Products Liability Pointers - Volume II, No. 8

Volume II, No. 8
Friday, August 13th, 2021
A Monthly Electronic Newsletter
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
With summer winding down, our edition this month is rather short and sweet. There is a dearth of appellate decisions this time of year, and with the Delta variant causing more mask mandates and potentially more shutdowns, it’s important that we all get out and enjoy the waning days of summer.
There is no summer slowdown of the trial courts, however.  Faced with an enormous backlog and threat of potential future closures, trial dates are real and the trial courts are pressing hard to either get cases resolved or get them tried.
Today is also the day that the Child Victims Act expires, and we have seen a blitz of last minute filings.  Rest assured that our Child Victims Act and Sexual Misconduct Coverage and Defense Team is here for all your defense and coverage needs. 
Who can’t use a refresher on insurance coverage?  My esteemed colleague Dan Kohane will be presenting What Every Trial Lawyer Needs To Know About Liability Insurance on August 18, 2021, at 12:00 Noon,  through the New York State Bar Association.  This presentation is designed to provide a practical and empowering approach to liability insurance coverage issues.  Dan is always graciously available to give this or similar presentations to your group or team.
Our Labor & Employment Team continues to keep us up-to-date on Covid-related employment questions and claims.  Check out their latest piece, What Employers Need to Know About Long Covid Disability Claims.
Lastly, I would like to congratulate the Hurwitz & Fine softball team for advancing to the playoffs for the first time in over a decade!
There are some decisions of interest this month, including a District Court addressing a “contentious” issue of whether the “unavoidably safe product” defense applies to medical device claims, a preemption defense under the Federal Food, Drug, and Cosmetic Act, and a tale of caution from the Northern District, which remanded a claim back to state court on timeliness grounds despite a valid basis for Federal Office Removal Jurisdiction.
And now for this month’s dad joke:
Why were the Tokyo Olympics so hot?
Because there were no fans.
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
By: Brian F. Mark
[email protected]

Unfortunately, the Covid-19 numbers are once again on the rise in the NYC Metro area due to the Delta variant.  Based on the recent message from the Chief Judge Janet Difiore, there are some new protocols.  Courts are requiring regular testing for judges and non-judicial employees who have not been vaccinated.  Of note, masks are not required to enter and remain in public areas of the courts with proof of vaccination.  It remains to be seen whether these protocols will change if the numbers continue to increase.
In Baccaro v. Coloplast Corp., the District Court addresses the “contentious” issue of whether the “unavoidably unsafe product doctrine” applies to medical device claims.

7/22/21           Baccaro v. Coloplast Corp.
U. S. District Court, Northern District of New York
Design defect claim survives as District Court declined to apply the “unavoidably unsafe product doctrine” to surgical mesh case.
The plaintiff underwent a procedure to implant a vaginal mesh in an effort to minimize the effects of stress urinary incontinence.  Following a number of surgeries due to complications with the mesh, plaintiff and her husband commenced suit against the manufacturer of the device. 
The Court dismissed the plaintiffs’ manufacturing defect claim due to their failure to identify any defect in the manufacturing process.  The Court noted that the record did not contain any evidence that the material in the subject mesh was uniquely damaged or uncharacteristically poor, as opposed to simply being made of the same material that the product is usually made from.
As to the design defect claims, defendant argued that New York does not allow design defect claims at all against prescription-only medical devices because they are “unavoidably unsafe products.” Under New York law, a product is “unavoidably unsafe” if in the present state of human knowledge, it is quite incapable of being made safe for its intended ordinary use.  The District Court noted that while this defense applies to prescription medications, its application to medical devices is much more contentious.  In distinguishing the case law relied on by the defendants, the Court found a world of difference between a life-saving heart valve with an unexpected (but minor) side effect of excessive noise and a mesh to cure incontinence that can make the patient's problem with incontinence worse and invite a host of more debilitating consequences.  As such, the Court declined to apply the unavoidably unsafe product doctrine relative to plaintiffs’ design defect claims finding same inapplicable in this matter.
The defendants also argued that the plaintiffs failed to provide expert evidence of a feasible alternative design.  The Court rejected such an argument, finding that the plaintiffs’ burden was satisfied by their expert’s testimony that every design flaw in the subject mesh is cured by an alternative product, making the alternative design safer.

Failure to Warn
By: Kara M. Eyre

For me, August has been about embracing uncertainty.  My family, like many, continues to forge through uncertain territory with ever-fluctuating Covid-19 conditions and a new school year just around the corner.  For those with children under 12, this uncertainty is amplified without information on whether, or when, young children will be eligible for a Covid-19 vaccine.  One thing is certain, however . . . it’s that time of the month again. . . for Lady Facts, a lesser known but nonetheless inspiring fact about women in history.  Women have been key developers of the Covid-19 vaccine!  After over 40 years of perseverance without receiving a single NIH grant, biochemist Katalin Karikó pioneered the breakthrough mRNA technology that made the Pfizer/BioNTech vaccine possible.  British vaccinologist Sarah Gilbert was the co-developer of the Oxford/AstraZeneca Covid-19 vaccine, and was recently honored with a Barbie Doll sharing her likeness.  Women in STEM get things done!

For products news, in Glover v. Bausch & Lomb Inc., et al., the Second Circuit engaged in a detailed evaluation of preemption doctrine in the context of product liability claims brought by a plaintiff whose vision was permanently damaged by a medical device.

 7/20/2021        Glover v. Bausch & Lomb Incorporated et al.
United States Court of Appeals, Second Circuit
The Second Circuit certifies two questions to the Supreme Court of Connecticut regarding the application of Connecticut law to plaintiffs’ product liability claims for injuries from a medical device.

Plaintiff suffered pain and loss of vision after she was implanted with Trulign Toric intraocular lenses in both of her eyes to correct her vision following cataract surgery.  She and her husband sued the manufacturer, Bausch & Lomb (“B&L”), and related entities.  The District Court had granted Defendants’ motion to dismiss the negligence and failure to report claims under the Connecticut Product Liability Act (“CPLA”) as expressly and impliedly preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”) and denied leave to amend the complaint to add a claim under the Connecticut Unfair Trade Practices Act (“CUTPA”) based upon wrongful marketing. Plaintiffs appealed to the Second Circuit, which concluded that both issues turn on questions of state law for which no controlling decisions of the Supreme Court of Connecticut exist, and reserved decision certifying the two questions to the Supreme Court of Connecticut.
Failure to Report Under the CPLA
Plaintiffs argued that their negligence and failure-to-warn claims are not impliedly preempted because Connecticut law includes a cause of action based on failure to warn a regulator, such as the FDA, of known safety risks and failure to comply with a regulator's post-approval safety requirements, and thus those claims proceed under traditional tort law are not expressly preempted by the FDCA because they impose no requirements different from or in addition to those imposed by federal law.  After evaluating several medical device cases implicating possible implied preemption, the Court concluded that failure to report adverse events claims must not be based upon the FDCA, but rather, upon traditional state tort law.  As such, the Second Circuit certified the question to the Supreme Court of Connecticut as to whether a cause of action exists under negligence or failure to warn provisions of the CPLA, or elsewhere in Connecticut law, based upon an alleged failure to report adverse events to a regulator like the FDA following approval of the device, or to comply with regulator’s post-approval requirements.
Deceptive Marketing Under CUPTA
Regarding the denial of Plaintiffs’ motion to amend their complaint to add allegations that B&L violated CUPTA by deceptively and aggressively marketing and promoting the medical device causing injury to Mrs. Glover’s vision, despite knowing that it presented substantial risk of injury, the Second Circuit first addressed whether Plaintiffs’ CUTPA claims were preempted by the CPLA.  The Court noted that the CPLA’s exclusivity provision states that the CPLA is the exclusive remedy under Connecticut law “for harm caused by a product.”  The CPLA permits claims, including those brought under CUTPA, only if they are for “an injury not caused by the defective product, or if the party is not pursuing a claim for personal injury, death or property damage.”  The Second Circuit concluded that Plaintiffs’ CUTPA claims may only proceed if they are for deceptive marketing and are not, in effect, product defect claims in disguise.  Finding that this issue turns on Connecticut law, the Second Circuit certified the issue of whether CPLA’s exclusivity provision bars a claim under CUTPA based upon allegations B&L deceptively and aggressively marketed and promoted product despite knowing that it presented substantial risk of injury to the Connecticut Supreme Court.
Toxic Torts, Asbestos, and Lead Paint
By: Nicholas J. Heintzman

The Canadian border reopened this week, and I am returning home to visit family and friends this Thursday-Sunday. I haven’t returned home since I started work at Hurwitz in October, and I am thrilled to return to familiar places and faces.
This week’s fun Canada fact: it has national parks bigger than countries. Wood Buffalo National Park, located in northeastern Alberta and the southern Northwest Territories, is Canada’s largest national park at 17,300 square miles (44,807 square kilometers). It is larger than countries like Denmark, Switzerland, and the Netherlands. Canada remains a premier destination for those who enjoy solitude.
In this month’s case, a defendant in an asbestos action that qualified as a “government contractor” removed the case to Federal Court on “Federal Officer Removal Jurisdiction” grounds. The District Court remanded back to New York State Court, holding that the removal was untimely brought.

07/08/21         Pezzo v. Air & Liquid Sys. Corp.
United States District Court, Southern District of New York
Despite “Federal Officer Removal Jurisdiction,” District Court remands case back to state court on timeliness grounds.
Plaintiffs commenced this asbestos action against 35 Defendants in New York State Court, alleging asbestos exposure throughout plaintiffs employment in various private and public sector roles.
On November 4, 2020, Defendant AMETEK received Plaintiffs’ responses to Defendants’ interrogatories. The responses detailed that while Dominic was employed as a ship serviceman on the USS Wasp from 1965-1967, he used asbestos-contaminated washers and dryers. In his November 10, 2020, deposition, Dominic clarified that the asbestos-containing laundry-equipment was Prosperity.
On December 10, 2020, AMETEK sought to remove this case to federal court under 28 U.S.C. § 1442(a). That provision permits “any person acting under any office of the United States” to remove a state action “relating to any act under color of such office.” It was undisputed that AMETEK was a government contractor that could invoke § 1442(a). However, Plaintiffs moved for remand back to state court, on the grounds that AMETEK’s removal was untimely under 28 U.S.C. § 1446(b). Section 1446(b) provides that defendants seeking removal must do so within 30 days of receiving notice of the basis for removal. There were two arguable instances of AMETEK receiving notice: Plaintiffs’ interrogatories responses, which fell outside the 30-day clock, and Dominic’s deposition, which fell within the clock. Thus, the question became whether Plaintiffs’ interrogatories responses, which did not specify the Prosperity brand containing asbestos, constituted notice of the basis for removal or whether Dominic’s deposition, which specified the brand, constituted notice.
The Court held that Plaintiffs’ interrogatories responses constituted sufficient notice, making AMETEK’s removal untimely. First, the Court noted that all doubts are resolved against removability, and the burden falls upon the removing party to establish its right to a federal forum. The Court explained that the test for when the 30-day removal period begins is when a defendant “applying a reasonable amount of intelligence” could ascertain the basis for removal. Under this test, defendants are presumed familiar with their own businesses and to understand the case materials considering that familiarity.
The Court, based on its review of case precedent, held that plaintiffs’ interrogatory responses which explained that plaintiff was exposed to asbestos-containing laundry while serving aboard the USS Wasp was a sufficient basis from which AMETEK should have understood the basis for removal. Further identification of the specific brand was unnecessary to provide AMETEK a sufficient basis for understanding the opportunity for removal. That plaintiff alleged he was exposed to asbestos while working aboard a United States Navy ship was sufficient notice. Thus, the Court remanded the case back to state court.
V. Christopher Potenza
[email protected]

Brian F. Mark
[email protected]

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