Czimmer v. Janssen Pharmaceuticals, Inc.

public bitch, lant acted with the intent to create motherfucking son of a what the hell he annoyance when made his offensive re you doing, get are light off my setting Maerz, in a and the remarks private marks house[.]” A.2d at 1268. As apparently only above, were discernible to Battis- noted the Maerz Court found the / tini. because, evidence insufficient among other things, the outburst was brief and did not

Furthermore, we do not believe Appel- cause a “upset disturbance or public recklessly lant created a risk of a hazard- peace.” Id. at Forrey, 1271. In the defen- physically ous or offensive condition under dant shouted: “all you fucking cops are 5503(a)(4). § Appellant’s conduct created Obama,” just communists like and “this “injuries no risk of resulting public from sucks,” fucking country “you better Williams, disorders.” 574 A.2d at 1164. your watch back.” Forrey, 108 A.3d at Here, brief, Appellant made a few offen- 897. The Commonwealth failed to prove sive remarks to Battistini then re- the defendant created a level of noise in- treated into his home. The two were sep- consistent neighborhood standards, fence, arated and the record fails to especially since the defendant uttered the anyone Appellant’s reflect that else heard in remarks a remote location. Id. at 898. statements. The encounter ended case, Similarly, in the instant Appellant’s Trial, 6/20/14, began. seconds after it N.T. remarks were brief and pub- did not cause at 24-26. lic unrest or create a risk thereof. We Appellant’s We also do not believe con- therefore conclude the record does not physically duct created a offensive condi- contain sufficient evidence to support a tion, Appellant engage as did not in a finding that Appellant physically created a direct assault on physical Battistini’s offensive condition.3 senses, as described Williams. reasons, For all of the foregoing Williams, we 574 A.2d at 1164. The Williams record, conclude the light read in a most Court described offensive odors or blind- Commonwealth, favorable to the does not ing light examples physically hazard- contain sufficient evidence to support Ap- ous conditions. Appellant also did not in- 5503(a)(4).4 pellant’s § conviction under physical vade Battistini’s privacy, as the We therefore judgment vacate the of sen- encounter present occurred when she was tence. yard her and visible Appellant from yard. his own Judgment of sentence vacated.

Here, Appellant’s conduct implicates only Battistini’s sense of sound. We turn to Forrey therefore Maerz and persuasive authority, as those cases were 5503(a)(2) (“unreasonable §

decided under noise”). 5503(a)(2). § 18 Pa.C.S.A. In April CZIMMER, Appellee Maerz, the defendant shouted across the neighbor: “you street at her goddamn decision, reaching

3. certainly Appellant this argues do the trial court erred in permitting Appellant’s proceed not condone Commonwealth behavior. We find un- 5503(a)(4), 5503(a)(3), §der § rather than Appellant’s reprehensible comments but not Appellant pled guilty summary which at the criminal. hearing. disposition, Given our we need not argument. address this PHARMACEUTICALS, JANSSEN

INC., Appellant. Pennsylvania. Superior Court Argued Oct. 2014. Aug. Filed 2015. Reargument Denied Oct. Jr., Putnam, for Philadelphia,

Alfred W. appellant. Bashman, Grove, J. Willow

Howard appellee. LAZARUS, J., MUNDY, J.,

BEFORE: PLATT, J.*

MUNDY, J.: BY OPINION Pharmaceuticals,

Appellant, (Janssen),1 from the trial appeals Inc. entering judgment court’s order in favor Czimmer, April 'as Appellee, guardian minor,2 Czimmer, following jury Blake review, After trial. careful affirm. proce- We take the relevant facts and history this case the trial dural from opinion our January court’s independent April of the record. review history migraine dating headaches has teenager.3 to when was a young back she August Lisa physician’s assistant to Basye prescribed Topamax4 April to treat, migraines, April and to her continued drug February At the use until 2007. Basye prescribed Topamax April, time to (FDA) Drug the Food and Administration categorized Pregnancy Category a C it as drug.5 2006, April preg- became December son, her Blake.

nant with Blake was born * Judge assigned Superior Retired Senior to when filed the instant See state she lawsuit. Sheet, 12/23/11, Court. Plaintiff’s Fact at 2. Topamax, antiepi- 4. Janssen manufactures Pennsylvania Corporation 1. with Janssen is leptic epilepsy and medication used treat place Jersey. principal in New business migraines. Brief 10. See Janssen’s at Matter, See Answer New Janssen's and 3/15/13, ¶2-3 10. (Topamax 5. See Exhibits 1210-1211 Plaintiff’s Physicians' Reference Desk 2011, April 4, 2. As and Blake Czimmer have same excerpts). classi- On March the FDA surname, we will refer to their Pregnancy them first Topamax Category D fied as a clarity. Matter, names for drug. See Janssen's Answer and New 3/15/13, ¶ at 6 26. April Virginia during categories resided in the relevant The FDA has established time-period drug of a cause potential reside in indicate the continued to 24, 2007, September with a severe cleft warn claim. On October jury lip palate and cleft hole above his returned a in verdict favor of April, as birth, undergone Since his he has four lip. guardian of Blake. It awarded surgeries repair his oral clefts and asso- $4,002,184.68 damages, in comprised of injuries. ciated Blake will need to under- $3,440,000.00for the non-economie loss of future, go surgeries a number of in the $562,184.68 pain and suffering and for fu- jaw including reconstruction and a bone ture health care costs. On November graft maturity. at the time of He will also post-trial Janssen filed a motion re- speech therapy, need treatment for his questing grant the trial court to judgment hearing, psychological and a evaluation. (JNOV) notwithstanding the verdict or a 31, 2011, May April On commenced this 2, 2014, January new trial. On the trial against by filing lawsuit Janssen a writ of court entered an order and opinion deny- in Philadelphia County summons ing post-trial motion. The trial 7, 2011, Pleas. On November Common judgment also entered jury’s on the complaint against she filed a short-form verdict, $207,713.38 adding in delay dam- in alleging, part, negligent- that it ages, in resulting judgment a total against warn, ly prescribing failed to her health $4,209,898.06. Janssen for timely ap- This provider potential care of the risks of birth peal followed.7 Topamax, defects associated with including if lip palate, during preg- used and/or appeal, On Janssen raises the following 25, 2013, nancy. On March Janssen filed a issues for our review. summary judgment, motion for which the granted part trial court denied 1. Does federal law preempt a state part.6 law negligent failure to warn claim (a) 15, 2013, where

On October could proceeded pro- [Janssen] case not have to a trial on the negligent failure to [April’s] vided proposed warning without women, during pregnancy. birth defects if used any pregnant as the risks clear- ly outweigh any Category adequate, A means that there are benefits..... (Sertraline Hydrochloride) In re Prods. well-controlled studies which have failed to Zoloft Litig., F.Supp.3d Liab. 453 n. 7 drugs demonstrate a risk to the fetus. Few (E.D.Pa.2014); see also Plaintiff’s Exhibit category are in A because controlled studies (listing Pregnancy Catego- FDA 3/08/13 during pregnancy of medication use are ries). ethically prohibited. Category B means an- We note that decisions of the federal district risk, imal studies show no but there are no binding Pennsylvania courts are not courts, on adequate and well-controlled studies of use may but we persuasive look to them as by pregnant Category women. C means Fin., LLC, authority. See v. Chase Home Dietz reproduction that animal studies have (Pa.Super.2012). 886 n. 3 fetus, shown an adverse effect on the but granted 6. summary judgment The trial court adequate there are no and well-controlled respect in favor of April’s Janssen with to humans, pregnant studies in and so women liability, negligent design, strict warranty, pu- weigh potential against should the benefits damages, nitive and loss of consortium potential Category the D risks. is used claims. The court denied the remainder of positive when there is evidence of human Order, the motion. See Trial Court 7/16/13. fetal risk based on adverse reaction data investigational marketing experi- from or 7. The trial court did not order Janssen to file humans, potential ence or in studies but a complained concise statement of errors of may drug. benefits still warrant use of the appeal pursuant Pennsylvania on to Rule of Category category, X 1925(b), is the lowest used Appellate Procedure nor did it issue drug 1925(a) when use of the opinion. is not recommended a Rule See Pa.R.A.P. 1925. pri- judgment for Drug reviewing a motion and Administration’s the Food (b) assistance, n.o.v., be and the evidence must consid- permission and/or FDA that in the favorable to light [the] was clear evidence ered most the there approved proposed winner, have that given he must be would verdict and warning? every reasonable infer- the benefit of law, therefrom, arising fact governed by Virginia ence of In a case 2. a applying any err in conflict in the evidence must be trial court did the Moreover, causa- of in factor” standard favor. a “substantial resolved his Supreme the be judgment tion that n.o.v. should en- the contrary to rejected as expressly any has tered in a clear case and doubts Virginia? law of the must be resolved in favor ver- (a) Further, by permit- judge’s winner. a ap- the trial court err dict 3. Did to to warn claim ting negligent a failure is not to be praisement of evidence involv- jury the in an action have proceed based on how he would voted warning, when ing prescription drug a jury, of the had he been a member but drug testified prescribers through the facts come they as knew, they pre- they the time jury’s sieve of the deliberations. alleged risk of drug, of the scribed upon There are which a two bases claim, that formed the basis harm one, judgment can be entered: n.o.v. (b) by relevant evi- excluding and/or judgment the movant is entitled to prescribers’ dence related those two, law, a matter of ... and/or knowledge of risk? evidence was that no two such reason (a) by permit- trial err Did the court disagree able minds could Blake damages an award of ting outcome should have been rendered costs in- future healthcare Czimmer’s favor of With first movant[.] during minority, his when his curred a court reviews the record con was damages claim for those parents’ cludes that even with all factual infer time-barred and Blake did not ences1decided adverse to movant them, right of action recover and/or requires the law nonetheless verdict (b) to decide by failing ask the favor, with the his whereas second their parents brought whether the had evidentiary the court reviews the rec limitations applicable within the claim ord and concludes that the evidence period? such for the movant was that a verdict Brief at 5. beyond peradventure. was stan begin by stating We our Questions credibility and conflicts review of a trial court’s denial of dard of in the evidence are for the [fact-finder] post-trial motions for new JNOV reviewing to resolve and the trial. the evidence. If reweigh should a appellate An court will reverse trial any is which the upon there basis grant court’s or denial of a JNOV award, properly could have made its appellate when the finds an abuse court judgment denial of motion for n.o.v. or an of law. Our of discretion error must be affirmed. respect of review with to whether scope Stores, Inc., 24 plena- v. A.3d judgment n.o.v. is is Braun Wal-Mart appropriate (brackets any questions (Pa.Super.2011) 890-91 ry, as with review of quotation marks original; citations and law. — omitted), Pa.-, affirmed, 106 A.3d approved would not have such a warning. (2014). Id. Janssen asserts that the doctrine of “impossibility preemption” precludes the reviewing In a trial court’s denial of a state-law claim of failure warn. Id. at trial, a motion for new the standard of — citing Inc. v. Mensing, U.S. appellate review for an court is as fol- PLIVA -, 131 S.Ct. 180 L.Ed.2d 580 lows: (2011). rejected This Court an identical that, is well-established law [I]t ab- argument by Janssen in Gurley v. Janssen by sent a clear abuse of discretion Pharm., Inc., (Pa.Su- 113 A.3d 283 court, appellate trial courts must not per.2015), as follows. interfere with the trial court’s authori- Appellant’s reliance on PLIVA is mis- ty deny to grant or a new trial.

guided. PLIVA involved pre- federal emption of state-law failure to warn Thus, when analyzing a deci claims brought against generic drug grant sion a trial court to deny manufacturers, and is not applicable to trial, proper new standard of re the instant case involving a brand-name view, ultimately, is whether the trial drug PLIVA, manufacturer. See supra court abused its discretion. at 2574. The explained PLIVA Court Moreover, our review must be tailored that, while a brand-name manufacturer well-settled, to a two-part analysis: responsible is for the accuracy and ade-

We must review the court’s alleged label, quacy of its generic manufactur- mistake and determine whether the responsible er is for ensuring that its and, so, court erred if whether the warning label is the same as the brand prejudice error resulted in necessitat- name’s label. See id. The Court stated: ing alleged new trial. If the mis- beyond “It is dispute that the federal law, take concerned error of statutes and regulations that apply to legal will scrutinize for error. Once drug brand-name manufacturers are we determine whether an error oc- meaningfully different than those that curred, we must then determine apply generic drug manufactur- [Djifferent whether the trial court abused its dis- ers.... federal statutes and cretion in ruling request on the for a regulations may ... lead to different new trial. preemption Thus, results.” Id. at 2582. we conclude Appellant’s argument ACE Am. Ins. Co. Underwriters at based legally persua- PLIVA not Cos., (Pa.Su- Lloyds sive. (citations omitted), per.2007) affirmed, 601 (2009).

Pa. (brackets 971 A.2d 1121 Gurley, supra at 291 and ellipses in original, citation to trial opinion appeal, its first issue on Janssen con- omitted). reasons, For the same tends it is entitled to JNOV because feder- argument identical in this case is merit- preempts April’s (cid:127)al law negligent state-law less.' failure to warn claim. Janssen’s Brief at Specifically, argues Janssen Appellant it also April’s contends failure to provided

could not have the proposed warn claim is preempted the FDA because warning potential about oral birth defects would not have approved the warnings without the approval of the April proposed United States provide in its la- Drug (FDA), Food and Administration and beling. citing Brief at Levine, there was clear evidence Wyeth the FDA v. 555 U.S. 129 S.Ct. (2009). stan- Specifically, Brief at 34. Our deferential L.Ed.2d 51 sen’s that, con- review is as Blake’s dard of follows. claims before Janssen warning insert a attempted it to ception, regarding jury Our standard review label- Topamax in the birth defects genital determining instructions is limited to change a FDA such ing, precluded but the a the trial court committed whether Again, rejected label. this Court to the law or error of clear abuse discretion fol- argument Gurley in identical this of the which controlled the outcome lows. Error in a occurs when charge case. review, Appel cannot credit Upon we charge inadequate as a or the whole presented it “clear lant’s contention that tendency or has a to mislead or not clear FDA would have evidence the clarify rather a material confuse than la [Topamax’s] change a to approved Conversely, jury instruction issue. a bel,” risk of cleft to warn of increased accurately if it reflects the upheld will be Wyeth, supra at 571 [129 lip/palate. jury in guide and is sufficient to the law added). Appel (emphases 1187] S.Ct. its deliberations. the proposed change to P[atient] lant’s proper test is not whether certain (PPI) in 2005 in P[ackage] I[nsert ][8] excerpts taken out portions isolated mal regarding a a minor warning

volved appear of context erroneous. We look in of some new genitalia formation the entirety, against charge to the in its Topamax; taking born to mothers borns background evidence in the risk of it did not address increased (cid:127) case, whether particular to determine Further, pro lip/palate. Appellant’s and or not error was committed PPI, change in 2005 was to posed to prejudicial whether error was to the To- patients, at and not directed complaining party. label, prescribers. pamax directed at words, right In other there is no Therefore, Appellant we conclude that given; any particular form of instruction preemp has failed establish federal enough charge clearly that the it is Appellees’ tion of state failure warn accurately explains relevant law. Wyeth. under claim Snyder, (first Krepps supra at 291-292 brackets in Gurley, (citations internal (Pa.Super.2015) parallel cita- original, emphasis original, omitted). Further, marks “to quotation omitted). reasons, tion For the same a new trial the trial court’s obtain based on argument preemption conclude Janssen’s moving jury’s question, treatment of a Wyeth merit relief. Ac- based on does not way in what party must demonstrate not err as cordingly, trial court did error caused incorrect result.” trial in denying of law Janssen matter JNOV Fiberglas Corp., v. Owens-Corning Jeter Braun, preemption. supra. See based (citation A.2d 636 (Pa.Super.1998) appeal, In its issue on second omitted). asserts that it is entitled to new Janssen Herein, trial erroneously contends the trial because trial court law, disregarded Virginia which the phrase “substantial factor” its court used trial parties agreed applied cause. Jans- jury instructions on factual 16, quoting Department n. of Health patient package "A insert contains informa- U.S. Services, Drug patients' understanding Food and of how to and Human U.S. tion for (2015). drug Gurley, supra Glossary Terms safely product.” Administration use to warn negligent Spe- adequately failure claim.9 physicians/healthcare warn cifically, argues Janssen the trial court’s providers Basye Ms. was a [who] —like jury instructions and verdict sheet over- physician assistant —of the extent of the Virginia Supreme looked the Court’s dis- risk of birth defects stemming from the approval using phrase “substantial use of Topamax? n

factor” to explain factual causation.10 That’s the negligence question. And argu- Janssen’s Brief at 36-37. Janssen’s you that, if answer that they were not ment invites us to isolate the words “sub- negligent, you question answer stantial factor” and take them out of the “No.” That your inquiry. ends You charge. context of the entire Pursuant to don’t have to go to causation. That review, our standard of we decline to do makes sense. Instead, so. See Krepps, supra. we ex- gave And I you a rote instruction. jury amine the instructions in their entire- But it would make I sense. don’t think ty and they accurately conclude that re- you my need rote instruction. provided flected the law and sufficient guidance jury. to the Id. you ‘Yes,” If answer you that then have to go to the question, causation

Our review of the record reveals the which is: Was the Defendant provided trial court following instruc- negligence jury prior tions to the substantial closing argu- factor—or ments. sometimes called a factual cause—in bringing about Blake Czimmer’s then, course,

And in a negligence lip/cleft palate? case, That’s the issue of cau- in order to find liability, it’s a two- sation. step process. Not you must find negligence, you but have to And the you If find negligence, did it cause the

requisite causal connection between that cleft lip or cleft palate? I’ll define the negligence and harm to plaintiff. legal term “substantial factor” some- child, In this case the plaintiff is the times called “factual cause” in my—in Blake. my charge. N.T., (morning),11at 12-14. 10/30/13 you So will have many three —as After closing arguments, the trial court

three questions to answer. And it de- instructed the jury respect to causa- (cid:127) pends your answer to the preceding tion as follows. question you whether go forward. question first would be: Did the But when we about liability and talk (cid:127) defendant, Janssen, negligently fail to negligence, it’s a two-step process. Not agree record, 9. Janssen Virgi- and the trial court supported by which reveals that applies April's negligent nia law failure to Virginia raised the difference in law 31-32; warn claim. See Janssen’s Brief at regarding the use of "substantial factor” to 12; 1/2/14, N.T., Opinion, Trial Court at N.T., (afternoon), explain causation. 10/29/13 10/09/13, April dispute at 73. does not Virginia applies law but instead maintains the trial court's instruction "was morning 11.The and afternoon session of each correct Appel- as a matter of law.” day of trial were separately, transcribed lee's Brief at 29. consecutively the two sessions are pag- not Therefore, clarity, inated. we refer to the opinion 10. The trial court states that Janssen' testimony by notes of both the date and ses- preserve failed to this issue. Trial Court - 1/2/14, sion. Opinion, at 12. This statement found, you I but how to define it. And some you negligence, find only must factual cause. Some said use causal between said use find a connection must case, harm, in this I think the words and substantial factor. negligence placed the other I have sub synonymous. child. One without are So to the the reach But enough. you my question. So would factor in if stantial answered question only you’ve if use in damage you thinking want to factual cause it, and causation negligence you to the can. “yes” about proceed would you and then questions, you substantial fac- But whether use damages. cause, legal or factual it’s a cause. tor _If cau- find but no you negligence Blake Czim- plaintiff, In order for the sation, 3 in- you Question don’t answer case, mer, to recover in this defen- damages. volving must have been negligent dant’s conduct Now, plaintiff has the burden factual cause in a substantial factor or prepon- by what we call a fair proving lip/cleft palate. about cleft bringing his weight fair of the evidence derance or recognizes, what as I That is the law case; liability damages and in this said, as a A substan- legal have cause. say, plaintiff prove must that is to or an tial factor factual cause is actual and that negligence factor, may although the result be real or cleft lip caused the cleft negligence it is not unexpected. unusual or But an damages Blake all in and Blake’s palate or or a imaginary fanciful factor factor or preponderance what we call fair insignif- no having connection or weight fair evidence. icant connection with the child Blake’s cleft lip palate.

cleft or said, liabil- ... As I’ve in order to find Now, mind, can keep you in here, ity you negligence, have to find more than one cause that is substantial you requisite and have to find the causal bringing factor or factual cause in about and negligence connection between that given end. the child in as I have harm to this case 127-128, N.T., 134- (morning), 10/30/18 Question in put it 2. Accordingly, provided verdict sheet you given But what I said I’ve or what questions, to the contained three two Defendant Question in is: Was the negligence, one to dam- relating to negligence factor a substantial 10/30/13, Sheet, at 1. ages. See Verdict cleft bringing in about Blake Czimmer’s question regarding The second causation here. lip/cleft palate? That’s the issue asked, negligence a [Appellant’s] “Was palate cleft lip Did he suffer cleft factor about bringing substantial in Blake De- arising negligence from the lip/cleft Id. palate?” Czimmer’s fendant Janssen? Now, “fac that the trial I sometimes use the word Janssen conténds court’s in factor. “substantial overlooks the place tual cause” of substantial use of factor” rejection years ago judicial Virginia Supreme A few had a state Court’s it causation. Jans Hershey, language explain conference in and we have 36-37, citing Brief at Ford Motor every summer. And we have about sen’s Boomer, 736 S.E.2d they in there. And were discuss Co. 285 Va. judges like; (2013). Boomer, this, ing causation cases rejected as to the trial court’s opinions Supreme there were 50 different contributing úse of “substantial factor” to have caused the Id. harm[.]” sufficient (italics proxi- without further definition to define original). at 731 language mate cause because that was case, In this looking at the trial court’s vague confusing jury. to the Boom- whole, charge as a we conclude that the er, The in supra. plaintiff Boomer sued use of “substantial factor” does not impli- Company wrongful Ford Motor for death cate the same concerns iii as Boomer be- by exposure due to mesothelioma caused cause here the trial court defined the term in to asbestos Ford’s automobile brakes. impact its on the burden proof. Virginia Supreme Id. at 726. The Court N.T., Compare (morning), at 127- 10/30/13 explained that determining causation in (explaining 134-136 “substantial fac- presents mesothelioma cases challenge tor”) Boomer, supra (stating at 730 identifying particular exposure because “the circuit court in this case never defined as causative is difficult due to long the term ‘substantial contributing factor’ in latency period potential and the for multi- instructions!;,] jury its . i. jurors some [so] ple exposures to asbestos over an individ- might construe the term to lower the ual’s lifetime. Id. at 729. In such “mul- proof required threshold of for causation cases, tiple-causation” the Boomer court might while others interpret it to mean the acknowledged that the traditional “but ]”). opposite[ The trial court’s charge conceptualization for” of causation would gave context and meaning to the term difficult, make recovery impossible, if not “substantial factor” that was in absent difficulty due to the of proving which ex- Boomer. The charge clarified that posure was the sole “but for” cause of the plaintiff had to prove that “negligence injury. attempt guide Id. In an lip caused the cleft palate cleft in jury Blake on the nuances of causation in multi- cases, ... a fair ple-causation preponderance or [ ] the trial in- fair weight -N.T., of the jury structed the that evidence.” plaintiff must 10/30/13 prove that either the exposure (morning), to asbestos at 128. The charge also ex- in products defendant’s or the plained question defendant’s that the causation on the failure to warn of products asbestos its verdict sheet of “[w]as the Defendant was a “substantial contributing factor” in negligence Janssen’s a substantial factor in causing plaintiffs injury. Id. bringing about Blake lip/ Czimmer’s cleft palate?” cleft was asking the but for causa- Virginia

The Supreme rejected tion question of he suffer the cleft “[d]id contributing “substantial factor” lan- lip arising or cleft palate from the negli- guage because without further definition gence of the Defendant Janssen?” Id. at its impact on the burden of proof was added); Boomer, (emphasis see also hand, ambiguous. Id. at 730. On one supra (defining at 732 a sufficient cause as jury could view a “contributing” factor as one “arising negligence”). from something cause, The trial less than “but-for” which court further clarified that would lower the burden of Al- “substantial proof. Id. factor” was synonymous with ternatively, jury could “factual interpret “sub- N.T., cause.” (morning), stantial” as elevating proof the burden of 10/30/13 plain meaning something more than a mere “factual cause” prepon- confusion, derance. the “harm Id. To avoid this would not have occurred Boomer, Supreme Court articulated the absent the conduct.” supra at standard for factual multiple quoting causation in (ThiRd) Restatement Liability Physical causation cases was “exposure to the de- ToRTS: and Emotion- fendant’s product (2010); § alone must have been al Harm see also Law Black’s 2009) (9th ambiguous, it does not (defining This is not cause ed.

Dictionary, cause”). proof. a more lenient burden of impose as “but for factual cause Instead, description it is an accurate Moreover, the court instructed the trial Accordingly, court did not law. the trial negli- it had find Janssen’s error commit a clear abuse of discretion or in “bring- real factor” was “an actual gence the outcome of the of law controlled palate,” lip/cleft “not ing [the] about Therefore, second case. See id. factor or a factor imaginary or fanciful an warrant relief. appeal issue on does not insignifi- connection or having no Co., supra. Am. Ins. See ACE (morn- N.T., cant connection.” 10/30/13 charge at the ing), Looking at 136. its appeal Janssen’s third issue on jury trial the entirety, the court instructed presents regarding two sub-issues the tes find, by of preponderance it had to a the timony Basye, physician’s of the assistant evidence, lip palate that Blake’s cleft or Topamax April, and we prescribed who ie., negligence, from arose Janssen’s that First, in address them turn. Janssen ar factual, negligence was a or but Janssen’s denying the trial gues that court erred for, though Even injury. cause of Blake’s JNOV the evidence did not estab because “substan- charge the contained the words causation, it warning lish as did not show a factor,” it adequately tial defined causation pertaining lip palate or cleft would jury that the such would misconstrue injury. have avoided Janssen’s Blake’s Therefore, proof. the the burden of trial Specifically, Brief at 42. claims Janssen court did not commit a clear abuse of Basye understood the risk of birth defects law because discretion error of the Topamax during preg associated use charge accurately as a whole reflects the nancy drug. it category because was a C Krepps, law. supra. See essentially argues Id. at 42-44. Janssen Further, in the of the context whole warning lip pa that a about cleft or cleft charge, Janssen failed to has demonstrate Basye’s late would not have altered deci way in what the use the words “substan- of prescribe Topamax April. sion to tial factor” an incorrect caused result. this record belies contention. merely contends that the “[u]se a Assuming plaintiff has established factor prejudicial substantial was because warn, duty a plain- both and failure to misleading, confusing, has found it proximate tiff must further establish capable imposing a more lenient by showing causation that had defendant proof burden of than the factual cause ], proper warning issued a he would [ actually requires.” standard injury have altered his the behavior and Boomer, citing, supra Brief at at 730 & would have been avoided. To create a Liability (Third) Restatement of Torts: jury question, the evidence introduced Physical § Harm For Emotional weight must be of sufficient establish (2010). j cmt. We decline to isolate the ... some likelihood that an reasonable the con- words “substantial factor” from adequate warning prevented would charge. Krepps, text of the entire See receiving drug. from plaintiff Instead, above, supra. explained as (alterations charge origi at 292 adequately Gurley, supra trial court’s as a whole Johnson, nal), Maya had to find & explained quoting v. Johnson proved preponderance (Pa.Super.2014), Blake 1213-1214 — denied, Pa. -, lip appeal evidence that he suffered cleft or cleft A.3d 653 (2015). palate arising negligence. from Janssen’s involving cases the failure to treat patient who symptoms had

to warn of risks associated with prescrip migraine? drugs, Pennsylvania

tion apply courts A. Yes. intermediary “learned doctrine.” intermediary Under the learned doc- Q. you Do expect the information that trine, a manufacturer will be held liable provided PDR[, in the Physician’s only where it fails to exercise reasonable Reference, Desk containing the drug’s care physician to inform a of the facts label,] complete to be and accurate? which make drug likely to be dan- Yes, A. I do. I believe that it’s basical- gerous. The duty manufacturer has the ly the best source for a lot of informa- to disclose physician, risks to the tion on all the drugs prescribe that we opposed patient, to the because it is the the time. duty prescribing physician to be Q. you Can adequately perform a risk (1) fully aware of the characteristics of analysis benefit if the PDR is not accu- (2) drug he is prescribing, rate complete? amount of the drug safely which can be No. (3) [A.] administered, and the different medi- patient taking.

cations the It is also duty prescribing physician to Q. you Let me ask you ask about Cate- patient advise the of any dangers or side gories C and D. you’re prescrib- When effects associated with the use of the ing a medication to a woman in her drug as well as how and when to take years, child-bearing you do pay attention the drug. as to whether or not a medication is a C 292-293, Id. at quoting Wyeth, Cochran v. versus a D? Inc., (Pa.Super.2010), A.3d ap- A. Yes. denied, peal 610 Pa. 20 A.3d 1209 Q. Which one has more risk of harm to (2011). While the Virginia Supreme Court fetus, an unborn a or aC D? not explicitly adopted has the learned in- Category [A.] D. doctrine, termediary it has seemingly ap- Q. youDo prescribe D Category medi- proved it in cases involving prescription cations to women in their child-bearing Jones, drugs. Pfizer, Inc. v. 221 Va. years? (1980); 272 S.E.2d Talley v. Danek A. my Not to knowledge. Medical, Inc., (4th 179 F.3d Cir. Q. you As 1999) today sit here in reviewing (predicting the Virginia Supreme [April’s] records, medical if Topamax adopt Court would the learned intermedi- had been a doctrine). Category you D when first ary prescribed it April, you would have Here, April established causation Topamax chosen migraines? to treat her through Basye’s deposition testimony, pre I [A.] don’t believe so. jury, sented to the that she would not have prescribed if Topamax Janssen had in specific

formed her of the risk of lip cleft Q. you If had been aware back in Au- or cleft palate. testimony Her pre was gust you of 2006 when prescribed Topa- jury, sented to the in part, as follows. max that there was a risk to her unborn Q. P[hysician’s] Assistant], As a did fetus of cleft palate, and cleft lip would you authority have the to determine that your have altered prescribing hab- which appropriate medications would be its? sub-issue, In Janssen’s second Yes.

[A.] appeal, its it contests within third issue Topa- prescribed have Q. you Would rulings the trial court’s exclude some you if August of 2006 April max [ ] purpose impeaching for the evidence to her un- had there was a risk known Brief at Our Basye. 46-47. born fetus? is as standard review follows. A No. Admission of evidence is within the To- prescribed Q. you have ever Would sound discretion of the trial court and that you if had known pamax [April] review trial court’s determina- lip increased risk of cleft there was an admissibility of evi- regarding tions palate? To dence for an abuse discretion. so. A. I believe don’t error, constitute reversible an evidentia- erroneous, ry ruling must be PDR, label, Q. warn Does that prejudicial but also harmful or to the car- you prescriber Topamax as a complaining For to be party. evidence lip ries risk of cleft with it an increased admissible, competent it must be and cleft palate? competent relevant. Evidence is if it is material to the issue to be determined No. [A] trial. Evidence is relevant if it tends to any Q. you knowledge Did back prove disprove material fact. Rele- could Topamax 2006 or 2007 proba- vant evidence is admissible if its palate? lip cause cleft or cleft value im- outweighs prejudicial tive its A. No. pact. rulings regarding trial court’s To- Q. [April] have received [ ] Would be relevancy of evidence will not you if known that? pamax you from had overturned an absent abuse of discre- No. [A] tion. [Q.] had Topamax If been a Class— 402, Pursuant rele- to Rule of Evidence Category D medication in 2006 and 2007 admissible, vant generally evidence is you [April], when it to prescribing were and irrelevant evidence is inadmissible. you prescribed would it? ex-, Further, may relevant evidence be A. No. eluded if out- probative its value is weighed by potential preju- its unfair 9/21/12, Basye, P.A., Deposition of Lisa at dice, tendency suggest defined as to 14, 20-21, 40-41, 49. decision on to div- improper an basis or Based foregoing, on the the evidence jury’s away attention from its er[t] weight jury was of sufficient to allow duty of weighing impartial- the evidence Basye not have to conclude that would ly- prescribed if Janssen Topamax April 409, Rosenwald, Conroy v. A.2d Topa- adequately Basye had warned (bracket (Pa.Super.2007) cita- original; lip max carried the risk or cleft omitted). tions supra. Viewing the palate. Gurley, See light evidence in most favorable Janssen contends the trial excluding Blake belies Jans- erred in evidence that “demon April, record April Basye sen’s that Blake and did strates Ms. understood the risks contention Accord- Plaintiffs’ to con establish causation. See id. claim failed [sic] vey.” Brief at 47. includ ingly, this claim does not warrant relief. This Braun, Basye prescribed April evidence supra. See ed Paxil, D Category drug, during another April. scribed it to See Janssen’s Motion years child-bearing Relief, her and evidence of 11/8/13, for Post-Trial at 6-10. Basye’s April’s Topamax Therefore, refusal to refill the trial court did not abuse its pregnant once she became prescription be- in denying discretion Janssen’s motion for cause of the risk to the fetus. Id. at 47. a new trial based on excluding portions of explained The trial court that it excluded Basye’s testimony. Co., See ACE Am. Ins. testimony regarding the circumstances supra. Basye prescribed under Paxil be- which In its fourth issue on appeal, cause it “was not relevant since it is an Janssen contends it was entitled to JNOV entirely drug prescribed different and was on the award of future healthcare costs to entirely under different circumstances. Blake that he will incur as an unemanci- open did not want to [trial] [c]ourt minor, pated until he attains age why door to a side trial as to Paxil was parents’ as his claim for those healthcare 1/2/14, Trial prescribed.” Opinion, costs was time-barred.13 Janssen’s Brief at at 13-14. discern no abuse of discre- We 49-56. Our review guided by the follow trial tion court’s decision to exclude ing. “The question of whether a statute of Paxil, relating evidence as it does not limitations has run on a claim is usually a tend prove disprove whether Janssen question but, of law for the judge, trial provided adequate warning an regarding times, a factual determination Therefore, Topamax. Conroy, supra. See may required.” be Sch. Dist. Borough ruling the trial court’s to exclude evidence Co., Aliquippa v. Md. Cas. 402 Pa.Su of Paxil does not warrant a new trial be- (1991) (citations per. 587 A.2d cause it was reasonable and not an abuse omitted). “The issue of which limitations Co., of discretion.12 See Am. ACE Ins. period applies to a particular cause of ac supra. tion question such, is a of law. As The trial court properly also ex exercise de novo review which is plenary in cluded Basye’s evidence of refusal to refill scope.” Burger Assocs., v. Blair Med. April’s Topamax prescription once she be Inc., (2009) 600 Pa. pregnant came as such evidence is not (citations omitted). question relevant to the of whether Jans- provided adequate sen warning before begin by We addressing which Basye prescribed Topamax to April. state’s statute applies of limitations in this Moreover, Janssen cannot show the exclu case. Because the Czimmers’ claims ac prejudicial sion of this evidence was Virginia be crued in but were filed in Penn cause it was cumulative of other sylvania, evidence apply Pennsylvania we Uni in the record that Janssen introduced to form Statute of Foreign Limitations on support Basye Act, its contention that knew § of 42 Claims Pa.C.S.A. 5521. Accord taking Topamax statute, risks associated with ing to that we apply must during pregnancy pre- at the time she statute of limitations of the state with the excluding 12. Even if the trial court erred in health care costs in the trial court. The trial Paxil, court, however, the evidence of it is a harmless error. parents' dismissed the claims overwhelming The evidence established that time-barred, permitted as but Blake to recov- Basye prescribed Topamax would not have Thus, expenses er right. for those in his own April if she knew of the risk of birth defects. appeal, Appellee April, guardian on is on behalf of Blake. father, Czimmer, April 13. Blake’s Aaron brought pre-majority claims for Blake's 1060 Clair, 86, (Pa.Super.2007), including accru v. 933 A.2d 88 period, limitations

shorter Hathi v. Park quoting Apart- 42 Pa.C.S.A. Krewstown tolling rules. al and 613, 1261, ments, 5521(b). two-year 561 A.2d Pennsylvania Pa.Super. § has a 385 (1989), nom., brought a claim vacated sub E.D.B. ex limitations for 1262 statute of Clair, 73, minor unemancipated of an D.B. v. 605 Pa. 987 A.2d 681 on behalf rel. in expenses (2009); Capozio, health care future accord Baumann v. 269 recover (2005) majority, 356, 597, reaches (recog- until minor 599 curred Va. 611 S.E.2d provision tolling has Virginia nizing while the same two causes of action for years to five period the limitations expands injury to a minor under personal law). 42 Compare Pa.C.S.A. for claims. such 5524(2) (codifying two-year statute of § two-year of statute limitations on limitations), El-Daief, v. 600 Pa. Wilson of independent minor’s cause action that (2009) 854, (noting claim A.2d 361 964 before the of 18 is tolled until age accrues sustained), 42 injury when is Pa. accrues turns 5533 by the minor Section of the 5533(b) that an un- (providing § C.S.A. Code, provides which as follows. Judicial minor’s of action emancipated cause is insanity Infancy, impris- § majority), minor until attains tolled onment Checcio, 582 Pa.

Fine v. (2005) Pennsylvania’s (describing 858-859 (b) Infancy.— doctrine), rule” with Va. “discovery tolling (1) (i) If an individual entitled to 8.01-243(B) (extending § two- Ann. Code bring a an civil action is unemanci- year personal of in statute limitations pated minor the time the cause years jury actions to five when minor’s accrues, period minority action the mi parents claims behalf of assert not be a portion shall deemed § injury), Id. 8.01-230 personal nor for which the period time within action claim accrues from the date (prescribing Such person must be commenced. sustained), 8.01-229(2)(a) § injury is Id. time for shall the same com- minor’s claim (stating unemancipated mencing attaining action after ma- tolled), Radiology is As Chalifoux jority as is allowed to others Richmond, Inc., 281 Va. socs. of chapter. provisions of this sub (2011) (noting Virginia has S.E.2d rule”). (ii) Be adopted “discovery paragraph, As used in this Pennsylvania’s any cause statute limitations term “minor” mean individu- shall shorter, apply Pennsylvania years law.14 yet al who has not attained age. Law[,] per Pennsylvania

“Under to a rise to injury gives sonal minor two 5533(b)(1)(i)-(ii). action, § and distinct causes of one Pa.C.S.A.

separate period a expenses Accordingly, the claim medical the limitations for parents[’] for is from during services minor’s claim measured the time and loss minor’s irrespective claim the minor turns of when minority, the other the minor’s for ex rel. pain suffering losses after the claim accrues. Fanesali Fanc and and for Pittsburgh, minority.” Bowmaster rel. Bowmaster sali v. Health Ctr. ex Univ. ' 50; agree age Appel parties of 18. Brief at 14. The and trial court also the two-year 55; Pennsylvania's period 1/2/14, for limitations Opinion, Brief at Trial Court lee's injury personal applies to the future actions at 9. care costs incurred until Blake attains health (2000). 2011, years Even over one and one-half after Pa. the tolled, Therefore, limitations is though period expired. the statute of limitations had still commence an guardian may parent Hathi, their claim was time-barred.15 See any minor at time on behalf of a Fancsali, action supra; supra. an action does it accrues. Id. Such after The parents’ trial court found that the period; the it re- not affect limitations claim for healthcare during minority costs the minor turns 18. suspended

mains until was by barred the statute of limitations.16 Id. 1/2/14, Trial at -Opinion, Despite 9. tolling provision, minority The this, the pro- trial court allowed Blake to however, parents’ does not to the apply ceed his own on the right claim for expenses claim for medical nonderivative future medical will incur costs he until he loss of the services during minor’s jury turns 18. Id. The awarded Blake hi, minority. at 1263. supra Hat Accord $562,184.68 health for future care costs.17 ingly, parents the limitations for the period Sheet, 10/30/13, Verdict at 1. Janssen con- minor’s cause of ac commences when the tends the trial court should entered Fancsali, supra. tion accrues. on JNOV the future medical costs issue these principles, Based on minor, Blake, because as a does not have for parents’ Blake’s claim medical ex independent right to recover these ex- during period he will incur penses penses parents’ when his claim for the time before he turns 18 time-barred. A same is right time-barred because the two-year applies of limitations statute to recover belongs parents to Blake’s alone.18 personal parents’ injuries Blake’s claim for Janssen’s Brief at 53-55. resulting negligence. from Janssen’s Pennsylvania Traditionally, courts have 5524(2). claim Pa.C.S.A. accrued on right held to recover medical ex- 24, 2007, September day on which penses a minor before attaining incurs lip/palate. Blake was born with cleft As such, age of 18 parents, accrues parents September his until had the minor independently 2009 to commence their cause of action. cannot recover Bowmaster, They May did not file action until those expenses. E.g., this supra addition, appeal, April attempts We note jury 15. that on 17. awarded Blake $3,440,00.00 argue pain suffering, apply- that the trial court erred in not which ing by Janssen does not claim is barred discovery to toll the stat- rule the statute of Sheet, 10/30/13, ute of limitations. Verdict at parents' limitations on the claim for future expenses. Appellee's medical Brief at 55-58. 1. However, record, review of the after careful argues 18. Janssen also the trial court agree parents court that the trial violated the law of the case doctrine when it argument, they have waived this did not despite allowed Blake to recover a March Opin- raise it in the trial court. Trial Court 2013 order from the Honorable Arnold L. ion, 1/2/14, 10; 302(a). Pa.R.A.P. New that denied the Czimmers’ motion to parents’ transfer the claim to Blake. Jans- In its of its second sub-issue fourth issue argument sen's Brief at 52-53. This is mis- appeal, argues that the trial placed. parents' The trial court found the failing erred in to ask decide claim was barred the statute of limitations parents brought whether had and, Blake’s their thus, did it. not transfer Notwithstand- applicable period. claim determination, within the limitations ing that the trial court decided properly Blake, Given that the trial concluded right, court that in his own could recover time-barred, parents’ that the was expenses during claim this future minority. medical his 1/2/14, Opinion, issue is Trial Court at meritless. 10-11. 2008). parents minor’s Shaffer-Doan, In “it is clear uneman- (concluding [the at 89 their a claim on behalf of asserted both not asserted could cipated minor] right expenses in her he antici- expense own minor for medical claim for medical son ]”). minority! In Bow- of after he turned 18 and during pated incurring her time master, minor of a born parents the behalf medical ex- claim on their own for against an filed action birth defects the they severe would incur before penses that months her behalf two hospital the on at The trial minor 18. Id. 503. turned birthday. Id. at 87. The her before 18th summary judgment granted partial an independent assert did not parents it was to claim because parents’ as the behalf for medical of on their cause action parties The then settled. time-barred. Id. the time before she paid during expenses the against Id. asserted a lien When DPW Notice of the law- at 88. turned Id. parents attempt- the proceeds, settlement Pennsylvania Depart- the given suit was the by the lien arguing ed avoid (DPW), the as ment' of Public Welfare represent payment not settlement did receiving medical assis- minor had been the any expenses medical incurred before the time before she throughout tance minor which identical to turned was lien for and DPW asserted a turned parents in argument the of the Bowmas- paid it had out to the amount of benefits opinion, In its ter. Id. at 506. the Com- expenses. Id. at cover the minor’s medical ultimately and monwealth Court examined eventually settled the parents 87. The rejected approach this in Bowmas- Court’s minor the against claims on behalf of the Instead, the ter. Id. at 512-514. Com- sought Id. to avoid hospital. parents of applied language monwealth the Court asserting that the settle- lien DPW’s minor is the that a FACA “conclude[d] reim- represent any not proceeds ment did ex- prevented seeking not from medical expenses the the medical bursement for minor, he so as penses incurred while is a of the minor parents incurred on behalf lien for to enable DPW to recover its part was not because such a claim such a expended, long monies it has as it was lawsuit. Id. at 88. DPW asserted duplicated by parents.” claim not under entitled reimbursement (footnote omitted). Id. (FACA), Act Fraud Abuse Control §§ This held P.S. 1401-1418. Id. Court in the pending was While Shaffer-Doan Court, that DPW not entitled reimburse- was our Supreme Commonwealth Court were the true parents ment because the appeal in Bowmas granted allowance of beneficiary paid of the benefits DPW dur- ter, of rel. D.B. the name E.D.B. ex under minority, pay- and those ing minor’s E.D.B., supra at 683. In its de Clair. ments were of the suit because part not cision, Supreme recognized Court parents parties. Id. at 91. were holding conflict this Court’s between on the concluding, In so the Court relied Bowmaster Commonwealth law Pennsylvania principle common Id. Court’s conclusion Shaffer-Doan. recover unemancipated minor cannot Bowmaster, vacating at 687. the Court time expenses during medical incurred approved critique of Shaffer-Doan’s before he or turns 18. Id. she antiquated on as based Bowmaster Bowmaster, property view children were the

After the Commonwealth at 688. The de case, their father. Id. factually similar but Court decided a reim cided was entitled to reached the conclusion. that DPW opposite Shaffer- solely statutory grounds, Dep’t Pub. bursement Doan v. Commonwealth (Pa.Cmwlth.Ct. larger question to decide the Welfare, declining 1063 minor an independent right whether a has nority, -and does not appear put a limit expenses to recover for the medical in- on the pre-majority amount of medical ex- age curred before the of penses 18. Id. at 691 n. the minor can recover. (noting, fact, cited the Common- capping “[w]e the amount at the total of thoughtful summary wealth of already Court’s the benefits received would contradict history rights of the parents duties of the of reasoning the Court that it inis the However, respect to their children. public protect interest taxpayers from we must out that point question assuming the broad a cost that should be paid by a of continuing validity Instead, the of the tortfeasor. See id. at 691. common allow- ing law doctrine that bars an the minor to recover all individual from pre-majority bringing expenses, suit for medical whether expenses medical in- incurred or an- ticipated, would best serve during minority public curred his or her is not the in- terest and avoid giving before us and is not the a windfall basis for our to tort- (citation ]”) omitted). feasors who are Thus, sued earlier in a minor’s decision! life. explicitly while not deciding question the may of whether a minor recover for medi- In light of the Supreme 18, expenses cal incurred before age of E.D.B., holding Court’s in vacating this Supreme judicial Court dicta called Bowmaster, Court’s order we conclude continuing validity into doubt the the common law doctrine prohibiting a mi common law doctrine that supplied the nor from recovering damages for medical rationale for the Bowmaster decision. Id. expenses incurred age before 18 is no that,

The Supreme “pursuant Court held longer viable.19 The common law doctrine [FACA], to the a Medicaid beneficiary has premise rested on the parents, specifi against a cause of action fathers, his or her tortfea- cally solely were responsible for sor, to recover and minors, reimburse DPW for support including medical Medicaid during expenses, benefits received the ben- and minors were property eficiary’s minority.” Id. at 691. Earlier in their turning fathers until 18. The com opinion, its the Court noted that “DPW’s mon law rule by was motivated a desire to claim in this case is far less than one-half allow the party actually who suffered the monetary recovery.” [the minor’s] Id. damages, parents ie. support with a at 690 n. 8. Because the monetary obligation, award to recover for the loss caused settlement, pursuant tortfeasor, occurred to a we can- prevent and to double not determine how much recovery by of the total parents both the and the mi apportioned amount was compensation as nor expenses. for the same Shajfer-Doan, for the expenses However, minor’s medical supra incurred at 509-511. as the Com pre-majority opposed to post-majority. monwealth in Shajfer-Doan Court ex Nonetheless, recog- plained, Court’s decision development of the law and statutory nizes a minor’s legislation cause of action recognize has come to that the expenses for medical during incurred mi- cause of action to recover pre-majority 693, recognize beyond pow 19. We (Pa.Super.2002).” "[i]t 2n. Common- Superior panel (Pa.Su- er Pepe, Court to overrule a wealth v. 897 A.2d Court, denied, prior Superior per.2006), decision of the appeal Com 596 Pa. cert, Hull, (Pa.Su (2008), denied, monwealth v. 705 A.2d A.2d 686 555 U.S. 1998), per. (2008). except in circumstances where in 129 S.Ct. 172 L.Ed.2d 141 We tervening authority by Supreme our question conclude that E.D.B. called into question previous calls into decision of this reliance of Bowmaster on the aforementioned Prout, Court. Commonwealth v. common law doctrine. 1064 error, and judgment I would the par- to both the vacate belongs expenses

medical 513, citing for a new trial. at remand minor. See id. and the ents Yaw, Pa.Super. DeSantis acknowledges, Majority As the learned (1981). represents E.D.B. A.2d agreed that parties court and the the trial right to expansion of a minor’s the latest fail- applied negligent law to the Virginia minority. during expenses medical recover (See Majority Opinion, claim. ure to warn an inde- Thus, the minor has we conclude 1052-53). object- Appellant specifically expenses medical right recover pendent language the use of substantial factor ed to long as turning before as the incurred rejected Virginia expressly has because the claim. We duplicate do not parents that language, requested and primary public on the our conclusion base instead, language court use factual cause responsi- a tortfeasor should be policy that (See N.T. Virginia consistent with law. tortious conduct for the harm its ble 34). Conference, 10/29/13, at Charging any reason cannot discern causes. We request, trial court this The refused based penalty tortfeasor to avoid allow a as de- interchangeably, both terms used parents of the minor’s the failure (See by Majori- the Majority. above tailed unwar- timely action. This is an bring 1053-54). ty Opinion, at responsible windfall in favor of a ranted Boomer, supra, Supreme Court There- age. due to a victim’s tortfeasor examined Virginia propriety fore, in declaring trial court did not err and stat- language use of substantial factor inde- Blake was not time-barred from ed: pre-majority his pendently recovering ... In the last several decades expenses. Accordingly, the trial medical factor” instruc- contributing “substantial denying did not err in prominent in oth- tion has become some Braun, supra. for JNOV. See motion jurisdictions. factor” er “Substantial foregoing, on the we conclude all Based in the Re- language was also utilized are meritless. appeal (First) (Sec- of Janssen’s issues on Restatement statement trial court not commit clear did ond) phrase of Torts. The “substantial or error of law that abuse discretion contributing grounded, factor” is not trial. warrant JNOV or a new See would however, jurisprudence in the of this id.; Co., Therefore, supra. Am. Ins. history ACE not, we have in the Court: judgment. January we affirm the law, lan- case invoked this our ever guage. Judgment affirmed. Considering it the first now time, problems find several Judge joins opinion. LAZARUS contributing factor in- the substantial matter, Judge dissénting opinion. PLATT files a cir- As an initial struction. defined the cuit court this case never PLATT, DISSENTING BY OPINION contributing factor” term “substantial J.: not clear jury instructions. It its proxi- it was to alter the respectfully I from the decision whether meant dissent way, in some judg- requirement mate cause Majority of the learned to affirm reducing cause-in-fact re- the trial such as ment. Because I believe to a “contribut- jury interrog- quirement referring court’s instructions and independent violat- factor rather than an atory ing” on substantial factor causation cause. The term substantial ed law constituted reversible but-for (Third) factor contributing could be construed to § Restatement of Torts cmt. any mean cause that is more than a j. The specifically comment also refer- merely Conversely, de minimis factor. tendency ences the of courts to at times the invocation of the term “substantial” interpret the language as either raising interpreted could be to raise the stan- lowering or the factual causation stan- proof beyond dard for of causation dard, leading to inconsistent and inaccu- preponderance mere of the evidence to rate statements of law. Id. If courts sum, some more elevated standard. In upon cannot be relied consistently jurors might some construe the term to language, construe the we expect cannot proof lower the threshold of required for lay jurors accomplish the same task. might causation while others interpret it (Third) The Restatement of Torts re- to mean opposite. We do not be- lies instead on the combination of sec- lieve that contributing substantial factor tions 26 and 27: single, has a meaning, common-sense § 26 Factual Cause and we conclude that a juror reasonable Tortious conduct must be a factual cause quantum could be confused as to the of harm for liability to imposed. be required prove evidence causation in Conduct is a factual cause of harm when the face of both a substantial contribut- the harm would not have occurred ab- ing proximate factor and a cause in- sent the conduct. Tortious conduct may struction. also be a factual cause of harm under § 27. Moreover, agree explicit with the § 27 Multiple Sufficient Causes rejection contributing of substantial occur, If multiple acts each of which language factor in the recent Restate- § under 26 alone would have been a (Third) ment Liability of Torts: factual cause of the physical harm at the (2010). Physical and Emotional Harm same time in the absence of the other (Second) The Restatement of Torts used act(s), each regarded is as a factual substantial factor ... language[.j cause of the harm. Restatement, The latest revision of the model, This as explicated in the com- however, deliberately abandoned this ments, quite consistent [Virginia language, explaining: Law regarding] causation. [T]he substantial-factor rubric (case Id. at omitted, 729-31 citations em- obscure, tends to rather than to as- added) phases (reversing and remanding sist, explanation and clarification of for further proceedings where trial court [causation] the basis of decisions. erroneously failed to sustain defendant’s established, The element that must be objections to “substantial contributing fac- proof, whatever standard of is the- instructions). jury tor” but-for necessary-condition stan- case, dard of this Section. Section 27 pro- In the instant the trial equat- finding vides rule for each of two ed the term “substantial factor” with “fac- acts that are elements of sufficient tual cause” and used them interchange- (N.T. competing causal sets to ably. Trial, 10/30/13, 135). be factual It causes without employing the substan- jury instructed the the terms were (Id.). tial-factor language prior Torts “synonymous.” law, Under however, Restatements. There question is no synonymous. these terms are not degree fact, for either concepts. of these Virginia Supreme Court has use rejected the of substantial expressly Megan and Robert I. SHINAL based instructions language

factor Husband, Shinal, J. her single, “a the term lacks its belief that Appellants meaning ... [and] [t]he common-sense obscure, rubric tends to substantial-factor assist, clari- explanation and than rather TOMS, M.D., Appellee. Steven A. deci- [causation] of the basis fication Boomer, (quoting Superior Pennsylvania. supra, at sions.” (Third) § cmt. of Torts Restatement June Submitted 2015. .J.). Thus, case, in the instant Aug. Filed question was asked causation Reargument Denied Oct. [Appel- form—“Was' on the verdict decide a substantial factor in negligence lant’s] lip/ Blake Czimmer’s cleft

bringing about palate?” contrary to —was law, term fac- which finds the “substantial easily being capable and confusing tor” jurors. both misconstrued courts (Verdict 10/30/13, Sheet, 1); see also Boomer, supra at 730. circumstances, I would con-

Under these charge as clude that the trial' court’s a tendency inadequate whole was had a clarify rather than a to mislead or confuse issue, new trial material See Passarello v. therefore warranted. Grumbine, 624 Pa. A.3d

(2014) (“Error charge in a is sufficient if ground charge new trial as a or not or has a inadequate whole is clear tendency to mislead or confuse rather than issue”) (citation omitted);

clarify material Costello, A.2d see also Gorman (determining (Pa.Super.2007) jury lacked tool to make essential needed

informed based on correct and decision

complete principles where court legal give failed to accurate definition of factual cause; re- judgment vacated arid case trial). I re- Accordingly, manded for new spectfully dissent.

Case Details

Case Name: Czimmer v. Janssen Pharmaceuticals, Inc.

Court Name: Superior Court of Pennsylvania

Date Published: Aug 20, 2015

Citation: 122 A.3d 1043

Docket Number: 459 EDA 2014

Court Abbreviation: Pa. Super. Ct.