V. Mueller & Co. v. Corley, 17127

• Decision Date: 27 July 1978
• Docket Number: No. 17127,17127
• Citation: 570 S.W.2d 140
• Court: Texas Court of Appeals
• Parties: V. MUELLER & COMPANY et al., Appellants, v. Albert CORLEY et ux., Appellees. (1st Dist.)

Page 140

570 S.W.2d 140

1 A.L.R.4th 910

V. MUELLER & COMPANY et al., Appellants, v. Albert CORLEY et ux., Appellees.

No. 17127.

Court of Civil Appeals of Texas, Houston (1st Dist.).

July 27, 1978.

Rehearing Denied Aug. 24, 1978.

Les Cochran, Houston, for appellants.

Jamail & Kolius, Richard W. Mithoff, Jr., Nat B. King, Houston, for appellees.

EVANS, Justice.

This personal injury action was brought by Mrs. Norma Corley against Dow Corning Corporation, the manufacturer, and V. Mueller & Company, Inc., the distributor of an allegedly defective silicone breast prosthesis which had been used in a surgical procedure performed on Mrs. Corley. The jury answered all issues of negligence and strict liability in favor of Mrs. Corley and awarded the sum of $170,000.00 as damages. Dow and Mueller bring this appeal.

In September, 1972, Mrs. Corley was referred by her family physician to Dr. E. J. Leeves, a general surgeon, for a condition diagnosed as chronic mastitis. Dr. E. J. Leeves then performed a surgical procedure on Mrs. Corley known as "subcutaneous mastectomy with prosthetic replacement" which involved the excision of the breast tissue underlying the skin flap of her breasts and the replacement of the removed tissue with a prosthesis implant. This procedure was performed without any apparent difficulty, but approximately one month afterward, Dr. Leeves observed that the incision site on Mrs. Corley's left breast was not healing properly. After extracting fluid from the wound with a hypodermic and noting what he believed to be the presence of a silastic fluid in the wound, he removed the implant and observed a tear in the "shell" or "envelope" of the prosthesis. Dr. Leeves performed a subsequent surgical procedure and implanted a second silicone prosthesis, but ultimately he was required to remove that implant because the incision again failed to heal. It was the opinion of Dr. Leeves that the presence of silastic fluid in the wound caused the failure of the wound to heal properly.

On this appeal the defendants contend that the evidence is legally and factually insufficient to support the jury's findings that the tear resulted from a defect in the prosthesis or was caused by their negligence; that the trial court erred in refusing certain requested instructions and definitions and also in the admission and exclusion of certain testimony, and that the jury's award of damages is excessive.

Mr. Arthur H. Rathjen, the senior clinical research specialist for the medical products business at Dow, testified that a silicone prosthesis is a shell or envelope made of silicone polymer which has been cured. The shell is molded on a mandrel, and when it is removed from the mandrel, a small hole, "a little less than the size of a quarter", remains in the back of the shell. The hole is patched, the envelope inspected, and a silicone liquid is introduced with a needle through a point in the silicone patch. The prosthesis is then subjected to a curing process which brings the contents of the shell to a gelatinous consistency, and from that point it passes through various quality control steps. It is then packaged, sterilized and placed in "quarantine" for 14 days, after which more tests and samples are made. The product is designed so that the contents inside the shell do not come into physical contact with the body of the recipient. Dow instructs physicians using the product that nothing sharp is to come in contact with the implant because if the envelope is damaged in any way the product is not suitable for use.

Mr. Tom W. Broadhagen, a Dow Quality Assurance Medical Products Unit employee, testified that each individual prosthesis is inspected under a magnifying lens to examine the surface of the envelope. Each patch is examined and pulled to make sure it is on properly. The prosthesis is then subjected to compression testing whereby all gel is squeezed into 1/2 of the shell, this being done with all four quadrants of the implant under a magnifying lens. If there are any leaks, cuts, or weaknesses in the envelope, the device will rupture during compression testing. Every prosthesis can be traced back to the testing process, the subject prosthesis being one of a lot of 450 which were inspected. Of this lot, 383 prostheses were approved and 67 were rejected. On cross-examination Mr. Broadhagen testified that in order for the prosthesis envelope to develop a tear, it would have to come about as a result of some imperfection on the surface (either a tiny hole, an improper thickness in the shell, or an imperfection imbedded in the shell itself) or as a result of someone cutting or nicking it. He conceded that compression testing was "far from being an exact science" and that the system was not "foolproof." He stated that different amounts of testing pressure would cause the prosthesis to rupture, depending upon the particular defect or weakness involved, but added that such varying pressures would have been well below the threshold of the compression tests conducted at the plant.

Dow represented its silicone prosthesis as being suitable for implantation into the human body and the most reliable restoration procedure to accompany a subcutaneous mastectomy.

Charlotte Seward, the scrub nurse for the surgical procedure on Mrs. Corley, testified that the circulating nurse, Kathy Welch, brought her the package containing the silicone prosthesis. She observed Nurse Welch break the seal on the box, take out the prosthesis and hand it to her. She then passed the prosthesis to Dr. Leeves and observed him place it in the incision in the plaintiff's body. Nurse Seward testified that she did not see Nurse Welch do anything to damage the prosthesis and that she, herself, did nothing to damage it. Nurse Seward did not see Dr. Leeves cut, tear or nick the prosthesis in any way, and from the time the seal on the box was broken until the time the incision was closed, she observed no leakage from the prosthesis.

Dr. Leeves testified that after he had performed the mastectomy on Mrs. Corley, he inserted the prosthesis through a 2 1/2 inch incision below her left breast and then used a "retractor" to cover the prosthesis so it would not be nicked in the suturing process. He examined the prosthesis carefully before its insertion and found no defects. Approximately a month later he found that Mrs. Corley had a separation of the skin at the incision site, and he used a hypodermic to extract fluid from the wound. He felt the fluid after emptying the hypodermic and was sure that it was silicone although he had no laboratory analysis made. He had never seen free silicone gel before and had no prior experience as to its appearance. When he removed the prosthesis he observed a tear approximately 1/4 to 1/2 centimeter in length.

Dr. Donald R. Sheperd, a board certified clinical and anatomical pathologist, examined the prosthesis after its removal in October, 1972. He found a tear measuring 5 centimeters along one side, but could not say what had caused the tear.

Dr. Frank Gerow, a specialist in plastic surgery, testified on behalf of the defendants. He testified that he and another doctor had been involved in the development of the Dow Corning prosthesis, and since 1963 he had performed "four or 500 hundred or more" surgical procedures involving the implant, of which about 100 were subcutaneous mastectomies. Dr. Gerow testified that he had never seen a spontaneous rupture in a seamless implant such as the one inserted in the plaintiff. Although Dr. Gerow was not permitted to give his opinion as to the cause of the tear in the prosthesis implanted in Mrs. Corley, he was allowed to testify as to possible risks. He testified that an implant could be torn by a surgeon in the wound closing process and that even using a shield or retractor, a potential existed for tearing because "you can catch the edges of the implant along the side of the malleable." He also testified that silicone gel was too viscous a substance to be manually aspirated through a hypodermic needle of the size used by Dr. Leeves.

The jury was submitted issues under theories of both strict liability and negligence. In response to the strict liability issues, the jury found that "the form or material or performance of the prosthesis in question" rendered it defective as manufactured and that such defect was a producing cause of the occurrence. In response to the negligence issues, which were accompanied by an instruction on res ipsa loquitur, the jury found that the failure of the "form or material or performance" of the prosthesis was due to the negligence of the defendants and that such negligence was a proximate cause of the occurrence.

It was the plaintiff's burden under either theory of recovery to prove the defective condition of the product at the time it left the control of the manufacturer or seller. Jack Roach-Bissonnet, Inc. v. Puskar, 417 S.W.2d 262 (Tex.1967); Bass v. General Motors Corp., 491 S.W.2d 941 (Tex.Civ.App. Corpus Christi 1973, writ ref'd n. r. e.). It was not essential that the plaintiff identify the specific engineering or structural cause of the defect. Bell Aerospace Corp. v. Anderson, 478 S.W.2d 191 (Tex.Civ.App. El Paso 1972, writ ref'd n. r. e.). However, the plaintiff was required to trace the defect to the manufacturer. Coca Cola Bottling Co. v. Hobart, 423 S.W.2d 118 (Tex.Civ.App. Houston (14th Dist.) 1967, writ ref'd n. r. e.).

The evidence shows that the prosthesis reached the hospital in a sealed, sterilized container. There was testimony that the prosthesis was not damaged by the nurses or the physician from the time it was taken from the sealed container until it was placed in a Mrs. Corley's body, and Dr. Leeves denied that he had cut or nicked the prosthesis during the suturing process. Dr. Leeves testified:

"Q. From the time it was removed from the sealed container by Nurse Welch to the time it was placed in the body of Mrs. Corley,...