Products Liability Pointers - Volume II, No. 9


Volume II, No. 9

Friday, September 10th, 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



It’s back to school time!  While normally this is a time for rejoice for parents, this year, like last, is filled with much stress and anxiety with the Delta variant causing a substantial increase in COVID-19 cases in children.  I hope that the return to the school routine will not be short-lived, so let’s all do our part to keep our children safe and schools operating with in-person instruction. 
We have a lot of exciting firm news to share.  I’m happy to announce that we were recently honored as a finalist in Buffalo Business First’s 2021 Healthiest Employers. We owe this to our internal Safety & Wellness Committee, who continually brainstorm and sponsor firm activities to contribute to the well-being of everyone at the firm.
I would also like to take the time to congratulate those that appeared in the 2021 Upstate New York Super Lawyers list. A total of 28 Hurwitz & Fine attorneys made the list this year, an amazing achievement both for those individuals and our firm as a whole. Products columnist Kara M. Eyre was also highlighted in the list as an Upstate New York Rising Star.
Additionally, we had 21 attorneys recognized by Best Lawyers in America. A special mention goes to Ann E. Evanko for her distinction as Best Lawyers 2022 Mediation “Lawyer of the Year” in Buffalo!
Lastly, congratulations to Firm President and Managing Member Jody E. Briandi for her spot on Buffalo Business First’s 2021 Power 200 Women!
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 and What New York Employers Need to Know About Implementing Their Workplace Safety Plans.
We are also excited to feature a guest columnist this month as Cara Pascarella of our NYC Metro office enlightens us on a Second Circuit drug label federal preemption decision.  The Connecticut District Court entertains a host of issues in a baby formula infant death case, and certifies the question of the "learned-intermediary doctrine" to the Connecticut Supreme Court.  The Southern District of New York declines to exercise jurisdiction in an asbestos claim involving California exposure and a foreign successor-liability defendant but grants plaintiff the option of transferring to California District Court.  Lastly, it’s been a while, and the decision itself is not terribly interesting, but we do have a new lead paint appellate decision. 
And now for this month’s return to school dad joke:
What is the leader of all school supplies?
The ruler.


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.


Manufacturing Defects
Guest Column By: Cara M. Pascarella
[email protected]
I am excited to guest write for this month’s Products Liability Pointers. Born and raised in Dix Hills, in Suffolk County, the Melville office is (literally) in my backyard. Although I would argue there is no better place than Long Island in the summer, I decided to venture towards the rest of the firm for Labor Day weekend. According to my Buffalo colleagues, this is what most people call “upstate.”
Since the eight-hour drive to Buffalo would take up most of the weekend, I settled for a three-hour trip to the Catskill Mountains. While I usually only make this trip to enjoy the ski slopes, Hunter Mountain offered an interesting summer twist on mountain adventures… ziplining! There were two choices: a midmountain adventure, which is only a mere 60 feet above the ground and a skyride tour, which is 600 feet above the ground. We decided to live dangerously and do the skyride tour.  While I started out holding on for dear life and refusing to look down, I’m happy to say by the end I was hanging one handed and optimizing go-pro footage. For anyone looking for an adventure and an awesome view of the mountains, I highly recommended!
As a reward for my survival, it is only fair to bring you a preemption decision this month. The Second Circuit recently agreed with the First Circuit in addressing when a change to a drug label will be considered “major” and thus subject to FDA approval and preemption by federal law.

8/06/21           Ignacuinos v. Boehringer Ingelheim Pharmaceuticals Inc.
United States Court of Appeals, Second Circuit
Second Circuit finds that proposed change to a drug label is considered “major” and subject to FDA approval, and thus plaintiff’s state law claims are preempted by federal law.
The plaintiffs were prescribed a metered-dose inhaler to help alleviate symptoms of chronic obstructive pulmonary disease. According to the product’s label, it would deliver 120 doses before running out. In 2016, the FDA approved an updated label to note the possibility of the inhaler delivering less doses due to human error. The plaintiffs’ inhalers delivered significantly less than 120 doses and as a result, they claimed physical and economic injuries.
Specifically, the plaintiffs argued that the defendants failed to comply with state laws that required them to provide the labeled number of doses. When a plaintiff brings a design and manufacturing defect claim regarding whether a drug manufacturer has breached its duties under state law, the court will look to whether the change would require FDA approval. If a manufacturer needs FDA approval to comply with state duties, then the lawsuit will be preempted by federal law.

According to 21 C.F.R. Section 314.70, a manufacturer must obtain prior FDA approval for any “major” change to the design and manufacturing of an already approved drug product. Section (b)(1) of the statute outlines that a change in drug design or manufacturing requires pre-approval from the FDA if it has a “substantial potential to have an adverse effect.” Section (b)(2) provides a specific but non-exhaustive list of these changes. 

The issue posed by the plaintiffs was whether a manufacturer must show that a change has a “substantial potential to have an adverse effect” to qualify as a “major” change, even if the change is specifically listed in section (b)(2).  The Court held the answer was no. They agreed with the First Circuit and found if a change fits under any of the categories listed in section (b)(2), that change constitutes a “major” change requiring FDA pre-approval, regardless of whether the defendant has shown the substantial potential for an adverse effect.


Failure to Warn
By: Kara M. Eyre
[email protected]
I love September.  The New Year gets all the credit when it comes to making a fresh start, but growing up, I always loved getting ready for the new school year – finding that first day outfit, meeting a brand-new teacher, and (nerd alert) opening that clean, fresh, homework planner! No matter what happened the year before, everyone starts with a clean slate. 
On that note . . . it’s that time of the month again for . . . Lady Facts, a lesser known but nonetheless inspiring fact about women in history:  Maria M. Love was a prominent Buffalonian and social services pioneer who founded the very first modern daycare center.  Founded in 1881 in Buffalo, New York, this daycare center was meant to provide support and stability for the children of working mothers.  It also was the first to implement a Froebel Kindergarten in the United States and became a model for other daycares nationally.  
In products news, in Hunte v. Abbot Laboratories, the District Court of Connecticut dismissed certain claims but permitted others to proceed in a lawsuit brought against Abbott Laboratories, Inc., alleging that its baby formula made with cow’s milk caused a premature infant’s death, and certified two questions to the Connecticut Supreme Court.

8/19/2021        Hunte v. Abbot Laboratories, Inc.
United States District Court, D. Connecticut
The Second Circuit refuses to dismiss the totality of plaintiff’s claims against manufacturer of baby formula following the death of a premature infant and certifies two questions for review to the Connecticut Supreme Court.
Plaintiff filed suit against Abbott Laboratories on behalf of her late son, who was born prematurely at 27-weeks and spent his entire three-month life in the NICU at Yale New Haven Hospital.  During this time, he was fed three of Abbott’s cow’s-milk-based infant formulas.  Plaintiff alleged that those formulas caused him to develop necrotizing enterocolitis (“NEC”) leading to his death.  Plaintiff sued defendant on multiple theories under the Connecticut Product Liability Act (“CPLA”), including failure to warn, design defect, negligent design and post-sale duty to warn, negligent misrepresentation, breach of express warranty. Plaintiff also alleged a cause of action for violating the Connecticut Unfair Trade Practices Act (“CUPTA”), and for intentional misrepresentation and loss of filial consortium under Connecticut Common Law.
Noting its prior ruling in the factually analogous case, of Ferry v. Mead Johnson & Co., the Court refused to dismiss plaintiff’s failure to warn and/or instruct claims because they depend on the threshold question of whether the warnings were adequate to warn medical professionals, or, rather, consumers.  This depends on whether the learned intermediary doctrine applies, which requires guidance from the Connecticut Supreme Court given the issue’s importance and broad potential implications.  The parties were allowed 30 days to submit facts that are relevant to the issue.
The Court also declined to dismiss plaintiff’s negligence claims.  Specifically, the Court found that plaintiff stated a plausible claim for negligent design by alleging that Abbott knew of the dangers of NEC and cow’s-milk based formula but continued its production and sale.  Similarly, the Court determined that plaintiff’s allegations that Abbot became increasingly aware of scientific evidence that cow’s milk causes NEC, but instead of warning consumers, continued selling and distributing its cows-milk based products without warning. 
The Court granted defendants’ motion to dismiss plaintiff’s negligent misrepresentation claim, finding that Plaintiff’s allegations were couched in fraud-like terms of “known falsity” requiring a heightened fraud pleading standard.  The Court concluded that plaintiff’s general allegations failed to meet that threshold, as the Complaint contained no allegations that she relied on any of Abbotts misrepresentations to their detriment.  Similarly, the Court also dismissed plaintiff’s breach of express warranty claims, finding that plaintiff’s allegations that she was exposed to pervasive marketing and did not know to prohibit doctors from feeding Abbott’s products to her son, failed to identify any statement that could be the basis of an express warranty that caused harm to her son.  Allegations of general marketing techniques are not enough to establish specific statements forming an express warranty.
The Court also dismissed plaintiff’s intentional misrepresentation claim, finding that Plaintiff failed to meet the pleading standard for fraud set forth in Fed. R. Civ. P 9(b) that “[m]alice, intent, knowledge, and other conditions of a person’s mind may be alleged generally.”  As with her claims of negligent misrepresentation, the Court held that general allegations regarding defendant’s marketing practices failed to set forth a plausible claim for negligent   misrepresentation.  Moreover, the Court determined that plaintiff failed to allege that she relied on any alleged misstatement to her detriment.
The Court readily dismissed plaintiff’s claim that Abbott violated CUTPA, citing long-known precedent that CUPTA is preempted by the CPLA, and stated that plaintiff’s CUPTA claim was “nothing more than a product liability act claim dressed in the robes of CUPTA.”
Lastly, the Court certified plaintiff’s claim of a loss of filial consortium to the Connecticut Supreme Court, finding that it is an open question whether Connecticut law recognizes such a cause of action, noting that the only statutorily mandated loss of consortium claim is one of spousal consortium.   Defendants did not argue that plaintiff’s design defect claims should be dismissed, and thus, it survived.


Toxic Torts, Asbestos, and Lead Paint
By: Nicholas J. Heintzman
[email protected]

Last month I returned home to Canada for four days. The trip was an outstanding success, and I was delighted to catch up with family and friends. Juggling time to see so many friendly faces was difficult, and, although I tried my best, the family cat Bella made me feel guilty about not petting her more when I left.
This week’s fun Canada fact: Canadian musician Drake’s new album, Certified Lover Boy, was released on September 3, 2021, and it quickly shattered Spotify’s record for the most-streamed album in a single day. The previous record was held by, you guessed it, Drake’s Scorpion, released in 2018. It appears the world cannot resist the allure of overly-sensitive Canadians rapping about fake friends. Sub-fact: Drake name drops Western New York’s Daemen College on the final track of the album.
We have two cases to report this month. The Fourth Department denies a defendant’s summary judgment motion in a classic battle of the experts on causation in a lead paint exposure case, and the United States District Court of New York transfers (potentially) an asbestos exposure case to California District Court on jurisdictional grounds.

08/26/21         Smith v. Cousins
Appellate Division, Fourth Department
The Fourth Department denies a defendant’s summary judgment motion on causation grounds in a lead paint exposure case.
Plaintiff sought damages for injuries she allegedly sustained because of lead paint exposure as a child. Defendant moved for summary judgment on the grounds that there was no evidence that plaintiff’s lead paint exposure caused her alleged cognitive defects and mental health injuries. The Court below denied defendant’s motion, and the Fourth Department affirmed. It held that where two experts held conflicting opinions on whether plaintiff’s lead paint exposure caused her cognitive and mental-health impairments, plaintiff successfully raised an issue of fact such that defendant’s summary judgment motion was defeated.
08/09/21         Paroni v. GE UK Holdings Ltd.
United States District Court, Southern District of New York
The United States District Court of New York denies personal jurisdiction on general and specific jurisdiction grounds but gives plaintiff the option of moving to transfer an asbestos exposure case to California District Court based on location of alleged exposure.
Plaintiff alleged that in the 1970s her decedent husband was exposed to asbestos from a turbine located at a wind turbine plant in California. The turbine was manufactured by Ruston Gas Turbines, Limited (“Ruston”), an English company that no longer exists. After several attempts to locate and sue Ruston’s proper successor in interest, including suits in California State Court and New York Federal Court, plaintiff identified General Electric UK Holdings Ltd. (“GEUKH”) as Ruston’s proper successor in interest. Plaintiff sued GEUKH in New York Federal Court. GEUKH moved to dismiss for lack of personal jurisdiction. The Court held that it lacked both general and specific personal jurisdiction over plaintiff.
For general jurisdiction, GEUKH had a parent company, General Electric (“GE”), with headquarters in New York City. Plaintiff attempted to “pierce the corporate veil” and argue that, since GE was headquartered in New York City, New York Federal Court had general jurisdiction over GEUKH. A finding of piercing the corporate veil for personal jurisdiction purposes requires that the parent company exercise “extraordinary control” over the subsidiary company. The Court held that since GEUKH had its own bank account which GE could not access, GE did not exercise “extraordinary” control over GEUKH such that personal jurisdiction existed over GEUKH.
Turning to specific jurisdiction, plaintiff argued that her claim arose out of transaction from the 2010’s in which GE purchased asbestos liabilities from Alstom SA (Rustom’s successor in interest prior to GEUKH) and subsequently transferred the liabilities to GEUKH. Since GE was headquartered in New York, plaintiff argued that this transaction occurred in New York and, as such, her claim arose out of New York. The Court found no evidence that such a transaction occurred, let alone one that occurred in New York. The Court also found that even if such a transaction occurred, plaintiff’s claim clearly did not “arise from it,” since decedent’s exposure occurred in the 1970’s and the transaction did not occur until decades later in the 2010’s.
Thus, the Court denied personal jurisdiction on general and specific jurisdiction grounds. However, the Court gave plaintiff the option to make a motion to transfer the case to California Federal Court, on the grounds that California had specific jurisdiction over the action, since decedent’s injuries occurred there.


V. Christopher Potenza
[email protected]

Brian F. Mark
[email protected]

Kara M. Eyre
[email protected]

Nicholas J. Heintzman
[email protected]

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