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Medical and Life Sciences

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Our Medical and Life Sciences Practice Group attorneys, capitalizing on insights resulting from their combination of medical and legal credentials, have earned a national reputation for successful defense of FDA-regulated manufacturers, including pharmaceuticals, medical devices and cosmetics, as well as healthcare, pharmacy and long-term care organizations. Harris Beach Murtha has the experience, relationships and resources to help industry stakeholders compete and succeed in this constantly evolving marketplace.

The medical and life sciences industry’s dynamic growth over recent years has been driven by a demographic shift in the U.S. population. As the ‘Baby Boomer’ generation continues to age, demand increases for prescription and over-the-counter (OTC) pharmaceuticals, medical devices, nutritional supplements and products enhancing overall health, as well as medical care and housing for these individuals. This results in heightened responsibilities for the medical and life sciences industry to continue advancing research and development, and increased complexities for legal counsel.

Due to their complex nature, medical and life sciences matters often demand integrated solutions involving many of our practice areas. To provide the greatest efficiency and value for our clients, we strategically leverage our broad knowledge base to build interdisciplinary, problem-solving teams of complementary disciplines. This team approach has proven beneficial in defending mass torts and addressing other legal issues, such as intellectual property, corporate and securities law, fraud and abuse, business and commercial litigation, labor and employment law, risk management, R&D, strategic alliances and licensing. Additionally, our cybersecurity practice can help protect against cyber threats to manufacturers, distributors and retailers of pharmaceuticals and nutritional supplements, as well as help protect medical devices from cyberattacks.

Harris Beach Murtha’s attorneys frequently address and chair national industry conferences as thought leaders in the product liability defense of pharmaceuticals, medical devices and nutritional supplements and in litigation of matters impacting healthcare and long-term care organizations. In a constantly changing industry, we stay on the cutting edge through membership and leadership in such medical and legal professional organizations as the American Bar Association, American Society for Pharmacy Law and DRI. We continuously monitor and explore new medical and scientific developments, such as nanotechnology, which will impact the industry’s future.

Representing clients in New York, New Jersey, Massachusetts, Connecticut and other states throughout the nation, our combination of legal and scientific acumen and first-hand industry knowledge sets us apart. Because some of our attorneys began their careers as nurses, pharmacists or other health care professionals, we routinely leverage our sophisticated industry insight to benefit clients and reach solutions quicker and more cost-effectively.

Defense of a Broad Range of Medical and Life Sciences Claims

When it comes to helping clients resolve complex business disputes in the pharmaceutical, OTC medication, personal care/cosmetic, medical device, biologic, nutritional supplement and other life sciences spaces, our attorneys have extensive experience litigating commercial disputes that may arise at each phase of the product’s lifecycle.

Harris Beach Murtha attorneys defend brand-name and generic pharmaceutical and medical device manufacturers and distributors, as well as manufacturers of OTC drugs, nutritional supplements, cosmetics, personal care products, biologics and products impacting women’s health.

Our extensive defense experience ranges from urology imaging systems and other sophisticated products, to contact lenses and personal care items, to cough and cold remedies and other OTC products, such as dietary and sports nutritional supplements.

Product Liability Defense

Our attorneys have earned a reputation for skillfully defending a wide range of pharmaceutical, medical devices and nutritional supplements companies throughout New York, New Jersey, Massachusetts, Connecticut and the nation. We have established a proven record of success defending clients in sophisticated, high-exposure, high-value catastrophic injury cases.

We defend claims involving a variety of allegations, including birth defects, cancer, cardiac injuries, autoimmune disease, neurologic injuries, learning disabilities and others by challenging “junk science” and through motions directed at causation under Daubert (federal) and Frye (state) standards.

We counsel and strategize with our clients to assess and resolve potential problems before they erupt into costly litigation. When litigation is necessary, we manage discovery intelligently and pursue resolution in an aggressive and efficient manner, using litigation management tools and innovative legal strategies.

Learn More About Product Liability Defense
Premises Liability Defense

Harris Beach Murtha attorneys frequently represent businesses or property owners accused of liability when personal injuries occur on their premises and have a track record of success avoiding hefty judgments and higher insurance rates. That work includes high-exposure personal injury cases, slip-and-fall cases, complex claims involving serious personal injury, complex multi-party matters involving contribution and indemnification disputes, alleged defective conditions, assaults with negligent security, false imprisonment and related tort claims.

We evaluate risk and analyze objectives at every stage of the process, while managing the impact on your business. When needed, we have access to a broad network of trusted technical experts to bolster our case.

Mass Torts Defense

Our Mass Torts and Industry-Wide Litigation Practice Group has been named a national Tier 1 Law Firm for Mass Torts Litigation/Class Action-Defendants since 2014. Our attorneys are recognized for their ability to handle cases in which complex scientific and legal issues overlap. They hold degrees or licenses in fields such as pharmacology, nursing, industrial hygiene, education, food and beverage operations, law enforcement and computer science. Others have held key positions in government, including United States Attorney.

Our trial lawyers regularly coordinate the defense of medical and life sciences industry-related mass torts. We have developed effective mass tort defense strategies for FDA regulated products such as pain pumps, contraceptives, analgesics, dental anesthetics, latex products, breast implants, Hormone Replacement Therapies, and diet drugs.

We represent foreign and domestic clients of all sizes and industry affiliations in some of the most complex and precedent-setting mass torts filed in the last 30 years. We are noted for our proprietary approach to large case management and litigation support. Our attorneys are recognized as thought leaders on emerging issues; are active members of industry groups; and are sought-after educators who write and speak for bar associations, trade councils, companies and insurers.

Learn More About Mass Torts Defense
Corporate Law

Harris Beach Murtha attorneys regularly assist medical device, biological and life sciences organizations with their broad corporate needs. We take a multi-disciplinary, problem-solving approach to each transaction we guide, including those in highly regulated industries such as health care, medical devices and pharmaceutical.

Our corporate legal services include financing, capital, U.S. Securities and Exchange Commission (SEC) issues, initial public offerings, tax issues, licensing agreements, export applications, and equity and technology exchange agreements. We also advise boards of directors on state and federal regulatory compliance; corporate governance and structure; and merger, acquisition and divestiture activities.

At Harris Beach Murtha, our entrepreneurial and strategic approach to working with business clients supports all phases of their growth and evolution and helps them define and meet their immediate and long-term objectives. The keen business acumen, legal knowledge and extensive public and private business transactional experience of our attorneys has consistently resulted in their professional peer-review recognition in The Best Lawyers in America ®.

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National, Regional and Local Counsel

Harris Beach Murtha attorneys serve as national, regional, and local counsel for some of the largest names in pharmaceuticals, biologics, medical devices, cosmetics, nutritional supplements and products impacting women’s health. While we have offices throughout New York, New Jersey, Massachusetts, Connecticut and Washington, D.C., our work is national and, when the stakes are high, our experience matters.

Intellectual Property

Our intellectual property (IP) attorneys focus on U.S. and foreign patent and trademark procurement for clients in all areas of advanced technology, including mechanical and electrical engineering, biotechnology, pharmaceuticals, nanotechnology, medical devices, materials science, environmental chemistry and agriscience.

We have protected numerous patents of leading pharmaceutical and life sciences companies. Our IP attorneys have a wide range of technical backgrounds in science and technology, as well as the medical and life sciences, well-positioning us to help clients identify and protect proprietary formulas and trade secrets.

We also assist clients with the analysis, purchase, sale and licensing of their IP, domestically and worldwide, as well as managing and assessing the scope and value of their IP portfolios.

We have procured, enforced and defended patents for leading medical device manufacturers, pharmaceutical and life sciences companies in administrative proceedings, alternative dispute resolution processes and federal district court litigation. Harris Beach Murtha attorneys are also experienced in developing, designing and implementing strategies to combat illicit trade on a global basis.

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Pre-Product Launch Risk Analysis and Management

Our Medical and Life Sciences Practice Group provides legal counseling concerning prelitigation risk assessments and submissions to the FDA, including package inserts, marketing materials, brochures, warnings, patient labeling, pharmacovigilance as well as development and use of Risk Minimization Action Plans.

To help our clients avoid potentially damaging legal actions, our attorneys also examine pre- and post-market liability issues relating to clinical trials, marketing and product recalls.

Health Care and Senior Living

Harris Beach Murtha’s attorneys have deep experience in regulated industries, including health care, long-term care and senior living. We represent some of the largest senior living and long-term care organizations in North America and defend a variety of health care, senior/assisted living and skilled-nursing companies in litigation and regulatory matters, including class actions, trials, arbitration, investigations, and regulatory responses.

Our work includes investigations and defense of lawsuits and regulatory actions pertaining to allegations of negligence, abuse and neglect; claims of inadequate supervision/hiring; medication errors and elopement. Additionally, we defend class actions concerning staffing and alleged violations of the Americans with Disabilities Act and other federal and state laws related to accessibility.

Many of our attorneys possess a combination of legal and scientific acumen and first-hand knowledge from beginning their careers as nurses, pharmacists or other health care professionals. We routinely leverage our sophisticated industry insight to benefit clients and reach solutions quicker and more cost-effectively.

Pharmacy Law

With years of experience in pharmacy ownership and supervision, our pharmacy law attorney team is headed by a pharmacist-attorney within the Medical and Life Sciences Practice Group. Our attorneys, drawing on insights gleaned from both scientific and legal credentials, have earned a national reputation for providing general business counsel and successfully defending some of the largest entities in the pharmaceutical industry.

We help ensure compliance with Medicare and Medicaid standards, pharmacy state laws, board of pharmacy rules, DEA regulations, and various Pharmacy Benefit Manager contracts and provider manuals. We also draft and negotiate related corporate agreements, represent clients before state and federal regulatory enforcement agencies, assist with pharmacy purchase and sale transactions, and defend clients in products liability and pharmacist professional malpractice litigation. We also defend the interests of pharmacies and pharmacists in litigation and reimbursement-related fraud and abuse investigations.

Our pharmacy law attorneys also serve the general counsel needs of pharmacies and pharmacists through regulatory compliance, PBM audit support, contract review, corporate transactional, government investigation, real estate, data privacy and cybersecurity, labor and employment, immigration and intellectual property services.

Harris Beach Murtha has the experience, relationships and resources to help industry stakeholders compete and succeed in this constantly shifting marketplace.

Learn More About Pharmacy Law
Nutritional Supplements

Harris Beach Murtha has extensive experience advancing and defending the interests of nutritional supplement manufacturers, distributors and retailers. Our attorneys serve the general counsel needs of these clients by providing the full range of corporate transactional, intellectual property and regulatory compliance services.

We support our clients through every phase of the product life cycle, including product development; securing and defending intellectual property rights; helping ensure compliance with advertising, marketing and distribution regulations; drafting and negotiating related corporate agreements; and defending the clients in products liability and mass tort litigation.

Labor and Employment Law

In the highly competitive medical and life sciences field, where “first-to-market” status and technological advances can increase the value of a company’s stock, Harris Beach Murtha attorneys help protect companies from harmful employee actions by safeguarding patents, enforcing noncompete and confidentiality agreements and taking other protective measures.

Our attorneys have partnered with management at businesses in a wide range of industries throughout the Northeast to proactively prevent labor issues, claims and conflicts by conducting risk assessments, developing sound policy, delivering training and strengthening positions at the bargaining table. Our clients include small privately held companies, large publicly traded corporations, tax-exempt organizations and public sector entities. Our attorneys also handle National Labor Relations Board and Equal Opportunity Commission regulations for their clients.

Employment and labor law is ever-changing and increasingly complex. Regularly emerging laws, regulations and court decisions will impact your daily operations and Harris Beach Murtha helps you understand and respond to avoid disruption and mitigate negative consequences.

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Government Compliance and Investigations

Today’s regulatory landscape is increasingly complex. Federal, state and even local governments have expanded compliance requirements and increased enforcement. Harris Beach Murtha attorneys help pharmaceutical and medical device companies, as well as manufacturers of nutritional and dietary supplements, vitamins and OTC products, stay abreast of changes in their highly regulated industries.

We represent a variety of medical and life sciences businesses throughout New York, New Jersey, Massachusetts, Connecticut and around the nation. Many of our attorneys also have backgrounds in complex, specialized fields, such as pharmaceuticals, forensic science, accounting, health care and banking. They understand the complexity of these fields and monitor regulatory updates and industry news, preparing Harris Beach Murtha to react quickly and strategically when needed.

We advise clients in the areas of corporate compliance, government ethics, lobbying compliance and white-collar crime, and we help clients conduct high-level internal investigations to help address government scrutiny. We help businesses develop effective compliance programs and mitigate risk so they can operate successfully and maintain profitability.

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Environmental Law and Sustainability

Our environmental and toxic tort team has years of experience dealing with the elimination of toxic and hazardous wastes and by-products from the manufacture of pharmaceutical and medical devices. We assist companies in New York, New Jersey, Massachusetts, Connecticut and states around the country and rely on our extensive experience to guide and support in these critical situations.

PFAS Compliance and Litigation

Per- and polyfluoroalkyl substances (PFAS) are a large, diverse, and complex family of manmade fluorinated chemicals that have long been used in the manufacturing of consumer and industrial products, such as fire suppression foams. Found in everything from water to wrappers, awareness and concern surrounding these “forever chemicals” is gaining steam, impacting organizations across a wide range of industries and municipalities.

Harris Beach Murtha helps clients assess PFAS risks and address these and other emerging contaminant issues that lead to actions by regulatory agencies, including site investigations, off-site contamination concerns, project delays, future liabilities and potential threats of litigation.

We work with scientific experts to help guide clients through the legal, regulatory and scientific challenges and uncertainties related to PFAS. We help develop effective risk communication and long-term strategies to investigate possible environmental contamination on-site and off-site, analyze past, present and pending remediation projects and cleanups, and advise our clients regarding possible liabilities, including enforcement and litigation.

 

Learn More About PFAS Compliance and Litigation
Cybersecurity

Medical and life science companies are often targeted by cyber criminals. Harris Beach Murtha offers a dynamic combination of legal and technical support to protect digital assets and business interests, as well as a rapid response team in the event of a breach.

Our cybersecurity team provides a full range of data privacy and cybersecurity services: compliance counseling and legal risk assessment, guidance on following the National Institute of Standards and Technology protocols and other state and federal regulations, defense in litigation and investigations, and rapid response in the event of breaches. Our attorneys, along with our information security and communications professionals, partner with you to reduce risk and defend your data.

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Database of Expert Witnesses

Our expert witness database consists of the nations’ leading authorities on epidemiology, teratology, toxicology, pharmacology, industrial hygiene, dysmorphology, oncology, genetics, pathology, biomedical engineering, cardiology, obstetrics, gynecology and economics.

First Response Emergency, Crisis and Disaster Team

Harris Beach Murtha established our First Response Emergency, Crisis and Disaster Team recognizing that, in the event of a catastrophe, response time is critical to manage liability exposure. This team helps clients prepare detailed emergency plans to mitigate risk before a crisis occurs. Our team is also available to help with evidence preservation all the way through the post-disaster investigation. Our 24-hour, on-the-scene legal guidance provides the insight, perspective, experience and required coordination to manage critical legal issues, as well as media coverage that could expose your organization to significant liability and reputation damage.

Crisis Communications Counseling

Protecting the image of a medical and life sciences company is critical, especially during a crisis or highly controversial situation. Harris Beach Murtha has extensive experience crafting effective communication strategies to maximize positive public exposure and lessen the negative impact to pharmaceutical, medical devices and nutritional supplement companies facing controversial situations.

We provide media training, respond to the media, develop talking points and work side-by side with you during and after the crisis so you have the support needed to weather the storm.

Practice Leader(s)

Colleen Hennessey

Colleen M. Hennessey

Member

(617) 951-2008

chennessey@harrisbeachmurtha.com

Partner Kelly Jones Howell

Kelly Jones Howell

Member

(212) 912-3652

khowell@harrisbeachmurtha.com

Team

Partner Richard J. Basile

Richard J. Basile

Member

(203) 653-5412

rbasile@harrisbeachmurtha.com

Brian Bender

Brian A. Bender

Member

(212) 313-5405

bbender@harrisbeachmurtha.com

Paulo Coelho

Paulo M. Coelho

Associate

(516) 880-8389

pcoelho@harrisbeachmurtha.com

Partner Judi Abbott Curry

Judi Abbott Curry

Of Counsel

(212) 313-5404

jcurry@harrisbeachmurtha.com

David Dino

David J. Dino

Member

(212) 313-5484

ddino@harrisbeachmurtha.com

Abbie Fuchs

Abbie L. Eliasberg Fuchs

Member

(212) 313-5408

afuchs@harrisbeachmurtha.com

Pamela Goldsmith

Pamela B. Goldsmith

Member

(212) 313-5494

pgoldsmith@harrisbeachmurtha.com

Matthew Griffin

Matthew J. Griffin

Member

(617) 951-2009

mjgriffin@harrisbeachmurtha.com

Kari Indusi

Kari A. Indusi

Senior Counsel

(516) 880-8391

kindusi@harrisbeachmurtha.com

Rebecca Leder

Rebecca A. Leder

Associate

(516) 880-8390

rleder@harrisbeachmurtha.com

Andre Major

Andre J. Major

Member

(914) 298-3003

amajor@harrisbeachmurtha.com

Alexandra Beaton

Alexandra Marlowe Beaton

Associate

(617) 951-2030

ambeaton@harrisbeachmurtha.com.com

Andrew Mezoff

Andrew Mezoff

Paralegal

amezoff@harrisbeachmurtha.com

Partner James R. Muldoon

James R. Muldoon

Member

(315) 214-2021; (212) 912-3517

jmuldoon@harrisbeachmurtha.com

Omar Nasar

Omar Nasar

Member

(212) 313-5442

onasar@harrisbeachmurtha.com

Andrew Orenstein

Andrew J. Orenstein

Member

(212) 313-5473

aorenstein@harrisbeachmurtha.com

Christopher Palermo

Christopher C. Palermo

Member

(914) 298-3032

cpalermo@harrisbeachmurtha.com

Marina Plotkin

Marina Plotkin

Member

(212) 313-5409

mplotkin@harrisbeachmurtha.com

Megan Pollastro

Megan Pollastro

Associate

(212) 313-5445

mpollastro@harrisbeachmurtha.com

Jaime Regan, Mass Torts and Industry wide Litigation attorney

Jaime L. Regan

Member

(212) 912-3506

jregan@harrisbeachmurtha.com

Attorney Anthony J. Ruzzi

Anthony J. Ruzzi

Associate

(516) 880-8116

aruzzi@harrisbeachmurtha.com

Partner Stephanie Sprague Sobkowiak

Stephanie Sprague Sobkowiak

Member

(203) 772-7782

ssobkowiak@harrisbeachmurtha.com

Jesse Wang

Jesse C. Wang

Associate

(212) 912-3570

jcwang@harrisbeachmurtha.com

Marita Williams

Marita A. Williams

Associate

(212) 912-3677

mwilliams@harrisbeachmurtha.com

  • Menza v. Slomin’s, No. 609206/16 (Sup. Ct. Nassau Cty, April 11, 2019): partial summary judgment awarded in toxic tort claim that alleged exposure to residential oil spill caused homeowner to develop lupus and/or the exposure exacerbated her lupus condition. Court dismissed the lupus claim, holding that evidence of a mere association between a toxin and an injury is not sufficient to establish causation, and further, even when general causation is satisfied, the plaintiff must still establish sufficient exposure to have caused the claimed adverse health effect.
  • Fleming v. Laakso, No. 1:18-cv-01527-RA-BCM (S.D.N.Y. February 27, 2019) dismissal of claims against psychiatrist in federal court action which alleged defamation by performing a mental assessment and deeming plaintiff unfit for duty at a hospital related clinic, medical malpractice and tortious interference with prospective business relations. Court held complaint failed to state a cause of action under FRCP 12(b)(6), did not plead the necessary elements of defamation, tortious interference with prospective business relations or medical malpractice, and dismissal was appropriate based upon the common interest qualified privilege.
  • Page v. Curlin Medical, B. Braun Medical and Moog, Inc, (Niagara County Supreme Court, January 8, 2018): Summary judgment in an action involving allegations of patient controlled analgesia (“PCA”) pump malfunction causing morphine over-infusion and the resulting sequelae of opioid overdose, causing respiratory depression and subsequent anoxic brain damage.  The court agreed that without any evidence that the PCA pump delivered anything other than the prescribed dose, the mere fact that the plaintiff experienced respiratory depression, a well-known adverse effect of morphine, was insufficient to support a valid inference of a manufacturing defect. Plaintiff’s design defect claims were “based upon speculation and a hope and a prayer” as the device was “state-of-the-art,” “functioned properly” and “dispensed to the plaintiff far less than the maximum dose of morphine prescribed by the plaintiff’s own doctor.”
  • Ford v. Riina, 2017 WL 1709471 (Sup. Ct. N.Y. Cty, May 2, 2017): summary judgment granted and affirmed on appeal to the Appellate Division First Department 160 A.D.3d 588, 75 N.Y.S.3d 13 (1st Dept. April 26, 2018) on behalf of endovascular device manufacturer Concentric Medical, Inc. (now Stryker Neurovascular) in medical device product liability case brought on behalf of a severely brain-damaged plaintiff, dismissing all claims under CPLR R. 3212, including design defect, failure to warn and breach of warranty; holding that device manufacturer established prima facie evidence that the product labeling conveyed adequate warnings; prima facie entitlement to summary dismissal of plaintiff’s design defect claim by establishing that the endovascular retrieval device was state of the art; and holding expert witness affidavits in opposition were speculative and conclusory, unsupported by any scientific basis, statistics, analysis or empirical data, as experts failed to disclose the experimental data and test conditions used to generate their opinions.
  • Tomaselli v. Zimmer, 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017): adopting Magistrate Report and Recommendation (Jan. 20, 2017) summary judgment granted and affirmed on appeal to the United States Court of Appeals for the Second Circuit 2018 WL 1612230 (2d Cir. Apr. 4, 2018) on behalf of GTR fixation medical device manufacturer Pioneer Surgical and distributor Zimmer under FRCP 56, holding that decision of a physician, as a learned intermediary, not to inform the patient of the risk of medical device fracture does not support the physician’s lack of awareness of the risk; the surgeon’s independent awareness of the risk severed the required causal connection between an alleged failure to warn and plaintiff’s injury; the instructions for use referred specifically to cable breakage and as such were adequate as a matter of law; failure to identify product defect and offer expert evidence of alternative feasible design or deviation from defendants’ design and engineering specifications were fatal to design and manufacturing defect claims, required summary judgment on negligence and strict product liability claims and breach of implied and express warranty.
  • Hudson v. Sunnyside Corp., 155 A.D.3d 1532 (4th Dep’t 2017): dismissal affirmed on appeal in toxic tort product liability action involving exposure to muriatic acid used to clean an indoor swimming pool. Plaintiff asserted several causes of action including negligence in failure to warn, specifically, that defendant’s product failed to provide an affirmative statement of the principal hazard associated with the use of the product, and adequate precautionary measures regarding actions to be followed or avoided when using the product, making the product a “misbranded hazardous substance” in violation of the Federal Hazardous Substances Act (“FHSA”), 15 U.S.C. § 1261(p). In a unanimous decision, the Appellate Division, Fourth Department affirmed finding that the label was in compliance with the FHSA in providing sufficient statements of the principal hazard and of the precautionary measures to be followed or avoided.
  • Greenwood v. Tehrani, 2017 WL 4083099, 2017 NY Slip Op 31963(U) (Sup. Ct. N.Y. Cty, September 15, 2017): dismissal of plaintiff’s medical malpractice, lack of informed consent, and negligence claims against a medical device manufacturer. Court rejected claims that sales representative’s presence invoked duty to warn patient, as the manufacturer’s duty is to warn the medical community, not the patient, of the product’s risks, as it is the physician whose duty it is to balance the risks against the benefits of various medical products and treatments and to prescribe them and supervise their effects. Medical device manufacturer did not have duty to ensure the device was used by the physician in accordance with FDA guidelines and plaintiff could not assert medical malpractice and lack of informed consent claims against medical device manufacturer, since a manufacturer neither practices medicine nor has a duty to inform a patient of the risks and benefits of a particular treatment.
  • Vidal v. Dentsply, Index 18110/2010 (Supreme Court of the State of New York, Washington County, April 23, 2015): summary judgment on all causes of action in a medical device product liability action involving dental equipment alleged to give patient an electric shock. In the face of learned intermediary testimony and plaintiff’s reliance upon a mere temporal relationship between exposure to the product and the subsequent development of later injury, the Supreme Court found plaintiff failed to make a showing of general causation by submission of expert reports or past events establishing that the device had propensity to cause electric shock.
  • Coratti v. Wella Corporation, 56 A.D.3d 343, 867 N.Y.S.2d 421 (New York Appellate Division, First Department 2008): summary judgment on behalf of L’Oreal, affirmed on appeal, establishing that the scientific community has not generally accepted the theory that MCS can be caused by daily, occupational exposure to the chemicals contained in hair dyes.
  • Hanlon v. Gliatech, (United States District Court, Eastern District of New York 2008): FRCP 12(b)(6) dismissal of negligence, strict liability and fraud claims on behalf of manufacturer of 510 (k) medical device, a surgical adhesive used in orthopedics.
  • Burger v. Union Carbide Corp., 304 A.D.2d 700 (New York Appellate Division, Second Department 2003): dismissal premised upon New York’s “toxic tort” statute of limitations.
  • Krasnopolsky v. Warner-Lambert, Co., 799 F. Supp. 1342 (United States District Court, Eastern District of New York 1992): pharmaceutical manufacturer discharged its duty to warn through Learned Intermediary.
  • Warner v. American Fluoride, 204 A.D.2d 1, 616 N.Y.S.2d 534 (New York Appellate Division, Second Department 1994): FIFRA preemption of pesticide labeling claims.
  • Successful representation of dietary supplement client in connection with a challenge before the National Advertising Division.
  • Successful representation of dietary supplement client in connection with trademark infringement claim against competing product.
  • Successful resolution for dietary supplement client in connection with breach of contract claim against distributor.

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Appellate Court Revives Acetaminophen-Autism Cases Without Deciding the Merits of Plaintiffs’ Causation Theory

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Supreme Court’s Roundup Decision Strengthens Preemption Defenses for FDA-Regulated Products

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Judi Abbott Curry to Lead Discussion on GLP-1 Weight Loss Drugs at 37th Medmarc Medical Device Seminar

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Brendan Hall Presenting During DRI’s 2024 Young Lawyers Seminar

June 13, 2024
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Kelly Jones Howell to Present During 2024 DRI Toxic Torts and Environmental Law Seminar

March 22, 2024
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Kelly Jones Howell to Present During DRI Virtual Corporate Counsel Roundtable

October 6, 2021
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Chris Palermo Moderating New York State Bar Association Webinar on State Drug Price Transparency Laws And Impacts On Manufacturers, Pharmacies, Patients

October 27, 2021
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Kelly Jones Howell Presenting During DRI 2021 Young Lawyers Seminar

June 24, 2021
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Medical and Life Sciences

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Harris Beach Murtha Attorneys at Law

Medical and Life Sciences

Legal Practice

Profile

Our Medical and Life Sciences Practice Group attorneys, capitalizing on insights resulting from their combination of medical and legal credentials, have earned a national reputation for successful defense of FDA-regulated manufacturers, including pharmaceuticals, medical devices and cosmetics, as well as healthcare, pharmacy and long-term care organizations. Harris Beach Murtha has the experience, relationships and resources to help industry stakeholders compete and succeed in this constantly evolving marketplace.

The medical and life sciences industry’s dynamic growth over recent years has been driven by a demographic shift in the U.S. population. As the ‘Baby Boomer’ generation continues to age, demand increases for prescription and over-the-counter (OTC) pharmaceuticals, medical devices, nutritional supplements and products enhancing overall health, as well as medical care and housing for these individuals. This results in heightened responsibilities for the medical and life sciences industry to continue advancing research and development, and increased complexities for legal counsel.

Due to their complex nature, medical and life sciences matters often demand integrated solutions involving many of our practice areas. To provide the greatest efficiency and value for our clients, we strategically leverage our broad knowledge base to build interdisciplinary, problem-solving teams of complementary disciplines. This team approach has proven beneficial in defending mass torts and addressing other legal issues, such as intellectual property, corporate and securities law, fraud and abuse, business and commercial litigation, labor and employment law, risk management, R&D, strategic alliances and licensing. Additionally, our cybersecurity practice can help protect against cyber threats to manufacturers, distributors and retailers of pharmaceuticals and nutritional supplements, as well as help protect medical devices from cyberattacks.

Harris Beach Murtha’s attorneys frequently address and chair national industry conferences as thought leaders in the product liability defense of pharmaceuticals, medical devices and nutritional supplements and in litigation of matters impacting healthcare and long-term care organizations. In a constantly changing industry, we stay on the cutting edge through membership and leadership in such medical and legal professional organizations as the American Bar Association, American Society for Pharmacy Law and DRI. We continuously monitor and explore new medical and scientific developments, such as nanotechnology, which will impact the industry’s future.

Representing clients in New York, New Jersey, Massachusetts, Connecticut and other states throughout the nation, our combination of legal and scientific acumen and first-hand industry knowledge sets us apart. Because some of our attorneys began their careers as nurses, pharmacists or other health care professionals, we routinely leverage our sophisticated industry insight to benefit clients and reach solutions quicker and more cost-effectively.

Services

Defense of a Broad Range of Medical and Life Sciences Claims

When it comes to helping clients resolve complex business disputes in the pharmaceutical, OTC medication, personal care/cosmetic, medical device, biologic, nutritional supplement and other life sciences spaces, our attorneys have extensive experience litigating commercial disputes that may arise at each phase of the product’s lifecycle.

Harris Beach Murtha attorneys defend brand-name and generic pharmaceutical and medical device manufacturers and distributors, as well as manufacturers of OTC drugs, nutritional supplements, cosmetics, personal care products, biologics and products impacting women’s health.

Our extensive defense experience ranges from urology imaging systems and other sophisticated products, to contact lenses and personal care items, to cough and cold remedies and other OTC products, such as dietary and sports nutritional supplements.

Product Liability Defense

Our attorneys have earned a reputation for skillfully defending a wide range of pharmaceutical, medical devices and nutritional supplements companies throughout New York, New Jersey, Massachusetts, Connecticut and the nation. We have established a proven record of success defending clients in sophisticated, high-exposure, high-value catastrophic injury cases.

We defend claims involving a variety of allegations, including birth defects, cancer, cardiac injuries, autoimmune disease, neurologic injuries, learning disabilities and others by challenging “junk science” and through motions directed at causation under Daubert (federal) and Frye (state) standards.

We counsel and strategize with our clients to assess and resolve potential problems before they erupt into costly litigation. When litigation is necessary, we manage discovery intelligently and pursue resolution in an aggressive and efficient manner, using litigation management tools and innovative legal strategies.

Premises Liability Defense

Harris Beach Murtha attorneys frequently represent businesses or property owners accused of liability when personal injuries occur on their premises and have a track record of success avoiding hefty judgments and higher insurance rates. That work includes high-exposure personal injury cases, slip-and-fall cases, complex claims involving serious personal injury, complex multi-party matters involving contribution and indemnification disputes, alleged defective conditions, assaults with negligent security, false imprisonment and related tort claims.

We evaluate risk and analyze objectives at every stage of the process, while managing the impact on your business. When needed, we have access to a broad network of trusted technical experts to bolster our case.

Mass Torts Defense

Our Mass Torts and Industry-Wide Litigation Practice Group has been named a national Tier 1 Law Firm for Mass Torts Litigation/Class Action-Defendants since 2014. Our attorneys are recognized for their ability to handle cases in which complex scientific and legal issues overlap. They hold degrees or licenses in fields such as pharmacology, nursing, industrial hygiene, education, food and beverage operations, law enforcement and computer science. Others have held key positions in government, including United States Attorney.

Our trial lawyers regularly coordinate the defense of medical and life sciences industry-related mass torts. We have developed effective mass tort defense strategies for FDA regulated products such as pain pumps, contraceptives, analgesics, dental anesthetics, latex products, breast implants, Hormone Replacement Therapies, and diet drugs.

We represent foreign and domestic clients of all sizes and industry affiliations in some of the most complex and precedent-setting mass torts filed in the last 30 years. We are noted for our proprietary approach to large case management and litigation support. Our attorneys are recognized as thought leaders on emerging issues; are active members of industry groups; and are sought-after educators who write and speak for bar associations, trade councils, companies and insurers.

Corporate Law

Harris Beach Murtha attorneys regularly assist medical device, biological and life sciences organizations with their broad corporate needs. We take a multi-disciplinary, problem-solving approach to each transaction we guide, including those in highly regulated industries such as health care, medical devices and pharmaceutical.

Our corporate legal services include financing, capital, U.S. Securities and Exchange Commission (SEC) issues, initial public offerings, tax issues, licensing agreements, export applications, and equity and technology exchange agreements. We also advise boards of directors on state and federal regulatory compliance; corporate governance and structure; and merger, acquisition and divestiture activities.

At Harris Beach Murtha, our entrepreneurial and strategic approach to working with business clients supports all phases of their growth and evolution and helps them define and meet their immediate and long-term objectives. The keen business acumen, legal knowledge and extensive public and private business transactional experience of our attorneys has consistently resulted in their professional peer-review recognition in The Best Lawyers in America ®.

National, Regional and Local Counsel

Harris Beach Murtha attorneys serve as national, regional, and local counsel for some of the largest names in pharmaceuticals, biologics, medical devices, cosmetics, nutritional supplements and products impacting women’s health. While we have offices throughout New York, New Jersey, Massachusetts, Connecticut and Washington, D.C., our work is national and, when the stakes are high, our experience matters.

Intellectual Property

Our intellectual property (IP) attorneys focus on U.S. and foreign patent and trademark procurement for clients in all areas of advanced technology, including mechanical and electrical engineering, biotechnology, pharmaceuticals, nanotechnology, medical devices, materials science, environmental chemistry and agriscience.

We have protected numerous patents of leading pharmaceutical and life sciences companies. Our IP attorneys have a wide range of technical backgrounds in science and technology, as well as the medical and life sciences, well-positioning us to help clients identify and protect proprietary formulas and trade secrets.

We also assist clients with the analysis, purchase, sale and licensing of their IP, domestically and worldwide, as well as managing and assessing the scope and value of their IP portfolios.

We have procured, enforced and defended patents for leading medical device manufacturers, pharmaceutical and life sciences companies in administrative proceedings, alternative dispute resolution processes and federal district court litigation. Harris Beach Murtha attorneys are also experienced in developing, designing and implementing strategies to combat illicit trade on a global basis.

Pre-Product Launch Risk Analysis and Management

Our Medical and Life Sciences Practice Group provides legal counseling concerning prelitigation risk assessments and submissions to the FDA, including package inserts, marketing materials, brochures, warnings, patient labeling, pharmacovigilance as well as development and use of Risk Minimization Action Plans.

To help our clients avoid potentially damaging legal actions, our attorneys also examine pre- and post-market liability issues relating to clinical trials, marketing and product recalls.

Health Care and Senior Living

Harris Beach Murtha’s attorneys have deep experience in regulated industries, including health care, long-term care and senior living. We represent some of the largest senior living and long-term care organizations in North America and defend a variety of health care, senior/assisted living and skilled-nursing companies in litigation and regulatory matters, including class actions, trials, arbitration, investigations, and regulatory responses.

Our work includes investigations and defense of lawsuits and regulatory actions pertaining to allegations of negligence, abuse and neglect; claims of inadequate supervision/hiring; medication errors and elopement. Additionally, we defend class actions concerning staffing and alleged violations of the Americans with Disabilities Act and other federal and state laws related to accessibility.

Many of our attorneys possess a combination of legal and scientific acumen and first-hand knowledge from beginning their careers as nurses, pharmacists or other health care professionals. We routinely leverage our sophisticated industry insight to benefit clients and reach solutions quicker and more cost-effectively.

Pharmacy Law

With years of experience in pharmacy ownership and supervision, our pharmacy law attorney team is headed by a pharmacist-attorney within the Medical and Life Sciences Practice Group. Our attorneys, drawing on insights gleaned from both scientific and legal credentials, have earned a national reputation for providing general business counsel and successfully defending some of the largest entities in the pharmaceutical industry.

We help ensure compliance with Medicare and Medicaid standards, pharmacy state laws, board of pharmacy rules, DEA regulations, and various Pharmacy Benefit Manager contracts and provider manuals. We also draft and negotiate related corporate agreements, represent clients before state and federal regulatory enforcement agencies, assist with pharmacy purchase and sale transactions, and defend clients in products liability and pharmacist professional malpractice litigation. We also defend the interests of pharmacies and pharmacists in litigation and reimbursement-related fraud and abuse investigations.

Our pharmacy law attorneys also serve the general counsel needs of pharmacies and pharmacists through regulatory compliance, PBM audit support, contract review, corporate transactional, government investigation, real estate, data privacy and cybersecurity, labor and employment, immigration and intellectual property services.

Harris Beach Murtha has the experience, relationships and resources to help industry stakeholders compete and succeed in this constantly shifting marketplace.

Nutritional Supplements

Harris Beach Murtha has extensive experience advancing and defending the interests of nutritional supplement manufacturers, distributors and retailers. Our attorneys serve the general counsel needs of these clients by providing the full range of corporate transactional, intellectual property and regulatory compliance services.

We support our clients through every phase of the product life cycle, including product development; securing and defending intellectual property rights; helping ensure compliance with advertising, marketing and distribution regulations; drafting and negotiating related corporate agreements; and defending the clients in products liability and mass tort litigation.

Labor and Employment Law

In the highly competitive medical and life sciences field, where “first-to-market” status and technological advances can increase the value of a company’s stock, Harris Beach Murtha attorneys help protect companies from harmful employee actions by safeguarding patents, enforcing noncompete and confidentiality agreements and taking other protective measures.

Our attorneys have partnered with management at businesses in a wide range of industries throughout the Northeast to proactively prevent labor issues, claims and conflicts by conducting risk assessments, developing sound policy, delivering training and strengthening positions at the bargaining table. Our clients include small privately held companies, large publicly traded corporations, tax-exempt organizations and public sector entities. Our attorneys also handle National Labor Relations Board and Equal Opportunity Commission regulations for their clients.

Employment and labor law is ever-changing and increasingly complex. Regularly emerging laws, regulations and court decisions will impact your daily operations and Harris Beach Murtha helps you understand and respond to avoid disruption and mitigate negative consequences.

Government Compliance and Investigations

Today’s regulatory landscape is increasingly complex. Federal, state and even local governments have expanded compliance requirements and increased enforcement. Harris Beach Murtha attorneys help pharmaceutical and medical device companies, as well as manufacturers of nutritional and dietary supplements, vitamins and OTC products, stay abreast of changes in their highly regulated industries.

We represent a variety of medical and life sciences businesses throughout New York, New Jersey, Massachusetts, Connecticut and around the nation. Many of our attorneys also have backgrounds in complex, specialized fields, such as pharmaceuticals, forensic science, accounting, health care and banking. They understand the complexity of these fields and monitor regulatory updates and industry news, preparing Harris Beach Murtha to react quickly and strategically when needed.

We advise clients in the areas of corporate compliance, government ethics, lobbying compliance and white-collar crime, and we help clients conduct high-level internal investigations to help address government scrutiny. We help businesses develop effective compliance programs and mitigate risk so they can operate successfully and maintain profitability.

Environmental Law and Sustainability

Our environmental and toxic tort team has years of experience dealing with the elimination of toxic and hazardous wastes and by-products from the manufacture of pharmaceutical and medical devices. We assist companies in New York, New Jersey, Massachusetts, Connecticut and states around the country and rely on our extensive experience to guide and support in these critical situations.

PFAS Compliance and Litigation

Per- and polyfluoroalkyl substances (PFAS) are a large, diverse, and complex family of manmade fluorinated chemicals that have long been used in the manufacturing of consumer and industrial products, such as fire suppression foams. Found in everything from water to wrappers, awareness and concern surrounding these “forever chemicals” is gaining steam, impacting organizations across a wide range of industries and municipalities.

Harris Beach Murtha helps clients assess PFAS risks and address these and other emerging contaminant issues that lead to actions by regulatory agencies, including site investigations, off-site contamination concerns, project delays, future liabilities and potential threats of litigation.

We work with scientific experts to help guide clients through the legal, regulatory and scientific challenges and uncertainties related to PFAS. We help develop effective risk communication and long-term strategies to investigate possible environmental contamination on-site and off-site, analyze past, present and pending remediation projects and cleanups, and advise our clients regarding possible liabilities, including enforcement and litigation.

 

Cybersecurity

Medical and life science companies are often targeted by cyber criminals. Harris Beach Murtha offers a dynamic combination of legal and technical support to protect digital assets and business interests, as well as a rapid response team in the event of a breach.

Our cybersecurity team provides a full range of data privacy and cybersecurity services: compliance counseling and legal risk assessment, guidance on following the National Institute of Standards and Technology protocols and other state and federal regulations, defense in litigation and investigations, and rapid response in the event of breaches. Our attorneys, along with our information security and communications professionals, partner with you to reduce risk and defend your data.

Database of Expert Witnesses

Our expert witness database consists of the nations’ leading authorities on epidemiology, teratology, toxicology, pharmacology, industrial hygiene, dysmorphology, oncology, genetics, pathology, biomedical engineering, cardiology, obstetrics, gynecology and economics.

First Response Emergency, Crisis and Disaster Team

Harris Beach Murtha established our First Response Emergency, Crisis and Disaster Team recognizing that, in the event of a catastrophe, response time is critical to manage liability exposure. This team helps clients prepare detailed emergency plans to mitigate risk before a crisis occurs. Our team is also available to help with evidence preservation all the way through the post-disaster investigation. Our 24-hour, on-the-scene legal guidance provides the insight, perspective, experience and required coordination to manage critical legal issues, as well as media coverage that could expose your organization to significant liability and reputation damage.

Crisis Communications Counseling

Protecting the image of a medical and life sciences company is critical, especially during a crisis or highly controversial situation. Harris Beach Murtha has extensive experience crafting effective communication strategies to maximize positive public exposure and lessen the negative impact to pharmaceutical, medical devices and nutritional supplement companies facing controversial situations.

We provide media training, respond to the media, develop talking points and work side-by side with you during and after the crisis so you have the support needed to weather the storm.

Experience

  • Menza v. Slomin’s, No. 609206/16 (Sup. Ct. Nassau Cty, April 11, 2019): partial summary judgment awarded in toxic tort claim that alleged exposure to residential oil spill caused homeowner to develop lupus and/or the exposure exacerbated her lupus condition. Court dismissed the lupus claim, holding that evidence of a mere association between a toxin and an injury is not sufficient to establish causation, and further, even when general causation is satisfied, the plaintiff must still establish sufficient exposure to have caused the claimed adverse health effect.
  • Fleming v. Laakso, No. 1:18-cv-01527-RA-BCM (S.D.N.Y. February 27, 2019) dismissal of claims against psychiatrist in federal court action which alleged defamation by performing a mental assessment and deeming plaintiff unfit for duty at a hospital related clinic, medical malpractice and tortious interference with prospective business relations. Court held complaint failed to state a cause of action under FRCP 12(b)(6), did not plead the necessary elements of defamation, tortious interference with prospective business relations or medical malpractice, and dismissal was appropriate based upon the common interest qualified privilege.
  • Page v. Curlin Medical, B. Braun Medical and Moog, Inc, (Niagara County Supreme Court, January 8, 2018): Summary judgment in an action involving allegations of patient controlled analgesia (“PCA”) pump malfunction causing morphine over-infusion and the resulting sequelae of opioid overdose, causing respiratory depression and subsequent anoxic brain damage.  The court agreed that without any evidence that the PCA pump delivered anything other than the prescribed dose, the mere fact that the plaintiff experienced respiratory depression, a well-known adverse effect of morphine, was insufficient to support a valid inference of a manufacturing defect. Plaintiff’s design defect claims were “based upon speculation and a hope and a prayer” as the device was “state-of-the-art,” “functioned properly” and “dispensed to the plaintiff far less than the maximum dose of morphine prescribed by the plaintiff’s own doctor.”
  • Ford v. Riina, 2017 WL 1709471 (Sup. Ct. N.Y. Cty, May 2, 2017): summary judgment granted and affirmed on appeal to the Appellate Division First Department 160 A.D.3d 588, 75 N.Y.S.3d 13 (1st Dept. April 26, 2018) on behalf of endovascular device manufacturer Concentric Medical, Inc. (now Stryker Neurovascular) in medical device product liability case brought on behalf of a severely brain-damaged plaintiff, dismissing all claims under CPLR R. 3212, including design defect, failure to warn and breach of warranty; holding that device manufacturer established prima facie evidence that the product labeling conveyed adequate warnings; prima facie entitlement to summary dismissal of plaintiff’s design defect claim by establishing that the endovascular retrieval device was state of the art; and holding expert witness affidavits in opposition were speculative and conclusory, unsupported by any scientific basis, statistics, analysis or empirical data, as experts failed to disclose the experimental data and test conditions used to generate their opinions.
  • Tomaselli v. Zimmer, 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017): adopting Magistrate Report and Recommendation (Jan. 20, 2017) summary judgment granted and affirmed on appeal to the United States Court of Appeals for the Second Circuit 2018 WL 1612230 (2d Cir. Apr. 4, 2018) on behalf of GTR fixation medical device manufacturer Pioneer Surgical and distributor Zimmer under FRCP 56, holding that decision of a physician, as a learned intermediary, not to inform the patient of the risk of medical device fracture does not support the physician’s lack of awareness of the risk; the surgeon’s independent awareness of the risk severed the required causal connection between an alleged failure to warn and plaintiff’s injury; the instructions for use referred specifically to cable breakage and as such were adequate as a matter of law; failure to identify product defect and offer expert evidence of alternative feasible design or deviation from defendants’ design and engineering specifications were fatal to design and manufacturing defect claims, required summary judgment on negligence and strict product liability claims and breach of implied and express warranty.
  • Hudson v. Sunnyside Corp., 155 A.D.3d 1532 (4th Dep’t 2017): dismissal affirmed on appeal in toxic tort product liability action involving exposure to muriatic acid used to clean an indoor swimming pool. Plaintiff asserted several causes of action including negligence in failure to warn, specifically, that defendant’s product failed to provide an affirmative statement of the principal hazard associated with the use of the product, and adequate precautionary measures regarding actions to be followed or avoided when using the product, making the product a “misbranded hazardous substance” in violation of the Federal Hazardous Substances Act (“FHSA”), 15 U.S.C. § 1261(p). In a unanimous decision, the Appellate Division, Fourth Department affirmed finding that the label was in compliance with the FHSA in providing sufficient statements of the principal hazard and of the precautionary measures to be followed or avoided.
  • Greenwood v. Tehrani, 2017 WL 4083099, 2017 NY Slip Op 31963(U) (Sup. Ct. N.Y. Cty, September 15, 2017): dismissal of plaintiff’s medical malpractice, lack of informed consent, and negligence claims against a medical device manufacturer. Court rejected claims that sales representative’s presence invoked duty to warn patient, as the manufacturer’s duty is to warn the medical community, not the patient, of the product’s risks, as it is the physician whose duty it is to balance the risks against the benefits of various medical products and treatments and to prescribe them and supervise their effects. Medical device manufacturer did not have duty to ensure the device was used by the physician in accordance with FDA guidelines and plaintiff could not assert medical malpractice and lack of informed consent claims against medical device manufacturer, since a manufacturer neither practices medicine nor has a duty to inform a patient of the risks and benefits of a particular treatment.
  • Vidal v. Dentsply, Index 18110/2010 (Supreme Court of the State of New York, Washington County, April 23, 2015): summary judgment on all causes of action in a medical device product liability action involving dental equipment alleged to give patient an electric shock. In the face of learned intermediary testimony and plaintiff’s reliance upon a mere temporal relationship between exposure to the product and the subsequent development of later injury, the Supreme Court found plaintiff failed to make a showing of general causation by submission of expert reports or past events establishing that the device had propensity to cause electric shock.
  • Coratti v. Wella Corporation, 56 A.D.3d 343, 867 N.Y.S.2d 421 (New York Appellate Division, First Department 2008): summary judgment on behalf of L’Oreal, affirmed on appeal, establishing that the scientific community has not generally accepted the theory that MCS can be caused by daily, occupational exposure to the chemicals contained in hair dyes.
  • Hanlon v. Gliatech, (United States District Court, Eastern District of New York 2008): FRCP 12(b)(6) dismissal of negligence, strict liability and fraud claims on behalf of manufacturer of 510 (k) medical device, a surgical adhesive used in orthopedics.
  • Burger v. Union Carbide Corp., 304 A.D.2d 700 (New York Appellate Division, Second Department 2003): dismissal premised upon New York’s “toxic tort” statute of limitations.
  • Krasnopolsky v. Warner-Lambert, Co., 799 F. Supp. 1342 (United States District Court, Eastern District of New York 1992): pharmaceutical manufacturer discharged its duty to warn through Learned Intermediary.
  • Warner v. American Fluoride, 204 A.D.2d 1, 616 N.Y.S.2d 534 (New York Appellate Division, Second Department 1994): FIFRA preemption of pesticide labeling claims.
  • Successful representation of dietary supplement client in connection with a challenge before the National Advertising Division.
  • Successful representation of dietary supplement client in connection with trademark infringement claim against competing product.
  • Successful resolution for dietary supplement client in connection with breach of contract claim against distributor.

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