Prescription Drugs

News & Analysis as of

Cymbalta Withdrawal Cases May Soon Have an MDL

Eli Lilly & Co., the producer of the popular antidepressant Cymbalta (duloxetine), is facing a spate of litigation over injuries associated with the drug. Plaintiffs allege that Cymbalta can cause severe withdrawal symptoms,...more

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

Lupin Appeals Fine Imposed by European Commission in “Pay-For-Delay” Crackdown

In July of this year, the European Commission imposed fines on French pharmaceutical company Servier and five generic drug makers, including Lupin Ltd., totaling €427.7 million. The fines were the result of a five-year...more

For the First Time PTAB Upholds Validity of Pharma Patents

On December 9, 2014, the Patent Trial and Appeal Board (“PTAB”) upheld the validity of three Supernus Pharmaceutical’s patents relating to once-daily formulations of doxycycline. The trio of decisions is significant because...more

Preliminary Injunction Precludes Actavis from Pulling Current Version of Namenda off the Market

Yesterday, Judge Robert Sweet granted the New York Attorney General’s request to block Actavis and its New York-based subsidiary Forest Laboratories LLC from pulling Namenda, a dementia drug commonly used to treat...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

Governor’s Council recommending mandatory use of SCRIPTS program

Prescription drug abuse is epidemic across the nation, and South Carolina has not been immune. According to a 2013 report from the State’s Inspector General, South Carolina ranked 23rd per in per capita opioid painkiller...more

Guidance, Not Regulations, Expected for 340B Drug Pricing Program

The long-awaited 340B “mega rule,” promised by the Health Resources and Services Administration (HRSA) to be published last summer, has now been officially nixed. HRSA recently announced that it will not release the...more

PTAB Update -- Hatch-Waxman-Watch Edition

The pharmaceutical industry has been closing watching the proceedings at the Patent Trial and Appeal Board ("PTAB" or "Board") to see if inter partes review ("IPR") will be a viable option for generic drug companies seeking...more

Damages in “Aggravated Breach” Cases

We have written before about the “aggravated breach of contract” theory under N.C. Gen. Stat. § 75-1.1. This theory can make a breach of contract a springboard to treble damages....more

Health Headlines: Also in the News - December 2014

CMS Extends Comment Period for Home Health Conditions of Participation Proposed Rule – As previously reported, on October 9, 2014, CMS published in the Federal Register a Proposed Rule that would revise the home health...more

Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)

Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more

Growth Of The 340b Program: Past Trends, Future Projections

The 340B program provides certain healthcare providers (referred to as “covered entities”) access to deeply discounted pharmaceuticals for outpatient use. Congress created the program in 1992 to help uninsured and vulnerable...more

Refill Reminders and the TCPA

The Telephone Consumer Protection Act (“TCPA”) presents another challenge as health care providers continue to engage patients and seek to meet Meaningful Use reminder objectives. Over the past year, there have been several...more

Ninth and Tenth Circuits Address Removal Under CAFA's "Mass Action" and "State Action" Provisions

In Corber v. Xanodyne Pharmaceuticals, the Ninth Circuit – on rehearing en banc –examined the applicability of the “mass action” provision of CAFA, which provides federal jurisdiction for any civil action in which monetary...more

December 2014: Life Sciences Litigation Update: MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft®...

MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft® Products Liability Litigation. This summer, the U.S. District Court presiding over a multi-district products liability litigation issued a pair of...more

Indiana Appeals Court Upholds Jury Verdict For Pharmacist’s Wrongful Use Of Patient Information

A recent decision by the Court of Appeals of Indiana reinforces the peril faced by health care employers when employees authorized to access confidential information do so for improper purposes. In Walgreen Co. v. Hinchy, the...more

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

FDA Updates Manual on Review of INDs Seeking Exception from Informed Consent for Emergency Research under 21 C.F.R. § 50.24

On November 17, 2014, the U.S. Food and Drug Administration (FDA) published a revised version of its internal review procedures and policies for Investigational New Drug applications (INDs) that implicate the exception to the...more

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which summarizes stakeholder engagements completed in fiscal year...more

Seventh Circuit Limits the Use of the Federal Assignment Law under the False Claims Act

It’s common in the healthcare industry for large insurers to negotiate discounts from pharmacies for prescription drugs. The federal government, the granddaddy of all insurers, does this too, when it negotiates discounts on...more

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

In response to a decision to deny coverage of approximately 1,000 active ingredients that are widely used by compounding pharmacies to create topical treatments, three compounding pharmacies have filed a lawsuit against the...more

Seventh Circuit Holds Pharmacy Billing Medicaid For Drug Prices Above Private Rates Is Not Fraudulent

On November 12, 2014, the Seventh Circuit upheld the dismissal of a False Claims Act action challenging a retail pharmacy chain’s practice of billing Medicaid for the price differential between the higher Medicaid-negotiated...more

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