Consumer

New Law Requires Doctors to Notify Patients About Site That Tracks Payments From Drug and Device Companies

After learning her doctor used an experimental device on her without her knowledge, Wendy Knecht complained to the Medical Board of California and set out to change the law. Just as new legislation takes effect, the Board has reached a decision about her doctor. But it is far from what she expected.

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A woman’s years-long battle over problems with her doctor leads to a new California law requiring more medical transparency. Carolyn Johnson reports for the NBC4 News at 11 p.m. on Thursday Feb. 3, 2023.

Pasadena Plastic surgeon Max Lehfeldt operated on Wendy Knecht after her double mastectomy in 2016, but she says he didn’t tell her he used an experimental device not cleared for breast reconstruction.

“I had continual pain," Knecht explained. "I had these seromas, these fluid buildups."

She first shared her story with the I-Team in 2019.

“I did not have any idea it was not FDA cleared or being used for the wrong purpose," said Knecht at the time.

Months after her surgery, she discovered Dr. Lehfeldt had received nearly half a million dollars from the maker of the device he used on her, without her knowledge. She sued and received a million-dollar settlement from Dr. Lehfeldt. 

I did not have any idea it was not FDA cleared or being used for the wrong purpose.

Wendy Knecht, Patient

Had she known that information before her operation, she said she never would have consented to that surgery with him.

Knecht reached out to her state assemblyman with a simple goal in mind:  Require California doctors to notify patients about any money they accept from drug or device companies. The legislation eventually drafted and signed by Governor Newsom late last year is even simpler: Doctors must notify their patients of the federal government’s Open Payments website.

“You just put your doctors name in there and it’s so detailed. I think you can never go wrong with more transparency,” said Knecht. “A lot of times doctors receive money and it’s a good thing, maybe they helped invent something. But you should be able to make that decision if you think it’s a conflict of interest or not.”

The site is run by the Centers for Medicare and Medicaid Services (CMS). It's where Knecht learned about the payments Dr. Lehfeldt received. And once she shared her surgery nightmare with the I-team, more patients of Dr. Lehfeldt came forward, including Tracy Carter.

“It's like a bomb went off in me. I’m in pain every day, I don’t really think I’ll ever be the same inside," Carter said. "It always hurts."

Tracy developed a life-threatening infection after her tummy tuck by Dr. Lehfeldt. She is patient D in the accusation by the medical board against him which cites his "repeated negligent acts in the care and treatment of patients A, B, C and D, making his license subject to discipline."

See the PDF below.

The medical board just recently announced its decision about Dr. Lehfeldt, which went into effect the first week of February, 2023: 3 years' probation.

See the PDF below.

Shame on the medical board... my life is never going to be the same, and he just keeps on practicing.

Wendy Knecht, Patient

"Shame on the medical board. It’s terrible," said Knecht after hearing the decision.

"I was completely outraged because my life is never going to be the same, and he just keeps on practicing."

We reached out to Dr. Lehfeldt’s attorney for comment, but did not hear back from him.

The next time you go to the doctor, you may or may not be told about the Open Payments website. 

The law reads “a physician and surgeon shall provide to each patient at the initial office visit a written or electronic notice of the Open Payments database… “.

The intent was for patients to receive notification at their initial office visit after the bill was enacted, but the way it’s written, it could be interpreted as only for new patients.

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