Practice/Industry Group Overview
Our considerable knowledge of the healthcare industry is the cornerstone of Duane Morris' healthcare industry litigation practice. Our lawyers support their clients in courts, arbitration, mediation and administrative proceedings by combining in-depth experience in healthcare matters with litigation skills developed in trials and hearings, as well as responding to government investigations and negotiating settlements. We provide comprehensive litigation services for any disputed matter, and strive to achieve the results for our clients that make sense in the context of the industry and the client's role in the healthcare environment.
Our healthcare litigation teams serve two distinct aspects of the healthcare industry. The first is healthcare providers, including doctors, hospitals and health systems, long-term care facilities, home health agencies, ancillary service providers, laboratories, pharmacies, free-standing ancillary and surgery facilities, information technology and other medical suppliers, healthcare consultants, medical and industry associations, and non-profit foundations. The other is pharmaceutical and medical device companies, including manufacturers, distributors, purchasing cooperatives, biotechnology companies and other vendors.
Range of Litigation Services for Healthcare Providers
Healthcare Fraud and Abuse. We defend healthcare providers across the nation in government or qui tam actions brought under the federal anti-kickback statute, Stark self-referral regulations, False Claims Act and similar state laws. On occasion, these types of claims also encompass RICO and SEC allegations to be defended. These engagements may begin with an internal compliance audit, a governmental audit or investigation, a third party payor audit or investigation, the filing of a lawsuit or upon receipt of subpoena from the Office of Inspector General, Department of Justice or state Attorney General. In defense of these matters, we understand the potentially devastating impact these claims can have on a provider and make use of our strong industry knowledge as well as our past experience with the government regulators who may be pursuing the claims.
Healthcare Fraud and Abuse Representative Matters
Professional Arrangements. Our lawyers represent physicians, nurses and other healthcare professionals and hospitals in disputes regarding staff privileges, misconduct, credentialing (including economic credentialing), employment, contractual arrangements, compensation and problems arising from partnerships and joint ventures. These matters typically involve complex ongoing relationships requiring firm but sophisticated handling of the issue in dispute to seek a creative solution. Our healthcare litigation team also includes employment and benefits litigators experienced in addressing claims of discrimination, ERISA violations and wrongful termination.
Professional Arrangements Representative Matters
Reimbursement and Managed Care. Healthcare providers denied reimbursement by federal healthcare programs or private payers turn to our lawyers to assist them in enforcing their rights. Managed care disputes often involve nonmonetary challenges to medical necessity, site of service, and other complex factors involved in payment for healthcare services, making this type of litigation much more than a contract or collection matter. We represent clients pursuing these issues not only in courts, arbitration and mediation proceedings, but in administrative hearings, before the Provider Reimbursement Review Board, in carrier or intermediary fair hearings, and through managed care grievance processes.
Reimbursement and Managed Care Representative Matters
Antitrust and Competition. Antitrust and unfair competition lawsuits often arise between dominant payers or hospitals and physicians or competing systems vying with them for patients and managed care positioning. These cases can also involve contract breaches in business relationships and attempts to enforce non-competition covenants. Because these cases are heavily dependent on market analysis, our healthcare experience gives our lawyers a head start in analyzing and litigating antitrust and competition lawsuits in the heavily-regulated healthcare industry.
Antitrust and Competition Representative Matters
Business Reorganizations and Financial Restructuring. Our industry knowledge is fundamental to the representation of failing hospitals in bankruptcy matters. Healthcare bankruptcies also involve adversary proceedings in which bankruptcy trustees seek to increase the assets in the estate by gaining control of the assets of other healthcare entities who were contractors to, or venturers with, the debtor. Relations with government payers and continuing exposure to professional liability are also significant factors. We have represented a number of parties needing defense in such proceedings and others, such as creditors' committees, interested in resolving these specialized litigation disputes.
Business Reorganizations and Financial Restructuring Representative Matters
Patient Care and Research. Informed consent, right to treat, medical records and confidentiality, data breach response, professional liability for negligent patient care, human subject research protection, research misconduct, FDA warning letters and conflict of interest infractions are all healthcare litigation issues which our lawyers have handled. Unlike firms that handle only malpractice claims, our industry focus often enables our lawyers to develop creative lines of defense that might not otherwise be pursued and to handle matters that involve complex combinations of patient care or information issues.
Patient Care and Research Representative Matters
Administrative Practice. Because the healthcare industry is heavily regulated, healthcare matters often involve appearing before administrative agencies or taking their decisions to court. On the federal level, such proceedings often involve reimbursement issues, but also challenge regulatory changes and provider status decisions. Our lawyers also have experience in appeals of state certificate of need (CON) decisions, challenges to state regulations and adversarial presentations to state planning boards and administrative review panels.
Administrative Practice Representative Matters
Nonprofit Institution and Tax Issues. Hospitals and health systems face many challenges in maintaining and taking advantage of their nonprofit status, under both federal and state taxation systems. Our healthcare and tax litigators have broad experience in litigating property tax exemptions, community benefit demonstrations, private inurement and excess benefit issues, and in gaining approval for transactions with for-profit entities. Through our representation of charitable healthcare foundations, we have considerable experience in litigating their entitlement to distributions and defending them against creditors of prior entities. Our hospital clients have also found it productive to engage us to defend their right to contested testamentary bequests.
Nonprofit Institution and Tax Issues Representative Matters
Environmental, Energy and Construction Litigation. Our environmental and energy attorneys represent clients in litigation matters involving regulatory compliance and enforcement concerns. Environmental issues affect hospitals and other healthcare facilities in unique ways and we have litigated these complex regulatory issues before government agencies and state and federal courts. Energy litigation to oppose electricity and gas rate increases also makes use of our industry experience.
Duane Morris' national and regional construction practice involving virtually all real estate, construction and development matters has extensive experience in matters relating to healthcare facilities. We are experienced in the full range of litigation confronting hospitals, nursing, surgery and other facilities related to the purchase, sale, leasing, development, financing, condemnation, eminent domain, valuation and tax issues, and construction disputes associated with real estate development for healthcare purposes.
Environmental, Energy and Construction Litigation Representative Matters
Range of Litigation Services for Pharmaceutical and Medical Device Companies
Intellectual Property. Companies in the pharmaceutical and medical device sector of healthcare rely on intellectual property rights to define their business expectations. Our patent litigators are adept at explaining complex technical issues in a straightforward manner while communicating the healthcare significance of the issue. We handle patent litigation for companies of all sizes as well as individual physician inventors and start-up enterprises. We also are experienced in conducting interference proceedings before the U.S. Patent and Trademark Office.
Our attorneys handle multi-billion dollar, market-defining pharmaceutical patent litigations for global pharmaceutical manufacturers. Duane Morris' intellectual property litigation practice is distinct in that our attorneys have decades of experience in trying cases to verdict, including those in the chemical/pharmaceutical arts. Our clients benefit from this perspective and insight, which can only be gained from years of "on-the-ground" patent trial experience in virtually every major jurisdiction in the United States.
Intellectual Property Representative Matters
Sales and Distribution Issues. Current government scrutiny of referral relationships has made manufacturers' sales and distribution arrangements with hospitals and physicians the focus of more traditional anti-kickback and False Claims Act litigation. As with our defense of healthcare providers, we are aggressive in defending pharmaceutical and medical device clients from claims of kickbacks and improper financial relationships in the distribution chain. Our industry knowledge facilitates a comprehensive defense of allegations involving the provider-manufacturer relationship, including improper research support, off-label marketing, unlawful promotion, improper consultant agreements and intellectual property development ventures and royalty arrangements.
Sales and Distribution Issues Representative Matters
Products Liability. Manufacturers of pharmaceuticals and medical devices are exposed to claims that their product has injured groups of people for whom the product was prescribed, resulting in a single case to thousands of cases in multi-district litigation or class actions. Our lawyers have experience handling these cases on a national or local basis, whether trying cases to juries or achieving resolution through arbitration or mediated settlements.
Products Liability Representative Matters
Environmental. The manufacturing process may involve releases of chemical agents that prompt administrative investigations and lawsuits. Duane Morris attorneys defend these cases in courts and before the EPA, and respond to DOJ requests and subpoenas for information.
Environmental Representative Matters
Construction. The design and construction of complex research and manufacturing facilities for pharmaceutical and medical device companies often leads to construction litigation. Our construction litigators have the experience and skill to handle these matters.
Construction Representative Matters
Commercial and Contract Matters. Our litigators are aggressive in pursuing and defending claims between competing pharmaceutical and medical device companies or involving other business matters, such as distributor termination disputes, breach of contract actions, trade secret violations, and enforcement of non-compete restrictions.
Commercial and Contract Matters Representative Matters
Employment Issues. Our employment and benefits attorneys are familiar with all aspects of defending discrimination and ERISA claims in state and federal courts and before administrative panels.
Employment Issues Representative Matters
Because we represent professional and trade associations within the healthcare industry, our litigation often raises issues, pursues claims or advocates for legal or regulatory changes on behalf of entire segments of the industry.
Industry-Wide Litigation Representative Matters
Healthcare Fraud and Abuse
- Achieved dismissal of RICO causes of action alleging fraudulent health care claims brought against physicians and chiropractors.
- In U.S. ex rel. Kite v. Lourdes Health System, et al., (D.N.J.), resolved claims against hospitals regarding allegations of improper receipt of outlier reimbursement from Medicare.
- Defended physician in Office of Inspector General (OIG) investigation regarding improper billing of radiation therapy.
- Counsel hospital client with respect to external audit and interaction with Attorney General in connection with fraudulent billing investigation.
- Defended a family practitioner in a Medicaid fraud investigation against accusation of providing substandard care without appropriate documentation; physician agreed to revise medical records.
- Represented a clinical laboratory in a civil investigative demand from a U.S. attorney regarding alleged billing fraud.
- Defended a physician in an insurance fraud claim in Illinois state court involving allegations that he prescribed drugs that were not medically necessary to a patient with knowledge that the patient intended the drugs for resale.
- Defended vein surgeon in a Zone Program Integrity Contractor (ZPIC) audit regarding claims of overpayments by Medicare, resulting in change to Local Coverage Determination (LCD) addressing issue raised in audit.
- Represented an Alaska orthopedic/sports medicine practice in multiple Recovery Audit Contractor (RAC) audits.
- Defended a Florida clinical laboratory in multiple Zone Program Integrity Contractor (ZPIC) audits regarding billing for services not rendered.
- Represented a physician in an inquiry by the state of New York into alleged misrepresentations on a website.
- Represented a health care provider in an audit by an insurer. Matter resolved for less than $500.
- Represented a medical supply company in an investigation by the state of New York into its billing practices.
- Represented a psychiatrist in license-revocation proceedings in several state administrative actions.
- Obtained dismissal of all charges against a physician following trial in one of first standard-of-care disciplinary actions brought by the Pennsylvania Board of Medicine.
- Represented anesthesiologist before state licensing agency on allegations of impairment and drug diversion and negotiated severance package for physician.
- Represented hospital in on-call and coverage dispute and contract dispute with international nurse-recruiting agency.
- Obtained summary judgment on behalf of the vice president of medical affairs of hospital system in a suit filed by an obstetrician whose medical staff privileges had been suspended.
- Obtained a verdict in favor of our client before an administrative law judge following a four-day trial in which the issue was whether a provider of home health care aides was permitted to discontinue agency-provided aides to this client due to alleged harassment of its employees. Lawson v. Homemaker Services of the Metropolitan Area, Department of Public Welfare.
- Defended medical resident in sexual harassment case seeking the termination of his residency and in separate criminal proceeding arising from same facts. Obtained arbitration award and trial verdict in favor of resident.
- Represented medical faculty physicians of a major university in settling a claim of gender discrimination brought by an employee.
- On behalf of a national health care company, obtained summary judgment in a race discrimination case, which was affirmed by the U.S. Court of Appeals for the Third Circuit.
Reimbursement and Managed Care
- When Medicare fiscal intermediary denied multiple claims for inpatient admission for lack of medical necessity, the fiscal intermediary recouped payments for inpatient admissions and indicated its intent to recover payments for many other similar inpatient admissions. We obtained a fully favorable Office of Hearings and Appeals decision concerning client’s appeal of fiscal intermediary’s determination.
- Our request that a fiscal intermediary reconsider its disproportionate share hospital (DSH) adjustment for our client resulted in a revised DSH adjustment payment in the amount of more than $700,000.
- Obtained favorable resolution of application of bad debt moratorium, causing hospital to retain $6 million of bad debt reimbursement.
- One month prior to a scheduled arbitration hearing, we obtained a settlement in excess of $1.3 million for a northern New Jersey hospital in action against a healthcare insurance company based on claims that the insurer failed to reimburse the hospital according to the parties’ written agreement.
- Obtained a multimillion-dollar settlement for a network of healthcare providers during arbitration with third-party payor in dispute over claims.
- Represented physician group practices in actions throughout the country in which payor sought to recoup payments ranging from $20,000 to $2 million. All matters were resolved without any payments by client.
- Assisted clients with recoupment of payments in excess of $30 million over the past five years.
- Represented group practices of pathologists in actions brought by commercial and self-insured plans in Texas, Tennessee, Illinois and Wisconsin seeking to recoup payments made to the practices. Resolved matters through arbitration or informal discussion.
- Represented group pathology practices in disputes with commercial and self-insured plans arising from their failure to compensate the practices at the contracted rates for the professional component of the clinical pathology services they provided. All matters were resolved through out-of-court negotiations.
- Represented a medium-sized hospital-based group pathology practice in an action for breach of contract and deceptive trade practices brought against payor for its failure to pay for the professional component of clinical pathology services provided. Resolved dispute through a creative going-forward resolution that addressed the physicians’ need to have their services recognized by payor.
- Represented a medium-sized group emergency-room practice in action to recover $2 million in underpayments resulting from the defendant payor having paid the non-participating group practice physicians at participating-provider rates. Resolved matter for near amount demanded.
- Represented non-participating emergency medicine providers in a class action brought in Massachusetts against a payor arising from payor’s unilateral reduction of the fees paid to the providers.
- Represented a medium-sized group emergency-room practice in an action to recover underpayments made by payor. Obtained lump-sum recovery in excess of $1 million through informal negotiations.
- Brought class action on behalf of non-participating emergency-room physicians against a national Medicaid managed-care plan arising from the plan’s unilateral election to reimburse the physicians at Medicaid rates. Resolved matter on a going-forward basis that netted the client an additional $4 million.
- Represented a group of California emergency-room physicians in an action against a local Medicaid plan for downcoding and failing to pay for emergency medical services provided to the plan’s members. During discovery, exposed underlying auditing manipulations used by Medicaid agent. Action resulted in a lump-sum payment going-forward resolution, the auditor’s termination and a investigation against the plan.
- Represented a class of independent physical therapists in Maine in an action for breach of contract, antitrust and quantum meruit against payor. Obtained lump-sum payment and going-forward concessions from payor.
Antitrust and Competition
- Represented defendant university in obtaining summary judgment in an antitrust case brought by cardiologist challenging a change in his privileges and faculty status. Huhta v. Children’s Hospital of Philadelphia, 1994 WL 245454 (E.D. Pa. 1994), aff’d, 52 F.3d 315 (1995).
- Obtained defense verdict after jury trial of antitrust claim by physician against three hospitals, one of which we represented. Angelico v. Lehigh Valley Hospital, 2000 U.S. Dist. LEXIS 18420 (E.D. Pa. 2000), aff’d, 85 Fed. Appx. 308 (3d Cir. 2004), cert. denied, 2004 U.S. Lexis 5591 (U.S. Oct. 4, 2004).
- Settled litigation after a three-day mediation on behalf of a group of seven hospital campuses in the Orlando area in longstanding litigation with two different radiation oncology groups.
- After seven-week jury trial, obtained a defense verdict in favor of hospital in a case involving an antitrust claim for $57 million.
- Obtained dismissal of state court class action alleging that hospital engaged in unfair trade practices in billing uninsured patients.
Business Reorganizations and Financial Restructuring
- Counsel to CareMatrix Corporation (publicly held) and its various subsidiaries in chapter 11 reorganization involving 36 assisted living and other long-term care facilities for the elderly in eleven states.
- Represented the official unsecured creditor committee in the bankruptcy proceedings of Jersey City Medical Center, one of the largest public hospitals in New Jersey.
- Acted as assignee for the benefit of creditors in Advanced Community Health Care, a nonprofit visiting-nurses organization.
- Represented various creditors and equipment lessors in the bankruptcy proceedings of Unitedhealthcare System, Inc.
- Represented creditor as claimant in a bankruptcy case in Delaware and in connection with claims against the trustee of special-purpose entity.
Patient Care and Research
- Represented hospital and researcher in response to FDA warning letter regarding off-label use.
- Obtained settlement of cervical cancer medical malpractice claim against national pap smear laboratory. McCall v. D’Amico, M.D., et al., Case No. 97160001/CC3052 (Baltimore County Circuit Court).
- Obtained seven-figure recovery in bad faith action prosecuted on behalf of assignor physicians subjected to excess judgment in medical malpractice action. Hutchinson, et al. v. Medical Inter-Insurance Exchange of New Jersey, No. ATL-L-003250-93 (N.J. Super. Atlantic County).
- Obtained a jury verdict in favor of defendant midwife in a case involving the development of a catastrophic brain injury allegedly as a result of the failure to diagnose a subarachnoid hemorrhage that occurred immediately before the birth of plaintiff’s child. Erlich and Sugarman v. Cohen, Patrick and Pennsylvania Hospital.
- Won verdict in favor of defendant orthopedic surgeon following a two-week jury trial in a case involving an allegation that the defendant’s care and treatment led to a below-the-knee amputation. Anderson v. Martinez.
- Defended neurosurgeon against case alleging that he over-prescribed steroids, which purportedly led to the plaintiff's bilateral hip replacements. Case was dropped on the second day of trial after cross-examination of plaintiff revealed that he failed to provide a candid prior medication history in a case. Heary v. Bruno.
- Obtained decision from the Pennsylvania Supreme Court in which it adopted the interpretation of the retroactivity of the MCare statute asserted in the amicus brief filed on behalf of our client, an orthopedic surgeon. Wexler v. Hecht (companion case to Bethea v. Philadelphia AFL-CIO Hospital Association).
- Won an arbitration on behalf of a midwife involving the alleged improper delivery of a baby resulting in a shoulder dystonia. Pressley v. Dawley.
- Achieved a defense verdict in favor of a physician in a double-amputee case. Wilson v. Daniels.
- Represented hospital in an appeal from agency action regarding award of certificate of need for licensure as a full-service cardiac catheterization lab.
- Represented nursing home before the state planning board regarding its certificate of need for relocation and gained approval for the multimillion-dollar project.
- Represented ophthalmology physician practice in the development of an ambulatory surgery center, including obtaining an exemption to the Georgia certificate of need laws for construction of such facility.
- Obtained appellate affirmance of award of certificate of need for hospital to participate in elective angioplasty demonstration project against challenge by competing hospital. Cooper Univ. Hospital v. Jacobs (N.J. App. Div. 2009).
- Represented hospital in appellate challenge to the award to the hospital of a certificate of need regarding its designation as regional perinatal center.
Nonprofit Institution and Tax Issues
- Represented orthopedic practice in workers compensation and unemployment state tax matter pertaining to independent contractor vs. employee status of physician.
- Represented seller of hospital in a breach of contract action regarding a managed care company’s claim for damages.
- Obtained court orders in favor of hospital foundation regarding right to payment under five testamentary trusts.
- Represented hospital in appeal of nonprofit tax exemption for real property.
Environmental, Energy and Construction Litigation
- Represented hospitals before state utility regulatory agencies opposing imposition of hourly electricity rates on hospitals.
- Represented universities, hospitals and other commercial customers for electric and gas service in electric and gas deregulation proceedings seeking unbundled rates and favorable to client interests.
- Astellas US LLC et al. v. Wockhardt, Case No. 09-CV-04654 (D.N.J.). Represented Wockhardt in ANDA litigation regarding Adenoscan® (adenosine). Case settled shortly before trial on terms the client found very favorable.
- Lead trial counsel for the plaintiff in the three-week trial of an inventorship action concerning polyethylene used in total joint replacements. Sagar v. Massachusetts Institute of Technology and Massachusetts General Hospital (District of Massachusetts, 2002-03).
- Represented start-up pharmaceutical company in patent infringement and theft of trade secrets case involving cutting-edge protein based treatment for ear infections and inflammation, the number one disease in the pediatric patient population.
- Represented a biopharmaceutical company in an action for damages based upon defendants' acts of unfair competition under Sections 43(a) of the Trademark Act of 1946 (Lanham Act), 15 U.S.C. § 1125(a)(1)(B), and for substantial and related claims of trade secret misappropriation, tortious interference with business relationship, unfair competition and violations of the Florida Civil Remedies for Criminal Practices Act (Civil RICO). Our client also sought preliminary and permanent injunctive relief and a declaratory judgment regarding the ownership, validity and future infringement of U.S. Patent No. 6,174,859 ('859 Patent) and our client’s commercialization of a revolutionary new drug called Alpha 1-Antitrypsin (AAT). AAT is a therapeutic protein.
- Represented a foreign inventor in the U.S. District Court for the District of New Jersey in multimillion-dollar case involving claims of a breach of and fraudulent inducement into a license agreement, breach of confidentiality agreement, misappropriation of trade secrets, and intentional patent infringement of gelatin-free capsule technology for pharmaceutical and nutritional applications.
- Mediated favorable settlement on behalf of regional medical device development company and scientist-inventor (macromolecular chemist) in the U.S. District Court for the District of Minnesota in a dispute concerning patented technology for a method and process for making hydrogel and a related spinal nucleus implant device.
- Represented a leading biopharmaceutical company and affiliates in actions brought for declaratory judgment that no royalties were owed for production of biopharmaceuticals, where multibillion-dollar claim for royalties was at stake; cases brought by several biopharmaceutical companies against same patentee were consolidated in a multi-district proceeding; following discovery of invalidity and prior art witnesses the patentee filed a covenant not to sue and the cases settled. Immunex Corp. v. Columbia University.
- Medicis v. Sandoz, Case No. 09-033 (D.Del.– J. Farnan) Represented Sandoz in ANDA litigation regarding SOLODYN® (minocycline hydrochloride). Duane Morris handled launch at risk, which then settled on terms the client found favorable.
- Endo v. Sandoz, Case Nos. 08-534 and 08-970 (D.Del. – K. Hayden). Represented Sandoz in ANDA litigation regarding OPANA® ER (oxymorphone hydrochloride). This case is believed to be the first patent case to be litigated in Newark, N.J., under the new Patent Local Rules of the District of New Jersey. Settled during trial.
- Wyeth v. Apotex Inc. et al., Case No. 08-022308 (S.D.Fla. – F. Moreno). Represented Apotex in ANDA litigation regarding EFFEXOR® XR (venlafaxine hydrochloride). Settled after two phases of trial were completed.
- Aventis Pharma S.A. and Sanofi-Aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Case No. 08-496 (GMS) (D. Del. 2010). Patent infringement action regarding Apotex's ANDA to make a generic version of Sanofi-Aventis' anti-cancer product TAXOTERE®, the active ingredient of which is docetaxel. Following a two-week trial, obtained an order for Apotex striking down the patents-in-issue as invalid and unenforceable due to Sanofi-Adventis' inequitable conduct in procuring the patents. Affirmed sub nom, Aventis Pharma S.A. and Sanofi-Aventis U.S., LLC v. Hospira, Inc., (Fed. Cir. 2012).
- Alcon v. Sandoz, Case No. 09-0103 (S.D.Ind. – L. McKinney, R. Young). Represented Sandoz in ANDA litigation regarding PATANOL®, the active ingredient of which is olopatadine hydrochloride. Settled prior to trial.
- Merck & Co., Inc. v. Sandoz Inc., Case No. 09-890 (D.N.J. – M. Cooper). Represented Sandoz in ANDA litigation regarding EMEND®, the active ingredient of which is aprepitant. Settled prior to trial.
- Allergan Inc. v. Sandoz Inc., Case No. 09-cv-097 (E.D. Tex). Patent infringement action regarding Sandoz's ANDA to make a generic version of Allergan's eye-pressure drops Combigan®, the active ingredient of which is brimonidine tartrate/timolol maleate.
- Sepracor v. Wockhardt, Case No. 09-CV-1302 (D.N.J. – D.Cavanaugh). Represented Wockhardt in ANDA litigation regarding LUNESTA®, the active ingredient of which is eszopiclone. Settled prior to trial on terms the client found favorable.
- Daiichi Sankyo v. Mylan, Case No. 2009-1511. Represented Mylan in appeal of district court decision to the U.S. Federal Circuit Court of Appeals regarding ANDA litigation regarding BENICAR® (olmesartan medoxomil), BENICAR HCT® (olmesartan medoxomil and HCTZ), and AZOR® (olmesartan medoxomil and amlodipine besylate).
- Pfizer Inc., et al. v. Mylan Pharmaceuticals, Inc., Case No. 10-00085 (D.Del. – J. Farnan). Represented Mylan in ANDA litigation involving Pfizer's cardiovascular product CADUET®, the active ingredients of which are atorvastatin calcium and amlodipine besylate. Settled prior to trial.
Sales and Distribution Issues
- Defended a major pharmaceutical manufacturer and its subsidiaries in drug-pricing litigation.
- Counsel to special committee of board of directors of a medical device company in an internal investigation relating to overbilling in government grants.
- Counsel to executive at medical device company in parallel investigations by the U.S. Department of Justice and Securities and Exchange Commission, and civil lawsuits following restatement due to revenue-recognition issues.
- Counsel to numerous individuals at medical device manufacturer in investigation of Food & Drug Act violations by the U.S. Department of Justice and the U.S. Food and Drug Administration, Office of Criminal Investigations.
- Lead trial counsel in more than 40 consolidated matters in West Virginia in defense of global medical device manufacturer; cases involved claims of improper off-label use of biologic products, illegal kickbacks to physicians, fraud and general medical device products liability.
- Represented a corporate client in federal criminal investigation of pharmaceutical pricing, including Average Wholesale Price (AWP)-related issues. In re Pharmaceutical Industry Average Whole Price Litigation, MDL 1456 (D. Mass.).
- Counsel to senior executives at biotechnology company in investigation of Federal Food, Drug, and Cosmetic Act violations by the U.S. Department of Justice and Veterans Administration.
- Obtained the return of $1.6 million worth of pharmaceutical product seized by the Drug Enforcement Agency on behalf of a firm client in response to a writ of mandamus and motion for preliminary injunction filed against the DEA and its director.
- National coordinating counsel for a pharmaceutical company’s entire PPA litigation. Responsible for the coordination of direct claims (approximately 250) and cross-claims for contribution and indemnity (approximately 540), including a settlement class action and involvement in co-defendants’ bankruptcy proceedings to obtain relief from all direct and cross-claims. Oversight of local counsel in 18 states. Oversight of federal multi-district litigation and the development of corporate and expert witnesses.
- Obtained a satisfactory settlement on behalf of an international manufacturer of hip- replacement medical devices in a products liability claim asserting that the client’s product failed after surgery, causing injuries to plaintiff and a second hip-replacement procedure. Warley v. Biomet, Inc. (D.N.J.).
- As counsel to an international pharmaceutical company in defense of all of its HIV/hemophilia blood factor products liability litigation in New Jersey, negotiated a satisfactory settlement with plaintiff and all other defendants in all cases pending against client in New Jersey.
- Moved to preclude plaintiff's expert testimony, and thereafter obtained dismissal with prejudice in favor of an international manufacturer of knee-replacement medical devices in a products liability claim asserting that the client's product failed after surgery.
- Tried to verdict the first Phen-fen case in Pennsylvania on behalf of a family practice physician and one of the first cases tried nationally. Scott v. Guinta.
- Handled internal investigation involving environmental issues and alleged violations of the Clean Air Act for pharmaceutical company with Puerto Rico operations.
- Settled Superfund case for Puerto Rico pharmaceutical company alleged to have discharged pesticides into a waterway.
- Conducted an extensive internal investigation for an international pharmaceutical company in connection with a "hot line" report that the company, due to its failure to properly maintain equipment, had intentionally released refrigerants containing ozone-depleting compounds in violation of U.S. Environmental Protection Agency regulations, and had altered related records. Defended EPA and U.S. Department of Justice civil and criminal investigations, which were ultimately terminated without criminal charges or the assessment of civil or administrative penalties.
- Represented pharmaceutical company in a claim by building worker that exposure to client’s water treatment chemicals caused respiratory illness. Obtained dismissal of case on statute-of-limitations grounds based on plaintiff’s own testimony. Griffin v. Garratt-Callahan Co., 74 F.3d 36 (2d Cir. 1996).
- Represented owner of $100 million pharmaceutical plant in New Jersey in multiple suits. Settled through mediation actions brought by an engineering, procurement and construction (EPC) contractor and approximately a dozen subcontractors.
- Represented Integrated Project Services, Inc., a designer-builder of pharmaceutical plant clean rooms and semiconductor plans in Pennsylvania, New Jersey, Massachusetts, Florida, North Carolina, Maryland, California and New Mexico regarding multimillion- dollar construction disputes, enforcement of mechanics lien claims, employment issues, corporate governance strategies, business succession planning and OSHA and other governmental regulations.
Commercial and Contract
- Secured dismissal of all claims, including multiple counts of misrepresentation, business fraud and breach of contract, against medical-device manufacturer sued in the U.S. District Court for the Eastern District of Pennsylvania.
- Obtained and collected a damages award for a medical device company in a contract action arising out of an alleged breach of restrictive covenants.
- Obtained preliminary injunction on behalf of plaintiff, a medical device manufacturing company, against medical device distributor for breach of non-compete and trade-secrets clause in distribution agreement.
- Negotiated resolution of federal court action on behalf of a major pharmaceutical company against claims by a competitor that the hiring of a prominent research and development executive amounted to theft of trade secrets and the inevitable disclosure doctrine.
- Settled a major antitrust class action brought on behalf of pharmaceutical company against U.S. and Japanese manufacturers of a key ingredient contained in all drugs in pill or capsule form who had conspired to fix the price of the ingredient during a 10-year period and obtain monopoly profits.
- Represented Fujirebio Diagnostics in a significant international arbitration of dispute between two international pharmaceutical companies over a development and distribution agreement for several “test kits” used in the course of diagnosing and/or treating patients with various forms of cancer.
- Represented a leading pharmaceutical packaging company in suit brought against former president and 49-percent shareholder for fraud, breach of fiduciary duty and commercial bribery. Obtained settlement under which the company bought out the defendant ‘s 49-percent interest at a deep discount.
- Represented medical device manufacturer in proceedings with the U.S. Department of Labor and the Internal Revenue Service with respect to significant plan failure involving misallocation of plan assets. Submitted plan correction to both the DOL and IRS.
- Represented pharmaceutical company and its officer accused of sexual harassment and other employment-related misconduct. Case was dropped after vigorous defense.
- Counseled international medical device manufacturing company in its defense of a wrongful termination case asserted by terminated distributors following an acquisition of their product line and consolidation of sales forces by the client. The firm advised and assisted our client in a coordinated response to similar cases throughout country and negotiated favorable settlement for client prior to completion of discovery and trial.
- Obtained defense verdict after jury trial in a case for wrongful termination and gender and pregnancy discrimination brought by a pharmaceutical sales representative who was placed on leave while the company investigated allegations that she provided drug samples to a person who was not a medical doctor. Silverstein v. Marion Merrell Dow (San Diego Superior Court) .
- Obtained return of $1.6 million worth of alleged contraband seized by the U.S. Drug Enforcement Administration.
- Obtained a temporary restraining order against the state of Washington halting a 6-percent reduction in Medicaid reimbursement to pharmacies.
- Negotiated the voluntary surrender of a U.S. Drug Enforcement Administration registration on behalf of pharmacy and its owner allegedly to have engaged in the significant diversion of controlled substances in violation of federal and state law. In return, the DEA agreed not to pursue criminal or civil actions and permitted the transfer of the controlled substances to another pharmacy.
- Obtained a no-further-action letter from state authorities for a corporation that had voluntarily self-reported violations of state controlled-substances act and statutes and regulations governing out-of-state wholesalers after conducting an internal investigation.
- Obtained preliminary injunction on behalf of the National Association of Chain Drug Stores and National Community Pharmacists Association in litigation against the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services enjoining implementation of reimbursement rule that would have cost pharmacies $8 billion.
- Represented more than 20 Pennsylvania health systems, comprising roughly 100 healthcare providers, organized by the Delaware Valley Healthcare Council and The Hospital & Healthsystem Association of Pennsylvania, in an action against the Pennsylvania Department of Public Welfare to obtain recovery on more than $60 million in claims owed to the providers by a failed Medicaid health maintenance organization. Settlement was also reached with the Pennsylvania Insurance Department regarding the distribution of the assets of the failed entity.
- Submitted amicus brief on behalf of hospital organization in support of community hospital that obtained important decision regarding the Health Care Quality Improvement Act (HCQIA) immunity issue in favor of defendant hospital.
- Obtained appellate decision in favor of The Hospital & Healthsystem Association of Pennsylvania (HAP) against the Pennsylvania Department of Public Welfare and Office of the Budget in a dispute over $465-$616 million in funding physician abated payments to the Commonwealth’s medical liability insurance fund (MCARE), which the commonwealth failed to transfer from a dedicated account in 2003 through 2007.
- Employment Issues. Our employment and benefits attorneys are familiar with all aspects of defending discrimination and ERISA claims in state and federal courts and before administrative panels.