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Medical and Life Sciences

Industry Team

2023 Best Law Firms - National Tier 1 Mass Torts litigation Class Actions -Defendants
  • EPA Releases Crucial PFAS Drinking Water Rule; Implications for Water Treatment Facilities
  • New York Bans PFAS in Apparel
  • Judi Abbott Curry Reviews Medical and Life Sciences Law in Rochester Business Journal
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Our Medical and Life Sciences Industry Team attorneys, capitalizing on insights resulting from their combination of medical and legal credentials, have earned a national reputation for successful product liability defense of pharmaceuticals, medical devices and nutritional supplements, including some of the largest entities in this FDA-regulated industry. Harris Beach 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, there is an increasing demand for prescription and over-the-counter (OTC) pharmaceuticals, medical devices, dietary and nutritional supplements and products enhancing overall health. This increased demand results in heightened responsibilities not only for the life sciences industry to continue advancing research and development, but also increased complexities for legal counsel.

Integrated Solutions

Due to their complex nature, medical and life sciences industry matters often demand integrated solutions which involve many of our areas of practice. 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 cyber attacks.

Industry Leadership in Product Liability Defense of Pharmaceutical, Medical Device and Nutritional Supplements  

Harris Beach attorneys frequently address and chair national industry conferences as thought leaders in the product liability defense of pharmaceutical, medical devices and nutritional supplements. In a constantly changing industry, our attorneys stay on the cutting edge through membership and leadership of such medical and legal professional organizations as the American Bar Association, American Society for Pharmacy Law, and the Defense Research Institute. Our attorney team continuously monitors and explores new medical and scientific developments, such as nanotechnology, which will impact the industry’s future.

Legal Experience Combined with Medical Knowledge 

Since some of our attorneys began their careers as nurses, pharmacists, or other health care professionals, they routinely leverage their sophisticated industry insight to benefit clients. Our attorneys’ combination of legal acumen and first-hand industry knowledge helps them reach client solutions quicker and more cost-effectively.

Pharmacy Law

Nutritional Supplements

Long-Term Care

Business and Commercial Litigation

Harris Beach has defended numerous Fortune 500 pharmaceutical and technology companies in a wide range of issues, such as patent enforcement, unfair competition, unfair importation, antitrust and breach of contract litigation.

Class Action, Multi-District and Multi-Party Liability

Our experienced trial lawyers regularly coordinate the defense of a wide range of complex litigation, defending companies in class action suits, multi-district litigation, as well as multi-party products liability actions.

Communications

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

Corporate Law

Harris Beach attorneys have assisted medical device, biological and life sciences organizations with their broad corporate needs. Our corporate legal services include financing, capital, U.S. Securities and Exchange Commission 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.

Cutting-Edge Litigation Techniques

Harris Beach routinely utilizes cutting-edge litigation management techniques for clients such as proprietary databases, and document imaging and coding software in electronic environments.

Cybersecurity

To protect your data, your business interests and your reputation, you need robust protection that extends beyond firewalls. Our cybersecurity team provides a full range of data privacy and cybersecurity services: compliance counseling and legal risk assessments, defense in litigation and investigations, advisement on state and federal regulations and rapid response should a breach occur. Our attorneys, information security and communications management professionals partner with you to reduce risk and give you data the defense it deserves.

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.

Defense of a Broad Range of MLS Claims

Harris Beach attorneys defend innovator and generic pharmaceutical manufacturers and distributors and medical device manufacturers and distributors that make or sell prescription and OTC drugs, medical devices, professional dental products, nutritional supplements 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. When it comes to helping pharmaceutical, OTC medication, personal care/cosmetic, medical device, biologic, nutritional supplement and other life sciences clients resolve complex business disputes, our Medical and Life Sciences attorneys have extensive experience litigating commercial disputes that may arise at each phase of the product’s life-cycle. Representative matters have included breach of contracts and agreements governing product development and manufacturing, clinical trial liability, disputes in joint ventures, and commercial litigation involving the supply, manufacture, distribution, licensing, profit-sharing, intellectual property, and royalty agreements for FDA regulated products.

E-Discovery (E-Info℠)

The attorneys in the e-info Practice Group are leaders in the areas of applying dataset analysis and computer assisted predictive coding to the challenges of complex litigation and investigations. This benefits our clients with substantial improvement in the analysis of their documents while lowering the total cost through increased efficiencies. Our e-discovery predictive-coding solutions are powered by software which acts as an efficiency engine to leverage attorneys’ analytical skills and Technology-Assisted Review (TAR) to increase accuracy in review by up to 70%, dramatically reduce review timeframes by up to 50% and cut client costs by up to 50%.

As a law firm with state-of-the-art technology, Harris Beach is well positioned to meet the defensibility and cost challenges associated with e-discovery. We leverage predictive-coding to make e-discovery reasonable for any litigation, regardless of size or industry, and we provide these services to a wide range of organizations, including national law firms. We have routinely been named as a Go-To Law Firm® for the Top 500 Companies for litigation e-discovery in the In-House Law Departments at the Top 500 Companies as published by Corporate Counsel. The e-info Practice Group leader, Alan M. Winchester, is recognized by the Courts as a thought leader in this area and has been appointed to chair the Operations e-Discovery Working Group. This group has drafted legislation and participates in the training for judges to improve the practice of electronic discovery.

Whether providing stand-alone document counsel, or document and legal counsel, our e-info team can help you control costs, ensure compliance, avoid sanctions, foster collaboration, and increase efficiency. Working with the Harris Beach e-info team also ensures attorney-client privilege is maintained throughout the litigation process.

Electronic Records Management Solutions for Risk Management and Operational Efficiency

Our team of attorneys and IT professionals understand the legal and IT issues associated with electronic records management systems. Their extensive experience in records management coupled with decades of litigation experience can provide unique insights into efficient and cost-effective records management solutions.

Effective Case Management

Harris Beach offers effective case management experience with large, high-risk cases and has established a track record for developing successful defense strategies for federal and state court cases.

Electronically Stored Information Risk Analysis and Management

Our risk analysis services also include ESI. By reviewing electronic files and electronic information infrastructure and recommending record retention policies, we can help clients eliminate up to 80% of e-discovery costs should litigation arise in the future.

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.

First Response Emergency, Crisis and Disaster Team

Government Compliance and Investigations

Harris Beach attorneys help pharmaceutical and medical device companies, as well as manufacturers of nutritional and dietary supplements, vitamins and OTC products, stay abreast of changing regulatory requirements and develop effective programs for ensuring compliance. We also assist companies subject to government, regulatory agency, or enforcement actions, as well as those dealing with government procurement rules and issues.

Intellectual Property

We have protected numerous patents of leading pharmaceutical and life sciences companies. Our intellectual property (IP) attorneys have a wide range of technical backgrounds in science and technology, as well as the medical and life sciences, which help our 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. Our 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 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 attorneys are also experienced in developing, designing and implementing strategies to combat illicit trade on a global basis.

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 attorneys can help protect companies from harmful employee actions by safeguarding patents, enforcing noncompete and confidentiality agreements, and taking other protective measures. Our attorneys also handle National Labor Relations Board and Equal Opportunity Commission regulations for their clients.

Mass Torts Defense

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 Food and Drug Administration (FDA) regulated products such as infusion pain pumps, methylprednisolone acetate, contraceptives, metoclopramide, dental anesthetics, Neurontin, latex products, silicone breast implants, ephedra, Diethylstilbestrol, Hormone Replacement Therapies, Phenylpropanolamine-containing pharmaceuticals and phentermine diet drugs.

National, Regional and Local Counsel

Harris Beach 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.

Pre-Product Launch Risk Analysis and Management

Our industry team 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.

Product Liability Defense

We defend claims of 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.

  • 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 relationships 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 510K 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.

Team Leader(s)

Kelly Jones Howell

Kelly Jones Howell

Member

Team

All Insights, All Publications, Legal Alert |
 March 28, 2023
New York Bans PFAS in Apparel
Governor Kathy Hochul prohibited the selling of apparel containing "intentionally added" per- and polyfluoroalkyl substances (PFAS). ...read more
All Insights, All Publications, Legal Alert |
 March 16, 2023
EPA Releases Crucial PFAS Drinking Water Rule; Implications for Water Treatment Facilities
The EPA has released its long-awaited proposed rule addressing levels of PFAS in drinking water across the United States....read more
All Insights, All Publications, Legal Alert |
 February 24, 2023
EPA Announces Perchloroethylene and Trichloroethylene Pose an Unreasonable Risk to Human Health
The EPA proposes risk management plans to contain harmful chemicals, Perchloroethylene and Trichloroethylene...read more
All Insights, Audio |
 February 16, 2023
The Hispanic National Bar Association Turns 50
On today’s episode of the Harris Beach podcast, we talk with Jessica and Christine about what they learned at the Convention and what they s...read more
All Insights, All Publications, Legal Alert |
 January 31, 2023
Fitness Companies Flex with Dismissal in New York UCC Elastic Band Case
New York's Appellate Court dismissed a case where a sporting retailer's and manufacturing exercise band injured a person's right eye....read more
All Insights, All Publications, Legal Alert |
 January 30, 2023
New York’s First Department Holds Trial Court Abused its Discretion in Limiting Scope of Independent Medical Examinations
Given the high “abuse of discretion” standard of review, any time a discovery ruling is altered by NY’s Appellate Division, the legal commun...read more
All Insights, All Publications, Legal Alert |
 January 26, 2023
Modernization of Cosmetics Regulation Act of 2022 Signals New Era of FDA Oversight
For the first time since the passage of the Food, Drug and Cosmetic Act in 1938, the Federal cosmetics law has been substantially updated....read more
All Insights, Advisory, All Publications |
 January 18, 2023
Medical and Life Sciences: Year in Review 2022
Partner Judi Abbott Curry reviews, analyzes and shares potential implications for future life science cases based on several key judicial ho...read more
All Insights, Advisory, All Publications |
 January 13, 2023
National Mass Torts: 2022 Year in Review
Harris Beach attorneys review and analyze key judicial holdings and legal developments in New York, the federal arena and across the country...read more

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2023 Best Law Firms - National Tier 1 Mass Torts litigation Class Actions -Defendants

Medical and Life Sciences

Industry Team

■ Profile

Our Medical and Life Sciences Industry Team attorneys, capitalizing on insights resulting from their combination of medical and legal credentials, have earned a national reputation for successful product liability defense of pharmaceuticals, medical devices and nutritional supplements, including some of the largest entities in this FDA-regulated industry. Harris Beach 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, there is an increasing demand for prescription and over-the-counter (OTC) pharmaceuticals, medical devices, dietary and nutritional supplements and products enhancing overall health. This increased demand results in heightened responsibilities not only for the life sciences industry to continue advancing research and development, but also increased complexities for legal counsel.

Integrated Solutions

Due to their complex nature, medical and life sciences industry matters often demand integrated solutions which involve many of our areas of practice. 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 cyber attacks.

Industry Leadership in Product Liability Defense of Pharmaceutical, Medical Device and Nutritional Supplements  

Harris Beach attorneys frequently address and chair national industry conferences as thought leaders in the product liability defense of pharmaceutical, medical devices and nutritional supplements. In a constantly changing industry, our attorneys stay on the cutting edge through membership and leadership of such medical and legal professional organizations as the American Bar Association, American Society for Pharmacy Law, and the Defense Research Institute. Our attorney team continuously monitors and explores new medical and scientific developments, such as nanotechnology, which will impact the industry’s future.

Legal Experience Combined with Medical Knowledge 

Since some of our attorneys began their careers as nurses, pharmacists, or other health care professionals, they routinely leverage their sophisticated industry insight to benefit clients. Our attorneys’ combination of legal acumen and first-hand industry knowledge helps them reach client solutions quicker and more cost-effectively.

■ Services

Business and Commercial Litigation

Harris Beach has defended numerous Fortune 500 pharmaceutical and technology companies in a wide range of issues, such as patent enforcement, unfair competition, unfair importation, antitrust and breach of contract litigation.

Class Action, Multi-District and Multi-Party Liability

Our experienced trial lawyers regularly coordinate the defense of a wide range of complex litigation, defending companies in class action suits, multi-district litigation, as well as multi-party products liability actions.

Communications

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

Corporate Law

Harris Beach attorneys have assisted medical device, biological and life sciences organizations with their broad corporate needs. Our corporate legal services include financing, capital, U.S. Securities and Exchange Commission 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.

Cutting-Edge Litigation Techniques

Harris Beach routinely utilizes cutting-edge litigation management techniques for clients such as proprietary databases, and document imaging and coding software in electronic environments.

Cybersecurity

To protect your data, your business interests and your reputation, you need robust protection that extends beyond firewalls. Our cybersecurity team provides a full range of data privacy and cybersecurity services: compliance counseling and legal risk assessments, defense in litigation and investigations, advisement on state and federal regulations and rapid response should a breach occur. Our attorneys, information security and communications management professionals partner with you to reduce risk and give you data the defense it deserves.

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.

Defense of a Broad Range of MLS Claims

Harris Beach attorneys defend innovator and generic pharmaceutical manufacturers and distributors and medical device manufacturers and distributors that make or sell prescription and OTC drugs, medical devices, professional dental products, nutritional supplements 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. When it comes to helping pharmaceutical, OTC medication, personal care/cosmetic, medical device, biologic, nutritional supplement and other life sciences clients resolve complex business disputes, our Medical and Life Sciences attorneys have extensive experience litigating commercial disputes that may arise at each phase of the product’s life-cycle. Representative matters have included breach of contracts and agreements governing product development and manufacturing, clinical trial liability, disputes in joint ventures, and commercial litigation involving the supply, manufacture, distribution, licensing, profit-sharing, intellectual property, and royalty agreements for FDA regulated products.

E-Discovery (E-Info℠)

The attorneys in the e-info Practice Group are leaders in the areas of applying dataset analysis and computer assisted predictive coding to the challenges of complex litigation and investigations. This benefits our clients with substantial improvement in the analysis of their documents while lowering the total cost through increased efficiencies. Our e-discovery predictive-coding solutions are powered by software which acts as an efficiency engine to leverage attorneys’ analytical skills and Technology-Assisted Review (TAR) to increase accuracy in review by up to 70%, dramatically reduce review timeframes by up to 50% and cut client costs by up to 50%.

As a law firm with state-of-the-art technology, Harris Beach is well positioned to meet the defensibility and cost challenges associated with e-discovery. We leverage predictive-coding to make e-discovery reasonable for any litigation, regardless of size or industry, and we provide these services to a wide range of organizations, including national law firms. We have routinely been named as a Go-To Law Firm® for the Top 500 Companies for litigation e-discovery in the In-House Law Departments at the Top 500 Companies as published by Corporate Counsel. The e-info Practice Group leader, Alan M. Winchester, is recognized by the Courts as a thought leader in this area and has been appointed to chair the Operations e-Discovery Working Group. This group has drafted legislation and participates in the training for judges to improve the practice of electronic discovery.

Whether providing stand-alone document counsel, or document and legal counsel, our e-info team can help you control costs, ensure compliance, avoid sanctions, foster collaboration, and increase efficiency. Working with the Harris Beach e-info team also ensures attorney-client privilege is maintained throughout the litigation process.

Electronic Records Management Solutions for Risk Management and Operational Efficiency

Our team of attorneys and IT professionals understand the legal and IT issues associated with electronic records management systems. Their extensive experience in records management coupled with decades of litigation experience can provide unique insights into efficient and cost-effective records management solutions.

Effective Case Management

Harris Beach offers effective case management experience with large, high-risk cases and has established a track record for developing successful defense strategies for federal and state court cases.

Electronically Stored Information Risk Analysis and Management

Our risk analysis services also include ESI. By reviewing electronic files and electronic information infrastructure and recommending record retention policies, we can help clients eliminate up to 80% of e-discovery costs should litigation arise in the future.

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.

First Response Emergency, Crisis and Disaster Team

Government Compliance and Investigations

Harris Beach attorneys help pharmaceutical and medical device companies, as well as manufacturers of nutritional and dietary supplements, vitamins and OTC products, stay abreast of changing regulatory requirements and develop effective programs for ensuring compliance. We also assist companies subject to government, regulatory agency, or enforcement actions, as well as those dealing with government procurement rules and issues.

Intellectual Property

We have protected numerous patents of leading pharmaceutical and life sciences companies. Our intellectual property (IP) attorneys have a wide range of technical backgrounds in science and technology, as well as the medical and life sciences, which help our 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. Our 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 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 attorneys are also experienced in developing, designing and implementing strategies to combat illicit trade on a global basis.

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 attorneys can help protect companies from harmful employee actions by safeguarding patents, enforcing noncompete and confidentiality agreements, and taking other protective measures. Our attorneys also handle National Labor Relations Board and Equal Opportunity Commission regulations for their clients.

Mass Torts Defense

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 Food and Drug Administration (FDA) regulated products such as infusion pain pumps, methylprednisolone acetate, contraceptives, metoclopramide, dental anesthetics, Neurontin, latex products, silicone breast implants, ephedra, Diethylstilbestrol, Hormone Replacement Therapies, Phenylpropanolamine-containing pharmaceuticals and phentermine diet drugs.

National, Regional and Local Counsel

Harris Beach 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.

Pre-Product Launch Risk Analysis and Management

Our industry team 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.

Product Liability Defense

We defend claims of 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.

Pharmacy Law Industry Team
Nutritional Supplements Industry Team
Long-Term Care Industry Team

■ People

Team Leaders

Kelly Jones Howell

Member
(212) 912-3652
khowell@harrisbeach.com

Team

Brian A. Bender

Member
(212) 313-5405
bbender@harrisbeach.com

Peri A. Berger

Member
(212) 912-3574
pberger@harrisbeach.com

Dominic Conoshenti

Law Clerk
(212) 313-5436
dconoshenti@harrisbeach.com

Judi Abbott Curry

Member
(212) 313-5404
jcurry@harrisbeach.com

David J. Dino

Senior Counsel
(212) 313-5484
ddino@harrisbeach.com

Abbie Eliasberg Fuchs

Member
(212) 313-5408
afuchs@harrisbeach.com

Wayne L. Gladstone

Senior Counsel
(212) 313-5491
wgladstone@harrisbeach.com

Pamela B. Goldsmith

Member
(212) 313-5494
pgoldsmith@harrisbeach.com

Stanley Goos

Member
(212) 313-5452
sgoos@harrisbeach.com

Brendan P. Hall

Associate
(212) 912-3635
bhall@harrisbeach.com

Kelly Jones Howell

Member
(212) 912-3652
khowell@harrisbeach.com

Andre J. Major

Member
(914) 298-3003
amajor@harrisbeach.com

James R. Muldoon

Member
(315) 214-2021
jmuldoon@harrisbeach.com

Omar Nasar

Member
(212) 313-5442
onasar@harrisbeach.com

Andrew J. Orenstein

Member
(212) 313-5473
aorenstein@harrisbeach.com

Christopher C. Palermo

Member
(914) 298-3032
cpalermo@harrisbeach.com

Marina Plotkin

Member
(212) 313-5409
mplotkin@harrisbeach.com

Thomas M. Porrazzo

Associate
(212) 313-5415
tporrazzo@harrisbeach.com

Jaime L. Regan

Member
(212) 912-3506
jregan@harrisbeach.com

Raymond J. Stapell

Counsel
(716) 200-5137
rstapell@harrisbeach.com

Christine D. Vasconcellos

Associate
(212) 313-5490
cvasconcellos@harrisbeach.com

Alan M. Winchester

Member
(212) 313-5403
awinchester@harrisbeach.com

Justine K. Woods

Associate
(212) 313-5416
jwoods@harrisbeach.com

Harris Beach and its subsidiaries provide a full range of legal and professional services for clients across New York state, as well as nationally and internationally. Harris Beach is among the country’s top law firms as ranked by The National Law Journal and is among the BTI Elite law firms based on in-depth interviews of more than 600 corporate counsel at the world’s largest and most influential companies. Our clients include Fortune 100 corporations, privately-held companies, emerging businesses, public sector entities, not-for-profit organizations and individuals. Principal industries we represent include education, energy, financial, food and beverage, health care, insurance, manufacturing, medical and life sciences, real estate developers, and state and local governments and authorities.

Industry Teams
Automotive and Vehicle Dealerships
Blockchain and Digital Assets 
Cannabis
Construction and Surety
Educational Institutions Higher Ed
Educational Institutions K-12
EMS and Fire Protection Providers
Energy
Financial Institutions and Capital Markets
Food and Beverage
Health Care
Industrial and Consumer Manufacturing
Medical and Life Sciences
Municipalities and Local Agencies
Nanotechnology
Photonics
Racing and Gaming
Real Estate Developers
Science and Technology
Telecommunications and Media
Unmanned Aircraft Systems
USA Collegiate Sports
Veterinary Medicine

Practices
Alternative Dispute Resolution
Appellate
Business and Commercial Litigation
Collection Law
Commercial Real Estate
Corporate
Cybersecurity Protection and Response
Diversity Compliance
E-Discovery (e-infoSM)
Employee Benefits
Employment Litigation
Environmental Law
Environmental, Social and Governance (ESG)
Financial Restructuring, Bankruptcy and Creditors’ Rights
Government Compliance and Investigations
Health Law
Immigration Law
Insurance Coverage
Intellectual Property Law
International Trade Law
Internet Law
Labor and Employment Law
Mass Torts and Industry-Wide Litigation
New Markets Tax Credit
Patent, Trademark and Copyright Law
Product Liability and Comprehensive General Liability
Public Finance and Economic Development
Real Property Valuation Litigation
Residential Real Estate
Tax Law
White Collar Crime
Wills, Trusts and Estates

Consulting Services
HB Solutions LLC
Collegiate Sports Compliance
Data Privacy and Cybersecurity
Economic Development and Public Affairs
Educational Institution Assistance
EMRG® (E-Discovery Management Resources Group)
Energy
Health and Human Services
Human Resources
Information Technology
Marketing and Communication Services
Municipal and Local Agency Assistance

HB Cornerstone LLC
Owner Representation
Design Services
Facilities Consulting
Move Management

Caetra.io
CyMetric (Cybersecurity Regulation Compliance Software)

Offices throughout New York:

Albany
677 Broadway
Albany, NY 12207
518-427-9700

Buffalo
726 Exchange Street
Buffalo, NY 14210
716-200-5050

Ithaca
119 East Seneca Street
Ithaca, NY 14850
607-273-6444

Long Island
333 Earle Ovington Boulevard
Uniondale, NY 11553
516-880-8484

New York City
100 Wall Street
New York, NY 10005
212-687-0100

Rochester
99 Garnsey Road
Pittsford, NY 14534
585-419-8800

Saratoga Springs
513 Broadway
Saratoga Springs, NY 12866
518-587-0551

Syracuse
333 West Washington Street
Syracuse, NY 13202
315-423-7100

White Plains
445 Hamilton Avenue
White Plains, NY 10601
914-683-1200

Offices also in:

New Haven, CT
195 Church Street
New Haven, CT 06510
203-784-3159

Newark, NJ
One Gateway Center
Newark, NJ 07102
973-848-1244

Washington, DC
800-685-1429

Attorney Advertising. Prior results do not guarantee a similar outcome.
© 2022 Harris Beach PLLC

Content current as of April 1, 2023 9:42 pm
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