Mayer Brown represents health care organizations in criminal and civil litigation including complex trial work, appellate and Supreme Court matters.
Our health care litigation experience includes:
- Defense of complex class action or nationwide litigation against pharmaceutical companies and other health care providers, including toxic torts, medical device products liability, antitrust, RICO, consumer fraud and deceptive trade practices; alleged violations of federal and state food and drug laws; state attorneys general matters; and securities fraud cases.
- Major experience in matters involving complex health insurance reimbursement and payment provisions governing insurers, third-party administrators, benefits managers, the federal and state governments and ERISA-related health care matters.
- Defense of civil and criminal investigations and qui tam, false claims and fraud litigation involving the United States Department of Justice, the Food and Drug Administration (FDA), the FDA's Office of Criminal Investigations and the United States Department of Health and Human Services' (HHS) Office of Inspector General (OIG), as well as corporate compliance plans and strategies consistent with United States Sentencing Commission Guidelines.
- Intellectual property litigation.
- Civil and criminal antitrust and trade regulation investigations and litigation, including price fixing cases, major class action litigation, hospital group purchasing alliance claims, credentialing litigation and mergers and acquisitions.
- State attorneys general's investigations and litigation.
- Significant appellate and Supreme Court work in the United States for health care, biotech, pharma and life science companies in drug law matters, toxic torts, antitrust, qui tam, RICO and ERISA.
- Administrative challenges and other health care regulatory litigation.
- Insurance coverage program advice, claims handling and complex litigation involving toxic torts, professional services liability, general liability, directors' and officers' liability, employee dishonesty claims and other overall insurance program matters from establishing and maintaining self-insurance trusts, offshore captive insurers and reinsurance arrangements to placement and implementation of direct commercial insurance programs.
- International arbitration.
Mayer Brown has a broad base of experience in its healthcare controversy practice, including:
- Administrative Challenges & Other Health Care Regulatory Litigation
- Appellate & Supreme Court Matters
- Civil and Criminal Antitrust and Trade Regulation Investigations & Litigation
- Civil and Criminal Investigations and Qui Tam, False Claims and Fraud Litigation Involving the United States Department of Justice, FDA, HHS OIG, CMS (formerly HCFA) and FEHBP
- Complex Class Action or Nationwide Litigation
- Health Insurance Reimbursement, Payment & ERISA Expertise
- Insurance Coverage Litigation, Claims Handling & Program Advice
- Intellectual Property Litigation
- State Attorneys General's Investigations & Litigation
Administrative Challenges & Other Health Care Regulatory Litigation
- Orthofix Jury Award. We obtained a $150 million damages verdict on behalf of three affiliate companies of our client, Orthofix International N.V. A federal court jury found that a former United States distributor of Orthofix, EBI Medical Systems, Inc., and its parent companies, Electro-Biology Inc. and Biomet, Inc., were liable for breach of contract, tortious interference, passing off, defamation and unfair competition in their dealings with Orthofix. The jury awarded over $48 million in compensatory damages and an additional $100 million in punitive damages.
- State of Illinois Permanently Enjoined From Enforcing Pharmaceutical Advertising Statute. We represented Knoll Pharmaceutical Company in a temporary restraining order and permanent injunction suit in federal district court challenging on constitutional grounds a State of Illinois statute prohibiting the advertisement of certain controlled substances. We won a permanent injunction, thereby permitting the client to move forward on a nationwide advertising campaign for its weight loss drug Meridia®.
- Ventricle Device Litigation. We represent Thermo Cardiosystems in litigation involving the preemption of state law claims by the Medical Device Amendments to the federal Food, Drug and Cosmetic Act.
- Illinois Technical Advisory Council. We represent a large pharmaceutical manufacturer, the maker of one of the most widely prescribed medications, in a lawsuit challenging the Illinois Department of Public Health's (IDPH) placement of our client's drug and one of its competitor's drugs on the Illinois formulary, thereby allowing pharmacists to interchange one product for another (without physician consent or knowledge) where FDA bio-equivalency of the drugs has not been established. We have been successful in obtaining a stay of IDPH's actions pending judicial review, raising regulatory, statutory and constitutional claims.
- Illinois Health Facilities Planning Board Challenges. We represent a number of nursing homes, hospitals and the Illinois Hospitals and Health Care Association in matters challenging the Illinois Health Facilities Planning Board's authority to grant certificates of need and exemptions for nursing homes and hospital systems in Illinois.
- Peer Review Challenge. We represented a Peer Review Organization in lawsuits by physicians alleging improper peer review and sanctions. We prevailed each time based on absolute immunity and also won on appeal.
- Utilization Review Litigation. We represent a utilization review company in a claim alleging improper utilization review practices.
- HIV Testing Without Consent. We represented Alexian Brothers Health System, Inc. in a suit brought by the American Civil Liberties Union alleging that a physician had tested a patient for HIV without consent in violation of the Illinois AIDS Confidentiality Act and federal law.
- Cardiac Surgery Group. We represent a cardiac surgery group in litigation against a hospital to maintain the group's status as the hospital's cardiac surgery group.
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Appellate & Supreme Court Matters
- "Fraud on the FDA" Claims Ruling. We represent Buckman Corporation in a United States Supreme Court case reviewing whether federal medical device law bars state tort claims that a company made fraudulent representations to the FDA while seeking marketing clearance for orthopedic screw systems.
- Medicare/Medicaid Termination Dispute. We assisted in the resolution of a hospital's appeal concerning termination of the hospital's participation in the Medicare and Medicaid programs by the United States Department of Health and Human Services.
- Pharmacy Provider Network. We represented U.S. Health Care in the appeal from a jury verdict finding that U.S. Health Care had violated antitrust law, RICO and state tort law by conditioning a pharmacy's participation in its provider network on the pharmacy's offer of U.S.
- Health Care benefits to its employees. The Third Circuit reversed the antitrust and RICO verdicts and directed entry of judgment in our client's favor. The appellate court also reversed the tort verdict for a new trial. On remand, U.S. Health Care (represented by non-Mayer Brown trial counsel) was again found liable in tort and we have again been retained to work on the appeal.
- HMO ERISA Preemption. We were retained following an adverse decision in the Supreme Court of Pennsylvania to petition the United States Supreme Court for certiorari on the question of whether ERISA preempts malpractice claims against HMOs based on their coverage determinations.
- Red Cross Charter. We briefed and won in the Supreme Court a case for the American National Red Cross, which concerned the question of whether the Red Cross's charter confers jurisdiction on the federal courts in all cases in which the Red Cross is a party.
- Workers' Compensation. In a recent case involving the insurance industry and payments to health care providers, we successfully argued to the United States Supreme Court to overturn a Third Circuit ruling that private insurance companies become state actors where the companies withhold payments to health care providers for care provided to injured workers while disputes over the reasonableness or necessity of the care are resolved and further that the suspension of payments to the health care providers (as well as the notice and opportunity to be heard concerning the suspension provided to affected workers) did not violate due process.
- Durable Medical Equipment. We represented Medtronic, Inc. in two Supreme Court merits cases--one involving the scope of preemption under the Medical Device Amendments to the Food, Drug and Cosmetic Act and the other a medical device patent dispute. We also have worked for Medtronic on FDA rulemaking and interpretation of the Medical Device Amendments preemption provision.
- Major Hospital System Reimbursement Payments. We represented a major hospital system in the appeal of a judgment requiring reimbursement payments for medical care.
- American Hospital Association Amicus Brief. We were retained by the American Hospital Association to file an amicus curiae brief in the United States Supreme Court in support of a certiorari petition filed by several hospitals concerning the validity of the method used by the Secretary of HHS to compute the reimbursement due teaching hospitals for Graduate Medical Education costs attributable to Medicare services.
- Hospital Surcharge Preemption. We assisted the Health Insurance Association of America in the briefing and argument of a United States Supreme Court ERISA case concerning whether a New York law imposing surcharges on the rates hospitals charge, depending on whether the charges are paid by commercial insurers, HMOs or other payors, is preempted by ERISA.
- Brand Name Prescription Drugs Antitrust Litigation. We assisted Abbott Laboratories in preparing a petition for a writ of certiorari to the United States Supreme Court in the Brand Name Prescription Drugs Antitrust Litigation.
Civil and Criminal Antitrust and Trade Regulation Investigations & Litigation
- VHA, Inc. Civil Antitrust Act. We represent VHA, Inc. in a civil antitrust action alleging exclusive dealing involving the purchase of needles, syringes and blood collection devices.
- Vitamin Antitrust Criminal Investigation. We represent Lonza AG and Lonza Inc. in connection with the United States Department of Justice's criminal investigation of price fixing in the vitamin industry, as well as the related civil cases brought by both direct and indirect purchasers of vitamin products. (See Complex Class Action or Nationwide Litigation Section.)
- United States Pharmaceutical Company Antitrust Investigation. We represented a pharmaceutical company in connection with a federal antitrust investigation of a settlement of patent litigation.
- VHA, Inc. Hospital Purchasing Alliance. We successfully represented VHA, Inc., one of the nation's largest hospital group purchasing alliances, against an exclusive dealing claim brought by a wholesale pharmaceuticals distributor. The plaintiff alleged that it had been improperly foreclosed from distributing pharmaceuticals to VHA hospitals in New England.
- Germany-based Dental Company Unfair Competition and Antitrust Matter. We represent a Germany-based major dental company in the areas of unfair competition, trademark litigation and the law of medical devices. The client is one of the market leaders in the area of dental products in Germany and other countries of the European Union and is active in the United States as well.
- Health Care Merger Activities. We have been involved in a number of major health care mergers, including Aetna's successive acquisitions of United States Health Care, New York Life Insurance's health care business and Aetna's recent acquisition of Prudential's health care business; Marion Merrell Dow/Hoescht AG; the merger of hospital systems in Rochester, New York and Savannah, Georgia; and several pharmaceutical company mergers. The Aetna/Prudential merger is the largest merger in history in terms of health plan enrollees (21 million). The $1 billion deal was completed after a lengthy investigation by the United States Department of Justice and several state attorneys general. In our representation of Aetna, we developed various presentations and white papers, which were presented to the government and resulted in a consent decree under which Aetna divested subsidiaries in Dallas and Houston, thereby permitting Aetna to succeed in acquiring Prudential.
Civil and Criminal Investigations and Qui Tam, False Claims and Fraud Litigation Involving the United States Department of Justice, FDA, HHS OIG, CMS (formerly HCFA) and FEHBP
- Health Care Service Corporation/Blue Cross Blue Shield of Illinois Criminal Verdict. We represented the lead individual criminal defendant in the twelve-week federal jury trial alleging criminal conspiracy and fraud for false reporting of Medicare claims processing statistics by Blue Cross and Blue Shield of Illinois. Our client and the other three individual defendants were acquitted of all charges. The charges arose from the government's investigation of a qui tam suit.
- Qui Tam Litigation Involving Plasma Testing. We have represented Baxter Health Care in a significant qui tam action brought under the False Claims Act, alleging that Baxter falsely represented the adequacy and effectiveness of its testing of plasma used to manufacture plasma derivatives. The plaintiff also alleged that she was fired in retaliation for bringing her qui tam action. Following full discovery, our motion for summary judgment was granted on all counts and the district court's summary judgment ruling was upheld in all respects by the United States Court of Appeals for the Seventh Circuit.
- Pharmaceutical Company Investigation. We represented a major pharmaceutical company in an investigation regarding alleged violations of the FDA product approval requirements.
- Medical Device FDA Criminal Investigation and Civil Forfeiture. We represented a medical device manufacturer in an investigation by the FDA Office of Criminal Investigations and a related civil forfeiture matter involving claims under the federal Food, Drug and Cosmetic Act.
- Corporate Compliance Program. We are assisting a major pharmaceutical and health care products company to develop a comprehensive corporate compliance program to address the major sales and marketing and government pricing risk areas identified by the HHS Office of the Inspector General.
- Criminal Audit Inquiry. We represented all "non-target" employees of a hospital in a criminal inquiry concerning a federal Medicare audit.
- Pharmaceutical Company Grand Jury and United States Department of Justice Investigation. We represented a major pharmaceutical company in connection with a grand jury and United States Department of Justice investigation concerning Medicare reimbursement issues.
- Clinical Laboratory Criminal Inquiry. We represented an officer of a clinical laboratory in a lengthy federal criminal inquiry regarding the lab's Medicare billings submissions.
- Community Health Systems Investigation. We represented a large number of employees in a United States Department of Justice investigation of a community health systems provider.
- Substance Abuse Programs. We represented a regional substance abuse and related services provider in investigations by two federal grand juries regarding the provision of and billing for federally funded substance abuse and related programs.
- Federal Health Insurance Program Case. We represent CareFirst Blue Cross/Blue Shield in a qui tam case joined in part by the United States Government alleging failure to give credits to the federal government under the Federal Employees Health Benefits Program ("FEHBP").
- Federal Anti-Boycott Law Investigation. We represented Baxter International in connection with an investigation by the United States Commerce Department and the United States Attorney's Office concerning alleged violations of the federal Anti-Boycott Act.
- Medicare Qui Tam Litigation Involving Laboratory Claims. We represent Regence Blue Cross/Blue Shield of Utah in a qui tam suit alleging that Regence violated the False Claims Act by paying Medicare claims submitted by a large national laboratory with non-specific diagnostic codes and other alleged documentation deficiencies.
- Major Insurer Matter Under Seal. We are handling a large and complex False Claims Act qui tam case that has been brought against a major insurer, which remains under seal and thus inactive until the United States Department of Justice determines whether to take over the case or let the qui tam plaintiffs pursue it.
- Medicare Qui Tam Suit. We represent Aetna in a federal district court action filed by a private relator alleging the filing of false claims for federal reimbursement for certain health care services.
Complex Class Action or Nationwide Litigation
- Dow Chemical Silicone Breast Implant Litigation. We served as national coordinating counsel for The Dow Chemical Corporation in the silicone breast implant litigation. As part of this work, we coordinate with the top medical experts in the country in a wide variety of disciplines, including medical toxicology and immunology. We also have developed considerable experience in immunological and serological test issues. Our experience in complex litigation has been invaluable in formulating motion and trial strategies, which wedded creative legal theories to the evolving facts and preserved critical legal issues for appellate review. We also provided advice on bankruptcy and insurance issues in connection with the litigation.
- BASF Vitamins Antitrust Litigation. We are national trial counsel for BASF Corporation in a large number of lawsuits alleging a conspiracy among vitamin manufacturers to fix prices, allocate markets and engage in other practices in violation of the Sherman Act and the antitrust, consumer protection and/or common laws of the various states. There are over 50 federal cases and over 75 state cases, most of which purport to be class actions on behalf of "direct purchasers" and "indirect purchasers" of vitamin products from BASF Corporation and other co-defendants. The plaintiffs claim entitlement to well over a billion dollars in damages in these lawsuits, which have received substantial publicity as a result of a United States Department of Justice investigation into alleged antitrust violations in the vitamin manufacturing business. The federal cases have been consolidated in the United States District Court for the District of Columbia under the Rules of the Judicial Panel on Multidistrict Litigation (MDL) and the state cases are being litigated in a coordinated fashion.
- Synthroid® Marketing Litigation. We represent BASF Corporation and its subsidiary Knoll Pharmaceutical Company in the Synthroid® Marketing Litigation, consumer and third-party payor class actions alleging consumer fraud and deceptive trade practices, antitrust, state and federal food and drug law issues, RICO and fraud claims. The state attorneys general asserted similar claims. The federal cases have been consolidated in a Multidistrict Litigation (MDL) proceeding in the United States District Court for the Northern District of Illinois, with over 25 state and Canadian court cases also pending. A favorable consumer and third-party payor settlement has been approved, with the state court cases stayed. We also negotiated a favorable resolution with a consortium of 37 state attorneys general.
- Lonza Vitamins Antitrust Litigation. We represented Lonza AG and Lonza Inc. as national trial counsel in connection with approximately 125 antitrust cases filed in federal and state courts around the country and arising out of the United States Department of Justice's criminal investigation of price fixing in the vitamin industry. The federal cases were consolidated in the United States District Court for the District of Columbia. In addition to the typical United States antitrust issues, these cases raised numerous questions of international significance under treaties, such as the Hague Convention, as well as various foreign antitrust and privacy laws. We also represented Lonza in connection with the government investigation.
- U.S. Bioscience Class Action. We successfully defended U.S. Bioscience in a class action.
- Psychiatric Services Class Action. We represent former officers of National Medical Enterprises in a class action suit alleging fraudulent conduct regarding the provision of psychiatric services.
- Nursing Home Class Actions. We represented Vencor's captive insurer on coverage matters involving an attempted nationwide class action of nursing home residents and a group of Chicago area nursing homes in their coverage litigation after residents were certified as a class for alleged claims involving medications, billing and scope of disclosure issues.
- Large Pharma Company Litigation. We represent a large pharmaceutical client in a number of litigation matters arising from regulatory compliance, marketing and sale initiatives and product liability issues.
- IMS Health Class Action. We represent IMS Health in a class action brought by independent pharmacies.
- Baxter Securities Fraud Class Action. We successfully represented Baxter in Isquith v. Baxter, et al., a federal securities fraud class action arising from an alleged kickback and Medicare fraud scandal at Baxter's former subsidiary, Caremark International. We obtained dismissal of this lawsuit in the trial court, which was affirmed on appeal in a widely covered opinion by then Chief Judge Posner of the Seventh Circuit Court of Appeals. We also successfully defended a shareholder derivative action in state court arising from the same underlying facts.
- Baxter Hemophiliac Litigation. We were retained as stand-by trial counsel for a series of cases filed against Baxter and other fractionator defendants by hemophiliacs who contracted AIDS following the use of factor concentrates in the 1970s and 1980s. As a result of this work, we have developed an extensive working knowledge not only of AIDS and HIV, but also hepatitis and other diseases that arguably could be transmitted by blood products.
- Workers' Compensation Subrogation Class Action. We are defending the Fremont Group from an attempted class action of all workers' compensation beneficiaries who had their third-party recoveries adjusted for statutory subrogation amounts, including disputes over whether various sums were expenditures for rehabilitation or administrative purposes.
Health Insurance Reimbursement, Payment & ERISA Expertise
- Synthroid® Third-Party Payor (TPP) Claims Expertise. As part of the global third-party payor (TPP) settlement of the Synthroid® Marketing Litigation (see Complex Class Action or Nationwide Litigation Section), based upon our health insurance reimbursement and payment expertise, we structured a streamlined yet effective claims process for TPPs and self-funded plans for the first-ever nationally certified class of TPPs. We also analyzed and have significant expertise in Medicaid payment structures, which enabled us effectively to resolve state attorneys general's claims.
- Breast Implant Litigation Insurance Reimbursement Issues. As part of the Dow silicone breast implant litigation, we reviewed and analyzed complex health insurance payment issues, including subrogation, reimbursement and indemnification.
- Workers' Compensation. We handled the 1999 Supreme Court appeal involving the administration of the Pennsylvania workers' compensation program, eight private insurance companies that write workers' compensation policies and various self-insured employers. (See Appellate & Supreme Court Matters Section.)
- Medicare and Medicaid Reimbursement. We successfully represented a subsidiary of HealthSouth in the trial a civil case concerning the purchase of a healthcare services company. The case centered around the issue of whether the seller had engaged in fraudulent Medicare and Medicaid billing practices, thus causing a significant loss in revenue for several years.
Insurance Coverage Litigation, Claims Handling & Program Advice
- Toxic Shock Trial. We conducted the federal court litigation, including the six-week jury trial, over coverage for toxic shock syndrome claims involving Procter & Gamble's product, Rely.
- Cornerstone Arbitration. We represent Cornerstone Insurance Company, the captive insurer of Vencor, Inc., in an arbitration of coverage disputes involving, among other things, one of Florida's largest nursing home jury verdicts.
- Whitehall Convalescent Litigation. We represent Whitehall Convalescent, affiliated companies and an individual officer in a coverage dispute over a certified class action that involves furnishing of medications, billings and disclosure claims.
- Directors' and Officers' Liability. We represent hospital and surgical foundations on their coverage claims for suits against the company and certain officers and directors after business transactions have gone awry or affiliations with physicians were terminated. We also have advised on such coverages following government investigations and premises searches of medical equipment manufacturers.
- Program Advice. We advise for-profit and not-for-profit foundations, medical associations, hospitals, nursing care groups, utilization review firms, product manufacturers and other health care companies on all aspects of their insurance programs and claims handling, including self-insurance, captive insurer issues and direct commercial coverage placement.
- Dow Chemical Silicone Breast Implant Coverage. We represented Dow Chemical in the insurance coverage issues and litigation concerning the silicone breast implant cases.
- Hospital Supply Company. We serve as principal counsel to the risk management group of one of the world's largest hospital supply companies.
- Subrogation Rights Counseling. We have provided advice to numerous health insurer clients regarding subrogation rights and related issues.
Intellectual Property Litigation
- Abbott Laboratories Patent Trial. We defended Abbott in a 14-week jury trial of a complex patent case involving a pharmaceutical composition used for the treatment of neonatal respiratory distress syndrome. Despite adverse patent claim construction rulings by the court prior to trial, we won the jury trial on all counts.
- Fresenius AG Patent Protection and Litigation. In 2001, we served as counsel to Fresenius AG in patent protection and litigation before the German Federal Supreme Court in appeal proceedings regarding a European patent of a major Japanese competitor. The patent claimed protection for a blood filter for removing leukocytes by making use of fibers of a very small diameter packed in a filter in the form of a non-woven fabric. We won the trial on all counts before the German Federal Supreme Court.
- Generic Manufacturer Patent Action and FDA Generic Use Challenge. We represented Novartis AG and Novartis Pharma AG in a patent infringement and antitrust action concerning Neoral, an immunosuppressant used by transplant recipients, against a generic drug manufacturer.
- Peer Review Organization Copyright. We represented a Peer Review Organization in copyright litigation involving a regulatory compliance manual.
- United States Blood Pressure Device Patent. We represented Omron Management Center of America, Inc. in connection with the alleged infringement of a blood pressure device patent.
- Alpha Hydroxy Patent Litigation. We represented Tristrata Technology, Inc. in litigation against infringers of alpha hydroxy patents.
- Orthofix Trademark Litigation. We represent Orthofix in breach of contract and Lanham Act trademark claims involving extended fixation devices.
State Attorneys General's Investigations & Litigation
- Synthroid® Matter. We represented Knoll Pharmaceutical Company and BASF Corporation in an attorneys general matter involving Synthroid®, a thyroid prescription drug, which raised federal and state legal and regulatory issues. We successfully resolved the matter with a large consortium of attorneys general through an Executive Committee structure and also negotiated several separate settlements with individual attorneys general.
- Nestlé U.S.A. We represented Nestlé U.S.A. in connection with a multistate attorneys general investigation as to the marketing and sale of a Nestlé product under applicable sections of the federal Food, Drug and Cosmetic Act.
- Confidential Attorneys General Matters. We have represented a number of companies in confidential attorneys general matters involving consumer fraud and state and federal health care laws and regulations.
The following companies are representative of those that have entrusted their healthcare related controversy work to Mayer Brown:
- Dow Chemical Corporation
- BASF Corporation
- Lonza AG
- Lonza Inc.
- Baxter Health Care
- Fresenius AG
- Abbott Laboratories
- Novartis AG
- VHA, Inc.