Health Care and Pharmaceuticals
Advertising and Health Care: An Overview of Litigation and Hot Topics
The program will provide an overview of the regulatory framework that governs the advertising of health related products such as pharmaceuticals, dietary supplements, medical devices, and food. In addition, the program will include a discussion of recent litigation concerning deceptive, or potentially deceptive, health related advertising, including the FTC’s actions against Nestle, Iovate, Kellogg, and Dannon and trends concerning agency and private litigation.
Date: Monday, February 7, 2011 • 11:30 PM - 01:00 PM EST
Papers from past programs can be found on the "Program Papers" page of the Committee's website.
The Ins and Outs of Sham Litigation Claims: Insights From Pharmaceutical Patent and Other Intellectual Property Cases
The Federal Circuit recognizes sham litigation and Walker Process claims as ways Plaintiffs can defeat Noerr-Pennington immunity and successfully pursue counterclaims against patent infringement suits. What should practitioners know about pleading and/or responding to sham litigation claims? How has the law evolved since Handgards, Inc. v. Ethicon, Inc.? What standards do courts use when assessing whether a patent claim is a sham? Should existing legal standards be modified?
Date: Tuesday, February 1, 2011 • 12:00 PM - 01:30 PM EST
Balancing Health Care Policy and Competition Policy: Provider Consolidation and Organizational Change
When do provider consolidations and organizational change -- horizontal and/or vertical -- create meaningful efficiencies that result in improvements in the quality, access and cost of health care services, and when do they result in price increases without offsetting benefits? The Affordable Care Act of 2010, particularly with regard to Accountable Care Organizations, adds a new dimension to the continuing debate. Join a lively discussion among our panel of health care and competition experts from different fields as we examine the extent to which tensions exist between health care policy and antitrust policy, and look for effective ways to bend the cost curve without sacrificing quality and access to care.
Date: Wednesday, December 15, 2010 • 12:00 PM - 01:00 PM EDT
Blue Cross - Red Light? Exploring the Implications of the Recent Case of United States v. Blue Cross Blue Shield of Michigan
The ABA Antitrust Section's Unilateral Conduct Committee, Health Care and Pharmaceuticals Committee and Insurance and Financial Services Committee are proud to present a Committee Program in the series of programs on Unilateral Conduct in Specific Industries: Blue Cross - Red Light? Exploring the Implications of the Recent Case of United States v. Blue Cross Blue Shield of Michigan.
Date: Friday, November 19, 2010 • 12:00 PM - 01:30 PM EDT
Health Insurance Transactions: Insights From The Front Line
A panel of experts will discuss recent health insurance transactions, providing insights into the antitrust issues raised by these transactions and the analytical approaches that are used in evaluating them. While historical transactions will be discussed, the panel will also consider what to expect in the future. Both federal and state enforcement initiatives and perspectives will be considered.
Date: Tuesday, November 9, 2010 • 12:00 PM - 01:30 PM EDT
The EC Sector Inquiry in the Pharmaceutical Industry
The program will discuss the Sector Inquiry in the pharmaceutical industry and resulting report and the 1st Report on the Monitoring of Patent Settlements, and how inside and outside counsel represented pharmaceutical manufacturers before DG COMPETITION during the Sector Inquiry and counsel them in the ongoing enforcement in the industry.
- Program Flyer
- Program Materials (Competition in the Pharmaceutical Sector)
- Program Materials (Mavroghenis, Stephen)
- Program Audio
Date: Monday, October 18, 2010 • 12:00 PM - 01:30 PM EDT; 18.00-19.30 Brussels time
FTC/State of Minnesota v. Lundbeck: Market Definition and Beyond
In the recently decided case FTC/State of Minnesota v. Lundbeck, the defendant (formerly Ovation) was accused of a merger-to-monopoly when it acquired two drugs, Indocin IV and NeoProfen, that are used to treat a rare heart condition in premature babies. After Lundbeck acquired rights to NeoProfen, it substantially raised the price for Indocin IV. The FTC and Minnesota charged Lundbeck with an anticompetitive acquisition and abuse of monopoly power. After a December 2009 trial, the court dismissed plaintiffs' claims for failure to prove that Indocin IV and NeoProfen were in the same relevant product market. Among other things, the court relied heavily on testimony of neonatologists regarding why they chose to use one drug or the other. In an interactive discussion, our panel---the attorneys who actually tried the case --- will address market definition and other critical aspects of this litigation.
Date: Tuesday, September 28, 2010 • 12:00 PM - 01:30 PM EDT
Open House Program: How to Get Involved in the Health Care and Pharmaceuticals Committee
This "open house" program will provide you with an opportunity to learn what the Health Care and Pharmaceuticals Committee offers you and how to get involved in the committee. The program will provide background on our various programs, publications, and other activities.
Date: Monday, September 13, 2010 • 12:00 PM - 01:30 PM EDT
Reform of the Health Delivery System
The health reform legislation has finally been enacted but it merely begins the process of health care reform, which will be ongoing. Cost saving measures in the reform bill will not come into effect for several years. In the meantime, an increasing portion of our GNP goes to health services and so health insurance premiums increase and there is dissatisfaction with the quality of care our system provides. How can physicians, hospitals and health insurers improve quality and contain costs within the parameters of the antitrust laws? Our panelists will discuss clinical integration, standards setting and joint ventures as possible solutions.
Date: Tuesday, June 15, 2010 • 12:00 PM - 01:30 PM EST
Predicting Post-Merger Price Effects: The Use of Hospital Merger Simulations at the FTC
Simulation models are used by the FTC and DOJ to evaluate the likely effect of mergers on prices. For example, the FTC uses simulation models when evaluating hospital mergers. This session will discuss the simulation models that are used to evaluate hospital mergers and tests that have been undertaken to explore the reliability of these models.
Note: Participants in the session include: FTC economists and an FTC lawyer who will discuss how the FTC uses simulation models to analyze hospital mergers, an academic economist who helped design the model, and a consulting economist that has written about the model.
- Program Flyer
- Program Audio
- Another View of Hospital Merger Simulation (Argue)
- Simulating Hospital Merger Simulations (Balan, Brand)
- Hospital Merger Simulations in Practice (Brand, Garmon)
- Hospital Merger Simulation at the FTC (Perry)
- Estimating the Price Consequences of Proposed Hospital Mergers: A New Approach (Town)
Date: Tuesday, June 1, 2010 • 12:00 PM - 01:30 PM EST
Antitrust in Healthcare 2010
On May 24-25, 2010, the American Bar Association's Health Law Section and Section of Antitrust Law and the American Health Lawyers Association will join together to present Antitrust in Healthcare 2010. The program will be held at the Ritz-Carlton, Pentagon City in Arlington, Virginia.
- Click here to view the program brochure
Health Insurers and the Antitrust Laws; The Impact of Proposed Changes in the Law in the District of Columbia and Elsewhere
This program focuses on whether health insurance markets would benefit from increased antitrust enforcement. Bennett Rushkoff will review the District Government's responses since 2005 to local concerns about the surplus accumulated by CareFirst's D.C. affiliate. David Balto and Jim Burns will debate, for DC and other markets, whether a small number of health insurers currently exert undue market influence and, if so, whether proposed reforms, such as repeal of the McCarran-Ferguson Act’s business-of-insurance exemption, would help. Finally, Seth Bloom will discuss prospects for McCarran repeal and other federal legislation, including proposals to address pharmaceutical patent settlements.
Date: Friday, May 14, 2010 • 12:15 PM - 02:00 PM EST
Analysis of Innovation in Merger Investigations
This program will discuss analysis of innovation in merger investigations, focusing on the FTC’s recent investigation of Pfizer Inc.’s acquisition of Wyeth.
- Program Flyer
- Program Materials: The Economics of Innovation Markets (Maness)
- Program Materials: The Role of Counsel (Stempel)
- Program Audio
Date: Wednesday, May 12, 2010 • 12:00 PM - 01:30 PM EST
Privacy and Data Security Relating to Medical Records
This program will discuss trends in the regulation, enforcement, and litigation of privacy and data security issues relating to individuals’ medical records. Specifically, it will provide an overview of how the privacy and security of medical records are regulated in the United States, discuss recent investigations and enforcement undertaken by the Department of Health and Human Services and the Federal Trade Commission, and provide guidance to health care providers on how to avoid litigation and liability in connection with their treatment of medical records.
Date: Monday, January 25, 2010 1:00pm - 2:30pm EST
The Interface of Antitrust and Intellectual Property: Examples Drawn From Pharmaceutical Life Cycle Management Strategies (Brown Bag)
Patent holders have developed a variety of strategies to respond to entry that may follow the expiration of their patents. "Line extensions," obtaining additional patents on existing products, and the introduction of "authorized generics" are illustrative strategies used by pharmaceutical patent holders. Strategic responses to threatened entry raise policy issues for both antitrust and intellectual law. For example, under what circumstances are the patents associated with line extensions sufficiently novel to be valid? Do these strategies harm consumers by deterring entry or do they lead to improved products and/or lower prices? In the case of pharmaceuticals, the FTC and courts have been grappling with these policy issues. The FTC's recently released Authorized Generics: An Interim Report and complaints that argue that line extensions may be part of an anticompetitive strategy, such as FTC v. Watson Pharmaceuticals and Abbott Laboratories v. Teva Pharmaceuticals, are illustrative. A panel of experts will discuss these issues, drawing from recent cases, the FTC's recent report, and economic research to discuss these policy issues.
- Presentation Materials - Albert
- Presentation Materials - Burling
- Presentation Materials - Shadowen, Leffler, Lukens
Date: Wednesday, October 28, 2009 12:00pm - 1:30pm EST
Essential Antitrust Concepts for the Changing Healthcare Landscape
As the healthcare reform debate continues to evolve, provider collaboration and consolidation strategies may collide head-on with increasing antitrust enforcement aimed at preserving competition. At this critical time, both new and seasoned healthcare attorneys and new antitrust practitioners can benefit from understanding the core antitrust concepts and how they apply to the healthcare industry. The presenters, a government prosecutor and an active private practitioner, will provide an overview of the antitrust statutes, case law, and enforcement-agency guidance affecting health care providers and payors. The discussion will cover important issues in physician price-fixing, pharmaceutical “pay to delay” settlement cases, HSR filing, and hospital mergers, as well as the speakers' thoughts on the impact of health care reform legislation on antitrust enforcement and compliance.
Date: Thursday, October 1, 2009 12pm - 1:30pm EST
Hot Pharmaceutical Topics in Antitrust
This brown bag program will provide an overview of hot pharmaceutical topics in antitrust, including proposed legislation regarding reverse-payment patent settlements between branded and generic drug manufacturers, the FTC's report on follow-on biologic drug competition, the FTC's interim report on authorized generics, and the FTC's current enforcement priorities in the pharmaceutical industry.
Date: Monday, September 21, 2009 12:30 - 1:30 p.m. EST
Recent Developments in Pharmaceutical Marketing Enforcement & Litigation
This telephonic brown bag program will provide updates in areas top of mind to pharmaceutical manufacturers, marketers, and lawyers, including FDA enforcement priorities and litigation developments and trends. The presentation will include an overview of the updates to PhRMA's self-regulatory Direct-to-Consumer (DTC) Guiding Principles, a discussion of the FDA's requirements for pharmaceutical promotions and the agency's recent enforcement activities including its focus on Internet marketing, and the use of DDMAC warning letters as evidence in private litigation. The panel will also delve into lessons learned from Lanham Act false advertising cases involving prescription pharmaceutical products including best practices for surveying doctors who have been detailed, navigating the issue of FDA primary jurisdiction and using FDA principles effectively in Lanham Act cases, and avoiding the typical traps regarding downplaying safety, hyping efficacy and making faulty comparisons.
Date: Monday, September 14, 2009 12 - 1:30 p.m. EST
The Latest Patent Settlement Cases, Solvay and Cephalon
The Federal Trade Commission recently filed a lawsuit in the central district of California against Solvay, Watson, Par and Paddock arising out of patent settlement agreements, and private companion lawsuits were filed shortly afterward.
Date: Tuesday, April 28, 2009 12:00 – 1:30 (EST)
Health-Care Mergers And Collaboration: Is Enforcement Keeping Pace With A Changing Sector?
Over the last decade, there has been continued M&A activity among health plans and joint ventures among providers. Most recently, United Healthcare acquired Sierra Health, resulting in a DOJ consent order, and the FTC is re-examining its policy on provider collaboration. What forms of relief are sufficient to protect competition in these matters? What trends are likely to emerge regarding M&A activity and enforcement in these markets under a new administration? This panel will address these questions and consider the antitrust implications of proposals to reform health care.
Date: Spring Meetings, Wednesday, March 25, 2009 3:45pm - 5:15pm
Highmark/IBC Merger Challenge -- A New Paradigm for Health Insurance Mergers?
Highmark, the dominant Blue Cross insurer in western Pennsylvania, sought to acquire its eastern Pennsylvania rival -- Independence Blue Cross...This was the first merger that was dropped in the face of a challenge by a state insurance commissioner and this panel will discuss what the Insurance Commissioner's decision means for future insurance mergers.
Date: March 2, 2009
The Use of Price Effects Evidence in Consummated Merger Analysis
Evidence of post-merger price increases has become an important aspect of investigations and litigation regarding the consummated mergers that are increasingly coming under the scrutiny of the Federal Trade Commission (FTC) and the Department of Justice (DOJ).
Date: February 26, 2009
Practicing Law in A Dynamic Environment: The Case of Biologics
Program US and EU competition and regulatory policy related to biologics. In particular, there are ongoing regulatory changes in both the US and Europe related to the approval of bio-similar/generic biologics. This ongoing change in different areas raises issues for antitrust counsel who must advise multi-national companies.
Date: February 19, 2009
Recent Developments in Dietary Supplement Regulation, Enforcement & Litigation
This telephonic brown bag program will provide updates in areas top of mind to dietary supplement manufacturers, marketers, and lawyers, including regulatory changes, FTC and FDA enforcement priorities, and litigation developments and trends.
Date: January 16, 2009
The Average Wholesale Price Litigation: A Report From The Front Lines
A panel of lawyers and economists that are participating in the ongoing litigation will discuss these cases. In particular, they will outline the economic and legal theories that underlie these cases and describe how the litigation is proceeding, with an eye to providing insights into the challenges that confront a litigation team that is handling a complex case which has related cases that are proceeding simultaneously in other courts.
Date: December 3, 2008
Patent Misuse and Abuse in the US and Europe: The Case of Pharmaceuticals
A diverse panel of leading antitrust experts will review cases and governmental investigations of alleged anticompetitive patenting behavior in the U.S. and Europe to identify policy issues that may arise in an increasingly global economy and that should be considered when counseling multinational clients.
Date: November 20, 2008
Biologics: Balancing Competition and Innovation—The Next Act
This program will explore the issues confronting regulators, Congress and the brand and generic sides of the biopharmaceutical industry as efforts are made to facilitate competition in this critical sector of the economy.
Date: November 06, 2008
Is There Convergence of Health Care Competition Policy in the US and Europe?
This program will identify areas where there is convergence and where there is divergence in the healthcare competition policies in the US and Europe, with a particular focus on hospital mergers, medical insurance mergers, and the provision of medical services.
Date: October 28, 2008
An Autopsy of the FTC's Challenge to the Inova Deal
This program will focus on the FTC's recent challenge to Inova Health's attempted purchase of Prince William Health System and what it means for FTC merger litigation.
Date: July 22, 2008
FTC v. Cephalon Case
A panel of antitrust experts will closely examine the FTC’s case challenging Cephalon’s patent settlements regarding Provigil. The panel will provide insights into how the Commission's factual allegations, approach under Section 2 monopolization principles, and filing in federal district court differ from prior patent settlement cases and how lawyers can effectively counsel clients in this area.
Date: June 23, 2008
Merger Remedies: Lessons from the Evanston Hospital Decision
Spring Meeting Program sponsored by Health Care and Pharmaceuticals Committee at the JW Marriott Hotel, Washington, DC.
Date: March 26-28, 2008
Pharmaceutical Cases: Tackling Product Market Definition Issues
A panel of antitrust experts will explore the unique challenges posed in determining product market definitions in pharmaceutical cases. The panel will examine current and past product market definitions in pharmaceutical matters and discuss practical approaches for addressing product market issues before the FTC or courts.
Date: March 5, 2008
Implications for Merger Analysis from the Evanston Decision
A panel of experts in antitrust and health law will analyze the Federal Trade Commission's recent unanimous decision to find unlawful a consummated hospital merger in Evanston Northwestern Healthcare, discuss the major holdings and predict how the decision may affect challenges to unconsummated transactions in the future.
Date: Thursday, September 27th, 2007
Time: 12:00pm-1:30pm EST
US and EU Pharmaceutical Antitrust: Counseling clients facing different regulatory systems
Thursday, October 25, 2007
This Teleseminar will review how the US and EU pharmaceutical regulatory systems differ, and how those differences may affect pharmaceutical antitrust enforcement. In particular, a panel of experts will consider both the treatment of branded/generic settlements and the analysis of alleged patent abuse by US and EU antitrust authorities to identify similarities, differences, and trends in enforcement policies. Recent or ongoing cases, such as AstraZeneca v. European Commission and Abbott Labs et al. v. Teva Pharma. et al (TriCor), will be considered.
Phone: 800.285.2221 and Select Option “2”, M-F, 8:30 AM - 6:30 PM Eastern
Online at www.abanet.org/cle/programs/t07use1.html
Event Code: CET7USE; Source Code: TCE7FUSE1
Physician Ownership of Hospitals and Other Health Facilities: Antitrust and Policy Issues
Thursday, October 25, 2007
Center for Health Law Studies
Saint Louis University School of Law
3700 Lindell Blvd. St. Louis, MO 63108
Co-Sponsored by American Bar Association Section of Antitrust Law and the Saint Louis Area Health Lawyers Association.
Economic Fundamentals of Health Care Antitrust (November 08, 2007)
Balancing Competition and Government Allocation of Health Care Resources: The Berger Commission Report
On September 20, 2007, our Committee and the Brooklyn Law School Center for Health, Science and Public Policy are presenting a program, "Balancing Competition and Government Allocation of Health Care Resources: The Berger Commission Report." The Berger Commission recommended the closure of 9 hospitals and reconfiguration of some forty-eight other hospitals in New York State. This program will explore the interaction between the Berger Commission policy decision intended to balance cost, quality and utilization and competition policy goals reflected in and protected by the antitrust laws. While the program is free, please do rsvp if you plan to attend. The program is scheduled for 9 a.m. to 12:30 p.m., with lunch to follow. You may also view a live web cast of the program by going to www.brooklaw.edu and clicking on the link to the live event.
Antitrust in Healthcare Conference
Co-sponsored with American Bar Association's Health Law Section and Section of Antitrust Law
September 17-18, 2007
Westin Washington, DC
City Center Hotel
Antitrust Basics Teleconference Series: Healthcare
July 11, 2007 12:30-1:30 ET
Presenter: Christine White Moderator: Albert Kim
Sponsored by the Antitrust Section's Young Lawyer's Division and the NY State Bar Association and State Enforcers.
"Dial in information and registration materials will be posted when they are available."
Spotlight on Ancillary Restraints in Clinically Integrated Provider Networks
June 19, 2007
Location: Hogan & Hartson DC
Format: Brown Bag
2007 Spring Meeting - April 19, 2007
Buying At Low Prices Can Violate the Antitrust Laws: Monopsony Lessons from Healthcare Antitrust Cases
Brown Bag: March 27, 2007
Can "New and Improved" Be Bad for Consumers?
Brown Bag: February 28, 2007
Clinical Integration: Where We Are & Where We're Going
Brown Bag: December 12, 2006
Cert Denial in FTC v. Shering: The Legislative and Enforcement Aftermath
Antitrust Heathcare Conference May 12 - 13, 2005
Co-sponsored with the ABA Health Law Section and the American Health Lawyers Association, this conference provides the most comprehensive review of antitrust developments in the health care industry. It will feature experienced practitioners and senior agency officials and will cover such topics as the FTC challenge to the Evanston hospital merger, the latest on clinical integration, health plan mergers, the clash between hospitals and specialty providers, antitrust issues raised by GPOs and PBMs, and the latest developments in the agency enforcement actions involving patent settlements in the pharmaceutical industry.