Patients and their doctors rely on the safety and effectiveness of medical testing devices when making decisions regarding diagnosis and medical care. Defective or faulty medical testing devices put patient safety at risk and may result in the wrong decisions being made regarding medical treatment, leading to harm ranging from insignificant to deadly. Therefore, it is imperative that the medical devices sold by medical device manufacturers function properly in the manner in which they were designed and intended, and that medical devices that fail to do so are not allowed to harm patients.
The U.S. Department of Justice announced on March 23, 2018 that medical device manufacturer Alere Inc. and its subsidiary Alere San Diego (“Alere”) have agreed to pay the United States $33.2 million to resolve allegations that Alere caused hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices.
The government contended that between January 2006 and March 2012, Alere knowingly sold materially unreliable rapid point-of-care testing devices marketed under the trade name Triage®. The Triage® devices aided in the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious conditions, and the devices were frequently used in emergency departments where timely decisions are critical to ensuring proper patient care.
According to the government’s allegations, Alere received customer complaints that put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making. Nonetheless, Alere failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012.
Of the $33.2 million to be paid by Alere, $28,378,893 will be returned to the federal government and a total of $4,860,779 will be returned to individual states, which jointly funded claims for Triage devices submitted to state Medicaid programs.
The Acting United States Attorney for the District of Maryland stated in announcing the settlement, “Physicians who work to treat patients with suspected myocardial infarctions rely upon devices such as Alere’s Triage Cardiac products for quick and accurate readings. When manufacturers such as Alere make changes to the specifications that affect the product’s reliability without informing physicians or the FDA, patient care is put at substantial risk.”
The settlement with Alere resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. The civil lawsuit was filed by Amanda Wu, who formerly worked for Alere as a senior quality control analyst. As part of the settlement, Ms. Wu will receive approximately $5.6 million.
The claims resolved by the settlement are allegations only, and there has been no determination of liability. The lawsuit is captioned United States ex rel. Amanda Wu v. Alere San Diego, et al., No. GLR-11-CV-1808.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publically known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act lawyer (also known as qui tam lawyers) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
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