Polsinelli

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act). The…more
| Health, Science, Computers, & Technology

Are Private Development Projects Covered by Prevailing Wage Laws?

When a governmental entity contracts with a general contractor to build a community center on government-owned land, the question of whether prevailing wages are required for workers on that project is easily answered. If…more
| Commercial Law & Contracts, Construction Law, Labor & Employment Law, Real Estate - Residential, Real Estate - Commercial

Phase 2 of the OCR HIPAA Audit Program Already Underway

On March 21, 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced the launch of the long-awaited Phase 2 HIPAA Audit Program (Phase 2), and OCR activities related to Phase 2 are already…more
| Commercial Law & Contracts, Health, Privacy, Science, Computers, & Technology

CMS Publishes Proposed Rule Implementing MACRA Physician Payment Model

On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) posted a pre-publication version of a proposed rule implementing changes to Medicare payment for physician services authorized under the bipartisan Medicare…more
| Health, Science, Computers, & Technology

New Federal Trade Secrets Law Passed – Major Implications for Trade Secret Owners and Their Employees

Congress just passed a major revision to U.S. trade secrets law, with enactment upon the President’s signature likely in early May. Entitled the Defend Trade Secrets Act of 2016 (“DTSA”), the legislation creates for the first…more
| Civil Procedure, Civil Remedies, Elections & Politics, Intellectual Property, Labor & Employment Law

Missouri Court Applies Borrowing Statute to Bar Illinois Asbestos Claims

In Wolfe, et al. v. Armstrong Int'l, Inc., et al., Cause No. 1522-CC11026 (Div. No. 4), the Circuit Court for the City of St. Louis, 22nd Circuit, entered an April 11, 2016, Order dismissing certain defendants from an asbestos…more
| Civil Procedure, Toxic Torts

The Devil's Dictionary of Bankruptcy Terms

The "Devil's Dictionary" is a quick-reference guide for commercial lenders and other restructuring professionals. In this series, we highlight many of the buzz words found in the Dictionary and used in today's bankruptcy arena…more
| Bankruptcy, Commercial Law & Contracts

Illinois Governor Initiates Fight Against Health Care Fraud Amid Growing Deficit

As Illinois' finances continue to deteriorate and the budget crisis remains unsolved, the Rauner administration recently announced an initiative to focus on identifying and recouping health care fraud in Illinois. On April 5,…more
| Business Torts, Elections & Politics, Finance & Banking, Government Contracting, Health

Delaware Supreme Court: No General Jurisdiction Over Non-Delaware Businesses Simply by Virtue of Registering to Do Business in Delaware

Merely registering to do business in Delaware does not subject a non-Delaware company to the general jurisdiction of Delaware courts. In Genuine Parts Company v. Cepec, Delaware Supreme Court Chief Justice Leo E. Strine,…more
| Civil Procedure, Commercial Law & Contracts, Constitutional Law

Much-Anticipated Fiduciary Rule Presents New Challenges to Financial Services Industry

The U.S. Department of Labor released its long anticipated "fiduciary rule" on April 6, 2016. The rule requires brokers and financial advisers to put their clients' interests ahead of their own when recommending retirement…more
| Finance & Banking, Labor & Employment Law

Appeals Court Confirms that HITECH Violations Do Not Violate FCA

In an important recent decision, the Sixth Circuit Court of Appeals confirmed that a qui tam relator's claim that her former husband improperly accessed electronic protected health information (e-PHI) of her and her relatives in…more
| Civil Procedure, Privacy, Health, Science, Computers, & Technology, Government Contracting

Grace Period Ends Soon for California Companies with Products Containing BPA

On May 11, 2016 products that contain Bisphenol A (BPA) manufactured, sold or distributed in California, without a proper warning, will be fair game for a Notice of Intent to Sue issued under the state’s Safe Drinking Water and…more
| Commercial Law & Contracts, Communications & Media Law, Environmental Law, Consumer Protection, Products Liability

USPTO Publishes Substantive Changes to PTAB Rules

On April 1, 2016 the USPTO published the final rules that make substantive changes to the Patent Trial and Appeal Board (PTAB) trial practice rules for inter partes review (IPR), covered business method (CBM), and post-grant…more
| Intellectual Property

DOJ Targets Nursing Fraud with New Task Forces

On March 30, 2016, the U.S. Department of Justice launched 10 regional task forces targeting “grossly substandard care” in nursing homes and other long-term care facilities across the country. The task forces combine federal,…more
| Government Contracting, Health

7th Circuit Decision Offers Valuable Lessons on Enforceability of Arbitration Clauses in E-Commerce

On March 25, the Seventh Circuit Court of Appeals issued a decision in Sgouros v. TransUnion Corp. in which the appeals court rejected TransUnion's effort to compel arbitration of a putative class action. The appeals court found…more
| Alternative Dispute Resolution (ADR), Civil Procedure, Commercial Law & Contracts, Communications & Media Law, Finance & Banking
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