Vest v. Waring

Decision Date31 May 1983
Docket NumberCiv. A. No. C82-325A.
PartiesLloyd VEST, et al., Plaintiffs, v. George O. WARING, M.D., et al., Defendants.
CourtU.S. District Court — Northern District of Georgia

COPYRIGHT MATERIAL OMITTED

Robert N. Meals, Jr., Meals & Parks, Atlanta, Ga., for plaintiffs.

Mesirov, Gelman, Jaffe & Cramer, David Creskoff, Philadelphia, Pa., for Dr. Laibson.

Nina Loree Hunt, Asst. U.S. Atty., Atlanta, Ga., for Ronald G. Geller, M.D., Carl Kupfer, M.D., National Eye Inst., Edward D. Norton, M.D. and Aran Safir, M.D.

Baker & Hostetler, Phillip A. Proger, Washington, D.C., for Roger Langston, M.D.

Hansell, Post, Brandon & Dorsey, Trammell E. Vickery, Kent E. Mast, Atlanta, Ga., for Stephen Obstbaum, M.D.

Phelps, Dunbar, Marks, Claverie & Sims, Rutledge C. Clement, Jr., New Orleans, La., for Dr. Safir and Dr. Kaufman.

Freeman & Hawkins, A. Timothy Jones, Atlanta, Ga., for Richard Thoft, M.D.

James J. Costello, University Counsel, University of Illinois, Urbana, Ill., for Joel Sugar, M.D.

Trotter, Bondurant, Miller & Hishon, Emmet J. Bondurant, Atlanta, Ga., Musick, Peeler & Garrett, Bruce A. Bevan, Jr., Los Angeles, Cal., for Schanzlin, Smith, Villasenor and Salz, M.D.

King & Spalding, A. Felton Jenkins, Jr., Atlanta, Ga., for Drs. Waring, Cavanagh and Wilson.

Nixon, Hargrave, Devans & Doyle, Robert C. Bernius, Rochester, N.Y., for James Aquavella, M.D.

Swift, Currie, McGhee & Hiers, James B. Hiers, Jr., Porter, Morris, Arthur, Atlanta, Ga., for Dr. Richard H. Keates.

Long, Weinberg, Ansley & Wheeler, Sidney F. Wheeler, Atlanta, Ga., for Drs. Waring, Cavanagh and Wilson.

Powell, Goldstein, Frazer & Murphy, E.A. Simpson, Jr., Atlanta, Ga., Dorsey & Whitney, James H. O'Hagan, James B. Lynch, Minneapolis, Minn., for Drs. Schoch, Bettman, McPherson, Reinecke, Newell, Spivey and Wilson.

Kilpatrick & Cody, Miles J. Alexander, Atlanta, Ga., for Edward D. Norton and Henry Gelender, M.D.

Mershon, Sawyer, Johnston, Dunwody & Cole, Felice K. Schonfeld, Miami, Fla., for Norton and Gelender.

Simmons, Perrine, Albright & Ellwood, Lawrence E. Blades, Cedar Rapids, Iowa, for Jay Krachmer, M.D. and Frederick Block, M.D.

Fellers, Snider, Blankenship, Bailey & Tippens, Burck Bailey, Oklahoma City, Okl., for Balyeat and Rowsey.

Leonard, Street & Deinard, Stephen J. Davidson, Minneapolis, Minn., for Richard L. Lindstrom, M.D. and Donald J. Doughman, M.D.

Perry Rosen, Atty., Civil Div., Dept. of Justice, Washington, D.C., for U.S.

Woodrow W. Vaughan, Jr., Atlanta, Ga., for Dr. Binder.

Robert S. Frank, Jr., Thomas F. Maffei, Lee T. Gesmer, Choate, Hall & Stewart, Boston, Mass., for Baum.

William J. Dunaj, Mershon, Sawyer, Johnston, Dunwoody & Cole, Miami, Fla., for Gelender, M.D.

Paul Terrence Dee, General Counsel, University of Miami, Coral Gables, Fla., for U. of Miami.

OPINION AND ORDER

ROBERT H. HALL, District Judge.

ORDER

This lawsuit, filed on February 19, 1982, involves a surgical procedure known as radial keratotomy that is performed on the cornea of the eye in an attempt to correct nearsightedness. The gravamen of the complaint, predicated on Sections 1 and 2 of the Sherman Antitrust Act, 15 U.S.C. §§ 1, 2,1 is that the defendants have conspired to restrict the ability of private ophthalmic surgeons to provide this surgery to willing patients, by creating, in effect, a monopoly group with pervasive control over the performance of the procedure. The defendants have responded to this charge by raising defenses based upon a form of "governmental immunity," lack of personal jurisdiction, and improper venue.

Factual Background

Dr. Leo Bores, one of the plaintiffs in this action, is the individual responsible for introducing radial keratotomy in this country. In 1976, Dr. Bores visited the Soviet Union and performed several radial keratotomies on human patients under the supervision of Dr. Svyatoslav Fyodorov, the Russian physician who developed the basic operative technique in use today. In 1977, Dr. Bores returned to Moscow and examined the six patients he had operated on the previous year. He then returned to the United States and performed the first radial keratotomy in this country in 1978. Subsequently, in November 1979, Dr. Bores joined forces with seven other eye surgeons to form the National Radial Keratotomy Study Group. ("NRKSG"). This group developed a basic scientific protocol for others to follow when performing the procedure, and created a detailed informed consent form to be reviewed with each patient prior to the operation. (Bores Affidavit ¶¶ 2, 3, 4, 9, 10). Throughout this time, as Dr. Bores was aware, all forms of "refractive keratoplasty," including radial keratotomy, were considered by the National Advisory Eye Council2 to be "experimental," and clinical procedures involving human patients were discouraged until the results of animal experiments employing the technique were available.3 (Bores Affidavit ¶ 6).

In early March 1980, Dr. George O. Waring of the Emory University Clinic in Atlanta, Georgia, a defendant in this case, joined the NRKSG at the invitation of Dr. Bores, and attended an organizational meeting with thirty other physicians in Santa Fe, New Mexico. A few weeks later, on March 15, 1980, Dr. Waring, assisted by defendants Jay Krachmer of the University of Iowa and Dr. J. James Rowsey of the University of Oklahoma, convened a meeting at Hartsfield International Airport. Approximately fourteen eye surgeons from across the country attended this meeting4, to discuss radial keratotomy and the possibility of obtaining a government grant in order to study the procedure in greater depth.5 Following this meeting, Dr. Waring contacted defendant Dr. Ronald Geller, Ph.D., the Associate Director of the National Eye Institute and also the Executive Secretary of the National Advisory Eye Council. Dr. Waring expressed his group's interest in performing some sort of collaborative study of radial keratotomy, and Dr. Geller indicated that the National Eye Institute was very interested in supporting such a study. Over the next several weeks, Dr. Waring began work on a rough draft of a protocol for this study, outlining in detail all procedures involved in the study, from patient selection through final data evaluation.

In May 1980, during the meeting of the Association for Research in Vision and Ophthalmology held in Orlando, Florida, Dr. Waring met with the same basic group present at the Atlanta meeting and Dr. Geller; this group agreed that a grant proposal for a radial keratotomy study should be submitted to the National Eye Institute, and divided among themselves various responsibilities for preparing the common protocol.

Shortly after this meeting, on May 28, 1980, the National Advisory Eye Council issued a statement indicating that "the Council considers radial keratotomy to be an experimental procedure because it has not yet been subjected to adequate scientific evaluation in animals or humans."6 The resolution also urged the NEI to "take whatever measures are necessary to encourage research on radial keratotomy ... in scientifically designed clinical trials conducted by qualified investigators." It is this resolution and its purported ramifications throughout the extended ophthalmological community, in conjunction with the publication and dissemination of the conclusions from the March 1980 Atlanta Workshop, that the plaintiffs point to as compelling evidence of a pervasive nationwide conspiracy to restrain the performance of radial keratotomy.

On or about July 18, 1980, Dr. Waring and his group formally submitted their grant applications and proposed protocol to the National Eye Institute. Twelve University-affiliated clinical centers submitted separate grant proposals based on the common protocol that had been developed during the preceding three months. The grant request, entitled "The Prospective Evaluation of Radial Keratotomy" ("PERK"), later became known as the "PERK Study." During August and September 1980, the applications and protocol were reviewed in detail by the National Eye Institute's Ad Hoc Vision Program Committee. Following this review, the Institute awarded the first two grants to Emory University in Atlanta; Emory was to be both the principal clinical center as well as the coordinating center responsible for administrative matters and data compilation. After a series of meetings between the NEI and the remaining PERK applicants, during which final arrangements for the study and its protocol were made, the NEI made seven more clinical center grants on approximately February 1, 1981.7 The final meeting between National Eye Institute employees and PERK representatives took place on April 27, 1981; approximately five NEI representatives, including defendant Dr. Carl Kupfer, Director of the National Eye Institute, attended this meeting to discuss the PERK Study.

While plans for the PERK Study were being developed by Dr. Waring and other ophthalmologists affiliated with the proposed clinical centers, certain allegedly related events were taking place in the private ophthalmological community. On May 1, 1980, the Georgia Ophthalmological Association, a private organization, passed a motion drafted by defendant Dr. H. Dwight Cavanagh. Dr. Cavanagh, an ophthalmic surgeon associated with Dr. Waring at Emory University, urged the Association to endorse the conclusions of the National Radial Keratotomy Workshop as they had been published in the Archives of Ophthalmology, (see n. 4 supra) and requested that "each member of the Society in good standing ... agree to refrain from participating in radial keratotomy surgery outside the framework of the proposed PERK study, for a period of one year, or until results indicate the technique is safe and effective."8 Similar resolutions were subsequently passed by the New Mexico Ophthalmological Society;9 the Florida Society of Ophthalmology on August 26, 1980;10 and the Arizona Medical Association on ...

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