In June, the U.S. Supreme court ruled on the case of Reigel v. Medtronic and decided (8 to 1) that because-Medtronic designed a pacemaker that met rigorous FDA requirements, the company should not be liable for a mishap that may have led to the death of a Mr. Reigel. In fact, the court ruled that medical OEMs working to FDA regulations should be protected from state-level lawsuits initiated because of alleged product flaws.

The Agency, of course, does not approve devices lightly or quickly. Approval of a new pacemaker takes years of lab tests and clinical trials, costing millions. The FDA demands extensive documentation which the agency reviews before it decides on the fate of new developments.

So the Supreme Court ruling was good news for device makers. But is it time to downsize legal departments and spend the freed-up funds on R&D? Don't be silly, say Senators Ted Kennedy (D-Mass.) and Patrick Leahy (D-Vt.). The Court overstepped its bounds, they insist. To correct the error, they have introduced an amendment to the Medical Device Safety Act of 2008 making it clear that individuals are not prevented from suing device makers under state tort laws. The Senators' amendment follows a similar House bill of July, H.R. 6381.

Passage of the bills will raise important questions. For example, if the FDA's rigorous approval process is insufficient for device clearance, what process is and who will determine it? And more importantly, what would this say about the purpose of the FDA?

The device industry, through its advocate group AdvaMed, warns the bill would result in more lawsuits and ultimately higher healthcare costs. “If enacted, this legislation would create a patchwork approach to medical device approvals where state courts would effectively review and regulate medical devices,” says AdvaMed President and CEO Stephen Ubl.

To help justify the senators' action, it becomes necessary for other Senators to join in. “The FDA used to be the gold standard, but the agency has come under scrutiny recently,” says Sen. Barbara Mikulski (D-Md.), a bill cosponsor. Then she huffed: “If manufacturers are putting faulty devices on the market, they must be held accountable to the patients who use them…”

That's a big “if,” Barb. It is difficult to imagine device manufacturers purposefully putting faulty devices on the market.

And to make sure you didn't miss the dubious announcement, Senator Leahy's office issued a press release explaining the amendment. It's first line reads: “Legislation will protect patients from dangerous and defective devices.” Even the Senators do not believe that.

Try as they might, the Senate cannot repeal the law of unintended consequences. Here's what will happen: Device companies will spend more time and resources defending themselves from frivolous lawsuits. Some companies will close their doors as a consequence. The now-pointless FDA will lengthen its approval cycles adding further cost to devices through additional testing, clinical trials, and paperwork, which in turn will raise health care costs for everyone and keep or delay useful devices from getting to suffering patients. Some innovative devices will only be available overseas because they would be be unprofitable in the U.S.

Of course, if the Senate really wants to help it would stand behind the Supreme Court's ruling, and order a streamlining of FDA operations. It would also encourage state-level judges to throw out frivolous cases and change the law so that losers in court battles pay all court costs.

What are your thoughts on the proposed amendments?