Nellcor Puritan Bennett LLC v. CAS Medical Systems, Inc.

11 F. Supp. 3d 861, 2014 U.S. Dist. LEXIS 41827, 2014 WL 1304428
CourtDistrict Court, E.D. Michigan
DecidedMarch 28, 2014
DocketCase No. 2:11-cv-15697
StatusPublished
Cited by1 cases

This text of 11 F. Supp. 3d 861 (Nellcor Puritan Bennett LLC v. CAS Medical Systems, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Michigan primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Nellcor Puritan Bennett LLC v. CAS Medical Systems, Inc., 11 F. Supp. 3d 861, 2014 U.S. Dist. LEXIS 41827, 2014 WL 1304428 (E.D. Mich. 2014).

Opinion

OPINION AND ORDER

SEAN F. COX, District Judge.

This case involves claims of false advertising under the Lanham Act and Michigan law.

Plaintiff Nellcor and Defendant CAS Medical Systems Inc. (“CAS”) are direct competitors in the manufacture and sale of cerebral oximeters. A cerebral oximeter is a device used by surgeons and anesthesiologists to monitor the oxygen level of blood in the brain. More specifically, cerebral oximeters measure the oxygen saturation level of blood in a region of the brain.

In this case, Nellcor alleges that CAS falsely advertised that its cerebral oxime-ter is more “accurate” than Nellcor’s cerebral oximeter. CAS based its advertising that its cerebral oximeter is more accurate on studies that compared readings from competing cerebral oximeters to an estimate of the average oxygen saturation level of blood in the entire brain called “field saturation” (fS02). Although Nellcor raises numerous reasons why CAS’s advertising is unreliable and deceptive, Nellcor’s principal argument is that CAS’s advertising is deceptive because it is based upon using field saturation, which is only a rough estimate of the oxygen saturation level of blood in the entire brain and does not measure the oxygen saturation level of blood in the region of the brain measured by a cerebral oximeter.

[865]*865The matter is currently before the Court on cross-motions for summary judgment regarding Plaintiff Nellcor Puritan Bennett LLC’s (“Nellcor”) false advertising claims (Docket Entry Nos. 105 & 109.)

Although the parties have raised numerous issues for summary judgment, the principal issue before the Court is whether it was proper for CAS to advertise that its cerebral oximeter is more accurate than Nellcor’s cerebral oximeter based on studies that used field saturation as the correct oxygen saturation level to compare with the readings from the Nellcor and CAS cerebral oximeters.

Nellcor has submitted strong evidence that field saturation is different than regional oxygen saturation and is only in fact an estimate of the average oxygen saturation level of blood in the brain. CAS has also submitted evidence to support its position that field saturation is a sufficiently accurate estimate of regional oxygen saturation when healthy subjects are used in the studies. Although the Court concludes that Nellcor has submitted the stronger evidence, the Court finds that CAS has submitted sufficient evidence to create an issue of fact for trial. Accordingly, the Court will deny the parties’ cross-motions for summary judgment as to this issue.

As to the remaining issues in the motion, the Court shall grant in part and deny in part the parties’ cross-motions for summary judgment.

Nellcor’s Motion for Summary Judgment shall be GRANTED to the extent that the Court rules that CAS has not established facts to support an affirmative defense of res judicata for advertising that occurred after November 11, 2010. It shall be DENIED in all other respects.

CAS’s Motion for Summary Judgment shall be GRANTED to the extent that the Court rules that Nellcor has not produced sufficient facts to show that: 1) the Bidder study is unreliable because it only included data for 23 persons; 2) the Bidder study is unreliable because CAS provided draft abstracts for the Bidder study and reviewed the data during the study; 3) the Bidder study is unreliable because CAS provided the cerebral oximeters used in the study and had employees present during the study; 4) the Bickler study is unreliable because cross-talk affected the results of the study; and 5) CAS’s “Clinical Corner” web page stating “Summaries of recent studies involving FORE-SIGHT absolute cerebral oximetry” with hyperlinks to ten summaries of studies was material to consumers purchasing decisions. It shall be DENIED in all other respects.

BACKGROUND

A. Background on Cerebral Oximeters

A cerebral oximeter is a device that monitors the oxygen level of blood in the brain by transmitting light into an area of the brain at various wavelengths corresponding to oxygenated and deoxygenated hemoglobin and detecting the light that is reflected. There is a correlation between the oxygen level in the blood and the amount of light that is thereby reflected by the blood. The algorithms used in cerebral oximeters to determine the amount of oxygen in blood in the brain are proprietary to the manufacturers. Surgeons use a cerebral oximeter to monitor for a drop in oxygen level during surgical procedures. If the reading from the cerebral oximeter drops significantly during surgery, then the surgeon will know to take corrective action to prevent permanent injury to the patient.

Cerebral oximeters measure the oxygen level of blood that is located in small vessels in a region of the brain where the light from the cerebral oximeter can penetrate. Cerebral oximeters do not measure [866]*866the oxygen saturation of blood in the brain as a whole. For this reason, cerebral ox-imeters are said to measure regional brain oxygen saturation (“rS02”).

B. Measuring Accuracy of Cerebral Oximeters

This case involves determining whether CAS’s cerebral oximeter is more accurate than Nellcor’s cerebral oximeter in measuring the oxygen level of blood in a region of the brain.

In order to determine the accuracy of any device, the reading of the device must be compared to the correct value or an accepted reference value. For this reason, the parties agree that accuracy is generally defined as “the closeness of agreement between a test result and an accepted reference value.” A useful analogy is to think of a shooter’s target having a bull-seye. The shots that are on the target are the measured values and the bullseye is the “accepted reference value.” The shooters accuracy can be determined based on how close the shots (the measured values) are to the bullseye (the accepted reference value).

Nellcor argues that the bullseye for a cerebral oximeter reading (i.e., the accepted reference value) is not known so it is impossible to compare the accuracy of competing cerebral oximeters. The best reference value for cerebral oximeter testing would be to take a physical blood sample from the region of the brain that the cerebral oximeter is testing and determine the oxygen level of the sample using proven techniques (called invasive testing). However, the parties agree that it is not possible to take such physical blood samples from the small blood vessels in the region of the brain where a cerebral oxim-eter takes its readings. Because it is not possible to take physical blood samples from the region of the brain that a cerebral oximeter tests to obtain a reference value, Nellcor argues it is not possible to compare the accuracy of cerebral oxime-ters.

Historically, because direct calibration and validation of cerebral oximeters was not possible, the first commercially available oximeters were used as “trend monitors,” not as absolute monitors which would give the true level of oxygen saturation in the blood. As a trend monitor, before beginning a surgery, a surgeon will read the displayed value on the cerebral oximeter and assume whatever number that is displayed is a healthy level. If during surgery the reading from the cerebral oximeter drops significantly, the surgeon will know to take corrective action.

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Cite This Page — Counsel Stack

Bluebook (online)
11 F. Supp. 3d 861, 2014 U.S. Dist. LEXIS 41827, 2014 WL 1304428, Counsel Stack Legal Research, https://law.counselstack.com/opinion/nellcor-puritan-bennett-llc-v-cas-medical-systems-inc-mied-2014.