Archives: Product Liability

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Insurance Coverage Considerations for Alleged Mislabeling of Herbal and Dietary Supplements

In the wake of the New York Attorney General's recent enforcement actions against four major retailers who allegedly sold herbal supplements that did not contain labeled ingredients or contained ingredients not explicitly identified on the labels, companies throughout the supply chain should consider examining their insurance policies to see whether or not they are sufficiently covered in the event of an investigation, enforcement action and/or litigation. Types of insurance policies that may provide coverage for affected companies are commercial general liability (CGL), directors and officers liability (D&O), errors and omissions liability (E&O), and product recall.… Continue Reading

3D Printing Raises Novel Questions About Potential Product Liability

Over on the Drug & Device Law blog, Reed Smith partner Jim Beck (aka "Bexis") offers his thoughts on the possible product liability implications of printing 3D medical devices. Specifically, Jim examines the question of what party (or parties) would be held liable as the manufacturer in a product liability case involving 3D printing. There are uncertainties surrounding each of the three primary parties who may be considered for liability: the hospital that owns the 3D printer used to produce medical devices; the manufacturer of the 3D printer; or the designer of the software used by the 3D printer to create the products. Jim's post discusses the current issues around naming each of those parties as the manufacturer, and concludes that - at least for the time being - 3D printing presents an unusual situation in which it is feasible that no entity qualifies as a "manufacturer" under the Restatements for strict liability. Additional legal issues like this will likely emerge as 3D printing's popularity continues to increase.… Continue Reading

A Call for Explicit Requirement of Ascertainability in Class Actions

Over on the Drug & Device Law blog, Reed Smith partner Jim Beck (aka “Bexis”) makes a case for adding an explicit ascertainability requirement to Fed. R. Civ. P. 23 (Rule 23), presently under examination by the federal Advisory Committee on Civil Rules for possible amendment. Bexis points out that many courts already (properly) impose … Continue Reading

Life Sciences and Health Care Industries Reap the Benefits of 3D Printing

This post was written by Colleen Davies and Lisa Baird. The past few years have seen 3D printing – a process that involves the creation of a three-dimensional object from a pre-conceived design – evolve from a futuristic idea into a multi-billion dollar business, and few industries have benefitted more from this technology than life … Continue Reading

A 50-State Survey of the Heeding Presumption

Over on the Drug & Device Law Blog, the bloggers have put together a survey of how each U.S. state (plus Washington, D.C. and Puerto Rico) has addressed the concept of the heeding presumption, which posits that if the manufacturer of a product had given an alternative "adequate" warning of the potential effects of using the product, then the consumer or learned intermediary of such product would have obeyed the warning. As the survey demonstrates, the states' reaction to this legal theory ranges from full recognition to limited recognition to full rejection.… Continue Reading

Updates to Adverse Event Report Cheat Sheet on Drug & Device Law Blog

Over on the Drug & Device Law blog, the team maintains several scorecards and cheat sheets on product liability litigation topics relevant to pharmaceutical and medical device manufacturers. Reed Smith associate Kevin Hara has updated the blog's adverse event report cheat sheet to include the most recent decisions from across the country addressing whether adverse event reports can be used as admissible evidence on the grounds of causation. In discussing this issue, Kevin advocates the legal principle that if a plaintiff cannot prove a particular product's capability of adverse event causation, the court should rule in favor of the defendent.… Continue Reading

Are You Sure Your Company Is “At Home” In All 50 States?

Reed Smith attorneys Jim Beck and Michelle Cheng explain in a recent Washington Legal Foundation Legal Backgrounder that the Supreme Court's decisions in Goodyear Dunlop Tires Operations, S.A. v. Brown (2011) and Daimler AG v. Bauman (2014) have narrowed the permitted scope of "general" personal jurisdiction against corporations. As a result, corporate defendants might want to think twice before making a general appearance in new cases filed in states other than the states in which they have incorporated or have located their principal place of business.… Continue Reading

The Good, the Bad and the Ugly: Top 10 Best and Worst Prescription Drug and Medical Device Decisions of 2013

As they do every year, authors from the Drug and Device Law blog have published a list of the top 10 best and worst medical device and pharma decisions of the past year. In addition to their standard analysis, this year two of the Reed Smith authors, Eric Alexander and Jim Beck, will be hosting a teleseminar on Wednesday, January 8th at 12 p.m. ET to discuss the decisions in more detail. Information on how to register can be found at www.reedsmith.com/events.… Continue Reading

Supreme Court Decision on Reverse Payments has Significant Implications for Pharmaceutical Manufacturers

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a detailed analysis of the Supreme Court’s decision in FTC v. Actavis, where the court ruled five-to-three that reverse payments, also called pay-for-delay settlements, can violate antitrust laws and are subject to antitrust review under the rule-of-reason. As reverse payments are commonly used by branded drug … Continue Reading

Supreme Court Decides Mutual Pharmaceutical Co. v. Bartlett

As reported on Drug and Device Law Blog, in a five-to-four decision by Justice Alito, the Supreme Court has decided Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, slip op. (U.S. June 24, 2013), a generic drug preemption case out of the First Circuit where that court had permitted the plaintiffs to recover on a “design defect” … Continue Reading

New Jersey Appropriations Committee Approves Off-Label Drug Coverage Legislation

On March 7, 2013, the New Jersey Assembly Appropriations Committee approved legislation related to off-label drug coverage. Assembly bill A1830 would require health benefits plans offered to individuals and small employers, the State Health Benefits Program (SHBP) and the School Employees' Health Benefits Program (SEHBP), to provide coverage for certain off-label uses for drugs that are approved by the U.S. Food and Drug Administration. The health plans would be required to provide coverage for off-label use of a drug if the drug is recognized as being medically appropriate for the specific treatment for which is has been prescribed in one of two established reference compendia (the American Hospital Formulary Service Drug Information or the U.S. Pharmacopeia Drug Information), or if the drug is recommended by a clinical study or review article in a major peer-reviewed professional journal. According to bill sponsor Herb Conaway M.D., "the purpose of [the] bill is to extend the medical benefits that may derive from the use of off-label drugs to individuals who may not be able to access these medications. In particular those individuals who are suffering from a terminal or chronically debilitating illness, because their insurance carriers won't cover these drugs." The full text and status of the bill are available here.… Continue Reading

New Law Spells MSP Relief For Private Sector

There seems to be growing awareness that engaging in a "business, trade, or profession," can easily subject any person or entity to what is known as the Medicare secondary payer ("MSP") law--a series of provisions in Title XVIII the Social Security Act, governing the hierarchy of who pays first among applicable insurers. Given its scope and complexity, understanding and complying with the MSP law can be overwhelming. Further, although failure to comply carries obvious risk, conforming to what the law requires may also trigger certain risks of its own.… Continue Reading

A SMART Change for Tort Defendants?

President Obama recently signed the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act (commonly referred to as the SMART Act) to alleviate some of the confusion surrounding the Medicare Secondary Payer Act (MSP), which allows Medicare to seek reimbursement, and potential penalties, from "responsible" parties. These "responsible" parties include tort defendants, such as drug and medical device manufacturers, who become primary payers once they settle or have a judgment awarded against them in a case involving a Medicare beneficiary. The SMART Act will, among other things, introduce a three-year statute of limitations for which the government may bring an action for reimbursement and create a minimum settlement/judgment threshold below which the government will not seek reimbursement.… Continue Reading

Practical Pointers for Protecting Your Insurance Rights in the Wake of Hurricane Sandy

This post was written by Paul E. Breene, Douglas E. Cameron, James M. Davis, John N. Ellison, Ann V. Kramer, Richard P. Lewis, Matthew J. Schlesinger, John D. Shugrue and Gary S. Thompson. Hurricane Sandy left a swath of major damage and destruction over a large area of the Northeastern United States. Commercial policyholders will … Continue Reading

Understanding of Global Data Privacy Regulations Helps Avoid Conflicts in Cross-Border Discovery Disputes

InsideCounsel recently published, "E-discovery: The need for a transnational approach to cross-border discovery disputes," an article on international discovery issues and the benefit of a respectful approach to document productions outside of the U.S. Written by Reed Smith Records & E-Discovery Group members David R. Cohen, Regis W. Stafford, Jr. and Caitlin R. Gifford, the piece notes that proposed EU Data Protection Directive regulations have the potential to subject multinational companies to sanctions of up to two percent of annual worldwide revenue for serious breaches, including unlawful data transfers to the U.S. In addition, although not binding on U.S. courts, the ABA recently issued a resolution and recommendation that states in part that U.S. courts should "consider and respect the data protection and privacy laws of any foreign sovereign..." This article underscores the importance of a comprehensive global approach to document production in cross-border litigation.… Continue Reading

Life Sciences Health Industry China Briefing – June 2012 (July 20, 2012)

Recent posts on www.lifescienceslegalupdate.com include: "Supreme Court Rules That Juries - Not Judges - Must Determine Facts Supporting Large Criminal Fines" The Reed Smith Global Regulatory Enforcement Law blog has an interesting post about a recent U.S. Supreme Court ruling that protects the Sixth Amendment rights of defendants in high-stakes criminal cases. In Southern Union Co. v. United States, the Court ruled that any fact supporting a "substantial" criminal fine must be found by a jury applying the "beyond a reasonable doubt" standard. In this post, Efrem M. Grail and Kyle R. Bahr explain the opinion and discuss the wide impact it will have on criminal actions, from investigation to sentencing. View the entire entry: http://www.lifescienceslegalupdate.com/2012/07/articles/health-care/supreme-court-rules-that-juries-not-judges-must-determine-facts-supporting-large-criminal-fines/ ... and "Life Sciences Health Industry China Briefing - June 2012 (July 20, 2012)" Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading
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