In re TMJ Implants Products Liability Litigation, 94-MD-1001.

• Citation: 872 F. Supp. 1019
• Decision Date: 17 January 1995
• Docket Number: No. 94-MD-1001.,94-MD-1001.
• Parties: In re: TMJ IMPLANTS PRODUCTS LIABILITY LITIGATION. This Document Relates To All Actions.
• Court: U.S. District Court — District of Minnesota

872 F. Supp. 1019

In re: TMJ IMPLANTS PRODUCTS LIABILITY LITIGATION.

This Document Relates To All Actions.

No. 94-MD-1001.

United States District Court, D. Minnesota, Third Division.

January 17, 1995.

COPYRIGHT MATERIAL OMITTED

MAGNUSON, Chief Judge.

I. INTRODUCTION

These matters, which are consolidated for pretrial purposes under 28 U.S.C. § 1407, are before the Court upon early Motions for Summary Judgment by Defendants¹ E.I. du Pont de Nemours & Company (DuPont) and American Durafilm Company, Inc. (American Durafilm), and upon a Motion to Dismiss, Sever and Remand by Duke University and Dr. Edward A. Dolan (Duke Defendants). For the following reasons, the Court grants DuPont and American Durafilm's Motions for Summary Judgment and grants the Duke Defendants' Motion to Dismiss, Sever and Remand as detailed below.

II. BACKGROUND

Plaintiffs in these actions allege injuries resulting from the implantation in their temporomandibular joints (TMJ) of a device known as the Proplast® TMJ Implant or the Proplast®/Teflon® Interpositional TMJ Implant. Vitek, Inc. manufactured the implants out of polytetrafluoroethylene (PTFE) powder and fiber, fluorinated ethylene propylene (FEP) film, and other raw materials. The purpose of the implant was to replace the meniscus or articulating surface of the temporomandibular joint, which is the joint that connects the upper jaw to the lower jaw. Plaintiffs allege that the implants eventually resorbed the surrounding bone, causing pain to the recipients of the implants. Plaintiffs then underwent surgery for removal of the implants and, in some cases, maxillofacial reconstructive surgery. They pursue recovery for their alleged injuries in these cases.

In these motions, Defendants DuPont and American Durafilm seek summary judgment. DuPont manufactured the PTFE and FEP used by Vitek to manufacture its Proplast® TMJ Implants.

Defendant American Durafilm is a distributor of a number of DuPont's products, including Teflon® FEP. It facilitated distribution to purchasers who desired to buy less Teflon® FEP than DuPont would sell directly. Plaintiffs allege that American Durafilm was one of the distributors who sold FEP film to Vitek for use in Proplast® TMJ Implants. American Durafilm did not play any role in the manufacture of FEP film nor did it alter the film in any way from the form it was in when received from DuPont.

Only one Plaintiff has named the Duke Defendants, and they are party only to that case, Fuller v. E.I. du Pont de Nemours, Civ. No. 3-94-190. The facts that relate to the Duke Defendants' Motion to Dismiss, Sever and Remand are set forth with the discussion of applicable law below.

Vitek is also a named Defendant in these actions. Because Vitek is currently in bankruptcy, however, it has not appeared in these proceedings.

There is no dispute that PTFE and FEP, sold by DuPont under the trademark "Teflon®," have numerous uses that are not inherently dangerous. For example, PTFE is used in bearings for jet aircraft, submarine piston rings, and most commonly as a nonstick coating for cooking pans. FEP is used in pipe lining, solar collectors, and other items. Medical device manufacturers have found applications for PTFE and FEP within the medical field, including artificial human veins, sutures, middle ear drain tubes, and maxillofacial reconstructive surgery.

Researchers first published studies regarding whether polymers such as Teflon® were appropriate for implantation in living organisms in the early 1950's. One of the experiments, conducted by Sir John Charnley, involved the use of Teflon® PTFE in the hip joints of dogs. After initial positive results, Charnley discovered that the PTFE abraded or disintegrated, and the dogs suffered serious injuries as a result of the foreign body reaction caused by the loose particles of PTFE. A later study by Dr. John Leidholt corroborated Charnley's findings, and other experiments found additional circumstances in which Teflon® had negative reactions when used as an injection for treating paralyzed vocal cords.

Dr. Charles Homsy, who earned his Doctor of Science degree in chemical engineering from the Massachusetts Institute of Technology and later founded Vitek, worked for DuPont from 1959 to 1966 as a research engineer and a regional sales representative. In 1966, Homsy proposed that DuPont undertake a project involving the development of orthopedic prostheses. His supervisor's supervisor, O.G. Youngquist, rejected this proposal, stating that he did not believe such a venture would be profitable for DuPont. He expressed particular concern over the potential liability that might result from such a project. Youngquist added that perhaps the best thing for Homsy to do might be to encourage DuPont's customers to consider development in that area.

In May of 1966, Homsy left DuPont and went to work for the Baylor University School of Medicine and the Methodist Hospital at the Texas Medical Center in Houston, Texas. Two years later, he invented the spongy and porous biomaterial Proplast® using PTFE particulate resin, PTFE resin fibers, carbon fibers, and sodium chloride. He patented the eight-step process used to manufacture Proplast®. In that process, the Teflon® PTFE lost its well-known mechanical and physical qualities of having a slippery, nonstick surface, but it maintained its original chemical composition. Homsy incorporated Vitek to develop and market Proplast® and related products.

A consultant to Vitek, Dr. John Kent, an oral surgeon who chaired the Department of Oral and Maxillofacial Surgery at Louisiana State University, conducted experiments in the 1970's to study the use of a Proplast® implant material. He formed the material by fusing together the Proplast® and FEP film purchased from distributors.

During this time, DuPont became aware that Vitek was exploring medical applications of DuPont's Teflon® products. DuPont sent a letter to Vitek that stated as follows:

DuPont Teflon® fluorocarbon resins ... 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.

At DuPont's request, Dr. Homsy, as President of Vitek, signed this disclaimer and returned it to DuPont.

This was not the first disclaimer DuPont had issued to Homsy. When he initially began working with DuPont fluorocarbon resins at the Methodist Hospital in Houston, DuPont sent a similar disclaimer to C. Gonzalez, the purchasing agent at the hospital, with a copy to Homsy. That letter informed Gonzalez and Homsy that DuPont was "reluctant to encourage the use of `Teflon' for surgical purposes." It also pointed out the findings in the Charnley study and other studies that showed some negative reactions associated with in vivo use of PTFE. Homsy wrote a letter in response, relating to DuPont that he was aware of these reports, but that they were not conclusive in establishing the full potential of implants involving PTFE or other polymers produced by DuPont. In addition, Homsy mentioned that he planned to meet with Charnley in the near future to discuss his findings.

After many years of working with Proplast®, Dr. Kent determined in 1982 that the Proplast® implant material was a success. Upon Kent's advice, Homsy and Vitek developed the Proplast®, Tefon® TMJ Interpositional Implant. The implant material was Proplast® on one surface and laminated with FEP film on the other surface. Doctors were to place the Proplast® side of the implant so that it would eventually be secured by tissue growth and place the FEP film side of the device next to the lower jaw.

In 1983, the Food and Drug Administration (FDA) granted Vitek permission to sell its Proplast® TMJ Interpositional Implant under § 510k of the Food, Drug and Cosmetic Act, which permits the sale of items that are substantially equivalent to other items that have been approved. Vitek sold its product under the name "Proplast®/Teflon® Implant" or "PT Implant." In accordance with federal law, Vitek included package inserts with the implants that warned of the risks associated with the implants.

One year later, Vitek's Proplast® TMJ Implant became the focus of the American Association of Maxillofacial Surgeons 1984 Clinical Congress. Michael Bernhardt, an employee at DuPont's Central Research Department who was studying the potential market for DuPont products for use in the temporomandibular joint, attended the conference. Bernhardt took notes on information he acquired at the conference, including some information regarding the use of Proplast® in human implants.

For a brief period in 1985 and 1986, DuPont and Vitek discussed the possibility of undertaking a joint venture. There is no evidence that DuPont ever entered into such a relationship with Vitek, however. Plaintiffs make much of their Exhibit # 39, a secrecy agreement signed by Vitek and DuPont in 1980. Nothing in that agreement indicates that it pertains to TMJ implants. In fact, DuPont has submitted a letter that reveals that the agreement related to an entirely different type of product with no medical applications. All of the evidence supports the conclusion that Vitek and DuPont had a typical relationship between a raw material supplier and a finished product manufacturer.

III. DISCUSSION

A transferee court has authority to enter dispositive orders...