FDA Steps Up Its Focus on Medical Device Cybersecurity

Microsoft has discontinued support for Internet Explorer. To access the Patterson Belknap website, please install a modern browser like Microsoft Edge or Google Chrome.

Publications

Back to Publications

November 1, 2018

FDA Steps Up Its Focus on Medical Device Cybersecurity

Law360

Download Publication as PDF

October was National Cybersecurity Awareness Month. No doubt this explains why the U.S. Food and Drug Administration stepped up its focus on the security of internet-connected medical devices.

To continue reading Michael Buchanan and Joshua Furman's article from Law360, please click here.

Firm Highlights

Ninth Circuit Finds First Amendment Right to Donate to Patient Assistance Charities, With Possible Impact on Enforcement of Federal Anti-Kickback Statute

Last week, the Ninth Circuit issued a published decision striking down California’s Assembly Bill 290 (“AB 290”) on First Amendment grounds. See Fresenius Med. Care Orange Cnty., LLC v. Bonta, No. 24-3654 (9th Cir. Apr. 7, 2026). Its central holding was that providers of medical services have a protected First Amendment right to make donations to patient assistance charities that engage in expressive activity, even if those donations are driven by commercial self-interest. Although the case did not directly involve the federal Anti-Kickback Statute (“AKS”)—or any federal statute—it arguably calls into question the constitutionality of AKS proceedings often brought against pharmaceutical manufacturers that make analogous donations to patient assistance charities out of alleged self-interest. AB 290, the California statute at issue...

Firm Secures Appellate Victory on Behalf of Brita Products Company

On April 16, 2026, the firm secured an appellate victory on behalf of Brita Products Company ("Brita"), a unit of The Clorox Company, in a putative class action challenging the labeling of Brita's water filtration products. The U.S. Court of Appeals for the Ninth Circuit upheld a lower court ruling dismissing the complaint, agreeing that the product labeling contained no misstatements and would not mislead a reasonable consumer. Plaintiff originally sued Brita in the U.S. District Court for the Central District of California, alleging that certain representations on the products’ labels, such as “Cleaner, Great-Tasting Water,” implied that the filters fully remove all contaminants from tap water or reduce them to levels below lab detection limits. The district court granted Brita’s motion to dismiss...

Jenny Longman to Speak at American Bar Association's 2026 May Tax Meeting

On Friday, May 8, Counsel Jenny Longman will speak on a panel at the American Bar Association's 2026 May Tax Meeting entitled "Entering the U.S. Tax System: Key Rules, Risks, and Planning Opportunities for High Net Worth Individuals." Ms. Longman will join Heather Fincher (Associate, Kostelanetz), Kirsten Burmester (Member, Caplin & Drysdale), Seth Entin (Shareholder, Greenberg Traurig), and John Fusco (Principal, EY) to share an overview of important U.S. federal income and transfer tax considerations for high-net-worth individuals and families seeking to immigrate to the U.S., along with practical strategies for evaluating existing structures, reducing risks of double taxation, and identifying planning opportunities while avoiding common pitfalls. To learn more, please click here.

Firm Achieves Significant Lanham Act Win for Johnson & Johnson

On April 17, 2026, Patterson Belknap secured a significant victory for our clients, Johnson & Johnson and Janssen Biotech, Inc. (“J&J”), when the U.S. District Court for the Southern District of New York denied a preliminary injunction in a Lanham Act suit filed by Bayer HealthCare LLC (“Bayer”). The dispute concerned a retrospective scientific study sponsored by J&J that compared the real-world efficacy of both companies’ prostate cancer medications, concluding that J&J’s ERLEADA was associated with a reduction in overall risk of death approximately 50% greater than Bayer’s NUBEQA. Bayer alleged that the study was methodologically flawed, and that J&J’s publication of the study results therefore constituted “false advertising.” The statements at issue included a presentation given by the study authors at a medical...

Fresenius Ruling May Shift Anti-Kickback Enforcement

When is it illegal to donate to a charity? According to the federal government, when you're a pharmaceutical manufacturer, and the charity helps Medicare patients afford your medicines. The government has argued that such donations may be illegal kickbacks. Courts have largely agreed with this view, but a recent decision by the U.S. Court of Appeals for the Ninth Circuit in Fresenius Medical Care Orange County LLC v. Bonta raises new doubts, suggesting that businesses have a First Amendment right to donate to certain charities — even when those donations are motivated by economic self-interest and have distortive economic effects. To continue reading Jonah Knobler's article in Law360, click here.

Bankruptcy Court Denies Motions to Convert Case and to Appoint an Examiner

A bankruptcy judge has ruled that a debtor can satisfy the Bankruptcy Code’s rehabilitation standard by selling its assets as a going concern and thereby avoid conversion from chapter 11 to chapter 7. In the same decision, the court denied a motion seeking the appointment of what the movants called an “examiner with expanded powers.” In re Deqser, LLC, Case No. 25-10687, 2026 Bankr. LEXIS 1004 (Bankr. D. Del. Apr. 22, 2026). The debtors operated a laundry business that serviced hotels located in New York City. The business suffered a downturn following an electrical fire at its facility as well as problems with its software. The debtors filed chapter 11 in early 2025. During their case, the debtors lost about $200,000 a...

It’s All Relative: Judge Komitee Holds That an Infringing Sale Can Take Place at Multiple Times Both Before and After a Patent Issues

Judge Eric Komitee recently denied a motion to dismiss patent infringement claims accusing flood prevention products sold pursuant to a contract that was entered into before the patent issued but delivered and installed after issuance. In 2013, plaintiff FloodBreak, LLC filed its patent application for a device that prevents flooding in subway systems. In 2016, while that application was pending, defendants T. Moriarty & Son, Inc. and James P. Moriarty, Jr. (collectively, “TMS”) contracted with the Metropolitan Transportation Authority (“MTA”) to supply flood-mitigation devices for the New York City subway. After the patent issued in 2017, FloodBreak sued TMS’s supplier and obtained a stipulated judgment that its devices infringe. FloodBreak then filed suit against TMS alleging infringement by TMS’s offer...

Department of Labor Proposes New Safe Harbor for Fiduciary Investment Selection in Participant-Directed Retirement Plans

Introduction On March 24, 2026, the Department of Labor (the “Department”) published proposed regulations (the “Proposed Regulations”) implementing Section 3(c) of President Trump's Executive Order 14330, titled "Democratizing Access to Alternative Assets for 401(k) Investors" (the “Order”). The Proposed Regulations address the fiduciary duty of prudence under the Employee Retirement Income Security Act of 1974 ("ERISA") related to the selection of investment options for participant-directed individual account plans, including alternative investments as defined under the Order (“Alternative Investments”)[1]. The stated goal of the Proposed Regulations is to alleviate regulatory burdens and litigation risks that, in the Department's view, have interfered with the ability of American workers to achieve sufficiently competitive returns and meaningful asset diversification through their retirement accounts. The Department...

SEC Enforcement Results for FY 2025: “Unique Period of Transition”

The Securities and Exchange Commission issued a press release on April 7, 2026, announcing the agency’s enforcement results for transitional period under the new presidential administration.[1] Describing FY 2025 as “a unique period of transition,” the statement pointed to a pulse of enforcement actions initiated between October and December 2024 [2] under outgoing SEC Chair Gary Gensler, critiquing the activity as “unprecedented rush” and the focus as an “aggressive pursuit of novel legal theories.”[3]. Current SEC Chair Paul S. Atkins described the shift as having “redirected resources toward the types of misconduct that inflict the greatest harm—particularly fraud, market manipulation, and abuses of trust.”[4] During FY 2025, the SEC brought 303 standalone enforcement actions, a combination of civil suits and administrative procedures that...

Justin Zaremby to Speak at American Law Institute’s 2026 Legal Issues in Museum Administration Conference

On Wednesday, April 29, Partner Justin Zaremby will speak on a panel at the American Law Institute's 2026 Legal Issues in Museum Administration conference titled "Structuring Collaborations Between Museums and Third Parties." Mr. Zaremby will join Barbara Andrews (Legal Manager and IACUC Administrator, California Academy of Sciences) and Cristina del Valle (Senior Associate General Counsel, The Metropolitan Museum of Art) to explore important governance, tax, and IP considerations for museums' transactional activities, including corporate sponsorships, licensing, and joint programming with for-profit and nonprofit entities. To learn more, please click here.

Ninth Circuit Finds First Amendment Right to Donate to Patient Assistance Charities, With Possible Impact on Enforcement of Federal Anti-Kickback Statute

Last week, the Ninth Circuit issued a published decision striking down California’s Assembly Bill 290 (“AB 290”) on First Amendment grounds. See Fresenius Med. Care Orange Cnty., LLC v. Bonta, No. 24-3654 (9th Cir. Apr. 7, 2026). Its central holding was that providers of medical services have a protected First Amendment right to make donations to patient assistance charities that engage in expressive activity, even if those donations are driven by commercial self-interest. Although the case did not directly involve the federal Anti-Kickback Statute (“AKS”)—or any federal statute—it arguably calls into question the constitutionality of AKS proceedings often brought against pharmaceutical manufacturers that make analogous donations to patient assistance charities out of alleged self-interest. AB 290, the California statute at issue...

Firm Secures Appellate Victory on Behalf of Brita Products Company

On April 16, 2026, the firm secured an appellate victory on behalf of Brita Products Company ("Brita"), a unit of The Clorox Company, in a putative class action challenging the labeling of Brita's water filtration products. The U.S. Court of Appeals for the Ninth Circuit upheld a lower court ruling dismissing the complaint, agreeing that the product labeling contained no misstatements and would not mislead a reasonable consumer. Plaintiff originally sued Brita in the U.S. District Court for the Central District of California, alleging that certain representations on the products’ labels, such as “Cleaner, Great-Tasting Water,” implied that the filters fully remove all contaminants from tap water or reduce them to levels below lab detection limits. The district court granted Brita’s motion to dismiss...

Jenny Longman to Speak at American Bar Association's 2026 May Tax Meeting

On Friday, May 8, Counsel Jenny Longman will speak on a panel at the American Bar Association's 2026 May Tax Meeting entitled "Entering the U.S. Tax System: Key Rules, Risks, and Planning Opportunities for High Net Worth Individuals." Ms. Longman will join Heather Fincher (Associate, Kostelanetz), Kirsten Burmester (Member, Caplin & Drysdale), Seth Entin (Shareholder, Greenberg Traurig), and John Fusco (Principal, EY) to share an overview of important U.S. federal income and transfer tax considerations for high-net-worth individuals and families seeking to immigrate to the U.S., along with practical strategies for evaluating existing structures, reducing risks of double taxation, and identifying planning opportunities while avoiding common pitfalls. To learn more, please click here.

Firm Achieves Significant Lanham Act Win for Johnson & Johnson

On April 17, 2026, Patterson Belknap secured a significant victory for our clients, Johnson & Johnson and Janssen Biotech, Inc. (“J&J”), when the U.S. District Court for the Southern District of New York denied a preliminary injunction in a Lanham Act suit filed by Bayer HealthCare LLC (“Bayer”). The dispute concerned a retrospective scientific study sponsored by J&J that compared the real-world efficacy of both companies’ prostate cancer medications, concluding that J&J’s ERLEADA was associated with a reduction in overall risk of death approximately 50% greater than Bayer’s NUBEQA. Bayer alleged that the study was methodologically flawed, and that J&J’s publication of the study results therefore constituted “false advertising.” The statements at issue included a presentation given by the study authors at a medical...

Fresenius Ruling May Shift Anti-Kickback Enforcement

When is it illegal to donate to a charity? According to the federal government, when you're a pharmaceutical manufacturer, and the charity helps Medicare patients afford your medicines. The government has argued that such donations may be illegal kickbacks. Courts have largely agreed with this view, but a recent decision by the U.S. Court of Appeals for the Ninth Circuit in Fresenius Medical Care Orange County LLC v. Bonta raises new doubts, suggesting that businesses have a First Amendment right to donate to certain charities — even when those donations are motivated by economic self-interest and have distortive economic effects. To continue reading Jonah Knobler's article in Law360, click here.

Bankruptcy Court Denies Motions to Convert Case and to Appoint an Examiner

A bankruptcy judge has ruled that a debtor can satisfy the Bankruptcy Code’s rehabilitation standard by selling its assets as a going concern and thereby avoid conversion from chapter 11 to chapter 7. In the same decision, the court denied a motion seeking the appointment of what the movants called an “examiner with expanded powers.” In re Deqser, LLC, Case No. 25-10687, 2026 Bankr. LEXIS 1004 (Bankr. D. Del. Apr. 22, 2026). The debtors operated a laundry business that serviced hotels located in New York City. The business suffered a downturn following an electrical fire at its facility as well as problems with its software. The debtors filed chapter 11 in early 2025. During their case, the debtors lost about $200,000 a...