Prescription Drugs

News & Analysis as of

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Price fixing not justified to protect pharmacies in rural areas

On 19 October 2016, the Court of Justice of the European Union (CJEU) issued an important judgment concerning the German law on fixing prices of retail prescription drugs. In the case before the Higher Regional Court of...more

Washington, D.C. Update – October 2016

In a rush to leave Washington and head home to campaign for reelection, members of Congress passed a continuing resolution (CR) avoiding a shutdown and extending federal government operations through December 9. In an effort...more

Health Alert (Australia) October 24, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Victoria 19 October 2016 - Damir Redzepovic v Western Health [2016] VSCA 251 The applicant sought leave to appeal from...more

Expert Who Admitted That He Was Unqualified and That His Opinions Lacked Methodology Not Allowed to Testify in Zoloft Litigation.

Last week, the Drug and Device Law Lifelong BFF asked us if we were interested in a quick trip to New York to use tickets for an early morning taping of “Live with Kelly.” Sure, we said – sounds like fun. And so, after...more

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

Agreement on Continuing Resolution Includes $37 Million (Annualized) to Fight Opioid Epidemic

In July, after months of negotiation, Congress overwhelmingly passed compromise legislation authorizing nearly $900 million in spending to help fight the growing opioid abuse crisis. The measure, which passed the Senate 92 to...more

Price hikes and product hype: Big Pharma’s relentless push

Just how rapacious can Big Pharma be? Makers hype more drugs as nation faces opioid drug abuse epidemic - In the face of an epidemic of opioid painkiller abuse, the drug industry’s answer appears to be: push even...more

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

Don’t Lose Sleep Over It…Yet

Seyfarth Synopsis: Do employers have to let employees sleep on the job as a reasonable accommodation for a disability? While far from being decided, a recent federal case in the Southern District of New York addresses the...more

Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection

In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an...more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

Bootstrapped Claim Against the FDA Gets the Boot

We’re pleased to report the demise of a plaintiff’s firm’s attempt to punish the FDA for rejecting the firm’s attempt to force the agency to create evidence helpful to plaintiffs in litigation. The ploy began in 2012, when “a...more

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

In a Groundbreaking Decision, Third Circuit Provides Framework for Evaluating Numerosity

One of the least disputed elements of class certification is Rule 23(a)(1) numerosity, and so there is relatively little analysis from the courts about it. Last month, however, a divided panel of the Third Circuit provided a...more

Health Alert (Australia) October 10, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: - Commonwealth. High Court 5 October 2016 - Lyons v Queensland [2016] HCA 38 The question in this appeal...more

Manatt on Health Reform: Weekly Highlights - October 2016 #2

Kentucky receives final approval from CMS to transition its Marketplace to the platform; Ohio puts a prescription drug price ceiling on its November 2017 ballot; and a new study links Medicaid expansion to...more

House Bill Would Block CMS Proposed New Payment Model for Part B Drugs

The Congressional Budget Office (CBO) released a report on October 4, 2016, estimating that a bill in the U.S. House of Representatives to block the implementation of CMS’s proposed payment model for Part B drugs would cost...more

The Learned Intermediary Rule in Consumer Protection Claims

We recently posted about a new California decision that was notable, in part, because it applied the learned intermediary rule to often-asserted (and equally often abused) California consumer protection statutes. See Andren...more

You Should Know - October 2016

“You Should Know” Risk and Prevention Guide - Opiate Drug Abuse, Deaths Soar Along with Drug Company Profits - In April, musician and icon Prince died in his home from an accidental overdose of the prescription...more

California's New End of Life Option Act Impacts Insurers

California's "End of Life Option Act" (the Act) went into effect June 9, 2016—making California the fifth state (behind Oregon, Washington, Vermont and Montana) to allow terminally ill adults with fewer than six months to...more

Your Daily Dose of Financial News

Some good news for the UK after a brutal few days for the pound? It appears that the pound’s precipitous fall has acted as a sort of “giant shock absorber” against Brexit—a release valve of sorts that has meant decreased...more

Third Circuit Focuses on Relevant Product Market and Lack of Anticompetitive Conduct in Doryx Product-Hopping Case

To prevail in a product-hopping case, a plaintiff must be prepared to establish both monopoly power and anticompetitive effects. On September 28, a unanimous panel of the U.S. Court of Appeals for the Third Circuit...more

FDA Regulatory and Compliance Monthly Recap — September 2016

FDA issues final rule modifying regulations for drug establishment registration, listing requirements - The final rule, which comes nearly 10 years after changes were initially proposed, updates the regulations to...more

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