Lawsuit claims health care cover-up

Fort Lauderdale business accused of hiding defects in tests, leading to health problems

A Fort Lauderdale-based manufacturer of blood glucose testing products knowingly distributed defective test strips that delivered inaccurate results and created health problems for patients with diabetes, a federal lawsuit claims.

Among the victims were two patients who lost their fetuses after relying on the test result to determine how much insulin they needed to manage their diabetes, according to the suit, which was filed against Trividia Health Inc. on behalf of the United States, 26 states and the District of Columbia.

The suit, which recently transferred to the Southern District of Florida in Fort Lauderdale, seeks damages under federal and state False Claims Acts, and reimbursement of money that it claims Trividia earned from federal and state-run health insurance programs.

A whistleblower notices a pattern

In the case, a former employee who worked for the company’s customer service department began noticing large numbers of complaints by consumers who said that test strips made at the company’s manufacturing plants on Northwest 55th Court were giving them inaccurate glucose readings.

The employee, Patricia Crocano, began working for the company in 2014 when it was called Nipro Diagnostics. Prior to that it was called Home Diagnostics.

Crocano is identified in the suit as a “relator,” which is essentially a whistleblower. Under state and federal False Claim Acts, relators can file suits on behalf of states or the federal government, attorney Reuben Guttman said in an email. Guttman is a partner in the Washington D.C.-based firm Guttman Buschner & Brooks, one of four firms pursuing the matter.

Attorneys for Trividia did not respond to requests for comment about allegations in the lawsuit. In a motion to dismiss the case filed on Dec. 21 by Wyche P.A. of Greenville, South Carolina and the Miami office of Greenberg Traurig P.A., Trividia argued that Crocano lacked standing to file a False Claims Act suit because the company had already acknowledged, in a voluntary recall in 2016,

that some of its test strips were defective.

Further, the lawsuit did not cite a single example of a “false claim” submitted to the government for reimbursement.

In late 2014 and early 2015, complaint calls averaged about 300 to 400 a day, the suit states. The most serious complaints focused on test strips sold under the brand names TRUEresult and TRUEtest. Consumers said their strips reported a low, high, or inaccurate result, or sometimes no result at all, the suit says.

Crocano said she came to believe that the large number of complaints, including 70 claims that the containers were opened when consumers bought them, pointed to a manufacturing defect that exposed the test strips to humidity.

Scripts to funnel complaints

Supervisors directed customer service representatives to address complaints by reading from a prepared script that blamed customers for mishandling or improperly storing the strips, the suit says.

Classifying complaints as caused by user error enabled the company to avoid reporting them to the Food and Drug Administration, the suit states.

It added, Crocano drafted new telephone scripts that would have enabled the company to pinpoint whether it had a manufacturing defect, but her new scripts were never used.

“Instead of investigating and resolving the TRUEtest manufacturing problem, Trividia’s modus operandi was to bury and ignore customer complaints,” the suit states.

Crocano’s supervisor at one point asked her to edit or alter a customer report that resulted in hospitalization, and on another, forged a document and placed Crocano’s initials on it, the suit states.

By summer 2015, the suit states, “Trividia could no longer ignore the manufacturing defect that was resulting in open TRUEtest strip vials and was forced to acknowledge the problem, but it only did so internally.” By that time, it said, the problem “was so severe that open-vial defects were becoming visible even to the untrained naked eye.”

Other allegations in the suit include:

„ Crocano’s supervisors acknowledged hiring engineers to recalibrate the packaging machine to correct the problem but they were unsuccessful.

„ In late 2015 and early 2016, Trividia received complaints of inaccurate glucose readings responsible for “fetal demise and compromised pregnancies,” the suit states.

„ The leader of a California Medicaid program for 300 high-risk pregnant women wrote that a 37-week pregnancy failed while the mother was using one of the company’s glucose meters. Apparently not knowing about the test strip defects, she said she was concerned that the meter “played a part and was ‘putting providers a[t] risk of inaccurately assessing and treating patients.’ ”

„ A Trividia clinical marketing executive logged the complaint with remarks stating it would be impossible to determine that the TRUEresult meter caused the pregnancy to fail. But the company failed to obtain samples of the testing strips used by the mother.

„ After learning of the death of another fetus whose mother blamed the company’s testing system, a supervisor asked Crocano to alter the mother’s complaint “to conceal the fact that the patient lost her pregnancy.” Crocono refused to comply.

Impending sale

The lawsuit claims that the company sought to conceal the defects while negotiations were under way to sell the company to a Chinese firm, SinoCare Group.

Three senior executives received $7 million after the sale closed in January 2016, the suit states.

It wasn’t until June 2016 — months after the FDA approved a new glucose testing product to replace the defective strips and the deal with SinoCare closed — that the company issued a recall for 5.5 million blood glucose test strip lots “that it acknowledged may provide incorrect low blood glucose results,” according to the complaint.

However, the company did not recall products made in the same plant that were sold under retailers’ own brand names, nor did it recall some products sold under its TRUEtest brand before April 2015, even though it knew defective products were sold prior to that date, the suit states.

Timing of suit

This case was initially filed in 2017 in U.S. District Court in South Carolina but remained under seal until September 2021 while the Department of Justice investigated its claims. It was unsealed after the department stated that neither it nor the states and District of Columbia intended to intervene by assigning its own attorneys to the case.

However, the government allowed the case to continue with the United States and the states named as plaintiffs. It also stipulated that the case could not be dismissed or settled without its consent and retained the right to intervene at a future date.

“The government can also dismiss a case but it has not done so here,” Guttman wrote.

The case, now unsealed, was transferred to the Southern District of Florida in Fort Lauderdale on Jan. 21 because Crocano lives in the district and Trividia Health is headquartered here as well.