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Kimberly Zundel and Charles Zundel, Individually, and On Behalf of v. Johnson & Johnson

August 5, 2011

KIMBERLY ZUNDEL AND CHARLES ZUNDEL, INDIVIDUALLY, AND ON BEHALF OF THEIR MINOR CHILD, STEPHANIE ZUNDEL, PLAINTIFFS-APPELLANTS,
v.
JOHNSON & JOHNSON, DEFENDANT, AND MCNEIL CONSUMER HEALTHCARE, A DIVISION OF MCNEIL-PPC, INC., AND MCNEIL-PPC, INC., DEFENDANTS-RESPONDENTS.



On appeal from the Superior Court of New Jersey, Law Division, Middlesex County, Docket No. L-6854-05.

The opinion of the court was delivered by: Per Curium

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION

Argued January 5, 2011

Before Judges Fuentes, Gilroy and Ashrafi.

Plaintiffs Kimberly and Charles Zundel, individually and on behalf of their minor daughter, Stephanie Zundel, filed a complaint against defendants Johnson & Johnson,*fn1 McNeil Consumer Healthcare, and McNeil's corporate parent, McNeil-PPC, Inc., asserting various claims, including a count alleging products liability based on defendants' failure to warn about "all possible adverse side effects and reactions and complications associated with the use of Children's Motrin." Plaintiffs alleged that when Stephanie was given Children's Motrin in December 1997 and January 1998, she contracted Toxic Epidermal Necrolysis, a rare disease that caused her severe injuries, including blindness.

The case was tried before a jury that found Stephanie's illness and resulting injuries were not caused by her ingestion of Children's Motrin. The trial court denied plaintiffs' motion seeking to set aside the verdict because it was against the weight of the evidence.

Plaintiffs now appeal, arguing the trial court erred in denying their motion for a new trial. Plaintiffs also challenge a number of evidential rulings made by the trial court that: (1) excluded certain documentary evidence; (2) limited the scope of testimony of plaintiffs' expert witnesses; and (3) permitted defendants' medical expert to testify concerning the cause of Stephanie's illness.

We reject these arguments and affirm. We gather the following facts from the record developed before the trial court.

I

Before we recite the events that led to this litigation, a brief description of the pharmacological history of the medication at issue is warranted.

At all times relevant to this litigation McNeil Consumer Healthcare (McNeil) manufactured Children's Motrin, an over-the-counter (OTC) medication intended to reduce fever and relieve pain for children ages six months or older. The United States Food and Drug Administration (FDA) first approved this medication for use as a prescription drug in 1989, and for OTC use in 1995. Before approving the OTC sale of Children's Motrin, the FDA required McNeil to conduct a large-scale clinical study to demonstrate that the product's active ingredient, ibuprofen, was safe for OTC pediatric use.

McNeil retained the Boston University School of Medicine's Slone Epidemiology Center to conduct what was denoted as the "Boston University Fever Study" (BUFS). The BUFS protocol approved by the FDA examined whether ibuprofen was more likely than acetaminophen to result in four specific adverse events that required either hospitalization or follow-up visits to a physician by a pediatric patient. The BUFS results indicated that "there seems to be no increase of risk factors [presented by ibuprofen] when compared to acetaminophen." Significantly, however, BUFS did not include Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) among the four adverse events looked for in the study.

SJS and TEN are acute life-threatening conditions which cause the patient's skin to erode and detach itself from the underlying tissues. According to plaintiffs' expert witness, ophthalmologist Dr. Charles Steven Foster, TEN manifests as a "very odd attack by the immune system on the patient's epithelial cells and the substratum under the epithelium."*fn2

Further, according to plaintiffs' expert witness, burn victim specialist Dr. Michael Marino, patients diagnosed with SJS are affected over "less than ten percent of [their] body surface area," while patients afflicted with TEN are affected over a greater percentage of their skin area.

SJS and TEN are rare diseases, with an estimated incidence rate of less than 5 persons per million per year in the general population. SJS has an estimated incidence rate of 1.2 to 6 persons per million per year. The even rarer TEN has an estimated incidence rate of .4 to 1.2 persons per million per year. Eighty to ninety percent of cases of TEN are triggered by exposure to various drugs; ten to twenty percent of SJS and TEN cases have no identified cause.

BUFS identified two reported cases of SJS in children who had received ibuprofen. BUFS did not draw a significant connection between the drug and the disease, however, because the reports were based on responses given by parents to questionnaires and the children involved were not hospitalized or did not have a follow-up visit with a physician after receiving ibuprofen.

There have been two large-scale epidemiological studies to determine whether there is an association between the use of certain drugs, including ibuprofen, and the onset of SJS or TEN:

the Study on Severe Cutaneous Adverse Reactions (SCAR Study), conducted between 1989 and 1995, and the much larger EuroSCAR-Study, conducted from 1997 to 2001. The SCAR Study was the subject of two medical journal articles that were relied upon by the parties' experts at trial: the "Roujeau 1995" article, published on December 14, 1995, and the "Mockenhaupt 2003" article, published on October 13, 2003. The EuroSCAR-Study was the subject of the "Mockenhaupt 2007" article published in 2007, which was also relied upon by the parties' experts.

The Roujeau 1995 article examined partial SCAR Study data concerning the risk of contracting SJS/TEN presented by a class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). Of particular relevance here, the article distinguished between NSAIDs derived from oxicam and those derived from propionic acid; ibuprofen is an NSAID derived from propionic acid.

The Roujeau 1995 article concluded that the use of oxicam-derived NSAIDs presented a significantly increased risk of contracting SJS/TEN. However, the "confidence limits" for the data dealing with propionic-acid-derived NSAIDs (including ibuprofen) were such that an increase in risk could neither be confirmed nor denied.

The Mockenhaupt 2003 article examined the complete SCAR Study data and arrived at a materially different conclusion. The article pertinently concluded that "[a]mong the NSAID[s], the oxicams . . . were associated with the greatest increase in risk of SJS and TEN . . . . Of the non-oxicam NSAID[s] with sufficient numbers of exposed cases, only diclofenac and ibuprofen had significantly increased risks of SJS and TEN[.]"

By contrast, the Mockenhaupt 2007 article examined the more expansive EuroSCAR-Study data and concluded that "[c]oncerning NSAIDs there were variable levels of risks. As already suspected, oxicam derivatives were associated with a high risk and acetic acid derivatives with a lower risk for SCAR (Mockenhaupt et al., 2003), whereas for ...


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