Harwell v. American Medical Systems, Inc.

• Decision Date: 14 September 1992
• Docket Number: No. 1:91-0107.,1:91-0107.
• Citation: 803 F. Supp. 1287
• Parties: Billy Glen HARWELL v. AMERICAN MEDICAL SYSTEMS, INC.
• Court: U.S. District Court — Middle District of Tennessee

803 F. Supp. 1287

Billy Glen HARWELL v. AMERICAN MEDICAL SYSTEMS, INC.

No. 1:91-0107.

United States District Court, M.D. Tennessee, Columbia Division.

September 14, 1992.

COPYRIGHT MATERIAL OMITTED

Stewart, Estes & Donnell, Nashville, Tenn., Thomas J. Elmlinger, Brentwood, Tenn., for plaintiff.

Clarence J. Gideon, Jr., Linda Willis, Gideon & Wiseman, Nashville, Tenn., Philip E. Mischke, Mark Vorder-Bruegge, Jr., Charles M. Weirich, Jr., McDonnell Boyd, Memphis, Tenn., for defendant.

MEMORANDUM

HIGGINS, District Judge.

The plaintiff, Billy Glen Harwell, a Tennessee citizen, filed this action¹ against American Medical Systems, Inc., a Minnesota corporation with its principal place of business in Minnetonka, Minnesota. The plaintiff's claims arise out of the malfunction of an inflatable penile prosthesis that is manufactured by AMSI. This prosthetic device was surgically implanted in Mr. Harwell on June 26, 1989. Mr. Harwell's claims are for negligence in the design of the prosthesis, strict liability for its unreasonably dangerous design, and breach of implied warranty of merchantability.

AMSI filed a motion for summary judgment on July 14, 1992 (Docket Entry No. 18) upon the grounds that the plaintiff's negligence and strict liability claims are time-barred under the applicable Tennessee statute of limitations and that there is no proof that its product was negligently designed, given the state of the art at the time its prosthesis was manufactured. Further, AMSI argues that this prosthesis is an "unavoidably unsafe product" under Section 402A, Comment k of the Second Restatement of Torts so that its warning to Mr. Harwell's physician, as a learned intermediary, precludes its liability to the plaintiff. Finally, AMSI contends that the Uniform Commercial Code does not extend to cover Mr. Harwell's breach of warranty claims because surgical implants represent the sales of services and the UCC applies only to sales of goods.

Mr. Harwell responds that his negligence and strict liability claims were filed within one year after he learned of the precise nature of the prosthesis' defect; that he was not warned of any dangers; that the UCC has been held applicable to surgical implants because the sale is to the physician as the patient's agent; and that based upon his expert's affidavit, there is a material factual dispute as to whether the prosthesis is unreasonably dangerous and was negligently designed. Mr. Harwell also seeks additional time under Rule 56(e), Fed. R.Civ.P., to submit evidence of a 1989 Food and Drug Administration investigation of this AMSI prosthesis about which Mr. Harwell's counsel recently learned.

For the reasons set forth below, the Court grants the defendant's motion for summary judgment upon the grounds that there has been adequate opportunity for discovery and that there is insufficient proof that AMSI's prosthesis was negligently designed or was an unreasonably dangerous product. The undisputed proof is that AMSI's prosthesis was the state of the art at the time. This device is also an unavoidably unsafe product for which AMSI made adequate disclosures to Mr. Harwell's physician, sufficient to preclude any liability to Mr. Harwell under Tennessee law.

I.

On June 26, 1989, Mr. Harwell underwent the implantation of an AMSI 700 CX inflatable penile prosthesis. The AMSI 700 CX is prescribed by some urologists for patients with organic impotence by simulating a natural erection. This device was designed first by AMSI, which began distribution of its first version in 1973. The original design of the implant has been modified since 1973 to improve the device. According to Robert W. Pugh, the engineer who worked on the original design and subsequent modifications, the AMSI penile prosthetic implant at issue represented the state of the art for such devices at the time of Mr. Harwell's surgical implant.

The AMSI 700 CX consists of two expandable cylinders that are inserted within the shaft of the penis with a small pump that is implanted in the scrotum. The cylinders and pump are connected by silicone tubing. The pump also is connected by silicone tubing to a fluid reservoir that is implanted beneath the abdominal muscles. By squeezing the pump, fluid is transferred into the expandable cylinders, causing the penis to become erect. A small valve in the pump holds the fluid in the cylinders until the erection is no longer desired. When the release valve on the pump is pressed, the fluid returns to the reservoir, and the penis returns to its flaccid state.

On June 26, 1989, Dr. Tom Nesbitt, Jr., an urologist, implanted the AMSI 700 CX inflatable penile prosthesis into Mr. Harwell at Baptist Hospital in Nashville, Tennessee. Dr. Nesbitt showed Mr. Harwell the device and explained how it worked. Dr. Nesbitt told Mr. Harwell that the AMSI 700 CX was "the best product available to meet Mr. Harwell's needs." Dr. Nesbitt also states that he "fully informed" Mr. Harwell of the risks involved, noting that "the primary mode of failure would be leakage."

As Mr. Harwell and his wife were going to have sexual relations on August 16, 1990, the device did not work. Mr. Harwell made an appointment with Dr. Nesbitt on the earliest available appointment date of August 30, 1990. On August 30th, Dr. Nesbitt determined that the prosthesis had a leak in its reservoir. Dr. Nesbitt replaced the reservoir in surgery on September 4, 1990. Mr. Harwell filed his complaint on August 30, 1991, in the Circuit Court for Lawrence County, Tennessee.

As to the cause of the leak in the reservoir, in his answers to interrogatories, Mr. Harwell states that "the device's reservoir broke while inside the plaintiff's body within fourteen months after it was implanted and after being used only for the purpose it was intended." In his supplemental answers to interrogatories, Mr. Harwell states that

this device has been recalled from the market three times by AMS for leakage. AMS underreported product complaints and failure to the FDA. After receiving over 3000 complaints about AMS' inflatable penile prosthesis, the FDA is requiring AMS to furnish evidence of the product's safety. See also attached affidavit of R.J. Hill.

Mr. Harwell notes that the AMSI warrants this device for five (5) years.

Mr. Harwell also submitted the affidavit of Dr. R.J. Hill, an engineer who inspected the prosthesis implanted in Mr. Harwell. Dr. Hill opines, in pertinent part, as follows:

4. I conducted the following tests on the reservoir of the AMS 700 CX device that is the subject of this lawsuit on July 31, 1992: A. microscopic examination of the reservoir, B. filling of the reservoir with water and visual examination for leakage.

5. My findings based on the preceding tests were as follows: A. A hole was found on the surface of the reservoir near the drain/refill tube, B. leakage of water was found from the observed hole, and C. cracks were observed in various places along the reservoir wall.

6. Based on the above findings, I have concluded the following: A. the hole was formed as a result of a crack that began on the interior wall and propagated to the exterior wall, B. the hole was not a result of a puncture or slash from the exterior of the reservoir, and C. the hole was the result of material failure from repeated inflation and deflation of the reservoir.

7. As a result of research conducted into the studies made on prosthetic devices, in my opinion, the aforementioned leak could have been prevented if the reservoir had been constructed of polyurethane instead of silicon-elastomer.

Hill Affidavit at 2-3 (Docket Entry No. 23, Exhibit B; filed August 4, 1992).

Dr. Nesbitt, who has implanted forty to fifty of these prosthetic devices, does not have a medical opinion on what caused the reservoir in Mr. Harwell to leak. As to the warnings about the implantation of this device, AMSI includes a list of disclosures to physicians about problems with the AMSI 700 CX. The leaking of the reservoir is among the "Precautions" listed. Dr. Nesbitt does not recall whether he showed this AMSI information brochure to Mr. Harwell, but does distinctly recall his display and demonstration of the device to Mr. Harwell as a more effective method of explanation. Mr. Harwell disputes that he was warned about leakage, pain or possible follow-up surgery. The hospital supplies the prosthesis that is designated by Dr. Nesbitt.

II.

"The very mission of the summary judgment procedure is to pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial." Fed.R.Civ.P. 56 advisory committee's note. In Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986), the United States Supreme Court explained the nature of a motion for summary judgment:

Rule 56(c) of the Federal Rules of Civil Procedure provides that summary judgment "shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." By its very terms, this standard provides that the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact.

As to materiality, the substantive law will identify which facts are material. Only disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment. Factual disputes that are irrelevant or unnecessary will not be counted.

Id. at 247-48, 106 S.Ct. at 2509-10, 91 L.Ed.2d at 211 (emphasis in the original and added in part).

The Supreme Court also defined a material fact for Rule 56 purposes as "where the record taken as a whole could not lead a rational trier of fact to...