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Is There Coverage for The Pill Mill Lawsuits?

In an effort to deal with the terrible epidemic of drug abuse and the human and economic costs of this dilemma, the state of West Virginia has brought lawsuits in several jurisdictions against pharmaceutical companies and...more

Washington Healthcare Update

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

Facebook and HIPAA: Strange Bedfellows

As a social media user, you may have experienced Facebook’s targeted advertising. Mere moments after searching for a specific item on Google or visiting another website, your Facebook ads reflect your recent browsing history....more

Just a Matter of Time: First-Ever Settlement of HIPAA Claims Against a Business Associate

On June 30, 2016, the Health and Human Services Office for Civil Rights (OCR) announced the first-ever settlement of Health Insurance Portability and Accountability Act (HIPAA) claims against a business associate. According...more

Analysis of Health Care Data Breach Litigation Trends

Companies that have a breach involving protected health information ("PHI") worry not only about fines and penalties imposed by the Department of Health and Human Services ("HHS"), but about class action lawsuits. The risk...more

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more

Courts Continue to Grapple with Data Breach Claims

Our last few blogs have focused on litigation under the Video Privacy Protection Act, including the recent ruling from the 10th Circuit in Yershov v. Gannett Satellite Information Network, Inc., 2016 U.S. App. LEXIS 7791 (1st...more

Insurer Held to Have Duty to Defend Allegations that Patients’ Medical Records Were Accessible Via Google Search

The Fourth Circuit Court of Appeals recently held that an insurer had a duty to defend an insured against class action allegations that the insured posted confidential medical records on the Internet. Two patients at Glen...more

The E-Cigarettes Industry Fights Back Challenging the FDA in Federal Court

Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in...more

Intermedix data breach class action case dismissed

We previously reported that Intermedix was sued in a class action lawsuit regarding the data breach involving millions of patient records....more

Superior Court of Pennsylvania Denies Data Breach Class Certification

In an encouraging development for data breach defendants, the Superior Court of Pennsylvania recently affirmed a trial court decision rejecting class certification in a suit filed against two Medicare programs for losing a...more

Prohibition on Pharmacy Inducements Beyond College of Pharmacists’ Authority

In Sobeys West Inc v. Alberta College of Pharmacists, 2016 ABQB 232, the Alberta Court of Queen’s Bench held that amendments to the College of Pharmacists’ Codes of Ethics and Standards of Practice prohibiting inducements to...more

Fourth Circuit Affirms Insurance Coverage for Cyber Claim Under CGL Policy

In a decision issued April 11, the Fourth Circuit added to a small but growing body of case law across the country finding coverage for cyber claims under traditional general liability insurance policies. In Travelers...more

USPTO Issues Subject Matter Eligibility Update

On May 5, 2016, the USPTO published a Memorandum to the Patent Examining Corps titled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” The...more

Class Certification Improper in Data Breach Case, PA Appellate Court Finds

The Pennsylvania Superior Court has affirmed a trial court's decision denying class certification in a data breach case against two health plans, reversing its own earlier ruling in the same case that the plaintiff did not...more

Patents-In Suit In ANDA Trial Are Non-Obvious

A 6-day bench trial was held from April 6-14, 2015. After trial, the court entered stipulations and orders regarding infringement of certain claims of the ‘178 and ‘206 patents. The court rejected defendant’s claim that the...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

The Writing's on the Wall: Wise Pharma Companies Will Heed FDA Warning in New Draft Guidance on Data Integrity cGMPs

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with CGMP that it was “troubl[ed]” by the growing number of such violations that...more

Supreme Court Denies Petition to Review Expanded Theory of Joint Infringement

On Monday the Supreme Court denied certiorari in Limelight Networks Inc. v. Akamai Technologies Inc. et al, Case No. 15-993. Limelight had petitioned the Court in January, urging for review of the Federal Circuit’s en banc...more

Court Report - April 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teva Pharmaceuticals USA Inc. et al. v. Biocon Ltd. et al. 1:16-cv-00278; filed April 19, 2015 in the District Court of...more

Epic Verdict in Trade Secrets Case

Last week, a federal jury in Wisconsin awarded almost $1 billion to Epic Systems Corporation in its trade secrets case against Indian consulting company Tata Consulting Services, Ltd., and its American unit, Tata America...more

Not a Check-the-Box Exercise: Failure to Have Signed BAA Results in Substantial Fine

A group practice that was the victim of a silver-harvesting scam has agreed to pay the U.S. Department of Health and Human Services (“HHS”) $750,000 to settle charges that it released protected health information (“PHI”) of...more

Sequenom v. Ariosa Diagnostics: A Supreme Court Petition that Requests Clarification on the Patent Eligibility of Diagnostic...

UUnder the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Common exceptions to what can be patented include laws of nature,...more

Ex-Husband's Revenge Leads to HHS Trophy

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurse, technicians, staff, management,...more

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...more

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