Category Archives: Pharmaceutical/Medical Device/Biotechnology

Alabama Supreme Court Decision Lends Support to Plaintiffs’ Innovator Liability Theory

It is a bedrock principle of the American legal system that a product manufacturer is typically not held responsible for an injury to a plaintiff when that manufacturer’s product was not used.  In other words, if a plaintiff was injured while using Product A, the manufacturer of Product B cannot be responsible. This common-sense rule has been challenged over the years by various plaintiffs’ theories, and one of those efforts – the so-called “innovator liability” theory – recently gained a bit more traction in a…

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Defendants in Mass Tort Pelvic Mesh Lawsuits May Now Succeed With Removal to Federal Court – Non-Diverse Defendant Wins Dismissal

In a significant win for Secant Medical LLC, (Secant), Judge Arnold L. New of the Court of Common Pleas of Philadelphia County granted its motion to dismiss mass tort pelvic mesh personal injury claims in a decision dated August 22, 2014.  The court held that under the Biomedical Access Assurance Act (BAAA), Secant is not a manufacturer or seller of the pelvic mesh. Secant, a Pennsylvania company, was undoubtedly named to defeat diversity jurisdiction in an effort by plaintiffs to stay in state court in…

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City of Chicago Files Suit Against Prescription Painkiller Manufacturers

Earlier this week, the City of Chicago filed a lawsuit against five major producers of pharmaceutical products, alleging that the manufacturers concealed the risks associated with certain types of painkillers, such as Oxycontin and Percocet, as well as a host of generics. According to the city, the manufacturers launched a campaign in the 1990s to expand the market for prescription opioids by exaggerating the drugs’ effectiveness while downplaying their risk, even though the companies supposedly knew that the drugs were addictive and could cause long-term…

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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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Keep Us Posted: FDA Updates Rules On Changes To Medical Devices

The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. Under the FDA’s updated guidelines, manufacturers are to disclose in their annual report all changes made to either the manufacturing or design of the device and the underlying rationale and scientific basis for the change. For more significant and…

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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…

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Drug Quality and Security Act

In October of 2012, a meningitis outbreak that caused the death of sixty-four people was traced to tainted steroids purchased from a Compounding Center in New England.  In response to this outbreak, last November President Barack Obama signed the Drug Quality and Security Act into law, which overhauls the FDA’s regulation of Compounding Pharmacies by establishing a system to trace the supply chain of prescription drugs. (See the bill here). Furthermore, under this bill, the FDA is given more authority to regulate and monitor…

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