Tag Archives: FDA

Pharma Opioid Suits Casting a Wider Net

Under both federal and state law, it is unlawful to advertise if the advertisement tends to mislead or deceive. States have enacted consumer protection laws to enforce and regulate such deceptive practices. In New York, under General Business Law §349, deceptive acts or practices in the conduct of any business, trade, or commerce, or in the furnishing of any service in the state, is declared unlawful. Over the years, the Federal Trade Commission has prosecuted many businesses accused of engaging in false and deceptive advertising.…

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Third Circuit Adopts Heightened Materiality Standard under False Claims Act

On May 1, 2017, the Third Circuit issued a decision in United States ex rel. Petratos v. Genentech Inc., 855 F.3d 481 (3d Cir. 2017) narrowing the ability of qui tam relators to show materiality under the False Claims Act (FCA). In essence, the court held that to be material, a misrepresentation or omission by a drug company must relate to the United States’ decision to pay a claim, not a doctor’s decision to prescribe a drug that would lead to a reimbursement claim…

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FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting…

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FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the…

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District Court Judge Denies Manufacturer of OTC Pain Reliever Summary Judgment Based on Preemption

Judge Lawrence Stengel of the United States District Court for the Eastern District of Pennsylvania denied summary judgment to the manufacturer of an over-the-counter pain reliever. The manufacturer had sought to dismiss the plaintiff’s fraud and fraudulent misrepresentation claims as preempted by federal law. The Food and Drug Administration (FDA) regulates how OTC drugs should be labeled and sold. The Federal Trade Commission regulates whether an OTC drugs advertising is misleading. In the case before Judge Stengel, the OTC manufacturer argued that the fraud claims…

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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…

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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…

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FDA Cracks Down on Promotional Claims Made on Facebook

In this day and age nearly everyone has a Facebook page, including companies which often use Facebook pages to promote their products and services. Given that Facebook is quite an informal marketing medium, companies may not always scrutinize everything they post as highly as they would more organized or targeted media. But that doesn’t mean the Food and Drug Administration isn’t scrutinizing every wall post and status update. On March 12, 2014, the FDA posted an untitled letter to a Switzerland-based international drug maker, noting…

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Pennsylvania Supreme Court Holds Plaintiffs May Assert Negligent Design Claims Against Drug Companies

The Pennsylvania Supreme Court in Lance v. Wyeth (2014 Pa.LEXIS 205) recently ruled that pharmaceutical companies can be held liable for negligent design, testing, marketing, and distribution of drugs regulated by the FDA. This decision alters the landscape of Pennsylvania law because pharmaceutical companies previously succeeded in having similar claims dismissed based upon the learned intermediary doctrine. Under this doctrine, the manufacturer of prescription medications discharges its duty to warn users of the risks associated with its products by warning the prescribing physician of…

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