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Warning Causation Potpourri in New Jersey Mass Tort

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving. The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super....more

16 data breach class action lawsuits filed again 21st Century Oncology consolidated

We previously reported that 21st Century Oncology suffered a data breach in October 2015 involving an intrusion into its systems which compromised around 2 million patients’ records, including their names, Social Security...more

Supreme Court Punts Again on FCA Claims Specificity

The U.S. Supreme Court recently denied certiorari in United States ex rel. Walterspiel v. Bayer AG. This case, arising out of the Fourth Circuit, raised yet again the question of how much detail a False Claims Act (FCA)...more

Supreme Court Again Refuses to Clarify Scope of Hatch-Waxman Safe Harbor

The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

Teladoc Receives Support from the Feds

Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board’s (the “Board”) appeal was inappropriate and...more

Amgen v. Hospira: Amgen Files Appeal Brief at Federal Circuit

As we reported in August, the Federal Circuit denied Hospira’s motion to dismiss Amgen’s interlocutory appeal from the district court (D.Del., J. Andrews) regarding a discovery dispute. The court ordered the parties to brief...more

BREAKING NEWS: FDA Approves Sandoz’s Erelzi, biosimilar to Enbrel (etanercept)

The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept). Sandoz’s biosimilar is called Erelzi. It is the first biosimilar etanercept approved by FDA, and the third...more

Update in Janssen v. Celltrion: Parties Stipulate that Celltrion Will Not Sell Remicade Biosimilar Before October 3, 2016

In a stipulation filed yesterday in Janssen v. Celltrion, Celltrion has agreed not to sell its Remicade biosimilar in the U.S. for use by doctors or patients before October 3, 2016, and the parties have agreed to dismiss all...more

Texas Medical Board’s Appeal Must Proceed Under Existing Jurisdiction Arguments

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

Plaintiffs Cannot Bring Data Breach Lawsuits Without Evidence That Information Will Be Used To Harm

The latest development in how American courts will handle the standing question for data breach class actions came last week when the U.S. District Court for the District of Columbia dismissed for lack of standing a putative...more

Conflicting Defence Evidence Not Sufficient to Deny Class Certification

The Divisonal Court’s recent decision in Dine v Biomet Inc, 2016 ONSC 4039 will be of particular interest to members of the class action bar in Ontario, as it will have implications for evidence led on certification motions....more

AbbVie Sues Amgen to Prevent Launch of Humira Biosimilar

As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61...more

FTC Reverses ALJ’s Decision In LabMD Case

Back in November 2015, Chief Administrative Law Judge (ALJ) D. Michael Chappell ruled that the Federal Trade Commission (FTC) failed to show that LabMD, Inc.’s (LabMD) data security practices caused harm to consumers stemming...more

Health Care Market Intelligence: Post-Acute Care Summary Report - Q2 2016

Key Findings - - CMS proposed an $800-million Medicare payment increase for SNFs in FY 2017, a 2.1% increase from this year, while hospice payments would rise by $330 million, or 2%. Home healthcare agencies may see a...more

July 2016: Product Liability Update

Curbing False Claims Act Liability for Off-Label Promotion. As class actions have become harder to certify following Wal-Mart v. Dukes and Comcast v. Behrend, the plaintiffs’ bar has increasingly turned to qui tam litigation...more

Alabama Department of Revenue Now Argues that ALL Software—Canned or Custom—Is Subject to Sales/Use Tax

The Alabama Tax Tribunal (the “Tribunal”) ruled in a recent case that the taxpayer-hospital was entitled to a refund of the sales tax paid on the purchase of software that had been customized for its particular functions...more

Protected Health Information: Providers Must Proceed with Caution

Medical records are a powerful weapon in the courtroom. They may reveal the extent of an individual’s injury in a personal injury case or substantiate the severity of an individual’s mental illness when that mental illness is...more

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

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