Terry v. McNeil-PPC, Inc. (In re Tylenol (Acetaminophen) Mktg., Sales Practices & Prods. Liab. Litig.)

• Decision Date: 19 April 2016
• Docket Number: MDL NO. 2436,2:13-md-02436,Civil Action No. 2:12-cv-07263
• Citation: 181 F.Supp.3d 278
• Parties: In re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation. This Document Relates to: Rana Terry, as Personal Representative and Administrator of the Estate of Denice Hayes, Deceased, Plaintiff, v. McNEIL-PPC, Inc., McNeil Consumer Healthcare, and Johnson & Johnson, Inc., Defendants.
• Court: U.S. District Court — Eastern District of Pennsylvania

181 F.Supp.3d 278

In re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation.

This Document Relates to:

Rana Terry, as Personal Representative and Administrator of the Estate of Denice Hayes, Deceased, Plaintiff,

v.McNEIL-PPC, Inc., McNeil Consumer Healthcare, and Johnson & Johnson, Inc., Defendants.

MDL NO. 2436

2:13-md-02436

Civil Action No. 2:12-cv-07263

United States District Court, E.D. Pennsylvania.

Singed April 19, 2016

MEMORANDUM

Stengel, District Judge

This case is part of a Multidistrict Litigation (MDL) involving claims of liver damage from the use of Tylenol

at or just above the recommended dosage.¹ This is the first "bellwether" scheduled for trial.²

The defendants have filed eighteen motions in limine. My rulings on each motion are explained below.

I. Evidentiary Standards

Several of the defendants' motions in limine involve arguments about the relevancy or prejudicial effect of certain evidence under Federal Rules of Evidence 401 and 403. "A district court is accorded a wide discretion in determining the admissibility of evidence under the Federal Rules." Sprint v. Mendelsohn, 552 U.S. 379, 384, 128 S.Ct. 1140, 170 L.Ed.2d 1 (2008) (quoting U.S. v. Abel, 469 U.S. 45, 54, 105 S.Ct. 465, 83 L.Ed.2d 450 (1984) ). See also Moyer v. United Dominion Indus., 473 F.3d 532, 542 (3d Cir.2007) (citation omitted). "Assessing the probative value of [the proffered evidence], and weighing any factors counseling against admissibility is a matter first for the district court's sound judgment under Rules 401 and 403...." Id.

Context is important to questions involving Rules 401 and 403. Luce v. U.S., 469 U.S. 38, 41, 105 S.Ct. 460, 83 L.Ed.2d 443 (1984) ("A reviewing court is handicapped in any effort to rule on subtle evidentiary questions outside a factual context."). To be admissible, evidence must be relevant. FED. R. EVID . 402. Relevant evidence is evidence having any tendency to make a fact of consequence in determining the action more or less probable than it would be without the evidence. FED. R. EVID . 401.

Under Rule 403, relevant evidence may be excluded "if its probative value is substantially outweighed by a danger of one or more of the following: unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence." FED. R. EVID . 403.

1. Defendants' Motion In Limine to Exclude Evidence of, or Reference to, Adverse Event Reports (MIL 1)

The defendants move to exclude evidence of, or reference to, adverse event reports (AERs). The defendants claim they are "irrelevant, unreliable, and unsubstantiated anecdotes."

Under FDA regulations, manufacturers are required to create an AER in their safety surveillance database whenever they receive information that a person taking their drug has experienced an adverse event. 21 C.F.R. § 314.80. AERs are created on a standard form and may be submitted alone or accompanied by few or dozens of pages of supporting medical records. See Office of Epidemiology and Biostatistics, Food and Drug Administration, Annual Adverse Drug Experience Report: 1996 (Oct. 30, 1997), at 2 (Doc. No. 61, Ex. A). AERs are prepared by an employee of a pharmaceutical manufacturer based either on telephone conversations with a third party or other correspondence received by the manufacturer. AERs are drawn from a variety of sources: patients, their family members, physicians, or even civil complaints. See, e.g., In re Carter-Wallace, Inc. Sec. Litig., 220 F.3d 36, 40 (2d Cir. 2000) ("Drug manufacturers receive these reports from several sources, including treating physicians.").

Both parties recognize that AERs have limitations in terms of their reliability. Because AERs are based on self-reported complaints of adverse events, they may not contain information which can make them a reliable source.³ AERs are not considered to "necessarily reflect a conclusion by the applicant or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse effect." 21 C.F.R. § 314.80(l).

a. Hearsay

First, the defendants argue that AERs would be inadmissible as hearsay: out-of-court statements offered to prove the truth of the matter asserted. See FED. R. EVID . 801. The defendants claim that they are not admissible under any of the hearsay exceptions or exemptions. The plaintiff counters that they would fall within the public records exception or the business records exception to hearsay. See FED. R. EVID . 803(c)(8)(A) ; FED. R. EVID . 803(c)(6). Whether an AER falls within an exception to the hearsay rule will require a more specific inquiry as to each document. It's entirely likely that an AER could be offered for a non-hearsay purpose. If offered for knowledge, or state of mind, and not for its inherent truth, the AER would not be hearsay as to each document. For this reason, I will defer any ruling on the hearsay objection to the AERs.⁴

b. Notice

Even if the AERs are hearsay, the plaintiff argues they are relevant to showing notice. The defendants argue that these AERs are not admissible to show "notice" because they are unreliable. This argument misses the point. An AER is notice of some event or problem. The "reliability" issue is more one of weight than of relevance. Reliable or not, they are notice of some event of significance to this case and that likely takes them out of the hearsay rule.

The purpose of recording AERs is to serve as a warning system or signaling system for drug manufacturers. SeeSoldo v. Sandoz Pharms. Corp., 244 F.Supp.2d 434, 463–64 (W.D.Pa.2003) (quoting Brief Description with Caveats of System, Surveillance and Data Processing Branch of the Division of Epidemiology and Surveillance, Division of Epidemiology & Surveillance, Dec. 1988, at p. 1). Drug manufacturers are expected to report AERs to the FDA, which compiles them into a database. See http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm. AERs are often reviewed by the FDA and its subcommittees to determine if changes to a drug composition or its label need to be made.⁵

Drug manufacturers are expected to take certain steps to ensure their products are safe for consumers. These steps are known as "pharmacovigilance." See Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemioliogic Assessment (2005)(Doc. No. 96, Ex. 3). Reporting AERs to regulatory authorities is at the heart of pharmacovigilance. See E. Kuffner Dep., Mar. 5, 2014 at 8 (Doc. No. 90, Ex. 3)("Reporting—reporting adverse event reports to the regulatory authorities would be my description of pharmacovigilance. I believe that's accurate."); E. Nelson Dep., Nov. 21, 2013 at 62-65, 98-101 (Doc. No. 96, Ex. 4)(confirming how AERs are used in the context of pharmacovigilance). Whether the defendants undertook the appropriate steps to carry out their duty of pharmacovigilance is important to the plaintiff's failure-to-warn and design defect claims.

With all this in mind, AERs would be admissible to show notice. See, e.g., Benedi v. McNeil – P.P.C., Inc., 66 F.3d 1378, 1385–86 (4th Cir.1995) ("[T]he district court did not abuse its discretion in admitting the DERs and case summaries, because the plaintiff offered the evidence solely to prove notice."); In re Gadolinium – Based Contrast Agents Products Liability, 956 F.Supp.2d 809, 815 (N.D.Ohio Jul. 25, 2013), affirmed by Decker v. GE Healthcare Inc., 770 F.3d 378 (6th Cir.2014) (citations omitted); In re Fosamax Prods. Liab. Litig., No. 06 MD 1789(JFK), 2013 WL 174416, at *4 (S.D.N.Y. Jan. 15, 2013) ("Adverse event reports received by Merck until the time of Plaintiff's injury are admissible if used as evidence that Merck was on notice of potentially serious jaw injuries

."); Wolfe v. McNeil–PPC, Inc., No. 07–348, 2012 WL 38694, at *2 (E.D.Pa. Jan. 9, 2012) ("However, reports submitted to the FDA before plaintiff's alleged injury occurred would not be hearsay if offered on the issue of defendants' notice of potential safety risks from the use of Children's Motrin."); Schedin v. Ortho–McNeil–Janssen Pharm., Inc., 808 F.Supp.2d 1125, 1139 (D.Minn.2011) ("The Court had denied its previously filed motion in limine regarding AERs, finding that the evidence was admissible to show notice and could also support a finding of causation."), reversed in part on other grounds , In re Levaquin Products Liability Litigation, 700 F.3d 1161 (8th Cir.2012) ; Hogan v. Novartis Pharm. Corp., No. 06–civ–0260, 2011 WL 1533467, at *13 (E.D.N.Y. Apr. 24, 2011) ("The motion to preclude admission of adverse drug experience reports is denied. Individual reports and the total number of ONJ reports before June, 2005 can establish notice regardless of whether Hogan's jaw condition was not similar to any of the patients described in the reports."); In re Fosamax Prods. Liab. Litig., No. 1:06–MD–1789–JFK, 2010 WL 4242708, at *3 (S.D.N.Y. Oct. 27, 2010) ("[A]dverse event reports are admissible only to prove when Merck had notice of the adverse events alleged therein."); Bartlett v. Mutual Pharmaceutical Co., Inc., No. 08–cv–358–JL, 2010 WL 3092649, at *1 (D.N.H. Aug. 2, 2010) ("The [adverse event] reports are not hearsay, though, if offered to prove that the FDA was on notice of Sulindac's safety risks, or that Mutual should have been on notice of such risks.").

If they are admitted for the purposes of "notice," the defendants ask that the AERs admitted be limited only to those involving similar circumstances to those surrounding the decedent's death. I agree that the AERs presented for the purpose of notice should be ones that would be similar to the circumstances of this case (i.e., persons who developed acute liver failure

/damage at or just above 4 g, persons who were fasting/malnourished). Other AERs would likely be irrelevant to the case.

The defendants claim that the admission of only one AER which is substantially similar is...