Friday, February 27, 2015

Adding Insult to Injury



A state Psychology Board recently hit one of its psychologists with a penalty that was perfectly tailored for the charges leveled against him.  It revoked his license for a minimum of five years.  It further held that if, by some unexpected turn of events, this doctor managed to get his license back, he would never be allowed to treat females.  It finally ruled that if he did get his license back, his practice would always be monitored by a Board-approved mental health professional.  By now, you can probably figure out the nature of some of the charges against Dr. A. 

From the mid-1980’s through 1996, Dr. A. provided psychotherapy to a female patient, referred to as “Client G.”  He initiated a sexual relationship with her from 1994-96.  The sex took place during weekly sessions.  The doctor billed the patient for those sessions.  While treating and having sex with her, he also made her a co-facilitator of a psychology group for sexually abused women.  He presented her to the group “in a way that suggested that Client G had qualifications as a mental health professional.”  I’m sure he billed for these sessions as well.  The Board also found that during this same period of time, Dr. A had an affair with Client R.

Meanwhile, Dr. A was also treating clients "S" and "M."  These women participated in group sessions for sexual abuse victims who had developed post-traumatic stress disorder.  On one occasion Dr. A called S to ask her to help M who was suicidal at the time.  The Board ruled that telling S that M was suicidal violated M’s privacy.  Dr. A argued that he made the call in an effort to save M’s life.  The Board dismissed this argument.

On appeal, Dr. A argued that it was error to allow “patient advocate” Board members to participate in hearing his case.  His state’s Psychology Licensing Act requires three board members to be members of the public “who are not mental health professionals.” Unfortunately, the statute refers to these members as “patient advocates.”  The Court threw out this defense because Dr. A offered no evidence of “specific bias or prejudice” on the part of these Board members.  

In a last ditch effort to save his license, Dr. A argued that Dr. Woodrow, one of the psychologist board members, should not have participated in his hearing.  He claimed that she was biased against him because she had treated patient “G.”  The evidence showed that almost 30 years before the hearing, Dr. Woodrow treated G.  However, she did not remember G and did not have records of her treating G. The Court found that this was not evidence of bias.

It’s hard to find a worse example of psychologist-patient abuse.  Dr. A chose a patient whom the Board described as “very vulnerable,” initiated a sexual relationship with her, charged her for the privilege of having sex with him, cheated on her, and had her misrepresent herself when she “facilitated” a group of sex abuse victims.  It is fortunate that the Board took this man’s license.  One can only hope he never gets it back.

Sunday, February 1, 2015

Drug Company Blames Doctor



It's not a pretty aspect of human nature.  In fact, if you've done it, you're probably ashamed of yourself.  An authority figure accuses you of breaking a rule or a law.  Fearful of the consequences, you look around for someone else to blame.  The other person is usually someone who is weaker than you.  It may be a little brother or some other person who can't fight back.  The following is a case in point.
In 2008, Dr. Benjamin prescribed Botox to treat his 2 year old patient for lower-limb spasticity caused by cerebral palsy.  Initially, he ordered 6 units per kilogram of body weight.  In 2012, he decided to increase the dosage to 12.33 units per kilogram of body weight.  The day after the first injection of the increased dose, the patient’s face began swelling and he experienced respiratory difficulties, slurred speech, and vomiting.  
After several hospitalizations, physicians discovered that the Botox injection may have triggered the epileptic seizures that caused these symptoms.

Prior to Dr. Benjamin’s treatment of this patient, Allergan, the manufacturer of Botox, had determined that the maximum dose for a child should not exceed 8 units per kilogram of body weight.   Because Allergan failed to convey that information to treating physicians, Dr. Benjamin was not aware of the dosage limit.  Arguing that Allergan had a duty to advise physicians of dosage recommendations, the patient’s parents sued the manufacturer.

In its effort to escape liability, Allergan argued that because the physician was a “learned intermediary,” he alone had the duty to determine the appropriate dosage for his patient.  It claimed that he alone had the duty to warn the patient of the risks of treatment.

Allergan is not the first drug company to urge the court to shift liability to the health care provider.  Upjohn successfully asserted the same argument in a case involving the death of a man who took Ansaid, a non-steroidal anti-inflammatory drug used to control pain.  Because the drug was a sample given by the physician, its packaging did not contain any drug warnings.  Abbott labs also successfully relied on the learned intermediary in a case involving its concentrated sodium chloride medication.   

Despite these earlier cases, the Court ruled against Allergan.  It held that the learned intermediary doctrine did not apply because Allergan had not warned the physician of “the dangers inherent in the product.”  Dr. Benjamin testified that he would have passed the dosage warning on to the plaintiffs if he had known about it.  He also said that he currently includes that warning in his informed consent procedure.  The plaintiffs testified that they would not have consented to the drug if they had known about the dosage issue.  They said that their son’s spasms were not severe and did not warrant taking the risk of contracting epilepsy.   Significantly, at the time of this case, the FDA had not approved Botox to treat lower-limb spasticity in children.  Accordingly, Dr. Benjamin’s use of the drug was “off-label.”

Health care providers should be certain that they convey in writing to their patients all relevant risks of recommended drugs.  This duty to warn is especially important when the provider’s use of the drug is “off-label.” It is also important when giving the patient a sample of the drug.  Because the packaging of drug samples does not include warnings of drug interactions, the patient does not receive a copy of the manufacturer’s warnings. 

While it is a compliment for the court to consider you “learned,” it can be very expensive for the court to decide that you are a “learned intermediary.”  Don’t become a scapegoat.


Wednesday, January 28, 2015

Jumping A Snake




Some people talk about having a “near miss.”  Others may say they “dodged a bullet.”  Whenever my Dad escapes grave danger he says, “Well, I certainly jumped a snake on that one!”  A few months ago, some North Carolina dentists “jumped a snake” in connection with a lawsuit alleging violations of the federal Anti-Kickback Act and the False Claims Act.

Current and former employees of a major dental supply company filed suit.  They claimed that their employer gave dentists illegal kickbacks for buying its supplies, including dental implants.  These “incentives” included cash, all-expense paid trips to international symposiums, and free dental equipment.  It also paid them to speak at numerous workshops in exchange for buying the supplies.

 The dentists who accepted these illegal incentives used the supplies in treating patients.  They then billed dental insurance carriers as well as Medicare and Medicaid for that treatment.  A health care provider who files a false or fraudulent claim for payment violates the False Claims Act.  A claim is fraudulent if the provider violates the Anti-Kickback laws in connection with treating the patient.  The Court viewed the incentives offered by the dental supply company as illegal kickbacks.

The defendant told the Court that it had not filed any claims with the government or insurance companies.  It argued that the dentists were the ones who accepted the kickbacks and filed the fraudulent claims.  Accordingly, it reasoned, the dentists were the proper defendants.

The Court rejected this argument.  It held that the dental supply company would be liable if it induced the dentists to accept the illegal kickbacks.  It ordered the case against the company to go forward to trial.

The Court noted that the complaint failed to identify the dentists who accepted these kickbacks.  It did list the states where these dentists practiced.  North Carolina is one of the states listed.  Fortunately the Plaintiffs did not file claims against the dentists.  The dentists have jumped a snake – for now.  Still, it is important to take note of the case and the types of “incentives” that the courts view as illegal kickbacks.  Very few folks can jump the same snake twice.