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Presentation | Speech
Andrew Ruskin
Morgan Lewis partner Andrew Ruskin presented on "Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges" at AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law. more
LawFlash/Client Alert | Antitrust LawFlash
J. Everett, Jr., Sean Duffy, Steven Reed, Scott Stempel
Decision by court of appeals affirms that settlements that do not expand the exclusionary scope of a patent are not subject to antitrust challenge.
LawFlash/Client Alert | Life Sciences & Healthcare LawFlash
Kathleen McDermott, Arianne Callender, Howard Young, Eric Sitarchuk
The Medicare Fraud Strike Force's use of a pivotal ACA regulation to suspend payments during criminal investigations signals a turning point in its prosecution strategy.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner
CMS formalizes its Medicare Part D Coverage Gap Discount Program rules as part of an omnibus Medicare Part C and Part D rulemaking.
Marketing Material | Supplemental Info
LawFlash/Client Alert | Insurance Recovery LawFlash
Kevin Dreher, Christopher Loeber
State and federal courts reject efforts to categorize salmonella as a "communicable disease."
Outside Publication | Article
Kathleen Sanzo, Lee Rosebush, Michele Buenafe
LawFlash/Client Alert | Intellectual Property LawFlash
Robert Smyth, Ph.D.
Court ruling applies law of nature; impacts patents directed to personalized medicine.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Lee Rosebush, Michele Buenafe
DEA's recent position against a national pharmacy chain and a wholesale distributor expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly medical necessity reviews.
Outside Publication | Article
Kathleen McDermott, Arianne Callender
LawFlash/Client Alert | Securities LawFlash
Anthony Fassano, Laura Hughes, Nicholas Schretzman, Brian Herman, John Vassos
In 2011, the Supreme Court and the federal circuit courts issued a number of important decisions concerning securities fraud class actions. These decisions address pleading standards, statutes of limitations defenses, class certification, and a number of other critical topics.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, Phoebe Mounts, Alexis Miller, Kathleen Sanzo
Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner, Stephen Ruscus
The Proposed Rule provides provisions that will significantly impact pharmaceutical manufacturers' rebate liability, price reporting calculations, and possibly their operations.
LawFlash/Client Alert | Class Actions LawFlash
Litigation Practice
Second Circuit sidesteps Concepcion and holds that the ability to enforce federal statutory rights mandates that a plaintiff be allowed to pursue a class action in court notwithstanding the parties' agreement to mandatory arbitration.
Presentation | Speech
Kathleen McDermott
Morgan Lewis's Kathleen McDermott presented "The Era of Individual Accountability-Is A Liability Hailstorm On The Way?" at the 2011 American Health Lawyer's Association Annual Meeting. Ms. McDe... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Alexis Miller
FDA draft guidance on responding to requests for off-label information foreshadows restrictive policies on use of social media.
Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Rebecca Osowski, Kathleen McDermott, Jonathan Havens, Michele Buenafe
The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.
Presentation | Speech
Stephen Mahinka
Topics presented include: Structural Changes in Pharmaceutical Industry Stimulating Focus on Comparative Effectiveness Research Potential Changes by Healthcare Reform Law Affecting Demand Levels and Prices/Payments ... more
Outside Publication | Article
Arianne Callender, Howard Young
Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers. more
Presentation | Speech
Howard Young
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, J. Everett, Jr., David Brenneman, Albert Shay
The Federal Trade Commission (FTC) and Department of Justice (DOJ) (together, the Agencies) issued their final "Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Sha... more
Outside Publication | Article
Donna Lee Yesner
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young
Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers.