Insurance Limits and Case Value - A Clear Correlation?
Polsinelli Podcast - What Employers Need to Know About Dealing With Cash
Medical PL Risks in Retail Healthcare
Physician Considerations When Prescribing Medical Marijuana
Do I need an expert witness in my case?
Electronic Medical Records: Help or Hindrance?
How Does King v. Burwell Decision Affect the Affordable Care Act?
Antitrust Law Issues for Health Care Providers
Variables Affecting Medical PL Settlement Values
Polsinelli Podcast - Is a Single U.S. Food Agency a Reality?
The Biggest Obstacle to Value-Based Care
Technology in Healthcare
Do healthcare professionals have to report legal trouble to their licensing board?
Health Care Enforcement: The Impact on Private Equity Investments
Polsinelli Podcasts: Cloud Computing, From Cybersecurity to Confidentiality Issues
Polsinelli Podcast - Pharmacy Compounding: What's Next in Regulation?
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
A Moment of Simple Justice - Vaccines
Government's Health Care Fraud "Cash Cow" Keeps Mooing
A week ago, in a post-script to a post on Daubert decisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN, 2015 U.S. Dist. LEXIS 109737 (C.D. Cal. Aug. 18, 2015), had granted...more
On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more
The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the...more
After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are...more
The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more
On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more
Syndax, based in Waltham, Mass., is a clinical stage biopharmaceutical company. It is developing entinostat, an investigational, targeted, epigenetic immunomodulator, as a combination therapy in multiple cancer indications...more
As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more
Federal and state hazardous waste handling and disposal requirements, which were established to address issues related to industrial waste generators and disposal facilities, are often a complicated and awkward fit for retail...more
On August 18, 2014, we posted our, “First Look at ACA Employer Compliance Software.” It’s time for an update. We invited less than a dozen vendors to answer these twenty-two questions....more
According to press releases, the American Association for Respiratory Care (AARC) and Edison Nation Medical have partnered to search for innovations for improving the process, outcomes, and comfort for patients requiring...more
On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more
On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more
On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more
In This Issue:
- Judgments; Legislation; and Reports.
- Excerpt from Judgements:
17 August 2015 - Bourke v Coroners Court  VSC...more
It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more
“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more
Alameda, California-based medical device company Penumbra, Inc. registered with the Securities and Exchange Commission (SEC) last Friday for an initial public offering (IPO) to raise up to $115 million. The company will be...more
On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more
The Federal Trade Commission’s (“FTC” or “Commission”) ever-expanding list of enforcement actions to preserve competition for generic pharmaceuticals just grew in a new direction. This week, two generic pharmaceutical...more
OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more
In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more
China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more
Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House.
House District 19 Special Election -
On November 3, 2015 the citizens of Sanford can take...more
Find a Health Author »
Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up to create your digest using LinkedIn*
Back to Top