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Products Liability Pointers - Volume I, No. 3

Volume I, No. 3

Wednesday, March 18, 2020
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.

WHAT PRODUCTS LIABILITY POINTERS COVERS

Negligence
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

 
 

NOTE FROM THE EDITOR:

As we all adjust to these changing times together, please rest assured that we here at Hurwitz & Fine are doing everything we can to continue to service our clients.  We have been proactive in addressing Coronavirus, and like the rest of the world, reacting on what feels like a minute by minute basis.  Protocols will likely change from the time this newsletter is sent and the time it is received.  We had issued a firm-wide travel ban early last week, and all attorneys and staff that had been traveling were asked to self-quarantine.  All our attorneys and paralegals are fully equipped to work remotely, and we are operating at half-staff on staggering days. 
 
With all the travel bans, quarantines, and court closures, this is a great time to get caught up with all the things we never seem to have the time to get to.  Although many of us here at Hurwitz & Fine are working from home during this crisis, we take this opportunity to remind everyone that we are still working and remain available to assist any needs that may arise.  We are also doing our best to provide up-to-date information and tips regarding the ever-changing effects of Coronavirus on employers and businesses.  You can access our this information here:


Please check our website for further information and developments as they become available.
 
Those of us in the Metro NYC area have been on the front lines of this crisis a little bit longer than our colleagues in Buffalo.  The big concerns down here have been trying to avoid the large crowds and staying far enough away from others on the trains and subways.  Anyone that lives or has traveled in and around New York City knows that this is next to impossible.  Luckily, with the recent court closures and protocols, we have been able to greatly reduce the number of trips to and from the City.
 
As of just a few days ago, I wasn’t sure if I would even have the time to contribute to this month's issue as I was scheduled to begin a trial this week on a significant Labor Law case in Queens County.  However, as the courts have shut down due to the Coronavirus, I received a reprieve.  Speaking of trials, I’d be remiss not to give a big shout-out to our own Chris Potenza on obtaining a complete defense verdict on a fall from a roof, Labor Law 240(1), jury trial in Ithaca, NY (Tompkins County).  Please reach out to Chris directly for details. 
 
We hope all of our readers and their families are staying healthy and safe.
 
Brian F. Mark


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. Coverage Pointers, the electronic newsletter that started it all, continues to offer guaranteed publication every other Friday, and a read-at-a-glance summary of important decisions as they happen. Contact Dan Kohane at [email protected]  to be added to the mailing list.

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. This e-mail direct newsletter is published the first Wednesday of each month on four distinct areas – New York Labor Law Sections 240(1), 241(6), 200 and indemnity/risk transfer. Contact Dave Adams at [email protected] to subscribe.

Premises Pointers This monthly electronic newsletter covers current cases, trends and developments involving premises liability and general litigation. Our attorneys must stay abreast of new cases and trends across New York in both State and Federal Court, and will now share their insight and analysis with you. This publication covers a wide range of topics including retail, restaurant and hospitality liability, slip and fall accidents, snow and ice claims, storm in progress, inadequate/negligent security, inadequate maintenance and negligent repair, service contracts, elevator and escalator accidents, swimming pool and recreational accidents, negligent supervision, assumption of risk, tavern owner and dram shop liability, homeowner liability and toxic exposures (just to name a few!).  Contact Jody Briandi at [email protected]  to be added to the mailing list.


Design Defect
By: V. Christopher Potenza
[email protected]

Strange times indeed as we all are adjusting to this post Covid-19 reality.  I will not pretend to be an information source for combating this disease and will leave that to the experts.  This is going to be challenging for everyone as we juggle remote working, home schooling, and everything else that comes with the lock down. Please rest assured that our attorneys have full remote access and can respond to client needs and inquiries as usual, despite the indefinite closure of the courts.
 
On a personal note, it was a bit sad not to be out celebrating St. Patrick’s Day, as this date holds a special place in the Potenza household as it the day my wife and I first met… at a bar at the St. Patrick’s Day Parade in Buffalo (which is one of the best in the country).  A little advice on a subject that gets my very Irish wife’s blood boiling.  The four-leaf clover, in fact, has nothing to do with St. Patrick’s Day.  The shamrock is associated with Ireland because Saint Patrick, Ireland’s patron saint, is said to have used the plant as a metaphor for the Catholic Holy Trinity of the father, the son and the holy spirit.  So, if you see some unsuspecting lad posting images of a four-leaf clover on St. Patrick’s Day, make sure to shame them appropriately on-line.


 
And now for this month’s St. Patrick’s Day dad joke:

What is a leprechaun’s favorite music?
Sham-rock!
 
As for decisions this month, the Second Department allowed the claims of out-of-state plaintiffs to go forward against the manufacturer of men’s hair dye. Highlighting the often murky world of federal pleadings standards, there are two medical device cases, both from the Northern District, which appear to hold the plaintiff to different standards at the pleadings stage. 

 

2/5/2020          Albright v. Combe Incorporated, et al.
Appellate Division, Second Department
Not only a “Just For Men” customer, but also a proper out-of-state plaintiff.
 
The plaintiffs are 21 individuals who allege that they sustained injuries from using “Just For Men” hair dyes and products. Only two of the plaintiffs are residents of New York. The defendants moved, pursuant to CPLR 327(a) to dismiss the complaint insofar as asserted by the nonresident plaintiffs on the ground of forum non conveniens, based upon an attorney's affirmation asserting no facts other than that the nonresident plaintiffs were out-of-state residents. The trial court granted that branch of the defendants' motion to dismiss and the Second Department reversed, holding that the defendants asserted no facts other than that the nonresident plaintiffs were out-of-state residents. The defendants did not meet their burden of proof on the issue of convenience of the witnesses, since, among other things, there was no statement as to whom the witnesses are and where they reside. Moreover, Just For Men's design, manufacturing, labeling, advertising, and executive decision-making all allegedly occurred in White Plains, New York, where Combe Incorporated has a principal place of business. Further, there is no per se rule stating that out-of-state plaintiffs cannot, on the ground of forum non conveniens, sue in New York based upon products liability despite the fact that evidence of damages would most often be found where the plaintiff resides.

 
2/5/2020          O’Neil v. Argon Medical Devices, Inc, et al.
U.S. District Court, Northern District of New York
No Filter: Plaintiff given leeway under notice standard in pleading design defect claim in IVC Filter claim.

Plaintiff commenced this products liability action alleging injuries from an implanted medical device, an IVC (“inferior vena cava”) filter used to combat blood clotting in the vein.  Defendants filed a motion pursuant to FRCivP 12(b)(6) to dismiss the complaint at the pleading stage.  Defendants argued, inter alia, that plaintiff did not sufficiently plead a defect in the device at issue or its warnings, or an injury resulting from use of the device. 
 
The Court held that the plaintiff adequately alleged facts which, if proved, would support a claim based on defective design. The amended complaint alleged that the Filter, as designed, was “unable to withstand the normal anatomical and physiological loading cycles exerted in vivo.” Plaintiff also alleged that the Filter is “designed in such a way that when exposed to expected and reasonably foreseeable in-vivo conditions, the filter[ ] will ... migrate, perforate internal organs and vasculature, fracture, and lead to the formation of thromboembolism and PE.” Furthermore, plaintiff alleged that “alternative designs of the Filter’s hooks and struts could lead to ease of removal after extended periods of implantation.”  The Court found that at this early juncture, plaintiff has adequately alleged a defect in the design of the Filter as well as a feasible alternative design. While courts sometime require a plaintiff to identify a particular problem in the design of a product, this requires a plaintiff to possess technical or scientific knowledge about the inner workings of the product, which would contravene the notice pleading requirement of the Federal Rules.
 
 
2/24/2020        Taylor v. Medtronic, et al.
U.S. District Court, Northern District of New York
Caught in a Web: Plaintiff’s cause of action for design defect dismissed in surgical mesh claim for failure to plead facts showing that there was a design defect.
 
Plaintiff alleges that he was injured from pelvic mesh used during hernia repair surgery.  Defendants filed a motion pursuant to FRCivP 12(b)(6) to dismiss the complaint at the pleading stage.   In order to establish a prima facie case in strict products liability for design defects, the plaintiff must show that the manufacturer breached its duty to market safe products when it marketed a product designed so that it was not reasonably safe and that the defective design was a substantial factor in causing plaintiff’s injury.  A plaintiff’s claim for design defect will fail if he does not allege a safer alternative design to the product. Further, a design-defect claim will not stand if the only alternative pled in the complaint is an outright ban. 
 
In his complaint, Plaintiff alleges that “[s]afer and more effective alternatives to hernia mesh exist and have existed since the introduction of hernia mesh products into the market.”  While the plaintiff listed various alternatives, the defendants pointed out that these are not safer mesh-related alternatives, but merely surgical techniques that do not involve the use of mesh at all.  Plaintiff further alleged various other potential defects in the design of the mesh, such as adverse tissue reactions caused by the material used, the propensity for the mesh to degrade or disintegrate, and that the mesh can cause pain upon normal daily activities that involve movement in the abdomen, but did not assert that any of these alleged defects caused him injury.  Plaintiff further “conclusively” alleged that “[a]s a direct and proximate result of the Product’s” alleged defects he has “experienced significant mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo future medical treatment and procedures ...”. Thus, the Court dismissed the plaintiff’s cause of action for design defect because he did not plead any facts showing that there was a defect in the design of the mesh implanted in his body, which, in turn, caused him harm, and did not allege a safer mesh-related alternative in his complaint.

 


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

Despite the craziness we are all going through, I am happy to bring you two recent cases that involved manufacturing defect claims.  In Rivera v. Hobart Corporation, the U.S. District Court for the Southern District of New York determined that the product at issue had been substantially altered after it left the defendant’s control and thus dismissed the plaintiff’s claims.  In Amica Mutual Insurance Company v. Electrolux Home Products, Inc., the U.S. District Court for the Western District of New York concluded that plaintiff’s expert opinion lacked foundation and as a result, the plaintiff was unable to meet his burden of establishing product defect claims. 
 

03/11/20         Rivera v. Hobart Corporation
U.S. District Court, Southern District of New York
Do’h: District Court dismisses manufacturing defect claim where dough mixer had been substantially altered after leaving the defendants’ control.
 
The plaintiff was allegedly injured as a result of getting his hand caught in one of the defendants’ commercial dough mixers.  An engineer from one of the defendants inspected the mixer at issue and noted that the mixer was not equipped with an interlocking bowl guard.  Significantly, the basic parts of a commercial mixer, such as the one at issue, consist of a mixer, bowl guard, agitator, and mixing bowl.  In order for the mixer to work, the interlocked bowl guard must be in place.  As designed, the interlock will not allow the mixer to run unless the bowl is in the raised position and the bowl guard is in place around the mixing bowl.  The engineer determined that the mixer in question had originally been manufactured with an interlocked bowl guard, which had been removed after the mixer was manufactured and sold by the defendants. 
 
The defendants moved for summary judgment arguing that the plaintiff’s claims failed as a matter of law because the plaintiff failed to offer expert testimony or other admissible evidence that the mixer was defectively or negligently designed or manufactured and that the mixer was substantially modified after it left defendants’ control.
 
The Court noted that a manufacturer, who has designed and produced a safe product, will not be liable for injuries resulting from substantial alterations or modifications of the product by a third party which render the product defective or otherwise unsafe.  The Court, in granting summary judgment in favor of the defendants, held that no genuine dispute existed regarding whether a substantial alteration was made to the mixer after it left defendants’ control, which rendered the machine unsafe and caused the alleged injuries.
 
02/18/20         Amica Mutual Insurance Company v. Electrolux Home Products, Inc.
U.S. District Court, Western District of New York
Foundation Dry: District Court rejects plaintiff’s expert’s opinion on manufacturing defect claim
 
This case arises from a property damage claim resulting from a fire, which was allegedly caused by a defective gas clothes dryer.  The subject dryer had been used by the plaintiff’s insured homeowner for approximately seven years at the time of the fire.  The plaintiff commenced suit alleging negligence and strict liability (stemming from the subject dryer’s allegedly defective design, defective manufacture, and failure to warn), and breach of warranty.
 
Although the plaintiff attempted to offer expert testimony in support of its claims, its expert was precluded from offering his opinion.  The Court, following the standards set forth in Daubert, determined that the plaintiff’s expert lacked knowledge concerning the subject dryer’s condition and configuration at the time it was designed and/or manufactured, or the type and characteristics of the wire insulation and/or wiring fasteners that were central to his theory as to the cause of the fire.  He had not conclusively identified a specific defect in the design or manufacture of the subject dryer, or pointed to a safer alternative design.  The Court held that the expert’s opinion lacked a sufficient grounding in scientific testing and methodology, which fell short of plaintiff’s burden to demonstrate its admissibility.  Specifically, in regards to the manufacturing defect claim, plaintiff produced no admissible evidence concerning the subject dryer's deviation from others of the same make and model.

 


Failure to Warn
By: Brenna C. Gubala
[email protected]

Well things took an unexpected turn. As we all adjust to our new reality with corona virus, we are still trying to figure out what it all means. When things feel out of our control, we can turn to the few things we can control. Which is what you ask? Focusing on one day at a time, one issue at a time, one case at a time. My dad (also a litigator) always told me, take it one step at a time. And he was not wrong.

This month’s decisions have to do with proper pleading standards and federal preemption which is almost as confusing as sorting through all the news about corona virus and COVID 19. The first case about proper pleading is pretty straightforward – Court says that you have to plead what warnings there were if you’re claiming they were insufficient.  Pretty much, if the complaint is that the warnings were inadequate or ambiguous, you have to plead what the warnings state to show how they are inadequate.  The second case is more of a quagmire. But basically, the complaint claimed defendant manufacturer companies used an agent in MRI’s that should have contained more adequate warnings even though the label was FDA-approved. The complaint claimed that the defendants knew or should have known about adverse reactions to people with normal kidney functions which would have permitted them to unilaterally alter the FDA-approved label. The Court said no they did not.
 
2/06/20        Bustamente v. Atrium Medical Corp.
                       Cosh v.  Atrium Medical Corp.
                       Boris. v. Atrium Medical Corp.
U.S. District Court, Southern District of New York
What a mesh: Plaintiff's cause of action for failure to warn dismissed in surgical mesh claim for failure to plead what warning was included.
 
In related actions, three plaintiffs filed lawsuits against Atrium Medical Corp. alleging all three sustained injuries as a result of the implantation of Atrium ProLite Mesh during hernia repair surgeries and allege a host of claims including failure to warn under a strict products liability.  Plaintiffs alleged that (1)  the device contained warnings that were inadequate and insufficient to warn physicians or consumers of dangerous risks associated with the product, (2) that the warnings were ambiguous, and (3) the website has minimal amount of advertisement and information for the general public.
 
The court found these allegations conclusory and noted the absence of the exact language of the warnings contained on the device. Thus there were no allegations how the provided warnings failed to accurately reflect reality and did not provide a plausible basis to support the claim that Atrium Medical Corp. misrepresented facts. 
 
Nevertheless, the Court granted plaintiffs leave to amend their complaint.  Thus, should the plaintiffs allege the specific warning on the device, this claim would very likely be sufficient. So a pyrrhic victory for defendants and a note to plaintiffs that they have to provide information, which might not be recoverable, save through discovery.
 
 
2/12/2020        Sabol v. Bayer Healthcare Pharm.
U.S. District Court, Southern District of New York
Blocked: Plaintiff's cause of action for failure to warn dismissed as Preempted by Federal law.
 
Plaintiff brought a strict products liability claim failure to warn theory against multiple defendants including Bayer Healthcare LLC alleging that the manufacturer of a contrast agent, gadolinium, used in an MRI to enhance the imaging remained in her body and caused serious injuries.  The Court dismissed the claims on ground that it was preempted by federal law.
 
Bayer Healthcare LLC manufactured Magnevist, a Gadolinium-based contrast agent.  The agent is toxic but is intended to pass through the body and be eliminated. Plaintiff claims the agent remained in her body causing fibrosis, cognitive impairments, pain, impaired mobility, bone and joint pain, muscle pain, depression and anxiety. The FDA approved the contrast agent.  Plaintiff alleges that after the FDA approved the agent, Bayer Healthcare LLC learned additional information about the risks of gadolinium retention that should have been disseminated. Bayer Healthcare LLC issued warnings about the contrast agents only to patients with chronic kidney disease. 
 
Bayer Healthcare LLC moved to dismiss the Amended Complaint on grounds that it failed to state a legally cognizable claim because the alleged injuries are preempted by the FDA-approved label among other grounds.  Basically, plaintiff’s claims are preempted by federal law.  The Court granted the motion on grounds that Bayer Healthcare LLC could not unilaterally have changed Magnevists’ label after FDA approval because it had no newly acquired information regarding a causal association between Magnevist and a clinically significant adverse reaction in patients with normal kidney function.
 
As an initial matter, Federal statutes and regulations govern the safety information on labels of prescription drugs marketed in the U.S.  A drug manufacturer may alter the label without FDA approval only under the Changes Being Effected (“CBE”) regulation.  Alterations to the label are permitted by CBE to reflect newly acquired information if the changes add or strengthen a contraindication, warning, precaution of adverse reaction for which evidence of causal association satisfies the labeling standard by federal regulation.  The “newly acquired information” must provide reasonable evidence of causal association of a clinically significant adverse reaction. This can include (1) something potentially fatal, (2) a serious reaction even if infrequent, or (3) a reaction that can be prevented or mitigated through appropriate use of the drug.
 
To state a claim for failure to warn in this context that the claims are not preempted by federal law, plaintiff must plead a label deficiency that Bayer Healthcare LLC could have corrected under CBE, meaning it had evidence of a clinically significant adverse reaction.  In turn to dismiss the claim, Bayer Healthcare LLC must (1) demonstrate that plaintiff fails to allege facts showing that it could have unilaterally changed Magnevist’s label under CBE or (2) present evidence that the FDA would not have approved a change in the label.
 
In this case, Bayer Healthcare LLC demonstrated that plaintiff’s allegations did not contain any newly acquired information by Bayer Healthcare LLC that had a causal association between Magnevist and a serious adverse reaction in a person with normal kidney function.  Significantly, at the time plaintiff used the Magnevist during the course of 23 MRI’s, Bayer Healthcare LLC had no new information that would indicate it should alter its FDA-approved label. The FDA recognized in 2018 that patients with normal kidney function may retain gadolinium, but also advised, that gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. 
 
The Amended Complaint contains only conclusory allegations that gadolinium retention causes the type of serious injuries alleged by plaintiff.  The conclusory allegations are contradicted by a document attached to the complaint, and the document controls.  The Court held that notwithstanding the 2018 FDA notice attached to the Amended Complaint, the allegations are too conclusory to state a claim.  The Court notes that the claims of “adverse reactions” in two cases studies cited by plaintiff are too vague, but also, lack “reasonable evidence” of a causal association between gadolinium retention and adverse events in patients with normal kidney function.  Plaintiff’s reference to studies on rats are unpersuasive to the Court and general studies about ill effects of gadolinium retention are too general. The issue is whether Bayer Healthcare LLC should have known of the risk to individuals with normal kidney function.
 
The Court found that plaintiff did not sufficiently plead that Bayer Healthcare LLC had reasonable evidence of a causal association between the gadolinium agent and a clinically significant adverse reaction in patients with normal kidney function.  As a result, plaintiff’s claims are preempted by federal law.  The claim for failure to warn as against Bayer Healthcare LLC was dismissed.

 

 


Toxic Torts, Asbestos, and Lead Paint
By: Marina A. Barci
[email protected]
 
In light of the current situation the world is in, in addition to your toxic torts news I have compiled a list of products you may need to survive/thrive during a quarantine. First, chocolate. Second, deodorant, especially if you live with other people! I would also recommend board/card games if you live with other people. My go-to’s are: Phase10, Bananagrams, Monopoly, Harry Potter Uno (much more exciting than regular Uno), and Risk. If you don’t live with others, a good book is always a nice distraction from the outside world. I am currently working on Kitchen Confidential by Anthony Bourdain and it is quite interesting. Since toilet paper is a hot commodity now, you can instead buy a portable bidet to attach to your toilet. Also, if you’ve bought a lot of canned goods, once you’ve eaten the contents you can clean them out, cut fun shapes in the sides, and put a candle inside to make a lantern. You can also connect two cans by cutting small holes in the bottoms and tying a string through each for an old-school telephone. Make sure the connection is long enough so that you can give one can to your neighbor! Finally, the all-important binge-able TV shows to keep you connected. I highly recommend Love is Blind if you haven’t already seen it; a good throwback to watch would be How I Met Your Mother; Brooklyn Nine-Nine is also a great choice; and if you’re interested in crime thrillers, Prodigal Son is a must. If you power through all of these options and have Disney+, I strongly suggest Ensemble! for a good laugh, especially if you like musicals.
 
In asbestos news, at the end of February, a Florida jury awarded $9 million against Johnson & Johnson at the end of another asbestos-talc trial. The jury determined that J&J’s baby powder contained asbestos and that this asbestos was the cause of the plaintiff’s mesothelioma. This is another in a slue of recent cases across the country that have had similar outcomes for J&J. It will be interesting to see what, if anything, J&J does now that more verdicts are coming in against them. Keep a lookout here for any news in the coming months.
 
For cases, I bring you two this issue. First, I recap a short decision out of the First Department that discusses summary judgment when there are inconsistencies about the asbestos products exposed to as laid out in the plaintiff’s interrogatories versus deposition testimony. Then, out of the WDNY, there is an extensive decision regarding a toxic tort claim for exposure to chemicals causing bladder cancer. If you would like a copy of the full decision, please reach out as it contains detailed analysis on toxic tort experts that could be helpful the next time you are considering someone for one of your cases. Read on for more.
 

02/27/20          Licul v. Mario & DiBono Plastering Co.
Appellate Division, First Department
Consistently inconsistent: Discrepancies in asbestos product identification deposition testimony and interrogatory responses create credibility issues that cannot be decided on summary judgment.
 
Plaintiff’s decedent, the wife of an employee of a plastering company, died from mesothelioma allegedly caused by exposure to asbestos containing fireproofing brought home by her husband from his jobsites. During the husband’s deposition, he mentioned that he had been exposed to spray-on fireproofing products, but these prodcuts were not listed in his prior interrogatory responses.  The court held that although the husband’s testimony was not entirely clear about the products he was exposed to, these inconsistencies create credibility issues that could not be resolved on a dispositive motion.
 

02/25/20          Sarkees v. E. I. DuPont de Nemours and Co.
U.S. District Court, Western District of New York
Bladder concerns: Expert opinion creates question of fact on causation of bladder cancer.
 
Plaintiff developed bladder cancer allegedly from his exposure to a chemical called ortho-toluidine (“OT”) while working at Goodyear Tire & Rubber Company. OT was an ingredient in a product called Nailax, which was used to preserve rubber during tire production at Goodyear. In order to prove his exposure to OT caused his cancer, plaintiff hired two experts: Dr. Melnick to opine on general causation and Dr. Oliver to opine on specific causation. Defendants moved to preclude both experts on the basis that the scientific research connecting OT to bladder cancer is too reliant on animal studies and not enough on direct human implications and epidemiological studies. The Court determined both experts were qualified and their testimony allowed based on the research they have done themselves on the issue. The other motions defendants made, including summary judgment and dismissal of the punitive damages claims, were denied based on the questions of fact plaintiffs’ experts’ testimony creates. However, the Court did grant the defendants’ motion for dismissal of plaintiffs’ loss of consortium claims since the alleged exposure to OT occurred 12 years before they were married.

 

NEWSLETTER EDITORS
V. Christopher Potenza
[email protected]

Brian F. Mark
[email protected]

ASSISTANT EDITORS
Marina Barci
[email protected]

Brenna C. Gubala
[email protected]

 

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