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Why is the Medical Device Safety Act a good thing? 

Here's why: 
http://www.mycentraljersey.com/apps/pbcs.dll/article?AID=2009908110304


August 11, 2009  - By JEFF WEBER • STAFF WRITER

Several years ago, Jan Beadling was driving with her daughter when she went into cardiac arrest and slipped into a coma. Beadling was rushed to a hospital, and her life was saved, but it was two weeks before Beadling started breathing again on her own. The Belle Mead resident began months of rigorous physical, cognitive, speech and occupational therapy, and her doctors recommended a defibrillator as a "safety net" in case her heart stopped again.

Everything seemed fine until New Year's Eve 2007. On what was supposed to be a celebratory night, Jan's husband, Walt, gave her a kiss on her cheek. Without warning, she jumped, having felt some sort of an electric shock course through her body. The Beadlings made a small joke about the "jolt" and the "electricity" between them, thought nothing more of it and enjoyed ringing in the new year together.

But the following morning, while Jan was preparing dinner, she was struck with several more electrical shocks. Something was not right, and doctors later confirmed that the defibrillator lead had fractured and needed to be replaced. Defibrillators are implanted heart devices that shock dangerous abnormal heart rhythms back to a normal rhythm. According to WebMD, the lead is a wire that connects the defibrillator to the heart.

Beadling received a new lead, but still lives with the defective one in place because removal could put her life at risk.

Medtronic, the maker of the defective lead, had recalled them after more than 120 incidents of fractures and malfunctions.

But unfortunately for Beadling, the U.S. Supreme Court in 2008 ruled in Riegel v. Medtronic that manufacturers of class III medical devices such as her defibrillator, which have been approved through the FDA's premarket approval process, essentially are immune from liability.

"I've been left with serious and permanent injuries as a result of Medtronic's faulty device," Beadling says. "The notion that the company is completely immune from accountability for the safety of its products is not only unfair but extremely dangerous."

But a bill has been introduced in CongressThe Medical Device Safety Actwhich would restore the rights of injured consumers to hold negligent medical device manufacturers accountable when their defective products cause injury or death.

On Aug. 4, the Beadlings traveled to Washington and addressed Congress, talking about Jan's experience and stressing the need to pass the Medical Device Safety Act.

Now, only time will tell if Beadling's case becomes an exception or the norm. This bill is only in the first step of the legislative process — the committee level. Introduced bills and resolutions first go to committees that deliberate, investigate and revise them before they go to general debate.

The majority of bills and resolutions never make it out of committee, however. Beadling hopes this time, things are different.  "This legislation is crucial to protecting patients," Beadling says. "I'm concerned about the next person harmed by these dangerous products."

More information about the Medical Device Safety Act is available by visiting www.govtrack.us/congress/bill.xpd?bill=s111-540.



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