Lifts At Center of Federal InquiriesJan 28, 2005 | St. Petersburg Times
Patient lifting equipment at James A. Haley VA Medical Center is the focus of investigations by the FBI and FDA into safety concerns and possible criminal activity.
Problems with overhead lifts used to move disabled patients at James A. Haley VA Medical Center are part of two federal investigations, one focusing on safety and the other on possible criminal activity.
The lifts were installed in 2001 at the 60-bed, $25-million Spinal Cord Injury Center, a specialty unit that has treated scores of soldiers injured in Iraq.
But the lifts and their manufacturer, Sweden-based Liko Inc., have come under increasing scrutiny because of several accidents around the country, one fatal, according to the U.S. Food and Drug Administration, which regulates medical equipment.
As the lift inquiry continues, the FBI is conducting a criminal investigation into Liko but will not discuss that case.
"The entire matter is subject to a criminal investigation involving the FBI," said Harry Glenn, a spokesman for Rep. C.W. Bill Young, R-Largo.
In a statement, Liko said it stood by its equipment but declined further comment.
In a letter to the FDA in December, former Liko executive Peter Castelli said overhead lifts the company installed at Haley are defective.
Castelli, former Liko vice president for the United States and Canada, said he submitted evidence of the problem to the FBI and the VA inspector general.
He also said a lift malfunctioned at the hospital in May 2002 and seriously injured a nurse. Castelli said Liko covered up the accident and that he took part.
"In this accident, Liko deliberately kept the true facts of the accident from the hospital personnel and also the FDA compliance reporting requirements," Castelli wrote in the letter, obtained by the St. Petersburg Times.
He added, "Along with the problem of not reporting the accident, I felt that there was a design flaw in the system and that it should have been corrected. Liko eventually did redesign this cross-over switch, but the original defective switches are still in use in the James (A.) Haley Hospital SCI area."
FDA spokesman Joseph Raulinaitis said he could not discuss the Castelli letter because of the two federal investigations. "We can't do anything to jeopardize anything that's still in an ongoing capacity."
Castelli said he resigned from Liko in April 2003 and now works for a competitor.
In an interview with the Times, Castelli said the lifts at Haley had defective springs.
"They're just very tenuous, the way they're built," he said of the overhead systems, which are equipped with a motor and a sling. "The consequences could be that the motor can fall off the end"
In his letter to the FDA, Castelli included a statement he said he submitted to federal investigators about the Haley accident. He said it injured nurse Laura Pasley.
"It was relayed to me that a lifting module (approx. 38 pounds) had fallen off the track and injured one of the nurses while she was moving the module along the overhead track," Castelli wrote.
Castelli said he went to the hospital and found that the trolleys wheels on top of the motor were improperly installed. As a result, he said he was able to replicate the accident, with the motor falling 8 feet to the floor.
He said he was later told by Liko president and owner Hans Sigvardsson to return to the hospital "when there was less activity" and fix the problem, and that he complied.
Further, he said, Sigvardsson advised him to tell Haley officials that the lifts were safe.
After that, he said, nobody believed Pasley's story.
In an interview outside her Tampa apartment, Pasley, 44, said she hurt her left wrist in the May 2002 accident.
She said it occurred just after she placed a patient in his bed, but that he was not injured.
"The whole thing came off the lift, the whole motor and everything," Pasley said. "And then the VA tried to send me to work the next day. They said work will keep your mind off of it."
Pasley said she required months of therapy. She said initially no lawyer would take her case because she could not prove the accident occurred.
She said she later reached a settlement with Liko.
In a "warning letter" Nov. 2, 2004, to Liko president Sigvardsson, the FDA cited 13 cases in which a patient lift malfunctioned.
In one case, a caregiver suffered a concussion, and in another, a patient broke a shoulder.
On July 4, 2004, a patient died after falling to the floor when a lift malfunctioned, the agency said, without disclosing details.
Liko did not report the accidents, as required by federal law, the FDA says.
"You should take prompt action to correct these deviations," the FDA said in the letter to Liko. "Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration," including "seizure, injunction and/or civil money penalties."
In a statement, Richard Fritz, a lawyer who represents Liko, said, "Liko stands by its reputation as a leading distributor of premier patient lifts."
He declined further comment, saying, "As the subjects about which you have inquired relate to pending legal matters, Liko believes it would be inappropriate to comment on them publicly at this time."
According to Liko, the company supplies 20 percent of the world market for patient lifts.
Little is known of the criminal investigation.
Neither the FBI nor the VA's office of inspector general would discuss the case, or acknowledge it.
Regarding the FBI investigation, Castelli wrote the FDA:
"I am not at liberty to discuss any of the particulars, but I feel it might be vital to your organization in learning the true intent of Liko Inc. here in the USA."