A specialized skin cream prescribed by a local doctor for a woman's back and knee pain killed her 5-month-old baby after he came in contact with it, according to a Los Angeles coroner’s report.
The infant's parents are suing the mother's doctor, whose involvement in the case also led to his being charged with involuntary manslaughter in an indictment filed last week by the Orange County Grand Jury.
The parents of the baby, Andrew Gallegos, have filed a product liability and medical negligence lawsuit against Dr. Andrew Jarminski, physician assistant Joseph Gutierrez, Healthcare Pharmacy, Allied Medical Group and Industrial Pharmacy Management.
The lawsuit claims Gallegos' mother, Priscilla Lujan, went to Jarminski’s Long Beach office in February 2012 for treatment of injuries she suffered while working at Goodwill Industries.
Medical records show Jarminski prescribed Lujan a compound transdermal cream comprised of the antidepressant amitriptyline, the pain reliever tramadol and the cough suppressant dextromethorphan.
A seemingly normal night and a tragic morning
Lujan’s attorney, Shawn McCann, claims she went home that night and applied the cream to her knee and back, as she was directed by Jarminski. After using the medication, she took care of her baby, including preparing a bottle for him and bouncing him on her knee and holding him over her shoulders, according to McCann.
Lujan put the baby to sleep in her bed and awoke in the morning to find him unresponsive. He died an hour later "as a result of multiple drug intoxication," according to the autopsy report.
The report also stated that Andrew had high levels of three drugs in his system – the same drugs in the compound cream prescribed by Jarminksi. Tramadol and dextromethorphan were present at lethal levels, the coroner found.
Ruling the death a homicide, the coroner’s report said the high levels of drugs in the baby’s blood could not result from incidental skin absorption or passive transfer, and instead suggested the baby ingested the medication. Medication residue was found on one of the baby’s bottles, the coroner reported.
Lawyers for Jarminski, Gutierrez, Healthcare Pharmacy, Allied Medical Group and Industrial Pharmacy Management did not return calls from KPCC seeking comment.
Lujan was arrested after her son's death, but the Los Angeles District Attorney declined to file charges because of insufficient evidence, according to spokeswoman Jane Robison.
An incomplete label
The lawsuit suggests the compound cream should not have left Jarminski's office because its label said it was only to be applied in a medical office under a doctor's direction. There were other problems with the label, McCann said.
"It wasn’t properly labeled with [Lujan's] name, what the prescription was for, or how to use it," he said.
Taking an antidepressant for pain is not unusual, but applying it as a cream is, said James David Adams Jr., Associate Professor of Pharmacology at the USC School of Pharmacy, who is not involved in the case.
Amitriptyline and the cough suppressant dextromethorphan both function partially as pain relievers, said Adams.
"I had never heard of a compound cream with these ingredients used before for the control of back pain, but it makes a lot of sense," he said.
He cautioned, however, that this combination is particularly toxic to babies.
"You certainly don’t want to get this compound on your infant," said Adams.
An expensive concoction
While it may have been a powerful pain reliever, the cream Jarminski prescribed for Lujan was costly. Workers' compensation records show Jarminski’s office billed $1,700 for the initial 25-day supply of the cream. That is much more than the prices of various mass-produced medications, asserted McCann.
Jarminski was informed the cream was linked to Lujan’s son’s death but, according to McCann, that didn’t stop the doctor from sending more creams.
"Priscilla had expressed she didn’t want to see that cream anymore or use it anymore," McCann said. "Despite that they continued to send her more creams by mail and bill workers' comp for it."
McCann said at least two to four more tubes of cream were sent to Lujan after her son’s death. It's unclear how much Jarminski billed in workers' compensation claims for those additional tubes.
"Compounds and the prices charged for them by compounding pharmacies are a growing problem for the health care system," said Riddhi Trivedi-St. Clair, a senior manager with Express Scripts Inc., which manages prescription benefits for thousands of employers, including Los Angeles County.
According to data provided by Express Scripts, the number of injured California workers filing a prescription for at least one compounded medicine increased by 157 percent last year, compared with 2012.
The prescription, production and distribution of compound transdermal creams are at the center of the sealed indictment delivered last week by the Orange County Grand Jury. Fifteen people were indicted for their roles in the alleged scheme, which purportedly involved more than $25 million in kickbacks paid to physicians who prescribed the creams.
Jarminski was among those indicted by the grand jury, as was Michael Rudolph, the owner of Healthcare Pharmacy, which is named in Lujan's lawsuit. Healthcare Pharmacy's name is on the label of Lujan's prescription as the preparer of the compound cream.
Rudolph was indicted along with Jarminski for fraud and involuntary manslaughter, as was the scheme's alleged mastermind, Kareem Ahmed.
Jarminski is associated with Allied Medical Group (another firm named in Lujan's suit), as is Dr. Daniel Capen, who was also indicted by the grand jury on fraud charges.
The third firm named in Lujan's suit, Industrial Pharmacy Management, has a connection to another massive workers' compensation fraud case. Industrial Pharmacy Management’s managing partner is Michael Drobot, who pleaded guilty in federal court in April to his role in a half billion dollar workers' compensation fraud scheme.
This story was updated on June 24, 2014 to reflect the correct percentage increase of the number of injured California workers filing a prescription for at least one compounded medicine last year, compared with 2012.