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The Courts

July 02, 2014 | Daily News

Reps. Diana DeGette (D-CO) and Jerrold Nadler (D-NY) said Wednesday (July 2) they are working on a legislative response to the Supreme Court's Hobby Lobby ruling that will ensure employers cannot use the Religious Freedom Restoration Act to avoid covering employees' contraceptives.

June 30, 2014 | Daily News

HHS in the immediate aftermath of the Supreme Court's contraceptive coverage decision should extend the “accommodation” it granted for religious non-profit organizations to for-profit companies because it's the only realistic short-term solution to mitigate the ruling's consequences, the head of consumer group National Health Law Program tells Inside Health Policy.

June 30, 2014 | Daily News

The Supreme Court, in its decision Monday (June 30) scaling back the ACA's controversial contraception coverage mandate, suggests that HHS' existing “accommodation” letting some religiously affiliated non-profit institutions avoid directly providing contraception coverage may have actually hurt the government's case that Hobby Lobby still needed to comply with the ACA provision and did not deserve a similar exemption.

June 09, 2014 | Daily News

A Supreme Court ruling last week, when taken in concert with a string of recent high court patent decisions, has put personalized medicine between "a rock and a hard place," one patent attorney said.

June 05, 2014 | Daily News

The Center for Medicare Advocacy has filed a class action lawsuit against HHS over the first two levels of the Medicare appeals system, which the center alleges “rubber stamp” coverage denials at both the Redetermination and Reconsideration levels of appeals.

April 28, 2014 | Daily News

The Solicitor General's position in the case POM Wonderful LLC v. The Coca-Cola Company received some pushback from Supreme Court justices during oral arguments last week, with justices asking why the two statutes involved, the Food, Drug and Cosmetic Act (FDCA) and Lanham Act, could not be complementary.

April 18, 2014 | Daily News

The Solicitor General recently told the Supreme Court, in a case slated to be heard next week, that companies cannot bring false advertising cases when FDA explicitly regulates a product, although FDA laws do not broadly prevent them from doing so.

April 15, 2014 | Daily News

In a move that one lobbyist says should not be a surprise, the American Hospital Association is challenging HHS over the controversial two-midnights inpatient admission policy, arguing in two related lawsuits filed Monday (April 14) that the rule burdens hospitals with unlawful, arbitrary standards and deprives hospitals of proper Medicare payment for caring for patients.

April 07, 2014 | Daily News

States worry that if the Supreme Court sides with Coca-Cola in the POM Wonderful LLC v. The Coca-Cola Company, the ruling could spill over to interactions between state consumer protection laws and the Food, Drug and Cosmetic Act (FDCA), according to an amicus brief filed by 10 state attorneys general.

March 25, 2014 | Daily News

Several Supreme Court justices raised concerns Tuesday (March 25) that a range of crucial medical services -- such as vaccines and blood transfusions -- might also be denied to employees based on their employers' religious views if the court rules that for-profit corporations do not have to comply with the ACA’s controversial contraception coverage requirement based on religious objection.

January 28, 2014 | Daily News

The Supreme Court's unanimous decision last week reiterate its earlier stance that patent owners bear the burden of proof in a declaratory judgment of non-infringement in patent litigation restores clarity that had been muddied by a diverging lower court ruling, an industry attorney said.

January 23, 2014 | Daily News

The American Hospital Association, several state hospital associations and four hospital systems on Wednesday (Jan. 22) took the first steps toward challenging CMS’ two-midnights inpatient admissions policy, according to AHA News.

January 23, 2014 | Daily News

A bicameral group of lawmakers -- including top Republicans on key committees and one of the architects of the generic drug law -- say FDA's proposal that generic drug makers unilaterally update their labels with new safety information conflicts with statutory requirements that Congress has declined to change in recent decades.

January 16, 2014 | Daily News

The top priority for the generic drug industry in 2014 will be combating a new regulation aimed at requiring generic drugmakers to make labeling changes to reflect new safety information -- a shift from the current FDA regulatory paradigm that would be "draconian," according to the generic drug lobby's top official, who pledged broad outreach on the matter extending to the White House.

January 07, 2014 | Daily News

Triclosan in toothpaste could be just as harmful if not more so than in hand washes, the Natural Resources Defense Council argues in filing a recent lawsuit that comes on the heels of FDA action on antibacterial hand washes.

December 26, 2013 | Daily News

A recent government filing countering application of the First Amendment in a false claims case involving off-label promotion shows that the government is trying to limit a high-profile off-label ruling to cases brought under the Food, Drug and Cosmetic Act, industry attorneys said.

December 18, 2013 | Daily News

The Supreme Court Monday (Dec. 16) denied cert in U.S. v. W. Scott Harkonen, a case in which a lower court upheld a CEO's fraud conviction based on a press release touting clinical trial results.

November 27, 2013 | Daily News

As the Supreme Court agreed Tuesday (Nov. 26) to take on the highly controversial issue of the ACA's contraceptive coverage requirements, the Obama administration joined by women's groups and some health care providers urged the high court to resist letting employers dictate whether their female employees should be able to access such coverage.

November 26, 2013 | Daily News

Home health providers are planning a “March on the Capitol” to protest CMS' cuts to home health pay in the 2014 final pay rule and say that, if necessary, they will work with seniors' advocates to take the agency to court.

November 25, 2013 | Daily News

Top FDA officials attribute advances in personalized medicine, including the agency's first authorization of gene sequencers, to regulatory science and a key Supreme Court ruling earlier this year.