Infectious Disease Expert Witness Testimony on Regulatory Approval of HIV Rapid Test to Screen Blood Donors Excluded

Infectious Disease Expert Witness Testimony on “Regulatory Approval of HIV Rapid Test to Screen Blood Donors” Excluded 

Mariette Waters was on a cruise ship when she had a medical emergency necessitating a blood transfusion. Since the cruise ship operator did not store blood on the vessel for transfusions, it began to solicit passengers to donate blood via the public announcement system. The cruise operator then screened the potential donors, their donated blood, and administered the transfusion. Waters later sued the cruise ship operator, alleging that during this process, it administered a transfusion with HIV infected blood.

Waters alleged three counts of negligence:

  • medical negligence (Count I);
  • vicarious liability for medical negligence based on actual agency (Count II); and
  • vicarious liability for medical negligence based upon apparent agency (Count III)

The Defendant retained Jeffrey Klausner, an infectious disease expert witness to testify in this case. One of the issues that Klausner sought to opine was the use of a particular testing kit by the Defendant — the MedMira Multiplo HBc/HIV/HCV test – and its approval status by regulatory authorities in different jurisdictions.

Note: MedMira is not a party to this litigation.

Waters moved to exclude testimony and opinions from Defendant’s HIV expert, Jeffrey Klausner, specifically, statements asserting approval of the MedMira Multiplo HBc/HIV/HCV test by any regulatory body in any country in the world. Additionally, Plaintiff sought to preclude Klausner from referring to a separate study he had conducted in Peru, involving a different HIV rapid test, in order to assess the sensitivity or reliability of the test used by the Defendant in this case.

Infectious Disease Expert Witness

Dr. Jeffrey D. Klausner, M.D., M.P.H., the subject matter expert in HIV at the U.S. Centers for Disease Control and World Health Organization, holds certification in Infectious Disease and Internal Medicine. He graduated with Honors from Cornell University Medical College and has a Master of Public Health in International Health and Infectious Disease Epidemiology from the Harvard School of Public Health. He has two professorships at the Keck School of Medicine, University of Southern California, and prior at the David Geffen School of Medicine and Public Health at the University of California Los Angeles. Klausner has authored over 650 peer-reviewed research papers on infectious diseases, with a particular focus on HIV/AIDS.

Discussion by the Court

Plaintiff claimed that during testimony, Klausner stated his belief that the specific model of HIV rapid test used by the Defendant, the MedMira Multiple HBc/HIV/HCV test (“Subject Test”), possessed regulatory approval in Canada and the European Union through the respective regulatory bodies. With regard to the European Union approval, Klausner initially thought he saw the relevant marking on the Subject Test box, but when presented with the box during deposition, the marking was absent. Klausner then conceded that he believed in European Union approval of the Subject Test, but had no knowledge or opinion on the matter. Regarding regulatory approval in Canada, Klausner testified that he thought he saw documents indicating approval by Health Canada, the regulatory body for Canada for the Subject Test. However, when questioned about providing any basis, data, document, or evidence for this approval, Klausner replied in the negative.

Plaintiff contended that, according to Daubert, an expert is obligated to have a “sufficient basis” for their testimonial evidence. Plaintiff argued that the expert had no basis, leading to the request for the preclusion of his testimony on this particular topic during the trial.

The Defendant countered by stating that Klausner had no intention of expressing an opinion about regulatory approval for the Subject Test. However, the Defendant requested the Court to allow Klausner to testify that the Subject Test shares a common underlying technology with another product from the same manufacturer, MedMira. Notably, the mentioned product does possess some degree of FDA approval.

The Court, after reviewing the record, including the deposition, concluded that there is sufficient support for precluding Klausner’s testimony regarding any regulatory approval that the Subject Test has or does not have from any country worldwide. Consequently, Plaintiff’s first motion was granted.

Plaintiff contended that Klausner’s opinions, derived from the Peru Study, lacked reliability and utility under Daubert, as there was no justification for imputing the study’s findings to the Subject Test. The Plaintiff argued that the tests were substantially different, with the Peru Study involving the MedMira Multiplo TP/HIV rapid test (“Multiplo”) that screens for HIV and syphilis. In contrast, the Subject Test, used aboard Defendant’s vessel and in its medical center, tests for HIV, Hepatitis B, and Hepatitis C. Despite Klausner acknowledging that Multiplo was not used by the Defendant, he expressed an expectation of similarity due to both tests being manufactured by the same company. Plaintiff asserted that such an insufficient basis for an expert opinion could mislead the jury, characterizing the testimony as lacking data, unreliable principles, and unreliable application of principles to the case’s facts.

To support the argument, the Plaintiff referenced the case Pessman v. Trek Bicycle Corp., 3:18-cv-50243 (N.D. Ill. Dec. 6, 2021). In Pessman, an expert’s testimony was excluded under Daubert for attempting to impute the defects of one bicycle model to a different model produced by the same manufacturer. The Court in Pessman emphasized that the expert had not sufficiently explained the scientific methodology behind his conclusion and stressed the necessity for expert opinions to be backed by “appropriate validation.”

In response, the Defendant with a review of Klausner’s qualifications, emphasizing that the Plaintiff had overlooked this aspect of the analysis. Klausner, a distinguished expert, graduated with Honors from Cornell Medical School and earned a Master of Public Health in International Health and Infectious Disease Epidemiology from the Harvard School of Public Health. Holding two professorships at the Keck School of Medicine, University of Southern California, Klausner served as the subject matter expert in HIV at both the U.S. Centers for Disease Control and the World Health Organization. His extensive expertise is further highlighted by his authorship of over 650 peer-reviewed research papers on infectious diseases, specifically focusing on HIV/AIDS. The Defendant contended that these qualifications affirm Klausner’s expertise and qualify him to opine on the subject matter.

In Klausner’s expert report, he expressed the opinion that the Multiplo test utilized in the Peru Study showcased “excellent performance in detecting HIV antibodies.” The Defendant argued that the Multiplo Test, manufactured by MedMira, a Canadian biotechnology company, is similar to the Subject Test as both are rapid tests designed to detect HIV antibodies. Emphasizing that MedMira holds the patent on Rapid Vertical Flow Technology (“RVF”), the Defendant highlighted that MedMira produces various healthcare products for the rapid testing of infectious diseases, such as HIV, hepatitis, and syphilis. RVF serves as the “core engine” for MedMira’s rapid testing solutions, encompassing the Subject Test, the Multiplo Test used in the Peru Study, and the MedMira Reveal G2 Rapid HIV-1 Antibody Test (“Reveal Test”). Notably, the Reveal Test obtained FDA approval on June 23, 2004. The Defendant contended that the shared RVF technology establishes a sufficient connection, indicating that regulatory approvals or field studies related to Multiplo or Reveal are pertinent and adequate to demonstrate the performance of other MedMira HIV rapid antibody tests, including the Subject Test.

The Defendant argued that Klausner’s various opinions supported the conclusion that different MedMira tests, including the Subject Test, share similarities. Klausner testified that MedMira products utilize the same HIV antibody detection technology, specifically the RVF technology, which had received FDA approval. Furthermore, Klausner stated that within the MedMira portfolio of tests, there would be an increased similarity between antigens used and the mechanisms of antibody detection. He also noted that there would be greater similarity between MedMira’s manufactured HIV antibody tests than there would be between different manufacturers’ products. These statements were presented by the Defendant as evidence supporting the contention that the various MedMira rapid tests, including the Subject Test, exhibit similarities.

The Defendant further argued that Plaintiff’s HIV expert lacked a basis to challenge the assertion that the RVF technology, approved by the FDA for testing HIV antibodies in the Reveal Test, is identical to the technology employed in the Subject Test. Consequently, the Defendant maintained that there was enough evidence of similarities among various MedMira HIV antibody rapid tests, justifying the utilization of Klausner’s Peru Study to demonstrate the performance of MedMira HIV rapid antibody testing technology.

The Defendant contended that Plaintiff’s reliance on the Pessman case was misplaced. In Pessman, the expert relied on information due to a product recall and speculation that issues spread to other models within that manufacturer’s portfolio of products. The Defendant argued that Plaintiff’s contentions pertained more to the weight the jury should assign to the expert opinion rather than its admissibility. Defendant also contended that the Supreme Court has acknowledged the district court’s “broad latitude” in permitting expert testimony grounded in “professional studies or personal experience.”

Furthermore, the Defendant argued that Klausner’s testimony should be deemed admissible because the opposing party has the opportunity to scrutinize the factual basis for the opinion during cross-examination. The Defendant cited the principle that expert opinions should only be excluded when they are so fundamentally unsupported that they provide no assistance to the jury. Consequently, the Defendant concluded that Klausner’s expert opinion was admissible, and any challenges to his opinions could be addressed during cross-examination by the Plaintiff.

In response, the Plaintiff contended that the Defendant’s attempt to establish a basis for admitting expert testimony, grounded in the shared use of RVF technology to assert a substantial similarity between the Multiplo Test used in the Peru Study and the Subject Test used by Defendant, was unfounded and flawed. Plaintiff argued that this claim lacked support from Klausner, as he neither mentioned RVF technology in his deposition nor opined that the tests’ similarity was based on its shared use. Plaintiff asserted that relying solely on this asserted commonality was irrelevant, incapable of establishing reliability, and deemed improper when imputing the results of one test to another.

The Court determined that Klausner’s testimony lacked both reliability and helpfulness to the trier of fact. Consequently, he was precluded from asserting that findings from the Peru Study, specifically related to the Multiplo test, had any relevance to the reliability of the Subject Test employed by the Defendant.

The Court clarified that the reliability of the Peru Study itself was not under scrutiny; instead, the issue revolved around the application of that study’s findings to the specific facts of this case.

The Court observed that the process of imputing findings from the Peru Study to the Subject Test necessitates an assessment of the RVF Technology. Although RVF technology may serve as a connecting feature among three MedMira tests, including the Subject Test, the Defendant did not argue that RVF is the actual technology responsible for detecting HIV antibodies. Rather, the Rapid Vertical Flow (RVF) technology facilitates the swift delivery of blood specimens to the elements within rapid HIV tests, enhancing the speed of antibody detection. Notably, the Court highlighted that Klausner did not testify that the shared RVF technology constituted a sufficient basis for imputing the safety or reliability of one test to another within the MedMira portfolio. In addition, Klausner did not discuss the RVF technology in his deposition or in his prepared expert statement, rendering the argument not properly categorized as an expert opinion under Federal Rule of Evidence 701, 702, or 703.

Furthermore, the Court deemed Klausner’s expert testimony, wherein he expressed an expectation that MedMira’s HIV antibody detection qualities would resemble each other more than tests from different manufacturers, as insufficient to meet the reliability prong. The Court held that it was not scientifically reliable to impute the findings from a well-funded study conducted by outstanding scientists in an excellent clinical research infrastructure, as mentioned by Klausner in his deposition, to a different HIV test merely based on an expectation of similarity.

In line with a district Court’s gatekeeping role under Daubert, it is essential to prevent speculative and unreliable expert testimony from reaching the jury. Klausner, in this case, has provided only speculative assertions regarding the similarities between the Subject Test and Multiplo test. Consequently, the expert testimony fails to meet the reliability and helpfulness prongs under Daubert.

As a result, Klausner was precluded from testifying that the study he conducted in Peru concerning a different type of HIV rapid test had any relevance to the reliability or sensitivity of the Subject Test.


The Court granted the Plaintiff’s Daubert Motion to Exclude certain opinions of Defendant’s Expert, Jeffrey D. Klausner.

The Court has not arrived on an outcome for this case since the remaining issues involved in this case still await resolution.

Key Takeaways

In this medical negligence case, the Defendant Celebrity allegedly infected the Plaintiff Mariette Waters with HIV during a blood transfusion at the shipboard medical center. The Defendant’s medical staff administered blood from a donor with an “advanced, longstanding, chronic” HIV infection, leading to the Plaintiff’s HIV diagnosis three months later. The Defendant’s failure to detect HIV in the donor’s blood was attributed to the failure to adhere to mandatory protocols for donor screening and blood testing.

The Court addressed Plaintiff’s efforts to exclude specific testimony from the Defendant’s HIV expert, Jeffrey Klausner. Plaintiff succeeded in precluding Klausner from testifying about regulatory approval for the HIV rapid test used in the case. The Court found insufficient basis for Klausner’s belief in approval and granted Plaintiff’s motion.

Plaintiff also challenged Klausner’s opinions based on a study conducted in Peru, arguing that the tests in question were materially different. The Court agreed, precluding Klausner from testifying about the study’s relevance to the reliability of the HIV test used by the Defendant. The Court emphasized the lack of a scientific basis to impute findings from one test to another based solely on the expectation of similarity.

Defendant argued that Klausner’s testimony should be admissible, emphasizing Klausner’s qualifications and asserting the similarity of the MedMira tests. The Court disagreed, finding Klausner’s opinions lacked reliability and helpfulness to the trier of fact. The Court held that Klausner’s expectation of similarity between tests, without a scientific basis, was insufficient. Consequently, Klausner was precluded from asserting the Peru study’s findings as relevant to the reliability of the Defendant’s HIV test. The Court emphasized its gatekeeping role under Daubert to ensure the exclusion of speculative and unreliable expert testimony from reaching the jury.

Case Details

Case CaptionWaters v. Celebrity Cruises, Inc.
Docket Number1:22cv22913
CourtUnited States District Court, Florida Southern
Citation2024 U.S. Dist. LEXIS 15064
Order DateJanuary 29, 2024


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