*1 here, the situation is not one the framers were likely to have considered.
The statute recognizes when districts are realigned, timetables are necessarily changed; when an rea- anticipated lignment court, is successfully challenged in the timetable is even further askew. I find the statute reasonable, to be a unconstitutional, not effort to address an unfortunate situa- tion. notes,
As Saylor Justice we are not presented with a properly framed constitutional challenge a statute. We are asked for mandamus relief. As the statute vests discretion in the Speaker under circumstances, the present mandamus is Hence, inappropriate. I dissent. joins
Justice ORIE MELVIN this Dissenting Statement.
v. JOHNSON, INC.; Ethicon, Inc., JOHNSON AND Subsidiary Company Johnson, Inc.; of Johnson and Ethicon Endo-Sur gery, Inc., Subsidiary Company Johnson, Inc.; of Johnson and Health, Inc., Cardinal Health; Cardinal and Cardinal t/d/b/a 414,Inc., Health, Health Appellees. Cardinal t/d/b/a
Supreme Pennsylvania. Court of
Argued April 2011.
Decided March *2 L.L.C., Sole, Stroyd Cavanaugh A. Del Del Sole Joseph & Kontos, Swensen, Perer, Perer William Shaw Alan H. L.L.C., IV, Stroyd Pittsburgh, Del Cavanaugh Stickman Sole Jeffrey for K. Beard. L.L.P., for Berger, Philadelphia,
Arthur L. Galfand Bugay, Curiae, for Pennsylvania Amicus Association Jus- tice. Drinker, Jr., Alfred W. Putnam Bid- Daly,
Michael Patrick Richardson, L.L.P., dle, Reath, J. C. Philadelphia, & John L.L.P., Zeszutek, Shohl, Pittsburgh, Dinsmore & James Inc. Endo-Surgery, Ethicon BAER, CASTILLE, C.J., SAYLOR, EAKIN,
BEFORE: McCAFFERY, MELVIN, TODD, JJ. ORIE
OPINION
Justice SAYLOR. appeal
This arises out of a product liability medical-device action in which a striet-liability, design-defect theory was asserted. Given that the surgical instrument in issue is said to have multiple we are applications, asked to determine whether a trial court’s threshold risk-utility analysis should be limited to the particular alleged one to have caused the plaintiff Additionally, harm. appeal was allowed to consider degree to which an appellate court is bound such weight credibility determinations as may be made aby trial court a risk-utility assessment.
By way background, the pertinent medical device ais linear cutting instrument, and stapling used in place of tradi- *3 tional scalpel-and-suture in techniques surgical various appli- terms, cations. In highly simplified the elongated device consists of: a hand-held control mechanism a resembling shaft; pistol grip; a thin and a compact, jaw. distal-end This jaw incorporates compression, and cutting, stapling features tissue, useful transecting organ while and seaming sealing resultant segments. a Through cartridge inserted into the linear, jaw, parallel of staples rows are fired into compressed tissue on both sides of the incision, blade during ideally leaving (or divided and seamed tissue ends hemostatic not bleeding). process needed, This is repeated, as to form longer staple-line seams. decedent,
The Selepec, Sandra gastric underwent 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 Ethicon Endo- Surgery, Inc. (“Appellee”), known as an ETS-Flex45 Articu- Cutter, lating Linear Endoscopic “endocutter,” or an as de- scribed above. As is from apparent its name and shape, (less instrument was designed for use in endoscopic surgery invasive procedures accomplished small through incisions in camera, which a source, magnifying light and surgical instru- inserted).1 However, marketed its also Appellee ments are in which surgery, in more traditional useful being product open view expose organs made to incisions are larger kind. was of this latter surgery accessibility.2 Selepec’s Mrs. Selepec’s in Mrs. litigation, to the relevance Of additional material— buttressing surgeon employed operation, lines. Further- staple reinforce the as peri-strips known —to used was more, endocutter surgery, particular after the (as these practice the common is apparently discarded surgery). in a single intended for use instruments complications, recovery, Selepec experienced Mrs. During They her abdomen. discovered reentered surgeons with the segments, in two small line were absent staples on we found was a defect “What report indicating: operative as well gastric pouch the left side of the line both on staple were consistent with findings remnant. These gastric as the N.T., 17, 2007, at 275. A May failure.” staple mechanical effectuated; however, leaked stomach contents was repair Selepec and Mrs. died. sepsis, fostered pres commenced the (“Appellant”) The estate administrator and others.3 The liability against Appellee ent action an multiple liability, including theories of complaint identified Presumably of the endocutter. asserted defective the actual instrument inability to examine light Appellant’s however, liability surgery, primary in Mrs. Selepec’s used in the was one of strict- theory emerging pre-trial proceedings Barnish v. generally malfunction. See KWI liability product *4 surgery generally endoscopic parties 1. The refer to the relevant form terms, which, surgery surgery, general endoscopic laparoscopic in as generally Stedman’s Medical Dictionary in the area of the abdomen. See (28th ed.2006) laparoscope "endoscope for (explaining that a is an examining peritoneal cavity”). specification for the endocut- example, For the manufacturer’s sheet 2. multiple open application that instruments have ”[t]he ter indicates ..., thoracic, urologic minimally general, gynecologic, invasive or added). (emphasis surgical procedures.” pediatric R.R. at 1842 by Selepec’s initially Mrs. husband his The action was commenced 3. administrator; present administrator be- right and as estate own Selepec’s plaintiff upon a later substitution after Mr. came the named own death. Co., 402, Bldg. 410-14, 602 Pa. 535, (2009) 980 A.2d 540-43 out (setting prevailing Pennsylvania subject law on this explaining “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 Prods., Inc., v. 176, Johnson & Johnson 523 Pa. (1989))). defended, alia, Appellee inter on the basis that Appellant had failed to satisfy obligation, his under malfunction theory, of excluding alternative causes. See id. In particular, Appellee had contended that the sur- geon failed to account for the peri-strips he elected to use in selecting (differentiated three among available staple sizes color-coding of the cartridges). According Appellee, surgeon should have employed the longest staple length, given the peri-strips added material width impacting staple mistake, formation. Such claimed, asserted Appellee had was a more probable cause of any failure than staple the alleged product malfunction. trial,
The day before 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 measur- ing device to surgeons aid in determining and, tissue thickness thereby, appropriate staple length. Alternatively, the supple- mental report suggested the incorporation into the design of some safeguard prevent jaws from closing around tissue too thick to allow proper staple formation.4
Appellee objected to the late submission of this design- defect theory. Appellant’s attorney responded that the con- templated (to testimony was in the nature of rebuttal address Appellee’s cause) assertion of an alternative and claimed such, there was N.T., no issue with the timing. See May (“This at 48 is like every other case here. There’s nothing special about this case that that requires any [sic] arguments, parties their have referred to such a feature as a “locking device.”
104 measures.”).5 court found it the trial Although extraordinary assertion,” the make this [defect] 11th hour to “unfair at the deposed by Hetzel to be Dr. permit it afforded was remedy Id. at 66. in the trial proceedings. breaks during the defense for continuance. a defense motion also denied The court the testimo- trial, case in chief with opened his At Leitman, Dr. Leit- Michael M.D. I. ny general surgeon, of a and success of increased prevalence man testified to the He described the id. at 172-73. surgery. See gastric bypass of health improvement including of the procedure, benefits id. obesity. from See suffering lifestyle persons Leitman, without at- is not procedure to Dr. According risk, die from the may one in two-hundred patients tendant as a leak.” id. at 174. [including] a of reasons variety “for surgery en- employed, describing particular bypass technique endocutter, Dr. Leitman indicated the use of the compassing thickness, on rely organ physicians tissue gauging of the endocutter’s sense, well as an unforced closure tactile as mechanism, “click.” id. at by manifested See compression 176-79, 189, tissue is not 201. He also noted that stomach in thickness. id. at 179. homogeneous See Next, operating the notes from the Dr. Leitman reviewed Dr. explained M.D. He Geor- Georgiades, Athan surgeon, and, consistent appropriately, the endocutter giades employed line and inspected staple with medical practices, standard According id. at to Dr. tested for leaks. See Leitman, an Dr. selection of intermediate-size Georgiades’ and this was evidenced overall staple appropriate, was (“If chosen an the seam. id. at 183 he had adherence of See would have something happened, inappropriate cartridge just apart, have fallen but it was thing likely the whole would area.”); importance see also id. at 203. Of central one small defect, concerning product Appellant’s present arguments below, however, design-defect theory ultimately developed was 5. As stand-alone, theory liability. presented jury alternative to the does, fact, special design-defect require presentation of a claim Such treatment, undertaking risk-utility including the of a threshold assess- Co., Pa. ment. See v. Black Bros. Azzarello infra). (1978) (discussed Dr. Leitman also testified that there are other devices on the *6 market, used in different and cutting stapling applications, that have a gauge permit a surgeon accurately measure thickness. See id. at 190. cross-examination, however,
On Dr. Leitman any disavowed that suggestion he believed the endocutter should have a gauge thickness and confirmed that he still uses endocutters (“I in his practice. See id. at 196 never said this particular meter[.]”), instrument had to have a thickness 199. He also noted that the products offered another major endocutter manufacturer also do not incorporate such a device. See id. at (“There’s 196-197 no linear endocutter on the market that has gauge.”). thickness In response to questions eliciting addi- tional details about the different cutter-stapler referenced in his direct Dr. testimony, Leitman disclosed that it was a circular, intraluminal instrument with substantially different functionality as compared to the endocutter. id. See at 197 (reflecting witness’s agreement that an intraluminal sta- stomach). pler cannot be used to divide the Finally, Dr. Leitman in acquiesced understanding the package insert accompanying Appellee’s product indicates if a surgeon elects to use buttressing material such as peri-strips, he should using consider 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 materials.”). line buttressing
Appellant presented Dr. Georgiades as his next witness. Among other things, Dr. Georgiades confirmed his adherence to appropriate procedures and in testing Mrs. Selepec’s sur- gery; 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 gone had well. See, e.g., id. at 218-22. He also confirmed that gastric leaks are among major complications of bypass surgery. See id. at
The next Ñaman, M.D., relevant witness was Peter a gener- al surgeon who in participated repairing the leaks which ensued after Mrs. Selepec’s surgery. He confirmed that the “mechani- alluded to operation remedial notes of the
recorded 277; his N.T., 17, 2007, at reiterated failure,” May stapler cal problem”; a “technical resulted from that the leaks belief or to operator related to the “could be either testified that this not 290. Dr. Ñaman could Id. at the instrument used.” in the staple-line openings the cause of the small identify at 282. any certainty. See id. seaming with voir was Mr. Hetzel. On major liability witness The next back- dire, witness’s educational it developed was he has no Although id. at 303. chemistry. is in See ground Mr. Hetzel his emphasized in training engineering, formal development and his research work previous lawyers with working consulting practice maintenance *7 at 303-06. of medical devices.” Id. analysis “forensic failure date, testimony have his consultations attendant To and/or staplers, in surgical of defects finding product included implants, pacemak- knee and breast hip replacements, failed batteries, chil- ers, bags, ventilation automotive seatbelts and handles, Styrofoam lighters, cookware toys, cigarette dren’s hoses, safety glass. See id. 308-18.6 cups, dire, renewed its motion to After the voir the defense In the trial testifying. response, Mr. Hetzel from preclude of proof design- its concern that repeatedly expressed court mechanically-engi- in a sophisticated, related deficiencies Never- testimony engineer.7 from an product required neered last-three-years’ receipts from that his his 6. Mr. Hetzel also testified represented nearly percent of his total litigation-related activities N.T., 17, 2007, May income. See at 314-16. above, Appellee’s that light it is difficult to overlook assertions of Schoffstall, generally Cooper professional witness. See v. Mr. Hetzel is 482, 505, 522-23, (2006) (commenting on the 588 Pa. by professional phenomenon). Further discussion of the use witness litigation beyond plaintiffs witnesses in is defendants such and/or opinion. scope of this N.T., 17, 2007, ("And See, May the Court would think that e.g., 7. at 331 obviously you’re looking develop an instrument that would do when to measurement, you have some type routine that would have to ("The backgroundf.]’’), nature of engineering 334-35 intrinsic sort of weigh in the product complicated can and must and its say why analysis person capable failed of whether a prod- go beyond measure to that that and offer a corrective and then theless, the court indicated that it wished to hear evidence of Mr. Hetzel’s methodology defect, in assessing product that it would defer its ruling until after such presentation. See id. at 344-48.
Before jury, Mr. Hetzel then opined that Appellee’s endocutter suffers defect, from an inherent design as it does not provide surgeons with accurate feedback concerning tissue thickness. See id. at 349-51. The explained witness that he tested the endocutter firing smallest-sized staples into “simulated tissue” wads, consisting paper upon which he uncovered various permutations of staple malformation. See 351; N.T., 18, id. at May at 400-11. proceeded He review complaints Appellee had received concerning the endo- cutter, including reports of malformed staples and leakage. N.T., 17, 2007, See May at 354-57. From these documents and his testing, Mr. Hetzel concluded “the staple is failing, and injuring it’s people[.]” Id. at 357. cross-examination,
On Mr. Hetzel conceded the many bene- fits associated with stapling over suturing, including decreased incidents of patient injury. N.T., May See at 399. As to his testing, he acknowledged that he did not consider density differences between the paper he used and human tissue, organ and he could offer no correlation between the two. See id. at
After the testimony, Appellee renewed its exclusionary mo- *8 tion. The trial court view, responded in its Dr. Hetzel was “one of the heard, worst witnesses it’s ever period.” Id. at 458. In terms of the methodology about which the court concerned, was it stated:
Now, his testing consists of—the best we get could out of that is his idea of compression, of course we’re about talking here, tissue 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, he tried to analyze know, paper----You the Court has emphasized uct.”), ("Now, the Court measuring would feel that a device surgical stapler attached to this high degree would sophisti- involve a of cationf]”). thinking of way in the least Court’s very not a
that’s —at compression, analogy or comparison finder —a good a fact tissue, paper. with compression compression the methodology, to review the doctor’s trying The Court that, as the Court to the fact cannot be oblivious Court the indicated, chemist, an and Court engineer, he’s a not degree sophistication I’m the saying previously had —and he reviewed products in terms of the analysis merit does that he is noteworthy that while it’s noted And Court I don’t know staple[r], a circular design [of] looking [the] whatever, but here in this bowel or if that was for the only like he used testing, it seemed instance when he did of it. obviously which is the thinnest staple, the white indicated, you get the more into has Although Court field, in the analyzed products he has although medical and field, degree a greater feels that medical Court the like to needed and engineeringwise sophistication lacking product. what is a determine Id. at 458-62. counsel stressed arguments, Appellant’s
In responsive malfunction, thus, and liability theory his was primary was of a evidence design-defect contended that role of he indicated: example, limited nature. For by if leaks caused gastric were] don’t even know [the [W]e where many there are so instances tissue thickness because fire, form We don’t they staples. don’t things these They or not. caused tissue thickness always know if it’s cartridge we know in the or have been bent for all may come out bent. They He checked them.
All know is that he fired them. we B, out. That’s malfunc- they came proper didn’t form prove specific even have to The Plaintiff doesn’t tion. going about is they’re talking All defect. this stuff *9 109 defect, and they’re saying they’re it saying was — too thick. We don’t know if it was too thick.
Id. at 482-83.8
In response to the the trial arguments, again court deferred a definitive ruling. Since Mr. Hetzel had “made career of obviously reviewing various products and determining whether these products are defective or unsafe for their use,” 462, intended id. at the court felt experience his was relevant and wished hear the defense evidence before further addressing the admissibility issue. See id. at 463. case,
At the close of Appellant’s Appellee sought a nonsuit on several grounds, including insufficient evidence to support Appellant’s design defect of theory liability. The motion was denied. case,
In the defense Appellee developed its theory the most likely cause of the gastric failure, leaks was a on the part of Dr. Georgiades, to account for the peri-strips in selecting See, among N.T., available staple 21, 2007, sizes. e.g., May alia, at 684-92 inter (reflecting, the testimony of Appellee’s representative, a mechanical engineer, applying “simple N.T., 18, 2007, ("We May 8. Accord prove 545 don't have to —there many why are reasons it happened. could have happened It could have they reason, stapler because came out of the crooked. For whatever it perform didn’t the function that it was intended to do based on the fact failed, that it subsequent and that events confirmed that. That is our theory.”); (reflecting closing id. at 854 argument Appellant’s counsel to the effect why staples that: "We don’t know came out in Nobody why. that area.... Maybe knows staples were bent in the cartridge. Maybe How they do we know? funny day.’’). came out juncture, At this we observe that there are a number of theoretical running through inconsistencies this case which tend to cloud the analysis above, example, of the argument issues. For as to counsel’s if Appellant prove could relating not that a defect to tissue thick- death, Selepec's ness caused simply Mrs. it prevail could not on a design-defect theory liability, since causation is an essential element Appellant on which proof. bore the burden of Brantly See Berkebile v. 83, 93-94, Helicopter Corp., (1975); 462 Pa. 337 A.2d see also Corp., v. Pa.Super. Davis Berwind (1994). Although beyond matter scope this accepted issues here, consideration jury fact that obtained a verdict on a which, trial, theoiy liability throughout unprova- he maintained was ble, least, very at the adds an element of dissonance to the review. *10 largest- the use of dictates
math,” of peri-strips the addition a endocutter); general at 783 (opinion id. in an staple size effect). highlighted Additionally, Appellee to similar surgeon see, product, its accompanying cautions instructions and the 684-92, events rarity relative of adverse and the e.g., id. in which endocutters the millions of incidences compared with Furthermore, 702, Appellee pre- 758. fired. id. at are See that size is a engineer mechanical from a testimony sented cutter- endoscopic to pertaining constraint material id. at 607. staplers. See again requested the defense jury charge,
Prior to the to testimony, Mr. Hetzel’s on the motion to exclude ruling its on ruling that it had “made responded which the trial court N.T., at 811.9 testimony. May the parameters” Penn- counsel described closing arguments, Appellant’s jurors as follows: strict-liability law to sylvania fail, the you your If drive a car and brakes very simple. It’s required business is to doing manufacturer the cost [as] profits they’re and out of their products, stand its injured prod- that’s if the to someone required compensate failed, strict liability. uct has and its no—it’s a nice say they’re don’t look at the manufacturer and We You don’t they intentionally. didn’t do this company fail, say can’t come back and to your they look at if brakes well, them inspected should have last you, maybe you relevant is only thing not relevant. The that’s year —that’s expected fail to as it was product perform did the perform[.] That’s they form the or did not? product staples
Did matter. The will called a malfunction. And it doesn’t Court They you company guarantor. guarantee tell became market. It’s as as that. simple when it’s on the unclear, meaning response reflects The of this since record continually deferred point proceedings, trial the court had to that in the ruling on the defense motion.
Ill Id. at 850-51.10
The jury returned a verdict favorable to Appellant, award- $5,000,000. the estate ing so, In doing jurors expressly rejected Appellant’s malfunction theory, predicating the award solely on Appellant’s design defect case.
In response Appellee’s motions, post-trial the court pro- vided the following very brief analysis of its risk-utility calcu- lus:
The endocutter’s defect exposed patients to a high risk of serious or fatal injury. The defect and its risks are un- *11 avoidable, the despite best care or training of the surgeon. The seriousness of the danger posed by the challenged clear; design is trial testimony included the likelihood of the occurrences of the danger even when surgeon the exercised care and proper Further, had training. the stapler could have been designed so that it would not fire if tissue was too thick or the defect could have been eliminated if the endo- cutter was equipped with a device measuring as used in other staplers.
While there are certainly benefits to society by the use of endocutter, the the foregoing analysis shows that the utility and benefit of this endocutter are outweighed by the danger poses. it
Selepec Johnson, Inc., v. Johnson & 04-17685, GD slip at 6 op. 2008) (citations 30, omitted). (C.P.Allegheny, Oct. appeal,
On
a divided Superior
panel
Court
vacated the
award in a memorandum opinion and directed the trial court
to enter judgment notwithstanding the verdict in Appellees’
favor.
Initially,
the majority observed
under prevailing
reasons,
example
problematic
10. Counsel’s
is
including
for several
its
burden,
plaintiff’s
failure to account for the
theory,
under malfunction
Barnish,
addressing
410-14,
alternative causes. See
Pennsylvania make a threshold trial must theory, judge strict-liability is product of the utility whether as to determination explanation, of further By way risk. by the outweighed Inc., 765, 772 Sofamor, 774 A.2d v. majority quoted Schindler follows: (Pa.Super.2001), danger unreasonably a product of whether question
The Brothers Azzarello v. Black Co. of law. question ous is (Pa.1978). 1020, 547], 1026 [sic] Pa. 391 A.2d [480 making a essentially a court is question this answering social as both a acting social determination policy Fitzpatrick risk-utility analyst. economic philosopher (Pa.Su 473], Pa.Super. Madonna [424 v. v. Mallis [336 In Dambacher Dambacher per.1993). 22], this Court (Pa.Super.1983), A.2d Pa.Super. making this determi certain factors to consider identified nation: design; danger posed by challenged gravity
The occur; the mechanical danger likelihood that such would consequences and the adverse feasibility design; of a safer that would result from a and to the consumer omitted). (citation safer Inc., Johnson, 2008, slip op. 925 WDA Beard v. Johnson & *12 2009). Rather than 712 (Pa.Super. Oct. the intermediate-court inquiry, out such an evaluative carrying “conclusory relied merely upon the trial court majority opined, majority, reading at 4. to the “a full According Id. language.” a minor only record leads to the conclusion that there is of the feasibility there is no danger likelihood that would occur and accomplish that would enable the to design of a safer its Id. at 5. goal.” testimony ad- majority relied on reasoning,
In its substantial, confirming both witnesses parties’ duced Further- compared suturing. to stapling net benefits more, expert testimony absence of the court stressed the with- alternative additions on the elaborating proposed id. at 5-6 to endocutters. See applicable in the constraints (“There from back to the old testimony, apart going is no method before laparoscopic surgery that utilized a full incision sutures, indicating that it would possible be to make an endocutter that can function with a measuring device or (“If locking mechanism.” (emphasis original)); id. at 2 we were to maintain the position that this device unreasonably dangerous because it had no locking or measuring capabilities, then no laparoscopic bypass could surgery performed.” ever be (emphasis in original)).
The majority also to appeared credit the defense theory Dr. Georgiades’ usage of the endocutter likely was the most (“The cause of Mrs. Selepec’s death. See id. at 6 surgeon did not read the endocutter, instructions on the peri-strips or the which were accurate and would have made the use device safe here.”); and avoided what happened see also id. at (“Of course, the doctors would know that they could not measure the thickness and therefore know they had to use the right sized cartridge.”). Additionally, the majority rejected Appellant’s allusions to measuring devices associated with intraluminal circular staplers, since “they are not used for laparoscopic surgery.” Id. at 6.11The majority concluded:
Overall, there is no showing that the endocutter is not superior to other methods or that there is a toway make it is____[A] safer than it currently full review of the record shows that there was malfunction, no evidence of the endo- cutter is a safe mechanism when used properly, and there is no feasible away measuring device or locking mechanism can be installed without making the endocutter unusable. Id. at 7.12
Appellant sought reargument on the basis that the court erroneously its analysis directed use endoscopic endocutter, when, instance, in the relevant the instrument was fact, the witnesses at trial did not make clear whether or not the were, not, staplers they circular referring to which were or were designed endoscopic surgery. be used in *13 dissent, Judge 12. Colville expressing issued a short his view that the finding trial unreasonably dangerous court’s that the endocutter was supported by sufficient evidence of record. unsuccessful, These efforts were surgery. in open in fact used however. Court, main- Appellant before this arguments present his analysis its by centering erred Superior
tains that the
Court
which he
the endocutter
a “use” for
surgery,
on laparoscopic
Moreover,
case.
Selepec’s
relevance to Mrs.
believes had no
of the trial court’s
court’s criticism
mirroring the intermediate
court’s own
challenges the intermediate
reasoning, Appellant
See,
Appel-
Brief for
e.g.,
analysis
being highly superficial.
(“Not
the fact
ignore
only
Superior
[the
Court]
lant at 12
does
device,
deter-
a doctor is unable to
measuring
a
absent
(and thus the
stapled
the tissue to be
mine the thickness of
use)
mentions
specifically
to
but
also
length
staple
[it]
incision’
an abdominal
surgery ‘requiring]
open
traditional
older, open
that Mrs.
received the
recognizing
Selepec
without
(emphasis
original)).
procedure.”
support
policy arguments
also offers
series
Appellant
assessment of a
risk-utility
contention that the
his broader
uses should be
designed
multiple
and marketed
the circumstances of a
solely
implicated by
to the one
limited
believes that wider
injury.
Initially, Appellant
plaintiffs
parties
presenting
the waters” for the
“muddy
focus would
claims,
needless
defect
as well as add
defending design
already complex
expensive
and burden to an
expense
Appellant,
at
narrow-
According
Id.
16.
litigation process.
the most
question
to the use in
“strikes
ing
analysis
product’s design-
the interests of a
balance between
equitable
Brief for
injured
Reply
Appellant
ers and the
consumer.”
Pennsylvania
underpinnings
also
discusses
of the Restatement
strict-liability theory in Section 402A
it, as
idiosyncratic developments attending
and the
Second
generally
in Azzarello and its
See
Schmidt
progeny.
reflected
(2011)
Co.,
924, Pa.
v. Boardman
“no-negligence-in-strict-liability
Azzarello’s
(explaining and inconsistencies
ambiguities
in material
rubric has resulted
*14
Pennsylvania’s
in
procedure.”).13 In particular, Appellant de-
velops
Azzarello’s efforts to
juris-
isolate strict-liability
from
prudence
negligence
has
theory
led to the
practice
risk-utility
threshold
trial
balancing by
judges, with reference
to a series of factors set out in the works of Dean John Wade.
Dambacher,
See generally
at 423 n. Wade, 5 (citing John On the Nature Strict Products, (1973)). Liability 44 Miss. L.J. 837-38 for According Appellant, an examination of these factors dem- onstrates that underlying policies entailing of the balancing — manufacturer’s in interests the production and distribution of a product against the safety of the consuming public—is served only where an independent inquiry is conducted for each intended use of a product. multi-use
Appellant has no difficulty in acknowledging the case of laparoscopic surgery, the risk-utility calculus favor may See, Appellee. (“The Brief e.g., Appellant at Superior Court’s statements about the health benefits laparoscopic surgery may be well placed and the may endocutter well very be the best tool available for use in laparoscopic surgery.”); (“A Reply Brief for Appellant at 13 finding that it is unreason- ably in dangerous open surgeries does not take away from its use in laparoscopic surgeries where it may very well be the case that its benefits outweigh its risks for that type of procedure.”). Appellant argues, however: analysis
The different, however, could not be more for the endocutter as a tool in open surgery. The record demon- strates that it would be affix possible to device, a safety measurer, such as a to the endocutter without sacrificing function an Indeed, open surgery tool. there surgical are staplers that Thus, have measuring devices. as to its use in traditional open surgeries, the consideration of (alleged) necessity of the endocutter’s design that was weighed against its risk of harm is simply present. not It is critical to note that this design change does not implicate, is, opinion 13. While part, the lead in opinion announcing Schmidt in an Court, judgment gained majority above observations support. surgery availability laparoscopic for use endocutter’s —a procedure. different completely citations original; 21 (emphasis Appellant Brief for (“[T]he alternative fact there is no better omitted); at 24 id. open to place used as an excuse should not be for laparoscopy shortcom- from the device’s at needless risk surgery patients exist.”). stresses also alternatives where safe ings (such in Mrs. as death injuries potential seriousness of the *15 case) inherent in of policy loss-spreading and the Selepec’s 402A. Section that, in Superior the Court argument second
Appellant’s discussion, the trial court’s by disregarding it erred risk-utility credibility of and weight of fact and determinations findings In testimony. particular, Appellant’s relative to trial witness amicus, Pennsylvania the Associa- and those of his arguments, Justice, majority’s inde- criticize the Court Superior tion for Mr. Hetzel testimony, of the as between weighting pendent hazards, witnesses, the concerning product and Appellee’s harm, of alternative sensibility and gravity potential that the intermediate court Amicus also observes designs. determination, to evidence contrary overt credibility made an record, not read Georgiades in its statement that Dr. did of or See peri-strips. inserts for the endocutter product N.T., (reflecting Georgiades’ at 233-35 Dr. May inserts, simply these but that he testimony that he had read he every performs surgery). not read them time does asserted brief several opens by cataloguing its Appellee For exam- argument. difficulties with Appellant’s structural trial Appellant’s posi- Appellee light observes ple, mere rebuttal sec- that his defect evidence was tion he never asked the trial theory, to his malfunction ondary assess- risk-utility threshold perform required court to notes, Furthermore, object did not Appellant ment. Appellee utility regarding to defense evidence with the endocutter in the associated use its constraints named, i.e., which it was endo- designed circumstance for limit his own evidence scopic surgery. Nor did N.T., See, e.g., May Appellee explains. open procedures, 2007, at 349-50 (reflecting Mr. Hetzel’s generalized assertions that “there is an inherent defect in the stapler”). light above, Appellee asserts that it should come as no surprise that the trial court also made no such distinction open between and laparoscopic surgery post-trial its risk-utility evalua- (“[NJowhere tion. See Brief for Appellee at 23 did [the court] even note that Mrs. Selepec open received surgery opposed surgery, closed let alone tailor analysis around any [its] two.”). unspoken distinctions between the Appellee also highlights Appellant’s various acknowledge- ments that (or its endocutter is not unreasonably dangerous so) least that it had not been shown to be in endoscopic use. According to Appellee, such concession poses an insurmounta- obstacle, ble theoretical since Appellant has conceded that there was and is no call for a different design of the endocut- ter, rather, but an merely admonition that it should not be used in open Nevertheless, surgery. Appellant limited his own case at trial to malfunction and design defect theories. (“[A] See Brief for Appellee at 25 claim that [Appellee] should have marketed the device for some procedures while warning against its use in connection with other procedures is not a *16 design defect claim: it is either a breach of warranty claim or a failure to warn claim. And those claims were either never pleaded or were never presented to the jury. They cannot fairly instance.”). be argued here in the first merits,
On the Appellee argues that: applying courts the risk-utility analysis have always risks, benefits, considered the and design constraints associated with all intended uses of a product; to artificially limit the utility risk analysis to the particular use to which a plaintiff put a product particular a case would be ignore inherent, to the essential characteristics that informed the design; and to hold multi-use products to the same standard as single-use products would be tanta- mount to the requiring sale of multiple single-use products, which would be inefficient and impractical, if not impossible.14 Owen, ah, Appellee 14. See Brief (citing for at 26-27 David G. et Madden (3d ed.2010) § 8:4 n. 14 (cautioning against Liability & Owen on Products tendency "narrowly compare to precaution the individuated costs of amicus cites nor his that neither observes Appellee otherwise, to militating or Pennsylvania from any authority, Moreover, acceptance according Appellee, contrary. and de- increase costs product would Appellant’s approach it explains: availability. particular, crease as to only evaluated are to be products multifunctional [I]f one put by particu- are they use to which particular the one case, manufacturers will then in one plaintiff particular lar multifunctional produce incentive to and have no manufacturers to Indeed, encourage law will products. each of its different of a for product make a different model sug- of such a and inefficiency impracticability The uses. and hard to overstate. easy are to demonstrate gestion widely that endocutter is undisputed [Appellee’s] It is used, laparoscopic in state-of-the-art highly product useful are procedures that bypass procedures; laparoscopic gastric than other and surgeons options; and patients better for are no procedures gastric bypass that non-laparoscopic would have the Court the norm. Yet longer [Appellant] useful, replace highly facts and ignore undisputed those supposedly fool-proof endocutter with a multifunctional in the outdated except “open” useless utterly product few still relatively surgeons perform. procedures were feasible—and there is no Even if such a that any that it is—there is no reason to believe evidence going capital manufacturer is to invest medical device shrinking market it to a small and design, manufacture and hand, safety particular accident at which course is benefits establishing design proper calculation never cost-benefit form of added)), Crespo Chrysler Corp., (emphasis v. defectiveness" (S.D.N.Y.1999) designs (explaining F.Supp.2d that alternative overall, just plaintiff,” not must be "safer to the relevant set of users position” dismissing argument contrary "an absurd an to the *17 413, added)), Corp., 414 Mich. (emphasis and Owens v. Allis-Chalmers 372, (1982) "[a]ny (recognizing that determination 377-78 326 N.W.2d essentially inquiry is an of a of the reasonableness variety given safety conditions was sufficient as to whether under of inquiry rejecting that an would be the notion such consideration” added))). competently adjudicated” (emphasis open-ended to be "too market. The end result would be that no one would make such a product, surgeons who prefer still to perform open procedures would be obliged to go without a stapler altogether resorting to the previous practice of suturing. — That, course, public would be bad policy every conceiv- Which, able level. with all due respect, is true of the change in the law [Appellant] is here. It advocating innovation, choice, would stifle limit decrease predictability, and increase costs. No rational “social policy philosopher” or “economic analyst” could credibly claim that such a system would benefit anyone....
Brief for Appellee at 38-40.
Compounding asserts, these problems, Appellee has provided no workable definition for the concept of multi- use products for purposes of limiting risk-utility analysis, opening up a new and wide corridor for “unpredictability and inconsistency in an already unpredictable and inconsistent area of the law.” Id. at 41. Appellee describes such an ungrounded approach untenable, as particularly plain- since tiffs have options other than design theory vindicate their (claims legitimate interests in negligence, breach of warranty, etc.) warn, failure to where a multi-function product poses peculiar risks specific uses.
In terms of the Superior Court’s asserted disregard of trial-
court weight
determinations,
and credibility
Appellee begins
explaining
assessment,
risk-utility
in a strict-
liability
case,
defective design
was christened by this Court as
law,
a question
Azzarello,
see
558,
the
incon-
particular
also identifies
jury.”). Appellee
of the
ince
advance-
the eve-of-trial
case given:
in the present
gruities
of
the assertions
theory;
defect
Appellant’s
ment of
in
nature of
was
the
that the claim
trial counsel
Appellant’s
the
required;
were
procedures
no additional
rebuttal and that
as a stand-alone
of the claim
contrary treatment
subsequent,
instructions;
overarching
and the
theory
jury
of relief in the
relative to
information
and economic
engineering
absence of
by Appellant.
design changes proposed
summary
a
of
arguments
its
with
concludes
Appellee
Pennsylvania
the foundation
confusion over
continuing
in
law,
recently by
most
this Court
strict-liability
developed
as
for the Third
Appeals
Court of
and
United States
Schmidt
(3d
Inc.,
F.3d 357
Cir.
in
v. Bell
651
Sports,
Coveil
Circuit
2011)
in the federal courts
application
the continued
(reflecting
Manufacturing,
v. Simplicity
from Berrier
prediction
(3d Cir.2009),
Inc.,
that this Court would overturn
As the before us review is plenary. Pennsylvania
I. The Present State Liability Product Law before, again recognize in we continu As Schmidt Pennsylvania in the arena of strict- disrepair state of ing Schmidt, 352-55, 11 Pa. at defect law. See liability design While, notes, several Justices Appellee A.3d at 939-41. questions past review of the foundational have favored decisions and have expressed their views as to the appropriate remedy, majority consensus yet has not been attained in any case. Mr. Chief Justice Castille and this author also have advocated issues, restraint the acceptance of subsidiary pending remediation of the foundational deficiencies. See Inc., Berrier v. Simplicity Mfg., 598 Pa. *19 (2008) J., Castille, (Saylor, joined C.J., by concurring certification).
in a denial of
noted,
As has been previously
“[ojbviously, all
are
Justices
not of a like
subject,
mind on this
as
appeal
this
involves subsidiary
Schmidt,
issues.”
II. The Risk-Utility Focus of Balancing In terms of the appropriate focus of design defect risk- utility analysis, for many of the reasons identified by Appellee, we decline to limit it to a particular intended use. For better worse, or this Court’s decisions have relegated our trial courts in the unenviable position of “social philosopher” and “risk- utility economic analyst.” This been having done—and as the present case does not provide an appropriate opportunity for reconsideration of such assignment decline to require the —we trial courts to put on blinders. It should be to enough say that a product’s utility obviously may be enhanced multi functionality, so that it would imprudent be deny trial courts the ability to assign some weight to this factor in assessing product design. supra Moreover, note 14. Cf. Appellant simply does not why address the other theories may which be available to a plaintiff, warn, such as failure to do not provide sufficient protection against deficient market and ing void, instruction practices. In this it is difficult to disagree with Appellee’s observation that Appellant’s conces sions of the net social utility calculus in the area of the endocutter’s primary design (endoscopic surgery) are irrecon cilably inconsistent with his claim of an inherent design def ect.15 open
15. This laparoscopic of an provides endocutter also —versus —use platform a somewhat strained for products, discussion of multi-use since, other than in the method of insertion and specialized use of faced difficulty by plaintiffs to the are sensitive
We
here,
where,
the instru-
defect,
as
particularly
proving product
In numerous
others.
destroyed by
has been
ment in issue
theory),
(such
malfunction
by way
acceptance
ways
also must
that burden. We
acted to alleviate
this Court has
stake in the
mind, however,
there is much at
bear in
any
beyond
above and
design,
a product’s
condemnation of
awards,
on
including
impact
award or
damages
individual
balance, we differ
innovation.16 On
costs and
a partic-
that the desire
streamline
Appellant’s position
with
priority
should be accorded
litigation
facet of products
ular
obviously in-
which was
wider-ranging assessment
over the
outset,
in the above character-
as manifested
tended from
factors
role, in the open-ended
of the trial court’s
izations
courts as the basis
by Pennsylvania
been accepted
which have
review,
otherwise.
risk-utility
Credibility
Weight
Determinations
III.
asserts,
obstacles to address-
presents
this case
Appellee
As
*20
every
there is
indica-
risk-utility balancing, since
ing threshold
this function on a
trial court never performed
tion that the
Nevertheless, under
in the first
instance.
pre-trial basis
the
by
has been determined
Pennsylvania law as
prevailing
date,
matter to
in absence of
court to address the
highest
courts are to assume
risk-utility balancing,
overt pre-trial
nonetheless.
process
undertook the
properly
the trial court
Inc.,
201,
Pa.Super.
443
Dougherty
Meloney,
v. Edward J.
See
(1995).17
375,
216,
appears
mechanically applied
viewing equipment, the
to be
endocutter
surgery.
type
in either
in the same fashion
limiting
justifications
policy
pragmatic
for
16. Various social
design by
incentivizing
reward-
liability manufacturers include:
safer
manufacturers;
recognition
plaintiff
ing
that a verdict for a
careful
design-defect
to a determination that the entire
in a
case is tantamount
defective;
burdening manufactur-
and the concern with
line is
insuring against
possible
all
their customers with the costs of
ers and
Co.,
670,
176,
Mfg.
v.
421 Mich.
365 N.W.2d
loss. See Prentis Yale
(1984).
very
knowledge,
Superior
Court has not been
clear as to
17. To our
may
why presumed
pre-trial
on
submissions
be subse-
decision based
ensuing
that this
quently
an
trial record. Given
evaluated based on
In terms of the Superior
review,
Court’s specific
Appellant’s
amicus aptly challenges the Superior
rejection
Court’s
of Dr.
Georgiades’ testimony that he read product inserts for the
See,
N.T.,
endocutter and peri-strips.
e.g.,
May
consideration, however,
235. That
does not
appear
have
one,
been a predominate
and other than
Appellant’s
complaint appears to be more with the intermediate court’s
balancing
factors than -with more traditional weight and
credibility considerations associated with true factual findings.
Appellee
As
explains, though, Azzarello conceived such risk-
utility balancing as
entailing
legal determination. See Azza-
rello,
480 Pa. at
decline,
We do not discount Appellant’s position that the Superior Court’s review appears to be and, extent, abbreviated to some conclusory. Indeed, one fair perspective is that appellate court acted simply to substitute one somewhat perfunctory analysis for another. Certainly, reasonable may minds dis- agree as to the respective conclusions drawn. We agree with however, Appellee, that the dearth of engineering econom- ic information on this record left those courts with little else to do but to draw somewhat abstract conclusions.19 yet Court has not addressed the beyond matter and it scope resides review, present accepted issues we will assume this is appropriate. may cogently It argued be risk-utility balancing legiti- is more mately assigned jury, acting ato community its role as a voice for the facts, power and with the to decide judge acting rather than to a trial *21 Indeed, summary on a record. approach such is the of the Restatement Third. 19. In engineering dynamic, terms of the example, for while circular, feasibility testimony stresses the relative to a intraluminal stapler, presented he no demonstrating concrete evidence how this design different functionality device's and Appellee’s related to endocut- N.T., 18, 2007, May ter. (reflecting at 475 the trial court's remark Cf. Appellant’s directed to “your expert, counsel nobody really had something say in there [incorporation that would proposed rationale the loss-spreading acknowledge we
Finally, again it- Nevertheless, Azzarello again, and Azzarello. motivating limits, rational manifest- some sort of implement sought self risk-utility evaluation. meaningful for a in its prescription ed constraint, argument contrary to of such light jury, Appel- and judge the trial trial counsel to Appellant’s matter. Accord simple was never a defect claim lant’s remark: 16, 2007, the trial court’s N.T., (reflecting at 60 May case.”)20 “Well, obviously complicated this is an considering are not restricted to hold that trial courts We threshold, defect, in design a multi-use product use of single the Superior also decline disturb risk-utility balancing. We risk-utility appropriate as to the legal determination Court’s calculus. affirmed. Superior
The order of the Court is CASTILLE, EAKIN and Justices ORIE Chief Justice join the opinion. MELVIN in which Justices concurring opinion BAER files
Justice join. TODD and McCAFFERY BAER, concurring. Justice myself
I
but write to distance
join
Majority Opinion,
I
footnote 18 of Part
II to the
from
Part
language
done”).
easily
The
safeguards
Appellee’s
could be
endocutter]
into
same is true relative to economic information.
by Appellee
Parenthetically, Appellant complains of various criticisms
testimony,
cross-petition
allowance of
of Mr. Hetzel's trial
since a
challenging
testimony
appeal
such
was denied
this Court. As
occasions, however, many
repeated
remarked on
trial court
overlapping
interdepen-
complications presented in this case are
See,
N.T., May
(reflecting
trial court’s
e.g.,
at 50
dent.
just wants to make known that the Court’s
comment that "the Court
argument
trying
when each
position
an awkward
to touch all the bases
step
every
argument”). We have
the next
other
sort of involves
testimony
developed
and the associated controversies
Mr. Hetzel’s
integral background
length
they provide
for the
some
both because
expert proffers
proceedings and since the looseness in
and/or
developed risk-utility
testimony impede a
assessment.
review,
framing
presented for
as well as
In view of the
of the issues
above, we
undertake an
the record as discussed
decline to
the state of
independent risk-utility evaluation.
*22
125
extent it may be read to express approval of the Restatement
(Third) of Torts:
I,
Products
In
Liability.
Part
the Majority
addresses what it deems the
state
“continuing
of
disrepair
the arena of Pennsylvania strict-liability design defect law” in
reference to Appellees’ request that we
adopt
Restatement
(Third)
reject
of Torts and
previous
our
adoption of Section
(Second)
402A of the Restatement
119,
of
Maj.
Torts.
atOp.
In footnote
Majority
could be interpreted to favor
the adoption
Third,
of the Restatement
“It
stating,
may be
cogently argued that risk-utility
balancing more legitimately
assigned
Indeed,
to a jury----
such is the approach of the
Restatement
Maj.
18,
Third.”
at 123 n.
Op.
the current Restatement Second. join concurring this and McCAFFERY TODD
Justices *23 opinion.
v. BOARD, Appellee. RELATIONS LABOR PENNSYLVANIA Pennsylvania. Supreme Court Argued April 2011. Decided March