The opinion of the court was delivered by: Rufe, J.
Memorandum Opinion and Order
This is an action for personal injuries sustained by Plaintiff
Eric Banks, which were allegedly caused by a defect in an inflatable
penile prosthesis manufactured by Defendant Coloplast Corp.
("Coloplast"). Plaintiff's Complaint alleges negligence, negligence
per se , and strict liability. Before the Court is
Coloplast's Motion for Summary Judgment. For the reasons set forth
below, the Motion will be granted in part and denied in part.
The parties have stipulated to the following facts:*fn1
1. On or about December 18, 2007, an inflatable penile prosthesis manufactured by defendant, Coloplast Corp. was implanted into plaintiff Eric Banks.
2. On or about August 1, 2008, the Coloplast implant was removed, resectioned and re-implanted into Mr. Banks.
3. On or about June 1, 2009, the Coloplast implant was removed and replaced with a product supplied by another manufacturer.
4. The present whereabouts of the Coloplast implant are unknown.
In addition, the record before the Court includes deposition testimony, correspondence, medical records, and affidavits.
During his deposition, Plaintiff testified that after initial implantation the Coloplast implant would not deflate once inflated. He was required to seek medical attention on several occasions due to the device's failure to deflate. A Coloplast representative was present at some of these medical appointments. After several failures, the representative told Plaintiff that the pump on the device was defective, and recommended replacing only the pump, which is one part of the three-part implant. The pump was replaced in a second surgery. Shortly thereafter, Plaintiff experienced a "blowout" or tear in the pump, after which the implant would no longer inflate. The Coloplast representative then recommended replacing the whole unit. A third surgery was performed. This time, however, Plaintiff opted to replace the Coloplast implant with one made by another company. After the prosthesis was removed, Plaintiff's physician photographed the damaged pump.
Plaintiff also provides the affidavit of Dr. Michael J. Metro, the doctor who first surgically implanted the Coloplast device. Dr. Metro offers no opinion or factual information regarding the cause of the first Coloplast pump's deflation problems. He states that he found a hole in the second Coloplast pump after he removed it, which had prevented the device from properly inflating, but he does not opine as to the source or cause of that hole.
After the Coloplast pump was removed, Plaintiff sent a letter to Albert Einstein Hospital ("Einstein"), where the procedure was performed, asking the medical staff to preserve the prosthesis. Einstein has provided an affidavit from its employee, Barbara Eissler, in which she attests that Einstein does not possess the prosthesis nor does it have any record indicating its whereabouts. A Perioperative Nursing Record indicates that the penile implant was returned to Coloplast. *fn2 However, Coloplast has no record of receiving it, nor of a request for the return packaging materials the company required due to the biohazards posed by removed medical implants. *fn3 Therefore, the device at issue is not available for inspection.
Plaintiff has not obtained an expert opinion in support of his claims.
Under Federal Rule of Civil Procedure 56, a court may grant summary judgment only "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." *fn4 A fact is "material" if it could affect the outcome of the suit, given the applicable substantive law. *fn5 A dispute about a material fact is "genuine" if the evidence presented "is such that a reasonable jury could return a verdict for the nonmoving party." *fn6 In considering a summary judgment motion, the Court does not weigh the evidence or make ...