Michael P. Luongo

All articles by Michael P. Luongo

 

FDA Considers Regulatory Overhaul of Over-the-Counter Drugs

Earlier this year, the FDA announced a review of the system through which it ensures the safety and use of over-the-counter (OTC) drugs, opening the possibility to the most significant reform of OTCs in decades. OTCs are used daily by millions of Americans and generate billions of dollars in revenue each year.  Yet most OTCs are not formally approved by the FDA.  Instead, the FDA publishes regulations, called monographs, that set forth lists of permissible OTC ingredients and labeling claims for therapeutic categories of OTC…  

FDA Track-and-Trace Rules Impose New Regulations on Pharmaceutical Industry

The Drug Quality and Security Act, signed into law in November 2013, includes a “track-and-trace” provision that will reform the manufacture and transport of prescription medications. The track-and-trace legislation is designed to curb counterfeit and contaminated drugs from entering the supply chain. As of January 1, 2015, manufacturers and wholesale distributors will be prohibited from shipping any medication unless it has a transaction history or documentation for each individual unit of a drug. Once the law takes effect, drug manufacturers and re-packagers will have to…  

Court Reverses Preemption of Medical Injury Suit

A California Appellate Court recently ruled in Coleman v. Medtronic, Inc. that state law tort claims against medical device manufacturers are not preempted by federal law. Medtronic manufactures and sells a medical device called Infuse that is used in spinal surgery. The U.S. Food and Drug Administration granted premarket approval of Infuse for use in certain types of spinal surgery where the incision is made on a patient’s abdomen, but did not approve the device for spinal surgeries where the incision is made on a…  

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.…  

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…  

Nutritional Supplement Health Claims and False Advertising Liability

In 2009, consumers David Johns and Marc Bordman filed a class action suit against Bayer Corporation and Bayer Healthcare in the Southern District Court of California for allegedly making false and deceptive claims about the nutritional supplement “One A Day Men’s.”  According to the Complaint, Bayer marketed the supplement, and its key ingredient selenium, as supporting prostate health, despite mounting scientific evidence that the supplement does not reduce the incidence of prostate cancer.  The plaintiffs claimed these statements constituted deceptive advertising in violation…  

Warning: Liability For Deficient Labels May Extend Beyond Your Own Products

Generally, the duty of care of a manufacturer for product liability is limited to consumers who use the manufacturer’s product.  This duty is based on the theory of strict liability in torts, which requires a plaintiff to prove that the defendant actually manufactured the injurious product.  However, in the pharmaceutical industry, courts are beginning to apply negligence principles to extend liability to persons who did not use the manufacturer’s product. In the 2009 case of Conte v. Wyeth, Inc., the California Court of Appeals…