Marco Gonzalez was prescribed an antibiotic and suffered serious adverse effects. He sued the healthcare providers and hospitals that were involved in his treatment for medical negligence, and a jury found in favor of the defendants.
Gonzalez filed a motion for a new trial, challenging the district court’s comments to the jury and its evidentiary rulings. The district court denied the motion, and then awarded costs to the defendants as the prevailing parties. The plaintiff appealed.

Background Facts

After experiencing symptoms of urinary urgency, frequency, and straining, Gonzalez went to a urology clinic on July 16, 2015, and was seen by Dr. Salem Shahin, a urologist employed by Mercy Medical Center in Williston, North Dakota. A urine test came back negative for infection, but Dr. Shahin determined that Gonzalez’s symptoms were consistent with a chronic prostate infection and prescribed Bactrim, an antibiotic. He instructed Gonzalez to take the antibiotic twice daily for a month.

A few weeks later, on July 30, Gonzalez experienced blurred vision and drainage from his eyes. He went to the emergency room at Mercy Medical, where he was seen by another doctor, Dr. Richard Martin. Dr. Martin was aware that
Gonzalez was taking Bactrim, but seeing no “Bactrim rash”—a common symptom of an adverse reaction to Bactrim—he did not believe Gonzalez was having a reaction to the antibiotic and decided not to discontinue it. Dr. Martin instead
believed Gonzalez had a viral eye infection and prescribed a medicated ointment for his eyes.

Gonzalez returned to the Mercy Medical emergency room several times. On his last visit on August 1, 2015, he reported worsening symptoms: he had also developed a rash. Gonzalez was admitted to the hospital, where he was again examined by Dr. Gilmore. Dr. Paul Andelin was consulted, and he decided to discontinue the Bactrim. Soon after, Dr.
Andelin diagnosed Gonzalez with Stevens-Johnson Syndrome, a rare disorder that can be caused by taking Bactrim. Some of Gonzalez’s symptoms improved on August 2, but when Dr. Andelin saw that Gonzalez’s rash was worsening, he transferred Gonzalez to a burn center for treatment.

Gonzalez sued doctors Shahin, Gilmore, Martin, and Andelin; physician assistant Adams; and Mercy Medical Center and McKenzie County Healthcare Systems for medical negligence. An eleven-day jury trial was held. At trial, Gonzalez offered into evidence the Physicians’ Desk Reference drug label for Bactrim (the Bactrim label), which noted that Bactrim’s “most common adverse effects” include “allergic skin reactions (such as rash and urticaria).” The label also
cautioned that fatalities, “although rare, have occurred due to severe reactions, including Stevens-Johnson Syndrome . . . .” Gonzalez argued that his medical providers had negligently treated him with Bactrim and failed to discontinue the antibiotic without consulting the Bactrim label. The defendants argued in response that the providers reasonably prescribed the Bactrim and acted with due care given Gonzalez’s symptoms.

After the Bactrim label was admitted into evidence at trial, the district court read Jury Instruction 19, which addressed the label. But the district court first stated that it wanted to “make sure” the jury did not “give [the label] more weight than it deserves.” And after reading the instruction, the court told the jury that such manufacturer-provided materials “are written by drug companies and lawyers that include all sorts of information to protect principally drug companies from having a lawsuit like this.” The parties stipulated to the instruction, but not to this additional commentary.

Gonzalez argued on appeal that the district court improperly denied his motion for a new trial, contending that the district court made improper comments about the Bactrim label and about his lawyer (as well as raising other issues). In its opinion filed on August 16, 2023, the United States Court of Appeals for the Eighth Circuit held: “We acknowledge Gonzalez’s concerns—the district court’s supplemental comments were ill-advised. Nevertheless, the district court emphasized that it was the jury’s choice to determine the “measure of weight” and the importance of the label. And the court instructed the jury that manufacturer information was “competent evidence” to consider “in determining whether each medical professional met the standard of care in this case.” On the whole, it was made clear to the jury that all factual questions—including the import of the Bactrim label to Gonzalez’s case—were to be resolved by them. We conclude, after considering “the complete charge to the jury,” that the district court did not abuse its discretion.”

Source Gonzalez v. Shahin, MD, No. 22-2012.

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