As companies, their insurers and their attorneys look at liability exposure and risks from COVID-19 testing, lessons from the past can help guide risk management decisions and the defense of these lawsuits. Part one of this two-part series looked at likely claims and defenses in product liability lawsuits involving COVID-19 tests.

This second part of the two-part series will examine past diagnostic equipment cases. There have been a number of cases involving allegedly defective diagnostic tests in the past, and the lessons from these cases are instructive as we try to predict the trajectory and defenses to COVID-19 test cases. As Mark Twain purportedly once said, “History does not repeat, but it does rhyme.” So let us take a look at past product liability cases and the lessons they teach us for today.

Lesson 1: An Allegedly Defective Test Can Spawn Nationwide Litigation

Probably the largest product liability litigation arising from a diagnostic product’s alleged failure is Abbott’s hCG test kit. By way of background on hCG tests, a typical method of testing for pregnancy is testing a female patient’s human chorionic gonadotropin (hCG) levels. However, if a patient has elevated hCG levels and is not pregnant, the elevated levels are a sign of either ectopic pregnancy or a deadly form of cancer called trophoblastic disease.

In the late 1990s and early 2000s, there were a series of lawsuits filed against Abbott by patients alleging that its hCG test was producing false positives. The various plaintiffs claimed that after being falsely diagnosed with high hCG levels by the test, and not being pregnant, they had undergone aggressive cancer treatment for trophoblastic disease, in spite of the fact that they did not have trophoblastic disease.¹

Abbott had some success getting some of the claims within these lawsuits dismissed. However, the majority of claims moved forwards against Abbott, and the company was hit with a large jury verdict in one of these cases.²

Fortunately, in spite of attempts by the plaintiffs’ bar to bring these claims as nationwide or statewide class action, the class action claims did not survive.³ This raises an interesting, but not terribly surprising, point. Class actions tend not to be a preferred method of resolving disputes against diagnostic equipment manufacturers. By way of another example, in litigation against a manufacturer of allegedly defective electronic testing devices helping patients monitor their blood clotting times at home, a court similarly denied the plaintiff’s motion for class certification.⁴

Lesson 2: Damages Can Be Large

Large verdicts in product liability cases against diagnostic equipment manufacturers for failures of the devices to provide accurate test results are not uncommon. By way of example, in one of the hCG cases, described above, a false high reading of hCG levels resulted in a plaintiff needlessly undergoing chemotherapy, a hysterectomy, and having part of her lung removed. A jury awarded the plaintiff $16 million, half of which was allocated to the defendant manufacturer.²

By way of another example, a case went to a jury trial in which a monitoring device malfunctioned and thus failed to stop a catheter from heating up and destroying the plaintiff’s heart. The jury awarded the plaintiff $40 million against the device monitor’s manufacturer.⁵

These sorts of verdicts are nothing new. Back in the mid-1970s, a blood glucose test gave false positives, which caused physicians to overprescribe insulin to the plaintiff, leading to the plaintiff’s brain damage. The jury in that case awarded the plaintiff the (then very large) sum of $750,000 against the blood glucose test manufacturer.⁶ In short, large verdicts are not uncommon.

Lesson 3: False Positive Cases Can be as Serious as False Negative Cases

At first blush, one might think that a diagnostic test that is more likely to provide a false negative (i.e., that the patient doesn’t have the disease) will open its manufacturer up to greater liability exposure than if the diagnostic test is more likely to provide a false positive. And, this could well turn out to be true for COVID-19 tests.

Indeed, there are a number of lawsuits that have been filed in the past that involve false negatives. For example, there have been multiple cases involving fetal monitors that reported that a fetus was doing well when it was not, causing physicians to delay more emergent measures to protect the fetus’s health.⁷ Of particular interest in the COVID-19 context is an HIV test case, as like COVID-19 it deals with an infectious disease epidemic and the rush to create a reliable test. In this HIV case, the plaintiff contracted HIV in 1986 as a result of blood transfusion, which had incorrectly tested negative for HIV.8 After a five-week jury trial, the jury reached a verdict in favor of the manufacturer of the test. After a tortuous appellate history, the New Jersey Supreme Court ultimately affirmed the jury verdict, holding that the FDA’s extensive involvement in the development of the HIV test, as well as its involvement in the tests’ warnings and sensitivity, meant that the claim was impliedly preempted.⁸

Perhaps more surprisingly, however, is that there are as many examples of false positive cases as false negative cases. As noted above, the largest set of litigation involving the failure of a test to work properly occurred in the context of false positives (i.e., the litigation involving the hCG tests). But this is not the only example. There have been multiple cases where plaintiffs have alleged that blood glucose tests gave falsely high readings, which resulted in unnecessary and dangerous medical treatment.⁹

And, for what it is worth, two of the three big verdicts discussed in the previous section came from false positives as opposed to false negative test results.¹⁰ Simply, litigation arises both from false negatives and false positives.

Lesson 4: It’s All About the Experts

Most drug and device product liability litigation is expert intensive. Cases often fail or succeed based upon the availability and skill of the experts on each side. Cases involving diagnostic and monitoring equipment are no exception to this rule.

For example, in a case where a medical monitoring device allegedly failed to sound an alarm when an infant stopped breathing, the fact that plaintiffs’ expert testimony was not reliable resulted in the defendant manufacturer obtaining summary judgment. Plaintiff’s experts simply could not reliably show what the software defect was in the device, and if the device was actually defective.¹¹ For another example, summary judgment for the manufacturer of a home blood pressure monitor was appropriate as the plaintiff did not have expert evidence to support his allegations that the monitor gave him inaccurately low blood pressure readings, which prompted him to stop taking blood pressure medication leading to a stroke.¹²

Experts are every bit as important in diagnostic testing cases as they are in other drug and device cases.

Lesson 5: Causation is Key

A major factor in drug and device litigation is whether the alleged defect actually caused the plaintiff’s damages. Unsurprisingly, this causation element is particularly applicable in cases involving diagnostic medical equipment. One can imagine these issues cropping up everywhere in future hypothetical COVID-19 claims. For example, if a plaintiff alleges after a negative test that he or she did not go to the doctor for another two days, can the plaintiff show that this caused a worse outcome? Or on the flip side, if the plaintiff got a false positive test and isolated, did that cause him or her any real damages?¹³

Again, it is instructive to look to past diagnostic test cases. For example, a plaintiff could not survive summary judgment when he could not show his diabetes was exacerbated by the alleged mistakenly low reading from the blood glucose test.¹⁴ Causation is key.

An interesting twist for COVID-19 testing claims may be who brings the claims. In the nearly 100 product liability diagnoses and monitoring equipment cases reviewed for this article, virtually every lawsuit was brought by the patient tested (or occasionally the healthcare provider harmed while performing the test). However, it doesn’t take much imagination to picture a plaintiff attorney taking a case where someone alleges that he or she contracted COVID-19 from another person who tested falsely negative, and was at work or socialized as a result of that false negative. In such cases, causation becomes an even bigger question, as how does the plaintiff prove that he or she got COVID-19 from the person who was tested, that the person who was tested would have behaved differently with a different test result, and that the exposure occurred after the false negative test result? Nevertheless, creative plaintiff attorneys may well push these claims.

Conclusion

While there are many open questions on how courts and juries will view COVID-19 product liability claims against COVID-19 test manufacturers, as discussed in part one of this series, the PREP Act and common law defenses provide some comfort for test manufacturers, though liability questions remain. And, as discussed in this second part of the two-part series, historical precedent from other diagnostic test cases shed light on the likely claims and defenses of these lawsuits.

References

1.  E.g., Goldman v. Abbott Labs., Inc., 2001 WL 1558281 (N.D. Ill. Dec. 5, 2001); accord Gibbs v. Abbott Labs., Inc., 2001 WL 1558279 (N.D. Ill. Dec. 5, 2001); Hofmann v. Abbott Labs., Inc., 2001 WL 1558299 (N.D. Ill. Dec. 5, 2001); Block v. Abbott Labs., 2002 WL 485364 (N.D. Ill. Mar. 29, 2002); Rufer v. Abbott Labs., 114 P.3d 1182 (Wash. 2005).
2. Rufer v. Abbott Labs., 114 P.3d 1182 (Wash. 2005); see also Block v. Abbott Labs., 2002 WL 485364, at *8 (N.D. Ill. Mar. 29, 2002) (discussing Rufer case).
3. Block v. Abbott Labs., 2002 WL 485364 (N.D. Ill. Mar. 29, 2002).
4. Andren v. Alere, Inc., 2017 WL 6509550 (S.D. Cal. Dec. 20, 2017).
5. Singh v. Edwards Lifesciences Corp., 210 P.3d 337 (Wash. App. 2009).
6. Kincl v. Hycel, Inc., 372 N.E.2d 385 (Ill. App. 1977).
7. E.g., Sheehan v. Corometric Med. Sys., Inc., 1993 WL 23715 (D. Mass. Jan. 28, 1993); McGee v. Corometrics Med. Sys., Inc., 487 So. 2d 886 (Ala. 1986).
8. R.F. v. Abbott Labs., 745 A.2d 1174 (N.J. 2000).
9. Gill-Samuel v. Nova Biomedical Corp., 298 F.R.D. 693, 695 (S.D. Fla. 2014); Kincl v. Hycel, Inc., 372 N.E.2d 385 (Ill. App. 1977).
10.  Rufer v. Abbott Labs., 114 P.3d 1182 (Wash. 2005); Kincl v. Hycel, Inc., 372 N.E.2d 385 (Ill. App. 1977).
11. Graves v. CAS Med. Sys., Inc., 735 S.E.2d 650 (S.C. 2012).
12. Roberts v. Albertson’s LLC, 464 F. App’x 605 (9th Cir. 2011).
13. As an aside, there are many cases holding that fear of contracting an infectious disease is insufficient to be actionable. E.g., Burk v. Sage Prod., Inc., 747 F. Supp. 285, 286 (E.D. Pa. 1990); Palmer v. Nan King Rest., Inc., 798 A.2d 583 (N.H. 2002); Seimon v. Becton Dickinson & Co., 632 N.E.2d 603 (Ohio App. 1993); but see Civitello v. Burger King Corp., 2002 WL 241491 (Conn. Super. Ct. Feb. 5, 2002).
14. McEvily v. Medisense, Inc., 2002 WL 1402242 (S.D.N.Y. June 28, 2002).