Opinion
DOCKET NO. A-4481-12T1
05-02-2017
ANDREW McCARRELL, Plaintiff-Respondent, v. HOFFMANN-LA ROCHE, INC., and ROCHE LABORATORIES, INC., Defendants-Appellants.
Gibbons P.C., Dughi Hewit & Domalewski, P.C., and Michael X. Imbroscio and Paul W. Schmidt (Covington & Burling L.L.P.) of the District of Columbia bar, admitted pro hac vice, attorneys for appellant (Natalie H. Mantell, Russell L. Hewit, Mr. Imbroscio and Mr. Schmidt, of counsel and on the brief). Seeger Weiss LLP, Mary Jane Bass (Beggs & Lane) of the Florida bar, admitted pro hac vice, and Michael D. Hook (Hook & Bolton, P.A.) of the Florida bar, admitted pro hac vice, attorneys for respondent (David R. Buchanan, Ms. Bass, and Mr. Hook, on the brief).
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
This opinion shall not "constitute precedent or be binding upon any court." Although it is posted on the internet, this opinion is binding only on the parties in the case and its use in other cases is limited. R.1:36-3. Before Judges Sabatino, Simonelli, and Leone. On appeal from the Superior Court of New Jersey, Law Division, Atlantic County, Docket No. L-1951-03. Gibbons P.C., Dughi Hewit & Domalewski, P.C., and Michael X. Imbroscio and Paul W. Schmidt (Covington & Burling L.L.P.) of the District of Columbia bar, admitted pro hac vice, attorneys for appellant (Natalie H. Mantell, Russell L. Hewit, Mr. Imbroscio and Mr. Schmidt, of counsel and on the brief). Seeger Weiss LLP, Mary Jane Bass (Beggs & Lane) of the Florida bar, admitted pro hac vice, and Michael D. Hook (Hook & Bolton, P.A.) of the Florida bar, admitted pro hac vice, attorneys for respondent (David R. Buchanan, Ms. Bass, and Mr. Hook, on the brief). PER CURIAM
This matter returns to this court upon a remand from the Supreme Court, directing that we address remaining issues that were not decided in our prior unpublished opinion from August 2015. See McCarrell v. Hoffman-La Roche, Inc., 227 N.J. 569 (2017) ("McCarrell III"), rev.'g and remanding No. A-4481-12 (App. Div. Aug. 11, 2015) ("McCarrell II").
We incorporate by reference the factual and procedural history of this case, as set forth in detail in the Supreme Court's opinion, see 227 N.J. at 575-81, and this court's two prior unpublished opinions. See McCarrell II, supra; see also McCarrell v. Hoffman-LaRoche, Inc., No. A-3280-07 (App. Div. Mar. 12, 2009) ("McCarrell I"), certif. denied, 199 N.J. 518 (2009). By way of brief overview, plaintiff, an Alabama resident, was prescribed by his dermatologist the acne medication Accutane, a drug manufactured by defendants. After his course of treatment with the drug, plaintiff developed inflammatory bowel disease ("IBD") and other gastrointestinal disorders. Eventually his colon and rectum were surgically removed, and he underwent years of treatment.
Plaintiff filed suit in the Law Division against defendants, alleging that Accutane is a defective product and that the defect proximately caused his injuries. In particular, plaintiff claimed that defendants' labeling and marketing of the drug was inadequate and failed to warn sufficiently of the risks of a patient contracting IBD. Along with other arguments, defendants countered that the Accutane label and other product warnings were adequate as a matter of law, that plaintiff cannot show proximate causation, and that plaintiff's lawsuit was time-barred under the Alabama statute of limitations. The trial court rejected the statute of limitations defense and other legal defenses, and allowed plaintiff's claims to go to trial before a jury. The case was tried twice, first in 2007 and once again on remand in 2010.
In the first trial, the jury found that plaintiff had established defendants' liability and awarded damages. On appeal, this court set aside that verdict because of erroneous evidentiary rulings not pertinent here, but rejected other arguments raised by defendants. McCarrell I, supra, (slip op. at 44-113). The matter was remanded for a new trial. The Supreme Court denied a petition for certification filed by defendants. 199 N.J. 518 (2009).
In the second trial, which is the subject of the present appeal, a jury again found defendants liable but awarded a much larger damages award. Defendants appealed, raising several arguments, including a contention that plaintiff's claims were time-barred under Alabama's statute of limitations. We agreed with that contention, and consequently reversed the verdict and ordered the entry of judgment for defendants on those statute-of-limitations grounds. McCarrell II, supra, (slip op. at 28-49). Plaintiff petitioned for certification, and the Supreme Court reversed, finding under choice-of-law principles that New Jersey's statute of limitations applies to this case rather than Alabama's statute of limitations. McCarrell III, supra, 227 N.J. at 580-99. Applying New Jersey law on that issue, the Court concluded that plaintiff's complaint was timely. Id. at 599.
The Court remanded the case to this court "for consideration of the unaddressed issues remaining on appeal." Id. at 600. Those issues, concisely stated, are whether (1) the trial court committed reversible error in limiting the number of expert witnesses; (2) the court erred under Alabama law in allowing plaintiff's claims of proximate causation to be considered by the jury and gave confusing instructions on the issue; and (3) the court erred in denying defendants' motion for a new trial or, in the alternative, for a remittitur. Thereafter, we considered supplemental briefs from the parties addressing those issues more fully, particularly in light of case law developments since the time that the appeal was briefed and argued in 2015.
For the reasons that follow, we reverse and remand this matter for a new trial.
We first address the expert limitation issue. Prior to the 2010 trial, the trial court instructed counsel that it would not allow duplicative expert testimony. In particular, the court limited the number of expert witnesses the parties could call with duplicative opinions about causation issues, confining the parties to a general causation expert and a specific causation expert. The judge allowed the parties to call an expert witness on epidemiology, but barred more than one expert from each party testifying duplicatively as to the merits of published epidemiological studies.
The parties quibble over whether this limitation, which did permit, in the judge's words, "tiny overlap," was provoked by an application by plaintiff or by defendants. Our review of the record shows that the limitation was first imposed by way of general guidance in ruling on a pretrial motion in limine filed by plaintiff, and that defendants subsequently, with that guidance, moved to restrict duplicative testimony from one of plaintiff's own experts.
The trial court imposed similar restrictions on the number of expert witnesses in another Accutane trial in Rossitto v. Hoffman-LaRoche, Inc., Nos. A-1236-13 and A-1237-13 (App. Div. July 22, 2016) (slip op. at 48-51). That evidential restriction became a basis for this court's reversal of the verdict for plaintiffs in those cases, and a remand for a new trial. Id. at 51. The Supreme Court denied the petition for certification filed by those plaintiffs. ___ N.J. ___ (2016).
As a result of the court's limitations, defendants lacked the ability to have both their expert epidemiologist, Dr. Lisa J. Herrington, and their expert gastroenterologist, Dr. Lloyd Mayer, present shared opinions on the disputed studies. Consequently, defendants only presented testimony from their gastroenterology expert about the studies.
During closing argument, plaintiff's counsel capitalized on defendant's presentation of only one expert who addressed the published studies. Counsel presented to the jury a demonstrative slide listing the "people with whom [defendant's testifying gastroenterologist Dr. Mayer] disagrees." That listing was primarily composed of authors of various published articles. Defendants argues that, had they been permitted to present two experts (i.e., both a gastroenterologist and an epidemiologist) to present shared opinions about the significance of the studies, plaintiff's summation would have been significantly less powerful because the additional testifying defense expert would have offset plaintiff's listing of experts who "disagree."
After this second trial and the verdict for plaintiff, this court issued its precedential opinion in McLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013). In McLean, we held that trial courts should not prohibit overlapping expert testimony in complex matters on a "central issue of liability." Id. at 168.
Here, as we similarly found in Rossitto, supra, (slip op. at 48-51), the trial court's decision to disallow overlapping expert testimony about the scientific studies relating to causation was error. The significance of those studies was a "central issue" in this hard-fought case.
We also do not regard the court's limitation to be harmless, given the tenor and nature of plaintiff's summation that attempted to portray defendants' sole expert who testified on the subject as, in essence, a lone outlier. See also State v. Ross, 249 N.J. Super. 246, 250 (App. Div.) (finding harmful and reversible error arose where counsel took advantage in summation of an evidentiary restriction by presenting arguments about proofs that opposing counsel was "precluded from adducing"), certif. denied, 126 N.J. 389 (1991). We conclude that a new trial is required, at which no such expert limitation is imposed.
We recognize that in Rossitto we did not reach whether the expert limitation alone would suffice to compel a new trial. Here, there is a sufficient basis to discern enough independent prejudice to order a new trial because of the limitation in the specific context presented.
The second issue raised by defendants concerning Alabama law on proximate causation provides a separate basis for a remand. Following this 2010 trial, the Alabama Supreme Court issued an opinion in Wyeth, Inc. v. Weeks ("Weeks"), 159 So. 3d 649, 673 (Ala. 2014), which provides some, if not comprehensive, guidance on Alabama law of proximate causation in the context of the "learned intermediary" doctrine. Under that doctrine, a drug manufacturer's duty to warn a patient about the dangers of using the drug "is limited to an obligation to advise the prescribing physician." Stone v. Smith, Kline & French Labs, 447 So. 2d 1301, 1305 (Ala. 1984). "Generally, the question of whether proximate cause exists is one for the jury; however, when the facts are such that all reasonable men must draw the same conclusion, the question of proximate cause then becomes one for the courts." Thompson v. Gaier, 512 So. 2d 775, 776 (Ala. 1987).
In Weeks, answering a question certified to it by the federal court, the Supreme Court of Alabama considered whether the defendant, a "brand-name" prescription drug manufacturer, owed a duty to warn of product risks to a plaintiff who took a generic version of the drug made by a different manufacturer. Elaborating on Alabama's version of the learned intermediary doctrine, the Court stated:
A prescription-drug manufacturer fulfills its duty to warn the ultimate users of the risks of its product by providing adequate warnings to the learned intermediaries who prescribe the drug. Once that duty is fulfilled, the
manufacturer has no further duty to warn the patient directly. However, if the warning to the learned intermediary is inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustained by the patient. The patient must show that the manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient's injury. In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient.The Court in Weeks did not decide the merits of the underlying case applying these principles. Id. at 677 n.11. Instead, it left it to a jury to determine if the warnings on the manufacturer's label were accurate or whether the plaintiff's physician did not rely on the warnings on the label authored by the brand-name manufacturer when prescribing the drug's generic version. Ibid.
[Id. at 673-74 (emphasis added).]
No published Alabama state court decisions have yet applied these principles from Weeks. Several federal district court opinions have done so, but have rendered somewhat mixed interpretations. We need not catalog those federal opinions here, except to note that one of them, in concluding that a plaintiff had failed to establish proximate cause, specifically noted that the treating physician's testimony was "unambiguous that an earlier warning would not have affected his decision to prescribe the drug." Garrison v. Novartis Pharms. Corp., 30 F. Supp. 3d 1325, 1337 (M.D. Ala. 2014).
We note that language concerning the strength of the proofs concerning a prescriber's decision-making has some parallels to New Jersey law on the subject. See Strumph v. Schering Corp., 256 N.J. Super. 309, 323-28 (App. Div. 1992) (Skillman, J., dissenting) (concluding that "a defendant drug manufacturer may not be held liable for an alleged inadequate warning where the only evidence on the issue of causation is the prescribing doctor's unequivocal testimony that his or her decision to prescribe the drug was not affected by the warning") (emphasis added), rev'd on dissent, 133 N.J. 33 (1993). That facet of Strumph was relied upon by this court in Rossitto, supra, (slip op. at 59-62), in upholding the trial court's decision to send the proximate causation issue to the jury.
Here, plaintiff's prescribing dermatologist, Dr. Ann Gerald, was questioned at her videotaped deposition in 2007, eight years before the Alabama Supreme Court's 2013 opinion in Weeks. Unfortunately, neither defendants' counsel on direct examination or plaintiff's counsel on cross-examination at that deposition, which was played for the jury, ever posed to Dr. Gerald the "linchpin" question set forth in Weeks, i.e., whether the doctor's decision to prescribe Accutane would have been different if the drug had come with a stronger warning. The doctor was not asked whether, and did not unambiguously testify that, she would have prescribed Accutane to plaintiff even if she knew that the drug, as plaintiff alleges, may cause IBD and has a latency effect. The doctor did testify that she understood from reading the warnings that Accutane was only "temporally associated" with IBD, which meant to her that the side effects only occurred during Accutane use. She also testified that if the label had warned that Accutane could cause IBD, she "[p]ossibly" would have conveyed that warning to a patient, but "certainly" would have considered that risk in making a risk/benefit analysis.
Given this important factual gap in the record made significant by ensuing Alabama precedent, this matter should be remanded to enable the record to be appropriately developed on this critical issue. See Lozano v. Frank DeLuca Constr., 178 N.J. 513, 536 (2004) (remanding a worker's compensation case to develop a gap in the record in light of the Court's interpretation of N.J.S.A. 34:15-7); Quinlan v. Curtiss-Wright Corp., 425 N.J. Super. 335, 342 (App. Div. 2012) (affirming liability but remanding for a new trial on damages in light of the Supreme Court's guidance on the burden of proof concerning mitigation); Sholtis v. Am. Cyanamid Co., 238 N.J. Super. 8, 29-30 (App. Div. 1989) (giving both parties "a brief opportunity to supplement their proofs directed to" the court's new interpretation of a manufacturer's liability for toxic asbestos exposure).
Assuming Dr. Gerald is still available, the parties should have the opportunity to re-depose her and obtain her sworn responses on the central prescribing question set forth in Weeks. The trial court shall exercise its discretion in overseeing that deposition and any other additional discovery or proceedings that may be warranted. Pending that remand, we do not resolve here whether, under current Alabama law, which side has the burden on the prescribing question and whether or not the proof on the subject needs to be "unambiguous" or "unequivocal."
The trial court, of course, did not have the guidance provided by Weeks when it allowed the proximate causation issue to go to the jury. --------
Because of our determination that this matter must be remanded on other grounds, it is not essential to reach the remittitur issue, but we do so for sake of completeness in light of the Supreme Court's remand directive. The trial judge applied the then-existing standards of New Jersey law set forth in Ming Yu He v. Miller, 207 N.J. 230 (2011), in concluding that the jury's award in the second trial was not manifestly excessive, relying in part on her personal knowledge of other verdicts in Accutane cases. In the meantime, our Supreme Court had disapproved of that comparative verdict approach, replacing it with a standard that evaluates whether the award "shocks the judicial conscience." Cuevas v. Wentworth Corp., 226 N.J. 480, 509 (2016). When performing that assessment, "a thorough analysis of the case itself; of the witnesses' testimony; of the nature, extent, and duration of the plaintiff's injuries; and of the impact of those injuries on the plaintiff's life will yield the best record on which to decide a remittitur motion." Id. at 510.
Here, the judge who tried this case is now deceased and, in any event, was not serving in the trial court when she passed away. There is no point in remanding the remittitur issue to be reconsidered under Cuevas to the trial judge currently overseeing the Accutane docket. Faced with these constraints, we simply note that, although the plaintiff's verdict in the second trial was very large, defendants have not met their burden of demonstrating that it "shocks the judicial conscience." The evidence reasonably supported plaintiff's contentions that he endured years of pain and suffering from his IBD condition, with multiple surgeries including the removal of his colon and rectum. He testified that, as of the time of the second trial, he still was experiencing incontinence and was having on average eight to sixteen bowel movements each day. The fact that the first jury issued a significantly lower verdict several years earlier, before plaintiff's symptoms continued for three more years until the second trial, is not dispositive of the excessiveness issue and, in fact, suggests a comparison of verdicts not authorized under Cuevas.
Any other points raised lack sufficient merit to warrant discussion. R. 2:11-3(e)(1)(E).
Reversed and remanded. I hereby certify that the foregoing is a true copy of the original on file in my office.
CLERK OF THE APPELLATE DIVISION