A nationwide medical gas supplier under contract to the U.S. Department of Veterans Affairs was shut down for repeatedly failing to correct major manufacturing violations, including some that FDA identified following 11 deaths at a Texas VA hospital.
Under a consent decree of permanent injunction entered Nov. 18, 1997, Air Liquide America Corp. became the first medical gas manufacturer to be enjoined for violations of regulations for drugs and hospital medical gas installations.
Though the Dallas County Medical Examiner's Office could not conclusively connect the patients' deaths to oxygen received during inhalation therapy, an FDA inspection identified a poisonous cleaning solvent in the Air Liquide stainless steel hose used to connect a temporary oxygen supply to the hospital's oxygen system.
In the consent decree, Air Liquide and its president and chief operating officer, Patrick Verschelde, agreed in the U.S. District Court for the Southern District of Texas to stop providing medical gas services to hospital clients until it could demonstrate compliance with current good manufacturing practices (CGMPs) for drugs. At press time, FDA was reviewing other medical gas production processes covered by the consent decree to confirm that the company was in compliance.
Air Liquide, an international multi-billion-dollar corporation with U.S. headquarters in Houston, manufactures and distributes medical gases for respiratory therapy in hospitals and at home, as well as industrial gases for food processing, metallurgy, waste water treatments, welding, and petrochemicals. Incorporated in 1994, the company sells medical oxygen to more than 700 U.S. hospitals--both public and private--mainly for use by patients with emphysema, lung cancer, chronic pulmonary obstructive disease, and heart disease.
Because of continuing problems, FDA, along with the states of Texas and California, inspected more than 20 of the company's facilities in four states in 1995 and 1996.
FDA's inspections consistently found that the company failed, among other things, to:
In March 1996, a VA hospital in Temple, Texas, notified FDA that 89 of its patients had received oxygen delivered through a system Air Liquide was installing that had a chemical odor. Three patients died within 24 hours of receiving the oxygen; eight others died shortly thereafter.
FDA collected a section of stainless steel hose from the oxygen delivery system Air Liquide had set up at the Texas hospital. FDA laboratory analysis found the hose contained trichloroethylene (TCE), a cleaning solvent that an Air Liquide contractor had used to clean the stainless steel hose. FDA determined that the hose and the oxygen delivery system had not been adequately flushed before patient use. FDA also sampled a similar though unused stainless steel hose from Air Liquide's contractor and confirmed the presence of the chemical in that hose.
Autopsies of the 11 deceased patients were inconclusive. But, in follow-up investigations of the company's headquarters facility in Houston and another facility in Louisiana, FDA again identified serious CGMP violations.
In a June 3, 1996, meeting with representatives from FDA's Dallas district office, Air Liquide executives reiterated their stance that hospital medical gas installations did not fall under CGMP regulations. FDA felt otherwise, and in a letter to the Justice Department in May 1997 requesting permanent injunction proceedings against Air Liquide, noted that medical gases, like traditional drugs, are used by doctors and other health-care providers to "cure, mitigate, treat, and prevent disease and can be intended to affect the structure or function of the body."
"[A]ll manufacturers of articles of drugs must abide by CGMP requirements and there is no reason to make an exception for the proposed defendants," FDA wrote.
The consent decree of permanent injunction required Air Liquide to cease operations and:
Paula Kurtzweil is a member of FDA's public affairs staff.
On April 20, the U.S. District Court for the Eastern District of Louisiana entered a consent decree of permanent injunction against Henry Vechery and Joyce Krantz of May's Seafood. The decree spells out the company's need to follow a modern food safety system known as Hazard Analysis and Critical Control Point (HACCP).
However, at press time FDA learned that May's Seafood decided to discontinue its crabmeat processing operations. The company continues to operate a live crab business, which was not affected by the court action.
HACCP focuses on identifying and preventing hazards that could cause food-borne illnesses rather than relying on spotchecks of manufacturing processes and random sampling of finished seafood products. HACCP became mandatory for all seafood processors in December 1997. (See "Critical Steps Toward Safer Seafood" in the November-December 1997 FDA Consumer.)
FDA inspected May's Seafood three times between 1995 and 1996, each time warning the company to correct "gross insanitary conditions," such as poor employee food handling practices and signs of mice and vermin infestation. After receiving each of the warnings, Krantz, May's Seafood manager, told FDA that the company would correct the violations.
But in an inspection June 30 through July 3, 1997, FDA found live mice in the processing areas and in areas where cooked products were held. FDA investigators also noted poor employee practices, such as workers failing to wash their hands, filthy processing equipment, and structural defects that allowed mice and rats to enter. Again, the company said it would correct the violations.
Three months later, an FDA inspection again noted vermin in the plant, filthy equipment, and continued sanitary violations by employees.
In December, the Justice Department submitted a complaint to the U.S. District Court requesting an injunction on behalf of FDA.
In signing the consent decree, May's Seafood agreed also to:
--John Henkel
Manouchehr "Max" Naami, owner of U.C. Imports of Los Angeles, was sentenced April 10 in the U.S. District Court for the Central District of California to 30 days in prison, three months of home detention, and two years of supervised release for attempting to bribe FDA inspector Kevin Fritz.
In February 1996, FDA detained a shipment of condoms in U.C. Imports' name because FDA analysis found too many of them leaked. FDA requires imported condoms to be tested to ensure they meet U.S. standards before they are released for sale.
According to Fritz, who is with FDA's San Pedro, Calif., resident post, Naami contacted him to ask him to explain his options for gaining release of the detained condoms. Naami knew Fritz from earlier sample collections.
"I told him, 'No problem. I'll be in the area the next day, and I'll be glad to help,'" Fritz recalled. "I had no reason to suspect he wanted anything more than information."
When Fritz met with Naami at his warehouse on March 22, Naami told him he was willing to do whatever was necessary to get FDA to release the detained shipment. "What do you mean?" Fritz recalled asking him.
"I can compensate you," Naami replied.
Fritz told Naami he would have to think about it. He then went to his office and notified his supervisor and the Department of Health and Human Services Office of Inspector General (OIG).
At OIG's request, Fritz agreed to talk with Naami again, and they arranged to meet at an Irvine, Calif., hotel on April 3. Undercover OIG special agents arranged to monitor the meeting.
When they met, Naami told Fritz he would give Fritz money for each of two shipments he wanted cleared for distribution. He revealed that he had already distributed about 60 cartons of the FDA-detained shipment. He offered to give Fritz cash on the spot if Fritz would fill out the paperwork to show the shipments had been cleared.
Fritz, feigning concern about Naami's offer of cash right then and there, told Naami the deal was off.
Fritz returned to his office to consult with OIG and FDA officials. They instructed Fritz to set up another meeting with Naami, so on April 5, Fritz returned to the Irvine hotel to meet with Naami. Again, undercover special agents with OIG, FDA's Office of Criminal Investigations (OCI), and FDA's Los Angeles district office monitored their activities.
At Naami's instruction, Fritz drove his car to the front of the hotel, left the trunk open, and walked into the hotel lobby. Naami got out of his car, walked over to Fritz's, and dropped an envelope in the opened car trunk. He then returned to his car, where he stayed for five minutes, apparently "waiting to see if he would get busted," Fritz said. Naami then returned to the car trunk with another envelope.
With the evidence captured on film, the special agents watched as Naami drove away. They then approached the car to find in the trunk two envelopes, the first of which contained note cards and the second a stack of $20 bills.
Upon receiving confirmation of the bribery attempt, special agents waiting outside U.C. Imports' warehouse seized the remaining detained condoms in storage. At the same time, OCI special agents prepared to retrieve the defective condoms Naami had released into interstate commerce and prevent distribution of more. They and personnel with FDA's Los Angeles district office spent one week contacting the customers on Naami's distribution list, successfully retrieving all cartons of the distributed condoms, according to Tom Sawyer, a compliance director in FDA's Los Angeles district office.
"Naami made it easy for us by cooperating," an OCI special agent said. "It could have been a nightmare trying the get the faulty condoms back."
In October 1997, Naami pleaded guilty to a one-count information. His sentence in April also included a $50 special assessment fee.
OCI retains custody of the seized and recalled condoms. Once the court gives its OK, defective condoms will be destroyed, and any that meet quality standards will be returned to U.C. Imports.
Fritz, who now verifies electronic submissions of incoming imports for FDA, says that working undercover on this case proved "stressful, but I couldn't let the attempted bribery go by. It's part of my job. He [Naami] would have done it to someone else."
--Paula Kurtzweil
FDA Consumer magazine (September-October 1998)
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