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FDA warns Medical Device Lawsuit against erring makers. Democrats in Congress just introduced measures to allow consumers harmed by a medical device approved by the U.S. Food and Drug Administration (FDA) to sue the device manufacturer in state court, reports Medical News Today. The move came the day following a Supreme Court ruling to […]
FDA warns Medical Device Lawsuit against erring makers. Democrats in Congress just introduced measures to allow consumers harmed by a medical device approved by the U.S. Food and Drug Administration (FDA) to sue the device manufacturer in state court, reports Medical News Today. The move came the day following a Supreme Court ruling to allow patients to sue drug makers in state courts, said the Wall Street Journal.
The Wall Street Journal noted that the Medical Device Safety Act of 2009 nullifies last year’s Supreme Court decision in Riegel v. Medtronic, which dismissed a lawsuit involving a ruptured catheter. In that case, the Supreme Court ruled that FDA approval of medical devices preempts state courts from hearing liability suits against their makers because such suits could minimize a device’s FDA-determined benefits and risks, said Medical News Today.
A boon for industry, the ruling also disallowed states from implementing or maintaining safety requirements that differ from federal standards.
Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.
Eight members of the high court agreed with Medtronic.
The recent Supreme Court ruling—Wyeth v. Levine—upheld a $6.7 million state jury verdict against preemption that was won by a guitarist, Diana Levine, from Vermont who suffered an arm amputation following injection with an anti-nausea medication, reported the Wall Street Journal.
The suit allows consumers to sue drug makers for liability and, now, the new Medical Device Safety Act legislation allows the same for device maker liability, said Medical News Today.
Representative Frank Pallone (Democrat-New Jersey) said, “… the Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product.
Today, we introduce legislation that gives patients that same right when injured by a medical device,” reported Medical News today citing a statement quoted by the Associated Press and the New York Times.
The Boston Globe reported, according to Medical News Today, that the verdict, “tells the pharmaceutical industry that it bears final responsibility for the way its products are made and administered,” adding, that drug makers “cannot hide behind the approval of an FDA that has shown a weakness for approving drugs before they are sufficiently tested and then failing to monitor closely the drugs’ often harmful side effects once they are on the market.
Meanwhile, earlier this year, a federal judge in Minneapolis dismissed hundreds of lawsuits filed by people injured by the defective Medtronic Sprint Fidelis defibrillator lead in one of the largest such dismissals of its kind.
In his decision, the judge wrote, “the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy.” The judge also wrote that it was up to Congress to change the law that bars such lawsuits.
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