1997 WL 69858
No Publication
(Cite as: 1997 WL 69858 (Tex.App.-Hous. (1 Dist.)))
<KeyCite History>
Only the Westlaw citation is currently available.
NOTICE: NOT DESIGNATED FOR PUBLICATION. UNDER TEX.R.APP.P. 47.7 UNPUBLISHED OPINIONS MAY NOT BE CITED AS AUTHORITY.
Court of Appeals of Texas,
Houston (1st Dist.).
Maxine CASON, Billy Cason, Joyce Englehardt, Randall Englehardt, Diane Harper,
Robert Harper, Theresa Lapoint, Robert Lapoint, Donna Shaw, and William Shaw,
Appellants
v.
E.I. DUPONT DE NEMOURS & COMPANY, BAYLOR COLLEGE OF MEDICINE, and Louisiana
State University, Appellees
No. 01-94-01191-CV.
Feb. 20, 1997.
On Appeal from the 295th District Court Harris County, Texas Trial Court Cause No. 93-11874-A.
OPINION
MIRABAL.
*1 This is a products liability case. Appellants sued appellees, E.I. DuPont de Nemours & Company (DuPont), Baylor College of Medicine (Baylor), and Louisiana State University (LSU), for injuries they allege were caused by implants placed in their temporomandibular (jaw) joints (TMJ). Appellants appeal the summary judgments granted in favor of DuPont and Baylor and appeal the special appearance and plea to the jurisdiction granted in favor of LSU. We affirm.
Overview
DuPont sells polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP) under the registered trademark "Teflon." DuPont is involved in this case because it sold PTFE and FEP to Vitek, a company formed by Dr. Charles Homsy. [FN1] Vitek used PTFE and FEP in making medical devices, including the TMJ implant at issue in this case. Appellants, who received the TMJ implants, sued DuPont under theories of strict liability, negligence, and "concert of action." Appellants sued Baylor for negligence in hiring and in supervising Dr. Homsy and for failing to warn them of the dangers of the TMJ implant developed by Homsy. Appellants also sued LSU for negligence, claiming LSU was liable because its employee, Dr. Kent, helped design and develop the TMJ implant.
FN1. Vitek is in bankruptcy and is not a party to this case.
Factual Background
DuPont's Products
PTFE is a generic chemical name for a type of fluoropolymer. Other manufacturers make and sell PTFE. PTFE became best known to the public in 1961 when nonstick frying pans, made with Teflon PTFE, were introduced in the United States. The chemical properties of PTFE make it difficult for it to bond with other materials or even itself. It is a slippery, nonwettable substance. PTFE's properties make it prone to abrasion. PTFE is sold in different forms, such as resin, powder, and fibers. Each of these forms is further differentiated into various grades or types.
Over the past 52 years, a wide variety of products and materials made with or containing PTFE have been created by manufacturers, including seals on car transmissions, parts in valves, quartz crystals, tubing, piston rings used in Navy submarines, and ball bearings and antenna insulators used in spacecraft and satellites. However, this case involves the use of PTFE in the TMJ implant. DuPont sold FEP and PTFE resin, powder, and fibers to Vitek. Like its sales to other manufacturers of products, DuPont sold its Teflon PTFE and FEP to Vitek in bulk form.
Homsy
Dr. Charles Homsy, who received a doctorate degree in chemical engineering, worked at DuPont from 1959 to 1966. His work at DuPont did not involve the medical application of any DuPont products. In 1966, he proposed to DuPont a venture study to consider using polymers for orthopedic prosthesis. DuPont rejected his idea. Homsy left DuPont in mid-1966. He accepted a job in biomaterials research at The Methodist Hospital in Houston. The hospital appointed him director of its prosthesis research laboratory, which pioneered work in human implants. Baylor and the University of Texas Medical Center appointed Homsy to research professorships. He taught medical students about man-made implant materials in the human body.
*2 In 1967, Homsy bought Teflon PTFE from DuPont. Before DuPont would agree to sell PTFE, it sent a letter, dated March 13, 1967, to Methodist Hospital and to Homsy advising that DuPont did not make Teflon fluoropolymers for medical use and that it had not conducted the detailed long-term studies necessary to determine its suitability for medical use. The letter provided:
Since the proposed use of these industrial materials is in the medical field, it is necessary for us to write you as follows.
I should point out that DuPont "Teflon" is not made for medical use. While we carry out such tests as are needed to protect the ordinary users of our products, we do not perform the detailed long-time studies which should be made before these products are employed for purposes such as in medicine and surgery. Accordingly, we are reluctant to encourage the use of "Teflon" for surgical purposes.
The letter advised Homsy and the hospital of medical studies reporting problems with Teflon:
There is a growing awareness of the lack of basic knowledge concerning the properties required of a synthetic material when it is used to replace bone, fascia, blood vessels or other body tissues. Moreover, articles have appeared ... suggesting that films of some modern plastics produce neoplasms when embedded for many months in the bodies of experimental rats. [Dr. John] Charnley ... reported tissue reaction from abraded particles of polytetrafluoroethylene. Furthermore, much of this material was reported as having produced foreign body reactions on skin....
In the letter, DuPont conditionally agreed to sell Teflon products to the hospital:
Since we have no knowledge of the suitability of "Teflon" for your medical use, and since the contemplated use is one that you propose and has not been recommended by us, it must be understood that you are relying upon your own medical judgment as to its safety and effectiveness. Therefore, we will provide you with material that you are ordering and such "Teflon" as you order in the future only on the understanding that you assume full responsibility for any consequences which may result directly or indirectly from its use.
Accordingly, if you are in agreement with the conditions outlined above, will you indicate your acceptance of these conditions by having an authorized representative of your hospital sign and return to us the enclosed copy of this letter.
Homsy signed and returned the letter on March 20, 1967. In his letter to DuPont, he commented on the studies cited in its letter:
Your references to the literature which suggests that implantation of films of plastics into rats produces neoplasms, are crucially incomplete. The original authors ... subsequently have shown that a solid sheet of practically any plastic or metal produces neoplasms and that incidence of the latter relates to response to mechanical form rather than to physio-chemical interaction of a given material....
*3 More recently, Calnan ... concluded from detailed histological studies with solid implants in rats, that TFE polymer induces notably less tissue reaction than all other plastics commonly used in modern surgery. He went on to recommend that "use of materials other than TFE polymer should be abandoned."
Charnley's report of tissue reaction from abraded particles of TFE, in the absence of comparative data, should rationally be ascribed to the mechanical form of the material and not to specificity of reaction to TFE polymer. Charnley's use of unfilled TFE for hip prostheses would naturally dispose to abrasive wear of the polymer. He will be here in April for a symposium on the "Painful Hip"; at that time I hope to inquire further on his work.
Homsy wrote and met with Charnley on several occasions, as far back as 1966. [FN2] Thus, when he began purchasing PTFE from DuPont, Homsy was aware of Charnley's studies and also with the studies of John Leidholt, an orthopedic surgeon who, in 1964, had reported results similar to Charnely's in a study involving unfilled PTFE implants in the hips of nine dogs. Leidholt concluded that straight or unmodified Teflon was unsuitable because of wear and deformation and should not be used in any part of a prosthesis in weight- bearing joints. Similarly, Dr. John Lontz, a DuPont employee, wrote a paper discussing the problems of plastic in joint prostheses and discussing similar problems encountered by Leidholt. The record does not show whether Homsy knew of Lontz's paper; however, in his deposition, Homsy testified that there was a wealth of literature on the use of PTFE and the successful use of PTFE in the human body.
FN2. In 1963, Dr. John Charnley wrote a letter to the editor of a scientific journal, The Lancet, in which he warned surgeons, especially orthopedic surgeons, that tissue reactions are likely to follow the implantation of PTFE because the material is subject to abrasion.
In 1981, Homsy wrote a chapter in a biomaterials treatise in which he reiterated the concerns about the use of solid, unfilled PTFE implants inside a hip joint and stated that the use of unreinforced PTFE polymer in the load- bearing hip joint is inappropriate in view of the bearing wear performance of the material. He testified that Charnley's experience with PTFE had little relevance to his experience with PTFE because, for his implants, he was using pure (cleanly manufactured) PTFE in Proplast, which is a compounded material containing PTFE, not a solid unfilled PTFE.
Proplast and the TMJ implant
In 1968, Homsy invented Proplast, an implant biomaterial. Proplast is a porous implant material designed to encourage tissue ingrowth. Proplast is a composite material in which filler material such as carbon fibers, aluminum oxide, or other materials are added to PTFE to change the surface energy characteristics and to increase its surface area. In the 1970s, Homsy patented both Proplast and the process for making it. Briefly, the process involves mixing PTFE powder and fibers with other ingredients, such as carbon or aluminum oxide, filtering the mixture, compressing it, rolling it, drying it, sintering it (that is, applying high heat and high pressure), leaching, and redrying.
*4 When PTFE undergoes the process creating Proplast, its molecular structure does not change, but its physical properties do. PTFE is a nonwettable, slippery solid; however, Proplast, as designed and manufactured with carbon or aluminum oxide additives, is wettable, spongy, and highly porous.
DuPont created the HS-10 process while Homsy worked there; in fact, Homsy worked on developing the process. The HS-10 process involves adding fillers or additives to PTFE and then blending, filtering, compressing, and rolling out sheets of the filled material. There is evidence that the process is very similar to Vitek's process for making Proplast. There is also evidence that DuPont knew Homsy was using a process similar to the HS-10 process.
Homsy began to test the uses of Proplast. He presented information about animal studies, laboratory studies, and clinical studies involving the use of Proplast to the Institutional Review Board (IRB) at Baylor and at Methodist Hospital. The clinical studies he submitted included stabilizing hip implants and knee ligaments with the use of Proplast. The Methodist and Baylor IRBs reviewed and approved Homsy's research protocols.
In 1969, Homsy formed Vitek to commercially develop discoveries from the prosthesis research laboratory (PRL) at Methodist Hospital. Vitek performed studies and testing on Proplast. It conducted laboratory testing, animal studies, and clinical studies on humans. For example, in the early 1970s, Vitek conducted a five-year study, involving 12 different university hospitals, in which 900 patients received various forms of Proplast and were evaluated with successful results. Vitek also successfully tested Proplast implants in numerous applications, including an artificial metal condyle (used in the jaw) coated with Proplast to adhere to the jaw and Proplast as bone replacement in reconstructive surgery.
In May 1977, after the passage of the medical device amendment to the Food, Drug and Cosmetic Act, DuPont wrote Vitek in response to its request regarding the sale of PTFE:
Your letter ... requesting DuPont's cooperation in meeting the proposed additional FDA requirements for medical implant manufacturers has been forwarded to this office.
As I am sure your company is already aware, Teflon fluorocarbon resins are made for industrial purposes only, and we market no medical or surgical grades. A statement of policy on this position is enclosed.
DuPont asked Vitek to sign and return a copy of its medical disclaimer, which stated:
The following is a statement of the conditions under which [DuPont] can supply either experimental or commercial quantities of its resins for medical or surgical purposes. By signing and returning to us a copy of this statement, persons contemplating such uses must understand and accept these conditions and must assure us the applicable legal requirements are being met before any shipments can be made or any technical help extended with respect to such uses.*5 DuPont Teflon fluorocarbon resins and Tefzel flouropohymers are made for industrial purposes only. We conduct such tests as are needed to protect the ordinary users of these products but do not perform the detailed, long-term studies which should be made before they are used for medical or surgical purposes. We make no medical or surgical grades and have not sought or received any rulings from the Federal Food and Drug Administration or from any governmental agency as to the safety or effectiveness of these products for such purposes.
Persons proposing to evaluate or to use these products for medical or surgical purposes must rely on their own medical and legal judgment without any representation on our part. They must accept full responsibility for all consequences, either direct or indirect. Any data or other information from DuPont is supplied in good faith but its applicability in any particular situation must be determined by the recipient.
It must further be understood that there is no guarantee of a constant composition with these resins. Our products are produced to within narrow specifications, but deliberate changes in formulation may occur and tests run at one time may not be adequate proofs of safety or suitability at some later date.
Homsy, as president of Vitek, signed the medical disclaimer with the following amendment:
Material received will be used only under a "Notice of Claimed Investigational Exemption" which I have filed with the U.S. Food and Drug Administration and that all clinical tests on humans will be conducted by me or under my immediate supervision in complete accordance with the Federal Food, Drug, and Cosmetic Act, as amended, and pertinent regulations thereunder.
Vitek began to sell Proplast in 1974. For example, Vitek sold sheets of Proplast laminated with FEP on one side or with silicone rubber on one side for use in facial plastic surgery. Before selling these products, Vitek performed laboratory and animal studies. Throughout the time that Vitek sold FEP laminated to Proplast, there were no reports made of foreign-body reactions.
Vitek learned Dr. Kent, an oral surgeon at LSU and later a consultant for Vitek, successfully used FEP laminated to Proplast in the TMJ in clinical studies. From 1975 to 1981, Kent used the material in two ways, as a cap over the condylar head and as a replacement for the disc itself. In 1982, Kent approached Vitek about making an implant for the TMJ. Kent designed, and in 1983 Vitek sold, the product at issue in this case known as the TMJ Interpositional Implant (the TMJ implant). Vitek also sold the glenoid fossa implant. Homsy testified that, before making the implant, he questioned Kent about the load in the TMJ and that Kent gave Vitek the results of animal and clinical studies and publications. Vitek used this information to calculate the maximum load through the TMJ and determined that the implant was appropriate.
Homsy was not alone in his opinion regarding the use of PTFE. Another researcher, Dr. H.P. Cook, published a study that appeared to demonstrate that Teflon cloth may be successfully used as an implant in the TMJ. He reported that the TMJ is not, as in the case of the hip joint, under heavy load. He reported that his experience showed that Teflon cloth in that situation would not fragment in the same way.
FDA approval
*6 Vitek sought FDA classification of Proplast as a medical device. Vitek made presentations to three FDA panels. The FDA review panels had their own pathologists who reviewed tissue slides from various Proplast uses and concluded that the Proplast implants had normal tissue reactions. In 1980 and 1982, the FDA recommended that Proplast be authorized for prescription-only sale as a Class II dental device, an ear, nose and throat device, and a general and plastic surgery device. The FDA noted that Proplast had been established through long-term clinical trials.
In March 1983, the FDA authorized the sale of the Proplast TMJ Interpositional Implant. When the FDA approved the sale of the implant, it knew of the earlier problems with the PTFE hip replacement. As required by law, Vitek sold the implants with package inserts containing indications, contra- indications, instructions for use, advice about adverse reaction and warnings to the prescribing doctors. Appellants received the TMJ implants in 1985 and 1986.
DuPont's summary judgment
In point of error one, appellants contend the trial court erred by granting DuPont's motion for summary judgment. Appellants contend that DuPont's motion was defective because it did not dispose of all causes of action, and they contend fact issues exist to preclude summary judgment.
Standard of review
Summary judgment is proper only when a movant establishes that no genuine issue of material fact exists, thereby entitling the movant to judgment as a matter of law. Randall's Food Mkts., Inc. v. Johnson, 891 S.W.2d 640, 644 (Tex.1995). In reviewing the summary judgment, we must indulge every reasonable inference in favor of the nonmovant and resolve any doubts in its favor. Id. A defendant is entitled to summary judgment if the evidence disproves as a matter of law at least one element of each of the plaintiff's causes of action. Lear Siegler, Inc. v. Perez, 819 S.W.2d 470, 471 (Tex.1991); Marchal v. Webb, 859 S.W.2d 408, 412 (Tex.App.--Houston [1st Dist.] 1993, writ denied).
In its order, the trial court did not state the grounds on which it granted summary judgment. Because the order does not specify the grounds on which the trial court granted summary judgment, we will affirm the summary judgment if any of the theories advanced is meritorious. State Farm Fire & Cas. Co. v. S.S.,tp:/ S.W.2d 374, 378 (Tex.1993); Jones v. Legal Copy, Inc., 846 S.W.2d 922, 924 (Tex.App.--Houston [1st Dist.] 1993, no writ).
Federal preemption
As a threshold issue, DuPont argues that the provisions of the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act, 21 U.S.C.S. § 360 (Law.Co-op.1984), preempt appellants' state law claims; therefore, the summary judgment should be affirmed on this ground. We disagree.
*7 The MDA specifies the classes of persons who must register their device manufacturing operations with the FDA, register their devices and warnings with the FDA, and convey thhavernings and labels to users of the devices. 21 U.S.C. § 360(c). In 1976, the FDA commissioner exempted from registration a manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the MDA. 21 C.F.R. § 807.65 (1976). The FDA commissioner found such registration was not necessary to the public health. Id. DuPont argues that appellants' state law claims are preempted; otherwise, the claims would result in a direct collision with federal policy.
Two courts have rejected this argument. Jacobs. v. E.I. DuPont De Nemours & Co., 67 F.3d 1219, 1236 (6th Cir.1995); Lamontagne v. E.I. DuPont De Nemours & Co., 834 F.Supp. 576, 586 (D.Conn.1993), aff'd, 41 F.3d 846 (2d Cir.1994). They concluded that an exemption in FDA regulations, stating that a raw material manufacturer need not comply with the agency's requirements, cannot also be read to say that federal law eliminates the applicability of any common law duties, including a duty to warn. Jacobs, 67 F.3d at 1236. The MDA and regulations do not provide that manufacturers of raw materials shall not be regulated; "[r]ather, the FDA has simply determined that for its own purposes such regulation is unnecessary.... State law requirements ... thus will not run afoul of any express provision of the MDA or any pronouncement of the FDA." Lamontagne, 834 F.Supp. at 586. We agree with this reasoning.
We hold that preemption under federal law does not provide a basis for affirming the trial court's summary judgment. Therefore, we will address the appropriateness of summary judgment on appellants' state law claims.
Strict liability
Appellants alleged a cause of action for strict liability under section 402A of the Restatement (Second) of Torts (1965). [FN3] Section 402A provides that one who sells any product in a defective condition unreasonably dangerous to the user or consumer, or to his property, is strictly liable for physical harm caused to the ultimate user or consumer or to his property. Barnes v. General Motors Corp., 653 S.W.2d 85, 88 (Tex.App.--San Antonio 1983, writ ref'd n.r.e.); see Lucas v. Texas Indus., 696 S.W.2d 372, 377 (Tex.1984) (op. on reh'g). Appellants assert that DuPont is liable under section 402A because its Teflon products had both manufacturing and marketing defects.
FN3. Texas has adopted section 402A of the Restatement. McKisson v. Sales Affiliates, 416 S.W.2l>On7, 789 (Tex.1967).
Manufacturing defect claim
To recover for a manufacturing defect under strict liability, a plaintiff must show a manufacturing flaw that renders the product unreasonably dangerous; that the defect existed at the time the product left the seller; and that the defect was the producing cause of the injuries. Fitzgerald Marine Sales v. LeUnes, 659 S.W.2d 917, 918 (Tex.App.--Fort Worth 1983, writ dism'd). A defective product is unreasonably dangerous. Mitchell v. Fruehauf Corp., 568 F.2d 1139, 1142 n. 1 (5th Cir.1978); Blackwell Burner Co. v. Cerda, 644 S.W.2d 512, 515 (Tex.App.--San Antonio 1982, writ ref'd n.r.e.). A manufacturing defect exists when a product does not conform to the design standards and blueprints of the manufacturer, and the flaw makes the product unreasonably dangerous for its intended or reasonably foreseeable uses. USX Corp. v. Salinas, 818 S.W.2d 473, 482 n. 8 (Tex.App.--San Antonio 1991, writ denied).
a. Procedural argument
*8 Appellants contend that the motion for summary judgment did not assert a specific ground that a manufacturing defect did not exist, and the summary judgment, therefore, should be reversed under McConnell v. Southside Indep. Sch. Dist., 858 S.W.2d 337 (Tex.1993).
DuPont filed its original motion for summary judgment in March 1994. In May 1994, appellants amended their petition to add a manufacturing defect claim. On June 1, the trial court signed an order permitting DuPont to amend and to supplement its pending motion to address appellants' newly raised claim. The order provided that any additional filing by DuPont would be in addition to, and would not displace, its pending motion.
On June 8, DuPont filed its supplemental and amended motion for summary judgment, which addressed the manufacturing defect claim as a ground for summary judgment. The amended motion provided that it was filed in accordance with the trial court's order. In its amended motion, DuPont raised a new ground specifically addressing appellants' manufacturing defect claim and supported it with summary judgment evidence.
b. Fact issue as to PTFE contamination
Appellants alleged that DuPont's PTFE and FEP were defective because they were contaminated. Contamination is a form of a manufacturing defect. See Shamrock Fuel & Oil Sales v. Tunks, 416 S.W.2d 779, 782 (Tex.1967). They assert that a fact issue exists as to whether DuPont's products were contaminated with glass, silica, or other matter.
John Prewitt, director of manufacturing at Vitek from May 1985 to 1988, testified that he tested polymers for wear. While he was at Vitek, DuPont PTFE fiber and resins were used to make Proplast. To his knowledge, Vitek always used DuPont PTFE and FEP in the TMJ implants. Vitek's specifications called for virgin grade PTFE (meaning it had no additives or processing aids). Vitek received from DuPont the virgin grade of PTFE for its specifications. Vitek did not depart from its specifications. Vitek did not alter the PTFE or FEP before processing it into Proplast.
Prewitt testified that Vitek's quality assurance department checked raw materials purchased. The materials' containers were checked to ensure they were the correct specification, i.e., the correct type and grade. Also, several tests were performed on the material received to ensure it conformed with Vitek's specifications. Homsy testified he preferred DuPont PTFE powder over that of another manufacturers' because he believed the other had a potential for contamination. Also, from working at DuPont, he had a high opinion about the care that DuPont used in manufacturing its products to its own specifications.
Appellants' chemistry expert, Dr. McCormick, testified that he had only analyzed the material bonded to an artificial metal condyle, one type of jaw implant, not at issue here. He had not analyzed the TMJ implant at issue. He assumed that the material was a flourinated polymer, at least part of which contained PTFE. His assumption was based on reading Homsy's patent. With respect to particulate matter in the unimplanted device he analyzed, he observed aluminum oxide pigment at various levels of dispersion. These particles would come from the aluminum oxide added to the PTFE (i.e., from the Proplast). He also observed fiberglass rods, uniform in diameter, at the interface between the resin on the metal alloy and the flourinated resin interior of the device. He concluded that these fibers were the FEP/PTFE interface described in the patent. He testified that generally glass fibers are added to polymers for reinforcement.
*9 He testified that the particulate material he observed in the device was a function of the composite nature of the whole device, in other words, as the device is put together. He testified, hypothetically, that if there were particles in the process of making the PTFE resin, then that would be a problem. He testified that PTFE is prone to particulate material. McCormick testified that PTFE in itself is not qualitatively a bad material, and in fact, has many good uses and successes.
This evidence does not raise a fact issue that the PTFE used in the TMJ implant was contaminated. The evidence shows that any glass or particulate matter observed by appellants' expert--in another type of implant--resulted from the fillers mixed with the PTFE by Vitek or placed by design in the implant.
Another of appellants' experts testified that, when PTFE is fabricated in porous form, as in Proplast, the likelihood that unsintered fine particles of the PTFE resin would fall out and cause a virulent inflammatory response is increased. This may be true, but it does not raise a fact issue that the PTFE received from DuPont--before it was filled with material and sintered by Vitek to make Proplast--was contaminated.
Appellants also rely on the testimony of Dr. Lontz, who retired from DuPont in 1972. He testified that glass or silica was used as filler for Teflon composites, beginning in the 1950s and continued to be used during his employment at DuPont. He testified that the degree of silica used would be determined by DuPont's customers' specifications. He testified that Teflon with a greater silica content would be more porous.
Again, this evidence does not raise a fact issue regarding whether the DuPont PTFE used by Vitek to make the TMJ implant was contaminated. The evidence merely shows that the degree of filler in Teflon PTFE was determined by DuPont's customers' specifications. Vitek's specifications called for virgin PTFE, not Teflon composites.
No fact issue exists with respect to appellants' claim that the DuPont PTFE in their TMJ implant was contaminated.
c. Fact issue as to FEP contamination
Prewitt testified that the quality assurance department at Vitek inspected all materials received. During the time he was with Vitek, the FEP he tested for Vitek was manufactured by DuPont. He testified that, during this time, the FEP layer in the TMJ implant was DuPont FEP. He testified that the DuPont FEP actually used in the implants met Vitek's specifications. In November 1985, Prewitt wrote the distributor that sold DuPont FEP to Vitek because he discovered in testing samples of FEP that they contained more "black spots" than acceptable to Vitek. He did not analyze the black spots. He reported the number of black spots of the films exceeded the number allowed by Vitek's specifications. Vitek accepted FEP film with no more than three spots per square centimeter for thin films and ten spots per square centimeter average for thick films. Vitek did not accept FEP that did not meet its specifications.
*10 A DuPont memorandum, dated February 1986, discussed samples of FEP film returned by Vitek because the samples contained high levels of black particle contamination. The memorandum concludes that the film would be unsuitable for a critical "optical" application such as Vitek's. [FN4] An expert for appellants testified that if the FEP at the surface were contaminated, the contaminants would become liberated and enter the body.
FN4. Prewitt testified that Vitek did not use FEP in any optical application.
Again, this evidence does not raise a fact issue that the FEP used in appellants' implants did not meet Vitek's specifications. The evidence merely shows that some FEP purchased by Vitek did not meet its specifications and was returned. The evidence does not raise a fact issue that the FEP, used to make appellant's TMJ implants, was contaminated.
We affirm the summary judgment on appellants' manufacturing defect claim.
Marketing defect (strict liability failure to warn) claim
Appellants also alleged that DuPont was strictly liable for its failure to warn them of the harm from its products. DuPont moved for summary judgment, asserting it was not liable to appellants because it owed no duty. DuPont asserted that it did not owe a duty because (1) it supplied an inherently safe, multi-use raw material to Vitek, who then used the material to manufacture its own finished product; (2) it supplied raw materials in bulk form to a sophisticated, fully knowledgeable finished-product manufacturer; and (3) it supplied raw materials to an FDA-regulated medical device manufacturer that had an independent duty to warn.
A strict liability action for failure to warn requires a showing that a product is defective and unreasonably dangerous because it lacks adequate warnings or instructions. Salinas v. General Motors Corp., 857 S.W.2d 944, 950 (Tex.App.--Houston [1st Dist.] 1993, no writ); Pearson v. Hevi-Duty Elec., 618 S.W.2d 784, 788 (Tex.Civ.App.--Houston [1st Dist.] 1981, writ ref'd n.r.e.). The existence of a duty to warn of dangers or instruct on the proper use of a product is a question of law. General Motors Corp. v. Saenz, 873 S.W.2d 353, 356 (Tex.1993); Joseph E. Seagram & Sons, Inc. v. McGuire, 814 S.W.2d 385, 387 (Tex.1991); Salinas, 857 S.W.2d at 950. Generally, a manufacturer has a duty to warn if it knows or should know of potential harm to a user because of the nature of its product. Saenz, 873 S.W.2d at 356. The determination of whether a duty to warn exists is made at the time the product leaves the manufacturer. Id.
Strict liability for component part manufacturers is limited when the component part is integrated into a larger unit before distribution. Koonce v. Quaker Safety Prods. & Mfg. Co., 798 F.2d 700, 715 (5th Cir.1986) (applying Texas law); Davis v. Dresser Indus., 800 S.W.2d 369, 370 (Tex.App.--Eastland 1990, writ denied). A component part manufacturer that supplies a product according to a purchaser's specifications is free from strict liability if the component part itself is not defective. Molina v. Kelco Tool & Dies, Inc., 904 S.W.2d 857, 861 (Tex.App.--Houston [1st Dist.] 1995, writ denied). Stated another way, if the component part manufacturer does not take part in the design or assembly of the final system or product, it is not liable for defects in the final product if the component part itself is not defective. Davis, 800 S.W.2d at 370.
*11 DuPont manufactured the PTFE and FEP that was used by Vitek to make Proplast, which then became part of the TMJ implant. We have already determined that no fact issue exists that the PTFE or FEP was defectively manufactured. The evidence shows that DuPont supplied these materials according to Vitek's specification, and that Vitek, as part of its quality assurance, tested these materials when they were shipped to it. No evidence shows that any defective or contaminated PTFE or FEP, not in conformity with Vitek's specifications, was used to make the Proplast, which, in turn, was used to make the TMJ implant. This evidence shows that, because DuPont manufactured a nondefective component part of the TMJ implant, it did not owe appellants a duty to warn as a matter of law.
We conclude that DuPont did not have a duty to warn appellants because it provided a nondefective component of Proplast, the material used to make the finished product. As a component part supplier, DuPont did not have a duty, independent of the finished-product manufacturer, to analyze the design of the completed product that incorporated its nondefective component part. Childress v. Gresen Mfg., 888 F.2d 45, 49 (6th Cir.1989); Davis, 800 S.W.2d at 370.
We disagree with appellants' contention that the PTFE that left DuPont's manufacturing plants was unchanged when it reached end users. PTFE was added with other materials to form a composite material, Proplast. The process altered the PTFE's properties. Moreover, the design and placement of the implant were paramount to its failure. DuPont had no part in creating or designing the finished product.
PTFE is not a defective or inherently dangerous product as manufactured. When manufactured into Proplast, its physical and mechanical properties are altered. The danger posed by the implant was a function of the design of the implant and its location in the joint. The evidence shows that PTFE can be an appropriate material depending on the design and application of the medical device. PTFE was successfully used in medical applications, such as vascular grafts and reconstructive surgery. The evidence shows that there are successful uses of PTFE and Proplast in the human body; the design and placement of the implant in the TMJ posed the danger to appellants.
We affirm the summary judgment on appellants' strict liability failure to warn claim. [FN5]
FN5. Although the above analysis may also apply to a negligent failure to warn cause of action, we will analyze appellants' negligence cause of action independently below.
Negligent failure to warn
Appellants asserted a cause of action, under section 388 of the Restatement (Second) of Torts (1965), for negligent failure to warn. DuPont moved for summary judgment on appellants' cause of action for negligent failure to warn, asserting it owed no duty to appellants. A prerequisite to tort liability is the existence of a legally cognizable duty. Firestone Steel Prods. v. Barajas, 927 S.W.2d 608, 613 (Tex.1996). Again, whether a duty exists is a question of law. Id.; Munoz v. Gulf Oil Co., 732 S.W.2d 62, 65 (Tex.App.--Houston [14th Dist.] 1987, writ ref'd n.r.e.).
*12 A manufacturer, as well as the supplier of a product, has a duty to inform users of hazards associated with the use of its product. Alm v. Aluminum Co. of America, 717 S.W.2d 588, 591 (Tex.1986) (citing section 388 of the Restatement (Second) of Torts (1965)). The issue in a negligent failure to warn case is simply whether a reasonably prudent person in the manufacturer's position would warn of hazards associated with the use of its product. Id.; Munoz, 732 S.W.2d at 65. Thus, DuPont has a duty to warn if a reasonably prudent person in the same position would have warned of the hazards. See Alm, 717 S.W.2d at 591.
A manufacturer or supplier may, in certain situations, depend on an intermediary to communicate a warning to the ultimate user of a product. Alm, 717 S.W.2d at 591; Firestone Tire & Rubber Co. v. Battle, 745 S.W.2d 909, 914 (Tex.App.--Houston [1st Dist.] 1988, writ denied). However, the mere presence of an intermediary does not excuse the manufacturer from warning those whom it should reasonably expect to be endangered by the use of its product. Alm, 717 S.W.2d at 591; Firestone, 745 S.W.2d at 914. The issue in every case is whether the original manufacturer has a reasonable assurance that its warning will reach those endangered by the use of its product. Alm, 717 S.W.2d at 591; Firestone, 745 S.W.2d at 914. Thus, to avoid liability, a manufacturer must affirmatively prove that the warning given by a third party provided the user with actual, adequate, and specific knowledge of the hazard. Firestone, 745 S.W.2d at 914.
In some situations, however, courts have recognized that a warning to an intermediary fulfills a supplier's duty to warn ultimate consumers. Alm, 717 S.W.2d at 591. For example, when a drug manufacturer properly warns a prescribing doctor of the dangers of its product, the manufacturer is excused from warning each patient who receives the drug. Id. The doctor stands as a learned intermediary between the manufacturer and the consumer. Id. at 591-92. In such a situation, it is reasonable for a manufacturer to rely on an intermediary to pass on its warnings. Id. at 592; see Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex.Civ.App.--Corpus Christi 1973, writ ref'd n.r.e.). However, when the warning to the intermediary is inadequate or misleading, the manufacturer remains liable for injuries sustained by the ultimate user. Alm, 717 S.W.2d at 592.
*13 The issue is the same for a bulk supplier--one who sells a product to another manufacturer or distributor who in turn packages and sells the product to the public. Alm, 717 S.W.2d at 592. The bulk supplier need warn only its intermediate distributor and not each individual consumer. Id. However, the supplier's reliance on the intermediary must be reasonable. Id. In other words, the supplier must be sure the intermediary is familiar with the propensities of the product and is thus capable of passing on a warning. Glenn v. Kinco Crane, Inc., 836 S.W.2d 646, 649 (Tex.App.-- Houston [1st Dist.] 1992, no writ). In determining whether a bulk supplier's duty to warn extends to ultimate users of a product, courts may consider whether the intermediary is adequately trained, is familiar with the properties of the product and its safe use, and is capable of passing on its knowledge to consumers. Id.
Appellants argue that DuPont, not Vitek, had the
superior knowledge regarding the use of PTFE in
medical devices and in the TMJ implant, but did not
warn Vitek. Appellants contend that their
We disagree with appellants' contention that Homsy or Vitek was not a learned intermediary and did not possess the technical knowledge regarding the properties of DuPont's PTFE. Appellants contend that because Homsy was not a biologist, pathologist, and toxicologist, he did not have the technical knowledge or training necessary to be a learned intermediary. This argument ignores the summary judgment evidence regarding the years of testing that Vitek undertook in developing Proplast products and the clinical studies that were done in university hospitals to study its application. It ignores that Vitek employed at least one consultant, Kent, who was an oral surgeon and thus medically trained. It ignores FDA approval of Vitek's products using Proplast. Moreover, it ignores Homsy's qualifications and credentials. DuPont's reliance on Homsy or Vitek was reasonable because they were familiar with the propensities of the product and capable of (and required by law to) pass on warnings. Glenn, 836 S.W.2d at 649.
*14 Appellants point to evidence that DuPont knew in the 1960s of problems with the medical use of Teflon. They assert that, armed with this knowledge, DuPont knew that the TMJ implant would fail. We will address appellants' arguments below.
The HS-10 process
To attribute knowledge to DuPont, appellants cite evidence that the HS-10 process developed by DuPont to create a filled Teflon composite and Vitek's process for making Proplast are similar. There is evidence that the two processes are very similar and that DuPont was aware Homsy was using a similar process to make his Proplast. However, even if the two processes are similar, Vitek decided how to employ the process. It decided what materials to combine with PTFE to make Proplast. It controlled the testing of and studies on Proplast. It developed the use of Proplast in, and the design of, the TMJ implant. DuPont did not participate in Vitek's decision to use its raw material in Proplast and did not design the implant that contained its raw material.
Appellants argue that based on DuPont's test results with the HS-10 process, anyone could have foreseen that Homsy's TMJ implants would fail. The evidence shows that DuPont attempted to use the HS-10 process to make hospital bed sheets, a sports jacket, and a heating tray from a composite or filled PTFE, but the process was not commercially feasible. DuPont did not employ the HS- 10 process to make a composite PTFE for use in medical devices. This evidence does not raise a fact issue that DuPont should have foreseen that another composite PTFE, used in a different design and for another purpose, would fail.
The evidence shows that DuPont did not exercise control or take part in the design or assembly of the final product, i.e., the TMJ implant. Vitek did not discuss the TMJ implant with DuPont. The evidence shows that in 1977 Homsy sent DuPont advertising on earlier applications of Proplast. The advertising was for Proplast sheets and blocks used in surgery and for a TMJ prosthesis made of a metal condyle coated with Proplast for external bone fixation. The advertising did not involve the use of Proplast in the joint or the implant at issue.
Dr. Lontz's testimony
Appellants rely on the testimony of Dr. Lontz, who worked for DuPont from 1947 to 1972, to support their contention that DuPont owed a duty to warn ultimate users. Lontz testified about an article he wrote in 1968. In the article, Lontz wrote that a device that includes Teflon and is subject to loading applications will wear. He testified that he was telling the reader that Teflon, when used in a prosthesis, is subject to wear. Lontz agreed this information would be important to Homsy and agreed that DuPont, if responsible, would want those using Teflon to be aware of it. Appellants argue DuPont had a duty to warn Homsy but never told him of this article written by its employee.
We disagree that this testimony established DuPont's duty to warn. First, Lontz testified that he wrote the article on his own and that DuPont had nothing to do with it. Second, DuPont warned Homsy in its 1967 letter. It told him that (1) Teflon is not made for medical use; (2) it tested the product to protect ordinary users, but did not perform detailed long-term studies that should be made before the product is used in medicine and surgery; and (3) it advised him of medical studies reporting problems with Teflon, specifically that particles abrade and might cause tissue reaction. Homsy wrote back that he knew of the medical reports cited in DuPont's letter and more.
*15 Appellants admit, and Lontz testified, that Lontz did not test the medical application of Teflon; his testing was strictly for industrial purposes. Lontz never discussed with DuPont the idea of using porous Teflon in human implants. He learned the mechanical properties of Teflon during his work at DuPont. He testified that, through his testing, he concluded that Teflon in loaded joints had potential wear problems. We note that Lontz's conclusion was the same as the conclusions reached in other medical reports of which both DuPont and Homsy were aware. Lontz testified that his article contained information regarding every aspect of the failure mode of the TMJ implant. He also testified, however, that the information in his 1968 article could not predict the precise failure mode that the TMJ implant experienced, and that proper design of any prosthesis made with Teflon was what was important. He reiterated that he did not write this article in the course and scope of his employment with DuPont. Lontz testified that, if he had known Homsy was using Teflon in a TMJ implant, he would not conclude, based on his knowledge, that it was a bad idea.
Silence and disassociation
Appellants argue that DuPont's policy of "silence and disassociation" is evidence that it owed or breached a duty. The "silence and disassociation" policy was stated in a 1971 DuPont memorandum discussing a possible television commercial on the use of Teflon in vocal chord repair. The memorandum's author states:
The desire for more technical information from DuPont was raised by Dr. Homsy. He said he understood, but did not agree with, DuPont's concern over the liability implications of use of DuPont products as implant devices or drugs when they were not so intended by DuPont. This point is mentioned here only to note that the medical profession apparently would welcome a TV commercial along the lines now being considered, particularly if it signaled, or caused, a reversal of the Company's long-standing policy of silence and disassociation in these matters. Dr. Homsy has done research in the use of "Teflon" sheeting in facial reconstruction--restoration of cheek and jawbones, eye socket etc., which in turn led to "Teflon" being specified as the preferred product for this use in many hospitals....
DuPont's policy to not endorse other companies' finished products that used Teflon is not evidence of a duty to warn. DuPont told Homsy of the wear properties of Teflon and of medical reports regarding the use of Teflon in the human body. DuPont stated that it did not perform the long-term studies for medical application of its products. Its reliance on Homsy was reasonable because he was familiar with the propensities of the product and was capable of (and required by law to) pass on warnings. Glenn, 836 S.W.2d at 649.
The potential joint venture
DuPont had exploratory discussions with Vitek and other companies about the possibility of a joint venture in the orthopedic field. Its discussions with Vitek, however, involved a femoral prosthesis, not the TMJ implant.
*16 Appellants cite a 1986 DuPont memorandum
that assessed a potential relationship with Vitek
involving a femoral prosthesis. The author states
that the development department recommends against
a joint venture with Vitek at the time principally
because such a relationship would not increase
DuPont's market strength and because DuPont
should explore opportunities with major orthopedic
suppliers. The author further comments on
Homsy's and Vitek's technology. He states that
Homsy's technology is not unique. He states that
Homsy's coating a prosthesis with a porous PTFE
composite (Proplast) to secure fixation by tissue
ingrowth is not unique to Vitek. The author further
states that the Proplast structure has not performed
well in trials and may be too soft and crushable,
which could result in abrasion of particulate
material. The author noted that the prosthesis was
very technique sensitive; if fitted just right, it works
well, otherwise, there are a high percentage of
failures. Lastly, the author comments that Homsy's
"short cut to evaluation of prosthesis in humans by
selling 'custom' prosthesis per surgeons
'specifications' may be appropriate for a small firm
like Vitek but might result in too great a liability" for
DuPont.
Again, DuPont's investigation of a potential joint venture with Vitek involved a femoral prosthesis, not the TMJ implant. Its evaluation of Vitek's femoral prosthesis in 1986 did not create a duty to warn appellants about Vitek's TMJ implant. [FN6]
FN6. Appellants also cite a technical brief on vascular and orthopedic implants prepared by DuPont, apparently in 1984. At one point, the report lists the pros and cons of six different materials used for tendon and ligament repair; one of the materials is Proplast. One "con" listed is that the Proplast product has abrasion resistance problems. Again, abrasion problems were known to DuPont and Vitek.
"Medical grade" Teflon
Appellants also contend DuPont knew Vitek advertised that it used "medical grade" Teflon in its products, and at the same time, DuPont maintained it did not make a medical grade Teflon. Appellants contend DuPont did nothing to stop Vitek's misrepresentations about using a "medical grade" of Teflon and argue DuPont knew Homsy and Vitek were unscrupulous.
A 1985 DuPont report noted that neither DuPont's disclaimer that it did not specifically make a medical grade Teflon nor the lack of a designated medical grade material has inhibited the use of DuPont's fluoropolymers in medical applications. The report provides that device manufacturers, which are required to comply with FDA regulations, do not require a medical grade polymer of any kind; consequently, DuPont did not need to develop such a grade of polymer, as one already existed "de facto."
Lontz testified that DuPont did not make a Teflon specifically designated as "medical grade." He testified, however, that Teflon wa, Dr sufficient quality to be used in medical applications. He testified Teflon could have been used in a medical application based upon purity and lack of contamination. Lontz testified that there is nothing about DuPont PTFE and FEP that makes them unsuitable for the use in the human body, and his opinion is not affected by the fact that DuPont does not make a Teflon designated as "medical grade." We disagree that, because DuPont was aware that Vitek represented it used a "medical grade" Teflon in its products, it was aware Vitek was an unscrupulous intermediary. The evidence shows a "medical grade," i.e., a grade of PTFE suitable for use in medical devices, existed de facto, even if DuPont did not market it as such.
*17 DuPont's PTFE and FEP have many industrial uses. Appellants argue, in effect, that DuPont needs to acquire, through experts and long-term testing, as much knowledge as every finished-product manufacturer has about products to which DuPont merely supplies a raw material. DuPont would be required to determine the possible risks associated with each potential use of its raw material. We disagree that DuPont owed such a duty in this case. Whether as a manufacturer of a nondefective component part or as a raw material supplier, DuPont did not owe a duty to warn appellants.
We affirm the summary judgment on appellants' negligent failure to warn claim. Because we affirm the summary judgment on the failure to warn claim for the reasons above, we need not address DuPont's alternative theory, that it did not owe a duty because the TMJ implant was an FDA regulated device.
Tortious concert of action
Appellants alleged that DuPont knew that Vitek's conduct in designing, manufacturing, and marketing the TMJ implants was a breach of Vitek's duty to use ordinary care and that DuPont gave substantial assistance to Vitek to violate that duty. They claim DuPont gave assistance by providing the component parts of the implants; by allowing Vitek to use its technology; by allowing it to use its registered trademark in marketing the implants; and by allowing Vitek to market DuPont's products as medical grade. They claim this assistance proximately caused their injuries. Appellants argue that public policy supports imposing liability on a knowing collaborator and that the summary judgment shows that DuPont was a knowing collaborator.
Under concert of action, those who are in pursuit of a common plan or design to commit a tortious act and actively participate in it or lend aid, cooperation, or encouragement to the wrongdoer are equally liable. Gaulding v. Celotex Corp., 772 S.W.2d 66, 69 (Tex.1989). In Gaulding, the court refused to apply the concert of action theory and declined to approve this theory of liability. Id.; Juhl v. Airington, 936 S.W.2d 640, 39 Tex. Sup.Ct. J. 830, 832 (June 28, 1996) (citing Gaulding, 772 S.W.2d at 71). In Juhl, the supreme court stated that "whether such a theory of liability is recognized in Texas is an open question." Id.
The Restatement (Second) of Torts § 876 (1977) defines the concert of action theory by imposing liability on a person for the conduct of another which causes harm if the defendant:
(a) does a tortious act in concert with the other or pursuant to a common design with the other; or
(b) knows that the other's conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself; or
(c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, separately considered, constitutes a breach of duty to the third person.
*18 In Juhl, the supreme court compared subsection (a) of section 876 with the cause of action for civil conspiracy. 936 S.W.2d 640, 39 Tex. Sup.Ct. J. at 832. Section 876(a) requires at least a tacit agreement to participate in some tortious act, done in furtherance of a common goal or plan, and which causes injury. Id. This has common elements with common law civil conspiracy, which is a long recognized tort in this state. Id. at 832-33. The court noted that a civil conspiracy requires a specific intent to accomplish an unlawful purpose or to accomplish a lawful purpose by unlawful means. Id. at 833. The court concluded that, because negligence is not an intentional wrong, one cannot agree or conspire to be negligent. Id.
In analyzing subsection (b) of section 876, the supreme court noted that it imposes liability not for an agreement, but for substantially assisting and encouraging a wrongdoer in a tortious act. 936 S.W.2d 640, 39 Tex. Sup.Ct. J. at 833. The court held that even if it were to adopt subsection (b), the plaintiff in that case could not recover under its terms because the summary judgment evidence conclusively disproved that the defendants breached any recognized or theoretical duty to the plaintiff. Id. at 833-34.
We have already held that DuPont did not breach any duty to appellants or commit the tortious acts asserted by them. Moreover, the summary judgment shows that DuPont and Vitek did not have a common plan or design to commit a tortious act. DuPont did not substantially assist or collaborate with Vitek in designing, manufacturing, or marketing the TMJ implant. DuPont sold raw materials that became part of the implant; it was not in concert with Vitek. Therefore, even if we were to adopt the concert of action theory of liability, appellants could not recover under its terms.
We affirm the summary judgment on this ground.
We overrule point of error one.
Baylor's summary judgment
In point of error two, appellants contend the trial nd lt erred by granting summary judgment for Baylor because the motion did not address all causes of action against Baylor and because fact issues exist regarding Baylor's negligence in hiring and supervising Homsy and in failing to warn them of the dangers of the TMJ implant.
Procedural argument
Appellants contend the summary judgment must be reversed and the cause against Baylor remanded because Baylor did not raise as grounds for summary judgment appellant's joint enterprise and gross negligence causes of action.
Appellants contend that, in their amended petition, they alleged both a joint venture and joint enterprise theory of liability against Baylor, but Baylor addressed only the joint venture ground in its motion for summary judgment. [FN7] Baylor counters that the two theories are the same; therefore summary judgment for one is summary judgment for both. [FN8] We agree. See LTV Energy Prod. v. Chaparral Inspection, 827 S.W.2d 593, 594-95 (Tex.App.--Houston [1st Dist.] 1992, writ denied).
FN7. Baylor's motion addressed joint venture, while appellants' response to summary judgment only addressed joint enterprise.
FN8. Baylor expressly raised the joint venture theory in its motion for summary judgment. On appeal, appellants did not raise error regarding the trial court's grant of summary judgment on the joint venture theory; therefore, appellants have waived any complaint on appeal about that theory.
*19 Appellants also contend that Baylor did not address its "cause of action for gross negligence" in the motion for summary judgment. However, in their petition appellants did not allege "gross negligence" as a separcaticause of action. As a matter of law, a party's conduct cannot be "grossly negligent" without being negligent. Trevino v. Lightning Laydon, Inc. 782 S.W.2d 946, 949-50 (Tex.App.--Austin 1990, writ denied). Baylor moved for summary judgment on the negligence claim, and as discussed below, the trial court correctly granted summary judgment in Baylor's favor on the negligence claim. As required by McConnell, 858 S.W.2d at 338, Baylor expressly presented "lack of negligence" as a ground for summary judgment. By proving the lack of negligence as a matter of law, Baylor proved that appellants were not entitled to recover actual or exemplary damages for any alleged acts of negligence.
Negligent hiring
Appellants contend Baylor was negligent in hiring Homsy because it knew or should have known he was unqualified to oversee the design of medical devices. Appellants contend Homsy was unqualified because he was not a medical doctor; did not hold advance degrees in immunology, histology, or allergies; was not an oral surgeon; and never had a biology or toxicology course.
The basis of responsibility under the doctrine of
negligent hiring is the master's own negligence in
hiring an incompetent employee whom the master
knows or by the exercise of reasonable care should
have known was incompetent and thereby creating an
unreasonable risk of harm to others. Arrington v.
Fields, 578 S.W.2d 173, 178 (Tex.App.--Tyler
1979, writ ref'd n.r.e.). Thus, Baylor is negligent
in hiring Homsy if Baylor knew or should have
known Homsy was incompetent or unfit for his
employment and Baylor, therefore, created an
unreasonable risk of harm to others.
Liability for negligent hiring and supervising is not dependent upon a finding that the employee was acting in the course and scope of his employment when the tortious act occurred. Dieter v. Baker Serv. Tools, 739 S.W.2d 405, 408 (Tex.App.--Corpus Christi 1987, writ denied). However, there is no question that there must be some connection between the plaintiff's injury and the fact of employment. Id. The negligence in hiring the employee must be the proximate cause of the injuries to the plaintiff. Portlock v. Perry, 852 S.W.2d 578, 583 (Tex.App.--Dallas 1993, writ denied); Dieter, 739 S.W.2d at 408.
Methodist Hospital hired Homsy as director of its prosthesis research laboratory (PRL) in 1966. He was hired by Methodist to establish the research laboratory to use his background in polymer technology to develop prosthetic implants. Homsy was director of the PRL until 1991.
*20 In 1967, Baylor hired Homsy as a part-time research faculty member to teach its medical students. Baylor hired Homsy in the orthopedic surgery department to teach, to help train residents, to assist in research, and to lecture. He also had the use of student assistance in his research activities. When hired by Baylor, Homsy had a doctorate degree from MIT, had obtained a patent on a polymer product, and had seven years of experience in polymer chemistry with DuPont. At the same time he was employed by Baylor, Homsy held other positions, such as a faculty appointment at the University of Texas Dental Branch and an appointment as a bioengineer consultant to the Rice University/Baylor artificial heart project. During his employment, Homsy was widely published in scientific journals in the biomaterials field and was respected in the biomaterials field.Appellants contend Baylor was negligent in hiring Homsy when it knew or should have known that he was utterly unqualified to design medical devices because he did not have a medical background. They contend he should never have been leading a program that developed materials to implant into the human body. However, Baylor did not hire Homsy to design, manufacture, or market any medical devices, nor did Baylor hire Homsy to lead any program that developed implants. There is no fact issue that Homsy was negligent in performing or unqualified for the duties for which he was hired by Baylor, that is, to teach, to help train residents, and to assist in research, or that Baylor was negligent in hiring him for these duties.
Moreover, there is no evidence that any negligence in hiring Homsy was the proximate cause of appellants' injuries. See Portlock, 852 S.W.2d at 583. The components of proximate cause are cause in fact and foreseeability. Doe v. Boys Club of Greater Dallas, Inc., 907 S.W.2d 472, 477 (Tex.1995). These elements cannot be established by mere conjecture, guess, or speculation. Id. The test for cause in fact is whether the negligent act or omission was a substantial factor in bringing about the injury, without which the harm would not have occurred. Id. Cause in fact is not shown if the defendant's negligence did no more than furnish a condition which made the injury possible. Id. In other words, even if the injury would not have happened but for the defendant's conduct, the connection between the defendant and the plaintiff's injuries simply may be too attenuated to be legal cause. Id.
There is no evidence that conor's hiring of Homsy as a part-time faculty member had anything to do with appellants' injuries. Specifically, Baylor was not involved in developing Proplast or obtaining its patent. Baylor was not involved in any way with the design, development, selling, advertising, or marketing of the TMJ implants. Baylor did not receive any royalties or monetary benefit from the product. Baylor's Institutional Review Boards did not authorize Homsy to do any research on or studies of the TMJ implant. Homsy did not in his capacity as an employee and part-time faculty member of Baylor develop the TMJ implant.
*21 Baylor also asserted that, as a matter of law, it was not foreseeable that Baylor's hiring of Homsy would result in appellants' injuries. Foreseeability, the other aspect of proximate cause, requires that a person of ordinary intelligence should have anticipated the danger created by a negligent act or omission. Doe, 907 S.W.2d at 478. The question of foreseeability asks whether the injury might reasonably have been contemplated as a result of the defendant's conduct. Id. We agree there is no evidence that it was reasonably foreseeable to Baylor, or contemplated by Baylor, that hiring Homsy as a part-time faculty member in 1967 would lead to appellants' injuries.
We affirm the summary judgment on appellants' negligent hiring cause of action.
Negligent supervision
Appellants contend that Baylor had a duty to supervise the scientific aspects of Homsy's work for Methodist, but completely failed to furnish adequate supervision. They contend that Baylor should have recognized the grave risks associated with Teflon implants. Again, liability for negligently supervising an employee is not dependent upon a finding that the employee was acting in the course and scope of his employment; however, there must by some causal connection between the plaintiff's injury and the fact of employment. Dieter, 739 S.W.2d at 408.
Appellants cite evidence regarding the relationship between Baylor and Methodist under an affiliation agreement, the role of Baylor's institutional review board, and a memorial fund that provided funds to Homsy in the PRL, to support their argument that a fact issue exists as to whether Baylor was negligent in supervising Homsy. The evidence is detailed below.
A contract existed between Methodist Hospital and Homsy in which products developed at Methodist's PRL would be assigned by Methodist for further development and for sale to a private corporation to be formed by Homsy. That corporation was Vitek, which Homsy formed in 1969. Under the contract, royalties from any product sales would be paid by the corporation to Methodist to reimburse it for 100 percent of the costs it incurred in the PRL, plus 40 percent for the time value of the money. Homsy founded Vitek to design, develop, test, market, manufacture, distribute, advertise, promote, and sell Proplast and other products invented by him. Homsy was the president, chairman of the board, and principal shareholder of Vitek.
Methodist and Baylor are separate legal entities. Methodist is one of the teaching hospitals affiliated with Baylor. Methodist operates a hospital. Methodist relies on Baylor for its expertise in education and research. An affiliation agreement between the two requires members of the active medical staff at Methodist to hold a faculty appointment at Baylor. Baylor was not involved in the contract between Methodist and Homsy. Again, Baylor and Vitek are separate legal entities, and Baylor never received royalties from Vitek on the sale of any Proplast product.
*22 The evidence shows that Methodist Hospital established the PRL independently, and without any involvement from Baylor. There is nothing in the affiliation agreement that requires the hospital to consult with the medical school about setting up a hospital department. The PRL did not have an organizational reporting relationship either to the chairman of orthopedics at Baylor or the chief of orthopedics at Methodist. The PRL was within their influence and medical specialty, but there was no reporting link between the PRL and the person who held those positions.
Dr. Joe King was on the staff of Baylor as chairman of its orthopedic department and on the staff of Methodist as chief of orthopedic service when Homsy was hired. In 1973, Dr. Hugh Tullos succeeded King as the head of the orthopedic department at Baylor and chief of service at Methodist. These appointments are essentially dual appointments under the affiliation agreement between Methodist and Baylor.
Dr. Tullos testified that Homsy received a salary from the orthopedic surgery department for teaching, for helping to train residents, and for lecturing. Tullos testified Homsy had an obligation to help residents and faculty in research in orthopedic surgery. He had the authority, as chief of orthopedics, to fire Homsy from Baylor. Homsy did his work for Baylor at the PRL at Methodist.
Dr. Tullos testified that he did not know whether anyone, other than Homsy, had anything to do with the quality of the work Homsy did in the PRL for Methodist. He was not in a position to review Homsy's chemical engineering work in the PRL. Tullos testified he was an orthopedist and did not have the expertise in chemical engineering to see whether Homsy's chemical engineer research projects were reasonable and pertinent. Homsy was the director of the PRL and had the expertise in polymer chemistry. Tullos was not competent to determine whether the Proplast and its components were manufactured correctly or whether they were free from impurities. However, Tullos was capable of reviewing, and did review, the clinical course of the experiments Homsy and he did at Baylor. Tullos testified that Homsy was also under his supervision and specific direction, as head of orthopedics at Baylor, with respect to his teaching at Baylor.
Dr. Bobby Alford, dean of medicine for Baylor, testified that Homsy was hired by Baylor to teach medical students and residents on a part-time basis. He also testified that the salary paid by Baylor to Homsy was solely compensation for his part-time teaching duties, not to manufacture and sell medical products. Some of Alford's testimony, however, conflicts with Tullos's testimony. Alford testified it was King's and then Tullos's responsibility to supervise Homsy's scientific activities in the PRL in their capacities as Baylor employees and as chief of service at Methodist. Part of the reason Baylor wanted its employees, King and Tullos, to review Homsy's work in the PRL was to provide oversight for the scientific integrity of the research and the development of safe products. As Homsy's supervisors, King, and then Tullos, could assess and evaluate the outcome of Homsy's work.
*23 The purpose of an IRB is to review proposed protocols. The IRB attempts to determine whether the risks to the subjects involved are minimized; the potential risk to the subjects justify the potential benefit of the proposed research protocol; patients are equitably chosen to participate in the study; and the patients in the research study had adequate information to make an informed decision whether to consent to the protocol. The review is an essential link for the proper evaluation and conduct of experiments. The experimental protocol is what is approved by the IRB.
Other than disapproving all or part of a proposed study, the IRB does not and cannot control the direction, results, or use of the research. The IRB would not stop a product development or testing. The IRB does not approve products for sale. It does not inquire about applications of drugs or devices not presented to the IRB or police the activities of researchers as to matters not brought for approval to the IRB. Homsy presented several research protocols involving the use of Proplast in the hip, bladder, and knee. These research protocols were all approved by Baylor's IRB. Baylor's IRB never reviewed any research protocol involving the use of Proplast in an implant device for the TMJ.
Proplast was invented by Homsy in the PRL. Proplast is still approved by the FDA as a general surgical and dental implant device. It is still used for multiple bioimplant purposes in the United States and around the world. The process of laminating Proplast to FEP for use on a hip implant was also developed at the Methodist PRL. However, no Proplast TMJ implant research work was done in the PRL, and the development of Proplast FEP laminated sheeting for the TMJ implant occurred at Vitek.
Proplaaineas tested for many uses and applications in the human body at Baylor. These tests included the use of different Proplast implants in animals, such as baboons, rabbits, chickens, and dogs. However, no testing or development of the TMJ implant occurred at Baylor or, again, at the PRL. It is true that Baylor-affiliated physicians participated in human clinical research involving various prostheses containing Proplast. However, none of the research performed by them was for prostheses involving the TMJ; the research was for the hip, hand, knee, bladder, and middle ear.
Homsy and Baylor-affiliated physicians worked together on research regarding a Proplast total hip replacement implant. In the early 1980s, Tullos stopped using the Proplast hip implant because of problems that developed involving the design and fit of the implant and the strength of the coating. He also observed osteolysis, or bone loss, in Proplast total hip replacement implants. Tullos, with others, wrote an article reporting on the success and failure rate of the hip implant, which was made of the femoral stem with a Proplast coating and another component. The article reported that 36 percent of the implants failed, which was unsatisfactory. Homsy disagreed with the authors' conclusion regarding the implant.
*24 Tullos testified that Baylor continued to send audit forms to the FDA regarding the hip implant, which was the supervisory agency under which it was performing. Tullos did not go back to the Baylor IRB after he ceased using the hip implant because there was no reason to do so. Tullos testified that the fact a product does not work in one area of surgery does not determine whether it will work or not in another area.
Homsy established a fund in memory of Dr. Joe King, and he determined how the money in the fund would be spent. The fund was set up by him to support research done by him and pay his expenses in the PRL. The money in the fund was from Vitek, Homsy's company, among other contributors. The fund was set up at Baylor. The fund was set up under orthopedics, and therefore came under orthopedics's budget and budget scrutiny. The money in the fund was not spent by the department of orthopedic surgery. Baylor provided funding for some students or other individuals to work in Methodist's PRL, through these restricted funds. Dr. Tullos testified that he administered the fund for Baylor and that money from the fund went to Homsy's projects at the PRL. Other doctors established such funds for their research.
From 1979 through 1984, John Davidson, a surgical technician employed by Baylor in the orthopedics department, worked in connection with the PRL. His sole function with the PRL was to attend every hip implant surgery involving a hip implant with a stem coating of Proplast. The hip implants were being researched during that time, and his purpose was quality control, to ensure that each hip implant was inserted in the same manner so that the results could be validly compared as a controlled study. He was not involved with the activities of the PRL in any other way. He was unaware of and never saw any TMJ implant investigated by any Baylor-affiliated doctor or department. Baylor orthopedists do not operate on joints above the neck, and Baylor had no department of dentistry. Although his salary was paid through the fund, he was never paid by Baylor, the fund, or anyone else to work on, investigate, research, or participate in any aspect of any TMJ implant. As part of his employment, he had an option to purchase Vitek common stock.
This evidence does not raise a fact issue that Baylor was negligent in supervising Homsy for work he performed at the PRL or at Baylor. Moreover, Baylor's supervision of Homsy at Baylor or even in the PRL did not proximately cause appellants' injuries. See Doe, 907 S.W.2d at 477.
The evidence above shows the TMJ implant was not researched, designed, developed, or tested at Baylor. No money from the Dr. Joe King fund was used for researching, developing, designing, or testing the TMJ implant. Homsy was assisted with the TMJ implants by Dr. Kent. Dr. Kent, who was not affiliated with Baylor and who held a faculty appointment with the University of Texas Dental Branch, was Vitek's exclusive consultant on the use of implants in oral surgery. [FN9] No Baylor affiliated physician worked on or considered the TMJ implant. The Baylor IRB did not review any protocols for the TMJ implant. In fact, Baylor does not have a dentistry department or an oral and maxillofacial surgery department.
FN9. Homsy also held a faculty appointment with the University of Texas Dental Branch.
*25 Moreover, Methodist, not Baylor, was vested by written contract with the rights to Proplast. All the patents for Proplast were applied for by Homsy and prepared by lawyers hired by Methodist. Baylor has never held any proprietary interest in any patent for Proplast or any patent for any TMJ prosthesis containing Proplast or otherwise. Baylor never sought FDA approval for Proplast. Baylor has never asserted any right to Proplast and is not entitled to a royalty or other payment from the sale of Proplast products. Baylor has not put any Proplast in the stream of commerce.
While Baylor may have supervised Homsy's teaching and research activities at Baylor, it had no control or right of control to supervise or otherwise interfere with the activities of Vitek. Homsy's part-time faculty position at Baylor did not prohibit him from forming Vitek, nor did Baylor have the right to claim an interest in the company. Baylor did not have the right to control the design and manufacturing of a product independently developed by and sold at Vitek, a separate legal entity.
Appellants argue that Baylor failed to supervise or adequately supervise Homsy's activities in the PRL. However, even if Baylor was charged with supervising Homsy in the PRL, none of his activities in the PRL included the development of the TMJ implant of which appellants' complain, and there is no evidence that Baylor inadequately supervised Homsy in developing or working with Proplast on the projects actually taking place in the PRL or at Baylor.
We affirm the summary judgment on appellants' negligent supervision cause of action.
Negligent failure to warn
Appellants contend there is a fact issue regarding Baylor's negligence in failing to warn of the dangers of the TMJ implant. In its motion for summary judgment, Baylor asserted that it had no duty to warn. We agree.
Again, the issue in a negligent failure to warn case is simply whether a reasonably prudent person in Baylor's position would warn of hazards associated with the use of its product. Alm, 717 S.W.2d at 591. We hold that the TMJ implae toas not Baylor's product; therefore, it had no duty to warn of its dangers.
Baylor was not involved in the design, development, selling, advertising, or marketing of the TMJ implant or Proplast as a product in general. Baylor was not involved in obtaining FDA approval for any of those products. Baylor did not participate in obtaining a patent on those products. While Baylor's IRB reviewed protocols for some Proplast implants (for example implants in the hip, bladder, and knee), Baylor's IRB did not review Homsy's or Vitek's protocol regarding any research, study, marketing, or implantation of the TMJ implant.
Vitek and Baylor are separate legal entities. Baylor had no control over Vitek or the design or marketing of the TMJ implant. Baylor was not a party to the contract between Homsy and Methodist Hospital. No contract existed under which Vitek paid any money to Baylor. Baylor never received a royalty from the sale of any of the TMJ implant. Baylor had no financial interest in the marketing and sale of the TMJ implant. Homsy was not working for Baylor when he, through Vitek, developed, designed, marketed, and sold the implant.
*26 We conclude that Baylor did not have a duty to warn of the dangers of the TMJ implant. We uphold the summary judgment on this ground.
We overrule point of error two.
LSU
Appellants contend the trial court erred by granting LSU's special appearance and plea to the jurisdiction and by denying their motion for continuance.
Plea to the jurisdiction
In point of error five, appellants contend the trial court erred in sustaining LSU's plea to the jurisdiction because Louisiana's Constitution unconditionally waives sovereign immunity in personal injury cases. [FN10]
FN10. Both sides agree that the issue of sovereign immunity applies to LSU as an agency of the State of Louisiana. LA. CONST. art. VIII, § 7; La.Rev.Stat.Ann. §§ 17:3215, 17:3217, 17:3220-21, 17:3351(A)(1) (West 1982 and Supp.1996); La.Rev.Stat.Ann. §§ 36:4(A)(14), 36:651, 36:801-01.01 (West 1985 and Supp.1995).
Comity is the principle under which the courts of one state give effect to the laws of another state or extend immunity to a sister sovereign, not as a rule of law, but rather out of deference or respect. Lee v. Miller County, Arkansas, 800 F.2d 1372, 1375 (5th Cir.1986); New Process Steel Corp. v. Steel Corp. of Texas, 638 S.W.2d 522, 524 (Tex.App.--Houston [1st Dist.] 1982, no writ). It is a doctrine grounded in cooperation and mutuality. K.D.F. v. Rex, 878 S.W.2d 589, 593 (Tex.1994). Texas will extend comity by recognizing the laws and judicial decisions of another state, unless the foreign state declines to extend comity to Texas or sister states under the same or similar circumstances. Id. at 593-94. Texas will also extend comity to the law of a cooperative jurisdiction so long as that law does not violate Texas public policy. Id. at 594. In the absence of a clear indication to the contrary, we will treat Louisiana as a cooperative jurisdiction. See id. at 595.
This Court recently extended comity to Louisiana. Hawsey v. Louisiana Dep't of Social Serv., No. 01-94-00882-CV, slip op. at 7 (Tex.App.--Houston [1st Dist.], August 15, 1996, writ requested) (op. on reh'g). We found that, although no Louisiana case shows Louisiana's exercise of jurisdiction over Texas, Louisiana has extended comity to other states. Id., slip op. at 6 (citing Succession of Fisher, 235 La. 263, 103 So.2d 276, 281 (La.1958); Fisher v. Bullington, 223 La. 368, 65 So.2d 880, 882 (La.1953)). Similar to Texas, Louisiana has held that comity requires it to recognize the laws of the other states unless those laws would violate the positive law or public policy of the State of Louisiana. Fisher, 103 So.2d at 281. In Hawsey, we determined that Louisiana was a cooperative jurisdiction for purposes of applying comity. Slip op. at 6.
We must now determine, as in Hawsey, whether the extention of comity to Louisiana in this case violates the public policies of Texas. Rex, 878 S.W.2d at 594; Hawsey, slip op. at 6-7.
*27 Article 12, section 10(A), of the Louisiana Constitution waives sovereign immunity from suit and liability for injury to person or property. La. Const. art. XII, § 10(A). However, section 10(C) provides that the legislature shall provide a procedure for suits against the state, its agencies, or political subdivisions. La. Const. art. XII, § 10(C). Section 10(C) allocates to the Louisiana legislature the power to establish procedures for suits authorized under section 10(A). Chamberlain v. State, 624 So.2d 874, 882-83 (La.1993).
In Chamberlain, the court held unconstitutional a state statute that imposed a $500,000 ceiling on general damages recoverable in personal injury suits against the state because the statute contravened the proscription against sovereign immunity in article twelve, section 10. 624 So.2d at 875. The court stated, "while the legislature can enact procedural requirements for enforcing the right to sue granted under Section 10(A)-- indeed Section 10(C) mandates that the legislature do so--the legislature cannot enact substantive requirements that would curtail, abridge, impair or burden the exercise of such constitutionally conferred right." Id. at 882. The court noted that statutes authorizing nonjury trials in cases involving governmental entities and authorizing different procedural rules in public and private suits does not violate the waiver of sovereign immunity. Id. at 883.
As authorized by article 12, section 10(C), Louisiana's venue statute provides that all suits filed against the state or any state agency may be instituted before the district court of the judicial district in which the state capitol is located or in the district court having jurisdiction in the parish in which the cause of action arose. La.Rev.Stat.Ann. § 13:5104 (West 1991). Moreover, the venue statute provides that a suit against the state or a state agency or political subdivision shall not be instituted in any court other than a Louisiana state court. La.Rev.Stat.Ann. § 13:5106(A) (West Supp.1996). Section 10(C) authorizes the Louisiana legislature to enact procedures for suits against the state; section 13:5106(A) is one such procedure.
In Rex, the Texas Supreme Court held a Kansas mandatory venue statute, which conditionally waived sovereign immunity for a state agency but required suits to be filed in a particular Kansas county, did not violate any Texas public policy because Texas has similar statutes serving the same purpose. Id. Likewise, Louisiana's mandatory statute, requiring suits against it to be brought in Louisiana state court, does not violate any Texas public policy. Hawsey, slip op. at 7.
Because Louisiana is a cooperative sister state and because applying its law does not violate the public policy of Texas, comity should be extended. Hawsey, slip op. at 7. The trial court properly sustained LSU's plea to the jurisdiction.
*28 We overrule point of error five.
We affirm the trial court's decision to sustain the plea to the jurisdiction; therefore, we need not address its decision to grant LSU's special appearance discussed in points of error three and four.
Conclusion
We affirm the summary judgments granted in favor of DuPont and Baylor. We affirm the plea to the jurisdiction sustained in favor of LSU.
HEDGES and FARRIS, JJ., also sitting. [FN11]
FN11. Justice David L. Farris, former justice, Second Court of Appeals, at fort Worth, Texas, sitting by assignment.
END OF DOCUMENT