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Batoh v. McNeil-PPC, Inc.

United States District Court, D. Connecticut

March 10, 2016

AMY BATOH, as Personal Representative of the Estate of Kyle Kimball, Deceased Plaintiff,



In October, 2010, Kyle Kimball developed rare and extremely painful skin conditions after taking one dose of over-the-counter Motrin. Over a year later, overcome by continued pain and suffering from these conditions and the damage they had done to his life, Kimball killed himself. His mother, Amy Batoh, has sued the manufacturer of Motrin and its parent company in this products liability case, claiming that the Motrin Kimball took contained inadequate warnings and was defective as designed, among other things. On cross-motions for summary judgment, I must decide principally (1) whether there is admissible evidence in the record from which a reasonable juror could find that Kimball would not have taken the Motrin had the label borne the more explicit warnings that Batoh says were required, and (2) whether the defendants have established their defense of “impossibility preemption” with respect to the claim that Motrin harbored a design defect in its chemical composition. The tragic circumstances of this case do not make these decisions easy. Nonetheless, after carefully reviewing the voluminous record and considering the parties’ briefs and oral arguments, I conclude (1) that there is no admissible evidence that Kimball would not have taken the Motrin had the label been more explicit and thus that Batoh cannot sustain the causation element of her failure-to-warn claim, and (2) that, because federal regulations barred the defendants from changing the active ingredient in Motrin without prior approval by the U.S. Food and Drug Administration (the “FDA”), federal law prevented the defendants from complying with the state law duties this lawsuit would impose on them to alter the chemical composition of Motrin. Federal law thus preempts the design defect claim. I therefore grant summary judgment to the defendants.


A. Relevant Factual Background[1]

The following facts-taken from the Amended Complaint, the parties’ Local Rule 56(a) Statements, and their exhibits-are undisputed unless otherwise indicated.

1. The Parties

Batoh, a Connecticut resident, is the mother and personal representative of Kimball’s estate. (McNeil’s Local Rule 56(a)1 Statement, ECF No. 117 (“McNeil’s L.R. 56(a)1 Stmt.”) ¶¶ 1-2; Plaintiff’s Local Rule 56(a)2 Statement, ECF No. 129 (“Pl.’s L.R. 56(a)2 Stmt.”) ¶¶ 1-2.) Defendants McNeil-PPC, Inc. (“McNeil”) and Johnson & Johnson (“J&J”) (together, “Defendants”) are New Jersey Corporations. (McNeil’s L.R. 56(a)1 Stmt. ¶¶ 3-4; Pl.’s L.R. 56(a)2 Stmt. ¶¶ 3-4.) J&J “owns all of the stock of Janssen Pharmaceuticals, Inc., which in turn owns all” of McNeil’s stock. (McNeil’s L.R. 56(a)1 Stmt. ¶ 5; Pl.’s L.R. 56(a)2 Stmt. ¶ 5.) McNeil manufactures and sells Motrin, an FDA-approved over-the-counter (“OTC”) medication for the relief of pain and inflammation and the reduction of fever. (McNeil’s L.R. 56(a)1 Stmt. ¶ 6; Pl.’s L.R. 56(a)2 Stmt. ¶ 6.)

2. Motrin

The nonsteroidal anti-inflammatory drug (“NSAID”) ibuprofen is the active ingredient in Motrin. (McNeil’s L.R. 56(a)1 Stmt. ¶ 7; Pl.’s L.R. 56(a)2 Stmt. ¶ 7.) The FDA approved ibuprofen as a prescription medication for adults in 1974, and approved Motrin as an OTC medication in 1984. (McNeil’s L.R. 56(a)1 Stmt. ¶¶ 8-9; Pl.’s L.R. 56(a)2 Stmt. ¶¶ 8-9.) The FDA reviewed drug applications for ibuprofen in 1974, 1984, and 1994, and concluded that “the drug is safe and effective for use as recommended in the submitted labeling.” (McNeil’s L.R. 56(a)1 Stmt. ¶ 10 (citing ECF Nos. 117-1, 117-2, 117-3); Pl.’s L.R. 56(a)2 Stmt. ¶ 10.) In 2006, the FDA estimated “that there are more than 100 million users of OTC ibuprofen each year in the United States and approximately 29 million prescriptions dispensed annually in this country.” (McNeil’s L.R. 56(a)1 Stmt. ¶ 11; Pl.’s L.R. 56(a)2 Stmt. ¶ 11.)

3. SJS and TEN

Stevens Johnson Syndrome (“SJS”) and Toxic Epidermal Necrolysis (“TEN”) are severe cutaneous adverse reactions (“SCAR events”) (Amended Complaint, ECF No. 90 (“Am. Compl.”) ¶ 65) “characterized by inflammation of the mucous membranes of the mouth, throat, eyelids, and anogenital region” (id. ¶ 9) and “painful and debilitating tissue injury and loss, epidermal blistering, necrosis, and sloughing.” (Id. ¶ 65) SJS and TEN can “result in massive skin loss, blindness, disfigurement, permanent disability, and death.” (Id.) “Cases involving skin detachment over less than 10% of total body surface are classified as SJS; cases with 10-30% detachment are referred to as SJS/TEN overlap; and cases over 30% are listed as TEN.”[2](McNeil’s L.R. 56(a)1 Stmt. ¶ 12; Pl.’s L.R. 56(a)2 Stmt. ¶ 12.)

SJS and TEN are rare conditions. In 2006, the FDA estimated that the incidence of SJS and TEN, respectively, ranges from 1.2 to 6 per million per year and 0.4 to 1.2 per million per year. (McNeil’s L.R. 56(a)1 Stmt. ¶ 13 (citing ECF No. 117-4 at 3); Pl.’s L.R. 56(a)2 Stmt. ¶ 13.) In its 1995 medical officer review of OTC Children’s Motrin, [3] the FDA stated that, in rare cases, NSAIDs including ibuprofen can cause SJS and TEN. (McNeil’s L.R. 56(a)1 Stmt. ¶ 17 (citing ECF No. 117-8); Pl.’s L.R. 56(a)2 Stmt. ¶ 17.)

4. Motrin Labeling

On September 30, 1996, McNeil submitted to the FDA revised warning language for Motrin aimed at people with aspirin sensitivity (“Aspirin Sensitivity Warning”), in response to draft language the FDA had sent McNeil several days earlier. (McNeil’s L.R. 56(a)1 Stmt. ¶¶ 19-20; Pl.’s L.R. 56(a)2 Stmt. ¶¶19-20.) In March of 1997, the FDA submitted recommended language to McNeil, and in June of 1997, McNeil submitted to the FDA its revised labeling for Children’s Motrin. (McNeil’s L.R. 56(a)1 Stmt. ¶ 21; Pl.’s L.R. 56(a)2 Stmt. ¶ 21.) Despite this correspondence in 1996 and 1997, the FDA advised McNeil in July of 1997 not to implement any changes to the Aspirin Sensitivity Warning because the FDA was evaluating class labeling appropriate for all similar products. (McNeil’s L.R. 56(a)1 Stmt. ¶ 22; Pl.’s L.R. 56(a)2 Stmt. ¶ 22.) Nearly a year later, in a letter to the FDA dated June 1, 1998, McNeil proposed a new Aspirin Sensitivity Warning directing users to seek “emergency medical help immediately” if certain allergic reactions occurred. (McNeil’s L.R. 56(a)1 Stmt. ¶ 23; Pl.’s L.R. 56(a)2 Stmt. ¶ 23.) On June 4, 1998, the FDA directed McNeil to revise the Aspirin Sensitivity Warning again. (McNeil’s L.R. 56(a)1 Stmt. ¶ 24; Pl.’s L.R. 56(a)2 Stmt. ¶ 24.) In a letter dated September 15, 1998, the FDA advised McNeil that it had completed its evaluation of class labeling issues, and required, among other things, that McNeil change the Aspirin Sensitivity Warning to an “Allergy Alert” warning. (McNeil’s L.R. 56(a)1 Stmt. ¶ 25; Pl.’s L.R. 56(a)2 Stmt. ¶ 25.) Both parties agree that McNeil submitted proposed warning language in a letter to the FDA dated October 23, 1998. (McNeil’s L.R. 56(a)1 Stmt. ¶ 26; Pl.’s L.R. 56(a)2 Stmt. ¶ 26.) McNeil characterized its proposed language as “expanded, ” but Batoh objects to that characterization. (McNeil’s L.R. 56(a)1 Stmt. ¶ 26; Pl.’s L.R. 56(a)2 Stmt. ¶ 26.)

On December 2, 1998, and again on February 11, 1999, the FDA sent faxes to McNeil, providing labeling revisions and directing McNeil to use the “Allergy Alert” warning that had been drafted by the FDA and sent to McNeil in the letter dated September 15, 1998. (McNeil’s L.R. 56(a)1 Stmt. ¶¶ 27-28; Pl.’s L.R. 56(a)2 Stmt. ¶¶ 27-28.) On March 15, 1999, McNeil submitted revised labeling that complied with the language in the FDA’s letter of September 15, 1998, and the FDA approved that labeling on August 25, 2000. (McNeil’s L.R. 56(a)1 Stmt. ¶ 29; Pl.’s L.R. 56(a)2 Stmt. ¶ 29.)

a. Citizens’ Petition

In February 2005, the FDA received a Citizens’ Petition (the “Citizens’ Petition”) that asked the FDA to withdraw its approval of OTC ibuprofen products based on the risks of SJS and TEN (McNeil’s L.R. 56(a)1 Stmt. ¶ 39; Pl.’s L.R. 56(a)2 Stmt. ¶ 39), or, at a minimum, require the following warning labels on OTC ibuprofen:

Serious Skin Reactions: Ibuprofen may cause serious skin reactions that begin as rashes and blisters on the skin, and the areas of the eyes, mouth and genitalia. These early symptoms may progress to more serious and potentially life-threatening diseases, including Erythema Multiforme, Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. Seek immediate attention if any of these symptoms develop while taking ibuprofen.

(McNeil’s L.R. 56(a)1 Stmt. ¶ 40; Pl.’s L.R. 56(a)2 Stmt. ¶ 40.) The Citizens’ Petition also asked for the following language on OTC ibuprofen, under the heading “stop use and ask a doctor if:

[A] skin rash or blisters on the eyes, mouth or genitalia occur because these symptoms may be an early sign of rare and life-threatening reactions including Erythema Multiforme, Stevens Johnson Syndrome and Toxic Epidermal Necrolysis.

(McNeil’s L.R. 56(a)1 Stmt. ¶ 41; Pl.’s L.R. 56(a)2 Stmt. ¶ 41.)

In 2005, the FDA reviewed the labeling on all OTC NSAIDs, including Motrin, and provided McNeil with a template for revisions to the OTC labels. The template added the words “skin reddening, ” “rash, ” and “blisters” to the list of symptoms in the “Allergy Alert.” (McNeil’s L.R. 56(a)1 Stmt. ¶ 32; Pl.’s L.R. 56(a)2 Stmt. ¶ 32.) The FDA asked NSAID manufacturers to implement the revised warnings according to the FDA’s template, and advised them that if they proposed different language, they must submit it to the FDA for “review and approval prior to implementation.” (McNeil’s L.R. 56(a)1 Stmt. ¶ 33; Pl.’s L.R. 56(a)2 Stmt. ¶ 33.) McNeil complied with the FDA’s instructions and revised the warning language on its OTC labels. After that revision, the Motrin label included the following language:[4]


Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives
■ facial swelling
■ asthma (wheezing)
■ shock
■ skin reddening
■ rash
■ blisters

If an allergic reaction occurs, stop use and seek medical help right away …. (McNeil’s L.R. 56(a)1 Stmt. ¶ 34; Pl.’s L.R. 56(a)2 Stmt. ¶ 34.) McNeil incorporated the FDA’s language on Motrin by 2006 and this language was on the label in 2010, when Kimball ingested Motrin. (McNeil’s L.R. 56(a)1 Stmt. ¶¶ 37-38; Pl.’s L.R. 56(a)2 Stmt. ¶¶ 37-38.)

b. FDA’s Response to the Citizens’ Petition

In its 2006 written response to the Citizens’ Petition, the FDA explained that it had “engaged in a comprehensive review of the risks and benefits, including the risks of SJS and TEN, of all approved NSAID products, including ibuprofen.” (McNeil’s L.R. 56(a)1 Stmt. ¶ 43; Pl.’s L.R. 56(a)2 Stmt. ¶ 43.) The FDA’s response stated that it “uses a number of methods to monitor the safety of marketed drugs, including review of clinical trials submitted to FDA for marketing approvals, review of other clinical studies available in the scientific literature, and review of the Adverse Event Reporting Systems (AERS) surveillance database implemented in 1997.”[5] (McNeil s L.R. 56(a)1 Stmt. ¶ 43 (quoting ECF No. 117-4 at 2); Pl. s L.R. 56(a)2 Stmt. ¶ 43.) The FDA concluded that “the overall benefit versus risk profile for ibuprofen products remains very favorable when they are used according to the labeled instructions.” (McNeil’s L.R. 56(a)1 Stmt. ¶ 44; Pl.’s L.R. 56(a)2 Stmt. ¶ 44.) The FDA noted that other OTC drugs used to reduce fever or relieve pain also have risks of severe adverse reactions. (McNeil’s L.R. 56(a)1 Stmt. ¶ 45; Pl.’s L.R. 56(a)2 Stmt. ¶ 45.) Finally, the FDA rejected many of petitioners’ suggested changes-including specific references to SJS or TEN-“because most consumers are unfamiliar with these terms.” The FDA stated that the words “skin reddening, ” “rash, ” and “blisters, ” were “more appropriate” than the Petitioners’ proposed language-e.g. “[s]erious skin reactions, ” “potentially life threatening diseases, ” and “rashes and blisters . . . in the areas of the eyes, mouth and genitalia”-because they were words that consumers could easily identify and were symptoms associated with SJS and TEN. (McNeil’s L.R. 56(a)1 Stmt. ¶ 47; Pl.’s L.R. 56(a)2 Stmt. ¶ 47.)

In August 2013, the FDA proposed a similar “Allergy Alert” for OTC acetaminophen that included references to “skin reddening, ” “blisters, ” and “rash, ” along with a warning: “[i]f a skin reaction occurs, stop use and seek medical help right away.” (McNeil’s L.R. 56(a)1 Stmt. ¶ 48; Pl.’s L.R. 56(a)2 Stmt. ¶ 48.) In order to address the risk of conditions such as SJS and TEN, the FDA requested the following changes in labeling for OTC acetaminophen:

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• Skin reddening
• Blisters
• Rash If a skin reaction occurs, stop use and seek medical help right away.

(ECF No. 117-33 at 1-2.)

5. Kimball’s Injuries

Batoh testified that, on October 3, 2010, Kimball told her that he felt ill, and was suffering from a fever, sore throat, and a stuffy nose. He took one dose of Motrin. (McNeil’s L.R. 56(a)1 Stmt. ¶ 53; Pl.’s L.R. 56(a)2 Stmt. ¶ 53.) Batoh testified that Kimball awoke the next morning, October 4, with pain, swelling, and blisters on his lips. Batoh drove Kimball to Bridgeport Hospital emergency room. (McNeil’s L.R. 56(a)1 Stmt. ¶ 54; Pl.’s L.R. 56(a)2 Stmt. ¶ 54.) Doctors there believed that Kimball was suffering from a herpes viral infection (McNeil’s L.R. 56(a)1 Stmt. ¶ 54; Pl.’s L.R. 56(a)2 Stmt. ¶ 54), and gave him a prescription for the drug Acyclovir. (Am. Compl. ¶ 22.) Kimball was unable to swallow the medication. Batoh testified that Kimball told her that his symptoms had worsened on October 5, and she drove him to the emergency room again. (McNeil’s L.R. 56(a)1 Stmt. ¶ 55; Pl.’s L.R. 56(a)2 Stmt. ¶ 55.) He was suffering from “a severe rash on his chest, hands, forearms, and face, increasing shortness of breath and dyspnea on exertion, generalized muscle pain, cough, sore throat, malaise and fever.” (Am. Compl. ¶ 23.) Kimball was admitted to Bridgeport Hospital on October 5, 2010. (McNeil’s L.R. 56(a)1 Stmt. ¶ 56; Pl.’s L.R. 56(a)2 Stmt. ¶ 56.) By October 7, 2010, Kimball was diagnosed with SJS and it was recommended that he be transferred to the hospital’s burn unit. (Pl.’s Disputed Issues of Material Fact (“Pl.’s DIMF”) ¶ 23, ECF No. 129 at 21.) Kimball was later diagnosed with SJS/TEN overlap. (ECF No. 131-3 at 4, Pl.’s Ex. 13, p. 00004). According to Plaintiff’s medical expert, Dr. Joseph Glenmullen, when he ...

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