Michael Brown and Lisa Baird from our Life Sciences Health Industry Team will be presenting an hour-long AdvaMed Medical Technology Learning Institute webinar on “Top 10 Product Liability Issues” on July 20 at 1 p.m. ET. Product liability litigation is ever-evolving, and the plaintiffs’ bar is continually adapting its business model and litigation strategy against … Continue Reading
Pharmaceutical and medical device manufacturers are increasingly finding themselves resolving disputes through international arbitration. After London, Singapore is now arguably the second most important arbitration center in the world, meaning the Singapore International Arbitration Centre’s (SIAC) new arbitration rules, which were due to come into effect on June 1, 2016, but will now come into … Continue Reading
Five of our Reed Smith life sciences team members – Jim Beck, Steve McConnell, Eric Alexander, Steven Boranian and Rachel Weil – blog on pharmaceutical and medical device product liability news for the award-winning Drug and Device Law blog. If you’re not already familiar with the Drug and Device Law blog, it’s your one-stop source … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Personal Jurisdiction: What Bauman Does and Doesn’t Mean, the Other Side’s Response, and Why Corporations Should Care” on June 14, 2016 at 12 p.m. ET. Reed Smith presenters Jim Beck and Steve McConnell will be discussing how plaintiffs’ lawyers are … Continue Reading
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
The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” addressed regulatory issues for medical devices and … Continue Reading
The FDA published a notice on February 24, 2016 requesting whether organizations (e.g. insurers, health technology assessment organizations) that evaluate clinical evidence used to support private payer medical device coverage decisions are interested in providing input to medical device developers on clinical trial design or other evidence-gathering needed to support positive coverage decisions. If coverage … Continue Reading
3D printing has been a common topic of discussion of the blog. We’ve written about it here and in a more in-depth review of the legal issues raised by the emergence of 3D printing in the medical device industry in our September 2015 white paper. 3D printing is in the news again thanks to the … Continue Reading
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
3D Printing has been a hot subject on this blog lately. From our first 3D Printing white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” to our posts here, here and here. Our friends over at the Drug and Device Law blog are no stranger to the subject either. … Continue Reading
Our 3D Printing task force prepared our first 3D Printing white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” last month because we are thrilled at the prospect of 3D printing changing the future of health care for the patients who need new treatments, devices and drugs, and we … Continue Reading
3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly. Reed Smith’s Life Sciences Health Industry Group recently launched its first 3D printing publication white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles. This paper explores unchartered legal issues … Continue Reading
By Andrew Stillusfen and Tsedey Bogale on Posted in Product Liability
When the New Jersey Supreme Court ruled in Perez v. Wyeth Lab, Inc. that if pharmaceutical manufacturer directly markets to consumers, the learned intermediary doctrine does not apply, it was deemed a “revolutionary,” decision. However, since the ruling, every New Jersey court which has confronted this issue has found that the DTC exception did not … Continue Reading
Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine … Continue Reading
Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading
3D printing is providing physicians with a steady flow of new options for medical treatment. Reports are constantly emerging about novel, life-saving procedures made possible through 3D printing. As one might imagine, however, 3D printing a medical device for use in humans carries particular challenges not present with 3D printing in other contexts.… Continue Reading
On April 16, 2015, President Barack Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The bill permanently transforms the structure of Medicare physician reimbursement and enacts several changes to Medicare payment, program integrity and policy provisions that will affect both health care providers and pharmaceutical/medical device manufacturers. The most … Continue Reading
The French government issued a bill on March 17 for the extension of class actions to health-related claims in France. Starting today, March 31, the text will be discussed at the French National Assembly, particularly to address the issue of compensation for personal injury within the framework of the proposed class action.… Continue Reading
Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading
Over on the Drug & Device Law blog, Reed Smith partner Jim Beck applauds the recent decision in Tyree v. Boston Scientific Corp., a case filed in the Southern District of West Virginia. Tyree manages to narrow the scope of the 2007 decision in State ex rel. Johnson & Johnson v. Karl, in which the … Continue Reading
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
Earlier this week, the FDA issued two draft guidances on social media, and Reed Smith attorneys Colleen Davies, Celeste Letourneau, Kevin Madagan, and Jennifer Pike have written a client alert that analyzes them both in detail. The first guidance pertains to product claims and risk information on platforms like Twitter and sponsored links, and the second to correcting third party misinformation that appears in social media, such as in comments on a Facebook page or website.
A key date to keep in mind is that the deadline for comments is September 16, 2014.… Continue Reading
Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the New Regulation). The State Council Legislative Affairs Office worked more … Continue Reading
The California Attorney General, Kamala D. Harris, has issued a long-awaited guide on how companies can comply with the California Online Privacy Protection Act (CalOPPA). CalOPPA applies to all companies which collect personally identifiable information from California residents online, regardless of whether that information is collected via a commercial website or a mobile application. This … Continue Reading
