Insights

Washington, D.C. – August 28, 2014: The Best Lawyers in America 2015 selected 40 Crowell & Moring LLP attorneys as leaders in their field. Attorneys were selected through peer nominations. The following Crowell & Moring attorneys are listed by the respective practice areas for which they were selected:

Washington, D.C. – March 11, 2013: Crowell & Moring LLP is pleased to invite members of the media and industry to attend its second annual one-day seminar, "Staying Afloat When Your Brand Is Under Pressure: How to Avoid, Mitigate, and Manage Product Crises," on March 19, 2013, from 8:30 a.m. – 5:00 p.m. at the firm's offices in Washington, D.C. With an increased need for companies to understand the ways to reduce or eliminate the risk of a crisis throughout their products and services lifecycles, the event panelists will discuss their approaches to minimizing business exposure to adverse events such as product defects, regulatory agency investigations and enforcement actions, port seizures, false advertising, and class action litigation.

Washington, D.C. – January 17, 2013: Crowell & Moring LLP is pleased to announce it has elected seven attorneys to the firm's partnership effective January 1, 2013. The firm has also promoted three attorneys to the position of senior counsel, and nine associates to the position of counsel. The new partners, senior counsel, and counsel have been promoted from within the ranks of the firm's Washington, D.C., San Francisco, Brussels, and London offices.

In Brown v. GlaxoSmithKline, LLC and Providence Health System – Oregon, 323 Or. App. 214 (Ct. App. Or. 2022), the Oregon Court of Appeals recently found that a hospital could be a “seller” of pharmaceutical drugs under Oregon law, subjecting it to strict products liability for alleged drug defects.  This decision contravenes—and thus threatens to upset—the overwhelming consensus among U.S. courts that hospitals are not strictly liable for allegedly defective drugs or medical devices used in the course of providing medical care to patients. 

On January 26, 2016, the U.S. Food and Drug Administration (FDA) released draft Guidance on interoperable medical devices. This provides important direction for medical device manufacturers to consider in the design of their products. Comments on the draft Guidance will be accepted by FDA for 60 days. 

On October 2, 2014, the FDA released a set of guidelines designed to improve the cybersecurity of medical devices and to combat increasing vulnerability to cyber-attacks. Compliance with the guidelines, although not mandatory, is strongly recommended to protect not only patients, but also manufacturers, facilities, and providers. In drafting the guidelines, the FDA was careful to consider the particular sensitivities involved in the regulation of instruments designed for health care. Overly strict regulations may run the risk of inhibiting a device's functional capabilities – a distinct concern in the case of devices intended for emergency response. Conversely, if regulations are not strict enough, there is an increased risk of potential cyber incidents that could result in patient harm such as illness, injury, or even death.

Advertising & Product Risk Management (APRM) Group partners and Group co-chairs Chris Cole and Cheri Falvey are profiled in the Washington Post's Capital Business section for their leadership and growth of the practice. The article highlights the strengths they each bring to the firm, and the unique ability of the APRM Group; "Now the group advises on the entire life cycle of consumer products, from their creation to safety testing, advertising campaigns, product recalls and designing consumer tests to back up marketing claims — which is almost like a science," Cole states. Additionally, Falvey highlights, "part of the reason she joined Crowell was because the firm's leaders understood that the science that must be conducted to back up marketing claims is the same science that federal regulators look at when evaluating the safety of products."

More companies than ever before are launching smart medical devices and industry growth seems endless as new products and technologies are announced daily. However, before companies push products to market, it’s crucial to understand key aspects of device approval, and company and patient protection. In this webinar, our speakers will outline intellectual property strategies, U.S. Food and Drug Administration considerations, and data cybersecurity concerns that are inherent to all smart medical devices. They will explore the legal issues that can significantly decrease the risk profile and potential liabilities throughout a product's lifecycle and create safer, more reliable products for consumers.