On appeal from the Superior Court of New Jersey, Law Division, Middlesex County.
Petrella, D'Annunzio and Keefe. The opinion of the court was delivered by Keefe, J.A.D.
Plaintiff William Graves suffered a spontaneous stomach rupture in the early morning hours of August 22, 1979, after ingesting Arm & Hammer baking soda manufactured by Church & Dwight Company, Inc. (Church & Dwight) which he had taken to resolve indigestion. Misdiagnosed as having suffered a perforated ulcer, Graves only came to believe in 1983 that the baking soda caused his injury. On August 8, 1984, he and his wife filed a complaint against Church & Dwight.*fn1 The eight-count complaint alleged misrepresentation and mislabeling; negligent failure to warn; strict liability in tort; breach of warranty; and fraud.*fn2
The matter was tried over several weeks. Only the strict liability warning issue was submitted to the jury, the other claims having been dismissed. The jury was given four interrogatories to answer pertaining to liability. The questions were:
1. Did the plaintiff consume defendant's Arm & Hammer Baking Soda on the night in question?
2. Was the Arm & Hammer Baking Soda product defective by reason of its failure to warn about possible stomach rupture?
3. Was the failure to warn a proximate cause of plaintiff's consumption of Arm & Hammer Baking Soda on the night in question?
4. Was the consumption of Arm & Hammer Baking Soda a substantial contributing factor proximately causing plaintiff's stomach rupture?
The jury unanimously found, in response to the first question, that defendant's product was involved in the incident. By a five-to-one majority it answered questions two in the affirmative and
three in the negative. Having found that the failure to warn was not a proximate cause of Graves' injury, the jury did not answer question four.*fn3
The trial Judge entered judgment in favor of defendant and denied plaintiffs' post-trial motion. Plaintiffs filed a notice of appeal, and defendant was permitted to file a nunc pro tunc cross-appeal from the denial of its summary judgment motion. However, defendant has not briefed the issue raised in its cross-appeal. Thus, the issue is deemed waived, and the cross-appeal is dismissed. Matter of Bloomingdale Conval. Ctr., 233 N.J. Super. 46, 48 n. 1, 558 A.2d 19 (App.Div.1989).
The trial record discloses the following pertinent facts. As a child, William Graves had been given Arm & Hammer baking soda as an antacid by his grandmother. She would take a teaspoon and measure out "a certain amount" and put it in a glass of water. Plaintiff, however, had not used this home remedy from the time he stopped living with his grandmother in 1939 until August 22, 1979, the date of his injury.
On August 21, 1979, Graves, then 52 years old, was senior assistant editor for National Geographic magazine. He and his wife Joyce, his bride of six months, were in Graves' house in Martha's Vineyard. His then 17 year-old son was also there. Graves ate dinner around 6:30 p.m.. He characterized the meal,*fn4 which was finished by 7:45 p.m., as "substantial but not huge."
He felt fine when he retired to the bedroom shortly after dinner. He took an iced brandy with him, and read for no more than an hour, before going to sleep between 9:00 and 9:30 p.m.
He awakened around or shortly after midnight with noticeable, although not severe, heartburn. Although he had been diagnosed with an ulcer at twenty-two, he had no real indigestion problems. He infrequently took Bisodol for bouts of indigestion; however, on this occasion, he had no Bisodol and thought of his grandmother's remedy.
He went to the kitchen and took a box of baking soda out, "sifted some of the baking soda into the bottom of the glass," and filled the approximately eight-ounce glass with water to within an inch of its top.*fn5 This was the same technique he used when he took Bisodol. The baking soda was sufficient in amount to cover the bottom of the glass.
At trial, Graves demonstrated the amount of baking soda he used on August 22 and the manner in which he mixed it with water. The amount was later stipulated to be 5.7 grams. The half-teaspoon dosage recommended by defendant measures 1.8 grams.
Graves drank the solution down quickly. In four gulps he emptied two-thirds of the glass. Before he could return the glass to the counter, an enormous pain drove him to his hands and knees. His wife heard his screams and called for help. Graves told his wife that if he passed out, to tell emergency personnel that "all he did was take a little baking soda."
Graves underwent surgery on August 22, 1979 and was misdiagnosed as suffering from a perforated ulcer. He had six subsequent surgeries for abscesses or hernia repair. His medical specials as of the time of trial totalled $55,085.84.
Baking soda has been used as an antacid for more than 100 years. When the Food and Drug Administration ("FDA") was formed in the 1930s, baking soda, like aspirin, was accorded
"GRAS" status; i.e., "Generally Recommended as Safe." Such products were exempt from FDA testing.
Over the years, the recommended dosage varied from one-quarter teaspoon to two teaspoons. In 1979, the Arm and Hammer box recommended one-half teaspoon in a glass of water.
In the 1960s and 1970s, the FDA conducted monograph studies on all GRAS products. Baking soda had its turn in 1974, when the FDA told manufacturers how to label their packaging, including a recommended dosage.
The FDA employed five physicians to help with its baking soda monograph. Two of these, Dr. John Morrissey and Dr. Edward Moore, testified for the plaintiffs at trial. Both said that they relied on the manufacturer to tell them of the potential for, or known, adverse reactions; neither relied on the articles suggesting a causal relationship between baking soda and spontaneous stomach rupture that were included in a bibliography provided to them by FDA researchers.
According to Morrissey and Moore, they would have been concerned with the possibility of stomach rupture from baking soda if they had known about these articles when they were consulting for the FDA. As it was, the FDA was concerned with the effect of long-term use on certain chronic conditions.
Much of the testimony at trial focused on these articles and Church & Dwight's lack of knowledge of their existence. There is no doubt that some of them predate Graves' accident by more than fifty years. The defendant, however, disclaimed any pre-1979 knowledge of them.
The basic premise of both sides was that Graves' stomach was overly distended by his meal, and that for some reason it was not emptying normally. Plaintiffs' theory essentially was that the baking soda combined with stomach acid to create a large volume of gas immediately that, in turn, caused the stomach rupture. Defendant essentially sought to prove that Graves' stomach, whether emptying properly or not, was full enough that the
volume of water in which Graves dissolved the baking soda was alone sufficient to cause the rupture, that the very small amount of gas produced was alone sufficient, or that the two factors acted together in concert.
Plaintiffs' gastroenterologists Lawrence Feinman, Morrissey, and Moore found baking soda, as an antacid, could be unsafe in any dosage. However, defense expert, Dr. John Fordtran, opined that it was possible for the amount of baking soda taken by plaintiff to cause spontaneous stomach rupture under certain circumstances, which he hastened to add were not present in Graves' case, and defense expert, Francis Morel, an M.I.T. "aqueous chemist," felt the volume of the bicarbonate solution, but not the bicarbonate, caused the rupture of the overfilled stomach.
In 1979, the Arm and Hammer label read in pertinent part:
Effective as an antacid to alleviate heartburn, sour stomach and/or acid indigestion.
DIRECTIONS: 1/2 tsp. in glass of water every 2 hours up to maximum dosage or as directed by physician.
WARNINGS: Do not take more than eight 1/2 tsp. for persons up to 60 years old or four 1/2 tsp. for persons 60 years or older in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician. Do not use this product except under the advice and supervision of a physician. Do not use this product except under the advice and supervision of a physician if you are on a sodium restricted diet.
Graves vacillated between saying that he had never read the label on the Arm and Hammer box, and saying that he must have read the label as a child in his grandmother's house. In any event, he did not read the label in the early hours of August 22, 1979.
Plaintiffs' experts denounced the label, but were far from unanimous as to what warnings should have been given. Dr. Morton Leeds, a pharmacologist, opined that the label, "at a minimum," should indicate that the recommended dose "should not be exceeded." Dr. Feinman testified that the label contained no warning against taking too much baking soda when the stomach was overly
distended. Dr. Morrissey said the label did not adequately warn of significant medical risks, although he characterized Graves' injury as a "rare phenomenon."
Dr. Moore suggested that only if "you replace the biceps [in the company's logo] with a skull and cross bones" was it possible that "maybe somebody would notice" the warning. Dr. Brian Strom, a clinical epidemiologist, opined that the 1979 label gave no notice of possible gastric rupture, and did not reveal the actual dangerousness of the product.
Finally, plaintiffs offered a human factors expert, Dr. Robert Cunitz, to testify about the psychology of warnings. He similarly opined that there should have been a warning as to the possibility of stomach rupture, and that the 1979 label was ineffective. He came as close as any of plaintiffs' experts to talking about what kind of warning was necessary.
Cunitz suggested that the warning be moved to the front of the package:
You can use the English language. You could use a pictograph of some picture of a stomach rupturing or something along those lines following somebody ingesting this product from a glass. I mean that would be pretty graphic[.] . . . [A] circle and a slash through it would do or an x across it would do to let people know not to do that. Alternatively, you might have to spell out the hazard in words but you also need to include an instruction to avoid harm and you might show a cup or a glass with the product in it and a circle with a circle and a slash through it to indicate that one shouldn't take it this way and then back up with the written language.
After acknowledging that there were probably "twenty ways" to warn, Cunitz went on to suggest that in order to be effective to change a long established pattern of use, the Arm and Hammer name should be relegated to the top one-eighth or one-quarter of the front of the box the logo ...