Supreme Court sets high bar for medical device lawsuits

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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 Will Begin Accepting CW-1 Petitions for Fiscal Year 2019

On April 2, 2018, U.S. Citizenship and Immigration Services (USCIS) will begin accepting petitions under the Commonwealth of the Northern Mariana Islands (CNMI)-Only Transitional Worker (CW-1) program subject to the fiscal year (FY) 2019 cap. Employers in the CNMI use the CW-1 program to employ foreign workers who are ineligible for other nonimmigrant worker categories. The cap for CW-1 visas for FY 2019 is 4,999.

For the FY 2019 cap, USCIS encourages employers to file a petition for a CW-1 nonimmigrant worker up to six months in advance of the proposed start date of employment and as early as possible within that timeframe. USCIS will reject a petition if it is filed more than six months in advance. An extension petition may request a start date of Oct. 1, 2018, even if that worker’s current status will not expire by that date.

Since USCIS expects to receive more petitions than the number of CW-1 visas available for FY 2019, USCIS may conduct a lottery to randomly select petitions and associated beneficiaries so that the cap is not exceeded. The lottery would give employers the fairest opportunity to request workers, particularly with the possibility of mail delays from the CNMI.

USCIS will count the total number of beneficiaries in the petitions received after 10 business days to determine if a lottery is needed. If the cap is met after those initial 10 days, a lottery may still need to be conducted with only the petitions received on the last day before the cap was met. USCIS will announce when the cap is met and whether a lottery has been conducted.