TERRY v. MCNEIL-PPC, INC. et al
MEMORANDUM AND/OR OPINION. SIGNED BY HONORABLE LAWRENCE F. STENGEL ON 8/31/2016. 8/31/2016 ENTERED AND COPIES E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 415 IN 13-MD-2436)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF PENNSYLVANIA
IN RE: TYLENOL
SALES PRACTICES, AND
MDL NO. 2436
HON. LAWRENCE F. STENGEL
This Document Relates to:
Rana Terry, as Personal Representative
and Administrator of the Estate of Denice
McNEIL-PPC, Inc., McNeil Consumer
Healthcare, and Johnson & Johnson, Inc.,
Civil Action No. 2:12-cv-07263
August 31, 2016
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
See Master Compl., 13-md-2436, Doc. No. 32. There are close to two hundred other cases included in this MDL,
along with several similar cases in New Jersey state court.
first “bellwether” case scheduled for trial.2 The plaintiff moves to exclude the testimony
of Dr. Judith Jones, the defense’s regulatory expert, under Daubert. For the reasons stated
below, I will grant their motion in part and deny it in part.
The admissibility of expert testimony is governed by Federal Rules of Evidence
702 and 703 as well as by Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993),
and its progeny.3 See In re Paoli RR Yard PCB Litigation (Paoli II), 35 F.3d 717, 735 (3d
Cir. 1994). “Under the Federal Rules of Evidence, a trial judge acts as a ‘gatekeeper’ to
ensure that ‘any and all expert testimony or evidence is not only relevant, but also
reliable.’” Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir. 2008)(quoting
Kannankeril v. Terminix Int'l, Inc., 128 F.3d 802, 806 (3d Cir. 1997)). The Third Circuit
recognizes a “liberal policy of admissibility” regarding Rule 702. Pineda, 520 F.3d at 243
(quoting Kannankeril, 128 F.3d at 806); United States v. Schiff, 602 F.3d 152, 173 (3d
“[B]ecause expert evidence is often more misleading than other evidence,
Rule 403 gives a judge more power over experts than over lay witnesses.” In re
A “bellwether” case is a test case. “Bellwether” trials should produce representative verdicts and settlements. The
parties can use these verdicts and settlements to gauge the strength of the common MDL claims to determine if a
global resolution of the MDL is possible. See FEDERAL JUDICIAL CENTER, MANUAL FOR COMPLEX LITIGATION,
FOURTH EDITION 360 (2004); DUKE LAW CENTER FOR JUDICIAL STUDIES, MDL STANDARDS AND BEST PRACTICES
Daubert held that the Federal Rules of Evidence, specifically Rule 702, controlled the issue of when experts were
qualified. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 587-88 (1993). It found that Rule 702 superseded the
Court’s prior precedent on the subject found in Frye v. United States, 54 App.D.C. 46, 47, 293 F. 1013, 1014 (1923).
Id. at 587. Daubert went on to clarify what was required under Rule 702, as compared to Frye. See id. at 589-598.
See also Holbrook v. Lykes Brothers Steamship Company, Inc., 80 F.3d 777, 780 (3d Cir. 1996); Zaprala v. USI
Servs. Gp., Inc., No. 09–1238, 2013 WL 1148335, at *6 (E.D. Pa. Mar. 20, 2013)(quoting Pineda, 520 F.3d at 243).
Paoli RR Yard PCB Litigation (Paoli II), 35 F.3d 717, 747 (3d Cir. 1994).
However, “in order for a district court to exclude scientific evidence, there must be
something particularly confusing about the scientific evidence at issue—
something other than the general complexity of scientific evidence.” Id.
a. Rule 702
Federal Rule of Evidence 702 has three major requirements: 1) the expert must be
qualified; 2) the expert must testify about matters requiring scientific, technical, or
specialized knowledge; and 3) the testimony must assist the trier of fact.5 Pineda, 520
F.3d at 243 (citing Kannankeril, 128 F.3d at 806). 702’s inquiry should be a “flexible
one.” Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 594 (1993).
Expert Must Be Qualified
An expert’s qualifications may include education, provided it is in a field
related to the one in which the expert intends to testify. Fedor v. Freightliner, Inc.,
193 F. Supp. 2d 820, 827 (E.D. Pa. 2002). Overall, the court will consider both
academic training and practical experience to determine if the expert has “more
Federal Rule of Evidence 702 states:
A witness who is qualified as an expert by knowledge, skill, experience, training, or education
may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of the case.
FED. R. EVID. 702.
knowledge than the average lay person” on the subject. Id. at 827-28 (citing
Waldorf v. Shuta, 142 F.3d 601, 627 (3d Cir. 1998)). “An expert may be generally
qualified but may lack qualifications to testify outside his area of expertise.”
Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 322 (3d Cir. 2003).
However, this does not mean that the “best qualified” expert must testify.
“[W]itnesses may be competent to testify as experts even though they may not, in
the court's eyes, be the ‘best’ qualified.” Holbrook v. Lykes Bros. S.S. Co., Inc.,
80 F.3d 777, 782 (3d Cir. 1995).6 “Rule 702 and Daubert put their faith in an
adversary system designed to expose flawed expertise.” U.S. v. Mitchell, 365 F.3d
215, 244-45 (3d Cir. 2004)(citations omitted). “As long as an expert's scientific
testimony rests upon ‘good grounds, based on what is known,’ it should be tested
by the adversary process—competing expert testimony and active cross–
examination—rather than excluded from jurors' scrutiny for fear that they will not
grasp its complexities or satisfactorily weigh its inadequacies.” Id. at 244
Expert’s Methods Must be Reliable
This Circuit interprets the second factor as one of “reliability,” i.e., the testimony
is admissible so long as the process or technique the expert used in formulating the
opinion is reliable. Pineda, 520 F.3d at 244. An expert’s opinion need not be correct, only
reliable. See In re Paoli RR Yard PCB Litigation (Paoli II), 35 F.3d 717, 744 (3d Cir.
1994)(“This does not mean that plaintiffs have to prove their case twice—they do not
See also Keller v. Feasterville Family Health Care, 557 F. Supp. 2d 671, 675 (E.D. Pa. 2008)(Rice, J.).
have to demonstrate to the judge by a preponderance of the evidence that the assessments
of their experts are correct, they only have to demonstrate by a preponderance of
evidence that their opinions are reliable.” (emphasis in original)). “[A]n expert is
permitted wide latitude to offer opinions, including those that are not based on firsthand
knowledge or observation.” Daubert, 509 U.S. at 592. “[I]t is the burden of the party
offering the expert scientific testimony to demonstrate reliability by a preponderance of
the evidence.” In re TMI Litig., 193 F.3d 613, 705 (3d Cir. 1999)(citing Paoli II, 35 F.3d
“Rule 702 grants the district judge the discretionary authority, reviewable for its
abuse, to determine reliability in light of the particular facts and circumstances of the
particular case.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 158 (1999). Judges
considering this factor should look to whether a theory, technique, or opinion can be
tested or has been subject to peer review or publication. Daubert, 509 U.S. at 593. “The
fact of publication (or lack thereof) in a peer reviewed journal thus will be a relevant,
though not dispositive, consideration in assessing the scientific validity of a particular
technique or methodology on which an opinion is premised.” Id. at 594. A court should
also consider the known or potential rate of error involved in a scientific method. Id.
“Reliability” does not require that a technique or methodology be generally accepted by a
scientific community. Id. See also id. at 597-98. However, “[w]idespread acceptance can
See also FED. R. EVID. 702, Advisory Committee Note (2000 Amendments)(“Under that Rule, the proponent has
the burden of establishing that the pertinent admissibility requirements are met by a preponderance of the evidence.”
(citing Bourjaily v. United States, 483 U.S. 171 (1987)).
be an important factor in ruling particular evidence admissible” while a minimally
supported technique “may properly be viewed with skepticism.” Id.
Expert Must be Helpful
The third factor “is typically understood in terms of whether there is a sufficient
‘fit’ between the expert's testimony and the facts that the jury is being asked to consider.”
United States v. Schiff, 602 F.3d 152, 172-73 (3d Cir. 2010)(citing Daubert, 509 U.S. at
591). See also In re: TMI Litigation, 193 F.3d 613, 670 (3d Cir. 1999). This factor is
about relevance. “Expert testimony which does not relate to any issue in the case is not
relevant and, ergo, non-helpful.” Daubert, 509 U.S. at 591 (quoting 3 Weinstein & Berger
¶ 702, p. 702–18). “Rule 702's ‘helpfulness’ standard requires a valid scientific
connection to the pertinent inquiry as a precondition to admissibility.” Id. at 591-92.
b. Rule 703
Under Federal Rule of Evidence 703, the data underlying the expert's opinion is
the central focus. Rule 703 states:
An expert may base an opinion on facts or data in the case that the expert
has been made aware of or personally observed. If experts in the particular
field would reasonably rely on those kinds of facts or data in forming an
opinion on the subject, they need not be admissible for the opinion to be
admitted. But if the facts or data would otherwise be inadmissible, the
proponent of the opinion may disclose them to the jury only if their
probative value in helping the jury evaluate the opinion substantially
outweighs their prejudicial effect.
FED. R. EVID. 703. The trial court must evaluate whether the data used by an
expert is reasonably relied upon by experts in the field. See In re Paoli RR Yard
PCB Litigation (Paoli II), 35 F.3d 717, 747-49 (3d Cir. 1994).
Judith Jones, M.D., Ph.D.
The plaintiff offers many reasons why Dr. Judith Jones should not be permitted to
testify as an expert under Daubert. In her expert report, Dr. Jones offers a wide range of
opinions about this case: 1) she opines that the defendants’ actions in terms of
pharmacovigilance were appropriate based on regulations and industry standards, 2) she
offers expert testimony about the regulatory structure governing Tylenol and
acetaminophen, 3) she opines about whether acetaminophen is “generally recognized as
safe and effective” (GRASE) under Food and Drug Administration (FDA) regulations,
and 4) she claims that the Extra Strength Tylenol label was adequate.
a. Dr. Jones is Qualified to Offer Some Opinions But Not All
Dr. Judith Jones has professional experience in medicine and pharmaceutical
consulting. Dr. Jones is a board-certified doctor of internal medicine with a Ph.D. in
pharmacology and a specialty in geriatrics.8 She has held a variety of teaching positions
at several medical schools and universities, including Tufts, Michigan, and Georgetown
and in the areas of public health, pharmacology, and medicine.9 Dr. Jones continues to be
licensed in Virginia, but she has not practiced medicine since 1989.10
Dr. Jones has experience working for and with the Food and Drug Administration
(FDA). From 1973 through 1978, Dr. Jones worked as a consultant for the FDA. In that
Curriculum Vitae of Judith Jones (Doc. No. 157, Ex. 1); J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1); J. Jones
Dep., May 5, 2015 at 47-49 (Doc. No. 157, Ex. B).
See J. Jones Expert Report at 1-2 (Doc. No. 157, Ex. 1); Curriculum Vitae of Judith Jones (Doc. No. 157, Ex. 1); J.
Jones Dep., May 5, 2015 at 50-52 (Doc. No. 157, Ex. B). I note, however, that most of these courses were typically
only one week long. Curriculum Vitae of Judith Jones (Doc. No. 157, Ex. 1); J. Jones Dep., May 5, 2015 at 50-52
(Doc. No. 157, Ex. B).
J. Jones Dep., May 5, 2015 at 47, 289 (Doc. No. 157, Ex. B).
role, she served on an advisory panel reviewing the safety of hemorrhoidal products at
the first level of the monograph process.11 From 1978 to 1983, Dr. Jones became the
Director of the Division of Drug Experience (later known as the Division of Drug and
Biological Experience) of the FDA.12 In this role, Dr. Jones drafted definitions,
guidelines, and procedures to expand the FDA’s adverse event reports (AER) system and
to instruct manufacturers on how to appropriately submit voluntary AERs.13 Her work
helped shape reporting procedures to identify “signals” from medical product adverse
events in order to determine of the marketed products continued to be safe as labeled.14
In 1983, Dr. Jones decided to work half-time; she stepped down from her role as
Director.15 From 1983 to 1985, she served as a part-time special assistant to the Director
of the Office of Biometrics and Epidemiology in the Bureau of Drugs.16 In 1985, she left
the FDA to pursue other opportunities.
In 1988, Dr. Jones founded a consulting and education company called The Degge
Group.17 Her company specializes in epidemiological studies and regulatory evaluation
J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1); Curriculum Vitae of Judith Jones (Doc. No. 157, Ex. 1); J.
Jones Dep., May 5, 2015 at 17, 21, 23 (Doc. No. 157, Ex. B).
J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1); Curriculum Vitae of Judith Jones (Doc. No. 157, Ex. 1); J.
Jones Dep., May 5, 2015 at 17-19 (Doc. No. 157, Ex. B).
J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1); J. Jones Dep., May 5, 2015 at 27 (Doc. No. 157, Ex. B).
J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1); J. Jones Dep., May 5, 2015 at 18 (Doc. No. 157, Ex. B).
J. Jones Dep., May 5, 2015 at 18 (Doc. No. 157, Ex. B).
J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1); Curriculum Vitae of Judith Jones (Doc. No. 157, Ex. 1); J.
Jones Dep., May 5, 2015 at 18 (Doc. No. 157, Ex. B).
J. Jones Dep., May 5, 2015 at 47-48 (Doc. No. 157, Ex. B).
of medical product safety.18 The Degge Group advises manufacturers on the appropriate
management of safety issues of their products including regulatory actions and product
labeling.19 Dr. Jones also heads a nonprofit organization called Pharmaceutical Education
and Research Institute (PERI), which was founded in 1989. PERI educates scientists and
other personnel in the pharmaceutical industry about the regulatory issues.20
Dr. Jones’ experience qualifies her to offer testimony about pharmaceutical
industry standards and AERs.21 She has been consulting on these topics for close to thirty
years and had prior experience working for the FDA. She is especially qualified to offer
testimony about AERs and what significance they may have in informing drug
manufacturers of risks to consumers.
Dr. Jones does not appear to be qualified to offer opinions about the regulatory
structure or duties of drug manufacturers under the monograph system. Dr. Jones’ only
experience working with the monograph regulatory system was her time as a consultant
on a recommendation panel over forty years ago.22 Her understanding of the monograph
system is based on guidance general counsel for the FDA gave her panel at that time.23
Dr. Jones has never worked in the FDA offices responsible for New Drug Application
J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1).
J. Jones Expert Report at 1 (Doc. No. 157, Ex. 1).
J. Jones Expert Report at 1-2 (Doc. No. 157, Ex. 1).
The plaintiff argues that Dr. Jones is not qualified to offer an opinion about the defendants’ pharmacovigilance
practices because she does not have expertise in this area nor has she reviewed the appropriate pharmacovigilance
documents of the defendants to render an accurate opinion. In response, the defendants indicated Dr. Jones will not
offer an opinion on the subject of pharmacovigilance at trial. The plaintiff’s argument is moot.
J. Jones Dep., May 5, 2015 at 186 (Doc. No. 157, Ex. B).
J. Jones Dep., May 5, 2015 at 186 (Doc. No. 157, Ex. B).
(NDA) or monograph compliance.24 She has never reviewed or drafted a tentative final
monograph or a final monograph.25 Her consulting company has never advised a client on
how to change the label on a monograph-regulated drug.26 For these reasons, Dr. Jones is
precluded from offering an opinion about whether the defendants complied with their
regulatory duties under the NDA or monograph systems.27 She is not qualified to offer an
opinion in this area.28
J. Jones Dep., May 5, 2015 at 20, 22, 23-25, 142 (Doc. No. 157, Ex. B); id. at 23 (“Other than your work as a
consultant to FDA on the hemorrhoidal panel from 1973 to 1978, have you ever been employed with FDA in any
capacity responsible for regulating monograph drugs? A. Not, not other than that, that panel.”). Dr. Jones was
involved in issues related to Reye’s syndrome’s link to aspirin, a monograph-regulated OTC drug. Beyond that, she
was not involved in drafting or enforcing monograph regulations. Id. at 24.
J. Jones Dep., May 5, 2015 at 24, 46 (Doc. No. 157, Ex. B).
J. Jones Dep., May 5, 2015 at 70 (Doc. No. 157, Ex. B)(“Q. Have you ever advised a company or assisted them in
drafting an NDA deviation [a method for amending a Final Monograph]? A. No. Q. Have you ever advised a
company or offered any advice to a company on how to change, and the steps to change a final monograph? A. No.
Q. Have you ever advised a company or assisted a company or offered, as it relates to changing a label or altering a
label of an OTC product that is governed solely by a tentative final monograph? A. No.”).
During her deposition, Dr. Jones was not aware of what the dosing regimen was for Extra Strength Tylenol under
the Tentative Final Monograph (TFM). See J. Jones Dep., May 5, 2015 at 118, 280-81 (Doc. No. 157, Ex. B). See
also Acetaminophen Panel Report, Jul. 8, 1977 (Pl. Ex. 10, filed under seal); TFM, Nov. 16, 1988 (Pl. Ex. 4, filed
under seal). This information is a key part of this case. Her inability to speak to this issue raises concerns about her
expertise on this subject.
See also In Re Gadolinium-based Contrast Agents Products Liability Litig., No. 1:08 GD 50000, MDL No. 1909,
2010 WL 1796334, at *30-31 (N.D. Ohio May 4, 2010)(excluding defense expert opining about labeling process
when expert only worked at FDA for three years as a medical officer).
Dr. Jones is also of the opinion that acetaminophen is safe when taken at recommended doses. The plaintiff argues
that she is not qualified to offer an opinion about the hepatic effect of acetaminophen at the recommended dose.
Though she is board certified in internal medicine and has a Ph.D. in pharmacology, Dr. Jones has not practiced as a
physician in over twenty years. Instead, her focus has been on regulatory and consulting work. Curriculum Vitae of
Judith Jones (Doc. No. 157, Ex. 1); J. Jones Dep., May 5, 2015 at 47-48 (Doc. No. 157, Ex. B). Though she has a
“special interest in effects of drugs on hepatic function,” Dr. Jones admits that she is not an expert on liver failure. J.
Jones Expert Report at 2 (Doc. No. 157, Ex. 1); J. Jones Dep., May 5, 2015 at 85 (Doc. No. 157, Ex. B)(A: “I’m not
an expert on liver failure.”). She also has not conducted academic studies in this research area. Dr. Jones has not
reviewed the available data on this topic (or if she did, could not speak about it in her deposition). See J. Jones Dep.,
May 5, 2015 at 270-71 (Doc. No. 157, Ex. B)(“Q. What is the data from the American Association of the Study of
the Liver, from the AIRS database, the FDA's own database show? A. I can't say. …Q. Have you looked at the,
provided in the course of your review for this case a document called the Acetaminophen Working Group's
document that was presented to Janet Woodcock on February 2nd, 2008?... A: I don't recall.”).
Her methodology is this respect is also questionable. Dr. Jones admits that she has not reviewed all the relevant
literature about this issue—from McNeil’s internal documents and from outside sources; at most, she read
b. Questions Regarding Dr. Jones’ Methodology Go to Weight, not
The plaintiff questions whether Dr. Jones’ methodology is appropriate. She points
out that Dr. Jones did not review all available documents in developing her opinions. Dr.
Jones is qualified to offer opinions about industry standards and offer an opinion about
whether the defendants’ actions fell below what a “reasonable drug manufacturer” would
do. However, Dr. Jones admited during her deposition that she has not reviewed many
internal documents of the defendants related to actions they have taken in reaching her
In rendering her opinions about the defendants’ handling of spontaneous reports
and/or adverse event reports, she admits that she only reviewed five to six years of annual
summaries of the reports prepared by the defendants.30 She did not review the reports
themselves to indicate whether they appropriately complied with regulatory and/or
summaries of the information provided in McNeil’s annual reports. See J. Jones Dep., May 5, 2015 at 82-83, 103,
112-13, 143, 159, 194-96, 217-18, 223-25, 238-40, 243-44 (Doc. No. 157, Ex. B). Dr. Jones testified that she only
read summaries of trials for Extra Strength Tylenol’s NDA that took place prior to 1975 (when the NDA was
approved), as well as summary material of the discussions held at the 2002 and 2009 advisory committee meetings.
She also bases her opinion on medical literature from forty years ago. See J. Jones Dep., May 5, 2015 at 115-16
(Doc. No. 157, Ex. B).
The defendants claim that Dr. Jones will not be testifying about general or specific causation or about
pharmacovigilance. Any opinion Dr. Jones offers about the safety of acetaminophen at recommended doses will be
excluded. She would not be qualified to offer this opinion based on her credentials and/or this opinion would not be
helpful to the jury for the purposes she is being called to testify.
See J. Jones Dep., May 5, 2015 at 82-83, 103, 112-13, 143, 159, 194-96, 217-18, 223-25, 238-40, 243-44 (Doc.
No. 157, Ex. B). Dr. Jones testified that she only read summaries of trials for Extra Strength Tylenol’s NDA that
took place prior to 1975 (when the NDA was approved), as well as summary material of the discussions held at the
2002 and 2009 advisory committee meetings.
See J. Jones Dep., May 5, 2015 at 237-38 (Doc. No. 157, Ex. B)(“Q. So how many spontaneous reports did you
review? A. I reviewed the summaries of the reports. I didn’t review, I, I did review some of the case reports of liver
effects, but I didn’t review all of the spontaneous reports. Just the summaries. Q. Well, where did you get the
summaries from? A. They were in the annual reports….And about how many years of annual reports did you read?
A. I don’t recall precisely, five or six.”).
industry standards. Dr. Jones did not read the depositions of Dr. Ed Kuffner, who was
previously in charge of drug safety and surveillance at McNeil.31 She said that she does
not usually review the “opinions of the company” before rendering her own opinion,
since it is meant to be independent.32
Dr. Jones admitted that she was not provided and did not review McNeil’s surveys
indicating that up to 40% of consumers take more than the recommended dose of overthe-counter (OTC) pain relievers, including Tylenol, because the medication is marketed
While the plaintiff’s arguments raise questions about the accuracy of Dr. Jones’
opinions, these questions are best addressed on cross-examination and answered by the
jury. Whether Dr. Jones’ opinion is based on all available information or the best
information available is an issue that goes to weight, not admissibility.
By all accounts, Dr. Jones’ actual methods—reviewing and deciphering the
information contained in documents provided her based on her professional experience—
are reliable ways of reaching opinions about industry standards and the use of AERs. For
these reasons, I find that Dr. Jones’ opinions on these two topics are reliable.
c. Dr. Jones’ Opinions Regarding a Manufacturer’s Duties Are
Misleading and not Helpful
See J. Jones Dep., May 5, 2015 at 35-36 (Doc. No. 157, Ex. B).
J. Jones Dep., May 5, 2015 at 36 (Doc. No. 157, Ex. B).
Dr. Jones also claims that changing a label under the Tentative Final Monograph cannot be done without a
company first having “a dialogue” with the FDA. Yet, she has not reviewed McNeil’s own documents about how
McNeil did just that in the past— voluntarily adding an alcohol warning before it was mandated or reducing the
maximum daily dose before it was mandated. I agree with the plaintiff that her opinions about the defendants’ duties
under the monograph system should be excluded, but more so because she is not qualified as an expert in this area
and her opinions, which contradict Wyeth v. Levine (explained below), are not helpful to the jury.
Lastly, the plaintiff points out that Dr. Jones’ opinions are contrary to the law
governing this case. Throughout her expert report, Dr. Jones opines that the FDA, and not
the manufacturer, is ultimately responsible for the content of the label on an OTC product
such as Tylenol.34 She also indicates that it is very difficult for a company like McNeil to
change the label or increase warnings on an OTC product such as Tylenol under the
In Wyeth v. Levine, the Supreme Court unambiguously rejected this interpretation
[The drug manufacturer] suggests that the FDA, rather than the
manufacturer, bears primary responsibility for drug labeling. Yet through
many amendments to the FDCA and to FDA regulations, it has remained a
central premise of federal drug regulation that the manufacturer bears
responsibility for the content of its label at all times. It is charged both with
crafting an adequate label and with ensuring that its warnings remain
adequate as long as the drug is on the market.
Wyeth v. Levine, 555 U.S. 555, 570-71 (2009).
Dr. Jones contends that the defendants are precluded from changing their label to
include a fasting warning because the FDA considered and rejected such a warning when
promulgating the 2009 Final Rule. This opinion is not legally correct. It contradicts my
ruling on the defendants’ motion for summary judgment on the plaintiff’s failure-to-warn
See J. Jones Expert Report at 4, 13, 14, 15 (Doc. No. 157, Ex. 1) and J. Jones Dep., May 5, 2015 at 245-46 (Doc.
No. 157, Ex. B)(“Q. And that is noted on Page 27 of your report. And it is the obligation of the pharmaceutical
company, that we have already discussed, that if they begin to see information, scientific data, and information that
may suggest that acetaminophen may cause hepatotoxicity other than at massive overdoses or at lower doses, to
assess that and alert the regulators, true?...
A. If they find that, of course. FDA is receiving, sometimes, the same information. Q. I'm not talking about the
FDA. I'm just talking about the duty of the manufacturer. That is the duty of the manufacturer, true? A. It is also the
duty of the FDA, that is part of their surveillance activities as well.”).
I note that Dr. Jones was also not given the FOIA letter from the FDA which explains what legal duties the
defendants have under the Tentative Final Monograph. See J. Jones Dep., May 5, 2015 at 110-11, 125-26 (Doc. No.
157, Ex. B). See also FOIA Letter to Gainer, Nov. 17, 2011 (Pl. Ex. 3, filed under seal).
claim and could mislead the jury as to the duties required of the defendants (i.e., if the
defendants found evidence that a fasting warning was needed, they were required to act
on this knowledge to prevent injury to consumers).36 Dr. Jones will be precluded from
offering such an opinion.
Dr. Jones admits that her opinion—that the FDA, not the manufacturer, is
ultimately responsible for the content of an OTC label—is not supported by Supreme
Court precedent and is, in fact, inconsistent with it.37 She also was unable to point to
regulations which supported her opinion.38 Dr. Jones’ opinions to this effect would be
misleading and not helpful to the jury. See In Re Gadolinium-based Contrast Agents
Products Liability Litig., No. 1:08 GD 50000, MDL No. 1909, 2010 WL 1796334, at
*30-31 (N.D. Ohio May 4, 2010)(“The Court will not permit Dr. Waymack to offer his
expert opinion on either of these topics because, as evidenced by both his expert report
and deposition testimony, Dr. Waymack intends to offer opinions that are contrary to the
Supreme Court's recent opinion in Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173
L.Ed.2d 51 (2009)”).39
See Memorandum Denying Motion for Summary Judgment on Plaintiff’s Failure-to-Warn Claim, November 15,
2015 at 41-43 (Doc. No. 181).
See J. Jones Dep., May 5, 2015 at 105-06 (Doc. No. 157, Ex. B)(“Q. When you say that the final decision on
labelling changes belongs to the FDA, is that consistent or inconsistent with what the United States Supreme Court
says? A: It is not supported by a decision of that particular court at that time. Q. Well that is our highest court, isn't
it? A. Yes. Q. Okay. So your position here in bold, at the bottom of Page 4 is, differs from what the United States
Supreme Court says, true? A: That's correct.”) and id. at 134 (reiterating same).
See J. Jones Dep., May 5, 2015 at 204-05 (Doc. No. 157, Ex. B).
See also In re Levaquin Products Liability Litigation, MDL No. 08–1943 (JRT), 2010 WL 8399949, at *4-6 (D.
Minn. Nov. 9, 2010)(excluding opinions of Paul Waymack which contradicted Wyeth v. Levine); In re Trasylol
Products Liability Litigation, No. 08–MD–01928, 2010 WL 4259332, at *3-7 (S.D. Fla. Oct. 21, 2010)(excluding
Dr. Waymack’s expert testimony “that, under the FDA regulatory scheme, it would have been inappropriate for [the
The defendants argue that Dr. Jones’ opinions are not contradictory to Wyeth
because Wyeth involved a prescription drug and not an OTC product. The defendants
also claim that Wyeth’s discussion of the Changes Being Effected procedure for making
label changes only applies to products covered by a New Drug Application (NDA).
Because Extra Strength Tylenol is no longer covered by an NDA and is only regulated
under the monograph system, they claim Wyeth is not entirely on point with this case.
This argument wholly ignores the defendants’ own actions in changing their labels
in the past. As I explained in my decision denying the defendants motion for summary
judgment on the plaintiff’s failure-to-warn claim, the defendants have, in fact, used the
CBE procedures previously for one Tylenol product covered by an NDA to change the
label for all Tylenol products (those covered by the NDA and those covered by the
monograph system). This label change was done voluntarily and without prior FDA
approval. See Memorandum Denying Motion for Summary Judgment on Plaintiff’s
Failure-to-Warn Claim, November 15, 2015 at 44-48 (Doc. No. 181).
Even if Wyeth leaves room for interpretation, Dr. Jones’ opinions could still be
misleading or could contradict my rulings in this case. See In Re Gadolinium-based
Contrast Agents Products Liability Litig., No. 1:08 GD 50000, MDL No. 1909, 2010 WL
1796334, at *30-31 (N.D. Ohio May 4, 2010)(“Technically, Dr. Waymack's observations
in his report that the FDA possesses an advantage in evaluating safety data for particular
classes of drugs and has ultimate authority over labeling may not wholly contradict
drug manufacturer] to unilaterally update the label for Trasylol” because this opinion contradicts Wyeth and/or
would mislead jurors).
Wyeth. However, Dr. Waymack's opinions are misleading because they attempt to
minimize the manufacturer's role in the labeling process and therefore should not be
presented to the trier of fact. Given that Dr. Waymack's probable testimony is at best
misleading and at worst directly contrary to the Supreme Court's holdings in Wyeth, the
Court, pursuant to Rule 702, precludes Dr. Waymack from testifying.”). See also
Memorandum Denying Motion for Summary Judgment on Plaintiff’s Failure-to-Warn
Claim, November 15, 2015 at 44 (Doc. No. 181)(“As Wyeth made clear, the onus has
always been on McNeil to ensure its label accurately reflects the risks of Extra Strength
The defendants are correct in pointing out that they could not unilaterally change
the language of the liver warning. It is not “incorrect” for Dr. Jones to opine that in
practice, pharmaceutical companies do not unilaterally change the labeling for a product
subject to a tentative final monograph. The liver warning only (not all of the conditions
which would make acetaminophen GRASE under the final monograph) is covered by a
final rule. Under that final rule, the defendants are required to at least have that warning
on their label.
However, the question of whether the defendants can strengthen that warning is an
entirely different one. If Dr. Jones had accurately explained the duties required by the
defendants for the final liver warning rule and those required by the Tentative Final
Monograph, the defendants may have a point. However, Dr. Jones does not make this
distinction and instead confuses the duties imposed by the final liver warning rule with
those imposed by the final monograph, which is non-existent. To allow her to offer
testimony to this effect to the jury would be confusing or misleading.
For these reasons, the following opinions of Dr. Jones will be precluded: that the
defendants were unable to change their label without prior FDA approval and that the
FDA—not the defendants—was responsible for the contents of the Tylenol label.40
d. Scope of Dr. Jones’ Opinion
The plaintiff argues that Dr. Jones’ recitation of the regulatory history of Tylenol
products is simply a regurgitation of known facts without any additional insight into how
those facts pertain to this case. “[A]n expert cannot be presented to the jury solely for the
purpose of constructing a factual narrative based upon record evidence.” See In re
Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009)(citations
omitted). Narrative testimony only for this purpose would invade the province of the
jury.41 A narrative may be admissible, however, if an expert’s explanation of
complicated facts can help a jury better understand them.42
The plaintiff also argues that Dr. Jones is not qualified to testify as an expert because she does not know that FDA
regulation 21 C.F.R. § 201.80 offers the standard for when a manufacturer is required to change a drug label. In
supplemental briefing ordered by the court, the plaintiff admitted that this regulation does not apply in this case.
This argument is moot.
See Wolfe v. McNeil-PPC, Inc., No. 07–348, 2011 WL 1673805, at *8 (E.D. Pa. May 4, 2011)(“It will be the role
of the jury, not Dr. Goldberg, to determine if McNeil acted negligently.”); Brill v. Marandola, 540 F. Supp. 2d 563,
570 (E.D. Pa. 2008)(“Mr. Newman's extensive interpretation of the relevant legal documents and suggested
credibility determinations as presently included in his written report are not admissible because they usurp the factfinding role of the jury and distract more than they aid.”); Gallatin Fuels, Inc. v. Westchester Fire Ins. Co., 410 F.
Supp. 2d 417, 423 (W.D. Pa. 2006)(“An expert simply is not in any better position than the jury to assess another's
See In re Welding Fume Prod. Liab. Litig., No. 1:03–CV–17000, 2005 WL 1868046, at *17 (N.D. Ohio Aug. 8,
2005)(“Thus, a ‘narrative’ by an expert is not automatically inadmissible; it is only when, as in In re Rezulin, the
narrative is purely ‘a repetition of the factual allegations in plaintiffs' complaint,’ involving ‘nothing technical or
scientific,’ that a court might find the expert testimony unhelpful, because the expert is providing only ‘simple
inferences drawn from uncomplicated facts.’… In this case, the great majority of the documents and articles that Dr.
Levy is reviewing and comparing are complicated, and the inferences those documents may or may not support are
Dr. Jones’ report goes through the legislative history of the FDA. Dr. Jones may
offer information about FDA regulations as they pertain to adverse event reporting (her
area of regulatory expertise). She may not, however, offer opinions about the regulatory
framework of the NDA or monograph system because she is not an expert in this area.
e. Opinions About Whether Tylenol is GRASE
Dr. Jones also offers an opinion about whether Tylenol is “generally recognized as
safe and effective” or GRASE by the FDA. She claims that the FDA considers it to be
GRASE. As I explained in a previous Daubert ruling regarding the plaintiff’s regulatory
expert, whether acetaminophen is considered GRASE by the FDA involves legal
interpretation of federal regulations.43 This legal determination is the job of the court, not
an expert or the jury. The FDA has not fully approved acetaminophen as GRASE
because a final monograph for acetaminophen has not been issued. Dr. Jones’ opinions
about the status of acetaminophen as GRASE will be excluded.
Dr. Jones’ opinion that acetaminophen has been approved by the FDA as GRASE
by implication is also legally and factually incorrect. See J. Jones Dep., May 5, 2015 at
184 (Doc. No. 157, Ex. B)(“So, by implication, if nothing, if not specifically, it is
generally recognized as safe and effective.”); id. at 214 (“[I]n essence what has happened
is that a tentative final monograph product, acetaminophen, has been treated as if a final
not at all simple. It is through the application of his expertise that Dr. Levy may allow the trier of fact to better
understand what the documents do (and don't) mean, and, thus, what the defendants did (or didn't) know.”)(citation
omitted). See also In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Products Liab. Litig., 3:09-MD02100-DRH, 2011 WL 6302287, at *8 (S.D. Ill. Dec. 16, 2011)(“As to defendant's argument regarding narrative
testimony, the Court has broad discretion over the mode and order of examining witnesses and presenting evidence
and may allow testimony in narrative form at trial if the Court finds that it would helpful to the jury.”(citing
FED.R.EVID. 611; United States v. Pless, 982 F.2d 1118, 1123 (7th Cir. 1992)).
See Memorandum Granting in Part and Denying in Part Motion to Exclude Gerald Rachanow’s testimony, Jul. 27,
2016 (Doc. No. 241).
monograph in the sense of modifying the label by providing public notice, and so the, the
regulatory process has just been speeded up.”); and id. at 319-20 (same). This opinion
contradicts basic administrative law principles. See, e.g., the Administrative Procedures
Act, 5 U.S.C. § 553; 21 CFR § 330.10. She also bases this opinion on that fact that Extra
Strength Tylenol was previously approved for an NDA; however, that NDA was
withdrawn by McNeil about twenty years ago. See J. Jones Dep., May 5, 2015 at 192
(Doc. No. 157, Ex. B)(“You have a tentative final monograph, and the acetaminophen is
marketed under that monograph as well as an NDA. And that is why, that is the basis of
my saying it is generally recognized as safe and effective.”); id. at 193. Her opinion to
this extent would be irrelevant and/or misleading.
For the foregoing reasons, I will GRANT the plaintiff’s motion in part and
DENY it without prejudice in part. Dr. Jones is qualified to offer testimony about
AERs—how they are regulated, what purpose they serve in the industry, their
advantages/deficiencies, etc. She also may offer general testimony about industry
standards related to label changes (i.e., how drug manufacturers typically interact with
the FDA when seeking label changes).44 This information may help the jury understand
what a “reasonable drug manufacturer” would have done and whether the defendants’
actions fell below this standard of care.
For this reason, she may offer an opinion about plaintiff’s expert opinions in these areas (case reports/AERs) but
is precluded from opining about areas outside her expertise (i.e., their qualifications as experts or legal conclusions
for the court to make).
However, she is precluded from offering testimony about the monograph or NDA
regulatory systems and the defendants’ legal duties under those regulatory systems. Dr.
Jones may explain the history of label changes for Tylenol products; however, her
opinions to this extent should not contradict my rulings in this action or Supreme Court
precedent Wyeth v. Levine.
An appropriate Order follows.
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