!
On March 8, U.S. District Judge Cathy Seibel barred four of the plaintiffs’ expert witnesses and limited the scope of testimony of the other two. Bayer, maker of the Mirena IUD, called the ruling a victory and began preparing a motion for summary judgment which would end any chance of recovery for the women injured by this product. However, blocked expert testimony isn’t necessarily the end of Mirena MDL, especially if the plaintiffs’ steering committee has its way.