Introduction
Mark Seltzer represents corporations, executives and professionals in government investigations and enforcement actions and related complex litigation.
My focus
In recent years, I have focused my practice on representing pharmaceutical companies and their executives, medical device manufacturers and their executives, clinical diagnostics manufacturers and other health care providers in government health care fraud investigations and related civil litigation under the federal False Claims Act and state counterparts; the federal Food, Drug and Cosmetic Act; the Medicare/Medicaid Anti-Kickback Statute; the Medicaid Drug Rebate Statute; and state consumer fraud statutes.
Outside the health care industry, I represent senior corporate executives in securities enforcement investigations, and financial institutions in various enforcement matters.
I have extensive experience in conducting confidential internal investigations for corporate clients. I regularly advise corporations on the design, implementation and monitoring of compliance programs.
Formerly, I was a federal prosecutor for 13 years both in Miami, as an Assistant United States Attorney for the Southern District of Florida and, in Boston, as Director of the New England Bank Fraud Task Force of the United States Department of Justice.
Representative experience
Clerkships
Judicial Clerk, the Honorable John W. King, Chief Justice of the New Hampshire Supreme Court
Looking ahead
I currently represent a pharmaceutical company in the defense of a civil enforcement action brought by an attorney general's office under a state consumer protection statute. This litigation represents a growing national trend in enforcement activity by state attorneys general offices.
In the news
- Law360
J&J hip implant FCA case tossed over secret info use
This article covers a significant litigation win, in which a federal judge dismissed a nearly decade-long False Claims Act lawsuit against Johnson & Johnson entities over allegedly defective hip replacement devices, noting that two whistleblower physicians used confidential information in their complaint. The article mentions Boston partners Mark Seltzer and Hannah Bornstein and associate Colin Missett, and Washington, DC partner Adam Tarosky—all of the Government Investigations & White-Collar Defense group—for representing J&J and its related entities.Dec 8, 2021 - Law360
Doctors say no secret info used in FCA suit against J&J
This article mentions Boston Government Investigations and White-Collar Defense partners Hannah Bornstein and Mark Seltzer for their representation of the defendants in a False Claims Act suit centering on faulty hip replacement devices. The defendants have argued the suit should be dismissed on the grounds that confidential information was used in the complaint.March 6, 2020 - Reuters Legal
GSK wins access to records on researcher’s link to Zofran plaintiffs’ lawyers
This story mentions Boston Government Investigations and White Collar Defense partner Mark Seltzer for his representation of GlaxoSmithKline in an ongoing matter regarding the drugmaker’s antinausea medication, Zofran.July 25, 2019 - Law360
GSK gets 2nd chance to argue preemption in Zofran MDL
The following articles mention Boston Government Investigations and White Collar Defense partners Mark Seltzer and Brian French for their representation of GlaxoSmithKline in an ongoing matter related to the pharmaceutical company’s anti-nausea drug Zofran. One of the issues is whether federal law pre-empts state law in the case.July 10, 2019 - Reuters Legal
Judge to seek FDA’s views on Zofran birth defect cases against GSK
The following articles mention Boston Government Investigations and White Collar Defense partners Mark Seltzer and Brian French for their representation of GlaxoSmithKline in an ongoing matter related to the pharmaceutical company’s anti-nausea drug Zofran. One of the issues is whether federal law pre-empts state law in the case.July 10, 2019 - Reuters Legal
GSK renews Zofran birth defect dismissal bid after Supreme Court ruling
This article mentions Boston Government Investigations and White Collar Defense partner Mark Seltzer for his representation of GlaxoSmithKline in an ongoing matter related to its anti-nausea medication Zofran.June 4, 2019 - Reuters Legal
GSK fights to subpoena publisher of Zofran study by plaintiffs' consultant
Boston Government Investigations & White Collar Defense partner Mark Seltzer is mentioned in this story for his representation of pharmaceutical company GlaxoSmithKline in an ongoing matter related to the company’s anti-nausea drug Zofran.April 3, 2019 - Reuters
GSK accuses Zofran plaintiffs' law firms of funding academic study
Boston Government Investigations and White Collar Defense partner Mark Seltzer is mentioned in this article for representing GlaxoSmithKline in an ongoing dispute related to the company’s anti-nausea drug Zofran.March 5, 2019 - Law360
FDA never saw birth-defect tests on GSK drug, families say
Boston Government Investigations & White Collar Defense partners Mark Seltzer and Brian French are mentioned in this article for their ongoing representation of GlaxoSmithKline in a suit regarding their drug Zofran.Sep 13, 2018 - Law360
GSK Zofran users bicker over scope of patient discovery
Boston government investigations and white collar defense partners Mark Seltzer and Brian French are mentioned in this story for their representation of pharmaceutical company GlaxoSmithKline in a lawsuit brought by users of its anti-nausea medication Zofran.April 25, 2018 - Law360
J&J won't get high court look at FCA 'particularity' rule
In the following coverage, Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned for their ongoing representation of Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc. in a False Claims Act case. The Supreme Court recently declined to review the First Circuit’s ruling in the case.April 16, 2018 - Reuters Legal
U.S. Supreme Court declines to review whistleblower case against J&J's DePuy
In the following coverage, Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned for their ongoing representation of Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc. in a False Claims Act case. The Supreme Court recently declined to review the First Circuit’s ruling in the case.April 16, 2018 - Law360
J&J unit wants whistleblower docs in hip implant FCA suit
Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned in this article for representing Johnson & Johnson Services Inc. and its subsidiary DePuy Orthopaedics in a suit alleging violations of the False Claims Act.April 12, 2018 - Law360
Judge keeps fraud claims against GSK alive in Zofran MDL
Boston government investigations and white collar defense partner Mark Seltzer and commercial litigation associate Josh Barlow are mentioned in this article about their client, GlaxoSmithKline PLC, in a case regarding labeling related to the use of the anti-nausea drug Zofran during pregnancy.April 24, 2017 - Law360
GSK says no basis for fraud claims in Zofran MDL
Boston government investigations and white collar defense partner Mark Seltzer and commercial litigation associate Josh Barlow are noted as representing GlaxoSmithKline (GSK) in this article about recent developments in a multidistrict litigation (MDL) about GSK’s anti-nausea drug Zofran.Jan 27, 2017 - Law360
J&J asks 1st Circ. to halt hip implant FCA suit
Boston government investigations and white collar defense partners Mark Seltzer and Danielle Pelot and associate Hannah Bornstein are listed as counsel representing Johnson & Johnson and its subsidiary DePuy in a First Circuit case. This article notes their argument to uphold the dismissal of a False Claims Act lawsuit.Dec 6, 2016 - Law360
Judge will hear GSK's arguments to dismiss Zofran MDL
This story covers a recent decision by a Boston federal judge to hear GlaxoSmithKline’s (GSK) arguments to discuss some cases and claims from its multidistrict litigation focused on the anti-nausea medication Zofran. Boston Government Investigations & White Collar Defense partner Mark Seltzer and Commercial Litigation associate Josh Barlow are noted as representing GSK.Nov 11, 2016
Admitted to practice
Massachusetts
Education
Boston College Law School, J.D.
University of Pennsylvania, summa cum laude, Phi Beta Kappa
Professional activities
Mark Seltzer is the former co-chair of the Criminal Law Section of the Boston Bar Association.
Recognition
- Boston Magazine Top Lawyers, Criminal Defense-White Collar (2021)
- Selected, through a peer-review survey, for inclusion in The Best Lawyers in America® 2025 in the fields of Criminal Defense: General Practice and Criminal Defense: White-Collar; listed in Best Lawyers since 2010
- Named a “Litigation Star” by Benchmark Litigation in its 2020 edition
- Recognized in the Legal 500 United States Editorial (2013) for life sciences
- Corporate Counsel’s Top Lawyers in Non-White Collar & White Collar Criminal Defense (2011-2012)
- Corporate Counsel’s Top Rated Lawyers Guide to Healthcare (2012)
- International Who’s Who of Business Crime Defense Lawyers (2012)
- Best Lawyers in New England (2012)
- ALM’s Top Rated Lawyers in Boston (based on an AV Rating with Martindale Hubbell) (2012)
- Best Lawyers in Boston (2011)
Professionals in the Practice Area
View AllRobert Fisher
Partner / Practice Group Leader, Government Investigations & White Collar Defense- Boston
- Office:+1 617.345.1335
- rfisher@nixonpeabody.com
-
Hannah Bornstein
Partner / Deputy Practice Group Leader, Government Investigations & White Collar Defense- Boston
- Office:+1 617.345.1217
- hbornstein@nixonpeabody.com
-