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Holland & Knight: FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

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FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

Holland & Knight
December 26, 2012
2 pages

Pharma & Life Sciences: Litigation & Enforcement

Davis Wright Tremaine: Under HIPAA, You Have the Right to Remain Silent

June 19, 2013 HIPAA Enforcement

Duane Morris: FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

June 19, 2013 Pharma Enforcement & Litigation

Duane Morris: FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

June 19, 2013 Pharma Enforcement & Litigation

HHS OIG Provides Guidance on Use of Permissive Exclusion Authority

Bass Berry Sims: Know Your People! OIG Issues New Special Advisory Bulletin on Excluded Persons

McGuireWoods: OIG Issues Updated Bulletin on Effect of Exclusion

Alston & Bird: Updated OIG Guidance on Health Care Program Exclusions – More Trouble for Health Care Entities Owned or Controlled by Excluded Persons?

Armed with Park Doctrine, FDA Ramps-Up Criminal Prosecutions of Individuals

Duane Morris: U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

Edwards Wildman: Attention Pharmaceutical and Medical Device Executives – Ignorance is not bliss

Duane Morris: D.C. Circuit Affirms HHS Power to Disqualify Corporate Officials Convicted of Misdemeanors Under the "Responsible Corporate Official" (RCO) Doctrine

Stark Anti-Kickback Laws

Haynes and Boone: Appeals Court Overturns $44 Million Judgment Against Tuomey Hospital in Important Stark Law Case

Foley & Lardner: Hospital - DMEPOS supplier arrangements and the Anti-kickback Statute

Foley & Lardner: First Circuit Rejects False Claims Act Analysis and Rescues Anti-Kickback Claims Against Medical Device Company

Health Care Reform & Stark Law

Mintz Levin: Federal District Court Upholds Stark Regulation Ban on Physician-Owned Under Arrangement Service Providers

Arent Fox: Intermountain Healthcare Settlement of $25.5 Million Stems from Stark Law Violations

Greenberg Traurig: Stark Law Violations Costly To Intermountain Health Care Inc.

CMS Implements PPACA Fraud and Abuse Controls

Mintz Levin: CMS Final Rule Strengthens Framework to Prevent Health Care Fraud

Mintz Levin: CMS Finalizes Regulations Intended to Strengthen Program Integrity

ReedSmith: CMS Final Rule Expands Medicare/Medicaid/CHIP Provider and Supplier Screening Requirements Under Affordable Care Act Authority

Pharma & Device Sectors Face FCPA Scrutiny

Arnold & Porter: Pfizer's FCPA Settlement Provides Important Lessons for the Medical Products Industry on Compliance Program Expectations

Vinson & Elkins: A Prescription for Trouble: Pfizer Hit with FCPA Charges as Focus on Foreign Corruption in the Pharmaceutical Industry Continues

Fulbright & Jaworski: Orthofix Makes Latest Medical Device FCPA Settlement

HIPAA Enforcement

Davis Wright Tremaine: Under HIPAA, You Have the Right to Remain Silent

Pepper Hamilton: Large Educational/Health System Targeted for HIPAA Enforcement

McGuireWoods: Settlement for Alleged Violation of HIPAA Security Rule Costs Idaho State University $400,000

PPACA: Fraud, Abuse & Waste

Wiley Rein: Your Problem Is Now My Problem--The New Era of Fraud and Compliance for Health Insurers

Morgan Lewis: No Change in Course on ACA Federal Antifraud and Transparency Provisions

Mintz Levin: Federal Compliance Blitz: Enforcement Challenges Ahead for Labs and Pathologists

Duane Morris: State Medicaid Fraud Control Units' Data Mining Likely to Increase Through Federal Funding

Morgan Lewis: HHS OIG Issues Report on Hospice General Inpatient Care Billing

Paul Hastings: OIG Classifies Physician-Owned Device Companies as Inherently Suspect of Violating AKS

Stanford v Roche & University Ownership of Federally Funded Patents

Baker Botts: Does Your Employment Agreement Contain A Time Bomb? 5 Minutes That Can Save A Lawsuit

Greenberg Traurig: U.S. Supreme Court: Bayh-Dole Act Does Not Supersede Inventors' Rights in Federally Funded Inventions

K&L Gates: Bayh-Dole Act Turned On Its Head?

Matrixx v Siracusano & Disclosure/Materiality of Adverse Event Reports

McCarter & English: Matrixx and Recent Lower Court Decisions

Pepper Hamilton: Lower Courts Follow Matrixx's Guidance on Motions to Dismiss

Akin Gump: Supreme Court Gives Guidance On Materiality Standard

Association for Molecular Pathology v. Myriad Genetics: SCOTUS Holds Isolated Genes Not Patentable

Dentons: DNA and Genetics Patents: What Impact Will the Myriad Decision Have?

Haynes and Boone: Not a Biotech Company? What Myriad Might Mean For You

Winston & Strawn: U.S. Supreme Court Holds That Portions of DNA Isolated From Naturally Occurring DNA Are Not Patent Eligible But That Synthetically Created DNA Is Patent Eligible

Ariad Pharms: Federal Circuit Upholds Separate Written Description Requirement

Patton Boggs: New Patent Fees Finalized

Dorsey & Whitney: Federal Circuit Reaffirms Existence of a Separate Written Description Requirement

Quarles & Brady: Substantive Advice for Research Institutions to Comply With The Written Description Requirement

Wyeth v Levine, Preemption & Adequacy of RX Lable

Simpson Thacher: The Supreme Court Considers Implied Preemption of Failure-to-Warn Claims Against Generic Drug Manufacturers

Duane Morris: Federal Government to Provide Its Position on Generic Preemption to the U.S. Supreme Court

Perkins Coie: Wyeth v. Levine: Important Implications for Drug Manufacturers

IMS Health v Sorrell & Sale of Prescriber Data

Arnold & Porter: Does Sorrell v. IMS Health Mark the End of Off-Label Promotion Prosecution?

Morgan Lewis: Supreme Court Strikes Vermont Data Mining Law and Protects Pharmaceutical Marketing

King & Spalding: U.S. Supreme Court Rules Vermont Prescription Data Privacy Law Unconstitutional

Smith v. Bayer Corp: Supreme Court Reverses Federal Court Injunction of State Court Class Action

Weil Gotshal: 'Smith v. Bayer': Can a Federal Court Enjoin Efforts to Certify a Class?

K&L Gates: No Pain Relief in Smith v. Bayer Corporation: the Supreme Court Rules on When a Federal Court Class Certification Denial Bars a Similar State Court Action

Simpson Thacher: Directors’ and Officers’ Liability: ‘Smith v. Bayer’: Decision on Class Certification and Preclusion

PLIVA v. Mensing: Generic Drug Makers Protected from Failure to Warn Claims

Bingham: The Federal Preemption Defense for Generic Drug Manufacturers May Be Short Lived

Haynes and Boone: Contemplating Pliva V. Mensing

ReedSmith: PLIVA Inc. v. Mensing: The U.S. Supreme Court Muddles Through Another One

Therasense v Becton & Inequitable Conduct

Ballard Spahr: Rule 56 After Therasense—Are We Bound for Change?

Haynes and Boone: The U.S. Patent and Trademark Office Proposes Changes to the Duty of Disclosure to Match the Therasense Standard

Orrick: Federal Circuit Tightens Standards for Establishing Inequitable Conduct in En Blanc Ruling

Bilski-Patentability of Business Methods

Baker Botts: Patentable Subject Matter Post-Bilski

Orrick: U.S. Supreme Court's Bilski Ruling Is Welcome News for Asian Clean Energy Innovators

Ashurst: Business methods patentable in the US in Bilski, but UK courts remain restrictive

Abbott Labs v Sandoz & Product-By-Process Claims

Lowenstein Sandler: Abbott Labs v. Sandoz: The Federal Circuit Provides Clarity On Product-By-Process Claims

Willkie Farr & Gallagher: Product-By-Process Claims Of Patents Are Limited To Products Made By The Recited Process [Abbott Labs v Sandoz, Inc.]

Sutherland: Federal Circuit Clarifies Limited Scope of Product-by-Process Claims [Abbott Laboratories v. Sandoz, Inc]

Astra Zeneca v Apotex: Skinny Labeling No Panacea For Inducement of Patent Infringement

Cravath: Induced Infringement Based on Filing an ANDA: It’s All in the Label

Fish & Richardson: Skinny Labeling and the Inducement of Patent Infringement [Astra Zeneca LP v. Apotex Inc]

K&L Gates: Skinny Labeling in Question — Federal Circuit Affirms Preliminary Injunction for Inducing Infringement of Orange Book Method of Use Patent Despite Section viii Labeling Carve-Out

Bruesewitz v Wyeth: State Law Vaccine Design Defect Claim Preempted

Morrison Foerster: Another Liability Shield for Vaccine Manufacturers: U.S. Supreme Court Rules that Design Defect Claims Against Vaccine Manufacturers Are Preempted [Bruesewitz v. Wyeth]

Locke Lord: The “National Childhood Vaccine Injury Act” Immunizes Vaccine Manufacturers from State Design Defect Claims

Winston & Strawn: Supreme Court Issues Narrow Ruling in Vaccine Preemption Case