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Jeffrey K. Beard, As Administrator of the Estate of Sandra L. Selepec v. Johnson and Johnson

March 22, 2012

JEFFREY K. BEARD, AS ADMINISTRATOR OF THE ESTATE OF SANDRA L. SELEPEC, DECEASED, APPELLANT
v.
JOHNSON AND JOHNSON, INC.; ETHICON, INC., A SUBSIDIARY COMPANY OF JOHNSON AND JOHNSON, INC.; ETHICON ENDO- SURGERY, INC., A SUBSIDIARY COMPANY OF JOHNSON AND JOHNSON, INC.; CARDINAL HEALTH, INC., T/D/B/A CARDINAL HEALTH; AND CARDINAL HEALTH 414, INC., T/D/B/A CARDINAL HEALTH, APPELLEES



Appeal from the Order of the Superior Court entered October 23, 2009 at No. 925 WDA 2008 reversing the Judgment of the Court of Common Pleas of Allegheny County entered May 13, 2008 at GD 04-: 17685.

The opinion of the court was delivered by: Mr. Justice Saylor

CASTILLE, C.J., SAYLOR, EAKIN, BAER, TODD, McCAFFERY, ORIE MELVIN, JJ.

ARGUED: April 13, 2011

OPINION

This appeal arises out of a medical-device product liability action in which a strict-liability, design-defect theory was asserted. Given that the surgical instrument in issue is said to have multiple applications, we are asked to determine whether a trial court's threshold risk-utility analysis should be limited to the particular one alleged to have caused the plaintiff harm. Additionally, appeal was allowed to consider the degree to which an appellate court is bound by such weight and credibility determinations as may be made by a trial court in a risk-utility assessment.

By way of background, the pertinent medical device is a linear cutting and stapling instrument, used in place of traditional scalpel-and-suture techniques in various surgical applications. In highly simplified terms, the elongated device consists of: a hand-held control mechanism resembling a pistol grip; a thin shaft; and a compact, distal-end jaw. This jaw incorporates compression, cutting, and stapling features useful in transecting organ tissue, while seaming and sealing resultant segments. Through a cartridge inserted into the jaw, linear, parallel rows of staples are fired into compressed tissue on both sides of the blade during incision, ideally leaving the divided and seamed tissue ends hemostatic (or not bleeding). This process is repeated, as needed, to form longer staple-line seams.

The decedent, Sandra Selepec, underwent gastric bypass surgery in August 2002. As part of the procedure, her stomach was transected to create a smaller stomach pouch. The surgeon used a product manufactured by Ethicon Endo-Surgery, Inc. ("Appellee"), known as an ETS-Flex45 Articulating Endoscopic Linear Cutter, or an "endocutter," as described above. As is apparent from its name and shape, the instrument was designed for use in endoscopic surgery (less invasive procedures accomplished through small incisions in which a magnifying camera, a light source, and surgical instruments are inserted).*fn1 However, Appellee also marketed its product as being useful in more traditional surgery, in which larger incisions are made to expose organs to open view and accessibility.*fn2 Mrs. Selepec's surgery was of this latter kind.

Of additional relevance to the litigation, in Mrs. Selepec's operation, the surgeon employed a buttressing material -- known as peri-strips -- to reinforce the staple lines. Furthermore, after the surgery, the particular endocutter used was discarded (as is apparently the common practice for these instruments intended for use in a single surgery).

During recovery, Mrs. Selepec experienced complications, and surgeons reentered her abdomen. They discovered that staples were absent in two small line segments, with the operative report indicating: "What we found was a defect on the staple line both on the left side of the gastric pouch as well as the gastric remnant. These findings were consistent with mechanical staple failure." N.T., May 17, 2007, at 275. A repair was effectuated; however, leaked stomach contents fostered sepsis, and Mrs. Selepec died.

The estate administrator ("Appellant") commenced the present product liability action against Appellee and others.*fn3 The complaint identified multiple theories of liability, including an asserted defective design of the endocutter. Presumably in light of Appellant's inability to examine the actual instrument used in Mrs. Selepec's surgery, however, the primary liability theory emerging in the pre-trial proceedings was one of strict-liability product malfunction. See generally Barnish v. KWI Bldg. Co., 602 Pa. 402, 410-14, 980 A.2d 535, 540-43 (2009) (setting out prevailing Pennsylvania law on this subject and explaining that "malfunction theory permit[s] 'a plaintiff to prove a defect in a product with evidence of the occurrence of a malfunction and with evidence eliminating abnormal use or reasonable, secondary causes for the malfunction" (quoting Rogers v. Johnson & Johnson Prods., Inc., 523 Pa. 176, 182, 565 A.2d 751, 754 (1989))). Appellee defended, inter alia, on the basis that Appellant had failed to satisfy his obligation, under malfunction theory, of excluding alternative causes. See id. In particular, Appellee had contended that the surgeon failed to account for the peri-strips he elected to use in selecting among three available staple sizes (differentiated by color-coding of the cartridges). According to Appellee, the surgeon should have employed the longest staple length, given that the peri-strips added material width impacting staple formation. Such asserted mistake, Appellee had claimed, was a more probable cause of any staple failure than the alleged product malfunction.

The day before trial, Appellant submitted a supplemental expert report from his primary liability expert, Frederick Hetzel, Ph.D. Mr. Hetzel opined that the endocutter was defective in design, because it failed to incorporate a measuring device to aid surgeons in determining tissue thickness and, thereby, appropriate staple length. Alternatively, the supplemental report suggested the incorporation into the design of some safeguard to prevent the jaws from closing around tissue too thick to allow for proper staple formation.*fn4

Appellee objected to the late submission of this design-defect theory. Appellant's attorney responded that the contemplated testimony was in the nature of rebuttal (to address Appellee's assertion of an alternative cause) and claimed that, as such, there was no issue with the timing. See N.T., May 16, 2007, at 48 ("This is like every other case here. There's nothing special about this case that that [sic] requires any extraordinary measures.").*fn5 Although the trial court found it "unfair at the 11th hour to make this [defect] assertion," the remedy it afforded was to permit Dr. Hetzel to be deposed by the defense during breaks in the trial proceedings. Id. at 66. The court also denied a defense motion for continuance.

At trial, Appellant opened his case in chief with the testimony of a general surgeon, I. Michael Leitman, M.D. Dr. Leitman testified to the increased prevalence and success of gastric bypass surgery. See id. at 172-73. He described the benefits of the procedure, including improvement of health and lifestyle for persons suffering from obesity. See id. According to Dr. Leitman, the procedure is not without attendant risk, as one in two-hundred patients may die from the surgery "for a variety of reasons [including] a leak." Id. at 174. In describing the particular bypass technique employed, encompassing the use of the endocutter, Dr. Leitman indicated that, in gauging organ tissue thickness, physicians rely on tactile sense, as well as an unforced closure of the endocutter's compression mechanism, manifested by a "click." See id. at 176-79, 189, 201. He also noted that stomach tissue is not homogeneous in thickness. See id. at 179.

Next, Dr. Leitman reviewed the notes from the operating surgeon, Athan Georgiades, M.D. He explained that Dr. Georgiades employed the endocutter appropriately, and, consistent with standard medical practices, inspected the staple line and tested for leaks. See id. at 185, 187. According to Dr. Leitman, Dr. Georgiades' selection of an intermediate-size staple was appropriate, and this was evidenced by the overall adherence of the seam. See id. at 183 ("If he had chosen an inappropriate cartridge and something would have happened, the whole thing would have likely fallen apart, but it was just one small area."); see also id. at 203. Of central importance to Appellant's present arguments concerning product defect, Dr. Leitman also testified that there are other devices on the market, used in different cutting and stapling applications, that have a gauge to permit a surgeon to accurately measure thickness. See id. at 190.

On cross-examination, however, Dr. Leitman disavowed any suggestion that he believed the endocutter should have a thickness gauge and confirmed that he still uses endocutters in his practice. See id. at 196 ("I never said this particular instrument had to have a thickness meter[.]"), 199. He also noted that the products offered by another major endocutter manufacturer also do not incorporate such a device. See id. at 196-197 ("There's no linear endocutter on the market that has a thickness gauge."). In response to questions eliciting additional details about the different cutter-stapler referenced in his direct testimony, Dr. Leitman disclosed that it was a circular, intraluminal instrument with substantially different functionality as compared to the endocutter. See id. at 197 (reflecting the witness's agreement that an intraluminal stapler cannot be used to divide the stomach). Finally, Dr. Leitman acquiesced in the understanding that the package insert accompanying Appellee's product indicates that, if a surgeon elects to use buttressing material such as peri-strips, he should consider using a larger size staple. See id. at 203 ("Selection of the appropriate staple cartridge should be based upon the combined thickness of both the tissue and the staple line buttressing materials.").

Appellant presented Dr. Georgiades as his next witness. Among other things, Dr. Georgiades confirmed his adherence to appropriate procedures and testing in Mrs. Selepec's surgery; indicated that he had no problems using Appellee's endocutter in the procedure; and explained that he had been satisfied after the procedure that everything had gone well. See, e.g., id. at 218-22. He also confirmed that gastric leaks are among the major complications of bypass surgery. See id. at 226.

The next relevant witness was Peter Naman, M.D., a general surgeon who participated in repairing the leaks which ensued after Mrs. Selepec's surgery. He confirmed that the recorded notes of the remedial operation alluded to "mechanical stapler failure," N.T., May 17, 2007, at 277; reiterated his belief that the leaks resulted from a "technical problem"; and testified that this "could be either related to the operator or to the instrument used." Id. at 290. Dr. Naman could not identify the cause of the small openings in the staple-line seaming with any certainty. See id. at 282.

The next major liability witness was Mr. Hetzel. On voir dire, it was developed that the witness's educational background is in chemistry. See id. at 303. Although he has no formal training in engineering, Mr. Hetzel emphasized his previous work in product research and development and his maintenance of a consulting practice working with lawyers in "forensic failure analysis of medical devices." Id. at 303-06. To date, his consultations and/or attendant testimony have included the finding of product defects in surgical staplers, failed knee and hip replacements, breast implants, pacemakers, automotive seatbelts and batteries, ventilation bags, children's toys, cigarette lighters, cookware handles, Styrofoam cups, hoses, and safety glass. See id. at 308-18.*fn6

After the voir dire, the defense renewed its motion to preclude Mr. Hetzel from testifying. In response, the trial court repeatedly expressed its concern that proof of design-related deficiencies in a sophisticated, mechanically-engineered product required testimony from an engineer.*fn7 Nevertheless, the court indicated that it wished to hear evidence of Mr. Hetzel's methodology in assessing product defect, and that it would defer its ruling until after such presentation. See id. at 344-48.

Before the jury, Mr. Hetzel then opined that Appellee's endocutter suffers from an inherent design defect, as it does not provide surgeons with accurate feedback concerning tissue thickness. See id. at 349-51. The witness explained that he tested the endocutter by firing the smallest-sized staples into "simulated tissue" consisting of paper wads, upon which he uncovered various permutations of staple malformation.

See id. at 351; N.T., May 18, 2007, at 400-11. He proceeded to review complaints Appellee had received concerning the endocutter, including reports of malformed staples and leakage. See N.T., May 17, 2007, at 354-57. From these documents and his testing, Mr. Hetzel concluded "the staple is failing, and it's injuring people[.]" Id. at 357.

On cross-examination, Mr. Hetzel conceded the many benefits associated with stapling over suturing, including decreased incidents of patient injury. See N.T., May 18, 2007, at 399. As to his testing, he acknowledged that he did not consider density differences between the paper he used and human organ tissue, and he could offer no correlation between the two. See id. at 405, 432.

After the testimony, Appellee renewed its exclusionary motion. The trial court responded that, in its view, Dr. Hetzel was "one of the worst witnesses it's ever heard, period." Id. at 458. In terms of the methodology about which the court was concerned, it stated:

Now, his testing consists of -- the best we could get out of that is his idea of compression, of course we're talking about tissue here, and documenting it -- tissue when compressed has a multitude of elements in it from water and fat and all these other things, and that his use of paper, that he tried to analyze paper . . .. You know, the Court has emphasized that's not a very -- at least in the Court's way of thinking as a fact finder -- a good comparison or analogy of compression, compression tissue, compression with paper.

The Court in trying to review the doctor's methodology, the Court cannot be oblivious to the fact that, as the Court indicated, he's a chemist, not an engineer, and the Court had previously -- and I'm saying the degree of sophistication does merit analysis in terms of the products he reviewed. . . ..

And the Court noted that while it's noteworthy that he is looking to [the] design [of] a circular staple[r], I don't know if that was for the bowel or whatever, but here in this instance when he did the testing, it seemed like he only used the white staple, which obviously is the thinnest of it.

Although the Court has indicated, the more you get into the medical field, and although he has analyzed products in the medical field, the Court feels that a greater degree of sophistication is needed engineeringwise and the like to determine what is lacking in a product.

Id. at 458-62.

In responsive arguments, Appellant's counsel stressed that his primary liability theory was product malfunction, and thus, contended that role of the design-defect evidence was of a limited nature. For example, he indicated:

[W]e don't even know if [the gastric leaks were] caused by tissue thickness because there are so many instances where these things fire, and they don't form staples. We don't know if it's always caused by tissue thickness or not. They may ...


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