Records in a newly filed federal lawsuit indicate the official death toll among Tennessee patients from the nationwide fungal meningitis outbreak may be understated.
According to the complaint filed in U.S. District Court in Boston last week, Gokulbhai Patel of Goodlettsville died Jan. 13 from fungal meningitis caused by two spinal steroid injections he received at the Saint Thomas Outpatient Neurosurgical Center in Nashville.
However, the official death count maintained by state and federal officials shows no deaths among Tennessee patients in that month from the outbreak blamed on the New England Compounding Center, the source of the tainted steroids.
The official Tennessee death toll, which climbed to 14 in mid-December, did not increase to 15 until a Kentucky woman, who had undergone injections in Nashville and contracted fungal meningitis, died April 16. The official count remains at 15, according to the latest data from the U.S. Centers for Disease Control and Prevention.
State health officials confirmed Thursday that no fungal meningitis deaths among Tennessee patients were reported in the month Patel died.
"We have not been made aware of any deaths that occurred in January linked to the meningitis outbreak associated with products from NECC," Tennessee Health Department spokeswoman Shelley Walker wrote in an email response to questions.
CDC officials said they rely upon state health officials to gather the data from health care providers on deaths from outbreaks.
Exact count elusive
While the Patel case gives the first indication of a possible undercount in a public record, it comes as no surprise to attorneys representing victims of the outbreak.
"Clearly we don't have the exact count," said J. Gerard Stranch, who represents several area victims or their families. He said he personally was aware of about a half-dozen cases not included in the official count.
Stranch said there could be a variety of reasons, including the fact that some other illness was listed as the final cause of death when, in fact, a cascade of illness initially was triggered by fungal meningitis.
The latest CDC data show that in addition to the 15 deaths, 153 Tennessee patients have been sickened from the outbreak. Nationwide, 63 deaths have been recorded with 749 patients sickened.
"There are potentially a significant number of additional patients who have been injured or killed by the contaminated medications sold in Tennessee and in other states," said Mark Chalos, a Nashville attorney who represents several area victims.
He said that he and other plaintiff lawyers have been pushing for the federal court to require health care providers to notify all possible victims, but some have been resisting those efforts.
Olivia Colonero at the law firm of Janet, Jenner and Suggs, which represents the Patel family, said she was not aware the death wasn't included in the official count.
"Maybe there was some miscommunication," she said, adding that the firm would look into the matter.
'Extreme conscious physical pain'
Patel, 80, died about five months after he received the second of two injections with methylprednisolone acetate at the outpatient center.
Sanmukh Patel said in a phone interview that his dad was hospitalized twice after contracting fungal meningitis. He said his dad, who came to the United States from his native India in 1997, got the injections seeking relief from chronic back pain.
He said his father, who was retired, had been sick "for a long time" and never recovered. "He spent a lot of time in the hospital."
According to the federal lawsuit, Patel was referred to the neurosurgical center by the Howell Allen Clinic, which is part owner of the outpatient center.
The complaint states the elder Patel was given injections on Aug. 27 and Sept. 10, 2012. He was admitted to Saint Thomas Hospital on Oct. 17 suffering from chills, fever, dizziness and weakness, and lower extremity pain.
"He was diagnosed with fungal meningitis after steroid injections," the complaint states. "From the time of Mr. Patel's illness to his death he experienced extreme conscious physical pain and mental suffering."
The 34-page complaint states that the elder Patel was first hospitalized for two days shortly after his second shot and then readmitted in October.
Named as defendants in the case are the owners of NECC, which has shut down and filed for bankruptcy. Other defendants include Ameridose, a sister company of NECC; Medical Sales Management, the sales arm for the two companies; and a testing company hired by NECC to check the sterility of its products.
The plaintiff is Pinal Patel, a grandson of the victim and personal representative of his estate.
The suit is one of several being filed as a deadline approaches under the state health care liability statute, which carries a one-year time limit for filing a claim.