Andren v. Alere, Inc.

207 F. Supp. 3d 1133, 2016 WL 4761806, 2016 U.S. Dist. LEXIS 124252
CourtDistrict Court, S.D. California
DecidedSeptember 13, 2016
DocketCASE NO. 16cv1255-GPC(NLS)
StatusPublished
Cited by4 cases

This text of 207 F. Supp. 3d 1133 (Andren v. Alere, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Andren v. Alere, Inc., 207 F. Supp. 3d 1133, 2016 WL 4761806, 2016 U.S. Dist. LEXIS 124252 (S.D. Cal. 2016).

Opinion

ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS WITH LEAVE TO AMEND

HON. GONZALO P. CURIEL, United States District Judge

Before the Court is Defendants’ motion to dismiss the complaint. (Dkt. No. 11.) An opposition and reply were filed. (Dkt. Nos. 16, 17.) Based on the reasoning below, the Court GRANTS Defendants’ motion to dismiss with leave to amend.

Background

On May 26, 2016, Plaintiffs Dina Andren (“Andren”) and Sidney Bludman (“Blud-man”) filed a purported class action complaint alleging that Defendants Alere, Inc., Alere Home Monitoring, Inc. and Alere San Diego, Inc. (“Defendants”) unlawfully, deceptively and misleadingly engaged in the manufacturing, marketing and sales of the INRatio products which include “IN-Ratio PT/INR Monitors,” “INRatio PT/ INR Test Strips,” “INRatio2 PT/INR Monitors” and “INRatio2 PT/INR Test Strips” (collectively, the “INRatio products”). (Dkt. No. 1, Compl.)

In the late 1990’s Defendants’ predecessor, HomoSense, Inc.1, developed and manufactured the “INRatio products” which are electronic testing devices designed to assist patients who have been prescribed blood-thinners, such as warfarin, to monitor their blood clotting time at home. (Id. ¶¶ 2, 14, 20.) The INRatio monitor, paired with the INRatio test strips are known as the “INRatio testing kit” (Id. ¶21.) The ability to monitor and test their blood-clotting times and adjust patients’ blood-thinner dosages is critical as an inappropriate amount of blood-thinners can result in serious bodily injury and death. (Id. ¶ 2.)

The International Normalized Ratio (“INR”) is a standardized metric used to determine the relative speed at which blood clots in a patient’s body. (Id. ¶ 17.) “A patient’s INR is calculated by comparing a patient’s prothrombin time (the speed at which the patient’s blood clots) against the normal mean prothrombin time (the average speed for bloodclotting in the general population). The resulting contrast between a patient’s prothrombin time and the normal mean prothrombin time is the patient’s INR.” (Id.) Doctors and patients use the INR to monitor the blood-clotting speed for patients who have been prescribed blood thinners to determine whether a patient should increase or decrease his/her dosage of blood thinners. (Id. ¶ 18.)

In October 2002, the PDA approved the INRatio testing kit for home use and sales began in 2003. (Id. ¶ 22.) The “INRatio2” testing kit was later developed and operated similarly to the INRatio testing kit. (Id. ¶ 23.)

Sometime immediately after the INRa-tio products became available to the public, Defendants received numerous complaints about the INRatio products’ efficacy and accuracy. (Id. ¶ 26.) For example, some consumers found that the INR results they were getting when using the INRatio products differed from the results they obtained when they sent blood from the same samples to independent labs for testing. (Id.) The deviations between the IN-Ratio products’ test results and those of independent labs were “clinically signifi[1136]*1136cant.” (Id.) Between 2002 and 2014, Defendants received over 18,000 complaints concerning malfunctions with the INRatio products, no less than 3 of which resulted in deaths. (Id. ¶ 28.)

In May 2005, after receiving numerous complaints about the INRatio products, the FDA conducted an inspection of Defendants’ San Jose operations facility and following the inspection, the FDA sent a warning letter admonishing them for their failure to file Medical Device Reporting (“MDR”) reports based on failing to report complaints about “discrepant lab results” and “generating clinically significant erroneous values.” (Id. ¶¶ 29-33.) From May 15, 2006 through July 13, 2006, the FDA conducted another inspection of the San Jose facility and on November 29, 2006, the FDA sent Defendants another warning letter for numerous failure to comply with statutory regulations. (Id. ¶¶ 34, 35.)

On April 16, 2014, Defendants issued a voluntary “Class 1” recall notice for the INRatio2 test strips, citing the disparity between INR results obtained with the INRatio2 system versus significantly higher INR results when re-testing was performed by an independent laboratory. (Id. ¶ 38.) Defendants’ recall notice requested that customers immediately cease using the INRatio2 PT/INR test strips and instead use alternate methods to perform INR testing. (Id.) Despite the recall, Defendants did not reimburse consumers for the purchase of these dangerous devices. (Id.) On December 5, 2014, Defendants issued a voluntary recall letter for the INRatio PT/INR Monitor and INRatio2 PT/INR Monitor, as well as the INRatio PT/INR Test Strips. The letter stated, “[i]n certain cases an INRatio PT/INR Testing kit may provide an INR result that is significantly lower than a result obtained using a laboratory INR system.” (Id. ¶ 40.) The letter also instructed customers, inter alia, to discuss the contents of the letter with their doctors and “arrange with your doctor to have your INR measured using a laboratory method.” (¾)

Despite receiving numerous complaints from users and multiple warning letters from the FDA, notifying them that the results produced by the INRatio products differed from those produced by independent laboratories, Defendants continued selling the INRatio products and marketed and advertised them as “accurate,” “convenient,” “effective,” “reliable,” “optimal” and “safe”. (Id. ¶ 3.) As a result, due to the erroneous results produced by the products, patients have been misled and have caused them to improperly adjust their blood-thinner dosages increasing the risk and likelihood of serious bodily injury or death. (Id. ¶ 4.)

Plaintiffs allege that Defendants misrepresented in its marketing advertising and promotional materials that the INRatio products were “accurate” “convenient,” “effective,” “reliable,” “optimal,” and “safe” and Defendants made further misrepresentations to consumers by omitting material information, particularly by failing to disclose that the INRatio products produce false and misleading results, from the packaging and marketing materials of the INRatio testing kit. (Id. ¶ 21.)

Plaintiff Dina Andren suffers from a medical condition that requires her to regularly take warfarin. (Id. ¶ 53.) As a result, Andren closely monitors her INR with an INRatio2 PT/INR testing kit she bought from a pharmacy on April 30, 2015 for $375 and which requires her to buy numerous boxes of replacement INRatio test strips, that range in price from $240-285 per box, to continue monitoring the INR. (Id. ¶¶ 53-55.) “When purchasing her IN-Ratio products, she relied on Alere’s representations that the products were accurate, convenient, effective, reliable, optimal [1137]*1137and safe.” (Id. ¶ 56.) Were it not for these representations or had she known that Al-ere was omitting that it knew its products produced erroneous INR results, Andren would not have purchased or used the INRatio products. (Id.)-

On the morning of May 24, 2015, Andren tested her INR using her INRatio2 testing kit. (Id. ¶ 57.) The test results indicated an INR of 2.7 and believing her INR was above 2.5, Plaintiff Andren did not take Lovenox. (Id.) Later that day, Plaintiff Andren was rushed to the hospital where doctors determined she had suffered a stroke. (Id. ¶ 58.) Following her stroke, Andren continued using her INRatio2 and accompanying test strips to closely monitor her INR and adjust her warfarin' dosage accordingly.

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Cite This Page — Counsel Stack

Bluebook (online)
207 F. Supp. 3d 1133, 2016 WL 4761806, 2016 U.S. Dist. LEXIS 124252, Counsel Stack Legal Research, https://law.counselstack.com/opinion/andren-v-alere-inc-casd-2016.