Maciag v. Strato Medical Corp.

• Decision Date: 24 June 1994
• Citation: 644 A.2d 647,274 N.J.Super. 447
• Parties: , Prod.Liab.Rep. (CCH) P 14,000 Stephen MACIAG, Executor of the Estate of Charlotte Maciag and Stephen Maciag, Individually, Plaintiff-Appellant, v. STRATO MEDICAL CORP. and Dow Corning Corp., Defendants-Respondents, and Richard Roe Corp., a fictitious name; Godfrey C. Pinder, M.D., St. Clare's/Riverside Medical Center, Jane Doe, a fictitious name, Barry A. Reiter, M.D., Stephen M. Schreibman, M.D., Stevan Adler, M.D., a professional association, and Barry A. Reiter, M.D., Stephen M. Schreibman, M.D. and Stevan Adler, M.D., individually, Defendants.
• Court: New Jersey Superior Court — Appellate Division

Page 447

274 N.J.Super. 447

644 A.2d 647, Prod.Liab.Rep. (CCH) P 14,000

Stephen MACIAG, Executor of the Estate of Charlotte Maciag and Stephen Maciag, Individually, Plaintiff-Appellant, v. STRATO MEDICAL CORP. and Dow Corning Corp., Defendants-Respondents and Richard Roe Corp., a fictitious name; Godfrey C. Pinder M.D., St. Clare's/Riverside Medical Center, Jane Doe, a fictitious name, Barry A. Reiter, M.D., Stephen M Schreibman, M.D., Stevan Adler, M.D., a professional association, and Barry A. Reiter, M.D., Stephen M Schreibman, M.D. and Stevan Adler, M.D., individually, Defendants.

Superior Court of New Jersey, Appellate Division.

Argued May 17, 1994.

Decided June 24, 1994.

Arthur L. Raynes, Morristown, for appellant (Wiley, Malehorn & Sirota, attorneys; Arthur L. Raynes, of counsel and on the brief, William J. Kemple, Jr., on the brief).

Kenneth R. Meyer, Morristown, for respondent Strato Medical Corp. (Porzio, Bromberg & Newman, attorneys; Lauren E. Handler, of counsel and on the brief, Morna L. Sweeney and Vanessa M. Kelly, on the brief).

Richard J. Shackleton, Ship Bottom, for respondent Dow Corning Corp. (Shackleton, Hazeltine & Bishop, attorneys; Richard J. Shackleton, on the brief).

Before Judges DREIER, BROCHIN and KLEINER.

The opinion of the court was delivered by

DREIER, J.A.D.

Plaintiff appeals from a partial summary judgment dismissing his product liability claims against Strato Medical Corp. and Dow Corning Corp., two of the several defendants in this case. He also appeals from the denial of his motions for reconsideration. Plaintiff's late wife, Charlotte Maciag, sustained injuries after a subclavian venous access catheter fragmented inside her. ¹

The defendants in this action are Strato Medical Corporation, manufacturer of the catheter, Dow Corning Corporation, manufacturer of the tubing incorporated into the catheter, Dr. Godfrey Pinder, the physician who surgically implanted the catheter, St. Clare's/Riverside Medical Center, the hospital in which the surgery implanting the catheter was performed, and Mrs. Maciag's treating oncologists, Dr. Barry Reiter, Dr. Steven Schreibman and Dr. Stevan Adler, sued individually and collectively as a professional association.

Strato and Dow Corning successfully moved for summary judgment. On June 11, 1993, the day on which the motions for summary judgment were granted, plaintiff's attorney received 291 additional documents from Strato. ² The documents were apparently provided by Strato in response to plaintiff's request for production of documents served approximately three years earlier. As a result of receiving the additional discovery, plaintiff moved on June 18, 1993 for reconsideration of his summary judgment motions. Subsequently, on June 25, 1993, Strato provided an additional 700 pages of discovery to plaintiff. On August 6, 1993, the trial court denied plaintiff's application for reconsideration without prejudice to his right to bring a future application "in the event that movant can set forth a specific claim that the additional materials ... in fact contain newly discovered evidence that could alter said judgment." On September 24, 1993, plaintiff unsuccessfully moved on the basis of a supplemental expert report to vacate the trial court's orders and reinstate all claims against Strato and Dow Corning. We granted leave to appeal and now reverse.

Plaintiff's decedent, Charlotte Maciag, was diagnosed with metastatic breast cancer for which a mastectomy was performed in 1986. On February 8, 1988, Mrs. Maciag underwent surgery for the implantation of a subclavian venous access catheter. The catheter was manufactured by Strato and contained two components: a circular stainless steel injection portal, and a segment of silicone catheter tubing, supplied by Dow Corning.

From February 1988 to September 1988, the catheter was used in the administration of chemotherapy to Mrs. Maciag. On September 9, 1988, x-rays revealed that the catheter tubing had fragmented into at least four pieces. Two surgeries were performed to remove the catheter and retrieve the two larger pieces of the tubing. Smaller fragments of the tubing could not be removed and remained lodged in or near Mrs. Maciag's pulmonary artery until her death on October 4, 1989.

When the pieces of the catheter were removed, they were examined by the pathology department at St. Clare's and photographs of them were taken. Strato was then permitted to remove the catheter from the hospital for further examination and testing. Unfortunately, Strato has certified that it is now unable to locate the catheter.

Plaintiff provided the trial court with expert opinions concerning the liability of both the medical defendants and the product liability defendants. Plaintiff's medical liability expert, Barry L. Singer, M.D., principally concluded that the shattering of the "portacath" was caused in part by the failure of the inserting surgeon and the attending oncologist to require follow-up x-rays and to monitor the patient. In the expert's opinion, the failure of the medical personnel to monitor the catheter when chemotherapy was being administered through it was a deviation from accepted medical standards of care. In addition, he claimed that the delay in treatment as a result of the catheter problem worsened the patient's prognosis for survival.

We here focus, however, on the expert opinion of Gary B. Witman, M.D., plaintiff's expert concerning the product liability defendants. Dr. Witman furnished four reports which we will summarize: September 5, 1992, November 23, 1992, April 29, 1993 and September 10, 1993. His initial report described the procedure for the insertion of the device by the vascular surgeon. The expert noted that the surgeon had never used the device prior to this surgery, although he had used another vascular access device. When the broken catheter was removed from the chest cavity on September 9, 1988, all that was left was the access port connected to a 12.8 centimeter piece of white tubing.

A CT obtained on 10/6/88 revealed that fragments of the catheter had been left behind, and had showered the pulmonary vasculature. The largest of these fragments was 8 mm. in size. They involved the superior segment of the left lower lobe, pulmonary artery branch, the left hilum, probably in the left pulmonary artery, the medial wall of the main pulmonary artery out flow tract, and the superior segment of the right lower lobe branch of the pulmonary artery.

Dr. Witman noted that the Journal of Clinical Oncology had documented a "pinch-off effect," when there was "long standing compression at the narrow space between the clavicle and the first rib." The expert stated, however, that "[t]his shower and fragmentation of the device tubing cannot be attributed in entirety to the 'pinch-off effect' as reported in the medical literature.... [I]n this case, the tubing has shattered into multiple pieces, and this cannot be explained on the basis of a stress fracture phenomenon." In this initial report, Dr. Witman stated unequivocally that a failure of this kind would not occur in the absence of negligence. He further stated:

Due to the loss of the catheter by Strato, it is impossible for me to provide you with the exact cause of the failure of this device. The possible causes include problems with the design, problems inherent in the manufacturing or sterilization flaws, or negligent or improper placement or use of the catheter.

In Dr. Witman's second report, he reviewed the preparation, sterilization procedures, performance criteria and insertion technique concerning the device. He first repeated the conclusions of his earlier report, and then questioned whether the tubing selected for catheter attachment was appropriate, "as this particular type of tubing is not intended for long term or permanent implantation." Relying upon the surgeon's deposition stating that the pieces of catheter removed were not a consistent color, but had been discolored in an irregular manner to a yellowish color, Dr. Witman stated that the

irregular discoloration suggests that the tubing was deteriorating. Without analyzing the actual tubing (which Strato claims to have misplaced), it is difficult to definitively determine the cause of the deterioration. However, the deterioration noted by Dr. Pinder is consistent with deterioration resulting from the use of the chemotherapy drugs ... administered by [the oncologists].

Dr. Witman also noted that the oncologist's medical records failed to indicate proper flushing of the catheter after use. Also, the surgeons apparently had relied upon literature provided by a different manufacturer and may not have followed the Strato instructions that a particular type and size needle be used, raising the possibility that the oncology staff "used an inappropriate needle and damaged the catheter." He again bemoaned the loss of the catheter, the examination of which could have revealed the cause of the problem.

Dr. Witman's third report concentrated on the actions of the surgeon, noting that Dr. Pinder attempted to comply with recommended guidelines in the insertion of the catheter and verification of its location. However, he noted that the device had been placed in the medial aspect of the subclavian vein, thus giving rise to the pinch-off effect which occurs in approximately one percent of patients utilizing a central venous line. According to Dr. Witman, the Food and Drug Administration in its approval for "Strato's Life Port Access System had recommended that the device be placed in the lateral aspect of the subclavian vein. In this way the catheter will not be compressed up against the medial wall and will be free to roam without experiencing 'pinch-off.' " The portacath system with which the surgeon had been familiar prior to this operation was different from the life port system, and each had "unique and distinct approvals and guidelines." Dr. Witman...