FDA Rule Proposal Could Lead to Liability for Generic Drug Manufacturers

The U.S. Food and Drug Administration (FDA) is proposing new rule changes that would permit generic drug manufacturers to amend drug warning labels when they receive new information related to drug safety; irrespective of whether the revised labeling differs from the brand name manufacturer. The proposed rules further provide that the generic manufacturer would be required to submit the labeling changes along with the data supporting the change to the FDA, which would review the request and post the data in a public web page.…
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First New York Court Rejects Controversial Drug Developer Liability Rule

In a controversial 2008 decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), a California Court of Appeals held defendant drug developer, Wyeth, Inc., liable for inadequate warnings in connection with the plaintiff’s use of a competitor’s generic version of the gastrointestinal reflux drug Reglan. The court in Conte held “the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product,…
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First New York Court Rejects Controversial Drug Developer Liability Rule

In a controversial 2008 decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), a California Court of Appeals held defendant drug developer, Wyeth, Inc., liable for inadequate warnings in connection with the plaintiff’s use of a competitor’s generic version of the gastrointestinal reflux drug Reglan. The court in Conte held “the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product,…
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Consumer Fraud Case Moves Forward Against Non-Purchased Product

The federal district court of the Southern District of California recently added to the growing body of case law on class action claims based on false advertising, breach of warranty and consumer protection statutes.  In Dorfman v. Nutramax, the plaintiff sought to be the putative class member and alleged that Nutramax’s statement that its’ Cosamin DS and Cosamin ASU (glucosamine hydrochloride with chondroitin sulfate) was: “the ONLY brand proven effective in controlled, published U.S. clinical studies to reduce joint pain,” was false and misleading. …
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New Jersey Supreme Court Rejects Federal Approach, Refuses to Consolidate Tylenol Liver Cases in New Jersey

On August 16, 2013 the New Jersey Supreme Court denied a request to consolidate all pending Tylenol liver injury lawsuits in the state court system before a single judge, finding that the cases were inappropriate for centralized management as “Multicounty Litigation”.  Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation established coordinated proceedings for Tylenol litigation, assigning Judge Lawrence Stengel of the United States District Court, Eastern District of Pennsylvania, to supervise all pretrial proceedings. Approximately 14 lawsuits have been filed in New Jersey…
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Pennsylvania – Is it Shifting the Burden in Product Liability Suits?

The Pennsylvania Supreme Court may soon turn the burden in product liability suits on its head.  Historically, Pennsylvania has applied the Second Restatement of Torts.  The Second Restatement focuses on the consumer’s expectations and only requires that he show at the bare minimum: that the product was defective when used for its intended purpose and that an alternative design exists.  Reasonableness and feasibility are not factors in the analysis. In Tincher v. Omega Flex, Inc., the Court is set to decide whether the Third…
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