Veil v. Vitek, Inc.

• Decision Date: 18 September 1992
• Docket Number: Civ. A. No. A3-90-197,A3-91-112 and A3-91-114.
• Citation: 803 F. Supp. 229
• Parties: Jayden VEIL, Plaintiff, v. VITEK, INC., a Texas corporation and E.I. du Pont de Nemours and Company, a Delaware corporation, Defendants. Gary BRACHT, Plaintiff, v. VITEK, INC., a Texas corporation and E.I. du Pont de Nemours and Company, a Delaware corporation, Defendants. Tammie L. KLEIN, Plaintiff, v. VITEK, INC., a Texas corporation and E.I. du Pont de Nemours and Company, a Delaware corporation, Defendants.
• Court: U.S. District Court — District of South Dakota

803 F. Supp. 229

Jayden VEIL, Plaintiff, v. VITEK, INC., a Texas corporation and E.I. du Pont de Nemours and Company, a Delaware corporation, Defendants.

Gary BRACHT, Plaintiff, v. VITEK, INC., a Texas corporation and E.I. du Pont de Nemours and Company, a Delaware corporation, Defendants.

Tammie L. KLEIN, Plaintiff, v. VITEK, INC., a Texas corporation and E.I. du Pont de Nemours and Company, a Delaware corporation, Defendants.

Civ. A. Nos. A3-90-197, A3-91-112 and A3-91-114.

United States District Court, D. North Dakota, Southeastern Division.

September 18, 1992.

Ronald Goldser, Zimmerman & Reed, Minneapolis, Minn., Steven C. Schneider, Schneider, Schneider & Schneider, Fargo, N.D., for plaintiffs.

John D. Kelly, Harlan G. Fugelstad, Vogel, Brantner, Kelly, Knutson, Weir & Bye, Ltd., Fargo, N.D., Thomas Klinkel, Barry Fish, Michael Miller, Edward M. Mansfield, Lewis & Roca, Phoenix, Ariz., for defendants.

MEMORANDUM AND ORDER

BENSON, Senior District Judge.

In the above captioned cases three separate plaintiffs have brought personal injury actions against defendants Vitek, Inc. (Vitek) and E.I. duPont de Nemours and Company (DuPont). Defendant Vitek is a bankrupt Texas Corporation that has not entered an appearance. The three cases against DuPont are hereby consolidated for disposition.

FACTUAL BACKGROUND

Each plaintiff is a recipient of defendant Vitek's Proplast (TMJ) Implant. The implant was designed by Vitek for use in the human jaw as a replacement for the cartilage disc in the temporomandibular joint. Vitek manufactured this implant utilizing a substance under its trademark, proplast. Proplast is a material made with polytetrafluoroethylene (PTFE) and other substances.¹ Defendant DuPont, and others, formulate PTFE. DuPont's PTFE is trademarked as teflon. For purposes of this Memorandum and Order the court will assume that Vitek purchased PTFE exclusively from DuPont.²

Defendant has filed a Fed.R.Civ.P. 56 motion for summary judgment on the issue of duty (Doc. # 12). Summary Judgment is available to a party when a review of the pleadings and other documents filed indicate there exists no genuine issue of material fact and a party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56, Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). A Court considering a motion for summary judgment must view the evidence in a light most favorable to the non-moving party. The non-moving party is entitled to all reasonable inferences that can be drawn from the evidence. Vacca v. Viacom Broadcasting of Missouri, Inc., 875 F.2d 1337, 1339 (8th Cir.1989).³

DISCUSSION

Plaintiffs' complaint (Doc. # 1) alleges causes of action based on negligence, strict liability, breach of warranty and misrepresentation. Under the negligence and strict liability theory, plaintiffs allege that DuPont breached a duty to warn of the dangers associated with Vitek's proplast implant.

Defendant DuPont contends that, "as a bulk material supplier to a medical device manufacturer of an FDA-regulated medical device, DuPont had no duty to assure the safety of the Proplast TMJ Implant designed, manufactured, tested and sold by Vitek." DuPont seeks summary judgment on all of plaintiffs' claims. DuPont's Motion for Summary Judgment on the issue of Duty (Doc. # 12) at 2.

Plaintiffs have framed the question of duty as it relates to defendant DuPont's summary judgment motion somewhat differently:

The issue then, is whether DuPont, as the sole supplier of the PTFE that went into proplast and ultimately failed, ... should be held responsible for such injuries, where it knew that Vitek intended to use the PTFE in a joint, knew that such use was certain to cause tragic consequences, and yet kept that information secret and failed to warn anybody of the terrible consequences.

Brief in Opposition to the Motion for Summary Judgment (Doc. # 15) at 4.

It appears to be undisputed that as long ago as 1967, DuPont was aware of certain studies questioning the propriety of using PTFE in medical implants. The record also indicates that DuPont expressed these concerns to Vitek founder and President, and, former DuPont employee, Charles Homsy. On March 13, 1967, George A. Wilkens, a Consultant in DuPont's Technical Services Laboratory, sent a letter to Mr. C. Gonzalez, a purchasing agent at Methodist Hospital in Houston Texas where Charles Homsy was then the Coordinator for Development of Prosthetic Devices. The letter was in response to the Hospital's purchase order for an amount of teflon to be used by the Hospital in a medical application. Memorandum in Opposition to the Motion for Summary Judgment By Defendant E.I. DuPont de Nemours (Doc. # 15) Appendix N. The letter informed Gonzalez that teflon was not made for medical purposes, that DuPont did not conduct the detailed long-time tests required to evaluate whether PTFE would be appropriate for use in medical devices and that results from tests performed in the United States and Germany had been unfavorable.

On March 20, 1967, Charles Homsy personally responded to Wilkens March 13, 1967 letter, Homsy claimed that the reports to which DuPont had directed the Hospital's attention were "crucially incomplete and not applicable to his intended application" and cited to more recent studies which allegedly concluded from long-time tests that medical applications of TFE polymers "produce less tissue reaction than all other plastics commonly used in modern surgery." Memorandum in Opposition to Motion for Summary Judgment By Defendant E.I. DuPont de Nemours (Doc. # 15) Appendix O.

Plaintiffs have characterized DuPont as having conclusive knowledge of the consequences of using PTFE in a medical device application such as the Vitek (TMJ) implant. While the record shows that DuPont expressed concern about Vitek's application of DuPont's teflon, plaintiffs have cited no admissible evidence supporting its contention that DuPont concealed independent conclusive knowledge of the impropriety of using PTFE in a medical application such as Vitek's (TMJ) implant. Contrary to plaintiffs' assertions, a review of the correspondence between the parties indicates DuPont's concern, because of its lack of knowledge on the subject, with Vitek's use of teflon in medical devices.

Once the motion for summary judgment is made, an affirmative duty is placed upon the opposing party to establish by affidavit, or otherwise designate specific facts within the record, which would establish a genuine issue for trial. Commercial Union Insurance Co. v. Schmidt, 967 F.2d 270, 271-272 (8th Cir.1992). As it relates to the issue of DuPont's knowledge of the impropriety of using teflon in the construction of a medical device, the plaintiffs have not met this affirmative burden.

The court takes judicial notice of the Food and Drug Administration (FDA) proposed rules on general and plastic surgery devices. In a lengthy comment, specifically approving PTFE with carbon fibers as a medical device, the FDA stated in part:

FDA agrees with the recommendation of both Panels and is proposing that polytetrafluoroethylene PTFE with carbon fibers composite implant material be classified into class II (performance standards). Although the device is an implant, the agency believes that pre-market approval is not necessary because there is sufficient information available to establish a performance standard that would provide reasonable assurance of the safety and effectiveness of the device.

47 Fed.Reg. 2819 (1982) (proposed Jan. 19, 1982). From these proposed rules and the FDA's subsequent approval⁴ of the proplast material, it can be concluded that the FDA was satisfied that PTFE with carbon fibers was safe for use in medical implants.

Federal law, as administered by the FDA, requires that medical device manufacturers assure that adequate valid scientific evidence exists to provide reasonable assurance that medical devices are safe and effective for their intended use. 21 C.F.R. § 860.7(g)(1). Section 860.7(g)(1) states in pertinent part;

It is the responsibility of each manufacturer and importer of a device to assure that adequate, valid scientific evidence exists and to furnish such evidence to the Food and Drug Administration to provide reasonable assurance that the device is safe and effective for its intended uses and conditions of use....

Id. (emphasis added). The plain language of section 860.7(g)(1) indicates intent to place upon the manufacturer of a medical device the obligation of assuring the existence of valid scientific evidence so that the FDA can provide reasonable assurance of a device's safety and effectiveness.⁵ Clearly, the entity responsible for overseeing and insuring the safety of medical devices such as the Vitek (TMJ) implant is the Food and Drug Administration.⁶

From a review of the numerous appendices, affidavits, depositions and exhibits submitted by the parties, the court concludes there is nothing in the record currently before the court from which a jury could find that DuPont had conclusive knowledge that teflon would be inappropriate for use in the Vitek proplast implant.

The remaining issue is whether DuPont as a supplier of bulk raw material to a FDA regulated medical device manufacturer is legally accountable to the plaintiffs on any of their alleged theories of recovery.

Failure to Warn

Negligent failure to warn cases have their genesis in Restatement (Second) of Torts § 388 (1965) which provides as follows;

§ 388. Chattel Known to be Dangerous for Intended Use

One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied if the supplier

(a) knows or has reason to know that the chattel is or

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