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FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses

This post was written by Evelien Verpeet The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do … 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

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

U.S. Senator Schumer Calls for Increased Regulation of Wearable Electronic Devices to Avoid Data Privacy Issues

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

Recent Data Breaches Serve as Warning for Companies to Assess Their Cybersecurity Insurance Coverage

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

Law360 Article – U.S. and French Sunshine Laws Present Compliance Challenges for Manufacturers

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

Closing Time: Considerations and Hurdles in Completing Pennsylvania-Based Health Care Transactions

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

Navigating the Complicated, Yet Rewarding, World of Social Media

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

UK Government Addresses Lack of Regulation and Legislation in Cosmetics Industry

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

A Comparison of the U.S. and French Sunshine Reporting Requirements

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

Are Internal Compliance Investigations Privileged? D.C. District Court Rules No

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

There are HOW many calories in that? FDA Proposes First Overhaul to Food Label in 20 Years – Comment Opportunity

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

EU Research Group Condemns EU Regulation for Restricting Growth in Life Sciences Sector; NHS Advocates Selling Confidential Patient Data For Secondary Purposes

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

Physician-Owned Distributor (POD) Update: Device Manufacturer’s Challenge to OIG Fraud Alert Fails; OIG Finds PODs Increase Medicare Costs; and Hospitals Continue to Adopt Anti-POD Policies

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

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

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

FDA Issues Final Guidance on DHCP Letters

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

Launch of the New French State Portal Allows for Electronic Information Disclosure by Health Care Companies

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

Drug and Device Law Blog Once Again Named to ABA Journal’s Annual Blawg 100

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

Sorry Just Might Cut It…Pennsylvania Enacts Benevolent Gesture Law

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

China: Life Sciences Regulatory Crackdown Spreads to Medical Device Sector

On August 15, 2013, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China announced (Chinese link) that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. In its announcement, the Beijing MOH noted that prior inspections of hospitals had found continuing problems with the misuse and overuse of medical devices to increase profits. The investigation is intended to strengthen hospitals' management of the use of medical devices and to regulate the use of high value medical consumables.… 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
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