The opinion of the court was delivered by: COOPER
There are two motions before the Court in this matter: (1) defendant Huntleigh Healthcare's ("Huntleigh") motion for summary judgment pursuant to Federal Rule of Civil Procedure 56; and (2) plaintiffs, William and Kimberly Pousts' motion in limine for a Order applying Pennsylvania law on the issue of the calculation of damages. The Court held a Federal Rule of Evidence 104 hearing on defendant's motion for summary judgment on November 6 and 7, 1997. Because we have determined that (1) the opinions of Robert Benowitz and Carl Goodman, M.D. are admissible pursuant to Rule 702 of the Federal Rules of Evidence, and (2) the opinion of Ray Eric Santos, M.D. is admissible pursuant to Rule 701 of the Federal Rules of Evidence, defendant's motion for summary judgment is denied. Further, plaintiffs' motion in limine seeking an Order applying Pennsylvania law on the issue of damages is denied. The Court finds that any calculation of future lost earnings will be governed by the law of the state of New Jersey.
Plaintiffs William K. Poust ("Poust") and Kimberly Poust
bring this negligence and strict products liability action and loss of consortium claim against defendant Huntleigh Healthcare as a result of complications during back surgery performed on Poust at the National Naval Medical Center in Bethesda, Maryland. Poust was a career Navy Petty Officer stationed at Willow Grove Naval Air Base. On April 6, 1994, after suffering from back pain caused by a spondylolesthesis condition, Poust underwent a laminectomy and fusion at the National Naval Medical Center. The chief surgeon was R. Eric Santos, M.D., assisted by Orvis Chitwood, M.D.
Throughout surgery, Poust wore surgical stockings, commonly referred to as "TEDs" that reached above his knees.
His legs were also connected to a Flowtron DVT device ("Flowtron") manufactured by Huntleigh Healthcare in order to reduce the risk of deep vein thrombosis, a condition which occurs from lack of blood flow to the calf muscles. The Flowtron DVT consists of calf-high (i.e., above the ankle and below the knee) pneumatic compression cuffs
and air hoses leading to a pump which, when functioning properly, provides intermittent cycles of compressed air to bladders sewn into the back of each legging. The pump also contains a dial which is intended to set the amount of pressure exerted on the calves, and an auditory and visual alarm. The Court will collectively refer to these discrete parts of the Flowtron DVT as "the pneumatic compression device."
The pneumatic cuffs used during surgery remained on Poust post-operatively, however the operating room pump was replaced at least two times over the next two days.
Upon awakening in the recovery room, Poust complained of bilateral pain in his calves. By April 8, 1994, which was the second day after the back surgery, Dr. Santos suspected that Poust's pain was caused by bilateral compartment syndrome, a condition caused by a decrease in the venous outflow which in turn is a response to an increased pressure within the compartment of the calf muscle. (Pls.' Statement of Mat. Facts in Dispute, Ex. 13 at 36: (Chitwood Dep.) Tests were performed which confirmed Santos' diagnosis. That same day, Dr. Chitwood, Poust's other physician, performed an emergency facsiotomy on him, with Dr. Santos assisting him. As will be discussed in more detail below, a fasciotomy is a surgical procedure in which the doctor cuts through the protective sheath over the affected compartments to reduce the pressure on those muscles. (Id., Ex. 14 at 35: (Santos Dep.) The operative notes of this first facsiotomy performed on April 8, 1994 report that "it was noted that there was a well-demarcated area of dusky muscle distally in the compartment. The muscle proximally in the compartment looked normal. . . . On [the right] leg as well, there was a well-demarcated area in the anterior compartment of dusky muscular tissue. (Id., Ex. 15 (post-operative notes (April 8, 1994)).) Poust underwent two additional procedures to alleviate the pressure in his calves, on April 10 and April 12, 1994 respectively. His discharge summary, written by Dr. Chitwood, states, "At fasciotomy, the muscle in the anterior and lateral compartments was noted to be normal with the exception of the distal third of both sides which had a well demarcated area that was later found to identically match the lower cuff of the venodyne compression stockings [venodyne being used to describe the Flowtron calf-high leggings] that had been placed on him intraoperatively." (Certif. of Jason Shaffron in Supp. of Def.'s Mot. for Summ. J., Ex. B: Discharge Summ. dated June 18, 1994 at 2-3.)
The fasciotomy and subsequent operations were of limited success, as Poust continues to suffer from compartment syndrome in both calves. Plaintiffs filed this lawsuit in December 1994, alleging negligence, strict products liability and loss of consortium claims against defendant. Poust alleges that the Flowtron DVT pneumatic compression device used either during surgery or in the recovery room malfunctioned and caused his compartment syndrome. (Am. Compl. P 7-8.) Poust further alleges that the malfunction was caused by defendant's (1) failure to properly design, manufacture and test the Flowtron DVT device; (2) failure to provide adequate and/or prominent instructions and/or warnings and/or labels; and (3) failure to adequately warn of the risks involved in using the Flowtron device. (Id. P 9-10.)
Defendant moves for summary judgment, which plaintiffs oppose. In addition, plaintiffs have filed a motion in limine for an Order allowing any damage calculation to be made pursuant to Pennsylvania law. Defendant opposes plaintiff's in limine motion.
A. Defendant's Motion for Summary Judgment
Because this Court held an evidentiary hearing pursuant to Federal Rule of Evidence 104, the outcome of which is dispositive of defendant's motion for summary judgment, it is appropriate to begin our analysis with our findings of fact and conclusions of law from that hearing held before the Court on November 6 and 7, 1997. See Diaz v. Johnson Matthey, Inc., 893 F. Supp. 358, 362 (D.N.J. 1995).
1. Ray Eric Santos, M.D. is a board-certified orthopedic surgeon who specializes in spine surgery. (Santos, Tr. 1 at 5.)
2. Dr. Santos attended medical school at Texas Tech University in Lovett, Texas. Upon graduation, he completed an orthopedic residency program at the University of Texas. After that program, he completed a one year fellowship in spine surgery in San Antonio. After his fellowship, Dr. Santos went to the National Naval Medical Center in Bethesda, Maryland ("Navy Medical"). (Id. at 4.)
3. At Navy Medical, Dr. Santos was an attending physician in orthopedic surgery and the Chief of Spine Service at the National Naval Medical Center. (Id. at 5.) After leaving Navy Medical, Dr. Santos entered private practice for one year. Currently, he is a professor of orthopedic surgery at the University of Texas, Medical Branch, located in Galveston, Texas. (Id.)
4. Dr. Santos has performed approximately 1,200 back surgeries throughout his career. (Id. at 6.) Dr. Santos was the attending physician at Navy Medical for the initial back surgery performed on Poust.
5. Santos first met William Poust when plaintiff went to the orthopedic clinic at Navy Medical complaining of back and right leg pain. Santos diagnosed Poust as having L5/S1 isthmic-type spondylolisthesis. After several attempts at non-operative treatment, he went back to Navy Medical for surgery to correct his problem. He underwent a laminectomy and fusion of the S1 and L5 vertebrae. (Id. at 29-30.)
6. There are operating tables developed specifically for use during spine surgery. One of those types of tables, the Andrews Spinal Table, was used during Poust's surgery. (Id.)
7. The Andrews Spinal Table was designed to alleviate any pressure points during spine surgeries. The Andrews Spinal Table allows the patient's abdomen to hang free and has a frame which has padded supports placed at the patient's chest, iliac crest, legs and thighs. (Id. at 8.)
8. Poust was placed on the table, supported by portions of the padded frame which contacted Poust at his rib-cage, the iliac crest (pelvis), leg (from mid-thigh to ankle). (Id. at 12-13.) The operating nurses positioned Poust on this table. (Id. at 112.) The operating room nurses placed additional pillows underneath Poust's thighs, knees and calves. (Id. 12-13.)
9. After positioning Poust on the Andrews Table, Santos checked the contact points to confirm that his positioning was correct and did not inhibit perfusion of blood to Poust's extremities. (Id. 14-15.)
10. Poust was attached to a pneumatic compression device manufactured by defendant, Huntleigh Healthcare. (Id.)
12. Pneumatic compression devices are used in spinal surgeries to prevent deep vein thrombosis. Deep vein thrombosis occurs when there is a decreased blood flow to the patient's lower extremities, which then causes the patient's blood to clot and adhere to the veins in the patient's leg. (Id. at 18.)
13. One aspect of the pneumatic compression device used on Poust is the pneumatic cuff. The cuff is comprised of the following components: (1) a fabric cuff unit fastened by velcro tabs which are wrapped around the patient's leg; (2) a plastic bladder which is inside the fabric cuff; and (3) a connection point on the bladder which connects to a hose. The hose runs from the air pump outside the cuff to the bladder which is inside the cuff. The bladder intermittently inflates and deflates to provide pressure to the calf muscle. (Id. at 24, 68). The velcro tabs are placed at the front of the leg, and the bladder is positioned to exert pressure on the four compartments in the calf muscles. (Id. at 71.)
14. Another aspect of the pneumatic compression device is the pressure-setting dial which allows the operating room staff to set the amount of pressure to be exerted into the bladder. (Id. at 23-24.) The recommended setting for the pressure gauge in the Flowtron DVT device is 40 millimeters of mercury. (Id.)
15. Santos did not place the pneumatic cuffs on Poust. (Id. at 107.)
16. Poust also wore thigh high anti-thrombobolic disease hose, commonly referred to as "TEDs" during his initial surgery. TEDs are also used to prevent venous stasis in the superficial veins, but do not provide a sufficient level of compression to affect the deep veins. (Id. at 27.)
17. Santos successfully performed the laminectomy and fusion as intended. After the surgery was complete, Poust awoke in the recovery room complaining of severe pain in the lateral aspect of his calves. (Id. at 35-37.)
18. Santos performed a differential diagnosis to determine the cause of Poust's pain. His methodology included the following steps: (1) examining the musculature for any swelling or tense compartments of the muscle; (2) monitoring and testing the pressure in both calf muscles; (3) testing for pain on passive motion of Poust's legs; (4) testing for decreased sensation in the problem area (paraesthesis); and (5) determining if the affected muscles were weak (paresis). This methodology confirmed Santos' suspicion of compartment syndrome as the cause of Poust's pain. (Id. at 39-43.)
19. Santos is familiar with the existence, diagnosis, and treatment of compartment syndrome. He first heard of the condition in medical school, and he routinely encountered it during his residency and now teaches his students about it. (Id. at 46.)
20. Compartment syndrome is a condition that results from elevated pressure within a closed osteofascial compartment. This elevated pressure, if high enough, can reduce muscle perfusion below the level necessary for cellular viability. (Id. at 48.)
21. The human calf contains four compartments, each essentially containing muscles, veins, arteries and nerves encased in a plastic-like sheath called fascia. (Id. at 50.) Poust's compartment syndrome is located in the lateral and anterior compartments of both of his calf muscles, which are found in the front and side of the lower leg. ( Id. at 51, 80.)
23. The fasciotomy and subsequent irrigation and debridement procedures were performed by Orvis Chitwood, M.D., with Santos serving as the supervising surgeon. (Id.)
24. The fasciotomy occurred on April 8, 1994. During the fasciotomy, Dr. Chitwood accidentally cut a branch of the perineal nerve, which in some instances causes a decreased sensation in the patient's foot. It would not, however, affect the patient's ability to move the foot. (Id. at 54-55.)
25. Once Dr. Chitwood cut the fascial layer of Poust's anterior and lateral compartments during the fasciotomy, Dr. Santos noted that a portion of the musculature in those compartments were a dark and dusky color, non-contractile, and non-viable. (Id. at 55.) Also at that time, Dr. Santos noted a "clear demarcation . . . a clear line between viable muscle at the proximal or the top part of the anterior compartment, as opposed to distally or down the leg. . . . And that was found on both sides. (Id. at 56.) At the top part of each of Poust's calf muscles, the muscle was "healthy, pink, very contractile to stimulation." (Id. at 57.)
26. Each of the four compartments of the leg is encased in a fascial sheath, and each compartment runs vertically from the knee to just below the ankle. Normally when compartment syndrome is diagnosed in a patient, it affects the entire compartment of the leg. (Id. at 58.)
27. The post-operative notes discuss Santos' findings during the fasciotomy and provide measurements of the location of the dead tissue. The line of demarcation where the dead muscle began was at approximately the distal half or the distal two-thirds of the lower leg. More specifically, from the patient's medial malleolus (the ankle joint) up seven centimeters (at the tendinous junction of the muscle), Dr. Santos noted no compartment syndrome. From about that same area (where the tendons became muscles) to approximately 12 centimeters up the calf, the muscle was dead. The remaining portion of the muscle was viable. (Id. at 64.)
28. During the second or third irrigation and debridement procedure, Santos compared the pneumatic cuffs to the dead muscle found on both of Poust's anterior and lateral compartments. Santos found that Poust's injuries corresponded to the placement of the cuff during surgery. (Id. at 67.) More specifically, when inflated, the pressure in the bladder is greatest in the middle, which causes the bladder to form into a "elongated sphere." Santos noted that the placement of the elongated sphere "approximated very closely where the patient's compartment was [located]." (Id. at 69.)
29. Santos attempted to determine the cause of Poust's compartment syndrome. Santos eventually concluded, with a reasonable degree of medical certainty, that Poust's compartment syndrome was caused by excessive pressure from the Flowtron DVT. (Id. at 93.)
30. He considered and ruled out several potential causes, including: (1) the type of operating table used for the surgery; (2) the patient's positioning during surgery; (3) the TEDs worn during the surgery; (4) undue pressure caused by outside forces such as operating room personnel leaning on the patient or placing instruments on the sheets covering the patient; (5) pressure points where the patient's body came into contact with the table; and (6) the TEDs or cuffs being ill-fitted and too tight for the patient's size. Santos also considered these factors along with his observations of the nature of the plaintiff's injury and his past medical history. (Id. at 74-85.)
32. Santos also considered whether Poust's positioning during surgery could have caused the problem. The point at which the patient's legs contacted the operating table was at or near the affected compartments. However, Santos ruled this out as a potential cause because: (1) additional pillows were placed at this contact point to provide more padding for the patient; (2) Santos was unable to find one reported case of compartment syndrome with a patient positioned in the prone position on the Andrews table; and (3) Santos checked plaintiff's pulse after he was positioned but before the surgery to ensure that the blood was flowing properly to the lower extremities. (Id. at 76-77, 79.)
33. Santos also considered and ruled out the size of the TEDs, and the possibility that they "kinked" or "bunched up" creating a tourniquet-like effect, because the TEDs could not generate enough pressure to cause compartment syndrome. (Id. at 81.) In reaching that conclusion, Santos did not speak to the member of the nursing staff responsible for fitting and placing the TEDs on plaintiff. (Id. at 103.)
34. Santos next considered any outside forces of pressure, such as operating room personnel leaning on the patient or placing instruments on him. Santos ruled this out as a possibility because of the distribution of the compartment syndrome on the calf muscle. (Id. at 82.)
35. Next, Santos reviewed Poust's medical history to determine if there were any predisposing factors which would make him more prone to the disease. Santos concluded that Poust did not suffer from ...