A growing number of severely overweight people are choosing weight loss surgery to battle obesity. But after several patients have died, some SoCal facilities that perform a procedure involving the Lap Band device have come under scrutiny. Those deaths were followed by a half dozen lawsuits filed against the surgery centers, an insurance fraud investigation into their operations and a federal reprimand.
Their continued operation has prompted some, like Betty Brown of Torrance, to question the manner in which California regulates doctor-owned surgery centers.
Brown was 17 when her sister Tami Walter was born. Their age difference made them more like mother and daughter than two sisters. "I was home when she was born," Brown said. "She was very fun-loving, happy, always smiling. If you see any pictures, she always had a smile on her face."
About ten years ago, Tami began having trouble shedding weight from her 5-foot-one-inch frame. At the age of 52, she weighed 225 pounds. "The last couple of years she was unhappy because of her size," Brown recalled. " She used to say she wanted to see her feet again."
Brown said her sister signed up for Lap Band surgery after learning about it through 1-800-GET THIN – the popular marketing campaign that, until recently, promoted the procedure all over Southern California with billboards, radio and TV ads, and on the Internet. In Lap band surgery, a doctor places a silicone ring around part of the stomach, which restricts how much one can eat. Two days before Christmas of 2010, Tami went in for the surgery at a clinic in Beverly Hills.
"She was quite excited. Quite excited," said Brown. "She felt this was going to be a new beginning for her."
But Tami never made it home. Instead, she was rushed to a nearby hospital where she died three days later. She’s now one of at least five patients who died after receiving a Lap Band at a SoCal surgery center associated with the 1-800-GET THIN campaign.
"These outpatient facilities aren’t strictly regulated, though people believe they are," said Beverly Hills Attorney Kathryn Trepinski, who represents Brown in a wrongful death lawsuit. "They think there is adequate oversight and enforcement so that patients are protected. But that's really not the case."
Trepinski said in California, outpatient surgery centers that are owned by doctors, such as the Lap Band clinics, operate in a regulatory limbo. She and others point to a 2007 appellate court ruling that essentially exempted doctor-owned clinics from licensing by the state health department and put oversight in the hands of the Medical Board of California, which licenses doctors.
"We look at the actual physicians or surgeons and their licensing skill and abilities," said Dan Wood, spokesman for Medical Board. "When a death occurs we’ll look at that, and if there is an immediate need, suspend the physician license right away."
The surgery centers do need accreditation every three years. But those inspections are by appointment. The Medical Board conducts no surprise inspections in between certifications – making it easy, critics say, for sub-standard clinics to operate.
"In California, if you own a private surgical center and you’re a licensed doctor, you can do basically whatever you want behind closed doors," said Alex Robertson, a Westlake Village attorney who has filed a number of lawsuits against the centers associated with the 1-800-GET THIN campaign. One of Robertson's lawsuits is a whistleblower complaint by former workers who claim the centers routinely violate health and safety laws.
A spokesman for the centers dismisses those claims as false accusations by vengeful ex-employees. But Robertson said the claims are similar to a string of violations uncovered by state health inspectors at the group’s Beverly Hills clinic in 2009 that are memorialized in a 22-page report.
Inspectors from the Department of Health and Human Services Centers for Medicare & Medicaid Services were reexamining the surgery center to determine whether it was suitable to continue to accepting Medicare patients. Among the violations health inspectors found: expired medications; failure to ensure sanitary conditions; failure to ensure nurses were trained in cardio-pulmonary resuscitation and failure to properly monitor patients for anesthesia risks. Medicare pulled its certification of the center, but no one shut down the clinic. And Brown said it was not long after that her sister Tami went there for Lap Band surgery.
The Los Angeles County Cororner's autopsy report said Tami died of post-operative respiratory failure associated with her anesthesia care.
"There is a mention that the anesthesiologist abandoned her and left her with a nurse when she was critically ill," Brown said. " And she gasped. She struggled to breathe. And she suffocated."
Robertson’s whistleblower lawsuit tells similar stories, including the case of Paula Rojeski, who had Lap Band surgery at the group’s West Hills clinic. The lawsuit said alarms sounded as Rojeski’s anesthesia flowed onto the floor, yet no one took action.
"Because the equipment at the West Hills facility malfunctioned so frequently, it’s a common occurrence they say for these alarms to go off and everyone just ignores them," Robertson said.
Nevertheless, the West Hills facility, and seven other centers in the group, remain accredited and open for business. Critics say that, at the very least, underscores the need for surprise inspections of doctor-owned facilities between certifications.
"It's the kind of safeguard the public would want to have," said Dr. Jonathan Fielding, director of the Los Angeles County Health Department. "It would make clear to everybody that they've really paid attention to patient safety issues, which are really critical."
But for now, the eight Lap Band clinics, along with all other doctor-owned surgery centers in California continue to operate, under an oversight system many consider to be less than ideal.