Products Liability Pointers - Volume III, No. 3


Volume III, No. 3

Friday, March 11, 2022
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



Hurwitz & Fine was proud to celebrate International Women’s Day this week.   As a woman-led law firm for multiple generations, Hurwitz & Fine has a long history of encouraging, supporting and hiring women and minority lawyers and advancing them to the ranks of partner and equity owners.

In fact, our current President/Managing Partner, Jody E. Briandi, began her legal career at the firm as an associate attorney, as did her predecessor, Ann E. Evanko. We find it important and vital to our organization to celebrate and commend all women that #BreakTheBias in their everyday lives. 

We have good news to share on the controversial Comprehensive Insurance Disclosure Act (“CIDA)” as the substantial modifications in the form of Chapter Amendments were finally passed and signed by the Governor.  Our Insurance Coverage Team has also prepared this checklist detailing our obligations under the amended law. Please contact us to schedule CIDA compliance training for your team. 

  • The disclosure requirement would only apply to lawsuits files after 12/31/21 effective date, and not retroactively to pending cases;
  • Disclosures of policies or declarations pages would be required within 90 days after answer is filed, rather than 60 days. Declarations pages may suffice if agreed to by plaintiff, but plaintiff would have option to later request the policies;
  • Disclosure would no longer require the application to be included;
  • Disclosure of contact information for person adjusting the claim would still be required, but only name and email address;
  • TPAs would no longer be required to disclose the name of the person to whom they are reporting;
  • Disclosure would require provision of the total limits available under the policy after accounting for erosion/offsets;
  • The amendments eliminate disclosure of lawsuits that may erode the policy and attorney contact information from such lawsuits;
  • The amendments would eliminate attorney fee disclosure that may have eroded the policy limits;
  • Instead of a broad “ongoing obligation” to ensure disclosures remain accurate and complete, defendants must make reasonable efforts at the time of the filing of the note of issue, entering into negotiations, or mediation to ensure that information is accurate and complete;
  • PIP lawsuits would be expressly excluded.

There are no further developments at this time on the proposed “Grieving Families Act” (S.74-A/A.6770),  which would amend New York’s Wrongful Death Statue to permit the families of wrongful death victims to recover compensation for their emotional anguish, not just pecuniary loss, and extend the statute of limitation for wrongful death from two years to three and a half years from the date of fatality.  While the bill still sits in the Senate Judiciary Committee, there are formidable lobbying forces supporting its passage.  If you are interested in learning more on this topic, please read our article, Redefining 'Family': Emotional Damages and the Grieving Families Act, published by New York State Bar Association.
Some interesting products cases this month to discuss.  The Northern District acknowledges the so-called Scarangella defense, which can absolve product manufacturers from strict liability if they can establish that the buyer was aware of an optional safety feature and declined to purchase it.    The Northern District also addressed the scope of the “Learned Intermediary Doctrine” and whether a pharmaceutical manufacturer's duty to warn extends beyond giving an adequate warning through the prescribing physician, but to the patient directly.  The Southern District affirms that New York does not recognize a standalone cause of action for failure to test a product.  In MDL news, find out what happens when a manufacturer posits its own employee as an expert witness in disguise.  Lastly, in asbestos news, a NYCAL court addresses a defendant’s obligation to respond to product identification interrogatories following plaintiffs deposition. 

This month we have a products themed dad joke:

What do you call a manufacturer of just ok products?

A satis-factory.

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]


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.  

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 Defects
By: V. Chris Potenza
[email protected]

02/10/2022      Arnold v. Toyota Material Handling, Inc.
United States District Court, Northern District of New York
Buyer beware.  District Court acknowledges optional safety feature defense while denying motion as premature.
Plaintiff's co-worker was operating a 2006 Toyota Forklift behind the plaintiff. At some point, a roll of industrial paper fell off the forklift and crushed Plaintiff's left leg.  Plaintiff moved to amend the complaint to allege additional causes of action sounding in premises liability.  At the time defendants manufactured the forklift, plaintiff claims that “attachment options” were available such as paper roll attachments and automatic clamp leveling equipment that would make the forklift safe to use when lifting large rolls of paper.  Defendants opposed the motion, in part by arguing that plaintiff's proposed amendments are futile because plaintiff has not alleged facts sufficient to meet the test established in Scarangella v. Thomas Built Buses, Inc., 93 N.Y.2d 655, 661 (N.Y. 1991), in that there was an optional safety feature of which plaintiff's employer was aware and chose not to use.   

In Scarangella, the Court of Appeals established the principle that a product is not defective where the evidence and reasonable inferences therefrom show that: (1) the buyer is thoroughly knowledgeable regarding the product and its use and is actually aware that the safety feature is available; (2) there exist normal circumstances of use in which the product is not unreasonably dangerous without the optional equipment; and (3) the buyer is in a position, given the range of uses of the product, to balance the benefits and the risks of not having the safety device in the specifically contemplated circumstances of the buyer's use of the product. In such a case, the buyer, not the manufacturer, is in the superior position to make the risk-utility assessment, and a well-considered decision by the buyer to dispense with the optional safety equipment will excuse the manufacturer from liability.

The District Court noted that Scarangella and the factors stated therein may provide an excellent defense once the parties have conducted discovery and established the particular facts of this case. The owner's manual, upon which defendants rely, is not properly before the Court in the context of this motion to amend. The question here is not whether there is evidence that the defendants could use to argue that the warnings included with the device were adequate, or that there was an optional safety feature of which plaintiff's employer was aware and chose not to use. The question here is whether plaintiff has alleged facts sufficient to make plausible his right to relief. Defendants have not offered a basis for denying the motion to amend.


Manufacturing Defects
By: Brian F. Mark
[email protected]

Following the predictable increase in Covid cases following the holidays, the number of cases continues to decline significantly and mask mandates are being shelved.  We can expect that trend to continue as the warmer weather approaches.  I am starting to hear rumors that the courts are looking to resume regular in-person appearances.  Here’s to hoping for a return to normalcy.
This week I bring to you a case involving an allegedly defective pelvic mesh device. In Dupere v. Ethicon, Inc., the United States District Court for the Southern District of New York examined whether negligent testing alone could support a liability finding against a product manufacturer.  The Court agreed with the defendants and held that New York does not recognize a failure-to-test cause of action.

02/22/2022    Dupere v. Ethicon, Inc.
United States District Court, Southern District of New York
Testing, Testing.  Southern District finds that New York does not recognize a failure to test cause of action.
The plaintiff asserts that she agreed to undergo surgery to implant a pelvic mesh to treat stress urinary incontinence.  After developing vaginal mesh exposure, she underwent a second surgery to remove the device.  The defendants designed, manufactured, and marketed the subject pelvic mesh implanted in the plaintiff. 
One of the plaintiff’s negligence claims alleged the defendants breached a duty to adequately test the subject device for safety before and after launching the product, which rendered the product unreasonably dangerous and defective.  The defendants moved to dismiss, arguing that New York does not recognize a standalone negligence claim for failure to test a product. 
After careful examination, the Court determined that while evidence of testing or lack thereof may be submitted in connection with a particular claim, New York does not recognize a stand-alone failure-to-test cause of action. 


Failure to Warn
By: Kara M. Eyre

This month, in Reynolds-Sitzer v. Eisai, Inc. and Arena Pharmaceuticals, Inc., the Northern District of New York addresses the “Learned Intermediary Doctrine” and whether a pharmaceutical manufacturer's duty to warn extends beyond giving an adequate warning through the prescribing physician, but to the patient as well. 
It is also that time of the month again for . . . Lady Facts, a lesser known but nonetheless inspiring fact about women in history.  March is Women’s History Month, where we recognize the many contributions of all women in society, including Madam C.J. Walker, America’s first female self-made millionaire.  Born in Louisiana and orphaned at age 7, Ms. Waker developed her own line of cosmetics and hair care products and founded the Madam C.J. Walker Manufacturing Company.  Ms. Walker expanded her business, building a factory, hair salon, laboratory, and beauty school to train her sales agents.  She later became an activist and philanthropist and was heavily involved in advancing civil rights and economic opportunities for African Americans.

02/16/2022    Reynolds-Sitzer v. Eisai, Inc. and Arena Pharmaceuticals, Inc.
United States District Court, Northern District of New York
Learned Intermediary Doctrine provides that a pharmaceutical manufacturer's duty to warn is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.
Plaintiffs claims involved the prescription weight loss drug, Belviq, which was ultimately removed from the market once it was linked to increased cancer for patients.  Defendants moved to dismiss plaintiffs’ claims at the pleadings stage pursuant to FRCP 12(b)(6). 
Regarding Plaintiffs’ strict liability claim for defective design, defendants argued that plaintiffs failed to adequately allege the existence of a feasible alternative design, as is required.  Judge Hurd disagreed, finding that plaintiffs’ allegations that a safer alternative existed to Belviq’s mechanism as a serotonin receptor antagonist was sufficient to place defendants on notice of the nature of their claim, because further information was more likely to be within the scope of defendants’ technical expertise. 
Plaintiffs' failure to warn claims arise under theories of negligence and strict liability. Defendants do not seek dismissal of these claims to the extent that they are based on a duty to warn plaintiff’s prescribing physician. Rather, relying on the Learned Intermediary Doctrine, they seek dismissal only insofar as these claims allege defendants owed a duty to warn plaintiff directly, or for that matter anyone other than the prescribing physician.
Under New York law, a pharmaceutical manufacturer has a duty to warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist.  While the Court recognizes that the scope of a pharmaceutical manufacturer's duty to warn is governed by New York's Learned Intermediary Doctrine, the Court noted that plaintiffs clearly allege that defendants failed to warn both plaintiff and the prescribing physician. Thus, the allegations concerning a failure to warn plaintiff directly are superfluous and am motion to dismiss may be more appropriate after discovery.


Multidistrict Litigation
By: Michael J. Williams
[email protected]
Welcome to March!  It’s football free agency time when we learn what weapons #17 will lead in 2022.  But as much as we enjoy an end-around scramble from our favorite quarterback impersonating a running back, we need to be wary of our fact witnesses trying their own end-runs impersonating expert witnesses.  Sanofi U.S. Services, Inc. was recently flagged for this infraction, giving 12,000 multidistrict plaintiffs a fresh set of downs. 
In re: Taxotere (docetaxel) Products Liability Litigation, __ F.4th __, 2022 WL 405298
(5th Cir. 2022), on appeal from the United States District Court for the Eastern District of Louisiana No. 20-30184
The chemotherapy drug Taxotere is alleged to cause permanent alopecia (hair loss), leading to 12,000 cases in a multidistrict litigation centralized in the Eastern District of Louisiana.  Sanofi’s defense relied on two medical doctors:  former employee and 30(b)(6) corporate designee Dr. Michael Kopreski for factual matters, and Dr. John Glaspy as a properly declared FRE 702 expert. 
During deposition and at trial, Dr. Kopreski offered permissible FRE 701 testimony as to facts, subjective beliefs and opinions regarding Sanofi’s use of various studies.  However, his opinions reanalyzing that same data for litigation purposes relied on the scientific, technical, and other specialized knowledge reserved for experts under FRE 702.  Disclosed expert Dr. Glaspy, in turn, testified that he did not independently verify Dr. Kopreski’s results and, if they were wrong, “then none of my opinions are valid.”  At trial, Sanofi concluded that “you have to read the book to know how the story ends. And the only person in this case that did that was Dr. Kopreski.” 
The Fifth Circuit reviewed Dr. Kopreski’s story as a discretion-abusing tragedy, “a calculated and troubling end-run around Rule 702 and Daubert.”  The reanalysis – excluding “ongoing” alopecia sufferers from “permanent” ones to report a “a vanishingly small number” of side effects -- required a court’s gatekeeping against “unsupported speculation or subjective belief” by an expert cloaked in percipient clothing.  When parties risk veering their 30(b)(6)/FRE 701 witnesses into inadmissible expert testimony, Daubert’s gates remain barred to the FRE 702 expert who relies on that same inadmissible evidence without independent verification. 


Toxic Torts, Asbestos, and Lead Paint
By: Jesse L. Siegel
[email protected]

Our thoughts and prayers are with the people of Ukraine, who are fighting so courageously to defend their homeland. 
In this issue, a discovery dispute takes center stage in an asbestos case at the trial court level addressing the question of when product identification interrogatories served on an asbestos defendant are legitimate or an improper fishing expedition. 
For this month’s quasi-relevant sports fact comes from the world of baseball, where one can only hope that the owners and players in Major League Baseball can come to some sort of agreement, and we can find our way to stadiums to see games in the near future.  Last fall, it was determined that the Korean Baseball League (KBO) had high levels of asbestos in five of its seven stadiums.  Perhaps a lockout is better than playing in this instance?

01/12/2022         Ferrari v. A.O. Smith Water Products Co.
Supreme Court, New York County
Special Master properly ruled that defendant must turn over information by product identification interrogatory as request was relevant and specifically tailored.
In NYCAL litigation, the Special Master supervises discovery.  A discovery dispute arose as defendant refused to respond to product identification interrogatories following the completion of plaintiff’s deposition. The Special Master then recommended that defendant respond to product identification interrogatories. defendant appealed.
The Supreme Court, New York County ruled that plaintiff's product identification interrogatories were a means to obtain general information about defendant’s whereabouts at the time the plaintiff was exposed to asbestos.  The Court found that this information bore significance.  The plaintiff testified he was in the presence of defendant at one of the job sites during the plaintiff's career but could not specifically recall if the moving defendant was present at other pertinent jobsites. The Case Management Order (“CMO”) allows for the plaintiff to serve defendant with product identification interrogatories for the purpose of general information regarding worksites. Here, though plaintiff was inquiring about information that was general in nature, the Court found he was not conducting a fishing expedition to disadvantage the moving defendant.  The requested information was deemed relevant to the causal relationship between the plaintiff's exposure and Defendant’s liability.
Product identification interrogatories are deemed sufficient so long as the questions are “specific enough” to apprise defendant of the categories of items sought, which are narrowly defined.  Even though the request spanned a 40-year period, the plaintiff provided the specific job sites for defendant at which it may or may not have been present at the time the plaintiff was working.
The Court held that the burden lies with the defendant to establish that the requested documents are “utterly irrelevant to any proper inquiry”.  Defendant could not satisfy this burden with relevant specificity.



V. Christopher Potenza
[email protected]
Brian F. Mark
[email protected]


Michael J. Williams
[email protected]
Jesse L. Siegel
[email protected]


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