Opinion
J-A01041-16 No. 2330 EDA 2014
05-11-2016
KELLY ANDERSON, PAYTON ANDERSON AND BRADLEY ANDERSON Appellee v. JANSSEN PHARMACEUTICALS, INC. Appellant
NON-PRECEDENTIAL DECISION - SEE SUPERIOR COURT I.O.P. 65.37
Appeal from the Order July 9, 2014
In the Court of Common Pleas of Philadelphia County
Civil Division at No(s): 01405 December Term 2011 BEFORE: LAZARUS, J., OTT, J., and STEVENS, P.J.E. MEMORANDUM BY LAZARUS, J.:
Former Justice specially assigned to the Superior Court.
Janssen Pharmaceuticals, Inc. (Janssen) appeals from the judgment entered in the Court of Common Pleas of Philadelphia County in favor of Kelly Anderson, Payton Anderson, a minor, and Bradley Anderson, following a jury trial. After careful review, we affirm, largely based upon the opinion of the Honorable Ramy Djerassi, dated May 4, 2015.
Kelly Anderson (Kelly) has experienced severe migraine headaches since the age of 10. Kelly was prescribed Topamax for migraine treatment beginning in 2006. Until 2011, Topamax was labeled as a Category C drug, indicating that some birth defects had been detected in animals, but no conclusive evidence showed the drug caused birth defects in humans. Kelly's neurologist, Dr. Veronica Sosa, prescribed Topamax in January 2006 and folic acid as a prenatal vitamin because Kelly was trying to conceive. In September 2006, Kelly began seeing Dr. Traci Purath, a neurologist specializing in headaches. Dr. Purath wrote new prescriptions for Kelly for Topamax in April and November 2007. Dr. Purath noted on her chart that Kelly was taking prenatal vitamins because she was trying to get pregnant. Kelly also saw her obstetrician-gynecologist, Dr. Joy Seldera, in April and November 2007. Dr. Seldera's chart noted that Kelly was trying to conceive and was taking Topamax.
Kelly determined that she was pregnant on December 26, 2007. Dr. Seldera and Dr. Sosa both told Kelly to stop taking two other medications she used to treat migraines, Methergine and Lyrica. These two drugs were labeled Category D by the FDA, meaning they were known to cause birth defects in humans. Kelly saw Dr. Purath two days later, on December 28, 2007. Dr. Purath prescribed Topamax to Kelly for the duration of her pregnancy. None of Kelly's doctors warned her that taking Topamax while pregnant would place her baby at risk of developing cleft lip and palate.
Kelly gave birth to her daughter, Payton Anderson, on August 17, 2008. Kelly and her husband, Bradley, learned that Payton had a severe bilateral cleft lip and palate when she was born. Payton has undergone multiple surgeries affecting her jaw, nose, and lips. Payton has experienced hearing loss and speech problems, and she has been bullied because of her speech and appearance.
On December 13, 2011, Kelly and Bradley Anderson, individually and as guardians for Payton, filed a complaint alleging, in part, that Janssen negligently failed to warn her prescribing health care providers of the risks of birth defects associated with the use of Topamax during pregnancy, including cleft lip and palate. Following a fifteen-day trial, the jury returned a verdict for the Andersons on March 7, 2014, awarding $1.5 million to Payton for non-economic damages and $1.5 million to Kelly and Bradley to pay for anticipated healthcare expenses for Payton.
On March 17, 2014, Janssen filed timely post-trial motions, and on March 19, 2014, the Andersons filed an untimely motion for delay damages. The trial court denied the post-trial motions on July 9, 2014, and denied the motion for delay damages on July 15, 2014. Janssen filed a timely notice of appeal and court-ordered statement of errors complained of on appeal pursuant to Pa.R.A.P. 1925(b).
On appeal, Janssen raises the following issues for our review:
1. A. Does federal law preempt a state law negligent failure to warn claim based upon the failure to change a prescription drug's pregnancy category set by the U.S. Food and Drug Administration [(FDA)] where federal regulations precluded [Janssen] from changing that designation without the FDA's prior permission and assistance?
B. Even if (contrary to fact) the FDA's prior permission and assistance had not been required to change the pregnancy category, would federal law still preempt Plaintiffs' claim because there is clear evidence that [the] FDA would have rejected that change at the relevant time?
2. Did the trial court err in allowing a negligent failure to warn claim to proceed against a prescription drug manufacturer
under Wisconsin law when the prescriber of the drug knew, at the time she prescribed it, of the potential risk that formed the basis of the claim?Brief of Appellant, at 4.
3. In a negligent failure to warn case governed by Wisconsin law, did the trial court err by refusing to instruct the jury on comparative negligence and by refusing to ask the jury to apportion fault between [Kelly Anderson] and [Janssen], when the record contained evidence that [Kelly Anderson's] conduct was negligent and contributed to the injuries at issue?
4. Did the trial court err in affirming an award of future medical expenses that was more than three times the amount supported by the evidence?
5. Did Janssen waive these issues (and others) by filing a [Rule] 1925(b) Statement that specifically identified each error and the places in the record where each error could be found?
We begin by addressing Janssen's assertion that it did not waive all issues raised on appeal. In its Rule 1925(a) opinion, the trial court found waiver based upon Janssen's "failure to comply in good faith with Pennsylvania Rule of Appellate Procedure 1925 by filing a multi-page, multi-paragraph Statement that defies a court order directing that [Janssen] should not file a Statement that is 'redundant, frivolous, or so lengthy as to defeat the purpose of the Rule.'" Trial Court Opinion, 5/4/15, at 10. While we agree that Janssen's Rule 1925(b) statement was not written in a concise manner, we note the complexity of this matter and decline to find waiver because the issues raised are clearly identifiable. Thus, we consider the issues Janssen raises on the merits.
Janssen first contends that federal law preempts the Andersons' negligent failure to warn claim since it could not unilaterally change the pregnancy category of Topamax from C to D. Janssen asserts that it
was found liable under a state law negligent failure to warn theory because the labeling for its drug, Topamax, did not carry a pregnancy category D designation in late 2007 and early 2008. Janssen argue[s] that [the Andersons'] claim was preempted because (1) federal law precluded Janssen from changing the pregnancy category of Topamax from C to D without prior FDA approval, and, in any event, (2) there was clear evidence that FDA would not have approved a change to the pregnancy category at that time.Brief of Appellant, at 23.
Janssen correctly points out that the Andersons have asserted that Topamax should have been labeled as a Category D drug at the time Kelly conceived. However, prior to trial, the court issued an order declaring that Janssen did not have the ability to unilaterally change the pregnancy category from C to D, and the jury was instructed as such multiple times during trial. See N.T. Trial, 2/11/14 p.m., at 48; N.T. Trial, 3/4/14 p.m., at 106-07. Thus, the jury's determination that Janssen is liable for its failure to warn was not predicated upon Janssen failing to change Topamax's pregnancy category from C to D. See Ferguson v. Morton , 84 A.3d 715, 725 (Pa. Super. 2013) ("Jurors are presumed to obey the court's instructions.").
Janssen argues that "the lack of pregnancy category D warning in early 2008 was the only alleged 'failure to warn' that [the Andersons'] presented to the jury as a basis for their claim against Janssen." Brief of Appellant, at 27. However, as the trial court noted, "[t]he issue was not whether Janssen could unilaterally change Topamax's pregnancy category, but rather what steps Janssen actually took to make doctors aware of known risks." Trial Court Opinion, 5/4/15, at 14. Evidence was presented to the jury regarding several methods other than changing the pregnancy category by which Janssen could have issued warnings of Topamax's known birth defect risks. One such method would have been to use the FDA's Changes Being Effected "CBE" procedures, which permit drug manufacturers to update and strengthen warnings and safety information without prior FDA approval. See Gurley v. Janssen Pharm., Inc., 113 A.3d 283, 289 (Pa. Super. 2015).
Moreover, Janssen's argument that "impossibility preemption" precludes the failure to warn claim has already been rejected by this Court in Czimmer v. Janssen Pharm., Inc., 122 A.3d 1043 (Pa. Super. 2015). In Czimmer and in the instant case, Janssen makes a nearly identical argument based on PLIVA , Inc. v. Mensing , ___ U.S. ___, 131 S. Ct. 2567 (2011). In Czimmer , this Court stated that
reliance on PLIVA is misguided. PLIVA involved federal preemption of state-law failure to warn claims brought against generic drug manufacturers, and is not applicable to the instant case involving a brand-name drug manufacturer. . . [W]hile a brand-name manufacturer is responsible for the accuracy and adequacy of its label, a generic manufacturer is responsible for ensuring that its warning label is the same as the brand name's label. . . . "It is beyond dispute that the federal statutes and regulations that apply to brand-name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers. . . . [D]ifferent federal statutes and regulations may . . . lead to different preemption results." Thus, we conclude that [Janssen's] argument based on PLIVA is not legally persuasive.Czimmer , supra at 1051 (quoting Gurley v. Janssen Pharm., Inc., supra at 291) (citations omitted).
Janssen's related argument that the FDA would not have approved a change to Topamax's label, relying upon Wyeth v. Levine , 555 U.S. 555 (2009), has also been rejected by this Court:
Upon review, we cannot credit [Janssen's] contention that it presented "clear evidence that the FDA would not have approved a change to [Topamax's] label," to warn of increased risk of cleft lip/palate. [Janssen's] proposed change to the P[atient] P[ackage] I[nsert (PPI)] in 2005 involved a warning regarding a minor malformation in the genitalia of some newborns born to mothers taking Topamax; it did not address increased risk of cleft lip/palate. Further, [Janssen's] proposed change in 2005 was to the PPI, directed at patients, and not to the Topamax label, directed at prescribers. Therefore, we conclude that [Janssen] has failed to establish federal preemption of Appellees' state failure to warn claim under Wyeth.Czimmer , supra at 1052 (quoting Gurley , supra at 291-92) (citations and footnote omitted).
For the foregoing reasons, and as Judge Djerassi aptly discusses in his opinion, we conclude that Janssen's preemption arguments based upon PLIVA and Wyeth do not merit relief.
In its second issue, Janssen claims that the Andersons' failure to warn claim is precluded because Kelly's prescribing physician knew, at the time she prescribed Topamax, of the potential risk of birth defects as a result of taking the drug during pregnancy. Indeed, Dr. Purath testified that she "could not state that there could not be some birth defects from [Topamax]." N.T. Trial, 2/21/14 p.m., at 42. However, Janssen's argument that this demonstrates that Dr. Purath was adequately warned regarding the risks is not persuasive.
Dr. Purath's statement acknowledges that she was aware of the potential risk of birth defects, which is consistent with the Category C label Topamax had at the relevant time. Janssen's argument fails to differentiate between the non-specific, potential risk that Topamax's Category C label implied and a known risk in which the drug has been scientifically established to cause particular birth defects. As Judge Djerassi's opinion details, the latter category applies in this matter. The evidence presented at trial indicated that Janssen knew of a causal relationship between Topamax and specific birth defects, including cleft palate, but failed to disseminate the information so that Kelly's physicians would be adequately warned.
Janssen takes the position that Kelly's physicians would not have allowed her to continue to take Topamax only if Topamax were labeled as a Category D drug. However, this argument is unavailing, because the record supports that neither Dr. Purath nor Dr. Seldera would have allowed Kelly to remain on Topamax if they had received an adequate warning through other channels, such as the FDA's CBE procedures or other publications. Dr. Purath testified that if Topamax had been classified as a Category D drug when Kelly conceived, she would not have continued to prescribe it to Kelly, and that medical literature that could have alerted her to evidence of birth defects in humans caused by Topamax did not contain any warnings regarding the risk of cleft palate. Together, this testimony provides the implication that if Dr. Purath had been made aware of the evidence that Topamax causes birth defects in humans (the basis for a Category D classification), she would have treated the drug as she would a Category D drug and would not have prescribed it to Kelly. See N.T. Trial, 2/21/14 p.m., at 20-21, 25. Dr. Seldera testified to taking a similar approach as Dr. Purath and being highly concerned with the risks a medication poses for pregnant women. See N.T. Trial, 2/19/14 p.m., at 78-82.
Next, Janssen claims that the trial court erred by refusing to instruct the jury on comparative negligence and by refusing to ask the jury to apportion fault between Kelly and Janssen. According to Janssen, Kelly is at least partially at fault for Payton's birth defects because she decided to continue to take Topamax during her pregnancy. We disagree.
Janssen cites to case law regarding the apportioning of negligence, which provides that
[o]nly one question must be affirmatively answered by the trial judge before submitting a negligence question to the jury: Is there evidence of conduct which, if believed by the jury, would constitute negligence on the part of the person or other legal entity inquired about. . . . [T]he apportionment must include all whose negligence may have contributed to the arising of the cause of action.Connar v. W. Shore Equip. of Milwaukee , Inc., 227 N.W.2d 660, 662 (Wis. 1975).
Here, Janssen's focus on Kelly's actions as a patient is misplaced, because the cause of action in this matter involves the learned intermediary doctrine. Under the learned intermediary doctrine, the pharmaceutical company's duty to warn flows exclusively to the prescribing physician. See Menges v. Depuy Motech , Inc., 61 F. Supp. 2d 817, 830 (N.D. Ind. 1999) (applying Wisconsin law, stating that "under the Learned Intermediary Doctrine, manufacturers of prescription medical products have a duty only to warn physicians, rather than patients, of the risks associated with the use of the product"). Thus, the cause of action involves no duty on the patient's part, and Kelly's choice to take Topamax when prescribed could not have "contributed to the arising of the failure to warn cause of action." Connar , supra at 662.
Moreover, as Judge Djerassi's opinion thoroughly discusses, a court would apply contributory negligence principles to a patient only in extraordinary circumstances. Wisconsin courts have not done so where the patient followed a doctor's prescription. See Brown v. Dibell , 595 N.W.2d 358, 370 (Wis. 1999) (patient not contributorily negligent for deciding to follow viable but risky treatment). Here, the record indicates that Kelly's doctors would have preferred that she stop taking Topamax. However, the drug's Category C label, without additional warnings, made it appear to be a "viable but risky" treatment. Thus, Dr. Purath continued to prescribe Topamax, and Kelly took the drug as directed in the prescription. Therefore, we find that the trial court did not err in not providing a comparative negligence instruction to the jury or asking the jury to apportion fault between Kelly and Janssen.
Janssen argues that Kelly was a non-compliant patient because she did not want to stop taking Topamax. Additionally, Dr. Seldera testified that Kelly was "not very compliant" in the sense that "sometimes we tell her to come in. She doesn't come into the office. If she calls us and complains of anything, we tell her to come in, but she doesn't." N.T. Trial, 2/19/14 p.m., at 124. However, the record reveals that Kelly was primarily a compliant patient, taking her prescriptions as directed. See N.T. Trial, 2/21/14 p.m., at 26; N.T. Trial 2/24/14 p.m, at 29-34. Kelly's physician chose to continue to prescribe Topamax as a treatment with potential risks, and Kelly took the medication in a compliant manner. Thus, Janssen's argument that Kelly was non-compliant with regard to continuing her Topamax prescription is without merit and fails to demonstrate that she was contributorily negligent in this matter.
Finally, Janssen asserts that the trial court erred in affirming the jury's award of future medical expenses because the amount was allegedly more than three times the amount supported by the evidence. We find this argument to be without merit.
We note that
[o]ur standard of review from the denial of a remittitur is circumspect and judicial reduction of a jury award is appropriate only when the award is plainly excessive and exorbitant. The question is whether the award of damages falls within the uncertain limits of fair and reasonable compensation or whether the verdict so shocks the sense of justice as to suggest that the jury was influenced by partiality, prejudice, mistake, or corruption. Furthermore, [t]he decision to grant or deny remittitur is within the sole discretion of the trial court, and proper appellate review dictates this Court reverse such an [o]rder only if the trial court abused its discretion or committed an error of law in evaluating a party's request for remittitur.Gurley , supra at 294 (citation omitted).
The Andersons argue that Wisconsin law should apply to our consideration of whether remittitur was appropriately denied, and that because Janssen argues the issue based upon Pennsylvania law, the claim should be waived. We note, however, that the Andersons did not raise this issue in their response to Janssen's post-trial motion for remittitur and, in fact, argued the motion using Pennsylvania law. Thus, the Andersons are precluded from raising the issue at this stage of the proceedings. See Pa.R.A.P. 302(a) ("Issues not raised in the lower court are waived and cannot be raised for the first time on appeal."); see also Discount Drug Corp. v. Honeywell Protection Services , Div. of Honeywell , Inc., 450 A.2d 49, 50 (Pa. Super. 1982) (where "choice of law is not an issue properly presented for our consideration, we cannot discuss this issue sua sponte"). Thus, we rely upon Pennsylvania law in our analysis.
Here, Janssen argues that because the award for Payton's future medical expenses exceeded the amount calculated by the Andersons' damages expert, it must be excessive. In making this argument, Janssen cites to Ferrer v. Trustees of Univ. of Pennsylvania , 825 A.2d 591, 611-12 (Pa. 2002). In Ferrer , our Supreme Court determined that the plaintiff's expert witness effectively established an outside boundary of $2,900,000 for the value of the plaintiff's loss and reduced the award from $5,000,000 to $2,900,000. Upon review of the record, we find that Ferrer is distinguishable from the instant matter.
Valerie Parisi, RN, testified as the Andersons' damages expert. She calculated a care plan for Payton totaling $447,324, which included various therapies, evaluations, counseling, antibiotics, and procedures. The plan included medical expenses until Payton turned 18, plus some medical care beyond 18. While Parisi indicated that her estimate included those procedures that would be necessary to a "certain degree of likelihood," she also acknowledged that "there may be more procedures even than what's been allocated." Thus, Parisi's estimate does not represent an "outside limit" as was determined to be the case in Ferrer.
The jury also heard evidence that Payton's oral clefts are severe in nature and have been resistant to repair. This has caused fistulas to develop between the nose and palate that have required additional surgeries. Repeated procedures have been required to repair fistulas on multiple occasions. Payton's particular case has been complication-prone, which is not specifically addressed in the life care plan Parisi developed for Payton. As the trial court opinion details, Payton's severe clefts, combined with her recurring ear infections, speech problems, and need for at least two major jaw surgeries indicate that the verdict is by no means shocking. Gurley , supra. Thus, the trial court did not abuse its discretion in denying remittitur in this matter.
We affirm based upon Judge Djerassi's opinion filed May 4, 2015, and we direct the parties to attach a copy of the opinions in the event of further proceedings.
Order affirmed. Judgment Entered. /s/_________
Joseph D. Seletyn, Esq.
Prothonotary Date: 5/11/2016
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