What California should learn from the 1-800-GET-THIN saga

The story, which includes the deaths of five Lap-Band patients, is really about how California regulators let a public health crisis erupt under their noses.

Today, 19 months after her death, we may finally have a good idea of what killed Paula Rojeski.

According to a lawsuit and public autopsy records, the causes included her doing business with the 1-800-GET-THIN folks and the slicing of her aorta during weight-loss surgery at one of their affiliated surgical centers.

There was also regulatory indifference on a truly majestic scale.

Rojeski, 55, died Sept. 8, 2011, shortly after surgery to implant a Lap-Band at Valley Surgical Center in West Hills, which her family's lawyer says is affiliated with 1-800-GET-THIN and the two brothers behind it, Julian and Michael Omidi. She was the fifth person since 2009 to die shortly after Lap-Band procedures at clinics affiliated with the 1-800-GET-THIN advertising campaign, according to lawsuits, coroner's records and interviews.

You remember the 1-800-GET-THIN campaign, don't you? For years it blanketed the Southland like a layer of adipose, pitching Lap-Band surgery from billboards, buses and the airwaves. The ads finally disappeared last year after the Food and Drug Administration warned that they misleadingly downplayed the risks of the surgery and after Allergan, the Irvine-based maker of the device, said it would stop selling to the affiliated surgery clinics.

Earlier this month the Los Angeles County coroner's office finally released its report on Rojeski's death, after a delay caused in part by the fact that four state and federal agencies were conducting their own investigations into the death — the FBI, the FDA, the California attorney general and the state medical board. The outcomes of those probes, as well as an investigation by the LAPD's robbery-homicide unit, aren't known. Rojeski's sister, Michele Pelter, has sued 1-800-GET-THIN, the surgical center and several individuals in Los Angeles County Superior Court alleging fraud and other wrongdoing in connection with her death.

Here's what the coroner did say: There was "negligence" in Rojeski's treatment. The coroner's surgery expert, Dr. Denis Astarita, recommended reporting the case to the California Medical Board for "gross negligence with incompetence." And in the opinion of Earl Strum, chief of anesthesiology at USC's Keck Medical Center, who was called in as a consultant by the coroner, the "major issues" were the "perforation of the aorta" during Rojeski's surgery and the lack of recognition by her anesthesiologist, Deming Chau, that she was bleeding internally. Strum termed Chau's performance "negligent."

Strum found that Chau didn't keep the surgeon, Julius Gee, informed that his patient was in distress after the operation. The indications were that the patient was bleeding, presumably from the aorta, Strum said, and Chau failed to ask for "additional interventions and help." Rojeski lost her pulse at 10:55 that morning, 70 minutes after the operation was completed, and died at a nearby hospital less than an hour after that.

Strum said he didn't label the case "gross negligence" in part because injuring the aorta is a "rare occurrence" during Lap-Band surgery so perhaps it's understandable that the crew didn't think of it. That's fascinating, because in its effort to contest the coroner's report, Valley Surgical produced opinions from at least two of its own consultants that injury to the aorta is a "known complication" of Lap-Band surgery. Valley argues that Rojeski's death was an "accident."

That's among the curiosities raised by the clinic's defense in the Rojeski case. But before going into the others, let's examine the contribution made by our state's inexcusably lazy medical regulators. Because the entire 1-800-GET-THIN saga is really about how California regulators let a public health crisis erupt under their noses.

The story begins in 2007, when an appeals court stripped the state Department of Public Health of jurisdiction over surgical clinics owned by doctors and transferred it to the Medical Board of California. The board had no expertise in regulating surgical facilities but it suddenly had responsibility for more than 700 of them.

The board vested its inspection power in four nonprofit independent accreditation organizations. That didn't work well, because a clinic that lost its accreditation with one often could just move on to another, with no one the wiser: A lost accreditation didn't have to be disclosed publicly.

Eventually, the Legislature mandated that the board make sure the four coordinated with one another, and also that it post the ownership and disciplinary records of every clinic on its website. The law went into effect Jan. 1, 2012; the board still hasn't finished acquiring and posting the information. You want to know who owns Valley Surgical Center, LLC? The board's website says: "Valley Surgical Center, LLC." Thanks a bunch.

The accreditation agency overseeing Valley Surgical is the Illinois-based Joint Commission. This organization's performance in relation to Valley Surgical helps defines what's wrong with leaving oversight of surgical centers to private agencies. The record shows that in the more than three years that the center has been accredited, the Joint Commission has subjected the place to a full survey inspection exactly once — in November 2010.

That's within the JC's normal time span for full inspections, but it doesn't sound like enough. According to a report it issued last September, after a quick but not full on-site inspection the JC judged the center "out of compliance" in 16 standards, including its "ethical principles," governance and various provisions relating to management, safety, emergency, post-operative care and other things.

Miraculously, the center appeared to have resolved these issues in time for the JC's next accreditation report three months later, because that report gives the impression it had a clean bill of health. It would be fascinating to know how this was achieved, especially given that resolving ethical shortcomings takes some people years, if not a lifetime, of personal introspection. If the management of Valley Surgical really got ethical in just three months, they shouldn't be running a surgical clinic but a spiritual shrine, like Lourdes.

I asked the Joint Commission how Valley Surgical managed to wipe the slate so clean. They didn't say, but perhaps they're not so satisfied with conditions at Valley after all. In the course of a federal lawsuit Valley filed against the county and the coroner's office last month, the surgical center said that it "will likely have its accreditation and certification withdrawn by the Joint Commission" if the coroner's report is released. The center said "the Joint Commission has indicated its intention to rely on this report in determining continuation of Valley's accreditation."

Of course, if you're merely a member of the public checking with the Joint Commission about Valley Surgical's accreditation standing, you wouldn't know that.

Who does own Valley Surgical? Remember, it has to be owned by a doctor to avoid regulation by the California Department of Public Health. The California Medical Board's website doesn't identify any individual owners. The California secretary of state's website doesn't say. Neither does the facility's recently filed lawsuit again the coroner. The state Department of Public Health says it has no record for Valley Surgical.

In May 2007, a medical board record stated that a surgery facility at the exact same address was co-owned by Michael and Julian Omidi. It was then known as Woodlake Ambulatory Surgery Center. The center filed a public document around the same time that identified Julian Omidi as its president.