Acknowledging a global decline in demand for its Essure contraceptive device, Bayer announced last week that it was pulling the device off the market around the world – except for the United States. In the same statement, the medical manufacturing giant sought to assure the public that the decision was “not linked to a safety or product quality problem.”
Tens of thousands of women in the ...
continue reading...
One of the key components of Bayer’s Essure defense has been to shift blame for injuries away from itself and onto other entities. However, with the latest decision by Alameda County Superior Court Judge Winifred Y. Smith, the pharmaceutical company’s ability to do that has become seriously impaired.
Federal preemption invalidates any state law that runs contrary to federal law. Put simply, it says that the law of the ...
continue reading...
A study conducted by researchers at Northwestern University has concluded that the FDA has largely failed in its responsibility of protecting women from faulty or poorly designed medical devices.
Of the 18 devices approved between 2000 and 2015 for high risk application to women’s medical care; including fetal monitoring, contraception, and uterine bleeding:
A federal judge in Philadelphia has determined that an Essure lawsuit filed against pharmaceutical giant Bayer has enough merit to proceed. Bayer had previously moved for the case to be dismissed.
The judge sided with Bayer on most of its motion. The plaintiffs had originally brought 12 claims against the company and, using an FDA provision specific to devices granted premarket approval, Bayer argued that Essure was effectively protected from any ...
continue reading...In what many would consider a long overdue move, the FDA has recommended a black box warning for Bayer’s Essure contraceptive device. The move comes after an ongoing public outcry and an FDA hearing last fall. The black box warning, if it does indeed make it to the Essure label, is the strongest warning that can be placed by the FDA and is designed to call ...
Plenty of medications and medical devices have faced the wrath of a displeased public. Thanks to the amplifying power of technology, it is now nearly impossible to ignore an organized group of citizens who have determined that a product or company is not aligned with their best interests. Recalls, black box warnings, and changes to entire product lines have occurred as consumers have confronted company after company; forcing them to ...
