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The convictions and sentences of a Wisconsin company and its president for smuggling unapproved animal drugs into the United States and adding them to veal calf and lamb feed mixtures will stand, under an appeals court decision earlier this year.
The company, Vitek Supply Corp. of Juneau, Wis., and its president, Jannes "John" Doppenberg, were each convicted in a June 1996 jury trial on 12 counts related to selling such black market drugs as the unapproved drug clenbuterol. Clenbuterol, which can make animals bulk up faster, has been associated with acute food poisoning in some people who ate the meat of treated animals. It can cause such symptoms as increased heart rate, muscle tremors, headache, dizziness, nausea, fever, and chills. It has not been approved in the United States by FDA or by any health agency in other countries for use in veal or other food-producing animals.
Vitek, which was featured in a Feb. 7, 1996, ABC News "PrimeTime Live" story on illegal drugs in food-producing animals, also smuggled into the United States the unapproved cancer-causing drugs furaltadone, furazolidone and nitrofurazone, as well as avoparcine, a drug whose wide use may lead to certain infections in humans becoming resistant to antibiotic treatment.
The U.S. 7th Circuit Court of Appeals' May decision to uphold the convictions means the company will have to pay the $350,000 fine imposed at trial. The company executive, who remained free pending the appeal, must begin serving his three-year and eight-month prison term and pay a $25,000 fine. The defendants must pay a meat-packing firm more than $700,000 to compensate it for expenses arising from the feed company's actions and reimburse the U.S. Customs Service about $30,000 in unpaid customs duties.
Special agents with FDA's Office of Criminal Investigations and other federal agencies determined that Vitek had shipped premix products to feed companies and animal growers in Kansas, Nebraska, Wisconsin, Minnesota, Pennsylvania, and Illinois, where they were used to make feed for livestock.
Vitek's products went into a "huge amount" of feed, says Michael E. Cleary, a special agent in charge at OCI's Chicago office. "Vitek is a small company making what may appear to be a small amount of product," Cleary says, "but its actions were particularly dangerous because the domino effect was so big." OCI estimates that about 68 million pounds of finished feed may have been made from Vitek's illegal premix, affecting as many as 125,000 animals.
FDA, along with the U.S. Customs Service and the U.S. Department of Agriculture, began investigating Vitek in 1994 based on tips from two sources: a confidential informant, who alleged that Vitek was smuggling bulk clenbuterol from its parent company in the Netherlands, and an owner of a lamb feed operation in Kansas whose lambs were mysteriously dying after eating Vitek feed.
In that year, government agents searched the premises of Vitek and some of its affiliates, seizing business records, feed mixtures, and drugs. FDA's forensic chemistry laboratory in Cincinnati determined that some of the premix samples seized at these offices, as well as other samples that U.S. Customs Service agents had intercepted at the U.S. border, were tainted with clenbuterol and other unapproved drugs.
Armed with the forensic evidence and the testimony of Sherry Steffen, Vitek's office manager, who had earlier pleaded guilty and become a cooperating witness for the government, the government proved its charges of smuggling and using unapproved drugs.
The government showed that Vitek smuggled the unapproved drugs into the United States from the Netherlands and added them to its feed premix. Between 1988 and 1994, Vitek sold over 1.7 million pounds of products with the unapproved drugs, worth about $1.3 million, according to the government's estimates.
While no specific injuries have been linked to Vitek's feed products, the danger should not be minimized, says OCI's Cleary. "The real risk to the public health arises when a person like John Doppenberg takes on himself the decision of what's safe and what's unsafe, and that drug gets into the food chain. People shouldn't look on those kinds of violations of food and drug law with the attitude of 'no harm, no foul.'"
Other companies convicted of violations related to the smuggling or use of these drugs include VIV Inc. of Springville, Pa., American Feed and Livestock Co. Inc. of Buffalo Grove, Ill., Spring Valley Specialties Inc. of Spring Valley, Minn., and Provimi Veal Corp. of Waukesha, Wis., a former half-owner of Vitek. In addition to Vitek's office manager, Sherry Steffen, other individuals who were convicted in related cases include feed company officials Jan Vanden Hengel, Hennie Vanden Hengel, Dan Shields, and Gerald Travis.
Gerard Hoogendijk of the Netherlands stands indicted as Vitek's main supplier of the black market drugs. Hoogendijk is the owner of Pricor, B.V., the Dutch animal premix company that owns a majority of Vitek. At press time, the government was awaiting Hoogendijk's extradition from the Netherlands to pursue prosecution.
Tamar Nordenberg is a staff writer for FDA Consumer.
A Louisiana crab meat and crawfish processor was ordered to cease operations after FDA inspectors repeatedly found unsanitary conditions and products containing potentially dangerous E. coli bacteria.
Under a consent decree of permanent injunction entered in the U.S. District Court for the Middle District of Louisiana May 27, Hue's Seafood Inc., of Baton Rouge, and the company's president, Tu Van Nguyen, agreed to implement a number of corrective measures before reopening its crab meat and crawfish processing business.
FDA inspected the processing plant June 26 and found the company had complied with the decree provisions. FDA authorized the facility to reopen on June 30.
Under the consent decree, Hue's Seafood agreed, among other things, to develop and implement a Hazard Analysis and Critical Control Point (HACCP) plan for its operations. HACCP regulations require all seafood processing companies to have in place a written HACCP plan. HACCP is a food safety system that identifies potential food safety hazards and specifies controls for preventing these hazards. It replaces a system that relied on spot-checks of manufacturing processes and random sampling of finished products to identify potential problems.
Hue's HACCP plan was the first FDA approved under the terms of a consent decree since HACCP regulations became effective in December 1997.
FDA became aware of the company's unsanitary crab-meat operations during a routine inspection in September 1996. Investigators found a filthy processing environment that included flies in the packing room, cockroaches in the picking room, unsanitized food contact surfaces, inadequately cleaned equipment, employees picking crabs with improperly cleaned knives and cracking blocks, employees touching cooked crabs after handling unsanitary objects, and an insufficient supply of sanitizing chemicals in processing areas. FDA issued a warning letter in October 1996 detailing the infractions, and the company promised in writing to correct them.
In August 1997, FDA again inspected Hue's and found many of the same filthy conditions, including flies and cockroaches in the plant, rodent feces in crab processing areas, inadequately cleaned equipment, inadequate employee hand-cleaning practices, and employees wearing unsanitized aprons.
After receiving another warning letter from FDA in September 1997, the company again pledged to correct its problems. But upon returning to the facility in October 1997, FDA investigators found little had changed: Insect and rodent problems remained, employees were handling cooked products in an unsanitary way, and processing equipment was encrusted with leftover food residues.
Additionally, FDA investigators took samples of finished crab meat products during each inspection. Testing by FDA's Southeast Regional Laboratory revealed that samples taken during the August and October 1997 inspections were contaminated with Escherichia coli. The presence of E. coli indicates the likely presence of fecal material--possibly from rodents or from employees who didn't wash their hands properly after using the bathroom.
Certain strains of E. coli can cause serious diarrhea and vomiting--and even death--especially in young children and older adults. However, FDA officials say there is no evidence that Hue's products caused any health problems.
On May 26, FDA and the Justice Department filed a complaint asking the court to impose an injunction on Hue's Seafood and Nguyen. The court entered a consent decree of injunction the next day.
Under the consent decree, Hue's Seafood agreed to implement a HACCP plan that included:
Hue's Seafood also agreed to pay FDA for the costs of conducting further plant inspections and analyses needed to ensure the company's compliance with the consent decree.
If the company violates any of the consent decree provisions or other aspects of federal food and drug laws, upon notification by FDA, the company must shut down its operation immediately and, if appropriate, conduct product recalls.
--John Henkel
A Minnesota doctor was sentenced to more than five years in prison and stripped of her medical license for drug tampering that endangered the lives of her critical-care patients. She stole their intravenous (IV) morphine to feed her own addiction and then replaced the missing doses with a saline solution.
Nancy Moyer, 36, of Hibbing, Minn., was convicted in the U.S. District Court of Minnesota in 1997 of four counts of consumer product tampering and six counts of obtaining a controlled substance through fraud. The internist was sentenced March 27, 1998, to five years and 10 months in prison, three years of supervised release, and 250 hours of community service. The state medical board revoked Moyer's license to practice medicine.
She is appealing her conviction.
According to Kathleen Martin-Weis, case agent with FDA's Office of Criminal Investigations (OCI), Moyer's offenses were unusual for drug pilfering because most related offenses involve stealing drugs in prefilled syringes, not IV bags.
Staff members in the critical-care unit at Methodist Hospital in St. Louis Park, Minn., where Moyer was serving a fellowship, became suspicious in January 1997 after they noticed that two IV pumps containing bags originally filled with morphine were leaking. Two days later they found another leaky bag. Because Moyer had been questioned in an earlier in-hospital, narcotics-related incident, in which she denied involvement, and because all the leaking bags had been connected to her patients, Moyer became a prime suspect. Hospital security was alerted to the suspicions, prompting a hospital investigation.
The hospital called in the FBI to investigate, but FBI agents discerned from preliminary findings that Moyer's actions fell under the Federal Anti-Tampering Act, which FDA has authority to enforce.
According to OCI's Martin-Weis, FDA's burden was to prove that Moyer tampered with the IV bags and, in doing so, acted with reckless disregard for her patients and showed extreme indifference to the danger she placed them in. OCI went about gathering potential evidence by interviewing patients and their families, examining medical records, and obtaining testimony of a pain expert from the Mayo Clinic.
FDA's investigation revealed that on five occasions in January, Moyer stole a key from the nurses' station to gain access to the patient-controlled analgesic pumps that contained IV bags filled with morphine. For security reasons, the hospital kept the analgesic pumps locked. FDA determined that, upon opening the pumps, Moyer punctured the enclosed IV bags with a syringe, taking the morphine for herself. She then replaced the missing morphine with saline solution because she feared the loss of fluid in the bag would be easily detected by nurses carefully monitoring the pumps.
FDA's investigation showed that in replacing the morphine with a saline solution, Moyer put the product back into interstate commerce, a critical element of federal anti-tampering laws.
"We also had to prove that her patients suffered when she deprived them of their medication," Martin-Weis said, noting that two of Moyer's patients whose cases were terminal received morphine for comfort care. Another patient was observed thrashing about and pulling fiercely at the breathing tube that connected him to a respirator, in response to not receiving the prescribed morphine. "And if a patient extubates himself," Martin-Weis said, "it creates a life-threatening situation."
According to Moyer's own lawyer, her addiction to morphine began in 1996 when she stole the drug from the narcotics' cabinet at a clinic at which she was then working. When access to a narcotics' cabinet became limited at Methodist Hospital, she started stealing from the IV pumps.
Moyer's conviction of obtaining a controlled substance by fraud resulted from a Drug Enforcement Administration investigation. That investigation found that Moyer perpetrated prescription forgery at least 30 times between 1994 and 1997 to obtain other narcotics.
--Carol Lewis
FDA Consumer magazine (November-December 1998)
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