by John Henkel
A California juice company was fined $1.5 million after pleading guilty to 16 misdemeanor criminal charges related to a 1996 outbreak of dangerous Escherichia coli O157:H7 bacteria. One child died and 14 other children were seriously sickened after drinking the company's fresh, unpasteurized apple juice.
The fine is one of the largest ever imposed in FDA history for a food injury case, and the criminal conviction by federal prosecutors is one of the first ever obtained in a large-scale outbreak of infectious pathogens.
Odwalla Inc., of Half Moon Bay, agreed in a criminal plea bargain in July to pay the fine and serve five years of court-supervised probation. The plea agreement, filed in the U.S. District Court for the Eastern District of California, also requires Odwalla to implement a Hazard Analysis and Critical Control Point (HACCP) plan in its facility. HACCP is a food safety system that identifies potential food safety hazards and specifies controls for preventing these hazards.
A $250,000 portion of the fine will be divided between a charitable organization, Safe Tables Our Priority (STOP), and the food safety research centers of the University of Maryland and Pennsylvania State University. The funds will be used to raise consumer food safety awareness and research the safety of fresh produce.
The tainted juice affected consumers in Colorado, California, Washington state, and British Columbia. Fifteen children who drank the juice developed the life-threatening condition hemolytic uremic syndrome (HUS), a leading cause of kidney failure in children. One of the children, a 16-month-old Colorado girl, died from HUS-related multiple organ failure. At least 51 others were sickened, but to a lesser degree. Food safety experts say survivors of this strain of E. coli may have significant health problems for years.
In late October 1996, FDA received word that the health departments from the three affected states had identified an E. coli O157:H7 outbreak. Washington state health officials also told FDA that using DNA "fingerprinting" methods, they had clustered 15 related cases of E. coli infection in which all the victims had reported drinking Odwalla apple juice.
When notified of these findings, Odwalla began a recall Oct. 31 of all its apple juice products. At the same time, FDA launched a 14-month investigation. An investigator with FDA's San Francisco district office, Helen Hamaoka, inspected the Odwalla plant and collected apple juice samples, which were shipped to FDA's analytical laboratory in Seattle. Tests showed the samples were negative for E. coli O157:H7. Hamaoka noted, however, that the company had ignored safety standards by centering its product testing more on shelf life than bacterial contamination.
On Nov. 5, 1996, FDA's Seattle district laboratory analyzed samples of juice found in an Odwalla warehouse in Washington state. One sample that came from juice processed around Oct. 7, 1996, tested positive for E. coli O157:H7. The laboratory analysis enabled FDA to link the E. coli outbreak positively to Odwalla juice.
As part of its criminal investigation of Odwalla, FDA's Office of Criminal Investigations began interviewing former Odwalla employees, suppliers, and others familiar with company operations. Their comments indicated that Odwalla had in the past had numerous deficiencies in its sanitation procedures. For example, accepted industry practice calls for use of a chlorine solution for washing and sanitizing fruit, but Odwalla had stopped using chlorine and was instead using phosphoric acid, which may not be effective as a fruit wash.
OCI also learned that the U.S. Army had rejected a contract with Odwalla in June 1996 after Army analysis identified a high bacterial count in an Odwalla product.
OCI also discovered that a consultant hired by the company had uncovered Listeria and other bacterial contamination in the processing plant during weekly microbiological tests he conducted between May 1994 and December 1995. OCI learned that Odwalla initially tried to identify and eliminate the source of the Listeria contamination but ultimately focused on extending shelf life without ever conclusively solving the contamination problem. Records showed that Odwalla had used an inferior grade of apples, which may have made the juice more prone to contamination.
After determining that Odwalla's operations created an environment within which E. coli O157:H7 could exist, OCI's investigation centered on determining the source of the contamination. Though officials could not pinpoint the exact source, several theories emerged. Among them:
As part of the consent decree, Odwalla implemented a HACCP plan whose provisions include:
In June 1997, Hamaoka inspected Odwalla again and took juice samples and swabs from the company's equipment for analysis. The samples proved negative for E. coli, and Hamaoka noted that the company had begun using more effective sanitation methods.
FDA will continue to inspect Odwalla regularly to ensure HACCP compliance.
John Henkel is a staff writer for FDA Consumer.
A man who posed as a doctor and claimed to have hundreds of thousands of patients worldwide was put out of business after FDA officials discovered the impostor had been diagnosing and treating nonexistent conditions and purchasing and selling unapproved drugs since 1989.
Edwin E. Kokes, owner of Independent Testing Labs of Grand Island, Neb., was sentenced Aug. 19, 1998, in the U.S. District Court for the District of Nebraska to two and a half years in prison and three years of supervised release for sending unapproved drugs and diagnostic analyses through the mail. He also was fined $5,000 and ordered to pay $80,000 in restitution to his victims.
According to the case agent in FDA's Office of Criminal Investigations, the 63-year-old Kokes generated nearly $1 million in seven years by claiming that he could diagnose and treat such medical conditions as AIDS, cancer and allergies from hair and fingernail samples. He boasted of his "technologically advanced laboratory," in which he analyzed hair and fingernail samples with what he termed a "laser" received from a friend at NASA and other hand-held devices, such as an electron microscope. He also told potential patients that the products he sold and various treatments he conducted in his office could cure their diseases, often offering them at inflated prices.
Questions surrounding Kokes' wrongdoings first surfaced during a 1993 FDA Minneapolis district office investigation of another self-proclaimed but uncredentialed physician, Karl Brunkow. Following complaints received about Brunkow's practice, FDA investigators posing as patients learned that Brunkow sent samples of his patients' hair to Independent Testing Labs, Inc., in Nebraska, and that he treated his patients based on hair analyses conducted by the laboratory's owner, Edwin Kokes.
During the investigation, an FDA investigator submitted several hair samples and one fingernail sample from himself and one other person to Kokes' laboratory. From these samples, each of which cost between $25 and $50, Kokes not only identified allergies, toxic blood levels, and problems with glands, reproductive organs, and the liver and kidneys, but he did so for three different people. He then prescribed his products--Zymex, Immuplex and M-Bone--all drugs that FDA has not approved. FDA's Forensic Chemistry Center in Cincinnati analyzed the M-Bone product and found it to be diluted sulfuric acid, a strong irritant, which Kokes was selling for up to $300 per 4-ounce container. Records reviewed later in the investigation revealed that one of Kokes' patients had complained to him that her skin was burned after he advised her to apply the M-Bone topically.
At one stage of the investigation, FDA investigators submitted guinea pig hair to Kokes, and from that analysis, he diagnosed human diseases.
FDA could find no evidence that Kokes was a licensed physician, chiropractor or osteopath, even though he always referred to himself as a doctor and signed his name "Edwin E. Kokes, UMM [ultramolecular medicine], Ph.D," according to case documentation. Other titles he assumed included "Dr." and "CRA," which stands for contact reflex analysis. Kokes also claimed to have been a surgeon during the Korean War.
FDA's case agent, who did not have ovarian cancer but told Kokes that she did, met with him undercover after he falsely confirmed her diagnosis from a hair sample she had sent him to analyze. He told her he had cured 400 to 500 AIDS patients and 97 percent of the 3,000 to 4,000 ovarian cancer patients he had treated with his products. In addition, he told her he often advised individuals with real, known diseases, such as cancer, not to seek traditional medical treatment or continue legitimate medicines prescribed by their doctors. He claimed that traditional treatments could cause the cancer to worsen or even cause death. The agent said Kokes also went on record as saying that he advised his patients not to tell their medical doctors about his treatment plans and convinced some of his patients to sign a waiver to keep office visits and conversations with Kokes from being disclosed to investigators.
During sentencing, defense attorneys argued that Kokes should not be sent to prison because he suffered from delusions and personality disorders and had no grasp of reality. However, a psychiatrist for the prosecution stated that Kokes did not appear to be delusional or psychotic but instead tended to make exaggerated statements. He said the fact that Kokes decided to legitimately register his business as a corporation with the state of Nebraska showed he was thinking rationally.
Kokes pleaded innocent in June 1996 to 11 counts of mail fraud and one count of using a fictitious name or title, but he reversed his plea in September 1997 as part of a plea agreement that allowed all but one count of mail fraud to be dropped. Kokes received the maximum penalty allowed under the plea agreement.
The U.S. Attorney's Office in Minneapolis declined to prosecute Kokes' accomplice, Karl Brunkow, now deceased, because of his age--92--at the time of the investigation. --Carol Lewis
A 40-year-old Arizona man who illegally sold prescription sex-change hormones over the Internet to a 16-year-old Ohio boy is spending six months under home confinement.
Thomas E. Steward, a Phoenix resident who communicated with the boy in Internet chat rooms on transgender issues, was sentenced Sept. 15, 1998, in the U.S. District Court for the Northern District of Ohio after pleading guilty in December 1997 to the felonies of selling prescription hormone drugs without a license and selling inadequately labeled drugs. In addition to home confinement, he was sentenced to two years probation and ordered to pay $18,000 restitution to the minor's family for the boy's psychiatric care.
The boy's parents, through an intermediary, contacted an Ohio county prosecutor's office in August 1997 after they found evidence in their son's room that the boy was communicating with Steward and had purchased drugs from him. The county prosecutor in turn asked FDA's Office of Criminal Investigations to investigate whether Steward had violated any food and drug laws.
In an interview with an OCI special agent, the boy's parents said that in early 1997, they had found a journal and e-mail notes in their son's room in which a man encouraged the boy to get a sex-change operation, leave his parents, and come live with him. Also, the man had offered to sell the boy prescription medicines to help him with the sex change.
In June 1997, the parents told the OCI agent, they found a shoe box with pharmacy vials and blister packages containing white and yellow tablets. The shoe box, which held wrapping from a Phoenix newspaper, had the address and return address labels removed. However, while doing laundry, the boy's mother found the shipping labels with the name T. Steward and a Phoenix address.
Later that year, the parents found an envelope in their son's room that contained $100 and was addressed to the same Phoenix destination, a shipment of purple pills with identifying marks removed and a letter saying they were Premarin (conjugated estrogens) pills and instructing the boy to take one every two days, another shipment of purple pills marked with the name Premarin, and white tablets marked only with numbers.
"The parents were concerned about the welfare of their child," says OCI Assistant Special Agent in Charge Rodney Turner. "The stakes were high. We were dealing with a 16-year-old kid who's decided he wants to be a girl, and an adult male who is not only encouraging him to have a sex change but is also illegally providing him the drugs to start the process."
In October 1997, OCI and FBI agents interviewed the boy, who turned over some tablets he said he had gotten from someone whose real name was Thomas Steward but who went by the name "Theresa" on the Internet. Those tablets and the drugs the parents had previously given to OCI were sent to FDA's forensic chemistry center laboratory, where tests revealed that the drugs were Premarin, spironolactone, medrogestone, and progesterone -- all hormonal drugs often used to prepare patients for a sex change. They are legally available only by prescription because of their potential to cause serious liver damage and other side effects.
The boy also provided copies of recent e-mail messages to and from Steward and other evidence of their relationship, including a letter and a map showing the way to Steward's home.
When OCI agents searched Steward's Phoenix home later that month, the man admitted that he had sent female hormone drugs to the boy, saying that he felt the boy would be better off as a female and would not have been able to get the drugs through legal channels. In his December 1997 plea agreement, Steward said he bought the drugs in Mexico, stripped them of their packaging and labeling, and brought them across the Mexican border into the United States by claiming they were for personal use, not commercial sale. A personal use claim can exempt certain drugs from FDA's importation rules.
--Tamar Nordenberg
FDA Consumer magazine (January-February 1999)
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