Erica Abshez Moran

Erica Abshez Moran helps clients prevent, defend, manage and resolve product liability litigation. Erica has been involved in all stages of litigation, including bringing multiple cases to trial. Her experience includes case evaluation and client counseling, drafting pleadings and motions, managing pre-trial discovery, negotiating with opposing counsel, trial preparation, and second-chairing arbitrations.

View the full bio for Erica Abshez Moran at the Faegre Drinker website.

Articles by Erica Abshez Moran:


The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

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Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show no sign of slowing, as the number and type of medical device products that are connected to the cloud increase (thereby increasing the attack surface for hackers), and as hackers become more sophisticated. Indeed, in a September 2022 FBI Private Industry Notification, the FBI noted that around 53% of connected medical devices and other internet of things (IoT) devices in hospitals had known critical vulnerabilities. These vulnerabilities could allow hackers to direct medical devices to give inaccurate readings, administer drug overdoses, or otherwise endanger patient health.

In the past, the U.S. Food & Drug Administration (FDA) has urged manufacturers to take measures to ensure the cybersecurity of their products through non-binding guidance. On December 29, 2022, President Biden signed into law the $1.7 trillion Omnibus Appropriations Act, which provided the FDA with authority to require manufacturers to take cybersecurity protection measures as to medical devices that are brought to market through future pre-market submissions. See H.R. 2617 (117th Congress, 2021-2022), text available here.

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Let Me Google That for You: A Recent Central District of Illinois Opinion Highlights the Limits of Googling by Expert Witnesses Under Rule 702 and Daubert

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While we all rely on Google or other internet search engines to find and absorb information quickly these days, a recent decision in the Central District of Illinois highlights the problems for expert witnesses relying on internet research as a methodology. See Sherman v. BNSF Railway Co., Case No. 1:17-cv-01192, 2022 WL 138630 (C.D. Ill. Jan. 14, 2022). While Googling is likely a practice that many experts may engage in (though may be loathe to admit it), Google searching alone is a suspect methodology upon which to base expert opinions.

In Sherman, Plaintiff sued Defendant BNSF Railway Co. (BNSF) pursuant to the Federal Employers’ Liability Act, alleging that during her employment with BNSF, she was exposed to toxic substances and carcinogens, including asbestos, that caused her to develop rectal cancer.

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CPSC’s Expanding Role under the Biden Administration

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During the Trump administration, the number of consumer product safety recalls fell for three years in a row. When Robert Adler became Acting Chair of the U.S. Consumer Product Safety Commission (CPSC) in 2019, he compared his role to that of a caretaker. Now, under the Biden administration, the CPSC is undergoing a shift toward increased regulation and more aggressive enforcement. Acting Chair Adler confirmed the same earlier this year, stating that the Biden administration “clearly views product safety in different terms,” and that he “plan[s] to modify [his] job’s metaphor from caretaker to gardener.”

This shift in thinking is evident in the CPSC’s actions in recent months. Since President Biden’s inauguration, the CPSC has announced 57 product recalls in addition to a $7.95 million civil penalty settlement with Cybex International, Inc. for alleged failure to immediately report a known product safety defect related to its exercise equipment. And on April 17, the CPSC issued an urgent warning to consumers to stop using the Peloton Tread+ exercise machine around small children or pets. The CPSC noted that though its investigation of reported incidents of injury or death related to the machine was still ongoing, it had “found that the public health and safety requires this notice to warn the public quickly of the hazard.”

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Considerations from the ABA’s Best Practices for Litigation Funding

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The exact dollar amount that third-party investors infuse in U.S. lawsuits every year is unknown, but conservative estimates begin around $2.3 billion, with agreement that the industry has room to grow. With the ongoing pandemic stretching litigation timelines and straining budgets, the litigation funding industry remains highly active. Despite the importance of litigation funding to all parties involved (lawyers, plaintiffs, and defendants), regulation varies by state, and litigation funders are largely left to self-regulate.

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FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional”

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The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional.” The FOA relates to the FDA’s RWE Framework published in December 2018, and is issued “to support research projects that examine real-world data (RWD), real-world evidence (RWE), and related issues such as data analytics, the use of digital health tools, and innovative trial designs utilizing healthcare settings.”

The FOA specifically seeks the submission of proposed projects that explore the utility of RWD and RWE in the generation of evidence supporting regulatory approval of new indications of use or post-approval study requirements for approved medicines. The FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWE is “clinical evidence about the use and potential benefits or risks of a medical product derived from analysis of RWD.”

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