California federal judge scraps suit over inaccuracy of home-blood-test system

October 7, 2016

Testing tubes are seen at the American Red Cross Charles Drew Donation Center in WashingtonA San Diego federal judge has dismissed a suit by two plaintiffs who say false readings from INRatio home blood test monitors caused them to change the dosages of their blood thinner medication, leading them to have strokes.

Although U.S. District Judge Gonzalo P. Curiel of the Southern District of California held that the plaintiffs lacked factual support for their material misrepresentation and fraudulent omission claims against Alere, he granted them leave to file an amended complaint.

Dina Andren of New York and Maryland resident Sidney Bludman jointly filed a nationwide class-action complaint against Alere, headquartered in California, in May. Both claim to have bought an INRatio2 PT/INR monitor to track changes in their blood and adjust the amount of blood thinner they used accordingly.

Andren and Bludman say Alere received many consumer complaints. They also say the U.S. Food and Drug Administration sent the company warning letters in 2005 and 2006 about potentially lethal inaccurate test results. Nevertheless, Alere continued selling its INRatio units and related test strips as “accurate” and “reliable,” they alleged.

Andren says that in April 2015, she bought an INRatio2 PT/INR unit at a pharmacy to monitor her “internal normalized ratio,” which is the speed at which blood clots within the body. She says she checked her blood May 24, 2015, and the meter showed she did not need to take blood thinner. Later that day, she had a stroke, she says.

She continued using the INRatio2 but had transient ischemic attacks, or “mini strokes,” in July 2015 and March 2016, according to the complaint. She says it was not until March 2016 that she found out Alere had voluntarily recalled the INRatio2 PT/INR units in December 2014 because of reports that they often delivered inaccurate results.

Bludman says he had his blood tested by a laboratory each month for 26 years before he bought an INRatio2 PT/INR in 2013 to perform tests himself at home. Bludman claims he had a mini-stroke Feb. 10, 2016, after reducing his warfarin dosage based on his INRatio test results.

Bludman says that after his hospitalization he noticed that his home INR readings consistently differed from tests conducted at the hospital.

The plaintiffs asserted four causes of action against Alere, Alere Home Monitoring Inc. and Alere San Diego Inc. They sought recovery for material misrepresentation under the California Consumers Legal Remedies Act, Cal. Civ. Code § 1750, and fraudulent omission under the unfair competition law, Cal. Bus. & Prof. Code § 17200. They also claimed common law fraud and unjust enrichment.

Alere moved to dismiss, telling Judge Curiel the plaintiffs failed to state a claim upon which relief could be granted, as required by Federal Rule of Civil Procedure 12(b)(6). The plaintiffs also had not identified the exact means of fraud alleged as required by Federal Rule of Civil Procedure 9(b), the defendant said.

Judge Curiel agreed and granted the dismissal motion. He noted that while Andren and Bludman said they had relied on Alere’s representations of product accuracy, convenience, effectiveness and reliability when they bought their test units, they never indicated how they saw or heard the representations.

“Therefore, plaintiffs cannot link their injuries to those alleged misrepresentations,” the judge said.

He also ruled that the plaintiffs failed to plead an effective claim for fraudulent omission as they did not show that Alere withheld exclusive knowledge of the material facts. Many facts regarding problems with INRatio2 PT/INR units were revealed in the FDA warning letters and Alere’s own voluntary recall notices, the judge said.

“These allegations demonstrate that the material facts were not within the exclusive knowledge of defendants but available to the public,” he said.

Judge Curiel granted the plaintiffs leave to amend their complaint. He said he would allow them an opportunity to furnish the missing information he had noted.

Because Alere has said it may rely on the “learned intermediary doctrine” defense, the judge said an amended complaint would allow Andren to explain whether her doctor prescribed the device she says she bought at a pharmacy. If she was provided a prescription, the doctrine would apply, the judge said.

The learned intermediary doctrine can shield drugs and medical device makers from product liability claims if it can be shown that the manufacture warned a doctor of a product’s risks, and that the doctor prescribed its use based on his or her professional discretion.

Andren et al. v. Alere Inc. et al., No. 16-cv-1255, 2016 WL 4761806 (S.D. Cal. Sept. 13, 2016).