Legal and Financial Consequences When Risk Management Goes Astray

Pharmaceutical Education and Research Institute (PERI)

“Developing a Risk Management Strategy: A Hands-On Workshop”

November 11, 2004Washington, D.C.

Presented by:

Michael A. Swit, Esq.Vice President, Life Sciences

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LECTURE -- OUR ORGANIZATION/OBJECTIVES

I. Administrative Enforcement Tools

II. Civil and Criminal Penalties

III. Collateral Damage – Worst Case Scenarios from Risk Management Gone Awry

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I. FDA Administrative Enforcement Tools

• Each FDA Center has its own Office of Compliance (OC)

• OC works with Office of Chief Counsel and Department of Justice

but, before they haul you into court …

• Administrative Enforcement Tools

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ADMINISTRATIVE ENFORCEMENT TOOLS

• Inspections– Planned and conducted pursuant to FDA annual

plan or center compliance program

– Pre-approval

– “For cause” (e.g., public health crisis due to defective or contaminated FDA-regulated product; follow up to 483 response)

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ADMINISTRATIVE ENFORCEMENT TOOLS …

• Inspections …– Government-wide Quality

Assurance Program•FDA may inspect at the request of the DoD

or VA to determine, for example, whether a company bidding on a government contract is in compliance with GMPs and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FDCA)

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ADMINISTRATIVE ENFORCEMENT TOOLS …

• Inspections . . .

– Combination or joint inspections (EPA, OSHA, or a state food and drug regulatory body)

– Consumer, trade, and other complaints

– Adverse product effect reports

– Congressionally inspired

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483/EIR: INSPECTION RESULTS

• NAI - No objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action)

• VAI - Objectionable conditions or practices were found, but the District is not prepared to take or recommend any administrative or regulatory action

• OAI - Regulatory and/or Administrative actions will be recommended

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ADMINISTRATIVE ENFORCEMENT OPTIONS BASED ON INSPECTIONAL

VIOLATIONS• If at investigational stage:

– Termination of IND or IDE (if in that phase)– Initiation of disqualification procedures or entry

into a consent agreement with the clinical investigator

– Disqualification of the investigator simultaneous to criminal prosecution (may occur later than during the investigational stage)

– Initiation of stock recovery by sponsor

• Warning letter

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ADMINISTRATIVE ENFORCEMENT TOOLS – OTHER

• Clinical hold• Withdrawal or suspension of

marketing permit• Recall (FDA-requested or “voluntary”)• Import detention or refusal• Civil money penalties

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THE PEN IS MIGHTIER THAN THE SWORD:

ADVERSE PUBLICITY• FDA Website• Press release• Talk paper• Press conference/television and radio interview• Speeches• Congressional and other testimony• Articles in scientific, professional and lay

publications

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FDA ENFORCEMENT TOOLS -- APPLICATION/DATA INTEGRITY

POLICY• The AIP applies to any application (e.g., NDA, BLA,

PMA), amendment, supplement, petition, or other submission in support of the approval or marketing of a regulated product

• Does not apply only to data tainted or possibly tainted by fraud or other intentional misconduct

“Data may be unreliable due to sloppiness and inadvertent errors. A pattern of errors by an applicant involving material subject matter may raise a significant question regarding the general reliability of data in applications from that applicant.”

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AIP• If FDA has significant questions surrounding the

reliability of the data in an application, it will defer substantive scientific review of all the data in the application - and, possibly, other applications

• Deferral will continue until all questions regarding the reliability of the data have been resolved

• CAP – Corrective Action Plan – detailed & costly

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FDA ENFORCEMENT DISCRETION – KEY FACTORS

WEIGHED• Prior History of Company’s Compliance

– prior 483’s, warning letters, and company’s response

• Health risks

• Likelihood of recurrence

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II. FDA Judicial Enforcement Weapons

• Seizure and destruction of product• Injunctions

– Consent Decrees– Fines/Disgorgement– Enforced via contempt proceedings

• Criminal prosecution

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CRIMINAL ENFORCEMENT• Criminal prosecution –

– Types of Violations – • Title 21 -- FDCA• Title 18 – Federal Criminal Code

– § 371 (conspiracy)– § 1001 (false statements)– § 1341, 43(mail and wire fraud)– § § 1505, 1509-10 (obstruction)– § 1962 (RICO)

– Penalties --• Imprisonment• Fines

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CRIMINAL PENALTIES -- or “Does Crime Pay?”

PRISON or JAIL: Felonies: up to five

(5) years in prison for each violation

Misdemeanors: up to one (1) year in jail for each violation

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CRIMINAL PENALTIES - - or “Does Crime Pay?” …

FINES: amountdepends on theperson (whether anindividual orcompany), the classof crime (felony v.misdemeanor), andif the crime resultedin a death

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CRIMINAL PENALTIES - - or “Does Crime Pay?” …

FINESIndividual:

– Misdemeanor: $100,000 per violation– Misdemeanor resulting in death or

felony: $250,000 per

violationCompany:

– Misdemeanor: $100,000 per violation– Misdemeanor resulting in death or

felony:$500,000 per

violation

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WHAT CAN FDA TARGET IN AN ENFORCEMENT ACTION?

Scope of Enforcement Action Can Be Very Broad:

• All areas where FDA perceives violations, and responsible persons involved in such violations

• Labeling, promotion, manufacturing, QA, distribution, regulatory affairs, quality control, etc., etc….

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WHO CAN FDA TARGET DURING AN ENFORCEMENT ACTION

Any and all individuals within the company that have a position of responsibility for the violative aspect of the company’s operation, including:

President/CEO/COO

Production Manager

VP or Director of Quality Control

Director of Regulatory Affairs

Director of Quality Assurance

Technicians

General Counsel (none in FDA setting; but see Tyco prosecutions)

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Bard (1993): Not only Executives are Charged

• Director for Regulatory Affairs and a supervisor in the R.A. Department among those charged

• 3 executives convicted of defrauding FDA, but vacated in March 2001 on appeal based on improper instructions to jury by judge

• June 2001 -- the 3 defendants settled and pleaded to misdemeanor charges in shipment of adulterated heart catheters: one year of probation and 8 months of in-home confinement; Bard paid $61M

• As with tax law, misunderstanding of FDA law may be a legitimate defense; given complexity of regulatory law, you can violate innocently

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DISGORGEMENT

• FDA recovery of company profits– Can’t profit from sales of an illegal product that is

nonetheless medically necessary

• FDA refrains from enjoining production of non-compliant products because it would compromise patient care by causing significant shortages of medically necessary products

• In return, firms will pay a fixed % of future sales to ensure that they did not profit from the violative products

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CONSENT DECREE• Order of a court• Entered by consent of the parties• Not technically a judicial sentence, but a negotiated

contract between the parties under the sanction of the court

• Parties represent that it is a just determination of their rights as if the alleged facts of the case had been proven

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CONSENT DECREES …• How do they come about?? • Settlement of a court case after FDA has

filed for an injunction– Voluntary negotiations with FDA after an adverse

inspection– Most terms/conditions negotiable -- but depends

on your leverage point– Companies more often concerned about naming

executives as individually responsible: FDA finds this point important as a deterrent and necessary to pursue contempt charges if decree becomes ineffective

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DUTY OF CARE

• Corporate directors can in turn be personally liable for losses incurred because of corporate failure to meet legal compliance standards

• McCall (2001): Columbia/HCA shareholder derivative action against board members;– Directors lose protection of “business

judgment” rule and are personally liable for failure to detect and correct violations

– Board’s duty of care breached through nonfeasance: failure to investigate items from internal audit

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DUTY OF CARE …• If you are subject to a search warrant at

one site, begin internal investigation at all sites to see whether similar violative practices exist (otherwise breaches duty of care)

• Need to investigate whistleblower cases, no matter how frivolous they appear

• Under FDCA – strict liability – U.S. v. Park

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III. Collateral Damage – Worst Case Scenarios from Risk Management

Gone Awry

Or

“Does Crime Pay?” – Problems Beyond Jail and Fines

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“Does Crime Pay?” – Problems Beyond Jail and Fines

• PROBLEMS FORINDIVIDUALS IFCONVICTED:– Lose right to vote– Lose right to run for

public office– Damage to reputation

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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)

• PROBLEMS FORINDIVIDUALS IFCONVICTED (cont’d):– Can be deported if

not a U.S. citizen– Financial ruin - -

lose your job

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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)

• PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS:– Shareholders sue the company, its

officers and directors– Other companies may sue the company

(e.g., Mylan Labs sued Par and others)– Federal government may suspend or

“debar” company from selling to government

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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)

• PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS:– “Qui Tam” actions under the False Claims

Act -- e.g., Lifescan & Neurontin cases -- “whistle blower” cases -- leading to civil damages and may also spawn a criminal prosecution

– SEC Enforcement Litigation if publicly held

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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)

• PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS (cont’d):

– FDA may refuse to approve NDAs under AIP

– May lose state licenses

– Customers abandon you

– Decreased sales may force lay-offs of employees

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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)

• PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS (cont’d):– Financing disappears -- banks may

refuse to lend money– May violate lending agreements, real

estate mortgages or leases– A criminal investigation can cause

greatdisruption to normal business activities

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“Does Crime Pay?” -- Problems Beyond Jail and Fines (cont’d ...)

• PROBLEMS FOR COMPANIES CAUSED BY CRIMINAL CONVICTIONS (cont’d):– High cost in money of an

investigation:• lost sales• stock price falls• attorney’s fees and costs• costs of complying with requests by

government for documents

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PRODUCTS LIABILITY EXPOSURE

• Negligence per se – legal violation leads to a presumption of violating a standard of care

• Mass Tort Exposure– Fen-Phen– Ephedra– Vioxx– Baycol

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QUANTIFYING THE DAMAGE• The Par Example (note: some figures are

estimated)– Criminal Fines $ 2,750,000– SEC Fines $100,000– Lost Sales (just 1 year) ± $49,000,000– Competitor lawsuits $3,000,000– Shareholder litigation settlement $2,250,000– Lost market cap ± $206,000,000

• Stock went from $26 to $3

– Attorneys fees ± $4,000,000

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QUANTIFYING THE DAMAGE

• The Par Example …– Expert consultant fees under AIP ±

$4,000,000 – Employees laid off 450 out of 900– Time under AIP ± 4 years– Time ineligible to sell to U.S. 2 yrs., 9

mos.

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QUANTIFYING THE DAMAGE …A FEW BIG BOYS

• Abbott -- $100,000,000 disgorgement (GMP case)

• Schering -- $500,000,000 disgorgement (GMP)

• Pfizer/Neurontin -- $343,000,000 qui tam award

• Wyeth – Fen/Phen -- $16.6 Billion reserved

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PARTING THOUGHTS …

• These are pictures you do not want to see ….– in your newspaper …. – on your local news …. – on the Internet ….

•or

– in FDA regulatory lawyers’ presentations for years to come ….

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Ex-Imclone CEO Exits Federal Court After Being Charged with Nine Felony Counts

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Ex-Imclone CEO exits federal court after entering guilty plea …

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THE RESULT …Pled guilty October 15, 2002 to six counts,

including:►Bank fraud►Securities fraud, aka “insider trading”►Conspiracy to obstruct justice, and ►Perjury

Faced: up to 65 years in prison; millions in fines

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THE SENTENCE• 7- year 3-month prison sentence

– with no parole

• $3 million fine • $1 million in back taxes • Where can you find him now?

– Schuylkill Federal Correctional Institute in Minersville, Pa. (been there since July 2003)

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QUESTIONS?Call, e-mail, fax or write:

Michael A. Swit, Esq.Vice President, Life SciencesTHE WEINBERG GROUP INC.336 North Pacific Coast Hwy. 101

Suite CEncinitas, CA 92024

Phone 760.633.3343Fax 760.633.3501Cell 760.815.4762

D.C. Office 202.730.4123michael.swit@weinberggroup.com

www.weinberggroup.com

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About the speaker ...

Michael A. Swit is Vice President, Life Sciences at THE WEINBERG GROUP INC, where he develops and ensures the execution of a broad array of regulatory and other services to clients, both directly and through outside counsel. His expertise includes FDA and CMS development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food and dietary supplement industries.

Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His vast and multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego.  He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius.

Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved.  A former member of the Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA.