Mitigating Litigation Risks with 3D Printing in Life Sciences

With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality.  Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]

Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.

To read the full text of this article by Duane Morris partner Sean Burke, please visit the 3DHeals website.

California Federal District Court Dismisses COVID-19 “Fear Cases” Against Princess Cruise Lines Holding Plaintiffs Cannot Recover Based Solely on Proximity and Fear of Contracting the Disease

On Wednesday, the District Court for the Central District of California granted Princess Cruise Line’s (“Princess Cruises”) Consolidated Motion to Dismiss all 13 “Fear Cases” stemming from the COVID-19 outbreak on the Grand Princess cruise ship.  The Grand Princess, bound for Hawaii, originally departed San Francisco on February 21, 2020 with 2,422 passengers and 1,111 crewmembers onboard.  On March 6, two weeks into the journey, of the 46 people tested on board, 21 people tested positive for COVID-19.  Three days later, while docked at the Port of Oakland, two passengers, Ronald and Eva Weissberger (while still on the ship), filed a lawsuit against Princess Cruises alleging negligence and gross negligence for failing to take necessary precautions and employ proper screening protocols to keep its passengers and crew safe.  Although the Weissberger’s did not test positive for COVID-19 nor suffer any symptoms, they filed a lawsuit seeking to recover for emotional distressed based on their fear of contracting COVID-19 while quarantined on the ship.  Soon after the Weissberger’s filed their lawsuit, numerous virtually identical lawsuits were filed against Princess Cruises.  These lawsuits, together with the Weissberger’s lawsuit, were termed the “Fear Cases” by the Court as they all involve plaintiffs who did not test positive or manifest symptoms of COVID-19 but who sought to recover solely based on their fear of contracting COVID-19 while on the cruise ship.  In an effort to preserve resources, Princess Cruise Lines filed a Consolidated Motion to Dismiss the 13 identical cases. [1]

As the Plaintiffs sought to recover damages only for their emotional distress and trauma of the fear of contracting COVID-19 while on the ship, the Court found the Plaintiffs’ claims for negligence and gross negligence were, in fact, claims for negligent infliction of emotional distress (“NIED”).  As the alleged injury occurred on a vessel on or over navigable waters, federal maritime law applied to Plaintiffs’ tort claims.  In order to recover for NIED under federal maritime law, a plaintiff must satisfy the “zone of danger” test, which limits recovery for emotional injury to plaintiffs who either (1) sustain a physical impact as a result of a defendant’s negligent conduct; or (2) are placed in immediate risk of physical harm by a defendant’s negligent conduct.[2]  Under the first category, a plaintiff must allege that their emotional distress accompanies a “physical impact”.  The mere exposure that poses some future risk of disease that only causes emotional distress does not constitute “physical impact”, rather, a plaintiff must manifest some symptom of the feared disease in order to recover.  Under the second category, a plaintiff must allege that the defendant’s negligent conduct placed that plaintiff in immediate risk of physical harm – for example, a “near-miss” collision case. Continue reading California Federal District Court Dismisses COVID-19 “Fear Cases” Against Princess Cruise Lines Holding Plaintiffs Cannot Recover Based Solely on Proximity and Fear of Contracting the Disease

New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers

On June 4, 2020, the U.S. Food & Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological product and device constituent parts. In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections  in which CBER is the lead center.

To read the full text of this Duane Morris Alert, please visit the firm website.

Third Circuit Seeks Help Deciphering Pennsylvania Strict Liability Law

On June 2, 2020, the Third Circuit, sitting en banc, took the unusual step of asking the Pennsylvania Supreme Court to decide a novel question of state law on strict liability for defective products sold through e-commerce websites in a case that will shape the future of products liability and online sales.

To read the full text of this Duane Morris Alert, please visit the firm website.

Two New Guidances from FDA for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19

On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products” and “COVID-19: Developing Drugs and Biological Products for Treatment of Prevention,” provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.

To read the full text of this Duane Morris Alert, please visit the firm website.

Liability Protections Under Consideration for Businesses Set to Reopen During the COVID-19 Pandemic

With the Senate set to return from recess on Monday, liability protections related to the COVID-19 pandemic are anticipated to be a hot button issue. While state and local governments are seeking financial aid from the federal government to assist in their battle against the COVID-19 pandemic, relief packages may also include protection from future legal actions against businesses.

As stay-at-home restrictions are beginning to be lifted, and businesses are starting to reopen, there are concerns that employees and customers will file suit against businesses, claiming that they were infected with COVID-19 as a result of the businesses’ failure to take appropriate measures to protect them once reopening occurs. This fear is likely in response to lawsuits that have already arisen against businesses related to COVID-19. For instance, earlier this month, a Celebrity Cruises crewmember, who contracted COVID-19 while working on a Celebrity ship, filed a proposed class action alleging that the cruise company failed to take adequate measures to protect the employees on its ships.[1] The crewmember filed the proposed class action in a Florida federal court, claiming that the cruise company failed to follow safety precautions after receiving notice that COVID-19 was or was likely present on the ships, such as permitting crewmembers to continue to eat in a buffet setting, and mandating crewmembers’ participation in shipboard drills.[2] Continue reading Liability Protections Under Consideration for Businesses Set to Reopen During the COVID-19 Pandemic

HHS Offers Details on Liability Immunity of PREP Act Following Passage of CARES Act

The Department of Health & Human Services (HHS) has provided an omnibus advisory opinion in response to various requests for clarification of the scope of tort immunity provided by the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act declaration provides immunity from tort liability for various persons, products and activities in response to COVID-19, as explained in our March 17, 2020, Alert. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) subsequently expanded these protections.

To read the full text of this Duane Morris Alert, please visit the firm website.

Artificial Intelligence and Machine Learning-Based Medical Devices: A Products Liability Perspective

Artificial intelligence (AI), once little-known outside of academic circles and science fiction films, has become a household phrase. That trend will continue to expand as the public becomes more exposed to AI technology in everyday products, ranging from their cars and home appliances to wearable devices capable of tracking the metrics of their everyday routines. Perhaps no facet of AI has sparked observers’ imaginations more than machine learning (ML), which is precisely as it sounds: the ability of computer programs to “automatically improve with experience.” Machine learning lies at the heart of the kind of independent and superhuman computer power most people dream of when they consider AI.

While the public’s imagination is free to run wild with the promises of ML—creating an appetite that will no doubt be met with an equal and opposite response from businesses around the world—traditional policy and law-making bodies will be left with the task of trying to adapt existing legal and regulatory frameworks to it. Therefore it bears consideration how existing products liability norms might apply to AI/ML-based products, if at all, and what sort of uncertainties may arise for product manufacturers, distributors, and sellers. No enterprise better illustrates the careful balance between the endless potential of AI against the unique risks of products liability concerns than the medical device industry. This article discusses the uses and unique benefits of AI in the medical device context, while also exploring the developing products liability risks.

To read the full article by Duane Morris partner Matthew Decker, visit the MD+DI website.

Depositions During the COVID-19 Crisis

With 95% of the country presently subject to stay-at home orders due to COVID-19, many litigators are considering whether and how to take depositions in the coming weeks. Federal court responses have varied, from blanket extensions of civil deadlines to encouraging remote depositions. Whether it is advisable or even permissible to depose a witness under current circumstances will depend on several factors, including the jurisdiction, the deponent, and the anticipated substance of the deposition.

Many Courts are Extending Discovery Deadlines:

Numerous courts have issued administrative orders extending all civil deadlines due to COVID-19. The District of New Jersey, for example, in Standing Order 2020-04, extended all filing and discovery deadlines which fall between March 25, 2020 and April 30, 2020 by forty-five days. See also, Standing Order 3:20-mc-105 (D.S.C. Mar. 16, 2020) (extending all civil deadlines); Standing Order 20-0012 (N.D. Ill. Mar. 30, 2020) (same).

Continue reading Depositions During the COVID-19 Crisis

Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL

On April 3, 2020, the United States District Court for the Southern District of Florida issued an order in the pending Zantac multidistrict litigation (”MDL”) requiring disclosure of funding arrangements and funding documentation between plaintiffs’ counsel and third-party litigation financiers. This order represents some increased traction in favor of arguments seeking to require disclosure of third-party funding arrangements in MDLs.

The Zantac MDL, In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, was originally formed by the Judicial Panel for Multidistrict Litigation on February 6, 2020. The plaintiffs sued various defendants, including manufacturer Sanofi and its distributors, alleging that the active ingredient in the heartburn medication Zantac breaks down to form a carcinogen that caused personal injuries. Included in the MDL are also six putative classes of consumers who sought refunds and economic damages based on their purchase of Zantac. Due to a number of actions already pending in the Southern District of Florida, the Panel transferred the remaining actions to that court to be assigned to the Honorable Robin L. Rosenberg.

Continue reading Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL