Alere Triage: A Quality Analyst’s Case About Unreliable Test Results
In the Alere Triage settlement, Alere agreed to pay $33.2 million to resolve allegations that it knowingly sold materially unreliable diagnostic devices and caused hospitals to submit false claims to Medicare, Medicaid and other federal healthcare programs. A former senior quality-control analyst brought the whistleblower case. The complaint described decisions someone inside a testing operation would recognize: release standards made easier to pass, marginal lots released under those standards, and internal complaints that told a different story from the public reporting.
The Department of Justice announced the settlement on March 23, 2018. It covered Alere Inc., a Massachusetts-based medical-device manufacturer, and its subsidiary Alere San Diego. The government alleged that the company sold the unreliable Triage devices from January 2006 through March 2012.
What Triage Devices Were Used For
Triage devices provided rapid point-of-care testing to help diagnose acute coronary syndromes, heart failure, drug overdose and other serious conditions. Hospitals frequently used them in emergency departments, where physicians needed timely results to make treatment decisions.
The government’s allegation concerned the information those devices gave clinicians. Customer complaints allegedly put Alere on notice that certain devices produced erroneous results, with the potential for false positives and false negatives that adversely affected clinical decision-making. A rapid result has value because a physician can act on it. An unreliable result puts that same decision at risk.
The government also followed the devices into hospital claims. Its case alleged that Alere caused hospitals to bill public health care programs by knowingly selling the unreliable tests. The manufacturer made and supplied the product, clinicians used it in care, and the hospital submitted the claim. The quality decisions inside Alere therefore mattered well beyond the factory: they concerned what physicians relied on and what taxpayers paid for.
The Release Standards Behind the Allegations
The whistleblower alleged that Alere lowered the specifications used to release devices while complaints about faulty products accumulated. In the complaint’s account of those decisions, the company ordered employees to follow revised thresholds that conflicted with the specifications it had submitted to the Food and Drug Administration.
The complaint places those decisions alongside the warning signs:
Thus, Defendants lowered their specifications thresholds and ordered employees to follow such revised specifications, even though they were in violation of their FDA-approved/cleared specifications submitted with their 510 (k)’s, they were in violation of federal laws and regulations, and did so in the face of thousands of complaints about their faulty devices.
United States ex rel. Wu v. Alere San Diego, et al., whistleblower’s complaint, paragraph 70
Marginal Lots Still Passed
An internal warning quoted in the complaint described lots that were marginal even under the company’s more lenient specifications. It compared those standards with the performance claims in the product insert:
Furthermore, it is disconcerting that we still release lots that are marginal to internal specifications, when these internal specifications are more lenient and more distant from our insert claims (from the above example, MYO spec is <=25%).
The internal warning described a product barely passing a standard already weaker than the performance claims sent out with it.
Blank-Sample Release Thresholds
The complaint also described an internal release specification that tolerated a signal in blank samples:
Despite this Alere SD’s internal specifications of final release allowed 15% of blank sample data to reach level >0.1 ng/ml.
United States ex rel. Wu v. Alere San Diego, et al., whistleblower’s complaint, paragraph 60
The specification allegedly allowed false signals in blank samples. Someone who worked with those specifications may understand a discrepancy that a hospital bill would never reveal.
Physicians Allegedly Missed a Warning About Myoglobin
The complaint alleged that Alere failed to eliminate or disclose a high-dose hook effect affecting the myoglobin marker in the Triage products. It described a risk of falsely low results and said physicians had not been told about the possibility:
Defendants have failed to eliminate or disclose the myo hook issue, and therefore physicians have had no idea of the possibility of a high-dose hook effect in the myoglobin marker in the subject Triage products.
United States ex rel. Wu v. Alere San Diego, et al., whistleblower’s complaint, paragraph 64
The alleged problem could give a physician a falsely low myoglobin reading without a warning about the limitation.
Internal Complaints and Public Reports Told Different Stories
The whistleblower alleged that Alere suppressed adverse-event reporting. The complaint contrasted the company’s internal record for a single assay with the public reports for the broader Triage TOX panel:
Defendants have suppressed and failed to report adverse events for their products, as required by federal law. For instance, there were only four MAUDE Adverse Event Reports for Triage TOX panel found in the MAUDE FDA database for the last 10 years. However, Defendants’ internal report showed that 346 complaints concerning THC assay (one of eleven assays on TOX panel) were submitted to Alere SD in 2010 alone.
United States ex rel. Wu v. Alere San Diego, et al., whistleblower’s complaint, paragraph 76
The complaint describes warning signs accumulating inside the company while little reached the public database.
The reporting system routes many individual reports from health care facilities and importers to the manufacturer, which investigates and makes reporting judgments about its own products. An employee handling those complaints can see information before it appears in a public database.
The Recall and the Hospital Claim
The government alleged that Alere failed to take appropriate corrective action until Food and Drug Administration inspections prompted a nationwide product recall in 2012. Its account begins with customer complaints and the company’s alleged knowledge of erroneous results. The recall comes after those warnings.
The Triage False Claims Act case also followed the money: the government alleged that Alere’s knowing sale of materially unreliable devices caused hospitals to submit false claims. That connection gives the internal release decisions their significance for a whistleblower case.
In the separate INRatio case, the government alleged that Alere sold blood-coagulation monitors with a defective software algorithm despite internal research, complaints and warnings. That case likewise turned on what the manufacturer allegedly knew about unreliable results while selling the devices.
The Settlement’s Federal and State Allocations
The March 2018 resolution allocated $28,378,893 to the federal government and $4,860,779 to individual states. Those states had jointly funded Medicaid claims for Triage devices the government alleged were materially unreliable.
How Much Is a Whistleblower Claim Worth?
The Triage announcement said the former senior quality-control analyst would receive approximately $5.6 million as part of the resolution. The analyst had brought the civil lawsuit under the False Claims Act’s whistleblower provision.
A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. In Triage, the published award shows the value of an insider’s knowledge of the product and the decisions behind its release.
What Evidence Is Needed to Prove Fraud?
In Triage, the evidence described in the complaint included release records, the specifications used to pass devices and internal complaint files, tied to the hospital claims alleged by the government. Those records connect what the company knew to what it shipped and what public programs paid for.
A quality employee may know why a lot passed and which version of a specification controlled the decision. A regulatory employee may understand how complaint information reached the Food and Drug Administration or physicians. Someone working with clinical or hospital payment records may see the next part of the chain. Those perspectives answer different questions about the same devices.
You Know Why the Devices Passed
If you saw release standards loosen while complaints accumulated, talk with our whistleblower experts about the decisions you witnessed. We build your case around what the quality records reveal and bring in medical-device whistleblower lawyers who understand diagnostic reliability and government healthcare claims. We stay with you as expert partners throughout the case.
