$4.1 Million Settlement Approved in Stanford Data Breach Action

Last week, Los Angeles County Superior Court Judge Elihu Berle tentatively approved a $4.1 million settlement of a class action claim that Stanford Hospital & Clinics violated the California Confidentiality of Medical Information Act when the medical information of about 20,000 emergency room patients was posted online for nearly a year from 2010 until […]

LITIGATION ROUND-UP

Settlements BioScrip agreed to pay $15 million to settle a False Claims Act (FCA) suit alleging that it received kickbacks from Novartis Pharmaceuticals related to its distribution of Exjade through its legacy specialty pharmacy operations.  The Department of Justice (DOJ) alleged that Novartis directed BioScrip to increase patient refills on Exjade and, over the next several years as BioScrip increased its Exjade refill […]

FDA Enforcement of Pharmaceutical Websites Continues

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently posted an untitled letter to Institut Biochimique SA (IBSA) and Akrimax Pharmaceuticals, LLC (Akrimax), the U.S. agent for Tirosint. The OPDP raised concerns regarding IBSA’s Facebook page for Tirosint because it failed to provide any risk information regarding its use, even though Tirosint is […]

County Pays $215,000 to Resolve Alleged HIPAA Non-Compliance

On March 7, 2014, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that Skagit County, Washington, has agreed to pay $215,000 and enter into a three year corrective action plan in order to settle alleged violations of the Health Insurance Portability and Accountability Act […]

CMS to Congress: “We Do Not Plan to Finalize” Certain Controversial Medicare Part D Proposals – All “Protected Classes” Will Remain Protected. For Now.

Yesterday, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Marilyn Tavenner responded to several Congressional concerns regarding CMS’ recent proposed rule on the Medicare Part D outpatient prescription drug benefit.  We previously reported on that proposed rule here.  In a Letter to Representative Sander Levin, Ranking Member of the House […]

Resource Launch: Introducing Cooley’s Health Exchanges Presentation

We are very pleased to introduce a new resource that has been added to our blog. On February 19, Cooley teamed up with New York City Health Business Leaders to sponsor “Health Exchanges: Passing the Torch to the Next Phase of Implementation,” a panel discussion led by Cooley Attorney, Wendy […]

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]