Infectious Disease Expert Links Causation to Contamination Mentioned in Recall Email

After using the alcohol prep pads in the injection kit the defendant sold, the plaintiff developed abdominal cellulitis. The plaintiff received an email from the defendant stating that the alcohol prep pads were possibly contaminated with bacteria.

Zach Barreto

Written by
— Updated on June 15, 2022

Infectious Disease Expert Links Causation to Contamination Mentioned in Recall Email

Court: United States District Court for the District of Columbia
Jurisdiction: Federal
Case Name: West v. Bayer Healthcare Pharms., Inc. 
Citation: 2018 U.S. Dist. LEXIS 16116

The plaintiff claimed that the bacteria present in the pads caused his infection. The infectious disease expert, retained by the plaintiff, opined on the cause of his illness. However, the defendants argued that the expert’s conclusion was inadmissible because the expert partially based his opinion on the recall email’s content. 

Facts

The plaintiff suffered from multiple sclerosis. The plaintiff received an injectable medicine called Betaseron for the care of his MS. The defendant manufactures Betaseron. The Betaseron injection kits the defendant sold included alcohol prep pads. One day after using the alcohol prep pads given, the plaintiff gave himself the injection of Betaseron. Immediately afterward, cellulitis (cell inflammation) formed in his abdominal wall. The plaintiff underwent treatment for an extended period of time, but the infectious cause of his infection was unidentifiable. The plaintiff received an email from the defendant while at the hospital. The email warned the plaintiff against using the alcohol prep pads due to possible contamination with the bacteria Bacillus cereus.

The plaintiff filed a suit alleging that the bacteria present in the alcohol prep pads caused his abdominal cellulitis. He retained an infectious disease expert witness to testify that this was the likeliest reason for his illness.

The Plaintiff’s Infectious Disease Expert Witness

The infectious disease expert witness was board certified in internal medicine and was an infectious diseases doctor. The expert served as a clinical director of the infectious diseases division at a medical school. He also was a professor of medicine at the medical school.

The expert reviewed the plaintiff’s medical records. After doing so, he testified that the plaintiff’s illness was highly likely due to infection with contaminated alcohol prep pads. The expert opined that the alcohol prep pads did not clean the surface of the skin. Furthermore, the alcohol prep pads caused a high burden of infectious pathogens that was likely due to Bacillus species. The expert acknowledged that he did not base his findings on cultures, microbiological data, or test results that could prove the cause of the plaintiff’s illness. The expert also acknowledged that it was possible that the plaintiff’s symptoms might have been consistent with other types of infections.

Nonetheless, the expert relied on a host of factors to come to his conclusion. One factor included the fact that the plaintiff’s clinical appearance, signs, and growth remained consistent with B. cereus infection. Another factor was the temporal proximity between the plaintiff’s self-injection and his illness. The plaintiff also had not had injection-related infections in the past. Furthermore, according to the e-mail recall, B. cereus may have contaminated the triad alcohol pad the plaintiff used immediately prior to his infection. With all of these factors in consideration, the expert determined that B. cereus was the most likely cause of this. However, the defendant sought to exclude his testimony.

Discussion

The court noted that the expert’s opinion focused on his extensive knowledge of infectious diseases and related medical literature and scientific knowledge. The expert also focused his opinion on his professional practice in the treatment of infectious diseases and the information provided in the plaintiff’s medical records. Furthermore, the expert based his opinion on the information given in the recall notice mentioning B. Cereus as the possible contaminant of the prep pads and the causal association between the plaintiff’s intake and symptoms. The court rejected the defendants’ argument that this conclusion derived from the remedial mail. Remedial mail was inadmissible as evidence. Thus, all conclusions derived from it were inadmissible as well. However, the court noted that Rule 703 allows expert testimony based on facts the expert knew of.

The court questioned whether infectious disease physicians diagnosing a patient should consider the information provided by that e-mail when making a diagnosis. The court concluded that doctors in this field would reasonably rely on the information relayed by e-mail recall as one factor doctors consider when formulating a diagnosis, despite the fact that they did not confirm with 100% certainty that the particular product the patient used was actually contaminated. This element of the specialist approach did not seem to the court to be so baseless or inaccurate that exclusion was appropriate.

Ruling

The court thus found the testimony to be admissible and denied the defendant’s motion.

Key Takeaways for Experts

It’s important that experts rely on both research and experience when forming their conclusions. In this case, the expert based his opinion on his professional experience and on related medical literature and scientific knowledge. The expert also relied on medical records when coming to his conclusion on causation. Whenever possible, experts should rely on available records as well as peer-reviewed literature. By doing so, it makes it harder for the opposing counsel to discredit the expert’s testimony.

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