Supreme Court sets high bar for medical device lawsuits
Legal Business News
The tiny balloon was supposed to stretch open a blocked artery on Charles Riegel's diseased heart. Instead, when the doctor inflated the balloon, it burst.
The patient went on life support but survived. His lawsuit against the manufacturer of that arterial balloon did not.
The U.S. Supreme Court ruled in favor of Medtronic, among the world's largest makers of medical devices, setting a precedent that has killed lawsuits involving some of the most sophisticated devices on the market.
The device that harmed Riegel had cleared the U.S. Food and Drug Administration's most rigorous review, known as "pre-market approval." To reach consumers, Medtronic provided regulators with documentation that the Evergreen Balloon Catheter would be safe and effective.
In Riegel v. Medtronic Inc., the justices grappled with whether Medtronic had any liability. They ruled that devices that have received pre-market approval are effectively immune from product liability lawsuits in state courts, where juries can award huge sums. The reasoning: Congress wrote that states couldn't add safety requirements beyond what the FDA imposes.
Since the Supreme Court ruling in 2008, rare is the case when a manufacturer must pay suffering, lost wages and other compensation to patients who claim they were injured by a pre-market approved device. Patients who believe they've been harmed can still sue device makers in federal court.
Related listings
-
Supreme Court to hear closely watched double jeopardy case
Legal Business News 12/07/2018The Supreme Court is set to hear arguments about an exception to the Constitution's ban on being tried for the same offense. The outcome could have a spillover effect on the investigation into Russian meddling in the 2016 election.The justices are ta...
-
Justice Beth Clement leading Supreme Court race
Legal Business News 11/07/2018Michigan Supreme Court Justice Elizabeth Clement is leading a six-candidate field for two seats on the state's highest court. Nearly 95 percent of votes have been counted. The top two finishers get black robes.Justice Kurtis Wilder and appellate lawy...
-
Trump visit stirs debate; massacre defendant in court
Legal Business News 10/31/2018The man charged in the Pittsburgh synagogue massacre was brought into court in a wheelchair Monday, as some members of the Jewish community and others objected to President Donald Trump’s plans to visit, accusing him of contributing to a toxic ...
Is Now the Time to Really Call a Special Education Lawyer?
IDEA, FAPE, CHILD FIND and IEPs: The Individuals with Disabilities Education Act (IDEA) guarantees all children with disabilities to a free appropriate public education (FAPE). FAPE starts with a school’s responsibility to identify that a child has a disability (Child Find) and create an Individualized Education Program (IEP) to suit the needs of the child. Parents need to be persistent, dedicated and above all else aware of the many services and accommodations that their child is entitled to under the law. As early as this point within your child’s special education, many parents will often find themselves in the situation asking, “is now the time to really call a special education lawyer?” Here are a few things to consider when asking yourself that question.