J.C. v. Pfizer, Inc.

• Decision Date: 15 May 2018
• Docket Number: No. 17-0282,17-0282
• Citation: 814 S.E.2d 234
• Court: West Virginia Supreme Court
• Parties: J.C., a Minor BY AND THROUGH his Mother and Next Friend, MICHELLE C., and I.H., a Minor by and through her Mother and Next Friend, Angela H., Plaintiffs Below, Petitioners v. PFIZER, INC., Roerig, a Division of Pfizer, Inc., and Greenstone, LLC f/k/a Greenstone, Ltd., Defendants Below, Respondents

814 S.E.2d 234

J.C., a Minor BY AND THROUGH his Mother and Next Friend, MICHELLE C., and I.H., a Minor by and through her Mother and Next Friend, Angela H., Plaintiffs Below, Petitioners

v.PFIZER, INC., Roerig, a Division of Pfizer, Inc., and Greenstone, LLC f/k/a Greenstone, Ltd., Defendants Below, Respondents

No. 17-0282

Supreme Court of Appeals of West Virginia.

Submitted: March 6, 2018

Filed: May 15, 2018

Benjamin L. Bailey, Esq., Counsel of Record, Ryan McCune Donovan, Esq., J. Zak Ritchie, Esq., Bailey & Glasser LLP, Charleston, West Virginia, Counsel for Petitioners

Michael J. Farrell, Esq., Counsel of Record, Erik W. Legg, Esq., Megan E. Farrell, Esq., Farrell, White & Legg PLLC, Huntington, West Virginia, Counsel for Respondents

LOUGHRY, Justice:

The petitioners (plaintiffs below), J.C., a minor by and through his mother and next friend Michelle C., and I.H., a minor by and through her mother and next friend, Angela H., appeal the order of the Mass Litigation Panel ("Panel") entered on February 15, 2017, through which summary judgment was granted in favor of the respondents (defendants below), Pfizer, Inc., Roerig, a division of Pfizer, Inc., and Greenstone, LLC f/k/a Greenstone, Ltd. (collectively "Pfizer"). The petitioners assert that the Panel’s decision was erroneously based on the absence of expert testimony to support their claims that Pfizer failed to adequately warn of the risks of a prescription medication. The petitioners further assert that even if expert testimony were required, summary judgment was erroneous because Pfizer’s experts could supply the necessary testimony. Upon our review of the parties’ briefs, the arguments of counsel, the appendix record submitted, and the applicable law, we affirm the Panel’s summary judgment ruling.

I. Facts and Procedural Background

This litigation commenced on July 11, 2012, when a complaint alleging products liability and negligence claims was filed by several unrelated mothers on behalf of their respective minor children. The petitioners alleged that the children had suffered birth defects

that were proximately caused by their mothers’ ingestion of the drug sertraline hydrochloride (brand-name "Zoloft") while they were pregnant.¹ Zoloft is a prescription antidepressant manufactured and marketed by Pfizer.²

In seeking to recover damages, the petitioners alleged that Pfizer failed to adequately warn of the risks of birth defects

from the use of Zoloft while pregnant and that adequate warnings would have prevented their injuries. The petitioners do not dispute that the federal Food & Drug Administration ("FDA")³ has evaluated the safety of Zoloft for decades and that it remains approved as safe and effective.⁴

FDA regulations require prescription medicine manufacturers to include one of five warnings in a drug’s label which reflect the potential of a drug to cause birth defects

if used during pregnancy.⁵ Based upon information supplied by Pfizer,⁶ the FDA determined that Zoloft should carry a Category C warning, which is required when animal studies show some risk in use of the drug during pregnancy; when there are no adequate, well-controlled studies in humans; and when the potential benefits of use during pregnancy may outweigh the potential risks. In 2003, when the petitioner mothers took Zoloft, the label stated:

Pregnancy—Pregnancy Category C—Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to approximately 4 times the maximum recommended human dose (MRHD) on a mg/m2 basis. There was no evidence of teratogenicity

at any dose level.^[7

^] When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0.5 times the MRHD on a mg/m2 basis) in rats and 40 mg/kg (4 times the MRHD on a mg/m2 basis) in rabbits. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in the number of stillborn pups and in the number of pups dying during the first 4 days after birth. Pup body weights were also decreased during the first four days after birth. These effects occurred at a dose of 20 mg/kg (1 times the MRHD on a mg/m2 basis). The no effect dose for rat pup mortality was 10 mg/kg (0.5 times the MRHD on a mg/m2 basis). The decrease in pup survival was shown to be due to in utero exposure to sertraline. The clinical significance of these effects is unknown. There are no adequate and well-controlled studies

in pregnant women. ZOLOFT

(sertraline hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pfizer also included in the Zoloft

label that patients should "notify their physician if they become pregnant or intend to become pregnant during therapy."⁸

The petitioners alleged that Pfizer negligently failed to adequately warn them of the risk of birth defects

through the ingestion of Zoloft during pregnancy.⁹ In their expert witness disclosure filed on March 16, 2016, the petitioners designated Adam C. Urato, M.D., as their expert on the adequacy of the Zoloft label in 2003, specifically as it related to the use of Zoloft during pregnancy. The petitioners disclosed that Dr. Urato would offer opinions concerning the label to "a reasonable degree of medical and scientific certainty, as an expert in Maternal-Fetal Medicine and based on his education, training, experience, review of the relevant literature, and specialized knowledge[.]"¹⁰

Although Dr. Urato was scheduled for deposition on June 13, 2016, he became unavailable due to unspecified health reasons. Dr. Urato’s unavailability prompted Pfizer to file a motion to exclude him from testifying as an expert witness in this matter. The petitioners opposed the motion, arguing that their labeling expert was a critical witness and their "key liability expert" without whom they would be severely prejudiced. The petitioners asserted that Dr. Urato was

an extremely well qualified and important liability witness for Plaintiffs. He has produced a 46[-]page expert report that explains his opinions, and the bases for his opinions, in great detail. He has done a great deal of work on this case in connection with his expert report and to form the opinions stated therein.

The petitioners advised the Panel that should Dr. Urato’s medical situation prevent him from testifying, they would "seek to designate a new expert in his place, considering the importance of the liability topics on which he is designated to opine[.]"

During an August 8, 2016, hearing, the petitioners’ counsel reiterated that "Doctor Urato is a key liability expert of ours. ... We also want a trial to go forward with our key liability expert. We shouldn’t be hamstrung and not have our key liability expert."¹¹ Although the Panel ordered that Dr. Urato’s deposition be taken no later than August 29, 2016, the petitioners remained unable to produce him for deposition. Thereafter, the petitioners filed a motion seeking leave to designate a replacement expert, again describing Dr. Urato as their key liability expert without whom the plaintiffs would be prejudiced. In response, the Panel ordered the petitioners’ counsel to file under seal, no later than September 7, 2016, an affidavit from Dr. Urato’s treating physician that contained, inter alia , a medical diagnosis for Dr. Urato and an affirmation that he was not medically able to sit for deposition. By letter dated September 7, 2016, the petitioners’ counsel advised the Panel that "we have had very limited contact with Dr. Urato and he has not supplied us with the affidavit from his treating doctor."

Through its September 9, 2016, order, the Panel found that the petitioners’ counsel were aware, no later than June 9, 2016, that Dr. Urato was unable to be deposed, and that counsel had failed to either make Dr. Urato available for deposition on August 29, 2016, or submit an affidavit from Dr. Urato’s treating physician, as previously ordered. Determining that good cause had been shown, the Panel granted Pfizer’s motion to exclude Dr. Urato as an expert in these cases "due to his inability to appear for deposition in these cases now or anytime in the foreseeable future." The Panel further found that although the petitioners’ counsel had "failed to ascertain Dr. Urato’s medical condition, determine whether Dr. Urato was able to testify in these cases, and request a replacement in a timely manner[,]" it "would be unfair to punish the litigants for their counsel’s lack of diligence." Accordingly, the Panel granted the petitioners’ motion for leave to designate a replacement expert and ordered that the replacement expert be designated no later than September 16, 2016.

In compliance with the Panel’s deadline, the petitioners filed a supplemental disclosure of experts in which they identified David A. Kessler, M.D., as their expert on failure to warn issues. Dr. Kessler is a nationally known expert and former Commissioner of the FDA.¹² Dr. Kessler’s deposition was noticed for November 17, 2016. The petitioners filed a motion seeking to limit Dr. Kessler’s deposition to no more than three hours, asserting that Pfizer was well aware of his opinions. They referenced Dr. Kessler’s 116-page report detailing his opinions and his deposition that was taken in 2015 in a federal Zoloft

multi-district litigation case—MDL No. 2342. See

In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation , 26 F.Supp.3d 449, 452 (E.D. Pa. 2014) (granting motion to exclude expert witness). The petitioners stated that

Dr. Kessler has been designated to testify regarding whether Pfizer adequately warned about the risks associated with exposure to Zoloft

, including the adequacy of its Zoloft labeling .... Dr. Kessler is also expected to provide testimony regarding the specific regulatory procedures and regulations with which pharmaceutical...