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Health Science, Computers & Technology Civil Remedies

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SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazadone drug submission

by Smart & Biggar on

On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that Apotex failed to mitigate the damage it incurred as the result of Health Canada’s misfeasance in public office and negligence in its...more

Fourth Circuit Excludes FDA Evidence in Transvaginal Mesh Products Liability Case

by Sands Anderson PC on

In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim....more

Teva awarded section 8 damages regarding pregabalin and olanzapine

by Smart & Biggar on

On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) regarding pregabalin (Pfizer’s LYRICA)...more

Punitive Damages Overkill: J&J Hit With Still Another Disproportionate Punitive Award In Pelvic-Mesh Litigation

As early as 1967, Judge Friendly worried about the phenomenon of punitive damages overkill in mass tort litigation. Fifty years later, the problem persists....more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Rx IP Update - February 2017

by Smart & Biggar on

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

by Reed Smith on

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

Lessons Emerging from Pinnacle Hip Bellwether Trials

by Cozen O'Connor on

In a staggering verdict, a Texas jury recently awarded over $1 billion against Johnson & Johnson (“J&J”) and its subsidiary DePuy Orthopaedics Inc. (“DePuy”) (collectively referred to as “Defendants”) to six California...more

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

by Dorsey & Whitney LLP on

Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims...more

Ninth Circuit Rejects FCA Suit Alleging Medical Device Inaccuracies

by Ropes & Gray LLP on

In United States ex rel. Ruhe v. Masimo Corp., 640 Fed. App’x 666 (9th Cir. 2016), the Court of Appeals for the Ninth Circuit affirmed a grant of summary judgment for defendant Masimo Corporation, a medical device...more

A Wise Decision: Recent Lessons on Evidence in Class Actions

by Bennett Jones LLP on

Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 was a recent pre-certification summary judgment decision, which was released after the Divisional Court's decision this past summer in Dine v Biomet Inc, 2016 ONSC 4029....more

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

by King & Spalding on

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Stop them in their tracks: key points in seeking a preliminary injunction against medical device infringers

by DLA Piper on

In 2006, the US Supreme Court reversed years of jurisprudence by eliminating the presumption of irreparable harm in patent litigations,1 which previously had resulted in virtually automatic grants of injunctions to prevailing...more

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

by Goodwin on

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

Celltrion Begins Shipping Remsima to the U.S.

by Goodwin on

As we reported last week, the district court granted Celltrion’s Motion for Summary Judgment of Invalidity for one of the two patents-at-issue in Janssen v. Celltrion. The Korea Times reports that Celltrion shipped its...more

AbbVie Sues Amgen to Prevent Launch of Humira Biosimilar

by Goodwin on

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

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

AGG Food and Drug Newsletter - May 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Congress acts on opioid drug epidemic as judge unseals OxyContin files

Here are some developments worth watching in the nation’s battle against the epidemic of opioid drug misuse that killed 28,000 Americans in 2014 alone...more

FTC Settles Monopolization Charges Stemming from Contract Exclusivity Terms Used by First-to-Market Medical Polymer Maker

by Mintz Levin on

The mere possession of monopoly power does not violate federal antitrust laws. The laws only address the anticompetitive acquisition, maintenance, or abuse of that power. The Federal Trade Commission (“FTC”) entered into a...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

by Jackson Walker on

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Olympus to Pay $632.2 Million to Resolve Allegations of Kickbacks

by Polsinelli on

Olympus Corporation of the Americas, the United States’ largest distributor of endoscopes and related medical equipment, recently agreed to pay $623.2 million to resolve criminal charges and civil claims, according to a...more

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