Recent Efforts to Tame the Opioid Epidemic

48,000 Americans were lost to opioid overdoses in 2017. Michigan opioid-related deaths and overdoses rank 18th-highest in the nation. Over the last year, significant attention was dedicated toward combating this widespread issue on both a Federal and State Level. Michigan Recently enacted Michigan opioid laws were executed with the intent to save lives and decrease …

Opioid Litigation Comes To Michigan – What Physicians And Hospitals Need To Know

Michigan, like the rest of the country, suffers from an opioid epidemic. Every day, more than 100 Americans die from an opioid overdose1. Some economists estimate that the opioid crisis has cost the U.S. economy more than $1 trillion since 2001 and is on pace to cost an additional $500 billion through 20202. The profligate …

Prescription for Fraud: Government Enforcement Activities in Compounding Pharmacies

On October 18, 2017, a Mississippi physician was charged with health care fraud for writing prescriptions for medically unnecessary compounded medications. This is the latest – though certainly not the last – example of the Department of Justice’s efforts to combat fraud within the TRICARE program. From California to Florida, federal prosecutors have charged physicians, …

Revisions to Federal Substance Abuse Confidentiality Regulations Improve Exchange of Medical Information, Attempt to Promote Clinical Integration

First published in 1975, 42 CFR Part 2 (Part 2) governs confidentiality and disclosures of medical records for patients of substance abuse treatment programs. The initial purpose of Part 2 was to ensure that a patient who receives treatment in a formal program for any substance use disorder is protected from the disclosure of his …

Attorney James Burns Speaks to Bloomberg BNA About Key Pharmaceutical Antitrust Topics for 2015

Dickinson Wright Member James Burns recently spoke to Bloomberg BNA’s Pharmaceutical Law & Industry Report for the article, “Biosimilars Policy, Accelerating Medical Breakthroughs Among Year’s Key Topics” (1/16/2015). In the article, Mr. Burns discusses some of the key antitrust issues for the upcoming year in the pharmaceutical industry. Mr. Burns noted that one significant issue …

Supreme Court Holds That “Pay for Delay” Pharmaceutical Patent Settlements May Violate the Antitrust Laws

By James M. Burns On June 17, the United States Supreme Court issued its highly-anticipated decision in FTC v. Actavis Inc., a case with significant implications for patent law, antitrust law and healthcare law.  The case involved a settlement of a patent infringement lawsuit brought by a branded drug manufacturer against a generic drug maker, …

FTC Issues New Report on “Pay for Delay” Patent Settlements

By James M. Burns According to a new report by the Federal Trade Commission, brand-name pharmaceutical companies increased their use of “pay for delay” patent settlements last year (October 2011 – September 2012).  Of the total 140 pharmaceutical patent infringement settlements in the year, the report identifies 40 as potential “pay for delay” settlements.  This …

James M. Burns Comments on the Supreme Court’s Decision to Hear the Androgel “Pay for Delay” Pharmaceutical Patent Settlement Antitrust Case

James Burns, a Member in Dickinson Wright’s Washington D.C. office, commented to several health care publications on the United States Supreme Court’s decision to hear the Androgel antitrust case (FTC v. Watson Pharmaceuticals).  The case involves so-called “pay for delay” settlements, in which a branded drug manufacturer typically sues a generic manufacturer for patent infringement, …

Federal Trade Commission Takes Aim at Pharmaceutical Industry “Product Hopping”

By James M. Burns Declaring that “The potential for anticompetitive product design is particularly acute in the pharmaceutical industry,” on November 21 the FTC filed an amicus brief in Mylan Pharmaceuticals v. Warner Chilcott Public Limited Company (E.D. Pa.), urging the court not to accept the view that “product-hopping” (the practice of repeatedly reformulating a …