FERNANDO VARGAS, 15, died when the ventilator he relied on to breathe stopped working during a two-hour power outage in East Boston. A backup battery appears to have malfunctioned. His death is a tragedy for those who loved him. It also raises serious questions for the state.
The Vargas family got the ventilator from New England Home Therapies, a company that works as a contractor for the state's low-income health insurance program, MassHealth. It now appears that the ventilator was among those targeted for recalls to fix the backup power supply. But the family, it seems, did not know about the recall.
The state said it didn't know about the recall, either. "We don't have any record of a recall of this individual's ventilator," said Jennifer Kritz, a spokesman for the department of Health and Human Services, which oversees MassHealth. Kritz indicated it is the job of the vendor, in this case New England Home Therapies, "to work directly with the consumer. . . They do the day-to-day management."
In this case, "the consumer" was a 15-year-old with multiple disabilities. Vargas was born with cerebral palsy, muscular dystrophy, mental retardation, and other ailments. He relied on a respirator and breathing tube since 2004. They were his lifeline.
In 2004, the manufacturer of the equipment, Pulmonetic Systems Inc., recalled more than 10,000 machines like Vargas's because of the potential for the backup battery to fail. So, why did Vargas have one?
A spokeswoman for New England Home Therapies declined to say whether it received a recall notice, and the vendor's role in this incident has yet to be established. But when the state is paying, it can't avoid responsibility for cases like Vargas's. The state is paying the vendor to provide a service that includes supplying life-or-death medical equipment. But the state's regulations and contracts don't specify how recalls should be handled.
Even if MassHealth doesn't hold itself responsible for making sure recall information gets to families, the court system might well. "The state obviously has oversight. They are contracting an obligation to a vendor," said Michael E. Mone, a Boston plaintiff's lawyer who specializes in medical malpractice and product liability. To put it another way, said Mone, "The state can't say, 'We contracted out the Big Dig, so we don't have to look at the fact it's leaking.' "
Lawyers who deal with MassHealth said it takes the position that it doesn't supply equipment. Or as Kritz put it, "MassHealth's role is to pay." But when the state is paying for the equipment, it should take an interest in whether that equipment is safe.