The firm's medical and radiological device practice covers a broad range of legal and regulatory services for clients involved in the manufacture, distribution, and sale of products regulated by the U.S. Food & Drug Administration (FDA) under the 1976 Medical Devices Amendment and 1990 Safe Medical Devices Act

Fish & Richardson attorneys have patent prosecution experience with a broad range of medical devices including:

• devices for magnetic resonance imaging, ultrasound and x-ray imaging
• cardiac pacing and defibrillation devices
• cardiac diagnostic equipment
• cerebrospinal fluid shunt valves
• endoscopes
• catheters (for use in drug delivery, diagnostic applications and surgical protocols)
• oxygenators
• guidewires
• dialysis equipment
• prosthetic organs and joints and orthopedic devices
• electrochemical pumps
• surgical instruments (for use in atherectomy and arthroscopic surgery)
• drug delivery devices

Our regulatory experience in the medical device area includes obtaining FDA marketing authorization (see here), providing advice regarding meeting responsibilities under the Radiation Control for Health and Safety Act of 1968 and FDA test procedures and reporting requirements, import and export rules, and labelling requirements.

We have an excellent track record in medical device patent infringement cases. Recent victories in medical device cases include:

Fresenius Medical Care v. Baxter Healthcare.

Represented Fresenius in a patent case in the Northern District of California involving four patents relating to hemodialysis machines. Jury returned verdict for Fresenius invalidating all asserted claims on all patents. Subsequently, the District Court overturned portions of the jury verdict. Case expected to be appealed.

Harvinder S. Sandhu, M.D. and Kyphon Inc. v. Medtronic Sofamor Danek, Inc., et al. and Medtronic, Inc. et al. v. Kyphon Inc. Represented Kyphon in a suit in the United States District

Court for the Western District of Tennessee alleging that Medtronic Sofamor Danek was infringing patents relating to the treatment of spinal compression fractures. Also defended Kyphon in a patent infringement suit brought by Medtronic in the United States District Court for the Northern District of California alleging patent infringement against Kyphon’s inflatable bone tamps. The suits were settled by Medtronic’s purchase of Kyphon for approximately $4.2 billion.

C.R. Bard v. Medtronic, Inc.

Obtained a jury verdict for non-infringement on behalf of Medtronic in a patent case in the United States District Court for the District of Delaware involving an asserted patent related to arterial blood filters used during cardiac surgery.

E. Neil Moore v. Medtronic, Inc.

Successfully defended Medtronic in a licensing and patent dispute brought by Moore in the United States District Court for the District of Minnesota involving technology relating to the circuitry used in Medtronic’s implantable cardiac defibrillators to detect accelerated heart rates. The case settled on favorable terms after the district court adopted Medtronics’ proposed patent claim construction following a Markman hearing.

Pacesetter, Inc. v. Cardiac Pacemakers, Inc.

Favorably settled case for Pacesetter after receiving a positive jury verdict of infringement and damages in a patent case in the United States District Court for the District of Minnesota involving cardiac pacemakers and defibrillators.

Cobe Cardiovascular, Inc. and Sorin Group Deutschland GMBH v. Terumo Cardiovascular Systems Corporation.

Favorably settled a patent infringement case involving heart-lung machines brought against our client, Terumo, in the United States District Court for the District of Minnesota. Mentor Corporation v. American Medical Systems and American Medical Systems v. Mentor Corporation. Represented Mentor Corporation in patent infringement litigation in the District of Minnesota regarding a surgical method of treating female urinary incontinence. Cases settled.

Daniel Brauman v. Mentor Corporation.

Represented Mentor Corporation in patent infringement litigation in the Southern District of New York regarding breast implants. Case settled.

Kyphon, Inc. v. Disc-O-Tech Medical Technologies, et al.

Obtained a jury verdict in favor of Kyphon in a patent infringement lawsuit in the United States District Court for the District of Delaware involving Kyphon’s patents on a ground-breaking procedure for treating spine fractures caused by osteoporosis. After receipt of the jury’s verdict, the defendants agreed to a consent judgment of infringement, validity, and enforceability, and to the entry of an injunction preventing them from selling the infringing product in the United States. The defendants previously had agreed to cease importation of the infringing product to resolve Kyphon's parallel action in the ITC.

Cardiac Sciences v. ZOLL Medical Corp.

Deborah Charms v. Cardiac Pacemakers, Inc., Guidant Corp. and Medtronic, Inc.

Successfully defended Medtronic against an appeal of a summary judgment granted for Medtronic in a patent infringement case brought by Deborah Charms in the United States District Court for the Western District of Texas alleging that her late husband’s patent covered virtually all of the implantable cardiac defibrillators sold by Medtronic and CPI/Guidant over the a period of seven years. The district court granted summary judgment in favor of the defendants, finding the patent invalid based on anticipation. The Court of Appeals for the Federal Circuit affirmed.

Haemonetics Corporation v. Medtronic, Inc.

Obtained summary judgment of non-infringement for Medtronic in a patent infringement case in the United States District Court for the District of Massachusetts. The case involved two patents relating to blood processing equipment. In addition to granting summary judgment of non-infringement for Medtronic, United Stated District Court Judge Woodlock also denied as moot the plaintiff ’s motion for a preliminary injunction.

Vartanian v. General Electric.

Successfully defended General Electric Company (GE) against an appeal to the Court of Appeals for the Federal Circuit brought by Vartanian. The District Court below had ruled in favor of GE in a case involving ownership of a patent on x-ray computed tomography.

Medical Devices Attorneys

Bing Ai
Peking University (Beijing, China) B.S. Physics 1985
University of Southern California Ph.D. Physics 1995
University of San Diego J.D. 2002

Michael R. Asam
Kenyon College A.B. Chemistry 1994 cum laude
University of North Carolina at Chapel Hill Ph.D. Analytical and Biological Chemistry 1998
Duke University School of Law J.D. 2001
Executive Editor, Alaska Law Review

James W. Babineau
University of New Mexico B.S. Mechanical Engineering Tau Beta Pi
University of Michigan M.S. Mechanical Engineering
Harvard Law School J.D.

Edmond R. Bannon
Fordham University B.S. Physics 1981
St. John's University School of Law J.D. 1987

Keith A. Barritt
University of Virginia B.A. Foreign Affairs and Philosophy 1983 cum laude
University of Virginia J.D. 1989
Editorial board member, Virginia Journal of International Law (1987-1989)

Joseph P. Benson
Brigham Young University B.A. Asian Studies (minor in math and physics) 2002 cum laude
Central University for Nationalities (Beijing, China), Fulbright Scholar 2002-2003
Utah State University B.S. Physics 2004
J. Reuben Clark Law School, Brigham Young University J.D. 2007 cum laude
Associate Editor, Brigham Young University Law Review

Brenda Leeds Binder
University of Calgary B.Sc. Mechanical Engineering 1992
University of Alberta LL.B. (J.D.) 1995

Richard G. A. Bone
University of Cambridge B.A. Natural Sciences 1988 First Class Honours
University of Cambridge Ph.D. Theoretical/Computational Chemistry 1992
Santa Clara University School of Law J.D. 2002
Editorial Board Member, Santa Clara University Law Review

Gregory R. Booker
University of Pennsylvania B.S.E. Bioengineering and Materials Science Engineering 1997 cum laude
Drexel University M.S. Materials Engineering 2002
Temple University Beasley School of Law J.D. 2005 cum laude
Temple Law Review

John F.T. Conroy
Duke University B.S.E. Biomedical Engineering 1990 cum laude
University of Utah Ph.D. Bioengineering 1996
University of San Diego School of Law J.D. 2005 magna cum laude

Michael E. Cox
University of New Mexico B.S. Physics and Mathematics 1996 magna cum laude, Phi Beta Kappa
Rice University M.S. Applied Physics 2000
University of Texas School of Law J.D. 2003

Sean P. Daley
University of Massachusetts B.S. Chemistry 1989 summa cum laude, Phi Beta Kappa
Massachusetts Institute of Technology Ph.D. Physical Chemistry 1994
Suffolk University Law School J.D. 1999 cum laude

Ahmed J. Davis
Morehouse College B.S. Chemistry 1994 cum laude
Emory University M.S. Chemistry 1996
Georgetown University Law Center J.D. 1999

Sean M. Dean
Duke University B.A. Mathematics 1987
University of Michigan M.S.E. Environmental Engineering 1993
University of Michigan Ph.D. Environmental Engineering 1998
University of Michigan Law School J.D. 2004

Lauren A. Degnan
Cornell University B.S. Mechanical Engineering 1992
Vanderbilt University School of Law J.D. 1995 Order of the Coif
Vanderbilt Journal of Transnational Law

Peter J. Devlin
Clarkson College B.S. Electrical and Computer Engineering 1980
Suffolk University Law School J.D. 1985 magna cum laude

Timothy Devlin
The Pennsylvania State University B.S. Physics with Honors in Physics and Economics; B.S. Mathematics, 1993
University of Michigan Law School J.D. 1996 cum laude

Roberto J. Devoto
University of Michigan B.S. Electrical Engineering 1993 summa cum laude
Massachusetts Institute of Technology M.S. Electrical Engineering 1996
Harvard Law School J.D. 1999 cum laude

Alex Eaton-Salners
Williams College B.A. Computer Science and Asian Studies 1999 magna cum laude, Phi Beta Kappa
University of California, Berkeley, School of Law J.D. 2005
Articles Editor Berkeley Technology Law Journal
Articles Team Berkeley Journal of International Law, Asian Law Journal, Ecology Law Quarterly

J. Peter Fasse
Massachusetts Institute of Technology B.S. Bioelectrical Engineering, May 1983, and B.S. Life Sciences, December 1983
George Washington University J.D. 1987

David L. Feigenbaum
Yale College B.S. Engineering and Applied Sciences 1969 magna cum laude, honors with exceptional distinction in major, Tau Beta Pi
Harvard Law School J.D. 1972

Richard P. Ferrara
Manhattan College B.S. Chemistry 1972 cum laude
Fordham University School of Law J.D. 1975

J. Patrick Finn III
Pennsylvania State University B.S. Biology 1991 with distinction
University of California, Los Angeles Ph.D. Microbiology and Immunology 1997
William Mitchell College of Law J.D. 2002 cum laude

Todd E. Garcia  
University of Rhode Island B.S. Microbiology (minor in Chemistry) 1993
University of Rhode Island M.S. Microbiology 1995
University of Rhode Island Ph.D. Microbiology 1999
Franklin Pierce Law Center J.D. 2001

Greg H. Gardella
University of Michigan J.D. 1995 cum laude
University of Minnesota M.S. Electrical Engineering (Thesis: Hybrid Analog/Digital Telephony System for Echo Cancellation)
University of Michigan, Ann Arbor B.S. Mechanical Engineering magna cum laude

John D. Garretson
Harvard University A.B. Biology 1989 cum laude
Universidad Complutense de Madrid C.S. Spanish 1990 with highest honors
Georgetown University Law Center J.D. 1993 cum laude

Kurt L. Glitzenstein
Massachusetts Institute of Technology B.S. Mechanical Engineering 1988 Phi Beta Kappa, Tau Beta Pi
University of California M.S. Mechanical Engineering, Controls 1990
Harvard Law School J.D. 1993 magna cum laude
Executive Editor, Harvard Journal of Law & Technology 1992-1993
Managing Editor, Harvard Journal of Law & Technology 1991-1992

John S. Goetz
University of Notre Dame B.S. Mechanical Engineering 1997
The George Washington University Law School J.D. 2004 cum laude

J. Kevin Gray
University of Oklahoma B.S. Medical Microbiology 1985
Oklahoma City University School of Law J.D. 1991 cum laude

Joshua A. Griswold
The University of Texas at Austin B.S. Mechanical Engineering 1995
The University of Houston Law Center J.D. 1999

Sean J. Grygiel
United States Coast Guard Academy B.S. Naval Architecture and Marine Engineering 1994
The George Washington University Law School J.D. 2001
Member, Public Contract Law Journal

Thomas L. Halkowski  
Marquette University B.S. Mechanical Engineering 1985 cum laude 
University of Florida M.S. Engineering 1986 
University of Wisconsin Law School J.D. 1989 cum laude, Order of the Coif 

Michael R. Hamlin
University of Alabama in Huntsville B.S. Engineering 2000
University of Michigan Law School J.D. 2003
Michigan Telecommunications and Technology Law Review

Heidi E. Harvey
Massachusetts Institute of Technology B.S. Chemical Engineering 1982
Cornell Law School J.D. 1986

Michael T. Hawkins
University of Minnesota B.S. Mechanical Engineering 2000 with high distinction
University of Minnesota Law School J.D. 2004 magna cum laude
Managing Editor, Minnesota Law Review

Mark J. Hebert  
Worcester Polytechnic Institute B.S. Mechanical and Nuclear Engineering 1978, M.S. Mechanical Engineering 1980 Pi Tau Sigma 
Suffolk University Law School J.D. 1985 cum laude 

Kelly C. Hunsaker
University of Texas at Austin B.B.A. 1990
University of California, Hastings College of Law J.D. 1993

William E. Hunter
University of California, San Diego B.S. Computer Science 1995
University of California, Hastings College of the Law J.D. 1999 cum laude

John T. Johnson
Union College B.S. Mechanical Engineering 1989
Albany Law School of Union University J.D. 1993 cum laude
Managing Editor of Research and Writing, Albany Law Journal of Science and Technology

George L. Kanabe
Rutgers University B.S. Electrical and Computer Engineering 2001 with highest honors, Tau Beta Pi, Eta Kappa Nu
Fordham University School of Law J.D. 2005 cum laude
Staff member, Fordham Urban Law Journal

Michael J. Kane
Iowa State University B.S. Mechanical Engineering 1981 with Honors
University of Minnesota J.D. 1994 magna cum laude

Daniel A. Kent
Grace College B.S. Communications 1986 magna cum laude
Duke University School of Law J.D. 1990 Semifinalist, Craven Cup National Moot Court Competition, Am. Jur. Book Award: Trial Practice
Editorial Board, Duke Law Journal

J. Kyle Komenda
Arizona State University B.S.E. Electrical Engineering 2004 cum laude, Eta Kappa Nu
University of Virginia School of Law J.D. 2007
Managing Editor, Virginia Journal of Law and Technology

Phyllis K. Kristal
Massachusetts Institute of Technology B.S. Mechanical Engineering 1987
University of Washington M.S. Mechanical Engineering 1991
Suffolk University Law School J.D. 1999

Hwa C. Lee
Georgia Institute of Technology Bachelor of Electrical Engineering 1995
University of Virginia M.S. Biomedical Engineering 1998
University of Virginia Ph.D. Biomedical Engineering 2002
University of San Diego School of Law J.D. 2009

Cameron M. Luitjens
University of North Dakota B.S. Biology 1994 summa cum laude, Phi Beta Kappa
University of Wisconsin Ph.D. Cellular and Molecular Biology 2000
Boston College Law School J.D. 2005
Staff Writer, Boston College Intellectual Property and Technology Forum

Gregory A. Madera
Massachusetts Institute of Technology B.S. Civil Engineering 1969
Richard Lee Russel Scholar award as top engineering graduate in class
Massachusetts Institute of Technology M.S. Geotechnical Engineering 1970, C.E. Advanced Engineering 1971
Harvard Law School J.D. 1975

Terry G. Mahn
University of Michigan B.S. Science Engineering 1970
Catholic University J.D. 1975

Ryan P. McCarthy
Oakland University B.S. Mechanical Engineering 1996
Wayne State University Law School J.D. 2002 cum laude

John Paul Mello
Vanderbilt University B.E. Mechanical Engineering 1996 magna cum laude, Tau Beta Pi
Vanderbilt University M.S. Mechanical Engineering 1998
Boston University School of Law J.D. 2007 magna cum laude
Articles Editor, Boston University Journal of Science & Technology Law

Andrew T. Meunier
Georgia Institute of Technology B.Ch.E. 1991
The University of North Carolina at Chapel Hill School of Law J.D. 1995

Todd G. Miller
San Diego State University B.S. Chemistry and Biochemistry 1987
University of San Diego School of Law J.D. 1992 cum laude

Indranil Mukerji
Cornell University B.S. Biological Engineering 1995
Cornell University M. Eng. Biological Engineering 1996
Boston University School of Law J.D. 1999
Articles Editor, Boston University Journal of Science and Technology Law

Wes Musselman
University of Virginia B.S. Mechanical Engineering 1981, with high distinction, Tau Beta Pi
University of Virginia School of Law J.D. 1987

Ralph A. Phillips
Pennsylvania State University B.S. Aerospace Engineering 1993 with distinction
North Carolina State University M.S. Mechanical Engineering 1995
University of Pennsylvania Law School J.D. 2000

John C. Phillips
University of Michigan B.S. Electrical Engineering 1984 cum laude
George Washington University J.D. 1992 valedictorian Order of the Coif

Frank P. Porcelli
Boston College A.B. English Literature 1968 magna cum laude
Harvard Law School J.D. 1971
Northeastern University M.S. 1981 Chemistry

Timothy W. Riffe
Virginia Tech B.S. Mechanical Engineering 1993
The George Washington University Law School J.D. 2001 with honors
The American Intellectual Property Law Association Quarterly Journal

Mathias W. Samuel
North Dakota State University B.S. Electrical Engineering 1991 Tau Beta Pi, Eta Kappa Nu
University of San Diego School of Law J.D. 1994 with honors, Order of the Coif

Stephen R. Schaefer
University of Kentucky B.S. Electrical Engineering 1985 with distinction, Tau Beta Pi, Eta Kappa Nu
University of Dayton M.S. Engineering Management 1995
University of Minnesota Law School J.D. 1992 cum laude
Law Review Board of Editors

Frank E. Scherkenbach
Stanford University B.S. Mechanical Engineering and A.B. Classics 1986 with distinction, Phi Beta Kappa, Tau Beta Pi
Harvard Law School J.D. 1989
Co-Founder, Editor-in-Chief Harvard Journal of Law & Technology

John P. Schnurer
Harvey Mudd College B.S. Electrical Engineering with Minor in Economics 1993
University of California, Berkeley, School of Law J.D. 1996
Articles Editor, Berkeley Technology Law Journal (1995-1996)

William Sekyi
Imperial College, London University B.S. Mechanical Engineering 1985 Honors
Louisiana State University M.S. Petroleum Engineering 1995
Georgetown University Law Center J.D. 2002

Jonathan E. Singer
Dartmouth College A.B. Chemistry 1986 Daniel Webster Scholar
University of Chicago Law School J.D. 1992 with honors

John M. Skenyon
Catholic University B.S. Electrical Engineering 1969
Catholic University J.D. 1973 (Law Review)

Craig R. Smith
Manhattan College B.S. Civil Engineering 1992, magna cum laude, Tau Beta Pi
University of Illinois M.S. Environmental Engineering 1994
New York University School of Law J.D. 1997 Order of the Barrister

Alan D. Smith
Massachusetts Institute of Technology B.S. Electrical Engineering 1979
University of Southern California J.D. 1984

Richard A. Sterba
Westminster College B.S. Physics and Mathematics 1995 magna cum laude
The George Washington University Law School J.D. 1998

Kevin Su
University of Pennsylvania B.S.E. Computer Science Engineering 2002
Northeastern University School of Law J.D. 2005

Luca Sutto
Politecnico di Milano Doctor in Aerospace Engineering 1991
University Robert Schumann, Strasbourg, Diploma in European Patent Litigation (CEIPI) 2008

Marc M. Wefers
University of Toronto B.S. Chemical Physics 1991 highest distinction
Massachusetts Institute of Technology Ph.D. Physical Chemistry 1996
Suffolk University Law School J.D. 2002 magna cum laude

William R. Woodford
Marquette University B.S. Electrical Engineering 1998 cum laude
University of Minnesota Law School J.D. 2002 cum laude

Limin Zheng
University of Pittsburgh Ph.D. Molecular, Cellular and Developmental Biology 1997
University of California, Berkeley, School of Law J.D. 2003

Medical Devices Technology Specialists

Elizabeth N. Kaytor
St. Olaf College B.A. Chemistry and Biology 1989 magna cum laude
University of Minnesota Ph.D. Biochemistry, Molecular Biology, and Biophysics 1997

Garrett Miedema
University of Minnesota Institute of Technology B.S. Astrophysics with a minor in Mathematics 1997

Yina Mo
University of Science and Technology of China B.S. Physics 2002
Harvard University Ph.D. Physics 2007
Suffolk University J.D. expected 2012

M. Angela Parsons
University of Nebraska B.S. Biological Sciences, emphasis in Molecular Genetics 1989 cum laude
Washington State University Ph.D. Genetics and Cell Biology 1994

Indranil Sarkar
University at Buffalo, The State University of New York Ph.D. Electrical Engineering 2007
University at Buffalo, The State University of New York M.S. Electrical Engineering 2004
Visveswaraiah Technological University B.E., Electronics and Communication Engineering 2002

Sushil Shrinivasan
University of Madras (Chennai, India) B.E. Mechanical Engineering 1998
University of Maryland, Baltimore County M.S. Mechanical Engineering 2001
University of Virginia Ph.D. Mechanical Engineering 2006
George Washington University Law School (J.D. expected 2012)

Juan Zheng
University of Toronto B.Sc. Bioorganic Chemistry 2000
Massachusetts Institute of Technology Ph.D. Organic Chemistry 2005