Pharmaceuticals and Medical Devices: Products Liability Risk - PowerPoint PPT Presentation

Presenting a live 90 ‐ minute webinar with interactive Q&A Pharmaceuticals and Medical Devices: Products Liability Risk Management Implementing Compliance Programs and Other Measures to Avoid FDA and State Law Violations and Minimize Tort Liability THURS DAY, JANUARY 19, 2012 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Today s faculty features: Kenneth Ross, Of Counsel, Bowman and Brooke , Minneapolis . McMenamin, Partner, McGuireWoods , Richmond, Va. Joseph P The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .

Conference Materials If you have not printed the conference materials for this program, please complete the following steps: • Click on the + sign next to “ Conference Materials” in the middle of the left- hand column on your screen hand column on your screen. • Click on the tab labeled “ Handouts” that appears, and there you will see a PDF of the slides for today's program. • Double click on the PDF and a separate page will open. Double click on the PDF and a separate page will open. • Print the slides by clicking on the printer icon.

Continuing Education Credits FOR LIVE EVENT ONLY For CLE purposes, please let us know how many people are listening at your location by completing each of the following steps: • Close the notification box • In the chat box, type (1) your company name and (2) the number of attendees at your location • Click the S END button beside the box

Tips for Optimal Quality S S ound Quality d Q lit If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. If the sound quality is not satisfactory and you are listening via your computer speakers, you may listen via the phone: dial 1-866-869-6667 and enter your PIN - when prompted Otherwise please send us a chat or e mail when prompted. Otherwise, please send us a chat or e-mail sound@ straffordpub.com immediately so we can address the problem. If you dialed in and have any difficulties during the call, press *0 for assistance. Viewing Qualit y To maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key again press the F11 key again.

Preventive Law , Ethics and Legal Compliance Kenneth Ross B Bowman and Brooke LLP d B k LLP Minneapolis, Minnesota 952 ‐ 933 ‐ 1195 952 ‐ 933 ‐ 1195 kenrossesq@comcast.net 5

Preventive Law Preventive Law “A branch of law that endeavors to minimize the risk of litigation or to secure risk of litigation or to secure more certainty as to legal more certainty as to legal rights and duties.” 6

Other definitions Other definitions  Systematic attention is given to minimizing the risk that the client’s affairs will be disrupted or its aspirations ff i ill b di t d it i ti not maximized because of some dispute or other legal problems arising in the or other legal problems arising in the future.  Litigating lawyers are historians. Preventive lawyers must be prophets Preventive lawyers must be prophets. 7

Other definitions Other definitions  It is more important to predict what people will do, than it is to predict what a court will do.  Thinking preventively is to be able to anticipate when and where a person’s perceptions of injury are likely to arise during ti f i j lik l t i d i the course of any particular transaction or business activity business activity.  Preventive law, in part, involves planning for litigation litigation. 8

Legal Compliance Legal Compliance  Oversight and enforcement of g specific legal requirements (regulatory and common law) (regulatory and common law).  Mitigate sanctions for violations of criminal law.  Application of legal requirements to Application of legal requirements to any corporate conduct.  Moral minimum. 9

Ethics and Integrity Ethics and Integrity  Set of moral principles and  Set of moral principles and values.  Concerns what should be done, not what must be done not what must be done.  Beyond compliance  Beyond compliance.  Rules for behavior. Rules for behavior. 10

Ethics and Integrity Ethics and Integrity  Business ethics refers to how a company integrates core values - such as honesty trust respect such as honesty, trust, respect, fairness - into its policies, practices and decision making throughout all and decision-making throughout all levels of the company.  Uncompromising honesty and integrity integrity. 11

Corporate Responsibility R ibilit  Business decision-making linked to ethical values, compliance with legal requirements, and respect for people, i t d t f l communities and the environment  Business meets or exceeds the ethical, legal commercial and public legal, commercial and public expectations that society has of business business. 12

Interrelationship of C Concepts t Ethical/CR/Preventive Law Legal Compliance Legal Compliance Ill Illegal/non-compliant/unethical l/ li t/ thi l 13

14 ASSESS RISKS IDENTIFY RISKS t ssessment t k Assessmen ocess Process Risk A A Ri k A ACT ness Ri Pr R usiness i i Bus SET OBJECTIVES B B MONITOR

Legal Risk Assessment g  Identify legal risk - before or after it occurs.  Quantify the probability it will happen in the future.  Identify consequences if risk occurs.  Identify techniques to minimize probability or severity of consequences.  Decide on future actions and implement. 15

Assess Risks CATASTROPHIC CATASTROPHIC 10 H High Impact h H High Impact h Low Likelihood High Likelihood Impact Impact p Low Impact Low Impact Low Likelihood High Likelihood 1 10 MINOR MINOR Probability Probability Probab l ty Probab l ty LOW LOW HIGH HIGH 16

Preventive Law , Compliance and Ethics Techniques d Ethi T h i  Before problem arises:  Before problem arises: • Legal audit/risk assessment • Legal and regulatory compliance systems • Risk minimization programs • Codes of conduct and ethics programs • Incentive analysis Incentive analysis • Client education 17

Preventive Law , Compliance and Ethics Techniques d Ethi T h i  After problem arises: Aft bl i • Establish systems to learn about possible or real problems, conflicts, legal concerns. • Have personnel promptly analyze this p p p y y information. • Take appropriate risk reduction or remedial Take appropriate risk reduction or remedial actions. 18

C Conclusion l i  Regulatory compliance is bare minimum. Compliance may or may not p y y be consistent with business ethics policy or code of conduct. p y  Should exceed to minimize future business and legal risks business and legal risks.  Need to anticipate and plan for defensibility of product and company defensibility of product and company. 19

 For more information on prevention and compliance techniques, see: p q , www productliabilityprevention com www.productliabilityprevention.com 20

Products Liability Risk Management: Compliance Measures to Minimize Tort p Liability Joseph P. McMenamin, MD, JD McGuireWoods LLP 804 775 1015 804 ‐ 775 ‐ 1015 jmcmenamin@mcguirewoods.com www.mcguirewoods.com

Disclaimer • The views expressed in these materials and in the webinar • The views expressed in these materials and in the webinar presentation are the personal views of the presenter and do not represent the formal position of McGuireWoods LLP, of any other individual attorneys at the firm, or of any of its clients. The presenter expressly reserves the right to advocate freely other positions on behalf of clients. y p 22

Topics • Tort Law: Policy Considerations • Product Liability 101 • Pharma and Device Claims • Preemption i • The Regulatory Compliance Defense – Variations Variations • Benefits of Compliance: The “Responsible Corporate Officer” (“RCO”) Doctrine • Compliance and Juries • Compliance as Prophylaxis 23

Tort Law: Policy Considerations 24

The Plaintiffs’ Case for Products Claims • Checks and balances against strength of the industry • Checks and balances against strength of the industry – Detailers’ influence on prescribers – Pharma, device company lobbying Pharma, device company lobbying – FDA “capture” • Agencies generate minimal, not optimal levels of safety – Law stimulates regulatory agencies, such as FDA, to take stronger action to safeguard public health • ↓ Inappropriate marketing and scientific fraud • ↓ Inappropriate marketing and scientific fraud – Law fosters informing the public about risks • ↑ Product research ↑ 25

Consequences of Products Claims • (a) Unrecoverable defense costs • (a) Unrecoverable defense costs • (b) High money damages – New claims – Bankruptcy • (c) Adverse publicity – Verdicts against a manufacturer are newsworthy – Verdicts favoring a manufacturer are not • (d) Loss of new sales • (d) Loss of new sales • (e) Adverse governmental action • (f) Potentially, derivative suits (f) Potentially, derivative suits 26