TERRY v. MCNEIL-PPC, INC. et al

Filing 183

MEMORANDUM AND/OR OPINION. SIGNED BY HONORABLE LAWRENCE F. STENGEL ON 11/13/2015. 11/13/2015 ENTERED AND COPIES E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 286 IN 13-MD-2436) (ems)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF PENNSYLVANIA
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IN RE: TYLENOL
(ACETAMINOPHEN) MARKETING,
SALES PRACTICES AND
PRODUCTS LIABILITY
LITIGATION

MDL NO. 2436
2:13-md-02436
HON. LAWRENCE F. STENGEL

This Document Relates to:
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Rana Terry, as Personal Representative
and Administrator of the Estate of Denice
Hayes, Deceased,
Plaintiff,
vs.
McNEIL-PPC, Inc., McNeil Consumer
Healthcare, and Johnson & Johnson, Inc.,
Defendants.

Civil Action No. 2:12-cv-07263

MEMORANDUM
Stengel, J.

November 13, 2015

A popular adage by Paracelsus, the father of modern toxicology, goes to the heart
of this case: “The dose makes the poison.” The plaintiff claims that her sister died of
acute liver failure after taking Extra Strength Tylenol.1 Defendants Johnson & Johnson
and McNeil manufacture and market Extra Strength Tylenol, a brand-name over-the1

See Compl., 12-cv-07263, Doc. No. 1.

1

counter pain reliever. The plaintiff claims the defendants knew or should have known that
consumers may develop acute liver failure after taking Extra Strength Tylenol at or just
above the dose recommended when her sister died. The plaintiff claims that the
defendants could have re-designed Extra Strength Tylenol to make it safer.
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.2 This is the
first “bellwether” scheduled for trial.3 The defendants moved for summary judgment on
the plaintiff’s design defect claim, arguing that the plaintiff has not offered sufficient
evidence of this claim and/or the claim is preempted by federal law. For the reasons
explained below, I will deny the defendants’ motion.
I. A HISTORICAL OVERVIEW OF TYLENOL4
The plaintiff’s claims are different than those previously asserted against the
defendants about the safety of Tylenol. While previous cases have questioned whether
Tylenol can cause liver damage, this case and others in this MDL question the extent of

2

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.
3

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
16-21 (2014).
4

Some of the information offered by the plaintiff relates to events that happened after the decedent’s death. Whether
this information can be presented at trial will depend upon the outcome of a pending motion in limine and objections
based on the Federal Rules of Evidence. I offer it here to provide a holistic picture of the background of Extra
Strength Tylenol. Some of the information may be admissible or relevant in this case and/or subsequent cases in the
MDL. In making my determinations about sufficiency of the evidence, I do not rely solely on this evidence but offer
it as potential evidence that, with other admissible evidence, could affect a jury’s decision.

2

such damage and the quickness with which it can occur. A historical overview of the
regulation and science of Tylenol is helpful.5
a. TYLENOL, ACETAMINOPHEN, AND LIVER DAMAGE
Extra Strength Tylenol is an over-the-counter (OTC) pain reliever; consumers do
not need a prescription to buy it. The active ingredient in Extra Strength Tylenol is
acetaminophen, which is an analgesic and antipyretic or pain reliever and fever reducer.6
Defendant McNeil manufactures and markets many different Tylenol products, including
Extra Strength Tylenol and Regular Strength Tylenol. The two products differ in that one
tablet of Extra Strength Tylenol contains 500 mg of acetaminophen while a tablet of
Regular Strength Tylenol only contains 325 mg of acetaminophen per tablet. Johnson &
Johnson is the parent company of McNeil and is involved in managing its operations.
Acetaminophen was first synthesized as a pain reliever in the 1890s and has been
available OTC since the 1960s.7 Tylenol is one of more than 600 acetaminophencontaining products on the market in the United States in OTC and prescription
formulations.8 Acetaminophen is one of the most widely used OTC drugs.9 Twenty

5

In addition, I rely on exhibits offered in the plaintiff’s response to the defendants’ motion for summary judgment
on her failure-to-warn claim. Information in these exhibits helps to offer a more holistic view of the background of
this case. The defendants’ motion for summary judgment on the failure-to-warn claims can be found at Doc. No. 49;
their motion for summary judgment on the design defect claim can be found at Doc. No. 50 (under seal). The
plaintiff’s response to the Failure-to-Claim MSJ is docketed at Doc. No. 95 (under seal) and her response to the
Design Defect MSJ can be found at Doc. No. 90.
6

E.g., http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm (last visited May 31,
2015); A. Temple Dep., Feb. 18, 2014 at 310 (Doc. No. 90, Ex. 1).
7

See, e.g., FDA Memorandum, Aug. 15, 2002 (Doc. No. 95, Ex. 17); Lee, W.M., Acetaminophen Toxicity:
Changing Perceptions on a Social/Medical Issue, Hepatology 46(4): 966-970 (2007)(Doc. No. 95, Ex. 9).
8

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm336581.htm (last visited Oct. 13, 2015).

3

percent of Americans—60 million people—ingest an acetaminophen-containing product
each week.10 The Food and Drug Administration (FDA) has found acetaminophen to be
a “safe and effective OTC analgesic” when taken in recommended doses and used
according to the label.11 However, acetaminophen has been known to cause severe liver
damage.12
i. Acetaminophen’s Link to Acute Liver Failure
Acetaminophen is different from other OTC pain relievers in two ways: 1) it has
an antidote and 2) its maximum total daily limit is the same for both OTC and
prescription products.13 Acetaminophen is a “dose-related toxin,” meaning it can be
safely used at certain doses but harmful at higher doses.14 As a result, there is evidence
that it has a “narrow therapeutic margin”—i.e., there is little difference between the

9

See Kaufman DW, et al., Recent patterns of medication use in the ambulatory adult population of the United
States: the Slone Survey, J. Am. Med. Assoc. (2002), 287:337-44 (Doc. No. 49-1, Ex. A); Slone Epidemiological
Center at Boston University, Patterns of Medications Use in the United States 2005: A Report from the Slone
Survey, available at http://www.bu.edu/slone/research/studies/slone-survey (last visited Oct. 13, 2015).
10

Kaufman DW, et al., Recent patterns of medication use in the ambulatory adult population of the United States:
the Slone Survey, J. Am. Med. Assoc. (2002), 287:337-44 (Doc. No. 49-1, Ex. A); Slone Epidemiological Center at
Boston University, Patterns of Medications Use in the United States 2005: A Report from the Slone Survey,
available at http://www.bu.edu/slone/research/studies/slone-survey (last visited Oct. 13, 2015).
11

See Defendants’ Statement of Facts at ¶ 9; Plaintiff’s Statement admitting this fact; 42 Fed. Reg. 35346, 35413
(Jul. 8, 1977)(Doc. No. 49-2, Ex. B).
12

See 42 Fed. Reg. 35356, 35447 (Jul. 8, 1977); Lee, et. al., MEETING REPORT: Acute Liver Failure: Summary of
a Workshop, Hepatology 2008; 47:1401-1415 (Doc. No. 95, Ex. 6); Larson, et. al., Acetaminophen-Induced Acute
Liver Failure: Results of a United States Multicenter, Prospective Study, Hepatology 2005; 42(6):1364-1372 (Doc.
No. 95, Ex. 7); Lee, W.M., Acetaminophen Toxicity: Changing Perceptions on a Social/Medical Issue, Hepatology
46(4): 966-970 (2007)(Doc. No. 95, Ex. 9).
13

See CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 8).

14

See Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:14011415 (Doc. No. 95, Ex. 6).

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current maximum recommended dose of acetaminophen and the doses that could cause
liver injury.15 The parties debate how narrow this margin is.
A simplistic explanation of how the body metabolizes acetaminophen helps frame
the issues in this case. Typically, glutathione—an antioxidant found in the liver—will
bind to the toxic parts of acetaminophen, to neutralize them and prevent them from
harming the body.16 These neutralized toxins are then excreted.17 However, if the body
does not have enough glutathione, those toxins can build up in the liver, causing acute
liver failure (ALF). Glutathione stores may be low when a person is malnourished or
when the liver has been neutralizing a lot of toxins at once.18
“Acute liver failure (ALF) is a rapid deterioration of the organ’s ability to function.”19 Patients who experience ALF can fall into a coma or die.20 They may require a

15

See, e.g., CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex.
8)(“Acetaminophen has a narrow therapeutic margin, that is, there is little difference between the current maximum
recommended dose of acetaminophen and the doses that are associated with a potentially elevated risk of
hepatotoxicity.”); AASLD Memo, Apr. 27, 2007 (Doc. No. 95, Ex. 19); Christina Chang, M.D., M.P.H., Division of
Nonprescription Clinical Evaluation, Office of Nonprescription Products, of the FDA, Powerpoint, Jun. 29, 2009
(Doc. No. 95, Ex. 21).
16

See Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:14011415 (Doc. No. 95, Ex. 6); Whitcomb & Block, Association of Acetaminophen Hepatotoxicity with Fasting and
Ethanol Use, 272 JAMA 23, 1845-1850 (1994)(Doc. No. 95, Ex. 13).
17

See 42 Fed. Reg. 35381 (Jul. 8, 1977)(explaining studies of acetaminophen’s effect on the liver)(“The
administration of acetaminophen to patients with impaired renal function results in increased accumulation of
acetaminophen conjugates in the plasma because of poor excretory capacity but only in minor changes in the plasma
concentrations of free acetaminophen.”).
18

See 74 Fed. Reg. 19397 (Apr. 29, 2009)(“Malnourished individuals have been shown to have reduced glutathione
levels.”); 63 Fed. Reg. 56796-02 (Oct. 23, 1998)(“In addition to dosage, hepatotoxicity due to acetaminophen use is
also dependent on factors such as liver glutathione stores, nutritional state, age, and in some cases, chronicity of
usage.”).
19

FDA, Some Drugs and the Liver Don’t Mix, May 2014 (Doc. No. 49-5, Ex. E).

20

See Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:14011415 (Doc. No. 95, Ex. 6); FDA Memorandum, Aug. 15, 2002 (Doc. No. 95, Ex. 17); Characterization of
Acetaminophen Overdose and Related Hepatotoxic Events, Joint Meeting of the Drug Safety and Risk Management,

5

liver transplant.21 A person who has recovered from ALF may still be at risk of
redeveloping it, if the person again consumes too much acetaminophen.22
If acetaminophen-induced ALF is recognized quickly, acetaminophen’s antidote
(N-acetylcysteine or NAC) can be given to a patient to supply glutathione and prevent or
decrease liver injury.23 However, persons who have developed ALF from an
unintentional acetaminophen overdose may not realize their liver injury because
symptoms of ALF are not readily apparent or may look like the symptoms the
acetaminophen is being used to treat (i.e., flu symptoms).24
ii. Actions to Address Acetaminophen-Induced Acute Liver Failure
The majority of acute liver failure cases in the United States are related to the use
of acetaminophen.25 Each year, acetaminophen is responsible for hundreds of deaths and

Nonprescription and Anesthetic and Life Support Drugs Advisory Committees of the FDA, Powerpoint, Jun. 29,
2009 (Doc. No. 95, Ex. 21).
21

See Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:14011415 (Doc. No. 95, Ex. 6).
22

See Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:14011415 (Doc. No. 95, Ex. 6).
23

See Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:14011415 (Doc. No. 95, Ex. 6); Larson, et. al., Acetaminophen-Induced Acute Liver Failure: Results of a United States
Multicenter, Prospective Study, Hepatology 2005; 42(6):1364-1372 (Doc. No. 95, Ex. 7); Lee, W.M.,
Acetaminophen Toxicity: Changing Perceptions on a Social/Medical Issue, Hepatology 46(4): 966-970 (2007)(Doc.
No. 95, Ex. 9).
24

42 Fed. Reg. 35356 (Jul. 8, 1977). See also CDER Working Group Executive Summary and Recommendations,
Feb. 26, 2008 (Doc. No. 95, Ex. 8)(“The symptoms of acetaminophen overdose may not appear for up to three days,
so people may continue to take acetaminophen and increase the damage. The symptoms of liver injury may mimic
the condition that they are treating (e.g., flu symptoms).”).
25

See FDA, Some Drugs and the Liver Don’t Mix, May 2014 (Doc. No. 49-5, Ex. E); Lee, et. al. MEETING
REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:1401-1415 (Doc. No. 95, Ex. 6). See
also Larson, et. al., Acetaminophen-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective
Study, Hepatology 2005; 42(6):1364-1372 (Doc. No. 95, Ex. 7); Gerald Dal Pan, M.D., Director of Office of
Surveillance and Epidemiology, CDER/FDA, Powerpoint, Jun. 29, 2009 (Doc. No. 95, Ex. 21); A. Temple Dep. at
224 (Feb. 18, 2014)(Doc. No. 90, Ex. 1).

6

liver transplants, in addition to tens of thousands of hospitalizations.26 These
acetaminophen-induced liver injury patients include both people who are intentionally
trying to harm themselves (i.e., attempting suicide) and those who take acetaminophen
for therapeutic reasons (i.e., to treat physical pain).27 There is evidence that patients
taking acetaminophen at 4 grams per day—the recommended maximum daily dose until
recently—may be at risk of developing acute liver failure.28
Medical literature began questioning the safety of acetaminophen at or just above
therapeutic dosing levels as far back as the 1980s.29 During the 1990s, members of the
medical community continued to raise concerns about acute liver failure occurring in
patients at or even lower than the maximum daily dose of 4 grams.30

26

See FDA Background Package for June 29-30, 2009 Advisory Committee Meeting (Doc. No. 95, Ex. 8); FDA
Safety Analysis Power Point, Sept. 19, 2002 (Pl. Ex. 11). See also Lee, W.M., Acetaminophen Toxicity: Changing
Perceptions on a Social/Medical Issue, Hepatology 46(4): 966-970 (2007)(Doc. No. 95, Ex. 9); FDA Memorandum,
Aug. 15, 2002 (Doc. No. 95, Ex. 17).
27

See FDA Background Package for June 29-30, 2009 Advisory Committee Meeting (Doc. No. 95, Ex. 8); FDA
Safety Analysis Power Point, Sept. 19, 2002 (Doc. No. 95, Ex. 11); Lee, W.M., Acetaminophen Toxicity: Changing
Perceptions on a Social/Medical Issue, Hepatology 46(4): 966-970 (2007)(Doc. No. 95, Ex. 9); FDA Memorandum,
Aug. 15, 2002 (Doc. No. 95, Ex. 17); Gerald Dal Pan, M.D., Director of Office of Surveillance and Epidemiology,
CDER/FDA, Powerpoint, Jun. 29, 2009 (Doc. No. 95, Ex. 21); Characterization of Acetaminophen Overdose and
Related Hepatotoxic Events, Joint Meeting of the Drug Safety and Risk Management, Nonprescription and
Anesthetic and Life Support Drugs Advisory Committees of the FDA, Powerpoint, Jun. 29, 2009 (Doc. No. 95, Ex.
21).
28

See 71 Fed. Reg. 77314 (Dec. 26, 2006)(2006 Proposed Rule on Liver Warnings)(Doc. No. 95, Ex. 10); Larson,
et. al., Acetaminophen-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective Study,
Hepatology 2005; 42(6):1364-1372 (Doc. No. 95, Ex. 7); FDA Safety Analysis Power Point, Sept. 19, 2002 (Doc.
No. 95, Ex. 11). See also CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc.
No. 95, Ex. 8).
29

There is also evidence the McNeil executives were aware of this medical literature. See McNeil Memorandum
Nov. 19, 1987 (Doc. No. 95, Ex. 14); P. Gussin Dep., Dec. 12, 2013 at 198 (Doc. No. 95, Ex. 15).
30

See Erikkson, L.S., et al., Hepatotoxicity due to repeated intake of low doses of paracetamol, J Intern Med, 1992:
231:567-570 (Doc. No. 95, Ex. 16).

7

Throughout this same time period, McNeil was also actively engaged in the
research and development of a drug or combination of ingredients that would reduce or
eliminate acetaminophen’s potentially toxic effects on the liver.31 One alternative design
considered by McNeil was to add methionine to acetaminophen.32 Methionine could
supplement depleted glutathione in the event of an overdose.33 This drug combination
was sold abroad after concerns about acetaminophen-induced liver damage were raised in
other countries.34 It was available as early as the 1990s.35 McNeil also considered a
combination of acetaminophen with the antidote diallyl sulfone and funded a patent for
that combination in the mid-1990s.36
Neither drug combination was introduced in the United States market. The
plaintiff offers evidence that the defendants were concerned that the introduction of an
acetaminophen/antidote combination would indicate to customers that acetaminophen
alone was not as safe as it was always advertised to be.37 The defendants claim the drug

31

See A. Temple Dep., Feb. 18, 2014 at 48-49, 125-26, 164, 176-77 (Doc. No. 90, Ex. 1).

32

See A. Temple Dep., Feb. 18, 2014 at 123-24, 164, 176-77 (Doc. No. 90, Ex. 1); McNeil Memo re:
Acetaminophen Plus Methionine, Jun. 3, 1994 (Doc. No. 90, Ex. 20).
33

See A. Temple Dep., Feb. 18, 2014 at 123 (Doc. No. 90, Ex. 1); McNeil Internal Memo from P.E. Stewart, Jun.
17, 1994 (Doc. No. 90, Ex. 19).
34

See A. Temple Dep., Feb. 18, 2014 at 225 (Doc. No. 90, Ex. 1); McNeil Memo re: Acetaminophen Plus
Methionine, Jun. 3, 1994 (Doc. No. 90, Ex. 20).
35

See Letter re: Methinione Combination, Feb. 17, 1999 (Doc. No. 90, Ex. 18).

36

See McNeil Memo re: Acetaminophen Plus Methionine, June 3, 1994 (Doc. No. 90, Ex. 20); Patent application,
Dec. 12, 1995 (Doc. No. 90, Ex. 17).
37

See A. Temple Dep., Feb. 18, 2014 at 253-54 (Doc. No. 90, Ex. 1).

8

combinations had their own harmful side effects which did not make them feasible
alternatives.38
McNeil also considered creating a new drug altogether, which would have the
same therapeutic effects as acetaminophen but reduce or eliminate the risk of liver
damage.39 Research and development on that drug began in the early 1990s, was put on
hiatus in the late 1990s, and then resumed in 2009.40 That research and development
project has not produced a new drug or analog as of yet that is market-ready.41
In 2002, the FDA, which regulates OTC drugs, convened an Advisory Committee
to discuss ways to prevent liver injury caused by unintentional acetaminophen
overdose.42 During the Committee Meeting, the FDA presented findings from medical
literature: 1) that hepatotoxicity may occur “at recommended doses of APAP [or
acetaminophen],” 2) that such cases were linked to risk factors such as alcohol use and/or
fasting, and 3) that some cases of unintentional overdose led to death.43 The FDA also
presented its own findings from a review of its internal Adverse Event Reporting (AER)
database. The FDA found hepatotoxicity (i.e., liver damage) in persons who have
38

See, e.g., McNeil Memo re: Acetaminophen Plus Methionine, Jun. 3, 1994 (Doc. No. 90, Ex. 20).

39

See E. Kuffner Dep., Mar. 5, 2014 at 29-30, 32-36, 54-55 (Doc. No. 90, Ex. 3).

40

See, e.g., E. Codd, Acetaminophen Analogs: Project Update and Request for Support, Powerpoint, Jun. 17, 2010
(Doc. No. 90, Ex. 5); E. Kuffner Dep., Mar. 5, 2014 at 111-112 (Doc. No. 90, Ex. 3).
41

See Internal Emails, Nov. 14, 2011 (Doc. No. 90, Ex. 6).

42

See FDA Safety Analysis Power Point, Sept. 19, 2002 (Doc. No. 95, Ex. 11); FDA Memorandum, Aug. 15, 2002
(Doc. No. 95, Ex. 17).
43

See FDA Safety Analysis (Doc. No. 95, Ex. 11). See also Larson, et. al., Acetaminophen-Induced Acute Liver
Failure: Results of a United States Multicenter, Prospective Study, Hepatology 2005; 42(6):1364-1372 (Doc. No. 95,
Ex. 7)(explaining how fasting may enhance toxicity and how unintentional “overdose” seemed possible at
recommended dosing levels).

9

ingested less than 4 grams/day and which had risk factors like alcohol and “poor
nutritional status.”44 At that meeting, the American Association of the Study of Liver
disease (AASLD), a group of medical professionals specializing in health effects of the
liver, and the FDA offered specific recommendations for enhancing safety warnings and
instructions of acetaminophen-based products.45
In 2006, the FDA proposed a rule to strengthen warnings regarding the risk of
liver damage from taking acetaminophen. The AASLD made a public comment regarding
the proposal.46 AASLD recommended that the maximum daily dose of acetaminophen be
reduced to 3 g to “add a measure of increased safety for all patients” because
“acetaminophen has a narrow therapeutic window.”47 After receiving and reviewing
public comments, the FDA promulgated a final rule outlining the liver warnings it found
to be necessary. 48 This final rule, issued in 2009, is explained further below.
In February 2008, the Acetaminophen Hepatotoxicity Working Group for the
Center for Drug Evaluation and Research (CDER) of the FDA met to discuss ways to
address unintentional acetaminophen overdose.49 The Group outlined several
44

See FDA Safety Analysis at Slide 44 (Doc. No. 95, Ex. 11). This data was later published in the Federal Register
as part of FDA’s Proposed Rule for the 2009 Label Change, discussed below. See 71 Fed. Reg. 77314 (Dec. 26,
2006)(Doc. No. 95, Ex. 10).
45

See FDA Safety Analysis at Slide 44 (Doc. No. 95, Ex. 11).

46

See also AASLD Public Comment, Apr. 27, 2007 (Doc. No. 95, Ex. 19).

47

See AASLD Public Comment to FDA on Proposed Rule, Apr. 27, 2007 (Doc. No. 90, Ex. 12).

48

See also Gerald Dal Pan, M.D., Director of Office of Surveillance and Epidemiology, CDER/FDA, Powerpoint,
Jun. 29, 2009 (Doc. No. 95, Ex. 21)(offering the history of the FDA’s efforts to address unintentional
acetaminophen-induced ALF).
49

CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 13).

10

recommendations, including a reduction in the maximum tablet strength from 500 mg to
325 mg.50 The reduction in tablet strength was intended to reduce the overall
recommended daily dose of Tylenol from 4,000 mg to 3,250 mg. 51 This recommendation
was made over the objection of an unnamed acetaminophen manufacturer which asserted
the data did not support a need for the change; the Group looked at Adverse Events
Reports (AERs) showing that daily doses of 4 grams presented a risk for some
individuals.52 Survey data also showed that “people routinely and knowingly take more
than the recommended dose of OTC pain relievers.”53
In June 2009, several advisory committees within the FDA held a joint meeting to
discuss the issue of liver injury related to acetaminophen use.54 At that meeting, the
committee members voted to recommend that the current maximum single dose of OTC
acetaminophen (i.e., 2 x 500 mg) be made available only by prescription.55 If this
recommendation were put into effect, Extra Strength Tylenol could only be sold by
prescription according to its current dosing. The majority of committee members

50

CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 13).

51

CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 13).

52

See CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 13).

53

CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 13).

54

See FDA, CDER, Joint Meeting of the Drug Safety and Risk Management Advisory Committee, NDAC, and the
Anesthetic and Life Support Drugs Advisory Committee, Questionnaire (Doc. No. 90, Ex. 14).
55

See FDA, CDER, Joint Meeting of the Drug Safety and Risk Management Advisory Committee, NDAC, and the
Anesthetic and Life Support Drugs Advisory Committee, Questionnaire (Doc. No. 90, Ex. 14).

11

recommended that the maximum single dose of acetaminophen be lowered to 650 mg
(i.e., two tablets of Regular Strength Tylenol).56
In response, McNeil proposed changing its dosing instructions to recommend that
consumers take one tablet, wait to see if that was effective at relieving pain, and then take
a second tablet if needed. This concept, known as dose titration, was one McNeil already
had included on other products such as Motrin.57 McNeil never implemented “dose
titration” on Extra Strength Tylenol instructions though the FDA approved this change.
b. THE REGULATORY FRAMEWORK FOR TYLENOL
OTC drugs are approved by the FDA through two separate routes: the New Drug
Application (NDA) process and the monograph system.58 During the forty or so years
Extra Strength Tylenol has been available OTC, it has been regulated under both FDA
regulatory processes that may govern OTC drugs.

56

See FDA, CDER, Joint Meeting of the Drug Safety and Risk Management Advisory Committee, NDAC, and the
Anesthetic and Life Support Drugs Advisory Committee, Questionnaire (Doc. No. 90, Ex. 14).
57

See McNeil’s Presentation to Joint Meeting of the Drug Safety and Risk Management Advisory Committee,
Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee, Jun.
29-20, 2009, Powerpoint at C-8, C-63 (Doc. No. 95, Ex. 22)(“Clinical trial data confirms that 1000 mg is more
efficacious than 650 mg”). See also McNeil Powerpoint Response regarding Advisory Committee Meeting on Jun.
29-30, 2009 (Doc. No. 95, Ex. 23); E. Kuffner, McNeil’s Presentation to Joint Meeting of the Drug Safety and Risk
Management Advisory Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life
Support Drugs Advisory Committee, Jun. 29, 2009 (Doc. No. 95, Ex. 50)(“McNeil is recommending changing the
current dosing directions on both the 325-milligram and 500-milligram formulations, seen here on your left, from
take two tablets every four to six hours while symptoms last, to the proposed directions shown on the right, take one
tablet, and if pain or fever does not respond to one tablet, two tablets may be needed. This dose titration model is
identical to the directions on the current over-the-counter ibuprofen label. This significant change will encourage
patients to use the lowest effective dose and should, therefore, decrease overall acetaminophen exposure within the
general population.”); Letter from FDA to McNeil re: Proposed Dose Titration Instructions, Jun. 10, 2010 (Doc. No.
95, Ex. 51)(“The proposed maximum dose of no more than 3000 mg acetaminophen per 24 hours is allowed the
tentative final monograph (TFM)…. The doses and dosing intervals in the proposed titration directions, to take 500
mg every 4 to 6 hours while symptoms persist and a maximum of 1000 mg every 4 to 6 hours if pain or fever does
not respond to 500 mg, are all at levels allowable under the TFM.”).
58

E.g., “How Drugs are Developed and Approved – OTC (Nonprescription) Drugs,”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm209

12

i. New Drug Application v. Monograph Process
The NDA process requires specific products be approved for sale with specific
labeling. 59 The monograph system allows for the marketing of OTC drugs containing
particular ingredients, which were already on the market before the FDA established the
monograph system in 1972.60 These active ingredients, which include acetaminophen,

647.htm; “How Drugs are Developed and Approved – Over-the-Counter (OTC) Drug Monograph Process,”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand
Approved/ucm317137.htm; Gerald Dal Pan, M.D., Director of Office of Surveillance and Epidemiology,
CDER/FDA, Powerpoint, Jun. 29, 2009 (Doc. No. 95, Ex. 21).
A detailed recitation of the regulatory process and history is also included in: the Declaration of Judith Jones, Ph.D.
(May 20, 2015)(Doc. 49-19 to 49-28); FDA/CDER, Guidance for FDA Staff and Industry, Marketed Unapproved
Drugs—Compliance Policy Guide, Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs, Sep.
19, 2011 (Doc. 49-20)(Ex. C attached to J. Jones Report, Def. Ex. S); the expert report of Cheryl Blume, Ph.D. (May
5, 2014)(Doc. No. 95, Ex. 26), and the Affidavit of Gerald Rachanow, Esq. (Doc. No. 95, Ex. 25). All three
experts—Jones (for the defendants) and Blume and Rachanow (for the plaintiff)—have offered expert opinions
about the FDA’s regulatory process. Each side has filed a Daubert motion to exclude the other’s opinion(s); these
Daubert motions are still pending.
59

E.g., “How Drugs are Developed and Approved – OTC (Nonprescription) Drugs,”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm209
647.htm; “How Drugs are Developed and Approved – Over-the-Counter (OTC) Drug Monograph Process,”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand
Approved/ucm317137.htm.
See also Mut. Pharm. Co., Inc. v. Bartlett, – U.S. –, 133 S. Ct. 2466, 2470-71 (2013)(“An NDA is a compilation of
materials that must include ‘full reports of [all clinical] investigations,’ § 355(b)(1)(A), relevant nonclinical studies,
and ‘any other data or information relevant to an evaluation of the safety and effectiveness of the drug product
obtained or otherwise received by the applicant from any source,’ 21 C.F.R. §§ 314.50(d)(2) and (5)(iv) (2012). The
NDA must also include ‘the labeling proposed to be used for such drug,’ 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. §
314.50(c)(2)(i), and ‘a discussion of why the [drug's] benefits exceed the risks under the conditions stated in the
labeling,’ 21 C.F.R. § 314.50(d)(5)(viii); § 314.50(c)(2)(ix). The FDA may approve an NDA only if it determines
that the drug in question is ‘safe for use’ under ‘the conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof.’ 21 U.S.C. § 355(d).”); In re: Fosamax, 751 F.3d 150, 159 (3d Cir. 2014)(“Under the
FDCA, a manufacturer must seek approval from the United States Food and Drug Administration (‘FDA’) to market
a new drug and, in doing so, must first file a New Drug Application (‘NDA’) and then prove the drug's safety and
efficacy and propose accurate and adequate labeling. 21 U.S.C. § 355(b)(1), (d).”); In re: Celexa and Lexapro
Marketing & Sales Pracs. Litig., 779 F.3d 34, 35-36 (1st Cir. 2015).
60

See “How Drugs are Developed and Approved – Over-the-Counter (OTC) Drug Monograph Process,”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand
Approved/ucm317137.htm.

13

were ones which had been found to be generally safe and effective through general
usage.61 Therefore, they were allowed to remain on the market OTC.
Because Extra Strength Tylenol’s active ingredient is acetaminophen, it was
automatically regulated by the monograph system as of 1972. In 1975, the FDA approved
Extra Strength Tylenol as “safe and effective for use as recommended in the submitted
labeling,” pursuant to a New Drug Application (NDA 17-552).62 In the FDA’s letter
approving Extra Strength Tylenol for OTC sale and use under the NDA, the FDA also
noted that “upon publication in the FEDERAL REGISTER of the OTC Monograph for
acetaminophen, revision of the labeling or other action affecting the marketing of [Extra
Strength Tylenol] may be required.”63 In 1998, McNeil voluntarily withdrew the NDA
for Extra Strength Tylenol.64 Since that time, Extra Strength Tylenol has been marketed
pursuant to the monograph system only.65
The monograph system is essentially an expanded version of administrative
notice-and-comment rulemaking, which required two rounds of proposals and comments

61

E.g., “How Drugs are Developed and Approved – OTC (Nonprescription) Drugs,”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm209
647.htm; “How Drugs are Developed and Approved – Over-the-Counter (OTC) Drug Monograph Process,”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand
Approved/ucm317137.htm.
62

FDA Approval letter (Hewes Decl. at Ex. 1)(Doc. No. 49-6, Ex. F). See also Defendants’ Statement of Material
Facts, Material Fact No. 10; Plaintiff’s Statement admitting fact.
63

FDA Approval letter (Hewes Decl. at Ex. 1)(Doc. No. 49-6, Ex. F).

64

Doc. No. 49, Ex. T-U attached to Jones Decl., Ex. S (May 1998 communications from McNeil requesting
withdrawal of approved NDA, and FDA letter in response acknowledging withdrawal).
65

Doc. No. 49, Ex. S and Ex. T attached to Jones Decl. (McNeil letter withdrawing NDA)(“We intend to continue to
market Extra Strength TYLENOL® Tablets as an OTC monograph product and will continue to submit
acetaminophen Adverse Drug Experience reports under NDA 19-872.”).

14

as opposed to just one. The monograph process includes four main steps: 1) a review by a
panel of qualified experts which then recommend the conditions under which the drug
can be used, 2) publication of the expert panel’s recommendations in the form of a
proposed rule in the Federal Register for public comment, 3) FDA review of the
comments on the experts’ proposed rule and publication of a tentative final monograph
(TFM) with a second opportunity for comments on the TFM, and 4) publication of the
final monograph which includes the FDA’s findings on when a drug is considered to be
generally safe and effective for use.66 See 21 C.F.R. § 330.10. A drug is considered
“safe” under the monograph system when it has “a low incidence of adverse reactions or
significant side effects under adequate directions for use and warnings against unsafe use
as well as low potential for harm which may result from abuse under conditions of
widespread availability.” 21 C.F.R. § 330.10(a)(4).
ii. Regulation of Acetaminophen Under the Monograph System
In 1972, acetaminophen was listed as “an effective analgesic” under the Drug
Efficacy Study Implementation program implemented by the FDA, which was the first
phase of what would become the monograph process.67 In 1977, the FDA published a
Proposed Rule for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Products
reflecting the Advisory Panel’s report on this category of ingredients.68 This Rule

66

See also Gerald Dal Pan, M.D., Director of Office of Surveillance and Epidemiology, CDER/FDA, Powerpoint,
Jun. 29, 2009 (Doc. No. 95, Ex. 21).
67

Fed. Reg. 7820 (Apr. 20, 1972)(Doc. No. 49, Ex. T).

68

42 Fed. Reg. 35346 (July 8, 1977)(Pl. Ex. B attached to Ex. 3 (Affidavit of Gerald Rachanow, Esq.)) and (Def.
Ex. I attached to Ex. S (Certification of Judith Jones, M.D., Ph.D.)).

15

categorized acetaminophen as a Category I active ingredient, meaning that it was
“generally recognized as safe and effective” or GRASE. That proposed rule made clear
that warnings on products containing those ingredients were still important: “[b]ecause
OTC products can be purchased by anyone [and] the public generally does not regard
those products as medicines which, if used improperly, can result in injurious or
potentially serious consequences.”69 The rule explained: “The consumer should be
informed of any possible signs of known toxicity or any indication requiring
discontinuation of the use of the drug so that appropriate steps may be taken before more
severe symptoms become apparent.”70 Specifically, the Proposed Rule noted:
“acetaminophen has no [] sign of toxicity or ‘safety valve’ to alert the consumer [to the
development of ALF].”71 For this reason, the Proposed Rule recommended that all
products containing acetaminophen contain the warning, “Do not exceed recommended
dosage because severe liver damage may occur.”72 The Proposed Rule also stated that a
single dose of acetaminophen (2 tablets) containing 500 mg—i.e., Extra Strength
69

42 Fed. Reg. 35355 (July 8, 1977).

70

42 Fed. Reg. 35355 (July 8, 1977).

71

42 Fed. Reg. 35356 (July 8, 1977). See also CDER Working Group Executive Summary and Recommendations,
Feb. 26, 2008 (Doc. No. 95, Ex. 8)(“The symptoms of acetaminophen overdose may not appear for up to three days,
so people may continue to take acetaminophen and increase the damage. The symptoms of liver injury may mimic
the condition that they are treating (e.g., flu symptoms).”); FDA, Some Drugs and the Liver Don’t Mix, May 2014
(Doc. No. 49-5, Ex. E)(describing symptoms of liver problems as fatigue, jaundice, and itchiness of the skin).
72

42 Fed. Reg. 35356, 35447 (July 8, 1977). The Proposed Rule also noted that acetaminophen advertising may
indicate that it is a safer product, when in fact, it may not be under certain circumstances. See id. The Rule went
further: “Because the consumer needs to be correctly and fully informed, the Panel recommends that the advertising
in any medium for these drugs that in any way uses the labeling, package or container not be inconsistent, even in
subtle implication through mood, focus or innuendo, with the applicable labeling in the OTC internal analgesic
monograph.” Id. Though the Proposed Rule recognized that the FTC regulated commercial advertising, it “strongly
urge[d] the [FTC] to require that the cautionary language and warnings developed by the Panel be given emphasis in
commercial advertising more so than is currently being done…” Id.

16

Tylenol—should be taken every 6 hours while a single dose of 325 mg tablets could be
taken every 4 hours.73
On November 16, 1988, the FDA issued a Tentative Final Monograph (TFM) for
Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) products, including
acetaminophen.74 In the TFM, the FDA reviewed comments on the 1977 Proposed Rule
and determined which parts remained valid and which it declined to adopt. Though the
FDA made its recommendations for regulating IAAA products, the TFM was still
considered proposed regulation subject to additional comments.75 In the TFM, the FDA
continued to categorize acetaminophen under Category I: GRASE.76 It adopted the
Panel’s recommended dosing as well.77 Specifically, products containing acetaminophen
were expected to have the following dosing instructions for adults: “325 to 650
milligrams every 4 hours or 325 to 650 milligrams every 3 hours or 650 to 1,000
milligrams every 6 hours, while symptoms persist, not to exceed 4,000 milligrams in 24
hours or as directed by a doctor.”78 It also “tentatively decided not to adopt the liver

73

See 42 Fed. Reg. 35358 (July 8, 1977)(chart).

74

53 Fed. Reg. 46204, 46248 (Nov. 16, 1988).

75

See 21 C.F.R. §§ 310, 343, 369, 53 Fed. Reg. 46204, 46248, 46254 (Nov. 16, 1988)(TFM)(Doc. No. 95, Ex. 48;
Ex. C attached to Ex. 3 (Affidavit of Gerald Rachanow, Esq.)) or (Def. Ex. J attached to Ex. S (Certification of
Judith Jones, M.D., Ph.D.)); FDA Letter re: FOIA request, Nov. 17, 2011 (Doc. No. 95, Ex. 4).
76

53 Fed. Reg. 46249 (Nov. 16, 1988).

77

53 Fed. Reg. 46251 (Nov. 16, 1988).

78

53 Fed. Reg. 46257 (Nov. 16, 1988).

17

warning recommended by the Panel” though the FDA was “aware that liver damage can
occur from acetaminophen overdosage.”79
The FDA has not yet issued a Final Monograph for IAAA products. These
products, including those containing acetaminophen, continue to operate under the
Tentative Final Monograph (TFM). During the relevant timeframe of this case, Extra
Strength Tylenol was only regulated by the TFM.80 The FDA has explained: “Under a
TFM, manufacturers market products at their own risk and are able to make voluntary
adjustments [to their product’s dosing] taking into account the information presented in
the proposed TFM.”81 Until that final regulatory determination is made—if it ever is—the
defendants remain responsible for all aspects of the Tylenol label.82
c. CHANGES IN EXTRA STRENGTH TYLENOL DOSING
From 1977 until 2011, Extra Strength Tylenol was marketed with dosing
instructions that differed from what was prescribed by the TFM. Extra Strength Tylenol
bottles instructed consumers to take two tablets every 4 to 6 hours.83 The TFM

79

53 Fed. Reg. 46214, 46252 (Nov. 16, 1988).

80

See FDA Letter re: FOIA request, Nov. 17, 2011 (Doc. No. 95, Ex. 4).

81

See FDA Letter re: FOIA Request, Nov. 17, 2011 (Doc. No. 95, Ex. 4). See also E. Kuffner Dep., Mar. 18, 2011
at 8-10 (Doc. No. 95, Ex. 5)(explaining what duties a drug manufacturer has when new risks come to light in postmarket surveillance); Wyeth v. Levine, 555 U.S. 555, 570-71 (2009)(“[I]t has remained a central premise of federal
drug regulation that the manufacturer bears responsibility for the content of its label at all times.”)(discussed further
below).
82

See McNeil letter to the FDA re: label change, Jan. 27, 1995 (Doc. No. 49, Ex. Q attached to Ex. S (Certification
of Judith Jones, M.D., Ph.D.))(“We believe that the language we are using in the Directions section of our labeling is
acceptable since the issue has not yet been finalized in the final monograph for Internal Analgesic Products.”)
(debating FDA’s recommendation that language in McNeil’s label be changed to conform with the TFM language
on dosing).
83

See 2007 Extra Strength Tylenol label (Doc. No. 90, Ex. 11).

18

recommended consumers take two tablets every 6 hours. In 1994, when McNeil sought
approval from the FDA to add an alcohol warning to the Extra Strength Tylenol label,
the FDA informed McNeil that the Extra Strength Tylenol label was not in conformity
with the TFM because it instructed consumers to take 2 caplets “every 4-6 hours” as
opposed to every 6 hours.84 McNeil objected to the claimed deficiency in the instructions.
McNeil continued to recommend consumers dose every 4 to 6 hours, as opposed to every
6 hours in accord with the TFM.85
In July 2011, McNeil voluntarily changed the dosing instructions on Extra
Strength Tylenol.86 McNeil had previously opposed reducing the daily dose when the
change was recommended years before.87 This change was made to “lessen the
84

See FDA Letter/Fax to McNeil, Nov. 23, 1994 (Doc. No. 95, Ex. E attached to Ex. 3 (Affidavit of Gerard
Rachanow, Esq.)); FDA Letter to McNeil, Mar. 31, 1997 (Doc. No. 95, Ex. F attached to Ex. 3 (Affidavit of Gerard
Rachanow, Esq.)). McNeil did not agree with the FDA’s determination. See McNeil letter to the FDA re: label
change , Jan. 27, 1995 (Doc. No. 49, Ex. Q attached to Ex. S (Certification of Judith Jones, M.D., Ph.D.))(“We
believe that the language we are using in the Directions section of our labeling is acceptable since the issue has not
yet been finalized in the final monograph for Internal Analgesic Products.”).
The FDA again sent a letter stating that the label dosing at 4 to 6 hours was not in compliance with the TFM. See
FDA Letter to McNeil, Mar. 31, 1997 (Doc. No. 49, Ex. R attached to Ex. S (Certification of Judith Jones, M.D.,
Ph.D.))(“The dosage recommendations are not consistent with the tentative final monograph or supported in the
application. The second sentence should be revised to read, “Take two tablets every 6 hours.”). On July 21, 1997,
the FDA then did send a letter to McNeil not to implement any of the changes in the previous two letters until the
FDA has instructed them to. See Def. Ex. S attached to Ex. S (Certification of Judith Jones, M.D., Ph.D.)).
Because the TFM is only a proposed rule not a final one, McNeil’s decision to provide different dosing instruction
would not be per se negligence. However, McNeil’s decision to intentionally label Extra Strength Tylenol with
instructions that could cause a person to consume more than the TFM’s daily recommended dose is evidence that
could lead a reasonable jury to believe that McNeil breached its duty to market a safe product.
85

See 2007 Extra Strength Tylenol label (Doc. No. 90, Ex. 11).

86

See Dear Doctor Letter (Doc. No. 90, Ex. 8). While this evidence would typically be excluded under the Federal
Rules of Evidence as a subsequent remedial measure, this information can be used to rebut the defendants’ defense
of impossibility. See FED. R. EVID. 407.
87

See E. Kuffner, McNeil’s Presentation to Joint Meeting of the Drug Safety and Risk Management Advisory
Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory
Committee, Jun. 29. 2009 (Doc. No. 95, Ex. 50)(“We disagree with FDA's options to completely eliminate over-thecounter access to the 1,000-milligram single adult dose and the 4,000-milligram maximum daily dose.”).

19

possibility of accidental acetaminophen overdose.”88 McNeil changed dosing from “4 to
6 hours” to “6 hours” as outlined in the TFM.89 McNeil also changed the maximum daily
dose from 8 caplets to 6 caplets, lowering the maximum daily recommended dose from 4
grams to 3 grams.90 In a letter to doctors about the dosing change, McNeil explained that
“1,000 mg has been demonstrated to provide effective relief at 6 hours.”91
In order to implement that change, McNeil worked with “other manufacturers of
acetaminophen products to help ensure consistency in dosing instructions.”92 According
to McNeil, the change was not a response to the FDA’s decision in January 2011 to limit
the amount of acetaminophen in prescription combination products. 93 As the FDA
explained, “McNeil’s voluntary act to reduce the maximum daily dose for Extra Strength
Tylenol® is a measure that can be commonly taken under the over-the-counter TFM and
is in accordance with the provisions of the IAAA TFM.”94

88

See Dear Doctor Letter (Doc. No. 90, Ex. 8).

89

See Dear Doctor Letter (Doc. No. 90, Ex. 8).

90

See Dear Doctor Letter (Doc. No. 90, Ex. 8).

91

See Dear Doctor Letter (Doc. No. 90, Ex. 8). See also Christina Chang, M.D., M.P.H., Division of
Nonprescription Clinical Evaluation, Office of Nonprescription Products, of the FDA, Powerpoint, Jun 29, 2009
(Doc. No. 95, Ex. 21)(questioning whether 1000 mg is much more effective than 650 mg); Jane Filie, M.D., Medical
Officer, Div. of Analgesia and Rheumatology Products of the FDA, Powerpoint, Jun. 29, 2009 at 120 (Doc. No. 95,
Ex. 21)(“Little data to support value of using products with 500 mg (1000 mg dose) over products with 325 mg (650
mg dose.”). But see McNeil’s Presentation to Joint Meeting of the Drug Safety and Risk Management Advisory
Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory
Committee, Jun. 29-20, 2009, Powerpoint (Doc. No. 95, Ex. 22)(“Clinical trial data confirms that 1000 mg is more
efficacious than 650 mg”); Transcript of Comments from Kuffner related to Powerpoint, Jun. 29, 2009 (Doc. No. 95,
Ex. 50).
92

See Dear Doctor Letter (Doc. No. 90, Ex. 8).

93

See Dear Doctor Letter (Doc. No. 90, Ex. 8).

94

FDA Letter re: FOIA Request, Nov. 17, 2011 (Doc. No. 95, Ex. 4).

20

II. OVERVIEW OF PLAINTIFF’S CLAIMS
a. FACTS REGARDING DENICE HAYES’S DEATH
Plaintiff Rana Terry brings this wrongful death and products liability action on
behalf of her deceased sister’s estate.95 Her sister Denice Hayes died on August 31,
2010.96 Denice was a single woman living with another sister Rebecca Hayes; the two
had lived together for most of her life, up until the time of Denice’s death.97 Denice was
not working at the time of her death due to health problems. Prior to leaving the
workforce in 2008 for health reasons, she was employed as a teacher for several years.98
Denice’s medical history included weight issues, back and leg pain, high blood
pressure, and type II diabetes.99 Denice had taken Extra Strength Tylenol periodically for
years to treat some of these health conditions with no adverse effects.100 She allegedly
preferred Extra Strength Tylenol to Regular Strength Tylenol.101 Rebecca typically did
the shopping for both she and her sister. Rebecca was unaware of the difference between

95

See Plaintiff’s Fact Sheet (Doc. No. 49-8, Ex. G).

96

See Plaintiff’s Fact Sheet (Doc. No. 49-8, Ex. G).

97

See R. Hayes Dep. at 191 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

98

See Plaintiff’s Fact Sheet (Doc. No. 49-8, Ex. G.).

99

R. Hayes Dep. at 201 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

100

Defendants’ Statement of Facts, Material Fact No. 3; Plaintiff’s Response admitting this fact. R. Hayes Dep. at
120-123 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1)(agreeing that Ms. Hayes used Tylenol without any adverse
effects for pain relief for at least 20 years before her death because it was safe and did not upset her stomach). In
addition, Dr. Rex Sherer, who performed Ms. Hayes’s 2009 gastric bypass surgery, testified to Ms. Hayes’s chronic
use of acetaminophen without incident. See R. Sherer, M.D. Dep., Mar. 23, 2015 at 76 (Doc. No. 49, Ex. O). See
also A. Anantharaju, M.D. Dep., Oct. 15, 2014 at 23-27, 28-30, 32, 37-39, 65-66, 71 (Doc. No. 49, Ex. P).
101

See R. Hayes Dep. at 39 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

21

Extra Strength Tylenol’s dosage and that of Regular Strength.102 However, she purchased
Tylenol over its generic version because she and her sister thought Tylenol was a better,
safer product.103 The two sisters often watched television together and viewed ads for
Tylenol.104 According to Rebecca, Denice believed Tylenol was easier on the stomach
based on advertising about the product.105
In August 2009, Denice underwent gastric bypass surgery to rectify her ongoing
health problems.106 After the surgery, she lost 180 pounds; she was able to stop taking her
medications for high blood pressure and diabetes.107 She used painkillers less than before
because her back and leg pain had lessened.108 In June 2010, she had a fall which
exacerbated her back pain.109
In mid-August 2010, Denice underwent lumbar laminectomy surgery.110 She was
instructed by her doctor to take Regular Strength Tylenol in conjunction with Lorcet, a
prescription drug containing acetaminophen, and was not to exceed 4 grams of

102

R Hayes Dep. at 114 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

103

R. Hayes Dep. at 127, 130 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

104

R. Hayes Dep. at 191-193, 199-200 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

105

R Hayes Dep. at 129-31 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

106

See R. Hayes Dep. at 50-53 (Doc. No. 49-9, Ex. I)(explaining how decedent was about 400 pounds at time of
surgery and over 200 pounds at time of death), 200-201 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).
107

See R. Hayes Dep. at 201, 229(Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1); R. Sherer, M.D. Dep. at 74-75
(Doc. No. 49-15, Ex. O)(explaining Denice’s conditions post gastric surgery).
108

R. Hayes Dep. at 201, 229 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

109

R. Hayes Dep. at 201-202 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1); R. Terry Dep. at 53 (Doc. No. 49-9,
Ex. I).
110

See R. Hayes Dep. at 156-57 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

22

acetaminophen in a 24-hour period.111 Denice took Extra Strength Tylenol from August
12, 2010 to August 29, 2010 at “appropriate times and in appropriate amounts.”112 She
allegedly took tablets from a medium-sized bottle Rebecca had purchased the previous
August to treat Denice’s gastric bypass surgery pain.113 That bottle was shared by the two
sisters during that year.114 Denice allegedly used that bottle until it ran out. Rebecca
purchased another bottle of Extra Strength Tylenol for her sister on August 28, 2010.115
After her surgery, Ms. Hayes also began taking Lorcet as instructed by her doctor.
However, she allegedly stopped taking Lorcet at some point before her death because she
didn’t like its side effects.116 She continued to only take Extra Strength Tylenol because
she thought it was gentler on her stomach.117

111

See R. Hayes Dep. at 156-57, 159-160 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

112

Doc. No. 28 (Short Form Compl. ¶10); Plaintiff Fact Sheet at 11-12 (redacted)(Doc. No. 49, Ex. H); Defendants’
Statement of Facts, Material Fact No. 5; Plaintiff’s Statement admitting this fact (as quoted from the plaintiff’s
complaint). However, plaintiff also admits that no fact witness has personal knowledge that Ms. Hayes took her
Extra Strength Tylenol as directed. See Defendants’ Statement of Material Facts, Material Fact No. 4; Plaintiff’s
Statement admitting this fact.
113

R. Hayes Dep. at 189, 229 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1). According to Rebecca, she had
purchased a medium-sized bottle of about 100 to 120 caplets of Extra Strength Tylenol in August 2009. Id.
114

R. Hayes Dep. at 122, 189 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

115

R. Hayes Dep. at 147, 230 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1). According to Rebecca, Extra Strength
Tylenol was all that was available; Regular Strength Tylenol was not being sold at the WalMart where she
purchased the product. R. Hayes Dep. at 207 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1). See also R. Terry Dep.
at 38 (Doc. No. 49-9, Ex. I).
116

See R. Hayes Dep. at 34-36, 60, 67, 203-205 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1). Denice also was
prescribed hydrocodone with acetaminophen which she took right after she was discharged from her back surgery
on August 12, 2010. See R. Hayes Dep. at 156 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1). At what point
between August 12th and 29th Denice stopped taking Lorcet is in dispute.
117

R. Hayes Dep. at 34-36, 60, 67, 203-205 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

23

Between August 12, 2010 and August 31, 2010, Denice was in and out of the
hospital.118 She was admitted to the hospital overnight on August 20, 2010 for “nausea,
vomiting, and impending dehydration.”119 She was experiencing back and rectal pain.120
She was released on August 23, 2010.121 During the week of August 23, 2010, Denice
continued to experience symptoms of nausea and vomiting.122 She was having trouble
eating solid foods.123 She allegedly took three to four doses of Extra Strength Tylenol
each day during that week.124 During this timeframe, Denice was cared for by several
members of her family.125
Denice was again admitted to the hospital on August 29, 2010.126 The doctor
diagnosed her with acute liver failure “most likely [from] accidental Tylenol overuse”
and treated her with the acetaminophen antidote.127 Denice died in the hospital two days

118

See R. Terry Dep. at 38 (Doc. No. 49-9, Ex. I); R. Hayes Dep. at 38-41 (Doc. No. 49-10, Ex. J and Doc. No. 95,
Ex. 1).
119

See R. Terry Dep. at 38 (Doc. No. 49-9, Ex. I); R. Hayes Dep. at 38-41, 58-61, 76, 162, 205 (Doc. No. 49-10, Ex.
J and Doc. No. 95, Ex. 1).
120

See R. Hayes Dep. at 38 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

121

See R. Hayes Dep. at 162-163 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

122

See R. Hayes Dep. at 56-57 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

123

See R. Hayes Dep. at 46, 56, 66-67, 237-238 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

124

R. Hayes Dep. at 209-210, 226-227 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

125

See R. Terry Dep. at 38-40 (Doc. No. 49-9, Ex. I); R. Hayes Dep. at 34-35, 39-40, 46, 56-57, 74; Plaintiff’s Fact
Sheet (Doc. No. 49-8, Ex. G).
126

See R. Hayes Dep. at 38-41, 58-61, 76 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

127

R. Hayes Dep. at 76, 171 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1).

24

later. Her cause of death is listed as “liver failure” caused by “acetaminophen
intoxication.”128
b. PLAINTIFF’S CLAIMS
In January 2012, Ms. Terry filed suit against Johnson & Johnson and McNeil
asserting, inter alia, a design defect claim. According to the plaintiff, the defendants
knew that Tylenol could cause liver damage at or just above the recommended dose,
especially when a person has been fasting or malnourished. The plaintiff claims the
defendants are liable for Denice’s death because they failed to design Extra Strength
Tylenol in such a way to reduce or eliminate the risk of liver damage to consumers. The
plaintiff offers several alternative designs that the defendants could have implemented.
The defendants move for summary judgment, arguing that the plaintiff cannot
offer sufficient evidence at trial to support her design defect claim. The defendants also
argue that the plaintiff’s design defect claim is impliedly preempted by Mutual
Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466 (2013).
III.

SUMMARY JUDGMENT STANDARD

Summary judgment is appropriate “if the movant shows that there is no genuine
dispute as to any material fact and that the movant is entitled to judgment as a matter of
law.” FED. R. CIV. P. 56(a). A dispute is “genuine” when “a reasonable jury could return
a verdict for the nonmoving party” based on the evidence in the record. Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A factual dispute is “material” when it
“might affect the outcome of the suit under the governing law.” Id.
128

See Denice Hayes Death Certificate (Doc. No. 45, Ex. A).

25

A party seeking summary judgment initially bears responsibility for informing the
court of the basis for its motion and identifying those portions of the record that “it
believes demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v.
Catrett, 477 U.S. 317, 323 (1986). Where the non-moving party bears the burden of proof
on a particular issue at trial, the moving party's initial Celotex burden can be met simply
by demonstrating to the district court that “there is an absence of evidence to support the
non-moving party’s case.” Id. at 325. After the moving party has met its initial burden,
the adverse party’s response must cite “particular parts of materials in the record,
including depositions, documents, electronically stored information, affidavits or
declarations, stipulations (including those made for purposes of the motion only),
admissions, interrogatory answers, or other materials.” FED. R. CIV. P. 56(c)(1).
Summary judgment is therefore appropriate when the non-moving party fails to rebut by
making a factual showing that is “sufficient to establish the existence of an element
essential to that party's case, and on which that party will bear the burden of proof at
trial.” Celotex, 477 U.S. at 322. 129
129

Alabama law governs the plaintiff's design defect claim. This standard is the same as the summary judgment
standard found in Alabama law. Alabama law requires that “proof by substantial evidence shall be required to
submit an issue of fact to the trier of the facts [for motions for summary judgment in all civil actions].”Ala.Code
1975 § 12-21-12. “‘Substantial evidence’ has been defined as 'evidence of such weight and quality that fair-minded
persons in the exercise of impartial judgment can reasonably infer the existence of the fact sought to be proved.’”
Mixon By and Through Mixon v. Houston County, 598 So.2d 1317, 1318 (Ala. 1992)(quoting West v. Founders
Life Assurance Co. of Florida, 547 So.2d 870, 871 (Ala. 1989)).
The moving party has the burden to make a prima facie case that no genuine dispute of material fact exists. When
the burden of proof at trial is on the non-moving party at the summary judgment stage—as is the case here—the
moving party “may satisfy the Rule 56 burden of production either by submitting affirmative evidence that negates
an essential element in the nonmovant's claim or, assuming discovery has been completed, by demonstrating to the
trial court that the nonmovant's evidence is insufficient to establish an essential element of the nonmovant's claim.”
Verchot v. General Motors Corp., 812 So.2d 296, 300 (Ala. 2001)(quoting Ex parte General Motors Corp., 769
So.2d 903, 909 (Ala.1999)(citations and quotation marks omitted))(emphasis in original). The non-movant then has
the burden to put forth sufficient evidence to prove each element of her claims. Id. This evidence is then considered

26

Under Rule 56 of the Federal Rules of Civil Procedure, the court must draw “all
justifiable inferences” in favor of the non-moving party. Anderson, 477 U.S. at 255. The
court must decide “not whether . . . the evidence unmistakably favors one side or the
other but whether a fair-minded jury could return a verdict for the plaintiff on the
evidence presented.” Id. at 252. If the non-moving party has produced more than a “mere
scintilla of evidence” demonstrating a genuine issue of material fact, then the court may
not credit the moving party’s “version of events against the opponent, even if the quantity
of the [moving party's] evidence far outweighs that of its opponent.” Big Apple BMW,
Inc. v. BMW of N. Am., Inc., 974 F.2d 1358, 1363 (3d Cir. 1992).
IV. The Plaintiff Has Offered Sufficient Evidence of Her Design Defect Claim
Alabama law governs all of the plaintiff’s claims. See Choice of Law Decision,
May 20, 2015 (Doc. No. 41, 42).
a. Alabama Products Liability Law (AEMLD)
Alabama's products liability doctrine is known as Alabama Extended
Manufacturer's Liability Doctrine (AEMLD). The AEMLD is a hybrid liability doctrine
which follows the tenets of Restatement 402A but allows defendants to show fault

in the light most favorable to the non-movant and all reasonable doubts resolved against the moving party. See id. In
other words, if the plaintiff as the non-movant cannot produce sufficient evidence to show her claim could be
successfully established at trial, the defendants are entitled to summary judgment. See Verchot v. General Motors
Corp., 812 So.2d 296, 300 (Ala. 2001)(“If the nonmovant cannot produce sufficient evidence to prove each element
of its claim, the movant is entitled to a summary judgment, for a trial would be useless.”)(citations and quotation
marks omitted)).
This standard is slightly different than if the party moving for summary judgment is also the party with the burden of
proof at trial. If the movant were the plaintiff, she would be expected to put forth “credible evidence” to support her
motion. See Verchot v. General Motors Corp., 812 So.2d 296, 300 (Ala. 2001)(“If the movant has the burden of
proof at trial, the movant must support his motion with credible evidence, using any of the materials specified in
Rule 56(c), [Ala.]R.Civ.P. (‘pleadings, depositions, answers to interrogatories, and admissions on file, together with
the affidavits’).”(citations and quotation marks omitted)).

27

through traditional tort defenses like assumption of the risk, lack of causation, or
contributory negligence. See Casrell v. Altec Indus., Inc., 335 So.2d 128, 131-34 (Ala.
1976); Atkins v. Am. Motors Corp., 335 So.2d 134, 137-43 (Ala.1976). The AEMLD
may be applied to wrongful death cases. Casrell, 335 So.2d at 134; Atkins, 335 So.2d at
144.
“Under the AEMLD, a manufacturer has the duty to design and manufacture a
product that is reasonably safe for its intended purpose and use.” Townsend v. Gen.
Motors Corp., 642 So.2d 411, 415 (Ala. 1994). This does not mean that the manufacturer
is expected to insure against all harm or “to produce an accident-proof or injury-proof
product.” Id. “Proof of an accident and injury is not in itself sufficient to establish
liability under the AEMLD; a defect in the product must be affirmatively shown.” Id.
(citing Casrell, 335 So.2d 128; Atkins, 335 So.2d 134. See also Sears, Roebuck & Co. v.
Haven Hills Farm, Inc., 395 So.2d 991, 994-95 (Ala. 1981); Thompson v. Lee, 439 So.2d
113, 115 (Ala.1983); Brooks v. Colonial Chevrolet–Buick, Inc., 579 So.2d 1328, 1332
(Ala.1991); Verchot v. Gen. Motors Corp., 812 So.2d 296, 301 (Ala. 2001).“Whether a
product is ‘unreasonably dangerous' is for the trier of fact, just as negligence, vel non, is
in a traditional negligence case.” Casrell, 335 So.2d at 133.
Under the AEMLD, “the important factor is whether [the product] is safe or
dangerous when the product is used as it was intended to be used.” Yarbrough v. Sears,
Roebuck and Co., 628 So.2d 478, 481 (Ala. 1993)(quoting Casrell, 335 So.2d at 133);
Atkins, 335 So.2d 134 (quotation marks omitted)). A product is considered “defective”
when “the product does not meet the reasonable expectations of an ordinary consumer as
28

to its safety.” Casrell, 335 So.2d at 133. “[I]t makes no difference whether it is dangerous
by design or defect.” Id. at 133.
b. Elements of a Design Defect Claim
To establish liability under the AEMLD, the plaintiff must show that her sister was
injured by the defendants’ product sold to her “in a defective condition unreasonably
dangerous…as the ultimate user or consumer.” Casrell, 335 So.2d at 132-33. “Showing
these elements, the plaintiff has proved a prima facie case although [the defendants have]
exercised all possible care in the preparation and sale of [their] product, and [the decedent
had] not bought the product from, or entered into any contractual relation with, the
seller.” Id. The plaintiff has offered evidence that the decedent died of acetaminopheninduced liver failure after taking Extra Strength Tylenol as directed.130 Viewing the
evidence in the light most favorable to the plaintiff, a jury could find that Extra Strength
Tylenol was defective.131

130

See Denice Hayes Death Certificate (Doc. No. 45, Ex. A); Expert Report of T. Davern M.D. (Doc. No. 95, Ex.
20)(discussing how Ms. Hayes’ liver was “normal in size” at the time of her gastric bypass surgery in August 2009
and how a colonoscopy in June 2010 produced benign results); R. Terry Dep. at 38-40 (Doc. No. 49-9, Ex. I); R.
Hayes Dep. at 34-35, 38-41, 46, 56-61, 74, 76, 171 (Doc. No. 49-10, Ex. J and Doc. No. 95, Ex. 1); Plaintiff’s Fact
Sheet (Doc. No. 49-8, Ex. G).
131

There is no debate about whether the defendants produce Extra Strength Tylenol or whether the product was
altered because it was sold to the decedent.
The plaintiff offers evidence from her own experts to show that Extra Strength Tylenol was unsafe at the
recommended dose. See N. Kaplowitz Dep., Apr. 21, 2015 at 271-73 (Doc. No. 90, Ex. 31)(“Q: “…you limit your
Tylenol recommendations to patients with liver injury to two gram maximum? A: Correct. Q: Why two grams? A:
Because I think that people with liver disease can't tolerate an insult, and two grams is what I would consider to be -I consider the – the literature to -- and my personal experience to be such that I don't think I've -- you know, it's
exceedingly rare. There may be a couple of cases in the literature where somebody described patients who were
taking two grams or less as having liver injury. But my feeling is that it's -- you know, it's not a dangerous dose for
somebody with liver disease. Q: You're testifying in this lawsuit and in the prior case that four grams can put
somebody into acute liver failure? A: Right….Q: So you're giving them two grams with people with liver injury? A:
Yeah. And that's exactly why the FDA lowered the dose from four grams to three grams; the recommended dose.”);
N. Kaplowitz, M.D. Expert Report (May 5, 2014)(Doc. No. 90, Ex. 37); L. Plunkett, M.D. Expert Report (May 2,
2014)(Doc. No. 90, Ex. 38). See also Neil Kaplowitz, M.D., Acetaminophen Hepatoxicity: What Do We Know,

29

For a design defect claim, “[t]he scope of a manufacturer's legal duty…depends
upon two factors: (1) the foreseeability of the danger; and (2) the feasibility of an
alternative design that averts that danger.” Bean v. BIC Corp., 597 So.2d 1350, 1352
(Ala. 1992). There is evidence that the defendants knew or should have known that Extra
Strength Tylenol could cause liver damage either because consumers took the OTC drug
at or just above the recommended dose or that consumers unintentionally took too
much.132 In fact, the defendants were actively working to find an acetaminophen
substitute that could provide its same benefits without its hepatotoxicity risks.133
Furthermore, the FDA was considering whether to remove Extra Strength Tylenol from

What Don’t We Know, and What Do We Do Next?, Hepatology, Jul. 2004 at 23-26 (Doc. No. 90, Ex. 39); William
Lee, Acetaminophen and the U.S. Acute Liver Failure Study Group: Lowering the Risks of Hepatic Failure,
Hepatology, Vol. 40, No. 1, 6-9 (2004)(Doc. No. 90, Ex. 40).
She also offers evidence from the defendants’ experts, questioning the safety of Extra Strength Tylenol at the
recommended dose. See R. Brown Dep. at 72-73 (Apr. 30, 2015)(Doc. No. 95, Ex. 32)(“I tell them to take no more
than six or eight regular-strength tablets in a day, knowing that they’ll take more….It’s neigh on 2 grams [daily].”);
S. Flamm Dep. at 168-73 (May 5, 2015)(Doc. No. 95, Ex. 33)(explaining why he only recommends that patients
take a maximum of 3 or 4 grams of Tylenol a day but advises them that this is the upper limit on what should be
taken because he recognizes the likely risk of patients taking too much).
132

See, e.g., Erikkson, L.S., et al., Hepatotoxicity due to repeated intake of low doses of paracetamol, J Intern Med,
1992: 231:567-570 (Doc. No. 95, Ex. 16). There is also evidence the McNeil executives were aware of this medical
literature. See McNeil Memorandum Nov. 19, 1987 (Doc. No. 95, Ex. 14); P. Gussin Dep., Dec. 12, 2013 at 198
(Doc. No. 95, Ex. 15); FDA Safety Analysis Power Point, Sept. 19, 2002 (Doc. No. 95, Ex. 11); FDA
Memorandum, Aug. 15, 2002 (Doc. No. 95, Ex. 17); Larson, et. al., Acetaminophen-Induced Acute Liver Failure:
Results of a United States Multicenter, Prospective Study, Hepatology 2005; 42(6):1364-1372 (Doc. No. 95, Ex. 7);
CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 8).
133

See E. Kuffner Dep. at 29-30, 32-36, 54-55 (Mar. 5, 2014)(Doc. No. 90, Ex. 3); E. Codd, Acetaminophen
Analogs: Project Update and Request for Support, Powerpoint, June 17, 2010 (Doc. No. 90, Ex. 5); Internal Emails,
Nov. 14, 2011 (Doc. No. 90, Ex. 6).
The plaintiff offers this possible analog as an alternative design; however, that design was not available at the time
of Denice’s death. The plaintiff argues that the analog could have been available at the time of her death if the
defendants had continued researching and developing the analog through the later 1990s and early 2000s. Whether
this is true is highly speculative. The plaintiff may offer evidence that the defendants were working to find an
analog, to show knowledge of a defect and/or defendants’ state of mind. However, the research and development
project for the analog cannot in itself be used to show an “alternative design.”

30

OTC status because of the risks it posed to uninformed consumers.134 Liver injury at or
just above the recommended dose was foreseeable.
c. Feasible Alternative Designs
To establish that a feasible alternative design existed, “a plaintiff must prove that
‘a safer, practical, alternative design was available to the manufacturer at the time it
manufactured the [product].” Hannah v. Gregg, Bland & Berry, Inc., 840 So.2d 839, 858
(Ala. 2002)(quoting Beech v. Outboard Marine Corp., 584 So.2d 447, 450 (Ala.
1991))(citations and quotation marks omitted)).135 To establish that an alternative design
was “safer” and “practical” the plaintiff must offer evidence that the plaintiff's injuries
would have been prevented or reduced if the alternative design were used and that the
alternative design would have been safer than the design actually used. Id. See also
Richards v. Michelin Tire Corp., 21 F.3d 1048, 1057 (11th Cir. 1994).
Once a plaintiff proves the existence of an alternative safer, practical design, a
defendant manufacturer cannot assert compliance with industry standards as an absolute
defense. See Elliot v. Brunswick Corp., 903 F.2d 1505, 1508 (11th Cir. 1990); General
Motors Corp. v. Edwards, 482 So. 2d 1176, 1198 (Ala. 1985)(overruled on other
grounds). The existence of an alternative safer, practical design may indicate failure on
the part of the entire industry. Elliot, 903 F.2d at 1508. A manufacturer can, however,
offer proof that the design was “state of the art.” See Frantz v. Brunswick, 866 F. Supp.
134

See FDA, CDER, Joint Meeting of the Drug Safety and Risk Management Advisory Committee, NDAC, and the
Anesthetic and Life Support Drugs Advisory Committee, Questionnaire (Doc. No. 90, Ex. 14).
135

See also McMahon v. Yamaha Motor Corp., U.S.A., 95 So.3d 769, 772 (Ala. 2012)(“In an AEMLD case, this is
done by proving that a safer, practical, alternative design was available to the manufacturer at the time it
manufactured the allegedly defective product.”).

31

527, 534 (S.D. Ala. 1994); Springer v. Jefferson County, 595 So.2d 1381, 1385 (Ala.
1992); Jones v. General Motors Corp., 557 So.2d 1259, 1261, 1265 (Ala. 1990).
Compliance with industry standards and proof of “state of the art” design are factors a
jury can consider when determining if the product was defective. See, e.g., General
Motors Corp., 482 So. 2d at 1198; Caterpillar Tractor Co. v. Ford, 406 So.2d 854, 858
(Ala. 1981).
i. Antidote combinations
The plaintiff points to several alternative designs to establish her claim. First, she
offers the acetaminophen/antidote combinations researched and developed by the
defendants in the 1990s. The acetaminophen/methionine combination was sold in other
countries.136 The acetaminophen/diallyl-sulfone combination was covered by a patent
funded by the defendants.137 Both combinations were alternative designs available at the
time of the Denice’s death; they were not simply hypothetical in nature. The defendants
claim that these alternative designs would not be “safer” or “practical.” Whether these
alternative designs were safer or more practical than Extra Strength Tylenol in its current
form is a question of fact. Viewing the facts in the light most favorable to the plaintiff, a
reasonable jury could find that one or both of these combinations was safer and more
practical.

136

See A. Temple Dep., Feb. 18, 2014 at 225 (Doc. No. 90, Ex. 1); McNeil Memo re: Acetaminophen Plus
Methionine, Jun. 3, 1994 (Doc. No. 90, Ex. 20); Letter re: Methinione Combination, Feb. 17, 1999 (Doc. No. 90, Ex.
18).
137

See McNeil Memo re: Acetaminophen Plus Methionine, Jun. 3, 1994 (Doc. No. 90, Ex. 20); Patent application,
Dec. 12, 1995 (Doc. No. 90, Ex. 17).

32

ii. Lowering the Dosage
The plaintiff also claims that Extra Strength Tylenol could easily have been redesigned to be safer by changing the dosing instructions for the drug, as the defendants
did after Denice’s death. The defendants claim this argument is not appropriate for a
design defect claim but, instead, relates to a failure-to-warn claim. I disagree.
If manufacturers are aware of a known defect, they expected to do one of two
things: warn of the unknown dangers or design the product to reduce potential harm. See
Casrell v. Altec Industries, Inc., 335 So.2d 128, 133 (Ala. 1976).138 The plaintiff brings a
separate failure-to-warn claim. I addressed the validity of that claim in a separate
memorandum. At issue here is whether the defendants could have designed Extra
Strength Tylenol differently so as to prevent liver injury in consumers.
Dosing instructions and warnings are two different parts of a label. A change in a
dosing instruction could have reduced the potential danger inherent in Extra Strength
Tylenol; this is an element of design for an OTC monograph product like Extra Strength
Tylenol. In the case of acetaminophen, dosing is what makes the product. The only
difference between Regular Strength Tylenol and Extra Strength Tylenol is the amount
of acetaminophen or the dose provided by each caplet. This is presumably why the
defendants filed a separate NDA for Extra Strength Tylenol initially.
Warnings, on the other hand, are used to reduce dangers that could not be designed
out of a useful product. It is possible that the defendants could have both changed the
138

See also Mutual Pharmaceuticals, Inc. v. Bartlett, 133 S.Ct. 2466, 2470 (2013)(“Because Mutual was unable to
change sulindac's composition as a matter of both federal law and basic chemistry, New Hampshire's design-defect
cause of action effectively required Mutual to change sulindac's labeling to provide stronger warnings.”).

33

dosage to reduce risk of liver injury and added better warnings to inform consumers
about the risk of liver injury that may never be designed out of acetaminophen. For this
reason, the plaintiff can assert both a failure-to-warn claim and a design defect claim. It is
the jury’s task to determine if the defendants are liable under one or both claims.139
Acetaminophen is a “dose-related toxin”—it’s safe at certain doses but unsafe at
higher doses.140 Dosing is what makes acetaminophen both effective and safe. Several
years before the decedent’s death, the defendants were made aware that Extra Strength
Tylenol could have a “narrow therapeutic margin”—i.e., the difference between its
current maximum recommended dose could be very little compared to the dose that
could cause liver injury.141 Yet, the defendants only lowered the maximum daily dose in
2011 to build in a wider margin of safety. By instructing consumers to take less, the
defendants lowered the risk that consumers would take too much acetaminophen,
intentionally or unintentionally. Consumers would have to take much more than directed
in order to “overdose” and put themselves at risk of liver damage.142

139

See Torkie-Tork v. Wyeth, 739 F.Supp.2d 895, 900 (E.D. Va. 2010)(“[I]t may well be that the dosage of a drug is
a fundamental characteristic of the drug, since a lower dosage may well alter or affect the positive impact the drug is
designed to have on the human body.…[T]he decision properly rests with a jury to determine whether an alternative
dosage of [the drug] would so fundamentally alter the drug as to render it an entirely different product.”).
140

Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of a Workshop, Hepatology 2008; 47:14011415 (Doc. No. 95, Ex. 6).
141

See, e.g., CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex.
13)(“Acetaminophen has a narrow therapeutic margin, that is, there is little difference between the current maximum
recommended dose of acetaminophen and the doses that are associated with a potentially elevated risk of
hepatotoxicity.”); AASLD Public Comment, Apr. 27, 2007 (Doc. No. 95, Ex. 19); Christina Chang, M.D., M.P.H.,
Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products, of the FDA, Powerpoint, Jun.
29, 2009 (Doc. No. 95, Ex. 21).
142

See CDER Working Group Executive Summary and Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex.
8)(“Acetaminophen is different from other OTC pain relievers in that the maximum total daily dose limit for
acetaminophen is the same for OTC and prescription products. For NSAIDs, the total daily OTC dose is

34

As evidenced by the defendants’ 2011 change, the defendants have control of
dosing instructions. The defendants could have instructed consumers to take two tablets
of Extra Strength Tylenol every 6 hours, as recommended by the TFM, to ensure that
consumers were taking no more than 3 grams a day. McNeil admitted that the change in
dosing would be no less effective than the 4 to 6 hour dosing. The defendants were
aware of this option but decided not to offer this dosing instruction. They were not in
compliance with industry standards for dosing 500 mg acetaminophen, as prescribed in
the TFM. This information alone could lead a jury to find that Extra Strength Tylenol
was defective as designed.
iii. Dose Titration
Lastly, the plaintiff claims the defendants could have offered instructions with
dose titration, as were included in their Motrin products. These instructions would
encourage consumers to take the least amount of Extra Strength Tylenol to treat their
condition and build in a wider margin of safety. Though the defendants proposed adding
dose titration to the Extra Strength Tylenol instruction in 2009, they never actually
implemented it.143 Whether the defendants should have changed the dosing sooner to

considerably less than the prescription dose. Doubling the maximum daily dose of OTC acetaminophen for several
days presents significant risk of developing liver toxicity. In contrast, doubling the maximum OTC dose of NSAIDs
for several days exposes consumers to a prescription-level dose, which only slightly increases the risk of
gastrointestinal bleeding and ‘is not even close to the seriousness presented by doubling the dose of
acetaminophen.’… Lowering the total daily dose will increase the margin of safety of acetaminophen.”),
(“[L]imiting both the tablet strength and single dose should provide a wider safety margin and should reduce the
incidence of hepatotoxicity.”), (“Lowering the dose will increase the margin of safety.”), and (“A wider safety
margin is needed for acetaminophen.”).
143

See McNeil’s Presentation to Joint Meeting of the Drug Safety and Risk Management Advisory Committee,
Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee, Jun.
29-20, 2009, Powerpoint at C-8, C-63 (Doc. No. 95, Ex. 22)(“Clinical trial data confirms that 1000 mg is more
efficacious than 650 mg”). See also McNeil Powerpoint Response regarding Advisory Committee Meeting on Jun.

35

build more of a safety margin into Extra Strength Tylenol’s design is a question for the
jury to answer.144 See Torkie-Tork v. Wyeth, 739 F.Supp.2d 895, 900 (E.D. Va.
2010)(“[I]t may well be that the dosage of a drug is a fundamental characteristic of the
drug, since a lower dosage may well alter or affect the positive impact the drug is
designed to have on the human body. …[T]he decision properly rests with a jury to
determine whether an alternative dosage of [the drug] would so fundamentally alter the
drug as to render it an entirely different product.”).
Viewing all the facts in the light most favorable to the plaintiff, a reasonable jury
could find that a feasible design existed at the time of Denice’s death and the defendants
breached their duty to market a safe product.145
29-30, 2009 (Doc. No. 95, Ex. 23); E. Kuffner, McNeil’s Presentation to Joint Meeting of the Drug Safety and Risk
Management Advisory Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life
Support Drugs Advisory Committee, Jun. 29. 2009 (Doc. No. 95, Ex. 50)(“ McNeil is recommending changing the
current dosing directions on both the 325-milligram and 500-milligram formulations, seen here on your left, from
take two tablets every four to six hours while symptoms last, to the proposed directions shown on the right, take one
tablet, and if pain or fever does not respond to one tablet, two tablets may be needed. This dose titration model is
identical to the directions on the current over-the-counter ibuprofen label. This significant change will encourage
patients to use the lowest effective dose and should, therefore, decrease overall acetaminophen exposure within the
general population.”); Letter from FDA to McNeil re: Proposed Dose Titration Instructions, Jun. 10, 2010 (Pl. Ex.
51)(“The proposed maximum dose of no more than 3000 mg acetaminophen per 24 hours is allowed the tentative
final monograph (TFM)…. The doses and dosing intervals in the proposed titration directions, to take 500 mg every
4 to 6 hours while symptoms persist and a maximum of 1000 mg every 4 to 6 hours if pain or fever does not respond
to 500 mg, are all at levels allowable under the TFM.”).
144

The defendants also could have limited the amount of caplets available in each package. Legislation in the United
Kingdom required acetaminophen manufacturers to limit the size of packages, resulting in a decrease of
acetaminophen related hospital admissions. See Lee, et. al. MEETING REPORT: Acute Liver Failure: Summary of
a Workshop, Hepatology 2008; 47:1401-1415 (Doc. No. 95, Ex. 6); Lee, W.M., Acetaminophen Toxicity: Changing
Perceptions on a Social/Medical Issue, Hepatology 46(4): 966-970 (2007)(Doc. No. 95, Ex. 9). Members of the
medical community also recommended this change prior to the decedent’s death. See Lee, W.M., Acetaminophen
Toxicity: Changing Perceptions on a Social/Medical Issue, Hepatology 46(4): 966-970 (2007)(. No. 95, Ex. 9).
Though the Acetaminophen Hepatotoxicity Working Group did not recommend that the package size be limited,
there were no regulations in place to prevent the defendants from changing the packaging to prevent liability, as they
had done in other countries for this same reason. See CDER Working Group Executive Summary and
Recommendations, Feb. 26, 2008 (Doc. No. 95, Ex. 8).
145

The defendants offer Yarbrough v. Sears, Roebuck and Co., 628 So.2d 478, 482 (Ala. 1993), to support their
argument that the plaintiff has not offered sufficient evidence to present the design defect claim to a jury. In
Yarbrough, the court found that the plaintiffs had only offered a “general statement” by their expert that a “simple

36

V.

Genuine Disputes of Material Fact Remain
Several facts remain in dispute about whether it was feasible for the defendants to

implement a safer design of Extra Strength Tylenol.146 How these facts are resolved
affects the outcome of the plaintiff’s design defect claim, making them genuine disputes
of material fact. The plaintiff has offered evidence that these safer designs could have
been implemented prior to the decedent’s death. The defendants counter with reasons
why the alternative designs would not have been better (i.e., diallyl sulfone was found to
evaporate after a month making it no more effective after a month’s time, the methionine
combination would have had other side effects).
These disputes center on whether the proffered alternative designs would have
been safer than the Extra Strength Tylenol already on the market. To determine if the
alternative design was safer and more practical, a jury should consider the following
factors: styling, cost, desirability, safety, the foreseeability of the particular accident, the
design modification” would have prevented their injuries, caused by their own misuse of the product. Id. Yarbrough
is factually distinguishable. The plaintiff here offers more than general expert statements that Extra Strength Tylenol
could have been re-designed. The plaintiff, instead, offers actual alternative designs which were possible at the time
of the decedent’s death. She relies on more than general statements by her experts. Yarbrough is not helpful.
In the same way, Smith v. Louisville Ladder Co., 237 F.3d 515, 519-20 (5th Cir. 2001), is not helpful. In Smith, the
plaintiff relied completely on his expert’s testimony to show a safer, alternative design. Id. at 519. Smith’s expert
offered only a “preliminary concept,” which was not market-ready, may be “awkward,” and might have safety issues
of its own. Id. The plaintiff here offers alternative designs that were either developed by the defendants (to the point
of applying for a patent), implemented by the defendants after the decedent’s death (i.e., dosage change), or were
available in other countries. For these reasons, Smith, and other analogous cases cited by the defendants, are
distinguishable. See Elliott v. Brunswick Corp., 903 F.2d 1505, 1508 (11th Cir. 1990)(“In short, although Elliott's
experts promoted the use of propeller guards, they agreed that companies could not yet market them for general use.
Both sets of experts, moreover, discussed the problems that these devices engender.”); Beech v. Outboard Marion
Corp., 584 So. 2d 447, 450 (Ala. 1991)(“We decline to hold, as a matter of law, that simply because ‘a feasible
propeller guard could have been designed by a proper use of the manufacturer's resources’ that an ‘alternative
design’ existed. Furthermore, a propeller guard that ‘arguably creat[es] other dangers’ is not a ‘safer’ design within
the meaning of General Motors Corp. v. Edwards.” (emphasis added)).
146

See Defendants’ Statement of Facts, Doc. No. 50; Plaintiff’s Response to Defendants’ Statement of Facts, Doc.
No. 95 (disputing ¶¶ 3-19).

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likelihood of injury from that accident, the probable seriousness of the injury, the
obviousness of the defect, and the manufacturer's ability to eliminate the defect. Hannah
v. Gregg, Bland & Berry, Inc., 840 So.2d 839, 858 (Ala. 2002)(quoting Beech v.
Outboard Marine Corp., 584 So.2d 447, 450 (Ala. 1991))(citations and quotation marks
omitted)).147
The plaintiff also offers evidence that the defendants’ real reasons for not
implementing the alternative designs were profit-driven. For example, the plaintiff points
to evidence that the defendants only seriously started investing in research and
development on an acetaminophen-like analog devoid of hepatotoxic effects after the
FDA committees recommended that Extra Strength Tylenol be available only by
prescription. Determinations about what the defendants’ real motives for not
implementing available alternative designs involve credibility judgments.148 They are for
a jury to decide, not the court.
For these reasons, the plaintiff’s design defect claim cannot be decided on
summary judgment.
VI.

Plaintiff’s Design Defect Claim is Not Preempted
The defendants also argue that the plaintiff’s design defect claim is impliedly

preempted under Mutual Pharmaceuticals, Inc. v. Bartlett, 133 S.Ct. 2466 (2013).
Preemption is a concept based on the Supremacy Clause of the U.S. Constitution that

147

See also Richards v. Michelin Tire Corp., 21 F.3d 1048, 1057 (11th Cir. 1994).

148

Defenses like compliance with industry standards and proof of “state of the art” design are also factors a jury can
consider when determining if the product was defective. See General Motors Corp. v. Edwards, 482 So. 2d 1176,
1198 (Ala. 1985)(overruled on other grounds); Caterpillar Tractor Co. v. Ford, 406 So.2d 854, 858 (Ala. 1981).

38

provides a conflicting state law will be trumped by its federal counterpart. See Bartlett,
133 S. Ct. at 2472-73 (citing U.S. Const., Art. VI, cl. 2). Even if a federal statute does not
expressly preempt a state law, the state law may be impliedly pre-empted where it is
“impossible for a private party to comply with both state and federal requirements.” Id. at
2473 (quoting English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990)(quotation marks
omitted)).149 There is a general presumption against preemption. See, e.g., Deweese v.
Nat’l R.R. Passenger Corp. (Amtrak), 590 F.3d 239, 246 (3d Cir. 2009)(citing Cipollone
v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)).
“Impossibility pre-emption is a demanding defense.” Wyeth v. Levine, 555 U.S.
555, 573 (2009). The Third Circuit has cautioned against “lightly infer[ring]” preemption
where “state compensatory regimes have traditionally played an important role.” Fellner
v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 249 (3d Cir. 2008). Whenever possible,
preemption analysis should attempt to reconcile the state law and federal law with one
another. See Deweese, 590 F.3d at 248. “[S]tate tort law and other similar state remedial
actions are often deemed complementary to federal regulatory regimes” and fall
“squarely within the realm of traditional state regulation.” Fellner, 539 F.3d at 248-49.
a. Bartlett Does Not Require a Finding of Preemption
Mutual Pharmaceuticals, Inc. v. Bartlett, 133 S.Ct. 2466 (2013), was a New
Hampshire drug products liability action involving a generic drug manufacturer brought
149

See also Deweese v. Nat’l R.R. Passenger Corp. (Amtrak), 590 F.3d 239, 246 (3d Cir. 2009)(“[I]mplied conflict
preemption exists when, ‘under the circumstances of [a] particular case, [the state law] stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of Congress.’”)(quoting Hines v. Davidowitz, 312
U.S. 52, 67 (1941)); Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142–143 (1963)(“A holding of
federal exclusion of state law is inescapable and requires no inquiry into congressional design where compliance
with both federal and state regulations is a physical impossibility for one engaged in interstate commerce”).

39

under both failure-to-warn and design defect theories. 133 S.Ct. 2466, 2470 (2013). New
Hampshire law requires drug manufacturers to ensure that their products are not
unreasonably unsafe, either because of inadequate warnings or inadequate design. Id.
Under federal law, however, generic manufacturers are unable to change their drug labels
or the composition of their drug products without prior FDA approval. Id. at 2741. For
this reason, the Court found that the plaintiff could not comply with both state and federal
law and the plaintiff’s claims were impliedly preempted under federal law. Id. at 2479. In
making its decision, the Court relied on PLIVA v. Mensing, 131 S.Ct. 2567 (2011).
PLIVA, decided shortly before, held that failure-to-warn claims against generic drug
manufacturers were preempted because “federal law prohibits generic drug
manufacturers from independently changing their drugs’ labels.” Id. at 2470, 2472. Their
products are expected to be identical to brand-name products. See Bartlett, 133 S.Ct. at
2475.
This case involves a brand-name drug manufacturer, not a generic manufacturer.
The Supreme Court has not addressed whether a design defect claim brought against a
brand-name OTC drug manufacturer is preempted. See Brown v. Johnson & Johnson, 64
F.Supp.3d 717, 721 (E.D. Pa. 2014). However, Supreme Court precedent on when
failure-to-warn claims are impliedly preempted offers some insight on how the Court
might rule if faced with this question.
As explained in PLIVA, the same federal regulations that apply to generic
manufacturers do not necessarily apply to brand-name manufacturers, such as the
defendants. “[B]rand-name and generic drug manufacturers have different federal drug
40

labeling duties.” PLIVA, 131 S.Ct. at 2574. While a brand-name manufacturer seeking
new drug approval is responsible for the accuracy and adequacy of its label based on 21
U.S.C. §§ 355(b)(1), (d), a generic manufacturer is only responsible for “ensuring that its
warning label is the same as the brand name’s” under § 355(j)(2)(A)(v), § 355(j)(4)(G),
and 21 CFR §§ 314.94(a)(8), 314.127(a)(7). Id. This explains why the failure-to-warn
claim brought against a generic drug manufacturer in PLIVA was preempted but failureto-warn claim brought against the brand-name manufacturer in Wyeth v. Levine was
not.150 See PLIVA, 131 S.Ct. at 2581; Wyeth v. Levine, 555 U.S. 555, 581 (2009)(“We
conclude that it is not impossible for Wyeth to comply with its state and federal law
obligations and that Levine's common-law claims do not stand as an obstacle
to the accomplishment of Congress' purposes in the FDCA.”).151 In the same way, generic
manufacturers cannot change the design of their products because their products have to
be the same as the brand-name manufacturer’s. See Bartlett, 133 S.Ct. at 2475 (“[T]he

150

PLIVA explained why Wyeth was distinguishable:
Wyeth is not to the contrary. In that case, as here, the plaintiff contended that a drug manufacturer
had breached a state tortlaw duty to provide an adequate warning label. 555 U.S., at 559–560, 129
S.Ct. 1187. The Court held that the lawsuit was not pre-empted because it was possible for Wyeth,
a brand-name drug manufacturer, to comply with both state and federal law. Id., at 572–573, 129
S.Ct. 1187. Specifically, the CBE regulation, 21 CFR § 314.70(c)(6)(iii), permitted a brand-name
drug manufacturer like Wyeth “to unilaterally strengthen its warning” without prior FDA
approval. 555 U.S., at 573, 129 S.Ct. 1187; cf. supra, at 2575 – 2576. Thus, the federal regulations
applicable to Wyeth allowed the company, of its own volition, to strengthen its label in
compliance with its state tort duty.…Had [the plaintiffs] taken Reglan, the brand-name drug
prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted.
PLIVA, 131 S.Ct. at 2581.
151

See also Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014)(“It is beyond dispute that the federal statutes and
regulations that apply to brand name manufacturers are meaningfully different than those that apply to generic
drug manufacturers. ... But different federal statutes and regulations may, as here, lead to different pre-emption
results.” (quoting PLIVA, 131 at 2582)).

41

FDCA requires a generic drug to have the same active ingredients, route of
administration, dosage form, strength, and labeling as the brand-name drug
on which it is based.”). Brand-name manufacturers, however, can petition the FDA to
change their drug’s dosing, strength, etc. if the design poses a risk to consumers. See
Wyeth, 555 U.S. 568-576. This is especially true in the context of acetaminophen which
still operates under a TFM and not a final monograph.152
Following from this logic, I find that Bartlett—a case involving a generic
manufacturer and following PLIVA v. Messing—does not apply to the plaintiff’s design
defect claim against a brand-name manufacturer. Under the dictates of Wyeth v. Levine,
preemption is not warranted.
b. It Was Not Impossible for the Defendants to Re-Design Extra Strength
Tylenol
Furthermore, I find no reason here why the defendants could not comply with both
their state and federal obligations.153 In terms of changing the dose of Extra Strength
Tylenol, the defendants could and did lower the dose after the decedent’s death. In fact,
the new dosage directions the defendants offered were more in line with FDA guidance
because they followed the TFM dosing instructions for 500 mg caplets. Operating under

152

“Under a TFM, manufacturers market products at their own risk and are able to make voluntary adjustments
taking into account the information presented in the proposed TFM.” See FDA Letter re: FOIA Request, Nov. 17,
2011 (Doc. No. 95, Ex. 4). See also E. Kuffner Dep., Mar. 18, 2011 at 8-10 (Doc. No. 95, Ex. 5)(explaining what
duties a drug manufacturer has when new risks come to light in post-market surveillance); Wyeth v. Levine, 555
U.S. 555, 570-71 (2009)(“[I]t has remained a central premise of federal drug regulation that the manufacturer bears
responsibility for the content of its label at all times.”)(discussed further below).
153

See Brown v. Johnson & Johnson, 64 F.Supp.3d 717, 721 (E.D. Pa. 2014)(“The Supreme Court has not
addressed whether federal law can preempt state law design defect claims brought against manufacturers of brandname or non-prescription drugs. I conclude that its preemption cases do not extend to the manufacturers of these
products.”)(citing Wyeth and Bartlett as distinguishable).

42

the TFM—a proposed rule—the defendants could have changed the dosing instructions
prior to 2011. The FDA even advised them in the 1990s that they should change their
dosing instructions to adhere to the TFM.154 McNeil determined this was unnecessary.155
The FDA also had approved the defendants’ proposal to add dose titration instructions to
Extra Strength Tylenol. Yet, the defendants never implemented these dose titration
instructions. It was the defendants, not the FDA, which prevented those instructions from
changing.
As for the alternative designs related to acetaminophen/antidote combinations, the
defendants put forth no evidence that the FDA would not have allowed those drugs on the
market in the United States. Impossibility preemption is a defense; the defendants bear
the burden of showing it. See Wyeth v. Levine, 555 U.S. 555, 573 (2009)(“Impossibility
pre-emption is a demanding defense. On the record before us, Wyeth has failed to
demonstrate that it was impossible for it to comply with both federal and state
requirements.” (emphasis added)). They have not made such a showing to require
preemption. The plaintiff’s design defect claims are not impliedly preempted. See
154

See FDA Letter/Fax to McNeil, Nov. 23, 1994 (Doc. No. 95, Ex. E attached to Ex. 3 (Affidavit of Gerald
Rachanow, Esq.)); FDA Letter to McNeil, Mar. 31, 1997 (Doc. No. 95, Ex. F attached to Ex. 3 (Affidavit of Gerald
Rachanow, Esq.)). The FDA again sent a letter stating that the label dosing at 4 to 6 hours was not in compliance
with the TFM. See FDA Letter to McNeil, Mar. 31, 1997 (Doc. No. 49, Ex. R attached to Ex. S (Certification of
Judith Jones, M.D., Ph.D.))(“The dosage recommendations are not consistent with the tentative final monograph or
supported in the application. The second sentence should be revised to read, “Take two tablets every 6 hours.”). On
Jul. 21, 1997, the FDA then did send a letter to McNeil not to implement any of the changes in the previous two
letters until the FDA has instructed them to. See Doc. No. 49, Ex. S attached to Ex. S (Certification of Judith Jones,
M.D., Ph.D.)). Because the TFM is only a proposed rule not a final one, McNeil’s decision to provide different
dosing instruction would not be per se negligence. McNeil’s decision to intentionally instruct consumers to take a
dose which was higher than that prescribed by the TFM could lead a reasonable jury to believe that McNeil
breached its duty to adequately prevent potential risks.
155

See McNeil letter to the FDA re: label change , Jan. 27, 1995 (Doc. No. 49, Ex. Q attached to Ex. S (Certification
of Judith Jones, M.D., Ph.D.))(“We believe that the language we are using in the Directions section of our labeling is
acceptable since the issue has not yet been finalized in the final monograph for Internal Analgesic Products.”); 2007
Extra Strength Tylenol label (Doc. No. 90, Ex. 11)(with 4 to 6 hour language).

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Brown v. Johnson & Johnson, 64 F.Supp.3d 717, 721-22 (E.D. Pa. 2014)(finding that the
“[d]efendants have not made out federal preemption” on the design defect claim because
the “[d]efendants have also failed to demonstrate that the FDA would have rejected a
proposed change to Children's Motrin's chemical composition…Defendants have failed to
meet their ‘exacting burden.’”).
VII.

CONCLUSION

For the foregoing reasons, I will deny the defendants’ motion for summary
judgment on the plaintiff’s design defect claim.
An appropriate Order follows.

44