Products Liability Pointers - Volume II, No. 10


Volume II, No. 10

Friday, October 15, 2021
A Monthly Electronic Newsletter

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As a public service, Hurwitz & Fine, P.C. is pleased to present this monthly e-newsletter providing summaries of and access to the latest products liability decisions from the New York State and Federal courts. The primary purpose of this newsletter is to provide timely educational information and commentary for our clients and subscribers. In some jurisdictions, newsletters such as this may be considered Attorney Advertising.

Strict Products Liability
Design & Manufacturing Defects
Failure to Warn
Breach of Warranty
Medical Device Litigation
Governmental Agencies and Regulations
Toxic Torts, Asbestos and Lead Paint



We have made it to October, but there is nothing frightening about this month thus far!   The weather has been amazing, fall foliage is at its peak, and the Buffalo Bills are legit contenders.  I even returned to the courtroom for trial in the Western District and am happy to report that even though our client did not contribute, the case settled shortly after opening statements.  It’s a cautionary tale, however, about the risk of trying cases in the midst of a pandemic.  We were informed a few days later that a courtroom employee was sick and had tested positive for COVID, which would have blown up the whole trial after many of the well-paid experts had testified.
We have more exciting firm news to share this month:

  • Hurwitz & Fine welcomed five new associates pending admission to the firm’s General Litigation and Insurance Coverage teams. This is the largest hiring class we have ever had in the firm’s 44-year history!
  • We are proud to announce that Hurwitz & Fine is participating in the Midsize Mansfield Rule Certification program. This national diversity certification is an 18-month rigorous process designed to increase the representation of diverse lawyers in leadership by broadening the pool of women, LGBTQ+ lawyers, lawyers with disabilities, and racial/ethnic minority lawyers who are considered for entry-level and lateral attorney job openings, leadership opportunities, equity partner promotions, and opportunities to connect with clients. This certification is another positive step we are taking as a firm toward achieving our goals of creating and maintaining a diverse team of attorneys to partner with our clients.

Our Labor & Employment Team continues to provide up-to-date COVID-19 related employment advice with their latest update on the New York HERO Act discussing the extension to the requirements placed on employers to implement COVID workplace safety plans.  COVID has not only taken its toll physically, but mentally as well.  Labor and Employment Member Joseph S. Brown, Esq. was featured in an interview with Buffalo Business First for his input on various employment law scenarios related to mental health in the workplace.   Further, Katherine L. Wood, Esq., offers her insight into some recent litigation filed by the Equal Employment Opportunity Commission (“EEOC”) alleging failure to accommodate and unlawful termination of a disabled employee who had previously requested to telework as an accommodation during COVID-19:  Telework as a Reasonable Accommodation During COVID: EEOC Takes a Stance
We do have some interesting products liability cases to discuss this month.  For all the epidemiology nerds out there, the Southern District provides a meticulous analysis in rejecting plaintiff’s causation experts on the claim that prenatal use of the antidepressant Lexapro is linked to childhood autism. A medical device defendant sought dismissal of a product liability claim on the ground of preemption – yet had failed to submit the evidence of the known defect as part of the rigorous FDA approval process for which it seeks shelter. In a claim involving defective software, the Western District provides a refresher on the “economic loss rule, ” which precludes a claim under strict products liability for purely economic damages claim absent injury to person or property.  The Second Circuit weighs in on a toxic tort bladder cancer claim, finding that the plaintiff’s expert was improperly excluded because the District Court relied on a state court evidence rule instead of the applicable federal evidence rule. Lastly, the Southern District of New York applied maritime law to dismiss an asbestos claim against a boiler defendant on a Navy ship.


And now for this month’s Halloween dad joke:

Knock, knock?
Who’s there?
Boo, who?
Don’t cry, it’s just a joke.


V. Christopher Potenza  ■  Member
Hurwitz & Fine, P.C.
1300 Liberty Building  ■  Buffalo, NY 14202
tel (716) 849-8900  ■ cell (716) 523-8941 ■ fax (716) 855-0874
Email:  [email protected]
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Your COVID-19 Resource Center: Legal Updates Regarding the Coronavirus
Our teams are hard at work keeping you updated on the latest New York State and Federal updates concerning the coronavirus. Our Resource Center compiles all of the information that could affect you and your business during this pandemic.


Don’t forget to subscribe to our other publications:

Coverage Pointers: This twice-monthly electronic newsletter summarizes important insurance law decisions from appellate courts in New York State with the occasional snapshot across borders. Contact Dan Kohane at [email protected] to subscribe.

Employment & Business Litigation Pointers:  Employment & Business Litigation Pointers aims to provide our clients and subscribers with timely information and practical, business-oriented solutions to the latest employment and general business litigation developments.  Contact Joe Brown at [email protected] to subscribe.

Labor Law Pointers:  Hurwitz & Fine, P.C.’s Labor Law Pointers offers a monthly review and analysis of every New York State Labor Law case decided during the month by the Court of Appeals and all four Departments. Contact Dave Adams at [email protected] to subscribe.

Medical & Nursing Home Liability Pointers:  Medical & Nursing Home Liability Pointers provides the latest news, developments, and analysis of recent court decisions impacting the medical and long-term care communities.  Contact Chris Potenza at [email protected] to subscribe.

Premises Pointers This monthly electronic newsletter covers current cases, trends and developments involving premises liability and general litigation. Contact Jody Briandi at [email protected] to subscribe.


Design Defect
By: V. Christopher Potenza
[email protected]
9/03/21         Daniels-Feasel, et al., v. Forest Pharmaceuticals Inc.
United States District Court, Southern District of New York
In dismissing a claim that prenatal use of antidepressant Lexapro is linked to autism, the District Court presents a case study on how to analyze epidemiology case studies.
This case involves product liability claims regarding the effects of Lexapro, a prescription antidepressant medication. Plaintiffs are women who allegedly ingested Lexapro during pregnancy, and their minor children who allegedly suffer from autism spectrum disorder ("ASD") as a result of their mothers' prenatal use of the drug. Defendants moved to preclude from introduction into evidence the expert testimony tendered by plaintiffs regarding the alleged causal relationship between Lexapro and ASD.

The depth of the court’s analysis into the methods and methodology of each expert is quite remarkable and worth a full read.

The question of whether there is a causal relationship between a prescription antidepressant medication and member of the therapeutic class of selective serotonin reuptake inhibitors ("SSRI") such as Lexapro and neurodevelopmental disorders, including ASD, is studied by epidemiologists. Epidemiology is the study of the cause of disease and its distribution in human populations. The process undertaken to reach any conclusions in epidemiology generally begins with an observation suggesting the possible link between an exposure and disease. Such an observation would lead to the formulation of a hypothesis that is then tested through “epidemiological studies of individuals who have been both exposed and unexposed to the putative risk factor, measuring the occurrence of disease in both groups.”

Here, plaintiffs proffered three experts who offer general causation and biological plausibility opinions regarding the relationship between Lexapro and ASD. Causation in pharmaceutical products liability, or toxic tort, cases has two components, general and specific, and the plaintiff must establish both in order to prevail.  General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury.
After extensive analysis, the District Court found the proffered opinions of all three experts unreliable.  The Court found that the experts relied on studies for conclusions they did not reach, cherry-picked data that supports their conclusions and failed to reconcile data that is inconsistent with or weakens their conclusions.   The Court further criticized the misleading representation of the available epidemiological data and failure to highlight or analyze inconsistent data.


Manufacturing Defects
By: Guest Columnist Cara M. Pascarella
I am excited to return for a second appearance in Product Liability Pointers.  Since the weather started to cool off on Long Island, my family decided there was no better way to get into the fall spirit than pumpkin picking.  To no surprise, almost every other Long Islander had the same idea, causing a standstill of traffic.  Once we finally arrived at the pumpkin patch, finding a park spot also proved difficult.  While parking about half a mile down the road didn’t seem problematic at first, carrying the pumpkins to the car was definitely a workout.  For anyone looking to pumpkin pick on Long Island, my suggestions are as follows: pumpkin picking in September and October will almost always be crowded; a close parking spot is essential, so the earlier you arrive the better; and if you must walk, make sure you pick a small and light pumpkin.
With no interesting caselaw this month on manufacturing defects, we instead look at the “economic loss rule” as a defense to strict products liability. 
9/02/21         Smith v. Pharos Systems International, Inc.
United States District Court, Western District of New York
District Court dismisses strict product liability claim for economic damages from software design defect.
The pro se plaintiff claimed allegations of negligence, strict liability, and products liability against the defendant corporation involved in the sale of print management software. Plaintiff alleged their software was defective and enabled 3rd party intrusions and invasions of privacy. Plaintiff used this design defect as the basis for her products liability claim, suggesting it posed a security risk to certain users and caused her to lose potential business income.
The Court classified plaintiff’s loss of potential business income as an economic loss and applied the economic loss doctrine. This doctrine indicates economic losses are not recoverable under a theory of negligence or strict products liability, including claims for design defect. Given that plaintiff only alleged economic losses and failed to allege any injury to person or property, she failed to state a viable claim against Pharos. Therefore, the Court dismissed Plaintiff’s Complaint for failure to state a claim.


Failure to Warn
By: Kara M. Eyre
[email protected]
It may be hard to believe, but the last quarter of 2021 is here, and things have been busy!  After many stops and starts over the last 18 months, cases are being moved through the courts, and litigators are feeling the burn.  It is an exhilarating time to be in practice.  Also, it’s that time of the month again . . . for Lady Facts, a lesser known but nonetheless inspiring fact about women in history.  The game Monopoly was invented by a progressive woman named Elizabeth Magie to teach about the dangers of income inequality.  Ms. Magie invented the game in 1904 with two sets of rules: the “Prosperity” set, where every player gained when someone acquired property, and the “Monopolist” set where players won by driving their opponents to bankruptcy.  Ms. Magie hoped that players would recognize the benefits of alternatives to capitalism’s zero-sum approach to property ownership.  Of course, Parker Brothers eventually bought Ms. Magie’s patent and re-launched the version of Monopoly we know today with just one set of rules that celebrate the triumph of one over all others. 
This month we have an interesting case from the Eastern District of New York which denied a pacemaker manufacturers’ motion to dismiss, finding that plaintiff’s claims were not subject to preemption when the company failed to disclose the very defect, which they were aware of, as part of the FDA approval process.
9/29/2021        Kaemmlein v. Abbott Laboratories et al.
United States District Court, Eastern District of New York
Eastern District of New York allows lawsuit for faulty pacemaker to proceed and not subject preemption where the alleged defect was concealed during the FDA approval process.
Plaintiff had surgery to upgrade his pacemaker to one manufactured by defendants.  A year later, plaintiff was notified that the device had a defect leading to undetectable premature battery depletion, which could have fatal consequences.  Plaintiff was thus forced to undergo surgery again to remove defendants’ unit and replace it with another device.  Plaintiff sued defendants and sought recovery for the unnecessary surgery based upon several New York State common law theories, including breach of implied warranty, negligence, failure to warn, misrepresentation by omission, and strict products liability.  Defendants moved to dismiss, arguing that the rigorous approval process of the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 360k(a), preempted Plaintiff’s causes of action. 
In its decision denying defendants’ motion, the District Court noted that the facts alleged in the Complaint and supporting FDA documents established that defendants had actively thwarted FDA approval and reporting requirements, as defendants knew about the battery issue long before plaintiff’s surgery and actively attempted to conceal its cause.  The District Court found that with their motion, defendants were seeking the legal benefit of the comprehensive FDCA federal regulatory scheme that they failed to properly comply with.
Under federal preemption doctrine, a private litigant cannot file suit solely to enforce violations of federal regulations, and thus lawsuits for noncompliance with medical device provisions of the FDCA are barred.  To avoid express or implied preemption, a plaintiff must thread the needle by suing for conduct that violates the FDCA but must not be suing because the conduct violates the FDCA.  In other words, to escape preemption, a litigant must base their claims “not upon the FDCA, but upon traditional state tort law which predates the federal enactments in question” (citations omitted).  The District Court found that plaintiff’s allegations in the Complaint fell squarely within these parameters, and their Complaint alleged facts that defendants violated the pertinent federal regulatory requirements without exceeding these requirements.


Toxic Torts, Asbestos, and Lead Paint
By: Nicholas J. Heintzman

This week’s fun Canada fact: the NBA regular season starts next week, and there are presently 26 Canadians on NBA rosters. This is a record for Canada. Former MVP Steve Nash remains easily the best Canadian player of all time. Of active players, the Oklahoma City Thunder’s Shai Gilgeous-Alexander, the New York Knicks' RJ Barrett, and the Denver Nuggets' Jamal Murray (from my hometown of Kitchener/Waterloo in Ontario) are all young players with enough talent to make multiple all-star teams, although none have done so yet. Nash and Jamaal “Big Cat” Magloire are the only Canadians in the history of the NBA to make all-star teams. Hopefully that changes this season.
This week, the United States Court of Appeals for the Second Circuit overturns a District Court’s decision to exclude plaintiff’s expert testimony on a chemical substance’s causation of bladder cancer.  And it’s anchors way as the Southern District of New York applies maritime law to dismiss an asbestos claim arising out of plaintiff’s work on a Navy ship.

10/06/21       Sarkees v. E. I. DuPont de Nemours and Co.
United States Court of Appeals for the Second Circuit
The Second Circuit overturns a District Court’s Decision to Exclude Expert Testimony on a Chemical Substance’s Causation of Bladder Cancer.
In 1974, when plaintiff was 19, he worked for seven months unloading railroad tank cars containing a chemical called ortho-toluidine (“OT”), drove a forklift loaded with Nailax (a substance made with OT), and he manually cleaned Nailax reactors and packaged Nailax. Defendants E.I. DuPont de Nemours and Company and First Chemical Corporation (collectively “defendants”) manufactured the chemical products plaintiff was exposed to. Plaintiff was diagnosed with bladder cancer in 2016 at 61 years old, 42 years after the exposure. Plaintiff files suit alleging that his bladder cancer was caused by his OT exposure from defendants’ products. Defendants moved to exclude the expert testimony of plaintiff’s specific causation expert and to dismiss the complaint. The District Court granted defendants’ motion.
On Appeal, the Court first noted that the District Court improperly applied New York state evidence law to determine the admissibility of the expert testimony. Since evidence is a procedural question, the Federal Rules of Evidence and accompanying federal law should have been applied.
The expert testimony was given by Dr. Christine Oliver. She concluded that plaintiff’s’ exposure to OT was a substantial contributing factor in his development of bladder cancer. The Second Circuit reversed and found that her testimony on causation was admissible. The Court found the following several factors particularly dispositive. Dr. Oliver had decades of experience in occupational and environmental medicine. She had personally inspected the subject plant a few years after plaintiff worked there. Her testimony acknowledged both positive and negative inferences for the amount of OT exposure plaintiff received. Dr. Oliver worked off a set of studies that were well-respected and reliably showed that OT exposure vastly increased the risk of bladder cancer. Dr. Oliver also noted non-OT factors that could elevate risk of bladder cancer and demonstrated that those alternative factors were not present in plaintiff’s life. Defendants argued that Dr. Oliver failed to provide a quantifiable range of plaintiff’s actual OT exposure. However, Dr. Oliver carefully reviewed available data, and precise quantification is not required for her testimony to be admissible.
09/16/21       Phelps v. CBS Corp.
United States District Court for the Southern District of New York
United States District Court Applies Maritime Law to Dismiss an Asbestos Claim Arising from Plaintiff’s work on a Navy Ship.
Plaintiff filed suit against defendant manufacturers, alleging that he developed mesothelioma due to exposure to asbestos containing products while working at the Brooklyn Navy Yard in the early 1960s. Defendant Foster Wheeler manufactured boilers that were aboard a ship plaintiff worked on. Foster Wheeler denied that their boilers required, used, or incorporated asbestos-containing products, and moved for summary judgment.
The Court first held that, under the two-part Grubart test, maritime law applied to plaintiff’s claims. First, under the “location test,” the Court determined that the alleged tort occurred on navigable water, notwithstanding that the USS Constellation was dry-docked when plaintiff was allegedly exposure. Then, under the “connect test,” the Court determined that because plaintiff was a naval worker injured while doing maintenance work in a ship’s boiler rooms, his injury had both a “disruptive impact on maritime commerce” and a “substantial relationship to traditional maritime activity.”
Applying maritime law, the Court used the three-part DeVries test, under which a manufacturer has a duty to warn when: 1) its product requires the incorporation of a part; 2) the manufacturer knows or has reason to know that the integrated product is likely to be dangerous for its intended uses; and 3) the manufacturer has no reason to believe that the product’s users will realize that danger. Under the first prong, the Court determined that Foster Wheeler never directed the Navy to incorporate any asbestos containing products into its boilers. Thus, the Court held that Foster Wheeler had no duty to warn under maritime law, and the Court granted its summary judgment motion.


V. Christopher Potenza
[email protected]

Brian F. Mark
[email protected]

Kara M. Eyre
[email protected]

Nicholas J. Heintzman


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