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Documents on Products Liability, Pharmaceuticals, Internet & E-Commerce
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|Pennsylvania Supreme Court Rules on Whether Drug Company Has Expanded Duties|
Henry F. Canelo, Kathleen D. Wilkinson; Wilson Elser Moskowitz Edelman & Dicker LLP;
February 19, 2014, previously published on February 10, 2014 On January 21, 2014, the Pennsylvania Supreme Court held in a 4-2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face negligence claims where the drug manufacturer introduced a drug into the...
|Lawmakers Express “Grave Concerns” with Generic Drug Labeling Proposal; Demand Answers from FDA|
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
January 28, 2014, previously published on January 22, 2014In a Januarry 22, 2014 letter to FDA Commissioner Margaret Hamburg, M.D. signed by 28 members of Congress, lawmakers express “grave concerns” about FDA’s November 2013 proposed rule to allow generic drug manufacturers to independently update product labeling (with respect to...
|A Short-Lived Victory for Generic Manufacturers? - Part 2|
Peter S. Reichertz; Sheppard, Mullin, Richter & Hampton LLP;
January 6, 2014, previously published on December 30, 2013In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) might be...
|The Eighth Circuit Paves the Way for More Removals under CAFA's "Mass Action" Provision|
Laura J. Bettenhausen; Baker Sterchi Cowden & Rice, L.L.C.;
December 10, 2013, previously published on December 4, 2013The Eighth Circuit’s recent opinion in Atwell v. Boston Scientific Corporation is bound to have an impact on mass action litigation nationwide. Atwell involves the interpretation of the Class Action Fairness Act of 2005 (“CAFA”), which provides for the removal from state to...
|Proposed FDA Rule Effectively Abrogates Pliva v. Mensing and Mutual Pharmaceutical v. Bartlett and Opens Up Liability for Generic Drug Manufacturers|
Whitney Deacon Lloyd; Baker Sterchi Cowden & Rice, L.L.C.;
November 21, 2013, previously published on November 15, 2013On November 13, 2013, the U.S. Food and Drug Administration proposed a new rule allowing generic drug manufacturers to independently change their product’s labeling to reflect newly discovered safety information. The FDA’s proposed rule allows generic manufacturers the ability to...
|FDA Proposes New Change to Generic Labeling Rule|
Peter C. Neger; Bingham McCutchen LLP;
November 20, 2013, previously published on November 13, 2013The U.S. Food and Drug Administration announced last week a proposed major change to its regulations governing the labeling of generic drugs, which represent more than 80% of the drugs prescribed to patients in the United States. The proposed rule, which was published in the Federal Register on...
|FDA Proposes a Rule that Would Undercut Generic Drug Preemption|
Jennifer M. Thomas; Hyman, Phelps & McNamara, P.C.;
November 15, 2013, previously published on November 12, 2013The generic drug industry has waited with bated breath since, FDA signaled that it was “considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.” See Amicus Brief of the United States at...
|FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do|
Duane Morris LLP;
November 15, 2013, previously published on November 12, 2013On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated New Drug Applications (ANDAs) to add warnings, precautions, adverse...
|Maryland District Court Finds Lack of Federal Question Jurisdiction, Under 28 U.S.C. § 1331, and Subject Matter Jurisdiction, Under 28 U.S.C. § 1332, in Products Liability Case|
Jhanelle A. Graham; Semmes Bowen Semmes A Professional Corporation;
November 12, 2013, previously published on November 2013In Karen Larson v. Abbott Laboratories, et al., Karen Larson, as guardian for her brother, Kraig Larson, sued several defendants in the Circuit Court for Baltimore City, alleging that Mr. Larson suffered severe and permanent brain damage proximately caused by his use of the prescription drug...
|Sanofi Sues FDA to Prevent Disclosure of OTC NASACORT Labeling Before Product Launch; Claims FOIA Exemption 4|
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
November 8, 2013, previously published on November 2013Earlier this week, sanofi-aventis U.S., LLC (“Sanofi”) filed a Complaint in the U.S. District Court for the District of Columbia against FDA in what appears to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of the labeling approved on...