About Rebecca Trela

Rebecca Trela represents major pharmaceutical and medical device companies in complex civil litigation, including mass tort and single-plaintiff actions. She defends against claims involving allegations of strict liability, negligence, failure-to-warn, and consumer protection act violations. Read Rebecca's full bio

New Jersey Ethics Committee: Beware Marketers that “Lead” to Ethics Violations

Increasingly popular online “lead generation” services offering to connect attorneys with potential mass tort plaintiffs may expose counsel to ethics violations, the New Jersey Advisory Committee on Professional Conduct cautioned in two recent advisory opinions.

New Jersey attorneys are charged with the affirmative responsibility to “question whether the marketing company is improperly labeling its services,” the committee stated in a June 21, 2021 joint opinion with the Committee on Attorney Advertising.  On the same date, the Advisory Committee issued another joint opinion with the Committee on the Unauthorized Practice of Law offering further insight on the circumstances in which a permissible client lead becomes an improper for-profit referral.

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Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer.  Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”).   Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

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Defense “Victory” Against Employee’s Spouse in COVID-19 Exposure Case

On May 7, a California District Court Judge granted Victory Woodworks, Inc.’s (“Victory”) motion to dismiss all COVID-19 liability claims in plaintiffs Robert and Corby Kuciemba’s amended complaint. Kuciemba et al. v. Victory Woodworks Inc., No. 3:20-cv-09355 (N.D. Cal. 2020). Relying on a novel theory of liability, the Kuciembas alleged that Mr. Kuciemba contracted mild COVID-19 in the course and scope of his employment at Victory, and subsequently passed it on to his wife, who suffered a severe case of COVID-19 with lasting injury. The Kuciembas sought damages from Victory for Mrs. Kuciemba’s injuries related to COVID-19.

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PREP Act Does Not Require Federal Forum for State Law Negligence Claims Related to COVID-19

A New Jersey District Court Judge has ruled that the March 2020 federal liability immunity statute for pandemic-related countermeasures does not create a basis for federal jurisdiction, resulting in the remand of two COVID-19-related personal injury actions.

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The Ship Has Sailed on Plaintiffs’ Efforts to Recover for Mere Fear of Contracting COVID-19

On February 21, 2020, the cruise ship Grand Princess embarked from San Francisco, headed to Hawaii.  Among the ship’s 3,533 passengers and crew were 62 people who had been exposed to COVID-19 on the ship’s immediate prior trip to Mexico.  The Hawaii voyage was curtailed and the ship docked off the cost of California for two weeks, during which passengers were confined to their rooms and two dozen people tested positive.  A number of personal injury lawsuits followed, the majority of which have been coordinated before Hon. R. Gary Klausner in the U.S. District Court for the Central District of California.

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FDA Gives Guidance on Reporting Medical Device Shortages

Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or surgery.  If there is an anticipated (or actual) disruption that may result in a shortage based on increased demand or supply-side interruption, the FDA must be notified no later than seven calendar days from the onset.  The requirement to notify the Agency applies to a broad range of devices and equipment, and lasts for the duration of the COVID-19 emergency.

The FDA’s guidance on this topic arises out of the March 27, 2020, CARES Act amendments to the Food, Drug and Cosmetic Act.  Those updates, codified at 21 U.S.C. § 356j, mirror similar provisions for prescription drug shortages implemented in December 2016.  While the statutory provisions contemplate that a device manufacturer would provide notice to the FDA of an anticipated shortage or interruption at least six months in advance, or “as soon as is practicable,” the recent guidance recognizes that this may not be possible under current market conditions.

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