A Medical Device Daily

Medtronic (Minneapolis) reported that U.S. District Court for the Northern District of California has ordered that the injunction preventing Medtronic's access to the Rapid Exchange delivery system will end on Oct. 29.

In its order, the court noted that Abbott (Abbott Park, Illinois) would not suffer any irreparable injury, and that an equitable assessment of this case clearly supports an end to the injunction.

Medtronic said it has abided by the injunction since it was originally issued in 2000, and will continue to do so until Oct. 29. Until that time, the company remains enjoined from manufacture, use, offer for sale or sale, within the U.S., of any rapid-exchange catheter which infringes claim three of the '233 patent.

Medtronic said it would announce its commercial intent related to the use of rapid-exchange technology after the injunction terminates.

In other legalities, a Boston jury has found that disability provider Unum Group (Chattanooga, Tennessee) defrauded the U.S. by forcing its customers to submit false claims for disability benefits to the Social Security Administration (SSA), when Unum knew that they were not eligible for government benefits.

By engaging in this fraudulent conduct, Unum imposed substantial burdens on an already overwhelmed Social Security program and caused the U.S. taxpayers to spend money to process and deny these false claims, according to the SSA.

The case was brought on behalf of the government by a whistleblower, Patrick Loughren, under the federal False Claims Act.

"Unum's conduct in threatening people to apply for Social Security under penalty of losing a significant portion of their private disability benefits is wrong," Loughren said. "After five years of intense litigation during which Unum refused to admit it was defrauding the United States, I am gratified that a Boston jury has called them to account."

Unum is accused of compelling people seeking disability benefits from Unum to apply for Social Security disability benefits even though its customers often told Unum they were not eligible. Social Security has much stricter criteria for disability benefits than private insurers like Unum, the SSA noted. In an attempt to enrich itself, Unum told thousands of claimants that it would cut their private disability benefits in half — or more — if they did not comply with Unum's directive that they must apply for Social Security disability benefits.

Unum admitted during the trial that it had caused many of its customers to apply for Social Security disability over the ten years covered by this case. Unum had nearly 500,000 long-term disability claimants over this period. The full extent and magnitude of Unum's conduct will be addressed in future hearings, the SSA said.

Before the trial started, the federal judge ordered that the case proceed in stages in light of its scope. As a test case, the judge submitted five people's disability benefits claims to the jury. After a four-week trial, the jury found that Unum had defrauded the U.S. with respect to two of those cases, was unable to decide a third, and found insufficient evidence with respect to two others.

By its verdict, the jury rejected Unum's primary contention that it was entitled to force people to apply for Social Security disability benefits based on SSA's open-door policy, which encourages individuals to apply for Social Security Disability benefits if they choose to do so. The jury found that Unum had violated the False Claims Act, confirming the court's earlier ruling that "an open door to claimants who are unsure they are eligible does not exonerate an insurer that knowingly causes ineligible insureds to apply."

The jury also rejected Unum's claim that it made people file frivolous Social Security claims because employers who bought group disability benefits from Unum wanted Unum to impose that requirement on their employees.

Loughren filed this qui tam (whistleblower) lawsuit in 2003.

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