Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Kiley Wolfe v. Mcneil-Ppc

March 30, 2011


The opinion of the court was delivered by: DuBOIS, J.



In this products liability action, plaintiff Kiley Wolfe alleges that the Children's Motrin manufactured and marketed by defendants caused her to develop serious, life-altering illnesses. Presently before the Court is defendants' motion for summary judgment. For the reasons that follow, that motion is denied as to plaintiff's failure-to-warn claims and claim for punitive damages and granted in all other respects.


In May 1996, plaintiff was nine years old and lived with her family in Bath, Maine.

During a trip to Louisiana over Memorial Day weekend that year, plaintiff complained to her mother, Janet Leland, that she had a headache. (Leland Dep. at 89:21-23.) Plaintiff was still ill when she arrived home in Maine the evening of Memorial Day, May 27. (Id. at 92:13-15.) Leland took plaintiff to her pediatrician, Dr. Mulla, two days later on Wednesday, May 29. (Defs.' and Pl.'s Statements of Undisputed Facts ("SUF") ¶ 6.)

Dr. Mulla recommended Leland give her daughter Children's Motrin to help relieve her symptoms, which by then included a headache, stomach pains and a fever. (Leland Dep. at 96:5-97:12.) Children's Motrin is an over-the-counter ("OTC") non-steroidal anti-inflammatory drug, generically referred to as ibuprofen. (SUF ¶ 33.) Plaintiff asserts that all of the defendants are involved in the design, testing, manufacturing, marketing and/or selling of Children's Motrin.

A. Plaintiff's Injuries

Despite taking Children's Motrin, plaintiff's symptoms did not improve. Instead, she developed a rash on her cheeks. (Leland Dep. at 105:8-19.) Nonetheless, nurses at plaintiff's pediatrician's office advised Leland to continue administering the drug to plaintiff. (Id. at 106:17-19.) Leland proceeded to give plaintiff doses of Children's Motrin until Saturday, June 1, when she noticed blisters on plaintiff's ears while the family was staying in Boston. (Id. at 108:13-22.)

Later that day, Leland took her daughter to Boston Children's Hospital. (Id. at 130:9-12.)

Doctors there diagnosed her with Stevens-Johnson Syndrome ("SJS") (See Pl.'s Resp. to Mot. for Summ. J., Exs. D-E.)*fn2 While hospitalized, plaintiff exhibited symptoms of acute Vanishing Bile Duct Syndrome ("VBDS"). (See id., Ex. C at 14:16-17.)*fn3 Because of damage to her liver, plaintiff eventually required a liver transplant. (See id., Ex. B at 745.)

B. The Warning Label

At the time of plaintiff's illness, the FDA-approved warning label on OTC Children's Motrin included, inter alia, warnings to "call your doctor" if:

* "Your child does not get any relief within first day (24 hours) of treatment, or pain or fever gets worse.";

* "Redness or swelling is present in the painful area.";

* "Sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting."; or

* "Any new symptoms appear." (SUF ¶ 38.)

In 2006, the FDA recommended that warnings for OTC ibuprofen products be strengthened. (Pl.'s Resp. to Mot. for Summ. J., Ex. F at 9.) Specifically, the FDA recommended that such labels include reference to skin reddening, rashes and blisters -- allergic reactions associated with SJS -- and warn customers that "[i]f an allergic reaction occurs, stop use and seek medical help right away." (Id.)

The first time Leland administered the drug to plaintiff, she did not read the warnings and only checked the dosage. (Leland Dep. at 101:3-4.) Later in the week, however, she did examine the box and bottle to "see if there was anything on there that I should look for." (Id. at 101:8-13.)

C. The Present Action

Plaintiff now resides in Louisiana. She initiated this action in 2007, alleging that Children's Motrin caused her to develop SJS and VBDS and that defendants were thus liable to her under a variety of legal theories. All defendants have moved jointly for summary judgment; that motion is fully briefed and ripe for review.


In considering a motion for summary judgment, "the court is required to examine the evidence of record in the light most favorable to the party opposing summary judgment, and resolve all reasonable inferences in that party's favor." Wishkin v. Potter, 476 F.3d 180, 184 (3d Cir. 2007). The party opposing the motion, however, cannot "rely merely upon bare assertions, conclusory allegations or suspicions" to support its claim. Fireman's Ins. Co. v. DuFresne, 676 F.2d 965, 969 (3d Cir. 1982). After examining the evidence of record, a court should grant summary judgment if the moving party "shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a); accord Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

A factual dispute is material when it "might affect the outcome of the suit under the governing law," and genuine when "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). "Where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no 'genuine issue for trial.'" Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (citation omitted).


Plaintiff's Complaint contains seven counts: (1) negligence, (2) strict liability under Restatement (Second) of Torts § 402A, (3) strict liability under Restatement (Second) of Torts § 402B, (4) breach of express warranty, (5) breach of implied warranty of merchantability, (6) violation of consumer protection law and (7) punitive damages. The first two counts each assert multiple theories of liability. In Count I, plaintiff alleges defendants were negligent in their failure to warn of the dangers of Children's Motrin, and in their testing, marketing and design of the product. In Count II, plaintiff claims defendants are strictly liable for her injuries for their failure to warn of the dangers of Children's Motrin, and design and manufacturing defects in the product.

The Court concludes that granting defendants' motion for summary judgment is appropriate on all claims other than plaintiff's failure-to-warn claims and her claim for punitive damages. As to those claims, the Court denies defendants' motion. The Court addresses each claim in turn.

A. Failure-To-Warn Claims

Plaintiff asserts both negligent and strict liability failure-to-warn claims against all defendants. To succeed on her negligence claim, plaintiff must meet the standard set forth in the Restatement (Second) of Torts § 388. See Overbeck v. Cates, 700 A.2d 970, 972 (Pa. Super. Ct. 1997). That section provides:

One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier (a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and

(b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and

(c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.

On her strict liability claim, plaintiff must prove "(1) that the product was defective, (2) that the defect existed when it left the hands of the defendant, and (3) that the defect caused the harm." Schindler v. Sofamor, Inc., 774 A.2d 765, 771 (Pa. Super. Ct. 2001) (citation omitted). "A product is defective due to a failure-to-warn where the product was distributed without sufficient warnings to notify the ultimate user of the dangers inherent in the product." Donoughe v. Lincoln Elec. Co., 936 A.2d 52, 61-62 (Pa. Super. Ct. 2007) (citations omitted).

Defendants raise two arguments in support of their contention that summary judgment is appropriate on the failure-to-warn claims. First, defendants contend that the claims are preempted by federal law. Second, defendants argue that plaintiff cannot prove causation based on the evidence in the record. The Court finds neither argument persuasive.

1. Preemption

As a general rule, FDA approval of a drug label does not bar recovery in a state-law failure-to-warn action. Wyeth v. Levine, 129 S. Ct. 1187, 1199 (2009); see also In re Budeprion XL Mktg. & Sales Litig., No. 09-md-2107, 2010 WL 2135625, at *16 (E.D. Pa. May 26, 2010) ("The Supreme Court in Levine broadly and unequivocally held that state law complemented federal law to ensure that drug makers market and sell only safe and effective drugs."). To the contrary, such claims are only preempted where defendant adduces "clear evidence that the FDA would not have approved the change" that was necessary to comply with state law. Levine, 129 S. Ct. at 1198. This is an "exacting burden" that cannot be met "simply ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.