The Justice Department has been asked to reopen an investigation into Syntex Laboratories' elimination of salt from its infant formulas, a decision that set off a chain of lawsuits from parents claiming that the salt-free formulas left their children seriously harmed.
Sen. Howard M. Metzenbaum (D-Ohio) made the request, citing a memo from the company's chief medical officer that labeled one argument used to justify the action "a seeming falsehood."
The memo was written in March 1980 to Syntex President Albert Bowers, who had decided to protest to ABC-TV about a "20/20" program report on defective lots of Syntex's Neo-Mull-Soy and Cho-Free infant formula. A draft protest letter included the following sentence: "In early 1978, partially in response to prevailing medical opinion which held it desirable to lower the sodium content in baby foods, salt was removed from the formulations."
"Our use of this statement has bothered me for months -- it seems unnecessarily self-serving and obfuscatory," Dr. S. John Ingram said in the handwritten memo. "As I understand it (and I know Syntex has made public statements of this kind before) this is not the case . . . I think our continued reiteration of this seeming falsehood may eventually come back on us. There are thoughtful outsiders who will eventually see through it."
The sentence to which Ingram objected was modified in the final version of the letter to say, "In early 1978, in an effort to lower the sodium content in the formulas, salt was removed, which caused the decrease in chloride levels."
According to his memo, Ingram believed that the company had eliminated salt from its formulas to compensate for what appeared to be rising levels of sodium in the product.
Metzenbaum said in a Dec. 20 letter to the Justice Department that the Ingram memo was not among the documents Syntex provided in response to a federal grand jury subpoena in January 1982, during a three-year Justice Department investigation which ended without prosecution. Based on the questions raised by the memo, discovered in a civil suit concluded earlier this year, and other documents, Metzenbaum has now called for the department to reopen its inquiry.
The department shut down the investigation in May 1984 over strong objections by the Food and Drug Administration, which had requested it, and by Metzenbaum.
Since then, however, Chicago lawyer John D. Hayes obtained the Ingram memo in a lawsuit in which he represented two six-year-old boys alleged to have been brain-damaged by defective Neo-Mull-Soy. In March, after a six-week trial, a jury awarded the boys $5 million for their injuries and $22 million as punishment of Syntex -- one of the largest punitive awards ever made against a pharmaceutical manufacturer. Syntex has moved to have the judgment set aside.
Metzenbaum has harnessed the Ingram memo and what he calls additional "compelling new evidence" to a request to Assistant Attorney General Richard K. Willard to investigate Syntex's "failure" to provide the department with "crucial information about the company's motive in removing salt from the formula."
The chloride deficiency occurred, the FDA told Justice in September 1983, because Syntex "chose not to incur the expense, in time and effort, of instituting an adequate quality control system." The criticism was contained in a letter from FDA's chief counsel, protesting a tentative decision by the Justice Department not to prosecute.
Metzenbaum, in his Dec. 20 letter to Willard, said that the new information "seriously undermines the cornerstone of the Syntex defense -- the claim that the company reformulated its baby formulas because of its concern for the health of infants."
"This so-called 'good faith' defense was accorded significant consideration in your investigation and deliberations," the senator continued.
Syntex has maintained that it had adequate quality control and has maintained that it acted in good faith in reconstituting the formula. The company has also said that the Justice Department investigation was thorough and that the Ingram memo does not warrant further action by the department.
As a substitute for breast milk, infant formula is supposed to contain all nutrients needed in the first weeks or months of life -- the period of swiftest brain growth. One of the nutrients is chloride. Sodium chloride -- salt -- was the source of about 90 percent of the chloride in the Syntex formulas. The Justice Department, in notifying the FDA of its decision not to prosecute, said that removal of salt cut the chloride in Syntex's formulas to less than half the recommended level.
Metzenbaum urged Willard to determine whether a perjury provision in the criminal code "may be applicable if any official of Syntex lied under oath in congressional testimony," if any Syntex executive or attorney had knowingly concealed material facts from or made false statements to federal investigators, and if illegal obstruction of federal proceedings had occurred.
The FDA told the department in 1983 that the conduct of Syntex and of nutritional services chief Sidney Saperstein "fully justifies prosecution." Saperstein ordered salt deleted in March 1978, saying it was "not required" any longer, according to Metzenbaum, who said at a Senate committee hearing that his source was an internal memo written by Saperstein. Metzenbaum said Saperstein also ordered the labeling changed to reflect the deletion, but a Pediatrics Magazine ad still listed salt as an ingredient nine months later.
Saperstein referred questions about his role in changing the formula to Syntex. A spokeswoman there, asked about the FDA's characterization of Saperstein's role, emphasized the Justice Department's decision not to prosecute.
The Justice Department's civil division, which is responsible for criminal as well as civil enforcement of food and drug laws, closed the investigation while Willard was its acting chief. Metzenbaum sharply criticized Willard's performance last July at a Senate Judiciary Committee hearing on President Reagan's nomination of Willard as an assistant attorney general to head the division.
Metzenbaum said in his letter to the Justice Department that he had met privately with Willard after the hearing. "You were frank to admit that if this case was brought before you again, the final decision might be quite different," the senator recalled.
"The department has no comment at this time" on Metzenbaum's letter, a spokesman for Willard said.
Kathleen N. Gary, a vice president of the parent Syntex Corp. in Palo Alto, Calif., said the Justice Department interviewed more than 20 present and former employes and reviewed more than 29,000 pages of documents before concluding it was "inappropriate" to prosecute. "We think that anyone who conducted a similar lengthy and unbiased review of all the facts in the case would reach a similar conclusion," Gary said.
Gary also said the Ingram memo and other documents cited by Metzenbaum were not important. In July, she said, a federal judge in San Francisco ruled the Ingram memo and other new evidence an insufficient basis for reopening an unsuccessful suit filed by Formula, a national group of parents who claim that defective Syntex products inflicted learning disabilities or other lasting harm on their children.
Washington lawyer Larry R. Pilot, who sued Syntex on behalf of his son and who has represented another child in a suit against the company, disputed Gary. The Ingram memo was not a factor in that case but "is important in a potential new Justice Department investigation," he said.
Two Washington-area women, Pilot's wife Lynne and Carol Laskin, are the co-chairs of Formula. They say that some 4,000 families have contacted Formula, but that tens of thousands of babies received the chloride deficient products during the 16 months before Syntex recalled it in August 1979. The company quit selling infant formula altogether in 1981.
Syntex's Gary also said, "We have seen no conclusive evidence that any infants suffered long-term damage as a result of the chloride-deficient formula." Lynne Pilot said long-term follow-up data obtained by the National Institutes of Health and questionnaires returned to Formula by about 1,800 families indicate otherwise.
"We are aware of at least 247 infants who had documented health problems while being fed these formulas," the Justice Department's Willard said in a Justice Department memo in 1983 quoted by Metzenbaum at a hearing on Willard's confirmation. "These problems range from very minor illness to death."
Gary said Syntex's internal reviews had not verified "either the number or any documented causal relationship with death."
The Pilots asserted in a suit of their own that their son, Bradley, now 6, suffered both short-term and long-term speech and memory and motor development problems, as well as learning disabilities that they claimed were caused by Neo-Mull-Soy. In April, a jury in Alexandria awarded the family $115,000 in compensatory and punitive damages for the short-term disabilities, but rejected the claim of long-term harm.
Larry Pilot also represented a Prince George's boy, Dante Morrison, 7, with serious learning disabilities in a case in U.S. District Court here. In October 1984, after Judge Norma Holloway Johnson granted a Syntex motion ruling out punitive damages, a jury awarded $400,000 in compensatory damages to Dante and his parents.
The information Metzenbaum sent to the Justice Department includes several hitherto unpublicized documents. In one, a letter to Justice Department investigators, Richard W. Alstin of Winston & Strawn, the law firm that represents Syntex, acclaimed the company's "consistent good faith." A criminal prosecution "would be contrary to the public interest," Alstin wrote. At the time -- March 1983 -- the federal grand jury investigation was under way.
Syntex is "devoted to public health," acted in "demonstrable good faith at all times," and "never cut costs or shirked its responsibility to produce a high-quality product," Alstin wrote.
The company "was motivated by a positive concern for the health of infants and a desire to improve the quality of the product," Alstin said. "The motivation for the product change was a purely salutary one."
But the claimed salutary motive "just wasn't true," Metzenbaum wrote Willard in his December letter.
Metzenbaum also sent Willard documents involving the sworn testimony of Paul E. Frieman, then president of Syntex Laboratories, and now a Syntex Corp. vice president, at a November 1979 hearing held by a House Energy and Commerce subcommittee.
Frieman told the subcommittee that Neo-Mull-Soy and Cho-Free had been reformulated in keeping with efforts by other companies to reduce sodium content.
"Many companies removed salt from their products and were praised for it," he said. "A number of infant companies, infant formula companies, infant food companies took salt out of their product to comply with this new finding that sodium content was contributing to high blood pressure levels and hypertension ," he said.
"Syntex was concerned about the salt levels in its own formulation as being on the high side," Frieman said. "We decided to reduce the sodium content. We did this, Mr. Chairman, by removing salt from the formulation."
Metzenbaum called the evidence "exactly the opposite," because "other companies were not reducing sodium content in infant formulas." He sent Willard a January 1980 letter in which the Infant Formula Council told the FDA that four members of the trade association -- manufacturers with an 87.4 percent share of the market for soy-based formula -- made "no efforts . . . to alter their formulations to reduce salt levels."
The four companies changed none of their brands because their salt levels "continued to fall well within the limits recommended by the American Academy of Pediatrics, and the AAP did not change its recommendations," the IFC said. It named the companies as Loma Linda Foods, Mead Johnson, Ross Laboratories and Wyeth Laboratories.
The possibility of a prosecution arose in March 1980 when the House subcommittee asked the Justice Department to determine whether Syntex or any of its officials should be charged with criminal violations of the adulteration and misbranding provisions of the food and drug law.
Fifteen months later, in June 1981, FDA chief counsel Thomas Scarlett referred the Syntex matter to the Justice Department for investigation and possible prosecution. Two years later, the department sent Scarlett a summary of the evidence it had accumulated and said it had tentatively declined to prosecute.
Scarlett, in an eight-page response in September 1983, rejected every major argument made against prosecution.
He noted that two Department of Justice investigators had said they had "sufficient evidence to prosecute" the company and chief nutritionist Saperstein, who had "unique . . . authority and responsibility." Nonetheless, one of the investigators recommended that prosecution be declined, a judgment sustained by his superiors but contested by Scarlett.
The Justice Department, arguing that the company should not be prosecuted, said Syntex "inherited" an inadequate quality-control system from a previous manufacturer in 1971. Scarlett replied that Syntex had had seven years -- "more than enough time" -- to correct this.
The formula plant in Elgin, Ill., stopped checking chloride levels three to five months before deleting salt, and, Scarlett wrote to Justice, "Syntex did not check" the levels afterward.
Willard wrote Scarlett in May 1984 that "no prosecutions would be appropriate" because the evidence "is not of sufficient weight and quality to meet our standards for criminal prosecution." Willard also said that the decision was based, in part, on a judgment that the company was well-meaning when it changed the product.
"I tried to make the decision in good faith," Willard testified at the July confirmation hearing. Metzenbaum told him: "The societal concerns were all on the side of the infants . . . Your societal concerns were somewhere else."