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Adkins v. Johnson & Johnson

Superior Court of Pennsylvania.
Apr 15, 2020
231 A.3d 960 (Pa. Super. Ct. 2020)

Opinion

No. 2700 EDA 2017

04-15-2020

Kimberly L. ADKINS v. JOHNSON & JOHNSON, Ethicon, Inc. Individually and d/b/a Ethicon, Gynecare, Secant Medical, Inc., Secant Medical, LLC, Prodesco, Inc., and Secant Medical Appeal of: Ethicon, Inc. and Johnson & Johnson, Appellants

Dorothy A. Hickok, Philadelphia, for appellant. Charles L. Becker, Philadelphia, for appellee.


Dorothy A. Hickok, Philadelphia, for appellant.

Charles L. Becker, Philadelphia, for appellee.

BEFORE: PANELLA, P.J., OLSON, J., AND FORD ELLIOTT, P.J.E.

OPINION BY FORD ELLIOTT, P.J.E.:

Ethicon, Inc. and Johnson & Johnson (collectively, "Ethicon") appeal from that part of the July 19, 2017 order entered in the Court of Common Pleas of Philadelphia County that granted the post-trial motion of Kimberly L. Adkins ("Adkins") and awarded a new trial on the issue of damages with respect to design defect in the underlying product liability action. We affirm and remand for proceedings consistent with this Opinion.

We note that the July 19, 2017 order also denied Adkins's post-trial motion with respect to juror number one and her failure to warn cause of action. Adkins did not appeal.
We further note that the record reflects that the trial court dismissed Secant Medical, Inc.; Secant Medical, LLC; Prodesco, Inc.; and Secant Medical from the underlying lawsuit prior to trial after it determined that these entities were not "manufacturers" of the product that was the subject of the underlying lawsuit as that term is defined under Ohio Rev. Code § 2307.71(A)(13), which law applies substantively. We further note that although the certified record before us is clear that the only defendants to proceed to trial were Ethicon, Inc. and Johnson & Johnson, it is not clear as to the procedural mechanism employed that resulted in Gynecare, a division of Ethicon, Inc., being dismissed from the underlying lawsuit.

The record reflects that Adkins, an Ohio resident, was implanted with a pelvic-mesh device known as TVT SECUR (the "Device") for treatment of female stress urinary incontinence. The implantation occurred in Ohio. Adkins instituted the underlying product liability action in Pennsylvania alleging defective design and inadequate warnings and seeking damages for injuries sustained as a result of the implantation of the allegedly defective Device. With respect to personal jurisdiction over Ethicon, the trial court concluded that because Secant Medical, Inc., a defendant below, manufactured, in part, the pelvic mesh in Pennsylvania and because Ethicon availed itself of the privilege of conducting activities in Pennsylvania by contracting with Secant Medical, Inc., to perform a portion of the manufacturing, the trial court had personal jurisdiction over Ethicon pursuant to Int'l Shoe Co. v. Washington , 326 U.S. 310, 66 S.Ct. 154, 90 L.Ed. 95 (1945), and its progeny. (Trial court opinion, 5/18/18 at 11-12.) Therefore, Pennsylvania law governs the procedural matters of this case. See Sheard v. J.J. DeLuca Co. , 92 A.3d 68, 76 (Pa.Super. 2014) (reiterating that the law of the chosen forum governs procedural matters). The certified record before us indicates that the parties agreed that their rights and duties would be determined under Ohio law.

The trial court summarized the relevant procedural history as follows:

On June 9, 2017, a jury returned a verdict for [Ethicon]. The jury found that [the Device] was defective in design and that [a]ppellants failed to adequately warn pelvic floor surgeons of the [Device's] risks of harm. However, the jury also found that neither the design defect nor the inadequate warnings proximately caused injury to [Adkins].

On July 19, 2017, the [trial c]ourt granted [Adkins's] Post-Trial Motion and ordered the case to proceed to a damages hearing [on design defect only]. On July 26, 2017, [Ethicon] filed a Motion for Reconsideration, which was denied on July 31, 2017. On August 16, 2017, [Ethicon] filed a timely Notice of Appeal to the Superior Court of Pennsylvania under Pa.R.A.P. 311(a)(6).

Pa.R.A.P. 311(a)(6) permits an appeal as of right of an interlocutory order in a civil action that awards a new trial. See Mirabel v. Morales , 57 A.3d 144, 149 n.6 (Pa.Super. 2012) (reiterating that under Rule 311(a)(6), Pennsylvania Superior Court has jurisdiction to hear appeal from order granting new trial limited solely to issue of damages).
We note that after Ethicon filed its notice of appeal, Adkins filed an application to dismiss the appeal in which she contended that this court lacks jurisdiction to entertain the appeal under Rule 311(a)(6) because the trial court's order did not grant a new trial, but merely ordered that the case should proceed to a damages hearing. (Adkins's motion to dismiss appeal under Pa.R.A.P. 1972, 11/1/17 at 4-7.) Ethicon filed a response citing to case law that holds that this court has jurisdiction pursuant to Rule 311(a)(6) to hear an interlocutory appeal of an order granting a new trial limited solely to the issue of damages after the jury has rendered its verdict. (Ethicon's answer to motion to dismiss appeal, 11/13/17 at 2-4.) Thereafter, this court entered an order denying Adkins's application to dismiss without prejudice to raise the issue in her appellate brief. Because Adkins did not raise the issue in her brief, she abandoned her jurisdictional challenge under Rule 311(a)(6).

Trial court opinion, 11/6/18 at 1.

In their notice of appeal, Ethicon correctly recognizes the interlocutory nature of the order on appeal and that the only issue it can appeal is the award of the new trial on the issue of damages. (Ethicon's notice of appeal, 7/19/17.) As such, there was no need for the trial court to enter an order directing Ethicon to file a concise statement of errors complained of on appeal pursuant to Pa.R.A.P. 1925(b), which it did not. The trial court did, however, file a Rule 1925(a) opinion. In that opinion, the trial court addressed its award of a new trial on the issue of damages for design defect and stated that

We note that throughout the litigation, Ethicon has challenged the trial court's personal jurisdiction over them. We further note that on April 3, 2019, a panel of this court, in an unpublished memorandum, held that because Hammons v. Ethicon , 190 A.3d 1248 (Pa.Super. 2018), petition for allowance of appeal granted , 206 A.3d 495 (Pa. 2019), is binding precedent, Pennsylvania could exercise personal jurisdiction over Ethicon in civil actions brought by non-resident plaintiffs who were implanted with one of eight pelvic devices, including the Device, because the mesh in the eight devices, including the Device, was knitted by a Pennsylvania company, Secant Medical, Inc. In re: Pelvic Mesh Litigation , No. 652 EDA 2018, unpublished memorandum (Pa.Super. filed April 3, 2019). Our supreme court granted Ethicon's petition for allowance of appeal in Hammons to determine the limited issue of "[w]hether the Due Process Clause of the Fourteenth Amendment to the United States Constitution and 42 Pa.C.S.[A.] § 5322(c) precludes Pennsylvania from asserting personal jurisdiction over [Ethicon] in a case brought by an Indiana resident asserting claims under the Indiana Product Liability Act." Hammons , 206 A.3d 495.

[u]pon further examination of the issue, the [trial c]ourt now believes that a new trial should not be limited to the issues of compensatory and punitive damages. Rather, the new trial must also involve re-litigation on the issue of [Ethicon's] liability for design defect.

Trial court opinion, 11/6/18 at 4.

Ethicon raises the following issues for our review:

1. Can [Adkins] avoid waiver -- given that she did not object prior to the discharge of the jury -- by recasting her argument as one that goes to the manifest weight of the evidence when there is contradictory testimony and the only way for [Adkins] to prevail on appeal is to rewrite the jury instructions as given and the verdict form as drafted?

2. When [Adkins] alleged multiple "defects" at trial, and alleged multiple "harms" as a result of different "defects," and there was testimony that challenged each "defect" and its relationship to each "harm," do truly exceptional circumstances exist that would warrant setting aside the jury's finding that there was a "defect" but that the "defect" it found did not directly and proximately cause any specific "harm(s)" that the jury credited?

Ethicon's brief at 4-5.

At the outset, we note that

[i]t is well settled that the grant of a new trial is a matter within the discretion of the trial court. A new trial will be granted on the grounds that the verdict is against the weight of the evidence where the verdict is so contrary to the evidence it shocks one's sense of justice. An appellant is not entitled to a new trial where the evidence is conflicting and the finder of fact could have decided either way. ...

An abuse of discretion is not merely an error of judgment, but if in reaching a conclusion the law is overridden or misapplied, or the judgment exercised is manifestly unreasonable, or [the judgment is] the result of partiality, prejudice, bias or ill-will, as shown by the evidence of record, discretion is abused. We emphasize that an abuse of discretion may not be found merely

because the appellate court might have reached a different conclusion, but requires a showing of manifest unreasonableness, or partiality, prejudice, bias, or ill-will, or such lack of support as to be clearly erroneous.

.... This [c]ourt has recognized that a weight of the evidence challenge concedes that there was evidence sufficient to sustain the verdict, but the verdict was against the weight of the evidence. We may not substitute our judgment for that of the trial court, we must only decide whether the trial court abused its discretion. Credibility issues are determined by the jury, and this [c]ourt rarely overturns the factual findings of a jury that are based on determinations of credibility, because we are confined to review a cold record.

Fanning v. Davne , 795 A.2d 388, 393-394 (Pa.Super. 2002) (internal citations omitted).

Ethicon first contends that even though Adkins characterized her post-trial claim as a weight of the evidence challenge, the true nature of her challenge is an inconsistent verdict and because she failed to object to the trial court's jury instructions, the verdict sheets, and/or to the verdict itself, she waives her inconsistent verdict challenge on appeal. We disagree.

In Dilliplaine v. Lehigh Valley Trust Co. , 457 Pa. 255, 322 A.2d 114 (1974), our supreme court held that in order to preserve a claim of trial error, a timely specific objection must be made. Over time, the rule announced in Dilliplaine has come to be known as the "contemporaneous objection rule" and has been codified in Pennsylvania Rule of Civil Procedure 227.1(b), which provides:

(b) Except as otherwise provided by Pa.R.E. 103(a), post-trial relief may not be granted unless the grounds therefor,

(1) if then available, were raised in pre-trial proceedings or by motion, objection, point for charge, request for findings of fact or conclusions of law, offer of proof or other appropriate method at trial; and

(2) are specified in the motion. The motion shall state how the grounds were asserted in pre-trial proceedings or at trial. Grounds not specified are deemed waived unless leave is granted upon cause shown to specify additional grounds.

Pa.R.Civ.P. 227.1(b) ; see also Stapas v. Giant Eagle, Inc. , 197 A.3d 244, 248-249 (Pa. 2018). The note to Rule 227.1(b)(1) states that "[i]f no objection is made, error which could have been corrected in pre-trial proceedings or during trial by timely objection may not constitute a ground for post-trial relief." Id. at note.

In order to preserve a weight of the evidence claim, however, a party is not required to object before the jury is discharged because the claim cannot be resolved by the jury. Stapas , 197 A.3d at 249-250. Unlike an inaccurate jury instruction or an erroneous verdict sheet, which are capable of correction in pre-trial proceedings or during trial, the manner in which a jury weighs evidence and arrives at a verdict is incapable of correction. See id. Therefore, because a weight of the evidence challenge ripens after the verdict, it is properly raised for the first time in a post-trial motion. Id.

Here, in her post-trial motion, Adkins contended that because the jury found that the Device was defectively designed and because the medical testimony was undisputed that Adkins suffered some injury because of the Device, the jury's finding of no causation was against the weight of the evidence. (Adkins's motion for post-trial relief, 6/19/17 at 1-2, 5-7.) Clearly, because that challenge could not be corrected in pre-trial proceedings or during trial and only ripened after the verdict was announced, it was a challenge to the weight of the evidence and Adkins properly raised it for the first time in her post-trial motion.

Ethicon next contends that even though the jury found that the Device was defective, its finding of no causation was not against the weight of the evidence. We disagree.

Under Ohio product liability law, which is codified at Ohio Rev. Code §§ 2396.61- 2307.81, the plaintiff bears the burden of proving (1) that there was, in fact, a defect in the product manufactured and sold by the defendant that existed at the time the product left the hands of the defendant; and (2) that the defect directly and proximately caused the plaintiff's injuries or loss. Bonacker v. H.J. Heinz Co., 111 Ohio App.3d 569, 676 N.E.2d 940, 942 (1996) ; see also State Farm Fire & Cas. Co. v. Chrysler Corp. , 37 Ohio St.3d 1, 523 N.E.2d 489 (1988) ; Ohio Rev. Code § 2307.73(A). Ohio law establishes two alternative theories for demonstrating design defect – the risk/benefit theory and the consumer expectation theory. In the underlying litigation, Adkins proceeded under the risk/benefit theory. Under this theory, a product is defective in design if, at the time it left the control of the manufacturer, the foreseeable risks associated with its design exceeded the benefits associated with that design. Ohio Rev. Code § 2307.75(A). The statute sets forth various factors to be considered when making this determination. Id. at (B)-(C).

Here, Ethicon contends that because its causation expert testified that factors other than the Device, such as smoking or a failure to properly use medication, could have caused or contributed to Adkins’ pain, vaginal bleeding, and the erosion of the Device, the verdict was not against the weight of the evidence. We disagree. As a threshold matter, the jury determined that the Device was defective because its risks outweighed its benefits. The jury then was required to determine whether the Device directly and proximately caused Adkins’ injuries. Ethicon's causation expert agreed on cross-examination that the Device caused certain of Adkins’ injuries, as follows:

Q. So these are undisputed facts. You would agree with me from 2011 to 2012, that the mesh-related problems Ms. Adkins experienced were vaginal bleeding, the pelvic pain, vaginal pain, palpable mesh, pain with sex, he partner was scratched, the mesh was exposed in her vagina, and there was surgery to remove the mesh?

A. I agree with that.

Notes of testimony, 6/7/17 at 66.

The record clearly demonstrates that it was undisputed that from 2011 to 2012, the erosion of the mesh as found to be a defect by the jury caused Adkins to suffer the following injuries: vaginal bleeding, pelvic pain, vaginal pain, palpable mesh, pain with sex, and mesh exposure in her vagina. There is also no dispute that because the Device caused these injuries, Adkins had to undergo surgical removal of the Device. Because the evidence did not conflict with respect to the injuries the Device caused in 2011 to 2012, as well as the necessity for surgical removal, the jury's finding that the Device did not cause any injury to Adkins was against the weight of the evidence. Therefore, the trial court did not abuse its discretion when it granted a new trial as to damages.

As set forth above, in its Rule 1925(a) opinion, the trial court opines that the new trial should not be limited to damages, but must include re-litigation on liability. (Trial court opinion, 11/6/18 at 4.) We agree. As set forth by the trial court in its Rule 1925(a) opinion:

Where liability is "vigorously contested," it cannot be considered free from doubt unless the defense was advanced capriciously. See Reid v. Oxendine , 275 Pa.Super. 548, 419 A.2d 36, 40-41 (1980) ; Gagliano v. Ditzler , 437 Pa. 230, 263 A.2d 319, 320-21 (1970) (new trial cannot be limited to damages where "both sides had presented credible, directly conflicting evidence"). Here, it beyond dispute that [Ethicon] fought tooth and nail on the issue of liability. They brought motions, among many other things, for summary judgment, compulsory nonsuit and directed verdict, and contested numerous pieces of evidence and proposed jury instructions presented by [Adkins]. In addition, they called numerous witnesses of their own to support their defense that the [Device] was not defectively designed and did not proximately cause injury to [Adkins]. The defense claims were colorable and made in good faith. Therefore, the issue of liability was not free from doubt and must be tried again.

Trial court opinion, 11/6/18 at 4-5.

Order affirmed. Case remanded with instructions consistent with this Opinion. Jurisdiction relinquished.

Panella, P.J. joins this Opinion.

Olson, J. files a Concurring and Dissenting Opinion.

CONCURRING AND DISSENTING OPINION BY OLSON, J.:

I agree with the learned Majority that Kimberly Adkins ("Adkins") did not waive her challenge to the weight of the evidence when she did not object to the trial court's jury instructions, verdict sheets, or the verdict itself. I am, however, unable to agree with my learned colleagues that this panel should affirm, in its entirety, the trial court's order directing a new trial on the grounds that the jury's verdict was against the weight of the evidence. I agree with my colleagues that a "no causation" finding as to Adkins’ claim for surgical removal of the TVT SECUR pelvic mesh device (the "Device") was against the evidence since there was no explanation other than the presence of the defective Device for why Adkins underwent surgical removal of the mesh product. However, I would hold that, because Ethicon, Inc. and Johnson & Johnson (collectively "Ethicon") presented evidence at trial showing that factors wholly unrelated to the Device may have caused Adkins’ pelvic conditions, the jury's "no causation" finding as to her claims for vaginal bleeding, pelvic pain, vaginal pain, palpable mesh, dyspareunia, and mesh exposure was not against the weight of the evidence. Accordingly, for the reasons set forth below, I concur in part and dissent in part.

In large part, the Majority affirms the trial court's determination that the jury's verdict was against the weight of the evidence because it finds that "Ethicon's causation expert agreed on cross-examination that the Device caused certain of Adkins’ injuries." Majority Opinion at 966. To reach this conclusion, the Majority cites testimony offered by Ethicon's causation expert in which he agrees that from 2011 to 2012, "mesh-related" problems experienced by Adkins included several conditions, including vaginal bleeding, pelvic pain, vaginal pain, pain during intercourse, scratching of her sexual partner, mesh exposure, and surgical removal. See id . at 966–67. On the strength of this testimony, the Majority concludes that "[t]he record clearly demonstrates that it was undisputed that from 2011 to 2012, the erosion of the mesh as found to be a defect by the jury caused Adkins to suffer [from the foregoing injuries and conditions]." Id . at 966. In the Majority's view, the jury's "no causation" finding was against the weight of the evidence because there was "no[ ] conflict in the testimony with respect to the injuries the Device caused in 2011 to 2012[.]" Id .

Unlike the Majority, I do not believe that the evidence, particularly the single exchange lifted from the cross-examination testimony of Ethicon's causation expert, produced such clear cut support of a causation verdict favorable to Adkins and justified the trial court casting aside the jury's finding on causation. As the Majority acknowledges, the substantive principles of Ohio product liability law that govern this dispute require a plaintiff to show both a defect in the product manufactured and sold by the defendant and that the defect directly and proximately caused the plaintiff's injuries and losses . See Majority Opinion at 965–66 (citing cases). The jury here found that the Device was defectively designed and that the warnings given by Ethicon were inadequate; however, the jury rejected a finding that a defect in the Device proximately caused any injury sustained by Adkins.

As a preliminary matter, the plain language of the sole exchange of expert testimony cited by the Majority did not contradict the jury's finding that causation was unproven. In the cited passage, Ethicon's expert agreed that, from 2011 through 2012, Adkins experienced various conditions that were "mesh-related." See id . at 966, citing N.T. Trial, 6/7/17, at 66. Notwithstanding this response, the fact that an injury or condition may be "mesh-related" does not mean that a defect in the mesh was the proximate cause of an injury. A condition may be "mesh-related" because it resulted from the surgical mesh implantation procedure or because the condition and the implant are both located in the same part of Adkins’ anatomy. In short, given the ambiguity of the terms employed in the question, it was for the jury to decide whether the words "mesh-related" meant "produced or caused by a defect in the mesh" or referred to some other non-causal connection between the mesh and Adkins’ conditions.

Inferential arguments in support of setting aside the jury's determination and awarding a new trial on grounds that the verdict was against the weight of the evidence are even less persuasive in view of the substantial evidence and testimony which tended to establish that several factors unrelated to the Device (and, more specifically, unrelated to any alleged defects in the Device), including implantation procedures, Adkins’ smoking history, tissue atrophy, non-adherence to post-surgical instructions, and the lack of feasible alternative designs that would have avoided any alleged risks, led to the injuries sustained by Adkins. See Ethicon's Brief at 33-34 and 40. Ethicon thus asserts that the verdict was not contrary to the evidence because the jury heard evidence that Adkins’ conditions and damages were not caused by defects in the Device. Against the factual record developed at trial, and bearing in mind the relevant principles of tort law, I am reluctant to conclude, as the Majority seems to do, that the agreement by Ethicon's causation expert that Adkins sustained "mesh-related" problems between 2011 and 2012 equates to a concession that defects in the Device were a direct and proximate cause of Adkins’ injuries and losses. Compare Majority Opinion at 966–67.

In fact, the same defense expert cited by the Majority in support of its conclusion also testified that Adkins’ vaginal tissue erosion in 2012 was a known risk of her surgical procedure that could be explained by poor wound healing characteristics, smoking, tissue atrophy, and age. See N.T. Trial, 6/7/17, at 78-80 ("So basically, there's medical conditions [such as smoking and poor wound healing], there's local factors like atrophy, and there's sort of like following the rules to let things heal well. And as a basic outline, those are the things that would increase the risk for erosion."). In view of this extensive testimony, it would not be accurate, in my assessment, to characterize the cited excerpt of the expert's opinion as a concession that a defect in the Device acted as the proximate cause of all of Adkins’ injuries and losses. Instead, the record, viewed as a whole, reflects that several factors were presented to the jury as potential causes of Adkins’ alleged conditions and damages. Within the context of the hotly contested dispute before us, the fact that the jury credited one or more causation factors that were not favorable to Adkins does not support the conclusion that the verdict was shocking or that a new trial is warranted.

Less obvious is the unstated line of reasoning gleaned from the Majority's rationale. After reciting an exchange in which Ethicon's expert agreed that Adkins experienced "mesh-related" problems from 2011 through 2012, the Majority concludes that "the erosion of the mesh as found to be defective by the jury caused Adkins to suffer the following injuries: vaginal bleeding, pelvic pain, vaginal pain, palpable mesh, pain with sex, and mesh exposure in her vagina. There is no dispute that because the Device caused these injuries, Adkins had to undergo surgical removal of the device." Majority Opinion at 966 (emphasis added). The Majority's logic is clear, if not expressly stated: if a product later found to be defective has been linked to injuries, it follows, a fortiori , that a defect in the product must have been the proximate cause of all of the injuries with which it is associated.

I cannot agree with this rationale given the record in this case. Merely linking a defective product to an injury, loss, or condition is simply not the same as demonstrating its causal connection to alleged damages. Here, the jury heard substantial evidence explaining why a defect in the Device did not cause most of Adkins’ conditions. In the face of such evidence, I am not convinced that the jury's "no causation" finding for the majority of Adkins’ conditions ran contrary to the weight of the evidence.

As there was no evidence of alternative reasons for removing the defective Device, I would agree that the jury's "no causation" finding as to surgical removal of the Device (as a condition or loss separate from the other vaginal conditions) was against the weight of the evidence. Hence, I would award a new trial limited to this claim.

I realize that we must give the gravest consideration to the findings and reasons advanced by a trial judge when reviewing a determination that a verdict was against the weight of the evidence. I also recognize that this is one of the least assailable rulings that can be issued by a trial court. See Brown v. Trinidad , 111 A.3d 765, 770 (Pa. Super. 2015). However, under the facts and circumstances of this case, I cannot agree that the trial court properly exercised its discretion when it granted a new trial as to all of Adkins’ alleged losses and damages. Thus, I must respectfully concur in part and dissent in part.


Summaries of

Adkins v. Johnson & Johnson

Superior Court of Pennsylvania.
Apr 15, 2020
231 A.3d 960 (Pa. Super. Ct. 2020)
Case details for

Adkins v. Johnson & Johnson

Case Details

Full title:Kimberly L. ADKINS v. JOHNSON & JOHNSON, Ethicon, Inc. Individually and…

Court:Superior Court of Pennsylvania.

Date published: Apr 15, 2020

Citations

231 A.3d 960 (Pa. Super. Ct. 2020)

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