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Marina Plotkin
D: (212) 313-5409  
mplotkin@harrisbeach.com

Marina Plotkin

  Member

(212) 313-5409
  mplotkin@harrisbeach.com
“I help clients work through legal, medical and scientific issues by utilizing my combined pharmacy and law backgrounds.”
  • U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi
Profile
Representative Matters
Professional and Civic
Areas of Experience
Admissions
Education
Location
Publications and Events

Marina is a pharmacist attorney on the Medical and Life Sciences Industry Team. With years of experience as a supervising pharmacist, Marina has unique insight for the defense of pharmacies and pharmacists.  She also counsels pharmacy clients on DEA, FDA, Medicare, Medicaid, and Board of Pharmacy matters.

Marina conducts internal pharmacy investigations for a national pharmacy chain in connection with opioid stewardship and proper interception of pain management prescribing practices. She represents pharmacy clients in healthcare fraud investigations on state and federal level, and conducts compliance assessments related to prior authorization assistance, effectiveness of compliance programs, and handling of third-party payor claims.

Marina provides audit assistance to community pharmacies audited by Pharmacy Benefit Managers, assisting with document preparation, discrepancy analysis, and appeal submission.  She also represents pharmacies audited by the New York State Office of Medicaid Inspector General (OMIG).  She offers Fraud, Waste and Abuse compliance development.  She is involved with the American Society for Pharmacy Law, having presented to a national audience on the Prescription Drug Monitoring Program.  She has also presented on the topic of pharmacist corresponding responsibility to identify and resolve red flags in filling controlled substance prescriptions.

Another major focus is the defense of product liability litigation involving pharmaceuticals, compounded preparations, biologics, and consumer household goods, utilizing the combination of pharmacy and legal credentials to provide strategic insight on complex issues.  She also defends medical malpractice, pharmacy malpractice, toxic mold, lead exposure and general liability cases.

Her experience includes all stages of discovery in state and federal courts, motion practice, oral argument, and strategizing litigation plans based on comprehensive medical research and analysis. Marina has worked with experts in neurosurgery, orthopedics, neuro-intervention, regulatory affairs, radiology and bioengineering. She has assisted in commercial litigation involving agreements governing clinical trial manufacturing. Marina was a member of the national coordinating counsel for New England Compounding Pharmacy in the fungal contamination mass tort, as well as national counsel for several medical device companies involved in mass tort litigation arising out of the use of a pain pump following arthroscopic surgery. Marina has experience advising clients on life science-related intellectual property rights.

Marina also has extensive experience defending long-term care providers including Independent Living Facilities, Adult Care Facilities/Assisted Living, and Nursing Homes, involving allegations such as medication errors, elopement, abuse and neglect, inadequate supervision, and deprivation of rights or benefits.

Representative Matters

  • OptumRx, Envision Rx (Elixir), Humana, Express Scripts, MedImpact pharmacy audit assistance, appeals, corrective action plans, successful network termination reconsideration requests.
  • 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 product liability case brought on behalf of a severely brain-damaged plaintiff, dismissing all claims under CPLR 3212, including design defect, failure to warn and breach of warranty, holding expert witness affidavits in opposition were speculative and conclusory based on failure to disclose the experimental data and test conditions used to generate their opinions.
  • Tomaselli v. Zimmer, No. 14-CV-4474 (RA) (SN) (United States District Court, Southern District of New York, 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, 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.
  • Hudson v. Sunnyside, Index 1136/2012 (Supreme Court of the State of New York, Steuben County, May 2016) dismissal granted and affirmed on appeal to the Appellate Division Fourth Department 155 A.D.3d 1532, 64 N.Y.S.3d 425 (4th Dept. 2017) in muriatic (hydrochloric) acid toxic exposure action involving issues of federal preemption and misbranding under federal law, finding as a matter of law that the product label complied with Federal Hazardous Substances Act.

Professional and Civic

  • American Society for Pharmacy Law, Education Committee Member
  • New York City Pharmacists Society, Board Member
  • Pharmacists Society of the State of New York, Legislative Committee Member

Recognition

  • Fordham Law Review
  • Fordham Law School – West Group Outstanding Scholastic Achievement Award
  • Henrietta Metcalf Prize for Excellence in the Study of Contracts
  • Fordham Law School Prize
  • Valedictorian – Arnold & Marie Schwartz College of Pharmacy and Health Sciences

Legal Practices

Government Compliance and Investigations
Intellectual Property
Mass Torts and Industry-Wide Litigation

Industry Teams

Health Care
Medical and Life Sciences

Sectors

Pharmacy Law
Nutritional Supplements
Long-Term Care

Admissions

New Jersey

New York

U.S. Court of Appeals, Second Circuit

U.S. District Court, New Jersey

U.S. District Court, New York - Eastern District

U.S. District Court, New York - Northern District

U.S. District Court, New York - Southern District

U.S. Patent and Trademark Office

Albany Law School

JD 
2005
magna cum laude

Long Island University

BS 
2000
summa cum laude

Location

New York, NY Office
Insights
November 22, 2022

U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi

U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi
November 17, 2022

New York Wraps Latest Round of Public Comment on Regulation and Licensing of Pharmacy Benefit Managers

After New York Governor Kathy Hochul created a new Pharmacy Benefits Bureau within the Department of Financial Services specifically charged
April 21, 2021

“About” Patent Claim Construction: Par v. Hospira

The use of the word “about” in a patent claim as part of a numeric range might permit the patent holder to preclude competitor formulations
February 2, 2021

U.S. Supreme Court Decision Supports State Regulation of Pharmacy Benefit Managers

The U.S. Supreme Court’s recent unanimous decision clears the way for state regulation of Pharmacy Benefit Managers (“PBMs”).  Rutledge v. P
September 29, 2020

New Jersey Reinforces the Trial Judge’s Gatekeeper Function in Expert Admissibility

In a recent decision, New Jersey Appellate Court applied the expert admissibility standard from the New Jersey Supreme Court’s landmark deci
September 14, 2020

IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112

In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of t
August 20, 2020

New Jersey Supreme Court Finds Products Liability Act Does Not Bar Consumer Fraud Act Claims Alleging Express Misrepresentations

In responding to the question of law certified by the United States Court of Appeals for the Third Circuit pursuant to Rule 2:12A-3, the New
June 4, 2020

Federal Circuit Holds That Patent Term Extension Under The Hatch-Waxman Act Does Not Apply to De-Esterified Metabolite of the Active Ingredient

In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute.  Biogen
April 22, 2020

Partial Summary Judgment Win for Major Pharmacy Chains in New York Litigation Deemed “Essential”

The pharmacy defendants – major national corporations CVS Pharmacy, Inc., Rite Aid of Maryland, Inc., Walgreen Co., and Walmart Inc., sued b
March 11, 2020

Plastic Bag Ban in New York State May Have Unexpected Impact on Retailers, Consumers

In an effort to reduce waste and plastic pollution, Governor Andrew Cuomo has signed legislation banning single-use carryout plastic bags in
September 5, 2019

DEA Enforcement Trend: Distributor Executives Criminally Charged in Opioid Epidemic

In a second criminal case against a pharmaceutical distributor and its executives this year, the Department of Justice has accused Ohio-base
May 24, 2019

Two Executives and Distributor Charged for Unlawfully Distributing Controlled Substances

Rochester Drug Co-Operative, Inc. (“RDC”), one of the 10 largest pharmaceutical distributors in the United States, was recently charged alon
May 3, 2019

DOJ Heightens Focus on Corporate Compliance Programs

Recent actions by the United States Department of Justice (DOJ) clearly demonstrate its focus on ensuring the effectiveness of both a corpor
April 15, 2019

Doe v. Merck: Vaccine Autism Lawsuit Dismissed as Baseless

The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co,
March 25, 2019

Pharmacists Must Identify and Resolve Red Flags in Dispensing Controlled Substances

The Controlled Substances Act and applicable regulations impose the responsibility for the proper dispensing of controlled substances on the
January 23, 2019

Lead-Paint Violation Found Not to Entail Personal Liability of Corporate Shareholders

Harris Beach attorneys Stanley Goos and Marina Plotkin successfully moved the New York Supreme Court, Bronx County to dismiss individual off
News
October 21, 2020

Kelly Jones Howell and Marina Plotkin Contribute to DRI RX for the Defense Newsletter

Harris Beach Medical and Life Sciences Industry Team attorneys Kelly Jones Howell and Marina Plotkin recently contributed an article to DRI
January 2, 2020

Harris Beach Elects Six New Partners

Attorneys Michael Condon, Emily Crowley, Michael Curti, Kelly Foss, Julian Modesti and Marina Plotkin have been elected partners of Harris
Events
June 18, 2020

Laura Smalley and Marina Plotkin to Present Complimentary Patent Law CLE Webinar Recording

Laura and Marina presented the complimentary patent law CLE webinar, “Update: Written Description and Enablement Requirements under 35 U.S.C
January 16, 2019

Rick Fern and Marina Plotkin Presenting at Pharmacists Society of State of New York

The presentation covered recent trends in pharmacist malpractice litigation, a pharmacist’s standard of care- how it is established, and the
External Publications
November 29, 2022

Speaker: DEA Red Flags: Proceed with Caution (Long Island University, Arnold and Marie Schwartz College of Pharmacy students, Pharmacy Law and Ethics, November 2022)

October 1, 2021

Speaker: DEA Red Flags: Proceed with Caution (Long Island University, Arnold and Marie Schwartz College of Pharmacy students, Pharmacy Law and Ethics, October 2021)

March 1, 2021

Speaker: Dispensing in Catastrophic Situations and National/State Emergencies (webinar, American Society for Pharmacy Law (ASPL), March 2021)

September 1, 2020

Speaker: Update: Written Description and Enablement Requirements under 35 U.S.C. § 112 (CLE, September 2020)

October 20, 2019

Speaker: Pharmacy Law Update – Practice Issues for the Pharmacist (10th Annual Arthur Goldberg Pharmacy Law Day, October 20, 2019)

July 31, 2019

Speaker: DEA Red Flags: Proceed with Caution (webinar, American Society for Pharmacy Law, July 31, 2019)

July 1, 2019

Publication: Pharmacists Must Identify and Resolve Red Flags in Dispensing Controlled Substances (New York State Pharmacist Century II, official publication of the Pharmacists Society of the State of New York Vol 93, Issue 3)

November 1, 2017

Speaker: Co-presented Prescription Drug Monitoring Programs - Solution to the Opioid Epidemic? (American Society of Pharmacy Law annual meeting, November 2017)

March 10, 2017

Publication: Best Practices: Is your care facility subject to New York Public Health Law § 2801-d? (DRI Medlaw Update)

All Publications, All Insights, Legal Alert |
 November 22, 2022
U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi
U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi...read more
All Insights, All Publications, Legal Alert |
 November 17, 2022
New York Wraps Latest Round of Public Comment on Regulation and Licensing of Pharmacy Benefit Managers
After New York Governor Kathy Hochul created a new Pharmacy Benefits Bureau within the Department of Financial Services specifically charged...read more
All Insights, All Publications, Legal Alert |
 April 21, 2021
“About” Patent Claim Construction: Par v. Hospira
The use of the word “about” in a patent claim as part of a numeric range might permit the patent holder to preclude competitor formulations ...read more
All Insights, All Publications, Legal Alert |
 February 2, 2021
U.S. Supreme Court Decision Supports State Regulation of Pharmacy Benefit Managers
The U.S. Supreme Court’s recent unanimous decision clears the way for state regulation of Pharmacy Benefit Managers (“PBMs”).  Rutledge v. P...read more
All Insights, All Publications, Legal Alert |
 September 29, 2020
New Jersey Reinforces the Trial Judge’s Gatekeeper Function in Expert Admissibility
In a recent decision, New Jersey Appellate Court applied the expert admissibility standard from the New Jersey Supreme Court’s landmark deci...read more
All Insights, All Publications, Legal Alert |
 September 14, 2020
IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112
In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of t...read more
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Marina Plotkin

mplotkin@harrisbeach.com
D: (212) 313-5409
New York, NY Office
Marina Plotkin
https://www.harrisbeach.com/people/plotkin-marina/

■ Areas of Expertise

Legal Practices

Government Compliance and Investigations Legal Practice
Intellectual Property Legal Practice
Mass Torts and Industry-Wide Litigation Legal Practice

Industry Teams

Health Care Industry Team
Medical and Life Sciences Industry Team

Sectors

Pharmacy Law
Nutritional Supplements
Long-Term Care

■ Profile

Marina is a pharmacist attorney on the Medical and Life Sciences Industry Team. With years of experience as a supervising pharmacist, Marina has unique insight for the defense of pharmacies and pharmacists.  She also counsels pharmacy clients on DEA, FDA, Medicare, Medicaid, and Board of Pharmacy matters.

Marina conducts internal pharmacy investigations for a national pharmacy chain in connection with opioid stewardship and proper interception of pain management prescribing practices. She represents pharmacy clients in healthcare fraud investigations on state and federal level, and conducts compliance assessments related to prior authorization assistance, effectiveness of compliance programs, and handling of third-party payor claims.

Marina provides audit assistance to community pharmacies audited by Pharmacy Benefit Managers, assisting with document preparation, discrepancy analysis, and appeal submission.  She also represents pharmacies audited by the New York State Office of Medicaid Inspector General (OMIG).  She offers Fraud, Waste and Abuse compliance development.  She is involved with the American Society for Pharmacy Law, having presented to a national audience on the Prescription Drug Monitoring Program.  She has also presented on the topic of pharmacist corresponding responsibility to identify and resolve red flags in filling controlled substance prescriptions.

Another major focus is the defense of product liability litigation involving pharmaceuticals, compounded preparations, biologics, and consumer household goods, utilizing the combination of pharmacy and legal credentials to provide strategic insight on complex issues.  She also defends medical malpractice, pharmacy malpractice, toxic mold, lead exposure and general liability cases.

Her experience includes all stages of discovery in state and federal courts, motion practice, oral argument, and strategizing litigation plans based on comprehensive medical research and analysis. Marina has worked with experts in neurosurgery, orthopedics, neuro-intervention, regulatory affairs, radiology and bioengineering. She has assisted in commercial litigation involving agreements governing clinical trial manufacturing. Marina was a member of the national coordinating counsel for New England Compounding Pharmacy in the fungal contamination mass tort, as well as national counsel for several medical device companies involved in mass tort litigation arising out of the use of a pain pump following arthroscopic surgery. Marina has experience advising clients on life science-related intellectual property rights.

Marina also has extensive experience defending long-term care providers including Independent Living Facilities, Adult Care Facilities/Assisted Living, and Nursing Homes, involving allegations such as medication errors, elopement, abuse and neglect, inadequate supervision, and deprivation of rights or benefits.

■ Representative Matters

  • OptumRx, Envision Rx (Elixir), Humana, Express Scripts, MedImpact pharmacy audit assistance, appeals, corrective action plans, successful network termination reconsideration requests.
  • 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 product liability case brought on behalf of a severely brain-damaged plaintiff, dismissing all claims under CPLR 3212, including design defect, failure to warn and breach of warranty, holding expert witness affidavits in opposition were speculative and conclusory based on failure to disclose the experimental data and test conditions used to generate their opinions.
  • Tomaselli v. Zimmer, No. 14-CV-4474 (RA) (SN) (United States District Court, Southern District of New York, 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, 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.
  • Hudson v. Sunnyside, Index 1136/2012 (Supreme Court of the State of New York, Steuben County, May 2016) dismissal granted and affirmed on appeal to the Appellate Division Fourth Department 155 A.D.3d 1532, 64 N.Y.S.3d 425 (4th Dept. 2017) in muriatic (hydrochloric) acid toxic exposure action involving issues of federal preemption and misbranding under federal law, finding as a matter of law that the product label complied with Federal Hazardous Substances Act.

■ Professional and Civic

  • American Society for Pharmacy Law, Education Committee Member
  • New York City Pharmacists Society, Board Member
  • Pharmacists Society of the State of New York, Legislative Committee Member

■ Admissions

  • Fordham Law Review
  • Fordham Law School – West Group Outstanding Scholastic Achievement Award
  • Henrietta Metcalf Prize for Excellence in the Study of Contracts
  • Fordham Law School Prize
  • Valedictorian – Arnold & Marie Schwartz College of Pharmacy and Health Sciences

■ Education

Albany Law School
 ,JD
 ,2005
 ,magna cum laude
Long Island University
 ,BS
 ,2000
 ,summa cum laude

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 March 22, 2023 8:09 pm
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