Pharmaceutical & Medical Device

Innovative Legal Strategy

The SHB Pharmaceutical & Medical Device Practice has also been at the forefront of several cutting-edge legal issues. For example, SHB attorneys have:

• successfully defeated adoption of market share and third-generation liability in the highest courts of Illinois, Ohio, New Jersey, Iowa, and Missouri, as well as the U.S. Court of Appeals for the Tenth Circuit.
• convinced the Seventh Circuit to affirm a district court’s ruling that a DES plaintiff’s claim was time-barred under the District of Columbia statute of limitations.
• prevailed on Daubert grounds to exclude six experts in a loss of vision case, obtaining summary judgment for the client.
• defeated the plaintiffs’ attempt to certify a nationwide class of non-injured prescription drug purchasers and third-party payors in the U.S. Court of Appeals for the Fifth Circuit, winning an outright dismissal.
• argued that application of the learned intermediary doctrine defeated a failure-to-warn claim against a prescription drug manufacturer arising out of an alleged injury that occurred during a clinical trial.

Other victories include: winning summary judgments based on statutes of limitations and proximate cause; removing cases where plaintiffs have attempted to defeat diversity jurisdiction by joining additional defendants; excluding plaintiffs’ expert witnesses at trial; affirming the applicability of comments j and k to the Restatement (Second) of Torts § 402A; and affirming that a brand-name manufacturer cannot be held liable for injuries allegedly caused by the generic version of the product.

Pricing and Marketing Practices Liability

Federal and state law enforcement agencies have recently secured more than $2 billion in fines and civil penalties against a number of pharmaceutical manufacturers based on alleged improprieties in the pricing and/or marketing of prescription drug products. In several instances, these substantial financial penalties were accompanied by corporate and individual guilty pleas. As enforcement activities and governmental investigations continue to expand, private party litigants have joined the crowded field of those attacking the industry for perceived improper pricing and marketing practices.

SHB lawyers have been leaders in defending industry participants caught in what has been described as a “perfect storm” of governmental, litigation and political assaults. The SHB Pharmaceutical & Medical Device Practice includes former prosecutors and seasoned civil trial lawyers. These talented attorneys are supported by economic and research analysts with many years of experience in defending the industry.

SHB lawyers have represented prescription pharmaceutical and medical device manufacturers in a number of complex matters, including:

• A criminal and civil investigation by the U.S. Department of Justice alleging Medicaid fraud.
• Multidistrict civil litigation premised on alleged manipulation of pharmaceutical pricing (National Counsel).
• Hearings before committees of the U.S. Senate and House of Representatives.
• Actions by various state attorneys general premised on pharmaceutical pricing manipulation.
• An investigation by the U.S. Department of Justice into allegedly improper payments to health care providers.
• Qui tam matters pending in state and federal courts involving allegations of pricing manipulation.
• Responses to subpoenas issued by the Office of the Inspector General of the U.S. Department of Health and Human Services involving allegations of Medicaid fraud.
• An investigation by the U.S. Securities and Exchange Commission.

In addition to defending actions by enforcers and private party litigants, SHB attorneys have designed and conducted internal investigations and counseled clients on compliance issues. SHB works closely with corporate counsel to ensure comprehensive, efficient and effective approaches to the management of potential liabilities in this important and developing area of law.

Robert McCully (Panelist), AdvaMed’s 2012 International Medical Device Industry Compliance Conference; Stockholm, Sweden (May 9-11, 2012)

Judy O'Grady (Moderator),"FDA Center Directors Roundtable," FDLI’s Annual Conference; Washington, D.C. (Apr. 24-25, 2012)

Frank Rothrock & Chris Johnson, "Evolving Product Liability Issues That Impact Manufacturers of Brand-Name and Generic Pharmaceuticals, Biologics, and Biosimilars," Silicon Valley Association of General Counsel’s (SVAGC) All Hands Meeting; Santa Clara, California (Dec. 6-7, 2011)

Michael Koon, "Personal Liability Concerns for Life Sciences Counsel and other Industry Professionals," ACI’s 16th Annual Drug and Medical Device Litigation Conference; New York, New York (Dec. 5-7, 2011)

Madeleine McDonough, "Creating Exit Strategies for Mass Torts and Selecting the Most Advantageous Settlement Model," ACI’s 16th Annual Drug and Medical Device Litigation Conference, New York, New York (Dec. 5-7, 2011)

Madeleine McDonough, "Consumer Fraud Claims," ABA Section of Litigation’s Women in Products Liability Workshop; Nashville, Tennessee (Oct. 27, 2011)

Madeleine McDonough, "Legal and Public Policy Implications of Global Infectious Diseases," Georgetown University Medical School; Washington, D.C. (Oct. 2011)

Madeleine McDonough, "From the Beltway: Are You Ready? Brace Your Legal Team for the Impact of Biosimilars, Nanotechnology, and Sustainability/Reputational Risks," ACC-SoCal’s Sizzling Topics in Pharmaceutical & Medical Devices MCLE; Irvine, California (Sept. 2011)

Hildy Sastre, "Navigating Increased Risks and Regulatory Challenges When Undertaking Global Product Recalls," American Conference Institute's Summit on Drug & Device Product Recalls; Philadelphia, Pennsylvania (March 22, 2011)

Madeleine McDonough, “The New Drug Approval Process: NDA Submission and Review,” Food and Drug Law Institute’s Introduction to Drug Law and Regulation Conference; Washington, D.C. (Nov. 8, 2010)

Gene Williams, Faculty Member, International Association of Defense Counsel’s (IADC’s) 38th Annual Trial Academy; Stanford Law School, Palo Alto, California (July 31-Aug. 6, 2010)

Lori McGroder, “Analyzing Clinical Trials Processes from a Products Liability Perspective,” American Conference Institute’s Products Liability Boot Camp for Life Sciences; New York City, New York (July 22, 2010)

Mark Hegarty & Doug Schreiner, “Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials,” 46th DIA Annual Meeting: Facilitating Innovation for Better Health Outcomes; Washington, D.C. (June 14, 2010)

Matt Keenan & Peggy Fonshell Ward, “Preparing the Corporate Representative for Deposition,” International Association of Defense Counsel’s Deposition 101 Webinar Series (May 26, 2010)

Mark Hegarty, “Potential Civil and Criminal Liability Arising from Clinical Trials,” DRI 26th Annual Drug and Medical Device Seminar; San Francisco, California (May 21, 2010)

Thomas Moga, Panelist, “IP and Innovation Roundtable Discussion,” U.S. Department of Commerce; Washington, D.C. (May 19, 2010)

Carol Poindexter, Moderator, “Organization for Economic Cooperation (OECD)/Foreign Corrupt Practices Act (FCPA),” 2010 International Medical Device Industry Compliance Conference; Berlin, Germany (May 4, 2010)

Jim Muehlberger, "Missouri Class Actions and the Merchandising Practices Act," Missouri Judicial Advanced Trial Skills/Complex Litigation Seminar Course (Apr. 30, 2010). View

Harvey Kaplan, Panelist, “Pursuing Settlement or ADR Strategies for Early Resolution of Drug and Medical Device Cases,” Marcus Evans CLE Conference – 6th Annual Drug & Medical Device Litigation Forum: Effective Strategies to Prepare, Respond and Litigate Drug and Medical Device Cases in a Cost Efficient Manner; Philadelphia, Pennsylvania (Apr. 15, 2010)

Carol Poindexter, ““Self-Disclosure of Health Care Fraud and Abuse: Risks, Benefits and Pitfalls,” University of Texas School of Law’s 22nd Annual Health Law Conference; Houston, Texas (Apr. 9, 2010)

Carol Poindexter, "Who’s Watching You: Government Enforcement in Clinical Trials," Liability Risks in Clinical Trials; Washington, D.C. (Feb. 25, 2010)

Mark Hegarty, "Litigation Update: What Can Happen with Clinical Trials," Liability Risks in Clinical Trials; Washington, D.C. (Feb. 25, 2010)

Lori McGroder, "Avoiding Liability, 'Bad' Documents and Bad Press," Liability Risks in Clinical Trials; Washington, D.C. (Feb. 25, 2010)

Mark Hegarty, Lori McGroder, Carol Poindexter & Douglas Schreiner, "Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials (Mock Trial)," Liability Risks in Clinical Trials; Washington, D.C. (Feb. 25, 2010)

Carol Poindexter, Speaker/Moderator, “How Will Investigations and Lawsuits Arising Under the Qui Tam Provisions of the False Claims Act Affect You and Your Company?,” ABA Health Law Section’s 11th Annual Conference on Emerging Issues; Phoenix, Arizona (Feb. 18, 2010)

Michelle Mangrum, Panelist, "Successfully Asserting a Preemption Defense and Managing Industry/FDA Relationships in a Post-Levine and Post-Riegel World," American Conference Institute (ACI) 14th Annual Drug and Medical Device Litigation Conference; New York City, New York (Dec. 9, 2009)

Eric Anielak, Panelist, "Strategies for Winning Cases" American Conference Institute (ACI) 14th Annual Drug and Medical Device Litigation Conference; New York City, New York (Dec. 9, 2009)

Marie S. Woodbury, "Preemption Defense Workshop: Lessons From Good, Levine & Riegel," Sixth Annual Update of the Law; Shook, Hardy & Bacon (June 25, 2009)

James Muehlberger, "How Product-Related Risk Management Can be a Lifeline for Your Company," Sixth Annual Update of the Law; Shook, Hardy & Bacon (June 25, 2009)

Harvey Kaplan, “Cross-Examination of the Plaintiff’s Cardiologist,” American Conference Institute (ACI) Drug and Medical Device on Trial Conference; New York City, New York (June 2009)

Harvey Kaplan, “What You Need to Know About Data Protection Laws for Your Litigation Practices,” Culture Clash! Data Protection, Freedom of Information and Discovery – How to Protect Your Business in Transnational Disputes, Defense Research Institute (DRI) Europe; Munich, Germany (May 2009)

James Muehlberger,"Managing Class Action Litigation Challenges: Winning Strategies for Tackling Certification, Experts, Damages, International Class Actions and CAFA," American Conference Institute (ACI) Managing Complex Litigation: The 6th National In-House Senior-Level Defense Litigation Forum (Feb. 27, 2009).

Harley Ratliff, Moderator, "Working with Experts 101 - The Do’s and Don’ts Every Young Lawyer Should Know," ABA Section of Litigation Joint CLE Conference; Vail, Colorado (Jan. 23, 2009) View

Harvey Kaplan, Moderator, Plaintiff’s Lawyer Panel, DRI Corporate Counsel Roundtable; New York City, New York (Jan. 2009)

Marie S. Woodbury,"Preemption and Wyeth v. Levine: Looking Into the Future," American Conference Institute (Dec. 10, 2008)

James Muehlberger,"Analyzing the Provisions of and Differences Between State Consumer Protection Statutes To Develop an Aggressive Defense Strategy," Drug and Device Forum on Defending Consumer Fraud Claims (Sept. 23, 2008).

Madeleine McDonough, "Clinical Trials Registries and Results Databases: Complying with FDAAA and Varying State Laws," American Conference Institute (ACI) 10th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials; Boston, Mass. (Sept. 2008)

Madeleine McDonough, "Setting Up Your Systems: E-Discovery/Risk Management and Preservation Obligations," BNA Conference on E-Discovery for the Enterprise: Preparing Your Corporate Clients for the Realities of the Post Rules Amendment World; Arlington, Va. (Sept. 2008)

Perry Goldman, Deborah Moeller & Anthony Vale, "Evaluating Whether to Pursue the Preemption Defense," American Conference Institute's Drug & Device Preemption; Philadelphia, Penn. (July 15, 2008)

Madeleine McDonough, "Food Liabilities: From China to Chinese Restaurants, What American Insurers Need to Know," Swiss Re Claims Conference; Chicago, Ill. (June 2008)

Madeleine McDonough, "Practical Considerations in Defending Corporate E-Discovery Programs and Reducing the Risk That E-Discovery May Improperly Be Used as Leverage," Electronic Discovery and Document Storage: Management and Litigation Issues in Missouri and Kansas – Including a View from the Bench; Kansas City, Mo. (June 2008)

Madeleine McDonough, "Downgrading Data to Inaccessible Format: Risky Business?," BNA Audio Conference; Washington, D.C. (June 2008)

Michelle Fujimoto, “Importing Defective Products: Legal Risks, Preventative Measures, And Defense Strategies," International Association of Defense Counsel (IADC) Mid-Year Meeting (2008)

Madeleine McDonough, "Electronic Discovery," 27th Annual Corporate Counsel Institute; St. Louis, Mo. (May 2008)

Madeleine McDonough, "Clinical Trials: Developments in Human Subject Protection," FDLI & FDA Annual Conference; Washington, D.C. (Mar. 2008)

Madeleine McDonough, "Protect Your Biomedical Discoveries and Reduce Litigation Risks," University of Kansas; Lawrence, Kan. (Mar. 2008)

Deborah Moeller, "Litigation and Public Relations Strategies to Respond to Product Recalls," MCCA's Seventh Annual CLE Expo; Chicago, Ill. (Mar. 28, 2008)

Harley Ratliff, Co-Presenter, "Mass Torts Litigation: Looking Back but Heading Forward," ABA Section of Litigation Joint CLE Conference; Snowmass, Colo. (Jan. 11-13, 2008)

Madeleine McDonough, "From Here to China – Domestic and Foreign Supply Chain Issues," Agricultural Business Council of Kansas City (Jan. 2008)

Amor Esteban, Speaker, “Navigating Data Privacy Issues for Multinational Data Collection & Review,” Annual LegalTech Event; New York, N.Y. (2008)

Amor Esteban, Speaker, “Clinical Trials: Managing Risk, Minimizing Exposure,” ACE Medical Risk Seminar; San Diego, Calif. (2008)

Harvey Kaplan, “Jury Communication: Changing Perceptions of the Industry/FDA and Putting Adverse Events and the Approval Process in Context,” American Conference Institute (ACI) Drug and Medical Device Litigation Conference; New York, N.Y. (Dec. 2007)

Harley Ratliff, Co-Presenter, "Update On Recent Mass Torts Cases," ABA Section of Litigation Annual Meeting; San Antonio, Texas (Apr. 14, 2007)

Amor Esteban, Speaker, “Food and Drug Administration Amendments Act of 2007,” Fourth Quarter BayBio Corporate Counsel Meeting; Palo Alto, Calif. (2007)

Michelle Fujimoto, “Preserving The Appellate Record At Trial,” Defense Research Institute (DRI) Young Lawyers Seminar (2007)

Madeleine McDonough, "Critical Privacy Issues in Electronic Discovery," The Center for Business Intelligence Summit on Pharmaceutical Global Data Security and Privacy; Washington, D.C. (Sept. 2007)

Madeleine McDonough, "Post-Sale Considerations for the Food Industry," American Bar Association Tort Trial & Insurance Practice Section CLE, American Bar Association Annual Meeting; San Francisco, Calif. (Aug. 2007)

Harvey Kaplan, Chair, Panel Discussion, "Catastrophic Injury Cases," 2007 Joint International Conference; London, England (May 2007)

Harvey Kaplan, "Practice Pointers for Cross-Examination of a Science Expert," DRI Drug and Medical Device Seminar; San Francisco, Calif. (May 2007)

Michael Koon, Speaker, 5th Annual In House Counsel Forum on Government Regulation of Prescription Drug Pricing; New York, N.Y. (March 2007)

Greta McMorris, "Too Hot to Handle: Hot Topics Under BAPCPA New Published and Unpublished Decisions," Kansas City Bankruptcy Bar Association (Feb. 2007)

Greta McMorris, "Too Hot to Handle: Hot Topics Under BAPCPA New Published and Unpublished Decisions," American Bankruptcy Institute Annual Rocky Mountain Conference (Jan. 2007)

Amor Esteban, Moderator, “Non-Compliance: How to Respond & Address When Preservation Goes Awry,” 4th Annual Advanced E-Discovery Institute: The Revised Federal Rules – A Year Later, Georgetown Law CLE; Washington, D.C. (2007)

Amor Esteban, Speaker, “Risk Management of International Clinical Trials,” American Bar Association Section of Litigation, Products Liability Committee, Subcommittee on Biotech, Second Annual Biotech Institute and Regional CLE Workshop; South San Francisco, Calif. (2007)

Amor Esteban, Speaker, “Establishing an International CTA Template to Streamline Negotiations With Investigators and Institutions,” American Conference Institute’s International Clinical Trials Conference; Boston, Mass. (2007)

Amor Esteban, Speaker, "Finding the Digital Smoking Gun," ABA Criminal Justice Section CLE on White Collar Crime; San Diego, Calif. (2007)

Amor Esteban, Speaker, "Clinical Trials: Managing Risks and Handling Common Dilemmas," ACE USA Seminar; San Francisco, Calif. (2007)

B. Joyce Yeager, "Motion Warriors: . . . Winning the Motion War," The Missouri Bar Solo and Small Firm Conference (2007)

B. Joyce Yeager, "Write On: Perfecting the Art of Legal Writing Skills," The Missouri Bar Solo and Small Firm Conference (2007)

Harvey Kaplan, "Identifying and Minimizing Litigation Risks of Clinical Trial Data and Post-Market Adverse Event Reports," American Conference Institute (ACI) Drug and Medical Device Litigation Conference; New York, N.Y. (Dec. 2006)

Bridgette Willauer, "A View from the Bench: Judges and Clerks Tell New Lawyers What They Need to Know," KMCBA Young Lawyers Section CLE Presentation (Nov. 28, 2006)

Harvey Kaplan, "Defusing Mass Tort Litigation: Advanced ADR Strategies for Early Resolution of Drug and Medical Device Cases," Marcus Evans Conference - Mass tort litigation...and beyond; New York, N.Y. (Nov. 2006)

Michael Koon, Speaker, National Forum on Drug and Medical Device Litigation; New York, N.Y. (Nov. 2006)

Madeleine McDonough, "Food Law Update – Litigation and Legislation," Defense Research Institute Food Liability – New Issues, New Strategies Seminar; Chicago, Ill. (Nov. 2006)

Michael Koon, Speaker, 6th Annual National Pharmaceutical Counsel Forum – Fraud and Abuse in the Sale and Marketing of Drugs; New York, N.Y. (Oct. 2006)

Michael Koon, Speaker, 3rd Annual National Medical Device and Pharmaceutical Counsel Guide to Off-Label Communications; Chicago, Ill. (Sept. 2006)

Harvey Kaplan, "The Admissibility of Expert Witness Testimony: Debunking Junk Science," American Conference Institute (ACI) Drug and Medical Device Litigation Seminar; Chicago, Ill. (June 2006)

Michael Koon, Speaker, "New Twists in the Enforcement Arena: The Advance PCS Consent Order Analyzed," ABA Teleconference CLE (Apr. 2006)

Harvey Kaplan, "The Liability Risks of Off-Label Promotion and Avoiding Those Risks," American Conference Institute (ACI) Fourth Annual Minimizing Legal Risks and Drug Advertising and Promotion Seminar; Philadelphia, Pa. (Mar. 2006)

Greta McMorris, "Notable Changes of the Law Under the Bankruptcy Abuse Prevention and Consumer Protection Act," Annual Business Law Update (Feb. 2006)

Michael Koon, Speaker, 4th Annual In House Counsel Forum on Government Regulation of Prescription Drug Pricing; New York, N.Y. (Jan. 2006)

Michael Koon, Moderator, New Frontiers in Corporate Responsibility and Compliance; New York, N.Y. (Jan. 2006)

Amor Esteban, Speaker, “Risk Management of Clinical Trials,” American Bar Association, Section of Litigation, Products Liability Committee, Subcommittee on Biotech, First Annual Biotech Institute and Regional CLE Workshop; Cambridge, Mass. (2006)

Amor Esteban, Speaker, “Pharmaceutical Liability Litigation,” Excess/Surplus Lines Claims Association Annual Conference; Bermuda (2006)

Amor Esteban, Editorial Board Member/Discussion Leader, The Sedona Conference International Working Group on E-Disclosure and E-Retention, Working Group 6 Annual Meeting; Madrid, Spain (2006)

Amor Esteban, Speaker, “Managing the Risk: E-mail Use, Retention Policies and Discovery Issues,” Mealey’s Email Discovery & Retention Policies Conference; San Francisco, Calif. (2006)

Amor Esteban, Speaker, “Advanced Litigation Issues in E-Discovery,” Mealey's Email Discovery & Retention Policies Conference; New York, N.Y. (2006)

Amor Esteban, Speaker, “Minimizing Risks in Clinical Trial Agreements: What You Can’t Afford Not to Know,” Managing Legal Risks in Conducting & Promoting Clinical Trials, 4th National Conference, American Conference Institute; New York, N.Y. (2006)

Lori C. McGroder, “Clinical Trials on Trial”; and “Avoiding Liability, Bad Documents and Bad Press," Mock Trial Program: Biotech Workshop; Thousand Oaks, Calif. (2006)

Harvey Kaplan, "An Update on Off-Label Use and Promotion," American Conference Institute (ACI) Drug & Medical Device Litigation Seminar; New York, N.Y. (Dec. 2005)

Madeleine McDonough, "Recent Litigation Developments in E-Discovery," Institute of Validation Technology Conference on Electronic Records Management; Philadelphia, Pa. (Dec. 2005)

Madeleine McDonough, "Preserving and Destroying Documents in the Electronic Age," The Missouri Bar Ethics & Litigation CLE (Dec. 2005)

Harvey Kaplan, "Electronic Discovery in the 21st Century: Is Help on the Way?," Practising Law Institute (PLI) Electronic Discovery and Retention Guidance for Corporate Counsel Seminar; New York, N.Y. (Nov. 2005)

Harvey Kaplan, "Recent Developments in Off-Label Use and Promotion," American Conference Institute (ACI) Third Annual Conference on Reducing Legal Risks in the Sales and Marketing of Medical Devices; Chicago, Ill. (Nov. 2005)

Harvey Kaplan, “Minimizing the Risk of Liability in the U.S. Arising from Clinical Trials,” C5 The Legal and Regulatory Risks of Clinical Trials Conference; London, England (June 2005)

Harvey Kaplan, “Off-Label Promotion: Marketing Pharmaceuticals in an Era of Scrutiny and Prosecution,” American Conference Institute (ACI) Third Annual Minimizing Legal Risks in Drug Advertising and Promotion; Philadelphia, Pa. (June 2005)

Madeleine McDonough, "Food Litigation in the Next Decade," Defense Research Institute Food Liability – Law, Science and Risk Management Seminar; St. Louis, Mo. (May 2005)

Madeleine McDonough, "Best Practices in E-Discovery Preparedness: Invest Reasonably Now to Avoid Paying Dearly Later," Product Liability Advisory Council Spring Conference on E-Discovery & Records Management; San Antonio, Texas (Apr. 2005)

Harvey Kaplan, Chair, Panel Discussion, “Should there be a Defence of Regulatory Compliance in Product Liability cases?”, British Institute of International & Comparative Law (BIICL) Conference on Pharmaceutical Regulation and Product Liability; London, England (Mar. 2005)

Harvey Kaplan, “Minimizing Liability in Clinical Trials,” American Conference Institute (ACI) Second Annual Forum on Managing Legal Risks in Conducting and Promoting Clinical Trials Seminar; New York, N.Y. (Feb. 2005)

Madeleine McDonough, "Food Safety Litigation Trends," Agricultural Business Council of Kansas City (Jan. 2005)

Amor Esteban, Speaker, “What’s Good for the Ganso. . .The Practical Aspects of Sanctions in Electronic Discovery,” Hispanic National Bar Association, 30th Annual convention; Washington, D.C. (2005)

Amor Esteban, Speaker, “What Every In-House Counsel and Risk Manager Needs to Know About Clinical Trial Agreements,” Managing Legal Risks in Conducting & Promoting Clinical Trials, 3rd National Forum, American Conference Institute; San Diego, Calif. (2005)

Amor Esteban, Participant, “Taking Control of the Corporate Litigation Discovery Process: Corporate America’s Imperative to Reduce Risk, Cut Costs, and Improve Quality in The Digital Age,” Association of Corporate Counsel/Xerox Global Services; Corporate Litigation Management Services Webinar (2005)

Amor Esteban, Speaker, “Electronic Discovery: Litigation’s Newest Pressure Point,” American Bar Association Continuing Legal Education, Litigation Series; TeleConference and Live Audio Webcast (2005)

Amor Esteban, Speaker, “What Every In-House Counsel and Risk Manager Needs to Know About Clinical Trial Agreements,” Managing Legal Risks in Conducting & Promoting Clinical Trials, Second Annual Meeting, American Conference Institute; New York, N.Y. (2005)

Amor Esteban, Invited Participant, Fordham Summit on Bio-Pharmaceuticals for the 21st Century: Responsibility, Sustainability, & Public Trust; Fordham University, N.Y. (2005)

B. Joyce Yeager, Volunteer Editor, MoBarCLE Publications (2005 and 2006)

B. Joyce Yeager, "He Said What? The Ethics of Staff-Client Contact," The Missouri Bar (2005)

B. Joyce Yeager, "Preserving the Win: The Transition from Trial to Appeal," The Missouri Bar (2005)

Harvey Kaplan, “Promotion of Prescription Drugs: Traps for the Unwary,” American Conference Institute (ACI) Drug and Medical Device Litigation Seminar; New York, N.Y. (Dec. 2004)

Madeleine McDonough, "E-Discovery Is Improperly Used as Leverage," Shook, Hardy & Bacon National Forum on Electronic Discovery and Corporate Compliance (Nov. 2004)

Madeleine McDonough, "Emerging Issues in Agribusiness," Greater Kansas City Chamber of Commerce Centurions Leadership Program (Nov. 2004)

Harvey Kaplan, “Storm Warnings from Across the Ocean? The Latest Drug Liability Developments in the US,” EuroLegal Pharmaceutical Product Liability Conference; London, England (Sept. 2004)

Vicky J. Alvarez, presenter and co-author, "HB4 and Products Liability Actions," Houston Bar Association, HBA 2004 CLE Seminar; Houston, Texas (June 24, 2004) View

Harvey Kaplan, “Off-label Promotion: An Update,” American Conference Institute (ACI) Second Annual Minimizing Legal Risks in Drug Advertising and Promotion; Philadelphia, Pa (June 2004)

Harvey Kaplan, “Punitive Damages in the New Millennium,” 2004 Joint International Conference; Barcelona, Spain (May 2004)

Harvey Kaplan, Chair, Panel Discussion: “What European Companies Look for in U.S. Lawyers? What American Companies Look for in European Lawyers?” 2004 Joint International Conference; Barcelona, Spain (May 2004)

Madeleine McDonough, "Criminalizing Tort Law: Efforts to Develop Criminal Theories Relating to the Design, Marketing and Prescription of Pharmaceutical Products," Defense Research Institute Drug and Medical Device Seminar; San Francisco, Calif. (May 2004)

Harvey Kaplan, “Corporate Crisis and Response: Litigation Strategies for Survival,” International Association of Defense Counsel (IADC) Corporate Counsel College - Electronic Discovery in the 21st Century: Preparing for the Inevitable; Chicago, Ill. (Apr. 2004)

Gene M. Williams, “The Use of PowerPoint in Daubert Challenges,” Federation of Defense and Corporate Counsel (Mar. 2004)

Harvey Kaplan, “Potential Liability Arising From Clinical Trials,”American Conference Institute (ACI) Clinical Trials Seminar; Washington, D.C. (Feb. 2004)

Amor Esteban, Speaker, “American Bar Association 2004 Amendments to Discovery Standards,” The Sedona Conference, Working Group on Electronic Discovery, Annual Meeting; Santa Fe, N.M. (2004)

Amor Esteban, Speaker, “How to Prevent and Manage Product Liability Claims Arising out of Clinical Trials,” Managing Legal Risks in Conducting & Promoting Clinical Trials, American Conference Institute; Washington, D.C. (2004)

Amor Esteban, Moderator and Speaker, “The Death of a Product Salesmen: Dealing with Product Issues and Recalls,” American Bar Association, Litigation Section Annual Conference, Scottsdale, Ariz. (2004)

B. Joyce Yeager, "Practical Legal Ethics in Kansas: Issues and Answers," National Business Institute (2004 and 2005)

Harvey Kaplan, “An Overview of Federal and State Tort Reform,” American Conference Institute (ACI) Drug and Medical Device Litigation Seminar; New York, N.Y. (Dec. 2003)

Harvey Kaplan, “The Sulzer Hip and Knee Implant Litigation: A Class Action Settlement that Worked for Everyone,”ABA Section of Litigation, Product Liability Committee - Current Issues in Pharmaceutical Litigation & Policy Seminar; Philadelphia, Pa. (Nov. 2003)

Harvey Kaplan, “Off-Label Promotion of Drugs: The Risks and How to Minimize Them,”American Conference Institute (ACI) Drug Advertising and Promotion Seminar; Philadelphia, Pa. (June 2003)

Harvey Kaplan, “The Insiders’ View of High Exposure Litigation: Corporate Credibility Under Siege,” International Association of Defense Counsel (IADC) Corporate Counsel College - Who’s the Enemy? Tending to the Relationship with Outside Counsel; Chicago, Ill. (Apr. 2003)

Harvey Kaplan, “Anatomy of a Lawsuit in the United States,” EuroLegal Pharmaceutical Product Liability Conference; London, England (Apr. 2003)

Amor Esteban, Speaker, “Communications with Public Relations Firms as Part of Trial Strategy – Privileged or Not?,” Drug and Medical Device Seminar, Defense Research Institute; New Orleans, La. (2003)

Michelle Fujimoto, “Major Dambert Decisions On Appeal – Current Update," Mealey’s Conference; Los Angeles, Calif. (2003)

Michelle Fujimoto, “Preparing For, Taking and Using Depositions," California Continuing Education of the Bar; Orange County, Calif. (2003)

James Shepherd, "House Bill 4: Texas Tackles Toxic Tort," DRI Annual Meeting; Washington, D.C. (2003)

James Shepherd, "What's Bubbling in Toxic Tort Land," DRI Toxic Tort & Environmental Law Seminar; San Diego, Calif. (2003)

B. Joyce Yeager, "Ethical Delegation to Paralegals: When Do Paralegals Cross the Line?," The Missouri Bar (2003)

B. Joyce Yeager, "Ethics and Delegation to Assistants," Johnson County Bar Association (2003)

Harvey Kaplan, “The Sulzer Hip and Knee Implant Litigation: A Class Action Settlement that Worked for Everyone,” American Conference Institute (ACI) Drug and Medical Device Litigation Seminar; New York, N.Y. (Dec. 2002)

Harvey Kaplan, “Strategy and Tactics for Handling the Multi-Forum Litigation,” International Association of Defense Counsel (IADC) Corporate Counsel College - The Insiders View of High Exposure Litigation; Chicago, Ill. (Apr. 2002)

Amor Esteban, Speaker, “Clinical Trials Litigation, a Risk Management Perspective,” Healthcare/Life Sciences Client Advisory Council; San Francisco, Calif. (2002)

Amor Esteban, Speaker, “Liability Issues in Biotechnology Research,” American Academy of Pharmaceutical Physicians, Annual Meeting; San Diego, Calif. (2002)

Amor Esteban, Meeting Co-Chair and Speaker, “It’s a Small World After All-The International Corporation in Domestic Products Liability Litigation,” American Bar Association Products Liability Midyear Committee Meeting, Section of Litigation; Orlando, Fla. (2002)

B. Joyce Yeager, Speaker, The Missouri Bar Solo and Small Firm Conference (2002 - 2007)

Harvey Kaplan, “Watching it Unfold: How the Courts are Interpreting the Drug and Medical Device Section of the Restatement (Third) of Torts,” American Conference Institute (ACI) Drug and Medical Device Litigation Seminar; New York, N.Y. (Dec. 2001)

Gene M. Williams, “Liability of Pharmaceutical Companies for Internet Sales,” Federation of Insurance and Corporate Counsel; London, England (July 2001)

Harvey Kaplan, “Anatomy of a Lawsuit in the United States,” DRI’s Second International Conference; Brussels, Belgium (May 2001)

Harvey Kaplan, “Managing Pharmaceutical and Device Litigation,” DRI Drug and Medical Device Litigation Seminar; Chicago, Ill. (May 2001)

Harvey Kaplan, “Adverse Events and Potential Liability for Failure to Warn,” Barnett Parexel Adverse Events Seminar; Arlington, Va. (Jan. 2001)

Amor Esteban, Seminar Co-Chair and Moderator, “Developments in Class Action Settlements,” The Fifth Annual National Institute on Class Actions; San Francisco, Calif. (2001)

Frank C. Rothrock, Lecturer, “Punitive Damages,” Orange County Bar Association (2001)

Frank C. Rothrock, Lecturer, “Punitive Damages,” California Continuing Education of the Bar (2001)

Amor Esteban, Speaker, “Legal and FDA Issues in Product Safety Surveillance: Strategies to Minimize Risk” West Coast Annual Conference on Adverse Drug Reaction Reporting; San Francisco, Calif. (2000)

Amor Esteban, Seminar Moderator and Speaker, “Media Impact on Product Liability Litigation,” ABA Product Liability Regional Conference, Emerging Issues in International Product Liability Law; Detroit, Mich. (2000)

Amor Esteban, Seminar Co-Chair and Speaker, “Settlement Techniques,” The Fourth Annual National Institute on Class Actions; Chicago, Ill. (2000)

Gene M. Williams, “Changing the Insurance Business Process: Primary Insurance Industry Initiatives,” Intermediaries and Reinsurance Underwriters Association (Nov. 16, 1999)

Gene M. Williams, “Internet and Technology Issues Facing the Insurance Industry and Corporate Legal Departments,” National Association of Independent Insurers Fall Legislative Meeting (Oct. 21, 1999)

Harvey Kaplan, Chair, “Strategies for the Prevention and Defense of Products Liability Litigation in the United States and Europe,” DRI’s First Annual Conference for European Manufacturers and Insurers; Brussels, Belgium (May 1999)

Gene M. Williams, “Security Issues in Internet Communication,” International Association of Defense Counsel Winter Meeting (Feb. 15, 1999)

Amor Esteban, Speaker, “Managing Complex Civil Litigation,” California Center for Judicial Education and Research, Continuing Judicial Studies Program; Dana Point, Calif. (1999)

Amor Esteban, Seminar Co-Chair and Speaker, “New Developments in Class Actions” and “Settlements of Class Actions: The Law, Mechanics and Ethics,” National Institutes on Class Actions, American Bar Association; San Francisco, Calif. (1999)

Amor Esteban, Seminar Co-Chair and Speaker, “Lessons Learned: Real Mass Tort Litigation” Annual American Bar Association Meeting, Section of Litigation; Dallas, Texas (1999)

Harvey Kaplan, “Potential Liability Issues Arising from Clinical Trials,” American Conference Institute (ACI) Drug and Medical Device Litigation Seminar; New York, N.Y. (Dec. 1998)

Harvey Kaplan, “Rule 23 – Class Actions and Multidistrict Litigation,” Tulane 10th Trial By Masters Seminar; New Orleans, La. (Dec. 1997)

Harvey Kaplan, “The Restatement (Third) and Its Impact on Drug and Medical Device Litigation,” American Conference Institute (ACI) Drug and Medical Device Litigation Seminar; New York, N.Y. (Dec. 1997)

Harvey Kaplan, Moderator, “International Law & Litigation: A Primer,” SHB Seminar; Kansas City, Mo. (Nov. 1997)

Harvey Kaplan, “Globalisation of Litigation - Discovery Trends,” SHB Product Liability Seminar; London, England (Oct. 1997)

Harvey Kaplan, “Cross-Examination of Expert Witnesses,” South Dakota Defense Lawyers Association Fall Seminar; Sioux Falls, S.D. (Sept. 1997)

Harvey Kaplan, Invited participant, Discovery Conference, Advisory Committee on the Civil Rules, Boston College Law School; Newton, Mass. (Sept. 1997)

Harvey Kaplan, “Restatement (Third) of Torts — What’s That?: An Overview of Key Sections, with a Foreword from Professor James A. Henderson, Jr.,” International Association of Defense Counsel Annual Meeting; Bermuda (July 1997)

Gene M. Williams, “Breast Implant Litigation (A Defense Perspective),” Texas State Bar Convention (June 1997)

Harvey Kaplan, “Restatement (Third) of Torts: Products Liability,” International Association of Defense Counsel Midyear Meeting; Pebble Beach, Calif. (Feb. 1997)

Amor Esteban, Moderator, “Behind Closed Doors: Should Judges of Mass Torts Exchange Information without Party Participation?,” ABA Annual Meeting; San Francisco, Calif. (1997)

Michelle Fujimoto, “Strict Liability For Failure To Warn: California’s Carlin Paradox,” Defense Research Institute (DRI) Drug & Medical Device Litigation Seminar (1997)

Harvey Kaplan, “Dealing with Plaintiffs’ Discovery Abuse Tactics,” DRI First Annual Meeting; Chicago, Ill. (Oct. 1996)

Harvey Kaplan, Co-Chair, Meeting of Attorneys for Self-Insureds — In-House and Outside Counsel, DRI First Annual Meeting; Chicago, Ill. (Oct. 1996)

Harvey Kaplan, “The Product Liability Risks of Direct-to-Consumer Advertising of Prescription Drugs,” IBC’s Fifth Annual Conference: Legal Quandaries in Advertising & Promoting Biologics & Pharmaceuticals; Boston, Mass. (Aug. 1996)

Harvey Kaplan, Open Forum Program, “Proposed Changes to Rule 23,” International Association of Defense Counsel Annual Meeting; White Sulphur Springs, W.V. (July 1996)

Gene M. Williams, “Texas Tort Reform Legislation, It’s Impact on Pharmaceutical & Toxic Tort Litigation,” Federation of Insurance & Corporate Counsel Winter Meeting (February 29, 1996)

Gene M. Williams, “Strategies and Imaginative Settlement Ideas,” Defense Research Institute

Harvey Kaplan, Chair, Andrews Continuing Education Institute’s 1995 National Pharmaceutical Litigation Conference; Pasadena, Calif. (Oct. 1995)

Frank C. Rothrock, Lecturer, “Anticipating, Avoiding, and Managing Electromagnetic Field Claims,” Business Development Associates; San Francisco, Calif. (Sept. 21-22, 1995)

Harvey Kaplan, “Update on Restatement of Torts 3d,” DRI Drug and Medical Device Litigation Seminar; Seattle, Wash. (May 1995)

Frank C. Rothrock, Lecturer, "Plaintiffs' Use and Misuse of MDL, Class Actions, and Other Vehicles for Consolidation," DRI Drug and Medical Device Litigation Seminar; Seattle, Wash. (May 1995)

Frank C. Rothrock, Lecturer, "Mass Tort and Complex Litigation 1994," Andrews Continuing Education Institute; Philadelphia, Pa. (Oct. 20-21, 1994)

Harvey Kaplan, “Stepping Through the Mine Field: Cross-Examining Plaintiff’s Expert at Trial,” DRI Drug and Medical Device Litigation Seminar; Nashville, Tenn. (June 1994)

Harvey Kaplan, “American Law Institute Restatement of Torts (Third),” DRI Drug and Medical Device Litigation Seminar; Toronto, Canada (May 1994)

Harvey Kaplan, “Pitfalls of Discovery From Inside and Outside — Potential for Criminal Liability,” DRI Seminar on Corporate Criminal and Tort Liability: The Expanding Criminalization of Business Conduct; San Francisco, Calif. (Feb. 1994)

Frank C. Rothrock, Lecturer, "Limiting Your Company's Exposure In Product Liability Actions," Health Industry Manufacturers' Association Programs; Costa Mesa, Calif. (Nov. 15, 1993)

Gene M. Williams, “How to Set Reserves, Identify and Dispose of Dangerous Cases Before Verdict,” Loss Claims Supervisor’s Seminar (Sept. 23, 1993)

Harvey Kaplan, Chairman, DRI Drug and Medical Device Litigation Seminar; San Francisco, Calif. (May 1993)

Harvey Kaplan, “U.S. Trends in Drug & Medical Device Litigation: Storm Warnings from South of the Border,” Canadian Institute Drug and Medical Device Liability Seminar; Toronto, Canada (Oct. 1992)

Harvey Kaplan, Chairman, DRI Drug and Medical Device Litigation Seminar; Boston, Mass. (May 1992)

Frank C. Rothrock, Lecturer, "The Safe Medical Devices Act," Health Industry Manufacturers' Association Programs; Minneapolis, Minn. (Apr. 21-22, 1992)

Harvey Kaplan, “Products Liability in the 90’s,” Rockhurst College Executive Fellows MBA Program, Rockhurst College; Kansas City, Mo. (Apr. 1992)

Harvey Kaplan, Chairman, DRI Drug and Medical Device Litigation Seminar; Chicago, Ill. (Apr. 1991)

Harvey Kaplan, “General Civil, Personal Injury and Business ADR,” Kansas City Metropolitan Bar Association Seminar on Alternative Dispute Resolution; Kansas City, Mo. (Oct. 1990)

Harvey Kaplan, “Exclusion or Limitation of Expert Witness Testimony,” Drug & Medical Device Litigation Seminar, Eli Lilly and Company; Indianapolis, Ind. (Aug. 1990)

Harvey Kaplan, Chairman, Open Forum Program: “The Pendulum Swings Back: Defending Crashworthiness Cases in the 1990’s,” International Association of Defense Counsel Annual Meeting; White Sulphur Springs, W.V. (July 1990)

Harvey Kaplan, “Practical and Ethical Considerations in Dealing with Treating Physicians and Expert Witnesses for the Plaintiff,” DRI Drug and Medical Device Litigation Seminar; San Diego, Calif. (May 1989)

Harvey Kaplan, “Cross Examination of Adverse Experts at Deposition and Trial: How to Maintain Control,” Joint Meeting of the Alabama, Mississippi, Tennessee & Florida Defense Lawyers Associations;Nashville, Tenn. (April 1989)

Harvey Kaplan, “Restrictions on the Use of Expert Witnesses,” DRI Drug and Medical Device Litigation Seminar; Boston, Mass. (April 1988)

Frank C. Rothrock, Lecturer, “Working with Expert Witnesses,” Hastings Center for Trial and Appellate Advocacy Fundamentals of Advocacy Program (January 1988)

Frank C. Rothrock, Lecturer,“Preparing for, Taking, and Using Depositions,” California Continuing Education of the Bar (1988, 1990, 1992, 1994, 1996, and 1997)

Frank C. Rothrock, Lecturer, "Medical Devices and Diagnostics and the Continuing Products Liability Predicament," Health Industry Manufacturers' Association Programs; Washington, D.C. (December 3, 1987)

Harvey Kaplan, Open Forum Program: “How to Try a Toxic Tort Case,” International Association of Defense Counsel Annual Meeting; Colorado Springs, Colo. (June 1987)

Harvey Kaplan, “Often Seen But Misunderstood Problems Faced by Litigators in Deposition,” ABA TIPS Second Annual Spring Meeting; Washington, D.C. (May 1987)

Harvey Kaplan, “Update on Recent Cases,” DRI Drug and Medical Device Litigation Seminar, The Stanford Court; San Francisco, Calif. (Apr. 1987)

Harvey Kaplan, “Product Liability – Drug Manufacturer’s Duty to Warn” and “Preparing the Toxicologist for Trial,” International Association of Defense Counsel, Toxicology and Toxic Torts Symposium; Breckenridge, Colo. (Mar. 1987)

Harvey Kaplan, “Learning the Federal Rules of Evidence the Easy Way,” International Association of Defense Counsel Mid-Year Meeting; Palm Beach, Fla. (Feb. 1987)

Frank C. Rothrock, Lecturer, "The Product Liability Dilemma," Health Industry Manufacturers' Association Programs; Irvine, Calif. (Nov. 17-18, 1986)

Harvey Kaplan, “How to Settle the Impossible Case,” International Association of Defense Counsel Annual Meeting; White Sulphur Springs, W.V. (July 1986)

Harvey Kaplan, “Evidence Issues in Drug and Device Cases,” DRI Drug and Medical Device Litigation Seminar; Washington, D.C. (Apr. 1986)

Harvey Kaplan, “Product Liability Law: Recent Developments Affecting Pharmaceutical Manufacturers,” Drug Information Association Workshop; Washington, D.C. (Mar. 1986)

Frank C. Rothrock, Lecturer, "Medical Devices and Diagnostics and the New Product Liability Law," Health Industry Manufacturers' Association Programs; Arlington, Va. (Nov. 19-20, 1985)

Frank C. Rothrock, Lecturer, Rutter Group Program on California Civil Discovery (1984 and 1985)

Harvey Kaplan, Seminars on Packaging Security in the Pharmaceutical Industry (following the Tylenol tragedy and the FDA’s promulgation of packaging regulations), 1982-83, [New Brunswick, N.J. - Nov. 1982; Los Angeles, Calif. - Jan. 1983; Park City, Utah - Feb. 1983; Dorado, Puerto Rico - June 1983]

Harvey Kaplan, Kansas City Bar Association, Products Liability Seminar (Oct. 1981)

Harvey Kaplan, U.S. International Foundation for Studies in Reproduction, Inc., Medico-Legal Seminar: Pan-American Conference on Fertility & Sterility; Dorado, Puerto Rico (Feb. 1977)

Frank C. Rothrock, Lecturer, “Mechanics' Liens and Related Remedies,” California Continuing Education of the Bar (1977, 1980 and 1984)

Frank C. Rothrock, Lecturer, “Fundamentals of Civil Procedure Before Trial,” California Continuing Education of the Bar (1979-1986)