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 clients in healthcare fraud investigations on state and federal level.
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, neurointervention, 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 and Adult Care Facilities/Assisted Living, involving allegations such as medication errors, elopement, abuse and neglect, and inadequate supervision.
RECENT PUBLICATIONS +
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 clients in healthcare fraud investigations on state and federal level.
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.
SPEAKING ENGAGEMENTS
- Presented to class of Long Island University, Arnold and Marie Schwartz College of Pharmacy students, Pharmacy Law and Ethics, “DEA Red Flags: Proceed with Caution,” October 2021.
- "'About' Patent Claim Construction: Par v. Hospira," Harris Beach Legal Alert, April 2021.
- Presented American Society for Pharmacy Law (ASPL) webinar, "Dispensing in Catastrophic Situations and National/State Emergencies", March 2021.
- "U.S. Supreme Court Decision Supports State Regulation of Pharmacy Benefit Managers," Harris Beach Legal Alert, February 2021.
- "Contractor Represented by Harris Beach Wins Summary Judgment on New York Labor Law Claims," Harris Beach Advisory, October 2020.
- “Buckman Implied Preemption Wipes Out Misbranding Claims that a Product is Not a Cosmetic but a Drug,” DRI For the Defense – newsletter of the DRI Drug and Medical Device Committee, October 2020.
- "New Jersey Reinforces the Trial Judge’s Gatekeeper Function in Expert Admissibility," Harris Beach Legal Alert, September 2020.
- Presented patent CLE webinar "Update: Written Description and Enablement Requirements under 35 U.S.C. § 112", September 2020.
- "IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112," Harris Beach Legal Alert, September 2020.
- "New Jersey Supreme Court Finds Products Liability Act Does Not Bar Consumer Fraud Act Claims Alleging Express Misrepresentations," Harris Beach Legal Alert, August 2020.
- "Federal Circuit Holds That Patent Term Extension Under The Hatch-Waxman Act Does Not Apply to De-Esterified Metabolite of the Active Ingredient," Harris Beach Legal Alert, June 2020.
- “Partial Summary Judgment Win for Major Pharmacy Chains in New York Opioid Litigation," Harris Beach Legal Alert, April 2020.
- Presented on recent pharmacist malpractice litigation “Pharmacy Law Update – Practice Issues for the Pharmacist” at the 10th Annual Arthur Goldberg Pharmacy Law Day on October 20, 2019.
- “DEA Enforcement Trend: Distributor Executives Criminally Charged in Opioid Epidemic,” Harris Beach Advisory September 5, 2019.
- “Pharmacists Must Identify and Resolve Red Flags in Dispensing Controlled Substances,” New York State Pharmacist Century II, An Official Publication of the Pharmacists Society of the State of New York, Volume 93, Issue 3, 2019.
- Presented American Society for Pharmacy Law Webinar on “DEA Red Flags: Proceed with Caution”, July 31, 2019.
- "Two Executives and Distributor Charged for Unlawfully Distributing Controlled Substances," Harris Beach Legal Alert, May 2019.
- ”DOJ Heightens Focus on Corporate Compliance Programs,” Harris Beach Advisory, May 2019.
- “Doe v. Merck: Vaccine Autism Lawsuit Dismissed as Baseless,” Harris Beach Legal Alert, April 2019.
- “Pharmacists Must Identify and Resolve Red Flags in Dispensing Controlled Substances,” Harris Beach Legal Alert March 2019.
- Presentation with Frederick H. Fern at the January 2019 Mid-Winter Meeting of the Pharmacists Society of State of New York on "Pharmacy Law Update 2019 – Practice Issues for the Pharmacist: A Legal Perspective."
- "Lead-Paint Violation Found Not to Entail Personal Liability of Corporate Shareholders," Harris Beach Legal Alert January 2019.
- "Second Circuit Affirms Summary Judgment in Hip Repair Product Liability Action," Harris Beach Legal Alert May 2018.
- “Circumstantial Evidence Ruled Not Enough in Case Against Medical Device Manufacturer,” Harris Beach Advisory April 2018.
- Presentation with Frederick H. Fern at the November 2017 American Society of Pharmacy Law annual meeting on “Prescription Drug Monitoring Programs - Solution to the Opioid Epidemic?"
- “Drug Product Liability Action in NY Declined to Apply the ‘Heeding Presumption’," Harris Beach Legal Alert September 2017.
- “Treating Physician Testimony Wins Plavix Product Liability Case Under NY Law,” Harris Beach Legal Alert September 2017.
- “Summary Judgment Awarded in Endovascular Medical Device Product Liability Case,” Harris Beach Legal Alert May 2017 (Ford v. Riina, 2017 WL 1709471 (Sup. Ct. N.Y. Cty, May 2, 2017)).
- “Summary Judgment Awarded in Medical Device Product Liability Action,” Harris Beach Legal Alert March 2017 (Tomaselli v. Zimmer, 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017)).
- “Best Practices: Is your care facility subject to New York Public Health Law § 2801-d?” DRI Medlaw Update, March 10, 2017.
- Presented at American Society for Pharmacy Law annual meeting on “Putting the Nutritional Supplement Industry to the Test – Looking for Transparency,” 2016.
- “Regulation of Nutritional Supplements,” presentation at the annual American Society for Pharmacy Law seminar, November 2016.
- “To Be or Not To Be: Recent New York Case Law on Prenatal Torts,” Harris Beach Legal Alert, December, 2015.
- “An Ounce of Prevention – Six Tips for Nutritional Supplement Companies,” DRI, In-House Defense Quarterly, Summer 2015.
- "Definition of Anabolic Steroids Expanded under New Law, Which Also Adds Civil Penalties” Harris Beach Legal Alert, January 2015.
- “FDA Proposes Equal Rights to Brand and Generic Manufacturers to Change Product Labeling,” American Bar Association, Section of Litigation, Products Liability, News & Developments, April, 2014.
- “Legal Impact of the Recent FDA Acetaminophen Dosage Guideline on Prescribers and Pharmacists,” Harris Beach Legal Alert, April 2014.
- "'Adverse Effects of the FDA-Proposed Rule on Mensing Preemption," Harris Beach Advisory, March 2014.
- “Plaintiffs Barred by Mensing: The End of State Tort Lawsuits Against Generic Drug Manufacturers?” September/October 2012 edition of American Society for Pharmacy Law, Rx Ipsa Loquitur.
