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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Dietary Supplement Company Slammed By FDA For Failure To Comply With CGMP

Brower Enterprises was recently hit with a warning letter from the U.S. Food and Drug Administration (FDA) that excoriates them for violating Current Good Manufacturing Practices (CGMPs). The violation of CGMPs caused a number of Brower’s products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). Examples of violations of CGMPs included keeping written procedures for quality control operations, holding and distributing operations, returned dietary supplements, and product complaints. Additionally, Brower failed to comply with CGMPs because it…
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FDA to Consider Permitting Dosage Information on OTC Children’s Fever/Pain Remedy Products

The Consumer Healthcare Products Association (“CHPA”) has petitioned the FDA to allow dosing information to be provided on fever/pain relief drug labels. The CHPA is a trade group representing OTC manufacturers of acetaminophen products. Any parent with young children knows that OTC fever/pain relief products currently do not contain dosing information for children under two years of age. Although parents may have obtained the proper dosing instructions from their child’s pediatrician, recalling and/or finding that information (especially in the middle of the night) can be…
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FDA Gets Aggressive With Companies Over Marketing of Alleged Diabetes Treatments

The U.S. Food and Drug Administration (FDA) has started its campaign to stop sales of multiple products advertised and labeled as diabetes treatments. According to data from 2011, over 25 million people in the U.S. have diabetes and perhaps more alarming is that 79 million people have prediabetes. Clearly there is a market for diabetes remedies. According to the FDA, companies are taking advantage of consumers seeking diabetes treatments by marketing products that claim to prevent, treat, or relieve symptoms of diabetes, but the FDA…
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Natural Product Claims Lead to Liability

On Tuesday, May 7, 2013, a proposed class action lawsuit was filed in the United States District Court for the Southern District of New York on behalf of plaintiff, Michael Goldenberg, and other similarly situated consumers, against Johnson & Johnson Consumer Companies, Inc. (“J&J”), alleging the consumer manufacturer mislead consumers about the nature of the ingredients in its personal care products sold under the Aveeno brand name (see, Goldenberg v. Johnson & Johnson, 7:13-cv-03073).  According to the Complaint, these products were marketed with…
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GAO: FDA Needs to Get to Work Tracking Adverse Events Related to Dietary Supplements

Senator Durbin (D-Illinois) and Representative Waxman (D-California) requested late last year that the Government Accountability Office (GAO) examine steps taken by the Food and Drug Administration (FDA) to enhance the regulatory oversight of the multibillion dollar dietary supplements market.  The GAO undertook the review and recently issues its findings.  The full report can be found here.  Specifically, the GAO was asked to examine the FDA Adverse Event Reporting System (FAERS) in overseeing dietary supplements.  The GAO found that from 2008-2011, the FDA received 6,307 …
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Labeling Inequality: FDA May Attempt To Overrule Mensing on Its Own

The Food and Drug Administration has indicated that it may allow generic drug manufacturers to alter their labeling.  The motivation for this change appears to be to address perceived inequalities stemming from the United States Supreme Court’s decision in Pilva v. Mensing, 131 S. Ct. 2567 (2011). In the Mensing decision, the Supreme Court held that patients who claim injury from generic drugs cannot sue the manufacturer for failure to warn because its labeling must match the labeling of the brand-name version of the…
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Stay Where You Are: Ruling in Eastern District of New York Keeps State-Law Claims against Generic Drug Manufacturers in Federal Court

In a decision that was seen as a victory for pharmaceutical companies, U.S. District Court Judge William Kuntz denied a remand motion made by a group of plaintiffs suing a number of manufacturers of generic anti-seizure drugs.  The plaintiffs in Bowdrie, et al v. Sun Pharmaceutical Industries, Ltd., et al, 1:12-CV-00853 in the U.S. District Court for the Eastern District of New York, claim that they suffered tissue damage from taking generic anti-seizure drugs manufactured by Sun Pharmaceutical Industries, Inc., Taro Pharmaceuticals USA
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Energy Drinks Take Center Stage: Risk Of Litigation For Beverage Manufacturers Heightens Under Scrutiny

Energy drinks are again under the legal microscope.  On the heels of the highly publicized wrongful death suit filed against energy drink titan Monster, involving the death of 14-year old Anais Fournier, a class action was launched in Florida against Vital Pharmaceutical Inc., manufacturer of the energy supplement drink, Redline.  In recent years the caffeine content of energy drinks has caused many to scrutinize the potential affiliated health risks associated with consuming high quantities of caffeine and the necessity for heightened FDA regulations.  Under…
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