A task force, composed of key antitrust enforcement agencies including the Federal Trade Commission (FTC), and the Canadian Competition Bureau, is seeking information from the public regarding the effects of pharmaceutical mergers. This information will be used to update the practices for future pharmaceutical mergers by the task force’s constituent agencies. Following concerns within the … Continue Reading
The Advanced Medical Technology Association (AdvaMed) – the national industry association of medical technology manufacturers – recently issued an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) (the AdvaMed Code or Code). Last revised in 2009, AdvaMed’s updated Code will go into effect January 1, 2020. The Code speaks to the evolving … Continue Reading
FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS regulatory agenda. Under the Drug Supply Chain Security Act (“DSCSA”), FDA was required to issue these regulations no later than two years following the law’s November 2013 … Continue Reading
In changes that have been five years in the making, amendments to the Federal Rules of Civil Procedure go into effect today, December 1, 2015. Two major amendments have received much attention and analysis. The first is the addition of an express proportionality requirement to Rule 26(b)(1) regarding the Scope of Discovery, and the second … 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
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
The January 25, 2015 edition of the Pittsburgh Post-Gazette featured an article in which Reed Smith partner Chris Healy commented on the dramatic rise in popularity of 3D printing technology and the legal issues that have come about – and may arise in the future – as a result of this trend. The article, “3D … Continue Reading
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 sciences and health care. 3D printing has been used to … Continue Reading
Reed Smith's Global Regulatory Enforcement Law Blog features a post on the recent phenomenon of wearable electronic devices and the legal issues that may arise from these gadgets. "Wearable Device Privacy - A Legislative Priority?," written by Reed Smith attorneys Frederick Lah and Khurram Gore, discusses a recent press release issued by U.S. Senator Chuck Schumer of New York expressing concern that personal health data collected by wearable devices and fitness apps, including medical conditions, sleep patterns, calories burned, GPS locations, blood pressure, weight, and more, will be provided to third parties without the user knowing it. Schumer, citing this as a threat to personal privacy, has urged the Federal Trade Commission to mandate that device and app companies provide users with an explicit "opt-out," allowing them to block the distribution of this information to any third parties.… Continue Reading
Earlier this week, numerous media outlets reported on the Russian crime ring which had managed to steal more pieces of Internet data than any other group of hackers in history – a whopping collection of at least 1.2 billion user name and password combinations and over 500 million email addresses. The magnitude of data that … Continue Reading
In “From Sea to Shining Sea: French and US Sunshine Laws,” (Law360 subscription required), Reed Smith attorneys Elizabeth Carder-Thompson and Daniel Kadar discuss recent legislation from both sides of the Atlantic designed to increase the transparency of relationships between drug and medical device manufacturers on one hand and physicians and teaching hospitals on the other. … Continue Reading
The health care industry has seen a recent shift towards consolidation, driven in part by legislation such as the Patient Protection and Affordable Care Act which encourages integration within the industry. As a result, health care entities are increasingly considering opportunities to merge with or acquire other companies. While this can be an exciting prospect … Continue Reading
The social media phenomenon has radically transformed the ways in which commercial businesses promote their services and products. However, as a result, companies must consider potential legal risks from an entirely new angle. To become a successful user of social media, a company must draft, review, disseminate and enforce a social media policy that addresses potential legal issues while at the same time emphasizing positive exposure for the business.… Continue Reading
In April 2013, an independent review of the regulation of cosmetic interventions in the UK was published, highlighting an insufficient amount of regulation in this industry by the UK government, due in part to the rapid growth of cosmetic procedures in the United Kingdom. Cases such as unauthorized (and potentially defective) materials being used in … Continue Reading
This past year both the U.S. and France enacted substantial new reporting and disclosure requirements under their respective Sunshine Acts, which were designed to increase the transparency of the financial relationships between manufacturers and health care professionals and to allow patients to make more informed decisions regarding their health treatments. The U.S. and French Sunshine … Continue Reading
We want to alert life sciences and health care entities to a recent decision out of the U.S. District Court for the District of Columbia. On March 6, 2014, the U.S. District Court for the District of Columbia granted a qui tam relator's motion to compel the production of documents relating to the defendant Kellogg Brown & Root Services, Inc.'s (KBR's) "Code of Business Conduct (COBC) investigations," holding such documents were not protected from disclosure under either the attorney-client privilege (ACP) or the attorney work product doctrine (AWP). The court concluded that the company's investigations were conducted pursuant to "regulatory law and corporate policy," rather than for the purpose of obtaining legal advice. Accordingly, KBR was ordered to produce some 89 documents that it previously claimed as privileged under the ACP and/or AWP. U.S. ex rel Barko v. Halliburton Company, No. 1:05-CV-1276 (D.D.C., March 6, 2014). The court's broader statements could have significant implications for companies in regulated industries where corporate compliance programs are commonplace, or even required.… Continue Reading
Today FDA has proposed updates to the Nutrition Facts label for foods. According to FDA, the goal of these proposed changes is not to dictate what consumers should or should not be eating, but rather to expand and highlight the information consumers need most to make well-informed choices regarding food. FDA will be accepting comments on the proposed updates for 90 days.… Continue Reading
Reed Smith’s Global Regulatory Enforcement Law blog features two posts of interest to those in the life sciences industry, both written by Reed Smith partner Cynthia O’Donoghue. “EU Research Group Condemns EU Regulation for Restricting Growth in Life Sciences Sector” discusses the opposition of a lobbying group, led by the Wellcome Trust, to amendments to … Continue Reading
We have been reporting for some time on issues involving the Office of the Inspector General (OIG) scrutiny of physician-owned distributors (PODs). In March 2013, we analyzed an OIG Special Fraud Alert on PODs and in October we reported on an interesting challenge to the Fraud Alert filed by a medical device manufacturer in the U.S. District Court for the Central District of California. That suit argued that the Fraud Alert unfairly and unconstitutionally burdened the plaintiff's First Amendment rights of free speech and due process. In this post, we report on the disposition of that case, and several other related POD developments.… Continue Reading
This post was written by John Tan, Amy Yang, and Crystal Xu. In late December, China’s National Health and Family Planning Commission (NHFPC), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013 Regulations on the Establishment of a Commercial Bribery Blacklist for the … Continue Reading
As mentioned on our Health Industry Washington Watch blog, the Food and Drug Administration issued a final guidance document on January 16, 2014 which provides specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. The recent guidance finalizes a draft guidance FDA published in November of 2010. To read … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law blog features a post on the recent launch of the new state portal in France. "The implementation of the French transparency regulation: first good news?," written by Reed Smith partner Daniel Kadar, discusses how the portal will allow health care companies to more easily disclose transparency information to the French government … Continue Reading
Congratulations to the Drug and Device Law Blog and its regular contributors, among them Reed Smith partners Jim Beck, Steven McConnell, Eric Alexander and Steven Boranian, for once again being named to the ABA Journal’s Blawg 100 ranking. To vote for Drug and Device Law in the Torts category, click here. After registering, simply scroll … Continue Reading
Pennsylvania physicians, hospital executives and other providers may now apologize and offer other benevolent gestures to patients, their families and representatives without such statements becoming evidence against them in medical malpractice suits. On October 23, 2013, Governor Corbett signed Senate Bill 379 into law which renders "benevolent gestures" inadmissible as evidence of liability in a malpractice suit.
This evidentiary rule has been championed as a type of medical tort reform intended to encourage frank discussions with patients and residents as well as their relatives and representatives. Commentators are divided, however, as to whether the measure will actually reduce the number of medical malpractice suits filed in the state.… Continue Reading
