Fitzpatrick Continues Fight against Dangerous Birth Control Device
Bucks County Congressman Mike Fitzpatrick believes consumers should have the right to file injury lawsuits and hold manufacturers accountable for injuries caused by defective and dangerous medical devices—specifically the thousands of women throughout the country who claim they were injured by the Essure birth control device.
Television viewers may be familiar with commercials advising patients injured by various drugs and medical devices to contact a lawyer to learn how to file an injury lawsuit. What makes Essure different?
The answer lies with the FDA (Food and Drug Administration) approval process. There a few paths in which a product can take to gain approval. Essure gained FDA approval through the “Pre-Market Approval” (PMA) pathway. A 2008 Statute –Riegel vs. Medtronic- shielded PMA products from becoming the subject of products liability lawsuits. The manufacturers of these products cannot be held accountable for injuries that result from their dangerous devices.
In December 2015, Fitzpatrick proposed an amendment to overturn the ruling, but his proposal was rejected based on technicalities, reported Philly.com. This set back is not the end of the Congressman’s crusade for consumer advocacy. Fitzpatrick is also trying to get the harmful contraceptive device removed from the market to prevent further woman from suffering Essure birth control injuries.