Involving any outside consultant in the attorney-client relationship gives rise to risks to the attorney-client privilege. Yet when a PR crisis erupts, good communications advice is essential, and a company’s media strategy can determine whether it is the subject of thoughtful, balanced articles or a maelstrom of misleading headlines – and whether unfair publicity infects … Continue Reading
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
Reed Smith’s Life Sciences Health Industry Group is proud to be hosting its third annual Life Sciences CLE Day at our Philadelphia office on Thursday, November 2. The day starts with breakfast and networking at 8:30 a.m. and sessions commence at 9 a.m. The event, which includes a working lunch, concludes at 4 p.m., with … Continue Reading
The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners … Continue Reading
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2016” on Wednesday, January 18, 2017 at 12 p.m. ET. Each year since 2007, James Beck, Reed Smith’s Senior Life Sciences Policy Analyst and the founder … Continue Reading
Reed Smith’s Life Sciences Health Industry Group is hosting a Life Sciences CLE Day at our Philadelphia office on Thursday, November 10. The day starts with breakfast and networking at 8:30 a.m. and sessions commence at 9 a.m. The event, which includes a working lunch, concludes at 2:30 p.m. This program is geared toward in-house … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Social Media Issues for Pharmaceutical and Medical Device Companies,” on November 2, 2016 at 12 p.m. ET. Social media can be a great way to engage with consumers and build your brand. For pharmaceutical and medical device companies, however, it … Continue Reading
Reed Smith attorneys Jason Casell and Steve Miller will be moderating and presenting respectively on the “Pharmaceutical and Medical Devices Industries Update” panel on November 10, 2016 at DRI’s Government Enforcement and Corporate Compliance Seminar. This panel will examine recent government enforcement activities and legal decisions that might shape investigations, litigation, and resolutions of government … 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
Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it will be removing two of its popular pharmaceutical advertising units. Black Box Ad Format On July 20, 2015, Google’s Black … Continue Reading
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
The United States Supreme Court has declined to hear a challenge to the Alameda County Drug Disposal Ordinance (“Ordinance”) brought by three pharmaceutical trade organizations. The Court’s decision leaves in force the Ninth Circuit decision, which found that the Ordinance, requiring pharmaceutical manufacturers to fund drug take-back programs in the county, did not interfere with … 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
On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… 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
The Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA) have jointly filed a Petition for a Writ of Certiorari with the U.S. Supreme Court, asking for review of the Ninth Circuit's decision in PhRMA v. County of Alameda, in which the court ruled that Alameda County's Safe Drug Disposal Ordinance - requiring pharmaceutical manufacturers to establish or participate in a program for collecting unwanted prescription drugs from consumers - was constitutional.… Continue Reading
The Alameda County (CA) Safe Drug Disposal Ordinance (Alameda County Code Chapter 6.53, §§ 6.53.010-6.53.120) is one of several county-wide regulations across the United States to enforce the establishment of and/or participation in Product Stewardship Plans on the part of pharmaceutical manufacturers, with the ultimate goal of collecting unwanted drugs for purposes of disposal. The … 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
The Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) on September 19, 2014 discussing the coupon programs employed by many pharmaceutical manufacturers to reduce or entirely eliminate patient copayments to obtain brand-name drugs. As mentioned on our Health Industry Washington Watch blog, the SAB … Continue Reading
