Beard v. Johnson and Johnson, Inc.

41 A.3d 823, 615 Pa. 99, 2012 WL 1021323, 2012 Pa. LEXIS 606
CourtSupreme Court of Pennsylvania
DecidedMarch 22, 2012
Docket35 WAP 2010
StatusPublished
Cited by25 cases

This text of 41 A.3d 823 (Beard v. Johnson and Johnson, Inc.) is published on Counsel Stack Legal Research, covering Supreme Court of Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Beard v. Johnson and Johnson, Inc., 41 A.3d 823, 615 Pa. 99, 2012 WL 1021323, 2012 Pa. LEXIS 606 (Pa. 2012).

Opinions

[101]*101 OPINION

Justice SAYLOR.

This appeal arises out of a medical-device product liability action in which a striet-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 EndoSurgery, 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 instru[102]*102ments are inserted).1 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.2 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.3 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 [103]*103Bldg. 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.4

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 [104]*104extraordinary measures.”).5 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.

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Bluebook (online)
41 A.3d 823, 615 Pa. 99, 2012 WL 1021323, 2012 Pa. LEXIS 606, Counsel Stack Legal Research, https://law.counselstack.com/opinion/beard-v-johnson-and-johnson-inc-pa-2012.