Prescription Drugs

News & Analysis as of

Telemedicine Providers Need to Keep Up with State Laws

Tech-savvy health care providers and tech-savvy patients in California can be grateful for California’s policies regarding telehealth practices. Consider the turmoil in Texas: telehealth practitioners who want to treat...more

Some Plaintiffs Just Have No Class

We’ve been thinking a lot about class actions lately. One reason is that the Rule 23 Subcommittee of the (federal) Advisory Committee on Civil Rules just came out with a “sketch” of possible amendments – and from the defense...more

What are the 2 leading causes of medication errors?

Every individual reacts to medication differently, as many a medical malpractice lawyer in Illinois knows. Discovering the appropriate drug and dosage for any given health issue is a process that requires careful attention by...more

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

Washington Healthcare Update

This Week: Montana Legislature Reverses Course, Endorses Medicaid Expansion... Final 2016 Medicare Advantage and Part D Rate Announcement and Call Letter... Upcoming: Energy and Commerce Subcommittee Hearing on Post-Acute...more

Dazed and Confused: The TCPA’s Health Care-Related Call Exemption

In early 2012, Robert Kolinek received an automated call on his cell phone from Walgreens reminding him to refill an eligible prescription. Despite the fact that even the plaintiff’s lawyers ultimately acknowledged that these...more

What Oklahoma's amended Uniform Controlled Dangerous Substances Act means for prescribing medical providers

Last Friday, Oklahoma Governor Fallin signed House Bill 1948 into law, amending the Uniform Controlled Dangerous Substances Act. The new law, which goes into effect on November 1, 2015, enhances access to Oklahoma’s...more

Court Declines to Certify Class Alleging Off-Label Marketing of Cancer Drug

Third party payors (“TPPs”) responsible for paying the costs of prescriptions for their beneficiaries sued Cephalon, Inc., alleging that it engaged in unlawful off-label marketing of Actiq, a drug approved to manage...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

District Court Holds Individual Issues of Fact Predominate in Unjust Enrichment Class Action

The US District Court for the Eastern District of Pennsylvania recently denied class certification to a proposed class of third-party payors of prescription drugs. The plaintiffs brought a class action for unjust enrichment,...more

Product Liability Update - April 2015

In This Issue: - First Circuit Holds State Law Claims Against Drug Manufacturer for Allegedly Misleading Efficacy Representations in FDA-Approved Label Preempted by Food, Drug & Cosmetic Act Because Plaintiffs’...more

HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More...more

Congress Holds Hearing on 340B Program

The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program to understand how it impacts patients,...more

Breaking News – Post-2002 NJ Accutane Labels Adequate As A Matter Of Law

This just in – after many years of litigation, the post April 10, 2002 warnings on Accutane were determined to be adequate as a matter of law by the New Jersey judge tasked with overseeing this mass tort....more

Walgreen Settles Prescription Robocall Suit for $11 million

Walgreen Co. this week settled a putative class action law suit alleging that it violated the Telephone Consumer Protection Act (TCPA) for $11 million. The plaintiffs alleged that Walgreen violated TCPA when it placed...more

Important Recommendations from the MedPAC March Report to Congress, Part One

Each March, the Medicare Payment Advisory Commission (“MedPAC” or the “Commission”) is tasked with reporting to Congress on the current state of the Medicare fee-for-service (“FFS”) payment systems, the Medicare Advantage...more

Result-Driven Affirmance of Birth Defect Verdict

We have said it before – birth defect cases are hard. Juries and judges are sympathetic where the individual whose health is at issue had no say in the matter. We have also said that we do not like it when judges frame the...more

Health Alert (Australia) - March 30, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 25 March 2015 - Smythe v Burgman (No 2) [2015] NSWSC 150 - The New South Wales Supreme Court has held...more

Brick By Brick, The Learned Intermediary Doctrine Paves A West Virginia Path

Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine. In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23,...more

Practical Steps for Building a Strong Life Science Patent Portfolio Worth Billions of Dollars

In the last four years, several companies with antiviral drug programs, including Alios BioPharma, Idenix, Inhibitex, InterMune and Pharmasset, have been acquired by large pharmaceutical companies (‘‘big pharma’’). One of the...more

Congressional Health Policy Hearings

Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program....more

340B Drug Pricing Program Questioned by Congressional Subcommittee

In This Issue: - Recent Developments for Multiemployer Pension Plans - Witness Statements - Questions & Answers - For More Information - Excerpt from Recent Developments for Multiemployer...more

Accidents Caused by Driving on Prescription Medication

Many of us, for one reason or another, end up taking prescription medications at some point in time. Unfortunately, fewer drivers consider how prescription medications affects their ability to safely drive. New research...more

Xarelto Cases Present Several Common Issues

In July 2011, the Federal Drug Administration (FDA) approved Xarelto, an oral anticoagulant prescribed for prevention of deep vein thrombosis, pulmonary embolism, and strokes in patients with atrial fibrillation. Based on...more

Washington Healthcare Update

This Week: Bipartisan, Bicameral Permanent SGR Fix Introduced... House Budget Committee Advances FY2016 Budget Proposal... National Coverage Determinations Proposed for Removal... HHS Releases Proposed Rules on EHR Incentive...more

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