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The Courts

Wednesday, 23 August 2017

Public interest groups are fighting the Department of Justice's novel claim that showing harm to the groups' ability to comment on regulatory repeals is not enough to give them standing to sue over President Donald Trump's executive order (EO) directing agencies to identify two rules to repeal for every new rule they issue, countering that DOJ's argument would limit citizens' ability to challenge a host of constitutional violations.

Monday, 21 August 2017

After receiving an unsatisfactory response to a citizen petition calling for FDA action on formaldehyde in keratin hair straighteners, two environmental groups are suing FDA in an attempt to force the agency to make a decision, within a set time period, on whether to ban the ingredient.

Thursday, 17 August 2017

Answering the calls of congressional Republicans, FDA is siding with the food industry in a lawsuit seeking to stop New York City's menu labeling regulation from being enforced until FDA implements its national standard.

Wednesday, 16 August 2017

The federal appeals court for DC said a lower court needs to look closer at HHS' claim that it would be impossible for the agency to lawfully reduce the Medicare appeals backlog at the Administrative Law Judge level by 2021, though the court said the burden should fall on HHS to prove that is so once the case goes back to the district court.

Tuesday, 08 August 2017

The U.S. Court of Appeals for the Third Circuit dismissed an appeals claim from a secular anti-abortion group that sought exemption from the Affordable Care Act's mandate that employers cover all FDA approved contraceptive services with no cost-sharing.

Tuesday, 08 August 2017

The government must pay Molina Health Care the full risk-corridor payments owed from 2014 and 2015, the U.S. Court of Federal Claims ruled Friday (Aug. 4).

Friday, 04 August 2017

A federal district court will allow a lawsuit calling for a right for beneficiaries to appeal placement under observation during a hospitalization to proceed as a class action suit, and the Center for Medicare Advocacy and Justice in Aging project hundreds of thousands of beneficiaries are likely to be members of such a class.

Thursday, 03 August 2017

Legal experts appear to agree that while this week's federal appeals court decision allowing Democratic attorneys general to intervene in House v. Price may not fully curtail the president's ability to end the Affordable Care Act's cost-sharing reduction payments, it complicates the White House's ability to do so unilaterally.

Tuesday, 01 August 2017

Adding a new twist to the ongoing saga over the ACA's cost-sharing reduction payments that President Donald Trump is threatening to withhold from insurers, a federal court on Tuesday said a group of Democratic attorneys general may intervene in the House GOP's high-profile suit against the Obama administration for making the payments absent a congressional appropriation.

Wednesday, 26 July 2017

The House Energy & Commerce Committee will mark up Thursday (July 27) a bill sponsored by Rep. Cathy McMorris Rodgers (R-WA) to loosen menu labeling requirements for certain food establishments and limit liability for noncompliance with labeling requirements.

Tuesday, 11 July 2017

House Republicans and the Department of Justice in separate filings Monday asked the DC Court of Appeals to reject a motion by Democratic attorneys general to intervene in the ACA cost-sharing reduction case.

Thursday, 06 July 2017

The Association For Accessible Medicines has filed a lawsuit in an attempt to block implementation of Maryland’s first-in-the-nation generic drug price gouging bill.

Wednesday, 05 July 2017

Despite the Supreme Court’s recent ruling that an injunction cannot be used to compel participation in the so-called biosimilar patent dance, one retired district court judge recently argued that this information will still be exchanged during discovery given that courts will develop local rules to compel information exchange, in an effort to ensure that declaratory-judgment actions can move forward.

Wednesday, 05 July 2017

FDA will not say whether it will answer a call from Supreme Court Justice Stephen Breyer for the agency to craft its own interpretation of the biosimilar pathway.

Friday, 30 June 2017

In the wake of the U.S. Supreme Court remanding portions of the closely-watched Amgen v. Sandoz biosimilar pathway case back to the federal circuit, Sandoz is asking the circuit court to further remand the lawsuit to the California district court.

Friday, 23 June 2017

Democrats would likely use the Supreme Court ruling against mandatory Medicaid expansion to fight federal Medicaid funding caps, a former Senate Republican staffer said, but legal scholars doubt that suit would be a good precedent to use against the caps should the GOP health reform legislation be enacted.

Monday, 19 June 2017

The U.S. Supreme Court agreed last week take up a case that will determine the constitutionality of the patent office’s inter partes review process -- an administrative procedure for challenging patents that some drug industry stakeholders have said undermines the drug pipeline and unfairly uses a lower standard for reviewing patents than that used by a district court.

Monday, 19 June 2017

In the wake of the U.S. Supreme Court's reversal of a lower court decision on patent exhaustion, which some see as partially clearing the way for drug importation, legal experts argue that the pharmaceutical industry will now turn to contract disputes over licensing to fight importation.

Tuesday, 13 June 2017

Amgen's pediatric exclusivity lawsuit against FDA was stayed after the agency agreed to reconsider its May 22 decision not to grant pediatric exclusivity to Amgen's Sensipar, a drug to treat secondary hyperparathyroidism.

Monday, 12 June 2017

NEW YORK --The Supreme Court’s decision to punt on whether the so-called biosimilar patent dance is mandatory in the highly-watched Amgen v. Sandoz case leaves the state of play filled with “uncertainty and gamesmanship,” but companies are still likely to follow the patent dance process, an attorney who represents innovator biologic companies said Monday (July 12).