© 2009 Foley Hoag LLP. All Rights Reserved. Presentation Title

Final Massachusetts Pharmaceutical and Medical Device Regulations

Penalties and Enforcement:

The Role of the State Attorney General

Dean Richlin, Esq.

April 9, 2009

Massachusetts Biotechnology Council

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These materials have been prepared solely for educational purposes. The presentation of

these materials does not establish any form of attorney—client relationship with the

authors or Foley Hoag LLP. Specific legal issues should be addressed through

consultation with your own counsel, not by reliance on this presentation or these materials.

Attorney Advertising. Prior results do not guarantee a similar outcome. © Foley Hoag LLP

2008.

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CIVIL INVESTIGATIVE DEMAND

DEMAND NO: 2009-HCD-00

TO: XYZ COMPANY

You are hereby required to produce and deliver to the Office of the Attorney General, for examination and copying, the documentary evidence in your possession, custody or control as described herein. . . .

The Attorney General makes this CID pursuant to Mass. Gen. Laws c. 93A, Section 6, which authorizes the Attorney General to investigate possible unfair and deceptive methods, acts, or practices in violation of c. 93A, Section 2(a).

THE MORNING MAIL

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The Gift Ban Statuteand Related Regulations

C. 111N, § 7:

This chapter shall be enforced by the attorney general, the district attorney with jurisdiction over a violations or the department of public health. A person that violates this chapter shall be punished by a fine of not more than $5000 for each transaction, occurrence or event that violates this chapter.

105 CMR 970.010:

A person who knowingly and willfully violates 105 CMR 970.000 shall be punished by a fine of not more than $5000 for each transaction, occurrence or event.

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The Gift Ban Statuteand Related Regulations

105 CMR 970.011:

1. Fines shall be issued by an authorized entity.

2. The Authorized entity shall provide 10 days’ advance notice and an informal opportunity to dispute the fine.

3. A person aggrieved may seek judicial review.

4. An authorized entity may file a civil complaint to enforce payment of a fine.

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“Who do these people think they are?”

—Senator John McCain

The New York Times

September 9, 1997

State Attorneys General

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State Attorneys General

Constitutional Officer

Publicly Elected

A member of the Executive Branch but not subject to Gubernatorial Direction and Authority

Independent Legislative and Common Law Authority

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Gift Ban Enforcementand The Attorney General

Nothing in c. 111N or the related regulations indicates that they provide the exclusive means of enforcement.

C. 12 § 10:

The Attorney General shall institute such criminal or civil proceedings as she may deem to be for the public interest and shall investigate all matters in which she has reason to believe there have been violations of law.

C. 93A § 2:

Unfair or deceptive acts or practices in the conduct of any trade or commerce are unlawful.

940 CMR 3.16(3):

Unfair or deceptive acts or practices include violations of any law intended to protect the public’s health, safety or welfare.

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Gift Ban EnforcementHow might the AG learn of you?

Under c. 111N, by a referral from the Department of Public Health.

But also from:Whistleblowers (employees; consultants;

competitors)Other states with similar requirementsFederal regulators

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The Attorney General’sInvestigative Tools

Civil Investigative Demands

Pre-litigation process; the process is one-way.Permits document requests, interrogatories and depositions.Limited rights to challenge the process.

MultiState Cooperation

Enhanced government resourcesInformation sharing.

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The Attorney General’sEnforcement Tools

Remedies:

Consumer RestitutionPenalties Injunctive ReliefCosts of Investigation/Enforcement

Form of Agreement:

Assurance of DiscontinuanceConsent Judgments

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Define objectives early, particularly the definition of a “win.”

Know with whom you are fighting.

Assess whether time works for or against you.

If you negotiate, get all the issues on the table.

If you litigate, take the long view.

Tips for Fighting Back