As the Project on Government Oversight reveals in a special report today based on internal FDA document obtained by POGO,  senior officials within the FDA made this decision without public notice.  Manufacturers have been trusted to monitor themselves ever since.

The problem is particularly alarming because last year the U.S. Supreme Court ruled that patients harmed by these devices have no right to sue the manufacturers, if the device was approved by the FDA.

So now, the FDA is letting the manufacturers set their own safety standards, and the Supreme Court is shielding those manufacturers from lawsuits.

So who’s watching out for the hapless heart patient?

Update: Congress could step in to do that.  First, it could boost funding for the FDA and require it to enforce those laboratory safety standards the agency effectively discarded.  Second, it could pass the Medical Device Safety Act of 2008, which would nullify the Supreme Court’s decision in Riegel v. Medtronic last year and restore the rights of patients injured by medical devices to sue the companies that made them — restoring a critical incentive for manufacturers to ensure the safey of their own products.

Officials ordered nine Muslim passengers, including three young children, off an AirTran flight headed to Orlando from Reagan National Airport yesterday afternoon after two other passengers overheard what they thought was a suspicious remark.

Members of the party, all but one of them U.S.-born citizens who were headed to a religious retreat in Florida, were subsequently cleared for travel by FBI agents who characterized the incident as a misunderstanding, an airport official said. But the passengers said AirTran refused to rebook them, and they had to pay for seats on another carrier secured with help from the FBI.

Kashif Irfan, one of the removed passengers, said the incident began about 1 p.m. after his brother, Atif, and his brother’s wife wondered aloud about the safest place to sit on an airplane.

“My brother and his wife were discussing some aspect of airport security,” Irfan said. “The only thing my brother said was, ‘Wow, the jets are right next to my window.’ I think they were remarking about safety.”

According to the article, five of the six adults in the party were of South Asian descent, and the men all wore beards while the women wore traditional headscarves. Kashif Irfan is an anesthesiologist and his brother, Atif, is a lawyer. Both were born in Detroit and currently live in Alexandria, Va. They said they suspected they were profiled because of their appearance, which AirTran disputed.

“At the end of the day, people got on and made comments they shouldn’t have made on the airplane, and other people heard them,” [AirTran spokesman Tad] Hutcheson said. “Other people heard them, misconstrued them. It just so happened these people were of Muslim faith and appearance. It escalated, it got out of hand and everyone took precautions.”

I realize that many people in this country want airlines to target Muslims for additional security screening, which, even if you agree with that idea, this seems a bit excessive. I’m not sure this approaches the level of impropriety of, say, someone joking that he had a bomb in their bag at the ticket counter.

More importantly, if you don’t agree with targeting travelers based on race, think about why. If a white person made a similar comment, it is very unlikely that anyone would even take notice. And that’s the point: If it was inappropriate for a Muslim, then it would also be inappropriate if someone like, say, myself said the same thing.

At the very least, the airline could have rebooked them on another flight after they were cleared.