The federal government's Food and Drug Administration reviews medical devices before the products are sold for use in surgeries and other procedures. The agency's access to manufacturers' research into product safety can be extensive, which is why a union that suspects a heart defibrillator is defective wants access to FDA documents on the device's maker.
But the FDA apparently redacted "almost every portion" of a report on troubles with the defibrillator, making it virtually impossible for the union and others to determine if the medical device is defective, according to a report.
Unite Here -- the union in question -- has more than 265,000 members, some of whom have had the implantable cardioverter defibrillator (ICD) devices implanted. After the ICDs (made by St. Jude Medical) were put in place, some union members apparently experienced significant medical problems that might be attributable to the devices.
Unsurprisingly, the union members with the health problems rang up enormous medical bills, for which the union's health care plan was then billed, which is why the union is so interested in these FDA reports and documents.
Some critics say the FDA wants to avoid embarrassment over approving of a faulty medical device, and is simultaneously shielding the defibrillator maker from legal actions.
The complaint against the FDA says the agency recalled the Riata-brand ICDs because of problems with wiring (also known as "leads").
The union is asking a court to step in and order the FDA to release the report without redactions or to give a copy to the court, which can then pass it on to the union.
For those injured by a defective medical device, the legal ins and outs between a federal agency and union is much less important than regaining health and ensuring that they have the means to get the best health care to help them do that.
The first step in that process is having a conversation with a law firm experienced in holding makers of defective medical devices accountable.
Source: Courthouse News Service, "Union Says FDA Is Hiding Document," Feb. 12, 2013
- Our Harris County, Texas, law firm helps those in Houston injured by defective medical devices.