Trejo v. Johnson

13 Cal.App.5th 110

220 Cal.Rptr.3d 127

Christopher TREJO, Plaintiff and Respondent,

v.JOHNSON & JOHNSON et al., Defendants and Appellants.

B238339

Court of Appeal, Second District, Division 4, California.

Filed June 30, 2017

Law Offices of Brian D. Witzer, Inc., Brian D. Witzer, Jeffrey E. Zinder and Michael P. Manapol for Plaintiff and Respondent.

Butler, Snow, O'Mara, Stevens & Cannada, Kari L. Sutherland ; Drinker Biddle & Reath, Thomas W. Pulliam, Jr., Vernon I. Zvoleff, Alan J. Lazarus, Kenneth P. Conour, Benjamin J. Holl, San Francisco; O'Melveny & Myers, Catalina J. Vergara and Charles C. Lifland, Los Angeles, for Defendants and Appellants.

WILLHITE, J.

After taking Motrin, an over-the-counter ibuprofen medication manufactured and sold by McNeil Consumer Healthcare (McNeil), plaintiff Christopher Trejo suffered a reaction in the form of a rare skin disease, Stevens-Johnson Syndrome, and the more severe variant, Toxic Epidermal Necrolysis (collectively SJS/TEN).¹ He sued McNeil and its corporate parent, Johnson & Johnson, on various theories of products liability, four of which went to trial: strict liability failure to warn and negligent failure to warn, based on defendants' failure to include the symptoms of SJS/TEN (skin reddening, rash, and blisters) on Motrin's warning label, and strict liability design defect and negligent design defect, based on McNeil's failure to sell an allegedly safer product, dexibuprofen (an isomer or component of ibuprofen ) rather than ibuoprofen.

Returning a special verdict, the jury found McNeil liable for negligent failure to warn (but not for strict liability failure to warn), negligent design defect, and strict liability design defect under the consumer expectation test (but not under the risk-benefit test). The jury found Johnson & Johnson liable for strict liability design defect on a consumer expectation theory (but not on a risk-benefit theory), and not liable on plaintiff's other claims.

In this appeal by defendants, we hold that the jury's verdict finding McNeil liable for negligent failure to warn must be reversed because it is fatally inconsistent with the verdict finding McNeil not liable for strict liability failure to warn. Accordingly, we reverse the negligent failure to warn verdict, and remand for a new trial on the claims against McNeil for negligent and strict liability failure to warn. We also conclude that the negligent failure to warn special verdict was defective on a second ground: the failure to include the necessary question whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger (an issue we consider because there might be a retrial).

Further, we hold that the verdicts against McNeil for negligent and strict liability design defect, as well as against Johnson & Johnson for strict liability design defect, must be reversed, because the design defect claims were based on a theory—failure to sell dexibuprofen—that is impliedly preempted by the United States Supreme Court's decision in Mutual Pharmaceutical Co., Inc. v. Bartlett (2013) ––– U.S. ––––, 133 S.Ct. 2466, 2473, 186 L.Ed.2d 607 ( Bartlett ). We also conclude that the strict liability design defect verdicts must be reversed on a second ground: the jury found McNeil and Johnson and Johnson liable solely under the consumer expectation test, but that test does not apply when, as here, the question of design defect involves complex questions of feasibility, practicality, risk, and benefit beyond the common knowledge of jurors. Accordingly, we reverse the verdicts finding McNeil liable for negligent and strict liability design defect, and finding Johnson and Johnson liable for strict liability design defect. Because plaintiff's negligent and strict liability design defect claims are preempted, and because the only theory of strict liability design defect found by the jury (the consumer expectation test) does not apply, none of plaintiff's design defect claims can be retried.

Therefore, the ultimate disposition is that the judgment as to McNeil and Johnson and Johnson is reversed, and the case is remanded for retrial on the sole remaining claims in the case: those against McNeil for negligent and strict liability failure to warn.

FACTUAL AND PROCEDURAL BACKGROUND

I. Factual Background

A. Ibuprofen

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). It was approved by the Food and Drug Administration (FDA or agency) for prescription use in the United States to treat arthritis and pain in 1974, and for over-the-counter (OTC) use in 1984. Both prescription and OTC ibuprofen are composed of the same ingredient, differing only in the dosage amounts. In 2006, the FDA estimated that approximately 29 million prescriptions for ibuprofen were dispensed per year, and that OTC ibuprofen had approximately 100 million users per year.

There are many different OTC ibuprofen products, both generic and brand name, sold by various companies. They all have the same labeling, regardless of the manufacturer. Motrin is a brand name ibuprofen product. McNeil acquired the right to produce Motrin from the Upjohn Manufacturing Company before the events giving rise to this action. In 1994, the FDA approved McNeil's application for OTC ibuprofen gelcaps, concluding "the drug is safe and effective for use as recommended in the submitted labeling."

Regarding the risk of SJS and TEN from taking ibuprofen, in 1989, the FDA provided McNeil with a medical officer review informing the company that, in 1982, 10 billion doses of ibuprofen were used worldwide, and that SJS was an adverse reaction reported with ibuprofen products at a rate of less than one percent. The labeling approved by the FDA in the 1980's for prescription ibuprofen contained a reference to SJS and TEN as possible adverse events. However, the FDA-approved label for OTC ibuprofen did not refer to SJS, TEN, skin reddening, rash or blisters. The labels differed because prescription labeling is intended for use by physicians, while OTC labeling is aimed at consumers.

The warning label on the bottle of OTC Motrin plaintiff took in October 2005 included the following FDA-approved warnings and instructions:

"Warnings"Allergy alert : Ibuprofen may cause a severe allergic reaction which may include:

"• hives • facial swelling • asthma (wheezing) • shock ...

"Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer....

"Stop use and ask a doctor if

"• an allergic reaction occurs. Seek medical help right away.

"• 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"

The label did not include specific warnings about skin reddening, rash, and blisters as possible allergic reactions. According to McNeil, the FDA did not require such a specific warning for OTC products prior to 2005 because the warning to seek medical help if any new symptoms appeared was a broader warning that included these symptoms. McNeil did not seek permission from the FDA to add SJS or TEN to its OTC labels. On one occasion before 2005, it had asked the FDA for permission to change the allergy alert language, but the agency advised it not to do so.

In July 2005, the FDA made a "class label change," directing McNeil and other manufacturers of OTC ibuprofen products to change their labels within six months to add three additional symptoms—skin reddening, rash, and blisters. McNeil made the requested changes to its labels.

B. Plaintiff's Use of Motrin

Plaintiff was born in November 1988 and lived in Honduras with his grandmother, great-grandmother, and sister. His mother, Naara Silver, lived in the United States with her husband and other children and occasionally sent plaintiff care packages that included OTC medication. In 2005, Silver purchased OTC Motrin and sent it to plaintiff. She had never purchased Motrin before, but she wanted her grandmother to try it for her arthritis pain. Silver testified that she would not have bought Motrin had she known of the possibility of blisters because her grandmother was elderly and had delicate skin.

In October 2005, plaintiff experienced aches and soreness in his legs after a strenuous soccer practice. Plaintiff took half a tablet of aspirin and took a nap.

Plaintiff took aspirin for two days because he continued to feel sore and very warm, but he stopped taking it after reading the label's warning about Reye's Syndrome.

Plaintiff continued to experience fever and muscle pain. He found Motrin in the medicine cabinet and read the label because he had never taken it before. After seeing that Motrin would treat pain and fever, plaintiff took one pill and felt better. However, his symptoms returned after a four-hour nap, so he took another Motrin and slept through the night. The following morning, he was warm and his legs hurt, so he took a third Motrin and continued to take it for two more days. When he awakened on the second day, he noticed blisters in his mouth. One of the blisters broke and started bleeding, so he asked his grandmother to take him to the doctor. He did not take any more Motrin.

Plaintiff testified that if there had been a warning about blisters on Motrin's label, he would not have taken it because he knew that blisters were painful and could lead to an infection. He also testified that a warning about skin reddening and rash would have convinced him not to take Motrin because he was a teenager and would not have wanted blisters or rash on his face. He acknowledged that he read the label, which included warnings about hives and facial swelling, and he took the Motrin even though he understood that facial swelling would affect his appearance.

Plaintiff was hospitalized in Honduras for about 10 days until November 4, 2005, when he was transferred to Shriners Hospital for Children in Galveston, Texas. When plaintiff arrived in...