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Documents on Products Liability, Pharmaceuticals, Internet & E-Commerce

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HTMLActos Decision Statement: $9 Billion Decision on Eli Lilly and Takeda Pharmaceuticals
Motley Rice;
Legal Alert/Article
April 11, 2014, previously published on April 8, 2014
On Monday, April 7, a federal court jury in Louisiana decided that Takeda Pharmaceuticals and Eli Lilly hid the risks of bladder cancer from the diabetes drug, Actos. Takeda was ordered to pay $6 billion and Eli Lilly was ordered to pay $3 billion.


HTMLDrager v. PLIVA USA, Inc.: Fourth Circuit Explicitly Rejects Stop Selling Attempt to Avoid Generic Preemption
Angela M. Higgins; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
March 24, 2014, previously published on February 19, 2014
The Fourth Circuit has recently weighed in on a generic drug maker’s duties in a post-Bartlett and PLIVA v. Mensing world. In Drager v. PLIVA USA, Inc., 2014 U.S. App. LEXIS 1696, 2014 WL 292700 (4th Cir. Jan. 28, 2014), plaintiff conceded that his failure to warn claims against the generic...


HTMLGeneric Drug Labeling Preemption: The Flavor of the Day
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
March 12, 2014, previously published on March 10, 2014
It was only about a year ago when the topic du jour was generic drug labeling and whether federal law - the FDC Act and FDA’s implementing regulations - preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug...


HTMLPennsylvania Supreme Court Rules on Whether Drug Company Has Expanded Duties
Henry F. Canelo, Kathleen D. Wilkinson; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
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...


HTMLLawmakers Express “Grave Concerns” with Generic Drug Labeling Proposal; Demand Answers from FDA
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
January 28, 2014, previously published on January 22, 2014
In 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...


HTMLA Short-Lived Victory for Generic Manufacturers? - Part 2
Peter S. Reichertz; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 6, 2014, previously published on December 30, 2013
In 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...


HTMLThe Eighth Circuit Paves the Way for More Removals under CAFA's "Mass Action" Provision
Laura J. Bettenhausen; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
December 10, 2013, previously published on December 4, 2013
The 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...


HTMLProposed 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.;
Legal Alert/Article
November 21, 2013, previously published on November 15, 2013
On 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...


HTMLFDA Proposes New Change to Generic Labeling Rule
Peter C. Neger; Bingham McCutchen LLP;
Legal Alert/Article
November 20, 2013, previously published on November 13, 2013
The 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...


HTMLFDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do
Duane Morris LLP;
Legal Alert/Article
November 15, 2013, previously published on November 12, 2013
On 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...


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