Searching over 5,500,000 cases.


searching
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.

PAZDZIORA v. SYNTEX LABS.

August 20, 1991

THOMAS PAZDZIORA, a minor, by MARJORIE PAZDZIORA, his mother and natural guardian, Plaintiff,
v.
SYNTEX LABORATORIES, INC., PET, INC., and SYNTEX (USA), Defendants



The opinion of the court was delivered by: MORAN

 JAMES B. MORAN, CHIEF UNITED STATES DISTRICT JUDGE

 Plaintiff, Marjorie Pazdziora, has brought the instant products liability claim on behalf of her son, Thomas Pazdziora, alleging that defendants' negligent manufacture of Neo-Mull-Soy, an infant formula, caused Thomas to suffer permanent physical and mental injuries, including speech and learning disabilities. In addition to compensatory damages, Pazdziora seeks punitive damages. Defendants, Syntex Laboratories, Inc., Pet, Inc., and Syntex (USA) (collectively, Syntex), have moved for summary judgment on Pazdziora's punitive damages claim. For the reasons set forth herein, this court grants Syntex's motion.

 BACKGROUND

 The following facts are undisputed. *fn1" In 1971, Syntex, a pharmaceutical company based in Palo Alto, California, acquired the Nutritional Products Division of Borden, Inc., which produced Neo-Mull-Soy and Cho-Free, soybean derivative formulas primarily intended for consumption by infants who were allergic to human breast milk or cow milk (Saperstein Aff. paras. 3,4). As part of the acquisition, Syntex obtained the right to produce Neo-Mull-Soy and Cho-Free, and acquired the Elgin, Illinois facility where these formulas were produced (Saperstein Aff. para. 3). *fn2" A number of Borden employees came to work for Syntex, including Sidney Saperstein, a microbiologist who had assisted in developing Neo-Mull-Soy and Cho-Free while with Borden (Saperstein Aff. paras. 2,3). Dr. Saperstein joined Syntex as a principal scientist, with primary responsibility for the infant formulas. Upon joining Syntex, he left the Elgin plant and moved to Syntex's corporate headquarters in Palo Alto (Saperstein Aff. paras. 1, 3).

 Because Neo-Mull-Soy is often consumed by infants for whom it is a total food source in the first four months of life (Saperstein Dep. Vol. I at 23), it must contain certain ingredients necessary for proper nutritional growth. Among these is chloride. A deficiency of chloride in an infant's diet can induce a condition known as metabolic alkalosis, indicated by fatigue and a lack of responsiveness. A severe chloride deficiency can result in slowed growth (Saperstein Dep. Vol I at 37-38, 48). In 1974, Dr. Saperstein set a target specification of 9.7 milliequivalents per liter for the chloride content of Neo-Mull-Soy (Saperstein Aff. para. 5). *fn3" At this time, he also requested that those responsible for quality control at the Elgin plant test Neo-Mull-Soy's chloride content on a weekly basis and inform him if the chloride levels, or those of any other element, failed to meet his specifications (Saperstein Aff. para. 5). *fn4"

 In 1977, Syntex decided to substitute softened water for the deionised water that was currently being used in the production of Neo-Mull-Soy (Saperstein Dep. Vol. II at 26). Some time later Dr. Saperstein observed that the sodium level of the formula was on the increase, which he attributed to the new water type (Saperstein Aff. para. 6). *fn5" At the time, the Neo-Mull-Soy "recipe" called for adding 2.1 pounds of salt (sodium chloride) per 3300 pounds of formula. Dr. Saperstein calculated that removing this added salt would reduce sodium levels for the formula to the desired level. Coupled with a concern within the medical community over the potential dangers of excess sodium in the infant diet, this calculation led Dr. Saperstein to order the Elgin and Pet plants on March 23, 1978 to cease adding salt to Neo-Mull-Soy in the manufacturing process (Saperstein Aff. para. 7).

 Although Neo-Mull-Soy contained chloride sources other than sodium chloride, *fn6" Dr. Saperstein's deletion order caused the chloride content of the formula to drop well below the target specification of 9.7 milliequivalents per liter (Saperstein Aff. para. 9). Syntex failed to detect these low chloride levels, however, because the two quality control personnel at the Elgin plant responsible for chloride testing each thought the other was conducting the weekly tests (Saperstein Aff. para. 9; Def. Interrog. Resp. 88). Although no one at Syntex's headquarters in Palo Alto, including Dr. Saperstein, or Syntex's plant in Elgin had ordered a halt to chloride testing, no chloride tests had been conducted on Neo-Mull-Soy since December 1977 (Saperstein Aff. para. 9).

 On May 5, 1979, Dr. Neal Buist, of the University of Oregon Health Sciences Center, wrote Syntex, explaining that he was studying the electrolyte contents of infant formula (Ingram Aff. at para. 2). Although Dr. Buist's letter referred to no specific test results or instances of illness, it suggested that Neo-Mull-Soy had a low chloride content and inquired whether Syntex had received any reports of electrolyte disturbances (Id.). Dr. S. John Ingram, Syntex's Director of Medical Services, responded on May 30, 1979, informing Dr. Buist that Neo-Mull-Soy had a chloride content of 9.7 milliequivalents per liter and that Syntex had received no reports of electrolyte disturbances in the ten years that the product had been on the market (Ingram Aff. para. 3). *fn7"

 Just over one month later, on July 2, 1979, Dr. Stanley Hellerstein, M.D., of Kansas City, Missouri, called Dr. Saperstein to report that he had been treating an infant suffering from what "looked like" metabolic alkalosis and to inquire about Neo-Mull-Soy electrolyte levels (Saperstein Aff. para. 11). When Dr. Saperstein inquired whether Dr. Hellerstein believed the infant's illness was related to consumption of Neo-Mull-Soy, Dr. Hellerstein replied that he was uncertain but would continue his investigation (Id.). Dr. Saperstein requested that Dr. Hellerstein furnish him with the code numbers of the Neo-Mull-Soy the infant had ingested, so that the Elgin plant could conduct an electrolyte analysis (Id.).8 Dr. Hellerstein, however, failed to provide the code numbers until several weeks later, after Syntex had recalled the product (Id.).

 On July 24, 1979, Dr. Shane Roy, a pediatric kidney specialist from Memphis, Tennessee, attempted to speak with Dr. Ingram but was unable to reach him. Dr. Roy informed Dr. Ingram's assistant that he was treating three infants under six months old, all of whom were suffering from chloride deficiencies (Ingram Aff. para. 4). Dr. Ingram attempted to reach Dr. Roy later that day and the next, but was unable to reach him until July 26. In the interim, Dr. Ingram had written Dr. Roy to request additional information (Id.).

 Dr. Ingram reported Dr. Roy's information to his supervisor, which resulted in a meeting of Syntex's Quality Assurance Advisory Committee on July 27. At this meeting, Dr. Ingram and Dr. Saperstein presented reports of illnesses that had been reported since July 24 (Ingram Aff. para. 5). As a result of the meeting, Syntex sent 25,000 mailgrams to pediatricians throughout the United States, advising them of the reports and warning them to observe their patients carefully, and convened a blue ribbon panel in San Francisco to make additional recommendations (Ingram Aff. paras. 5,6). The panel, comprised of Syntex personnel, two physicians who had reported the most cases of chloride deficiency, a representative of the Centers for Disease Control, and a former chairman of the Committee on Nutrition of the American Academy of Pediatrics, met on August 1, 1979 (Ingram Aff. para. 6).

 That evening, Syntex held an additional meeting of its personnel at its headquarters and decided to initiate an immediate product recall (Ingram Aff. para. 7). Syntex worked throughout the night and mailed out 25,000 mailgrams and 100,000 letters to physicians, nurses, and wholesalers the next day, August 2. Syntex sent an additional recall letter to every pediatrician and pediatric nephrologist in the United States on August 3 (Ingram Aff. para. 8). Finally, Syntex commissioned its sales force to remove all Neo-Mull-Soy and Cho-Free from store shelves, released news of the recall to the media, and contacted "thousands" of food brokers and "approximately 25,000" drug stores (Ingram Aff. para. 9).

 On January 28, 1978, Marjorie Pazdziora gave birth to Thomas, who consumed Neo-Mull-Soy as his "near total" food source from February to November 1978 (Pazdziora Complaint para. 5). Alleging that Thomas has suffered permanent speech and learning disabilities as a result of ingesting Neo-Mull-Soy deficient in chloride, Marjorie Pazdziora filed the instant suit, in which she seeks compensatory and punitive damages on behalf of her son. Syntex now moves for summary judgment on Counts VII and XII of plaintiff's complaint, which comprise the punitive ...


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.