E. R. Squibb & Sons, Inc. v. Stickney

• Decision Date: 08 March 1973
• Docket Number: No. R--50,R--50
• Court: Florida District Court of Appeals
• Parties: E. R. SQUIBB & SONS, INC., a Delaware corporation, Appellant, v. Shirley STICKNEY, as Executrix of the Estate of David F. Stickney, Deceased, Appellee.

Page 898

274 So.2d 898

E. R. SQUIBB & SONS, INC., a Delaware corporation, Appellant, v. Shirley STICKNEY, as Executrix of the Estate of David F. Stickney, Deceased, Appellee.

No. R--50.

District Court of Appeal of Florida, First District.

March 8, 1973.

Rehearing Denied April 10, 1973.

Chester Bedell and Robert P. Smith, Jr., of Bedell, Bedell, Dittmar, Smith & Zehmer, Jacksonville, and Sanders, McEwan, Mims & McDonald, Orlando, for appellant.

Hoffman, Hendry & Parker, Orlando, and Alan R. Schwartz, of Horton, Schwartz & Perse, Miami, for appellee.

WIGGINTON, Judge.

Defendant has appealed a judgment based upon a jury verdict awarding plaintiff both compensatory and punitive damages.

The controlling facts in the case are not in material dispute. Appellee's decedent, David F. Stickney, sustained a lower back injury in an automobile accident on June 17, 1966. He consulted one Dr. Davis, an orthopedic surgeon practicing in Daytona Beach, and it was determined that he had suffered two herniated discs which required laminectomies of the L4 and L5 vertebrae and a spinal fusion to prevent the recurrence of residual pain from the disc removals between the L4, L5, and S1 levels. The operation was performed by Dr. Davis on July 26, 1966, in which the product, Boplant, produced and sold by appellant-Squibb, was used as grafting material and was obtained from a shipment previously supplied to Halifax Hospital in Volusia County where the operation took place. The surgical procedure performed on Stickney appeared to be satisfactory, and he was discharged from the hospital in due course.

Three years following his operation Stickney returned to Dr. Davis with recurring back pain. X-rays showed a marked resorption of the graft, so another operation was performed by Dr. Davis on September 3, 1969, and the Boplant originally implanted in Stickney's spine was removed. It was found that the implant material was not united to the vertebrae nor was it replaced by new bone. Surgical investigation revealed that the graft was practically eaten away, was thinned down to one-third of its original thickness, and was encircled by fibrous membrane. The graft failed because the implant material had been rejected and isolated as a result of an antigenantibody response to the implant material itself. A refusion was performed by Dr. Davis in which he used bone taken from Stickney's body, which operation proved successful.

Stickney brought this action against Squibb and claimed damages suffered by him as a result of the use of Squibb's product, Boplant, in his initial operation. His cause of action was based upon the alternative allegations of negligence, breach of implied and express warranty, and fraud. The jury returned a verdict awarding compensatory damages in the amount of $70,000.00 and punitive damages in the amount of $500,000.00, upon which judgment was entered. It is from that judgment that this appeal is taken. During the pendency of this appeal Stickney died and his personal representative had been substituted in his place as party appellee herein.

Since Stickney's cause of action revolves around the use by him of a product produced and sold by appellant, a review of the record concerning the development, manufacture, and sale of the product is in order. From the evidence it appears that for many years medical science has been intensely interested in developing a process by which animal bone might be made suitable for implantation in the human body in connection with orthopedic bone grafting procedures. The desirability of developing a processed animal bone for this purpose stems from two primary considerations. The most desirable bone implant as a grafting material is what is known medically as autogenous bone taken from one part of the patient's body and implanted in another part of the body where the defect exists. The advantages of this type of bone implant is that it normally will not produce an antigen-antibody reaction in the implant site and possesses an osteogenic or bone-making capacity of its own which complements that of the host bone in producing a successful graft. The procedure for utilizing autogenous bone has marked disadvantages, however, in that it requires two operations simultaneously at different sites in the patient's body; such second operation presents possibilities of infection, discomfort, morbidity, and other harmful effects. Another type of bone grafting material used in orthopedic bone grafting procedures is known medically as homogenous bone. This type of bone is taken from another human being and procured either from a live donor or from a bone bank in which the bones of deceased humans are stored. The utilization of homogenous bone in orthopedic procedures is highly impracticable because of the lack of donors, the scarcity of bone banks over the country, and the difficulties experienced in storing and preserving the bone until needed. It is because of the disadvantages and undesirable results which flow from the use of both autogenous and homogenous bone as grafting material that efforts were made over a period of many years to develop a process whereby readily available animal bone could be made acceptable for this purpose.

In response to the foregoing need, Squibb inagurated in the 1950's a program of studies and experiments with bovine bone in an effort to develop a process which would make it a useable implant material in orthopdedic bone grafting procedures. Bone of this type is characterized by the medical profession as heterogenous bone to distinguish it from the other two types of bone taken from human beings. It is an established fact that bovine bone contains a high degree of protein known as antigens. When the bone containing such antigens is implanted in another animal or a human being, the body produces antibodies which cause a rejection reaction resulting in an incapsulation of the implant bone and its resorption by the bodily processes of the host tissue. Such reaction which normally occurs as a result of the proteincontaining antigens present in the implant bone causes the graft to fail. The research which Squibb undertook was directed toward the development of a process whereby the major antigens in the calf bone could be extracted without significantly altering the mechanical or biological properties of the bone to such a degree as to render it useless as a grafting material. By a series of clinical studies and laboratory experiments with both animals and human beings extending over a number of years, Squibb developed a process by which practically all of the antigen properties normally present in the bone of a baby calf were removed, leaving a nearly sterile bone for use as an implant material. The testimony of the medical scientists is to the effect that only by further subjecting the processed bone to boilding under intense heat could it be completely freed of all antigen properties, but to do so would destroy the structural qualities of the bone and its use for the purpose intended.

In its laboratory experiments and clinical tests Squibb confined its efforts to the development of four different forms of implant material for use in different types of surgical procedures. One form was the cortical strip consisting of the outer layer or bark of the bone; another was the cancellous slab consisting of the spongy cellular mass beneath the bark; another was the ground cancellous slab which consisted of cancellous bone ground into small granules; and, finally, the rib matchsticks composed of a sandwich-like arrangement with cortical bone on each side and cancellous bone in the center.

In the first human clinical trials conducted by Squibb, its processed implant material in all its various forms was used by 27 orthopedic surgeons in performing operations on 400 patients. The clinical success rate attained in these 400 cases was reported by the surgeons to have been in excess of 90%. A similar success rate had previously been experienced by independent research scientists as well as Squibb's research staff in the performance of orthopedic procedures on animals. The results of these clinical experiments were widely publicized in medical journals, in published manuscripts and summaries, and in papers read at medical seminars over the country.

After Squibb had developed its process to the highest degree attainable by it at the time, it applied to the Food and Drug Administration of the United States in February, 1962, for authority to commercially produce and offer for sale its newly developed product to be marketed under the trade name of Boplant. Squibb's application recited in detail the source, composition, processing, and testing of its product. For the next approximate 2 1/2 years the FDA made consecutive demands and requests upon Squibb for more complete detailed information, explanations, specifications, and clinical test data concerning the process developed by it and the product for which approval was sought. After studying and verifying such data and satisfying itself as to the safety and effectiveness of Boplant for use as a bone grafting material in orthopedic surgical procedures, the FDA issued its formal approval of Squibb's application on November 9, 1964. This approval was subject only to proper labeling and packaging of the product as might later be recommended by the FDA. Accordingly, Squibb included as an insert in its packaged product a warning statement and other information recommended by the FDA concerning the use of Boplant.

After receiving approval from the FDA on November 9, 1964, and prior to February, 1966, Squibb processed and commercially distributed more than 23,800 market packages of Boplant which included 5,253 packages of cortical strips. (Attention is focused on this form of Boplant because it was the type used by plaintiff-Stickney's orthopedic surgeon in the operation which forms the basis of this action.) The record reveals that...