LexisNexis® Legal Newsroom
Supreme Court: Generic Drug Makers Not Liable For Warnings

WASHINGTON, D.C. - (AP) The Supreme Court on Thursday ruled that makers of generic drugs cannot be sued for failing to warn consumers of the possible side effects of their products if they copy the exact warnings on the brand-name equivalents of the medicines. The majority opinion acknowledged that the...

How Washington State Is Beating the High Cost of Prescription Drugs

Washington State Combines Preferred Drug List and Volume Buying By John Stahl, Esq. Like the weather, increasingly high costs of the deluge of prescription drugs prompt complaints by everyone who provides workers’ compensation coverage and benefits. A November 16, 2011 session at the...

Duane Morris Alert: Supreme Court Orders 9th Circuit to Revisit Preemption Ruling Against Generic OTC Ibuprofen Manufacturer

During its October 28, 2011, conference, the U.S. Supreme Court remanded to the Ninth Circuit its ruling denying federal preemption to a generic manufacturer of ibuprofen to be reassessed in light of the Court's Mensing decision last term. The remand potentially presents an opportunity for the Supreme...

Medications We Frequently See in Workers’ Comp Physician Reports

By Robert G. Rassp, Esq. The following chart lists the brand or common and chemical names of drugs we regularly see in our cases embedded in medical-legal reports, treating physician reports and subpoenaed medical records. Some physicians randomly use the brand names, and others use the chemical name...

Medications We Frequently See in Workers’ Comp Physician Reports

By Robert G. Rassp, Esq. The following chart lists the brand or common and chemical names of drugs we regularly see in our cases embedded in medical-legal reports, treating physician reports and subpoenaed medical records. Some physicians randomly use the brand names, and others use the chemical name...

Brinks Hofer Gilson & Lione: Supreme Court Issues Key Ruling Regarding Pharmaceutical Litigation

On April 17, 2012, the Supreme Court issued a unanimous decision favorable to generic pharmaceutical companies in Caraco Pharmaceuticals, Ltd. v. Novo Nordisk , No. 10-844 [ enhanced version available to lexis.com subscribers ]. The Court held that a generic pharmaceutical company may pursue a counterclaim...

Duane Morris LLP: Federal Circuit Addresses Infringement of Method-of-Use Patents by Generics in Yasmin® Case

The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz, Inc. , Nos. 2011-1143, -1228 (YASMIN®), affirmed a district court's holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of an...

Duane Morris LLP: U.S. Supreme Court Restores Generic Pharma's Ability to Challenge Orange Book Use Code Information

The U.S. Supreme Court's unanimous ruling on April 17, 2012, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S was a resounding win for both Caraco and the generic pharmaceutical industry as a whole. Specifically, the Court held that a generic manufacturer may employ the counterclaim...

Sheppard Mullin Richter & Hampton LLP: Section viii Statements -- Still A Viable Route to Generic Approval Where the Application Is Not Claimed in an Orange Book Patent

By Nagendra Setty and Mark E. McGrath In its recent decision in AstraZeneca Pharmaceuticals LP v. Apotex Corp ., Nos. 2011-1182 - 2011-1190 (Fed. Cir. Feb. 9, 2012) (hereinafter the " AstraZeneca Decision") (Rader*, Bryson & Linn), the Federal Circuit affirmed a District of Delaware...

Generics May Seek Correction Of Overly Broad Use Codes

In Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S , 132 S. Ct. 1670 (April 17, 2012) [ enhanced version available to lexis.com subscribers ], the Supreme Court unanimously held that a generic drug company may use a counterclaim provision of the Hatch-Waxman Act to seek correction of an overly broad use...

Trips and Bits: An Essay on Compulsory Licenses, Expropriation, and International Arbitration

By Peter B. Rutledge * * Professor of Law, University of Georgia School of Law. Excerpt from Trips and Bits: An Essay on Compulsory Licenses, Expropriation, and International Arbitration , 13 N.C. J.L. & Tech. On. 149 (June, 2012) In the early 1980s, the World Bank forecast that more than 1...

Supreme Court confirms that generic drug manufacturers can challenge brand-name use-code descriptions in patent litigation

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S 566 U.S. ___, 132 S. Ct. 1670 (Apr. 17, 2012) By Nagendra Setty and Bill Blonigan The Hatch-Waxman Act Congress designed the Hatch-Waxman Act (codified at 21 U.S.C. § 355 (b), (j), (l) and 35 U.S.C. §§ 156 , 271 , and 282...

Brinks Hofer Gilson & Lione: Third Circuit Issues Key Ruling Regarding "Reverse Payment" Settlement Agreements

On July 16, 2012, the Third Circuit issued a key ruling in In re K-Dur Antitrust Litigation [ enhanced version available to lexis.com subscribers ] regarding so-called "reverse payment" settlement agreements, which are not uncommon in the pharmaceutical industry. In these types of agreements...

Sunstein Kann Murphy & Timbers LLP: Generic Drugmakers Gain Safe Harbor Protection For Compliance Activities That Occur After FDA Approval

By Isabelle Blundell , a member of our Life Sciences Practice Group E ver since the Hatch-Waxman Act became law in 1984, generic-drug manufacturers have had increasing success in lowering barriers to entry in the marketplace. The Act created a streamlined process, the Abbreviated New Drug Application...

5th Circuit: Mensing Doesn't Make Brand-Name Defendants Liable For Injuries

NEW ORLEANS - (Mealey's) The U.S. Supreme Court's ruling that preempts failure-to-warn claims involving generic drugs does not change Louisiana state law and make manufacturers of brand-name versions liable, a Fifth Circuit U.S. Court of Appeals panel ruled Oct. 25 ( Julie Demahy v. Schwarz Pharma...

Obamacare’s Impact on Workers’ Compensation Prescription Drug Costs: Experts Predict Greater Drug Utilization and Offer Solutions

By John Stahl, Esq. The near certainty that provisions in the Affordable Care Act (ACA), a.k.a. Obamacare, will contribute to the increasing tendency to prescribe workers’ compensation claimants opioids prompted Risk & Insurance to conduct an October 23, 2012 webinar entitled “Affordable...

High Court Will Consider Whether Reverse-Payment Settlements Are Anti-Competitive

WASHINGTON, D.C. — (Mealey's) The Supreme Court on Dec. 7 granted the Federal Trade Commission’s petition for a writ of certiorari seeking consideration of whether reverse-payment settlements of patent litigation between the holder of a drug patent and generic manufacturers of the drug...

Alabama High Court Says Wyeth Can Be Liable For Injuries Caused By Generic Drug

MONTGOMERY, Ala. - (Mealey's) An 8-1 majority of the Alabama Supreme Court on Jan. 11 ruled that Wyeth can be held liable for failing to warn doctors about the risk of long-term use of Reglan if a patient was injured by metoclopramide, the generic version of the drug made by other manufacturers ...

U.S. High Court Allows Solicitor General To Argue For Drug Design Defect Preemption

WASHINGTON, D.C. - (Mealey's) The U.S. solicitor general will be allowed to argue March 19 that design defect claims involving generic drugs are preempted by federal law, the U.S. Supreme Court decided March 4 in granting the federal government's motion to participate in oral arguments ( Mutual...

National and State-by-State Workers' Comp News Roundup Powered by Larson's (3/11/2013)

Sign up here for our free workers' compensation enewsletters (National or California Edition) to receive weekly news items. Be sure to select the enewsletter of your choice. NATIONAL NEWS: New Survey on WC Bill Review Shows More Than $2B in Unwarranted Medical Payments . NAIC Posts 2012...

National and State-by-State Workers' Comp News Roundup Powered by Larson's (4/1/2013)

Sign up here for our free workers' compensation enewsletters (National or California Edition) to receive weekly news items. Be sure to select the enewsletter of your choice. NATIONAL NEWS: 7th Circuit Rejects Liberty Mutual’s Challenge to AIG Class Action Settlement Order . NAIC Ranks...

Generic Drug Pricing Transparency: Kentucky, North Dakota and Arkansas Fight the Good Fight

At the heart of the health care crisis in this country are rising drug costs. How do we control drug costs, particularly generic drugs that account for 80 percent of prescriptions? This year Kentucky became the first state in the nation to enact a generic drug pricing transparency bill that provides...

Alabama High Court Again Says Brand-Name Drug Makers Liable In Generic Injury Case

MONTGOMERY, Ala. —(Mealey’s) A brand-name drug manufacturer may be liable under Alabama law for fraud or misrepresentation in a drug label used by generic drug makers, the Alabama Supreme Court held Aug. 15 after reconsidering its 2013 decision in a Reglan/metoclopramide case ( Wyeth, Inc...

Failure-To-Update Claims For Generic Drugs Not Preempted In New Jersey, Court Says

TRENTON, N.J. — (Mealey’s) A New Jersey state appeals court panel on Nov. 12 affirmed a lower court ruling that generic drug manufacturers can be sued for failure to update their labels with warnings added to the labels of the predecessor drug ( In Re: Reglan Litigation , No. A-2014-13T4...

Thomas A. Robinson on Prescription Drugs and Workers’ Compensation

Last week LexisNexis published an Emerging Issues Analysis article on prescription drugs and workers’ compensation written by Thomas A. Robinson, the co-author of Larson’s Workers’ Compensation Law . The article examines opioid use, medical marijuana, physician dispensing, generic drugs...