Physicians Pharmaceutical Industry

News & Analysis as of

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

Justice Department Charges Pharma President with Kickback Conspiracy

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

Philly Court Applies Michigan Law to Dismiss Risperdal Cases

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida. True, Justified was set in Kentucky. But...more

Divided Infringement Between Doctor and Patient

Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the...more

MedPAC Convenes to Discuss Open Payments, Payment for Post-Acute Care, and Other Issues

On September 10-11, 2015, MedPAC held a meeting to discuss several issues related to the Medicare program, including (1) improving the Open Payments program, which makes public the payments from drug and device manufacturers...more

SDNY Sacks Treanda Failure to Warn Claim

Failure to warn cases remind us of sports talk radio and paleontology. Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination. The Iggles are terrible, their deficiencies...more

Health Alert (Australia) - September 14, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments New South Wales (NSW) 9 September 2015 - Idameneo (No 123) Pty Ltd v Auzcare Pty Ltd [2015] NSWSC...more

Health Alert (Australia) - September 7, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Australia. High Court 2 September 2015 - AstraZeneca AB v Apotex Pty Ltd AstraZeneca AB v Watson...more

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

Health Alert (Australia) - August 31, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpts from Judgments New South Wales (NSW) 28 August 2015 - Smith v Pennington [2015] NSWSC 1168 The Supreme Court gave judgement for the...more

Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

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

Breaking News: Proposed 340B Omnibus Guidance Released

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

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Preemption (and Other Things) Defanging Depakote Claims

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

Central District of California "Discontinues" Much of Plaintiffs' Experts' Testimony in Cymbalta "Discontinuation Symptoms" Case

“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

How Does a Bad Idea Get Implanted?

Not so long ago we discussed how Pennsylvania law clearly precludes prescription medical product strict liability, but plaintiffs keep asserting that cause of action anyway. The plaintiff bar is nothing if not persistent. ...more

Practical Implications from Amarin

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech...more

Federal Court Grants First Amendment Injunction in Amarin Case

Federal Court Grants Requested Injunction in Amarin: Confirms Caronia Stands for Proposition that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the...more

Guest Post - Just the Fax, Ma’am

While Bexis is on vacation, here is a guest post to take up some of the slack. Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith's Chicago office. This one's a little different. It's about the impace of...more

A Couple of Law Review Articles We Actually Like

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

Blog: 2014 Open Payments Infographic

Policy and Medicine published today an interesting infographic prepared by Open Payments Analytics regarding the 2014 Open Payments data, which contains 11.41 million payments and other transfers of value totaling $6.49...more

Health Alert (Australia) - July 13, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: United Kingdom (UK) 7 July 2015 - Ross v A [2015] EWCOP 46 The England and Wales Court of Protection has held that a...more

Blog: Minimal Media Interest to Date in Recently-Released Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) released last week the 2014 Open Payments data, the first release of data reported by applicable manufacturers and group purchasing organizations (GPO) for a full calendar...more

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