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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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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Alabama Supreme Court, Latest to Consider Liability for Generic Drugs

The relationship between brand name and generic drugs on the market continues to fuel litigation battles across the country.  On June 24, we reported that the United States Supreme Court held that state-law tort claims against generic drug manufacturers are preempted under the Hatch-Waxman Amendments to the federal Food, Drug and Cosmetic Act. Our June report is available click here.  In July, we reported that the Eastern District of Kentucky dismissed claims against a brand name manufacturer for warnings contained on generic versions of…
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Supreme Court Holds that State Law Tort Claims Regarding Labeling of Generic Drugs are Preempted

In Mutual Pharmaceutical Co. v. Barlett, plaintiff Karen Bartlett alleged that she took Mutual’s generical non-steroidal anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it for shoulder pain.  She suffered a rare hypersensitivity reaction three weeks after she started taking and she was left severely disfigured with burn-like lesions over two-thirds of her body.  The plaintiff’s action was based upon a design defect theory after her failure-to-warn claims were dismissed prior to trial and the district court rejected the defendant’s preemption defense. A…
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New Jersey Mass Tort Court Rejects Brand-Name Liability for Generic Drugs

In a long-awaited and important decision issued on June 26, 2012, New Jersey Superior Court Judge Carol E. Higbee joined dozens of other courts in dismissing pharmaceutical product liability claims against brand-name companies in cases in which plaintiffs had taken generic versions of the drug in question.  Judge Higbee is one of three judges presiding over cases in New Jersey’s Mass Tort Program, in which there are pending approximately one thousand cases where plaintiffs claim they were injured by ingestion of generic versions of the…
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New Jersey Court Backs Mensing Preemption

Several weeks ago, we discussed the issue of Mensing generic drug preemption and the anticipated decision from Judge Carol Higbee, who is presiding over the consolidated Reglan and metoclopramide litigation pending in Atlantic County.  As readers may recall, generic preemption is a battleground issue now in pharmaceutical litigation, as generic pharmaceutical defendants seek to take full advantage of the U.S. Supreme Court’s favorable ruling last year in Mensing, and plaintiffs’ attorneys try creatively to limit and narrow the scope of Mensing preemption. Judge Higbee…
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Mensing Update

Recently, we posted about the awaited decision from Judge Carol Higbee in response to the generic defendants’ motion to dismiss the plaintiffs’ claims in the consolidated litigation involving metoclopramide on the basis of the U.S. Supreme Court’s ruling last year in Pliva v. Mensing.  While courts across the country continue to take up and decide this issue – including a very favorable opinion from Judge Danny Reeves in the multi-district litigation involving propoxyphene – generic pharmaceutical manufacturers continue to await a ruling from Judge Higbee. …
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Mensing Generic Preemption Decision Awaited in New Jersey

In 2011, the US Supreme Court’s landmark decision in PLIVA v. Mensing altered the world of pharmaceutical product liability litigation, holding that claims challenging the adequacy of warnings provided by generic drug makers were preempted.  The basic underpinning of the Supreme Court’s opinion was that, under federal law, a generic pharmaceutical had to be the same — and provide the same warnings — as the branded drug, and that any deviation by a generic manufacturer would run afoul of federal law.  Mensing involved claims against…
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