Supreme Court sets high bar for medical device lawsuits

National Court 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.

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USCIS Adjusting Premium Processing Fee

U.S. Citizenship and Immigration Services (USCIS) announced today it is adjusting the premium processing fee for Form I-129, Petition for a Nonimmigrant Worker and Form I-140, Immigrant Petition for Alien Workers beginning on Oct. 1, 2018 to more effectively adjudicate petitions and maintain effective service to petitioners.

The premium processing fee will increase to $1,410, a 14.92 percent increase (after rounding) from the current fee of $1,225. This increase, which is done in accordance with the Immigration and Nationality Act, represents the percentage change in inflation since the fee was last increased in 2010 based on the Consumer Price Index for all Urban Consumers.

“Because premium processing fees have not been adjusted since 2010, our ability to improve the adjudications and service processes for all petitioners has been hindered as we’ve experienced significantly higher demand for immigration benefits. Ultimately, adjusting the premium processing fee will allow us to continue making necessary investments in staff and technology to administer various immigration benefit requests more effectively and efficiently,” said Chief Financial Officer Joseph Moore. “USCIS will continue adjudicating all petitions on a case-by-case basis to determine if they meet all standards required under applicable law, policies, and regulations.”

Premium processing is an optional service that is currently authorized for certain petitioners filing Forms I-129 or I-140. The system allows petitioners to request 15-day processing of certain employment-based immigration benefit requests if they pay an extra fee. The premium processing fee is paid in addition to the base filing fee and any other applicable fees, which cannot be waived.