Tag Archives: Product Liability

FDA finalizes guidance on voluntary recalls, issues recommendations for industry

By Kevin Madagan and Matthew Loughran on Posted in Industry Developments, Product Liability, Product Recalls
The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall. The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable … Continue Reading

Join Us for a CLE Webinar on Strategies for Addressing Common, but Seldom Discussed, Mass Tort Litigation Irritants

By Lisa Baird on Posted in Industry Events
As part of the Greater Philadelphia chapter of the Association of Corporate Counsel’s Litigation Law CLE Week, I am pleased to be joining my Reed Smith colleague Jim Beck and Endo Pharmaceuticals’ Vice President and Assistant General Counsel – Litigation and Risk Jobina Jones-McDonnell to present a 12 p.m. ET webinar tomorrow on “Out of … Continue Reading

Upcoming Free CLE Webinar: “Multidistrict Litigation: What to Expect from JPML Consolidation Through Trial”

By Lisa Baird on Posted in Industry Events
With more than half of all cases pending in the federal courts now docketed in multidistrict litigations (MDLs), pharmaceutical and medical device companies facing large-scale litigation should expect to find themselves before the Judicial Panel on Multidistrict Litigation (JPML) with an MDL on the horizon. That’s why Melissa Geist and Jennifer Eppensteiner are pleased to … Continue Reading

Senate Bill Seeks to Provide “Floor” for Cybersecurity Operational Standards for Internet-Connected Devices Purchased by Federal Agencies

By Mildred Segura, Maryanne Woo, Holly Roth and Christopher Butler on Posted in Industry Developments
A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency. Should the legislation be enacted, the expectations it sets forth regarding the security of IoT devices could be interpreted by courts as the minimal floor for any … Continue Reading

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

By Matt Jacobson on Posted in Industry Developments
The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where … Continue Reading

Upcoming Free CLE Webinar: “The Internet of Things’ Impact on the Health Care Industry: Diagnosing the Dangers with Disruptive Technology”

By Lisa Baird on Posted in Industry Events
Reed Smith not only assists our pharmaceutical and medical device clients with their current legal challenges and opportunities, we look around corners to anticipate the next industry disruptor – and to help our clients navigate the legal issues that come with it. For our life sciences clients, the Internet of Things is clearly a game … Continue Reading

Upcoming Free CLE Webinar: “3D Printing: Component Parts/Raw Materials Product Liability & Health Risks”

By Lisa Baird on Posted in Industry Events
Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into patient care. Our 3D printing team has authored two white papers (available here and here) … Continue Reading

Upcoming Free CLE Webinar: “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”

By Lisa Baird on Posted in Industry Developments
The Reed Smith life sciences product liability and 3D printing teams will be hosting an upcoming CLE webinar “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8, 2017 at 12 p.m. ET. Reed Smith presenters Jim Beck and Matt Jacobson will be discussing 3D … Continue Reading

Reed Smith Launches Second Edition of 3D Printing White Paper

By Lisa Baird on Posted in Industry Developments
Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly:  3D Printing of Manufactured Goods: … Continue Reading

MDR Reporting Final Guidance

By Lisa Baird on Posted in Industry Developments
FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”.  As with all such guidance documents, it is nonbinding:  “It does not establish any rights for any person and is not binding on FDA or the public.”  Nevertheless, for those interested in medical device reporting, the document is required reading as … Continue Reading

Reed Smith Attorneys to Speak at Upcoming “Women Leaders in Life Sciences Law” Conference

By Lisa Baird on Posted in Industry Events
Two members of Reed Smith’s Life Sciences Health Industry (LSHI) group will be speaking at the American Conference Institute’s 3rd Annual Conference on Women Leaders in Life Sciences Law taking place in Boston on July 27-29, 2016. On July 28, Reed Smith partner and co-chair of the firm’s LSHI group, Melissa A. Geist will discuss … Continue Reading

French Supreme Court Ruling Clarifies Liability For Defective Products

By Benoit Charot, Laura Ferry and Delphine Lapillonne on Posted in Product Liability
A February 25, 2016, decision by the French Supreme Court clarifies some conditions for the imposition of liability with respect to defective products in ways that may be surprising to those more accustomed to U.S. product liability law. In the case at hand, a patient was prescribed Mediator, an appetite suppressant, between 1998 and 2008. … Continue Reading

FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices

By Kevin Madagan and Matt Jacobson on Posted in Industry Developments
The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug.  It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014.  FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading

IEEE Developing New Standards for 3D Printers For Medical Uses

By Lisa Baird and Farah Tabibkhoei on Posted in Industry Developments
The Institute of Electrical and Electronics Engineers Standards Association (IEEE) is developing new interoperability standards for medical devices, 3D printers and other eHealth devices.  IEEE P3333.2.5, Draft Standard for Bio-CAD File Format for Medical 3D Printing is intended to develop standard methods for the printing of 3D-printed prosthetics and medical devices.  IEEE proposes to define … Continue Reading

Attention Out-of-State Plaintiffs: The Tour Ends Here. Next Stop, Home

By Kevin Hara on Posted in Product Liability
Last year, the Supreme Court sent a resounding message regarding personal jurisdiction when it decided Daimler AG v. Bauman, 134 S.Ct. 746, 752 (2014).  Bauman announced a significantly more stringent standard for finding a corporation to be “essentially at home” in a foreign jurisdiction and, as a result, made personal jurisdiction harder to establish in … Continue Reading
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