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Blane Newman, A Minor, By and Through His Father and ) Stepmother v. Mcneil Consumer Healthcare

January 9, 2012

BLANE NEWMAN, A MINOR, BY AND THROUGH HIS FATHER AND ) STEPMOTHER AND NATURAL GUARDIANS, GARY NEWMAN AND DEBRA NEWMAN, AND MARIAM KHAWAM,
PLAINTIFFS,
v.
MCNEIL CONSUMER HEALTHCARE, A DIVISION OF MCNEIL-PPC, INC., AND JOHNSON & JOHNSON, DEFENDANTS.



The opinion of the court was delivered by: Magistrate Judge Maria Valdez

MEMORANDUM OPINION AND ORDER

This matter is before the Court on Defendants' motion pursuant to Rule 56 of the Federal Rules of Civil Procedure for summary judgment [Doc. No. 121]. The parties have consented to the jurisdiction of the United States Magistrate Judge pursuant to 28 U.S.C. § 636(c). For the reasons set forth below, Defendants' motion is denied.

FACTS*fn1

Defendant Johnson & Johnson is a New Jersey Corporation. (LR 56.1(a)(3) ¶ 1.) Defendant McNeil Consumer Healthcare ("McNeil") is a division of McNeil-PPC, Inc., a New Jersey Corporation. (Id. ¶ 2.) McNeil manufactures and markets Motrin products. (Id.) Motrin is an over-the-counter ("OTC") medication whose active ingredient is ibuprofen, a nonsteroidal anti-inflammatory drug ("NSAID") derived from propionic acid. (Id. ¶ 5.) Ibuprofen is widely used to treat pain, inflammation, and fever, with billions of doses sold worldwide. (Id.) The Food and Drug Administration ("FDA") approved ibuprofen for adult prescription use in 1974, and for adult OTC use in 1984. (Id. ¶ 6.) The FDA approved a prescription version of Children's Motrin in 1989, and approved an OTC version of Children's Motrin in 1995. (Id.)

Stevens-Johnson Syndrome ("SJS") is a rare and unpredictable skin disease. (Id. ¶ 8.) Toxic Epidermal Necrolysis ("TEN") is even rarer.*fn2 SJS and TEN are acute, life-threatening conditions involving extensive skin detachment and erosion of the mucosal tissue. (LR 56.1(b)(3)(C) ¶ 1.) TEN is the more severe form, characterized by skin detachment affecting more than thirty percent of the total body surface area. (Id.) Since 1983, McNeil's labeling for its prescription Motrin products has listed SJS as having a "probable causal relationship" with ibuprofen. (Id. ¶ 5.) Since 2006, the FDA has required McNeil to expressly state on its prescription Motrin label that "NSAIDs, including Motrin [ ], can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal." (Id.) The FDA-approved labels for OTC Motrin and OTC Children's Motrin have never mentioned SJS or TEN or described any diseases or reactions as potentially fatal. (LR 56.1(a)(3)R ¶ 5.)

On February 15, 2005, a Citizen Petition was submitted to the FDA. (LR 56.1(a)(3) ¶ 39.) In it, petitioners requested that a full risk assessment of SJS and TEN associated with ibuprofen be conducted by the FDA; that FDA require the manufacturers of ibuprofen to amplify their prescription and OTC labeling to adequately warn prescribers, health care professionals and consumers of the increased risk of SJS and TEN associated with ibuprofen; and that the FDA require the manufacturers to provide to physicians and consumers instructions to discontinue any/all ibuprofen products at the first sign of a rash, mucosal blisters, or sores in the mouth, eyes, throat, or genitalia, and any unexplained or persistent fever. Citizen Petition to Request Risk Assessment of SJS and TEN at 1-2.

(February 15, 2005) (Hereinafter "Citizen Petition"). The Petition also requested that the FDA withdraw approval of OTC ibuprofen products such as Motrin, and alleged that OTC ibuprofen manufacturers, including McNeil, had misled the FDA in obtaining approval for OTC ibuprofen and its label. (LR 56.1(a)(3) ¶ 41.)

On June 22, 2006, the FDA responded to the Citizen Petition.*fn3 (Id. ¶ 43.) The FDA stated that the agency 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. (Id.) The FDA also reviewed other available evidence on the incidence of SJS and TEN, "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." (Id.) In its response, 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" and rejected the petitioners' requested that the agency revoke OTC approval of ibuprofen products. (Id. ¶ 44.) The FDA refused to require the petitioners' proposed warning, and specifically declined to require that manufacturers include references to SJS and TEN in OTC ibuprofen labels.

(Id. ¶ 47.) The FDA noted that adding easily identifiable references to the symptoms associated with SJS and TEN under the "allergy alert" subheading (e.g., skin reddening, rash and blisters) and a warning that instructed consumers to stop use and seek medical help right away if an allergic reaction occurs would alert and educate consumers about the nature of the allergic reaction associated with SJS and TEN. (Id. ¶ 48.)

When the FDA responded to the Citizen Petition, it notes that a search of the U.S. adverse event report database showed that there had been 49 reports of SJS/TEN related to ibuprofen from 1975 through March 2005. (LR 56.1(b)(3)(C) ¶ 32.) The FDA thought that there had been "no notable trend over the years." (Id.) Since that time, McNeil has continued to receive adverse event reports ("AERs") regarding ibuprofen-related SJS/TEN cases. (Id.) In response to Plaintiffs' discovery request in this case for AERs that McNeil received from 2005 to the present, McNeil produced 117 AERs of ibuprofen-related SJS/TEN cases. (Id. ¶ 33.) Eighty-seven of those AERs were received by McNeil prior to June 2009. (Id.)

Plaintiffs assert that Mariam Khawam's ("Mariam") and Blane Newman's ("Blane") use of Motrin in the summer of 2009 caused each of them to develop SJS and/or TEN. (Id. ¶ 15.) Blane's allegations pertain to OTC Children's Motrin, while Mariam's allegations pertain to OTC Motrin IB; both OTC Children's Motrin and OTC Motrin IB have the same active ingredient and include materially identical labels.*fn4 (Id.) On June 25, 2009, Mariam's mother gave her a dose of Motrin to treat a fever; Mariam was given at least two more doses that day to treat the fever. (Id. ¶ 19.) The next day, Mariam's fever had reached 103.5 degrees, her eyes were bloodshot, and she had lumps in her throat. (Id.) Mariam's pediatrician recommended that she continue taking Motrin at double the recommended dosage while her fever remained high. (Id. ¶ 20.) Mariam's fever continued to rise and she developed a small rash on her abdomen; on the morning of June 27, Mariam's temperature reached 104 degrees and the rash spread to her arms and back. (Id.) By the morning of June 28, Mariam's skin had started to blister. (Id. ¶ 21.) She was given another double-dose of Motrin and taken to the Emergency room where she was diagnosed with SJS/TEN. (Id.) Mariam has suffered serious and ongoing injuries as a result of the disease. (Id.)

On July 6, 2009, Blane's stepmother gave him a dose of Motrin to treat a fever. (Id. ¶ 24.) Blane took several more doses of Motrin the next day but remained feverish and continued to feel unwell. (Id.) By the afternoon of July 7, Blane's stepmother noted that he had developed reddish bumps on the back of his neck; by that evening, he had more bumps on his back and the bumps spread to Blane's upper body, back, chest, face, arms and neck by July 8. (Id.) Blane's stepmother decided to stop giving Blane further doses of Motrin and took him to the doctor's office. (Id. ¶ 25.) There, a nurse practitioner diagnosed Blane with a severe reaction to poison ivy and recommended that he continue to take Motrin, along with Benadryl and a steroid. (Id.) Blane's symptoms continued to worsen and by July 9, the bumps had turned to blisters, which had spread to other parts of his body. (Id. ¶ 26.) Blane's stepmother took him to the emergency room later that day, and the ER doctor who saw Blane suspected SJS and transferred him to Loyola University Medical Center, where he was diagnosed with SJS/TEN. (Id.; LR 56.1(b)(3)(C) ¶ 8-9.) Blane has suffered serious and ongoing injuries as a result of the disease. (LR 56.1(a)(3) ¶ 26.)

In June and July of 2009, the label for Motrin provided as follows:

WARNINGS:

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 [ ]

Stop use and ask a doctor if ! you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. ! pain gets worse or lasts more than 10 days ! fever gets worse or lasts more than 3 days ! stomach pain or upset gets worse or lasts ! redness or swelling is present in the painful area ! any new symptoms appear (Id. ¶ 36.) This warning language has not changed in the years since Blane and Mariam consumed Motrin, and these were the warnings on the labels of the products Blane and Mariam used. (Id.)

Plaintiffs maintain that Motrin caused Blane's and Mariam's injuries, that the drug was negligently designed, and that it included improper warnings. (Id. ¶ 27.) Plaintiffs' Second Amended Complaint ("Complaint") alleges that Motrin's warnings are defective because there was no adequate warning that consumption of the drugs could result in the severe consequences of SJS and/or TEN. (Id.) The Complaint also alleges that the warnings and instructions that accompanied the drugs provided inadequate warnings about the degree of the risk of SJS and/or TEN. (Id.) Plaintiffs also contend that the label should state the possible consequences of SJS/TEN reactions including, among others, blindness, massive skin loss, burns over large portions of the body, massive scarring, damage to bodily organs, extensive external and internal injuries, and severe and permanent disability. (Id. ¶ 27-29.)

DISCUSSION

A. Summary Judgment Standard

Summary judgment is appropriate where "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c). The Court must draw all reasonable inferences in favor of the non-movant. Bennington v. Caterpillar Inc., 275 F.3d 654, 658 (7th Cir. 2001).

However, once the movant has carried its burden under Rule 56(c), "its opponent must do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). The party opposing summary judgment must offer admissible evidence in support of his version of events, and hearsay evidence does not create a genuine issue of material fact. McKenzie v. Ill. Dep't of Transp., 92 F.3d 473, 484 (7th Cir. 1996); see Larimer v. Dayton Hudson Corp., 137 F.3d 497, 500 (7th Cir. 1998) ("'If the non-moving party bears the burden of proof on an issue, . . . that party may not rest on the pleadings and must instead show that there is a genuine issue of material fact.'") (citation omitted). "The mere existence of an alleged factual dispute is not sufficient to defeat a summary judgment motion. . . . The non-movant will successfully oppose summary judgment only when it presents 'definite, competent evidence to rebut the motion.'" Vukadinovich v. Bd. of Sch. Trs. of N. Newton Sch. Corp., 278 F.3d 693, 699 (7th Cir. 2002) (citations omitted).

"In considering a motion for summary judgment, this court is not required to scour the record in search of evidence to defeat the motion; the nonmoving party must identify with reasonable particularity the evidence upon which the party relies." Pleniceanu v. Brown Printing Co., No. 05 C 5675, 2007 WL 781726, at *7 (N.D. Ill. Mar. 12, 2007) (citing Johnson v. Cambridge Indus., Inc., 325 F.3d 892, 898 (7th Cir. 2003)); see also Estate of Moreland v. Dieter, 395 F.3d 747, 759 (7th Cir. 2005) ("We will not scour a record to locate evidence supporting a party's legal argument."); Knapp v. County of Jefferson, No. 06 CV 4028, 2007 WL 496396, at *1 (S.D. Ill. Feb. 13, 2007) (denying ...


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