Chicago, ILPlaintiffs in testosterone lawsuits against defendant AbbVie Inc. found themselves momentarily distracted from the allegations at hand earlier this month when the Illinois federal judge overseeing multidistrict litigation over testosterone side effects needed to rule on a motion submitted by the defendant to trim a report from an expert witness in the case.
The expert in the testosterone lawsuit is Dr. B. Bud Gerstman, the physician who penned the rebuttal report for the plaintiff’s steering committee in the testosterone side effects case. Gerstman, according to court documents, is a professor at San Jose State University. Gerstman is described as having authored an original report for the proceedings in October of last year, followed by a supplemental report dated December 26.
AbbVie had petitioned US District Court Judge Michael Kennelly, who is overseeing the multidistrict litigation in the case, to trim the expert witness’ supplemental report in order to confine the document to the scope of scientific articles associated with testosterone replacement therapy and heart health to which all parties had previously agreed.
In sum, AbbVie held that there was an agreement in place that limited the studies available to Gerstman for his supplemental report.
The judge disagreed.
“The studies addressed in the report are properly part of a rebuttal report,” Judge Kennelly wrote. “Even though two of them were issued before Dr. Gerstman’s initial report, they were issued just before that report was due, and plaintiffs were not reasonably able to have Dr. Gerstman include them in his initial report. All three of the studies were addressed in defense expert reports.”
Testosterone replacement therapy is not new. The treatment available to treat severely diminished levels of testosterone has been around for decades, and was originally approved by the US Food and Drug Administration (FDA) for the treatment of hypogonadism, which in lay terms represents a severely low, or in rare cases the virtual absence of testosterone.
Severely low levels of testosterone can foster serious health complications for the affected patient. Testosterone replacement therapy (TRT), which is alleged to harbor health implications on its own, has been thought to be worth the risk for those individuals suffering from hypogonadism. For them, the benefit outweighs the risk.
The current issue driving testosterone side effects lawsuits continues to be the marketing of testosterone replacement therapy as a virtual fountain of youth for middle-aged men experiencing the natural changes in energy levels and libido that comes from aging. Testosterone levels will fluctuate and diminish over time, but in the majority of cases not to any critical level.
It is alleged in many a testosterone lawsuit that drug manufacturers saw an opportunity and exploited it, creating in its wake a disease out of thin air now popularly known as ‘Low-T,’ encouraging doctors to prescribe TRT to their patients who complain of low energy. Other lawsuits have alleged TRT manufacturers encourage otherwise healthy middle-aged men to conduct self-tests available online in order to gauge their need for TRT.
Plaintiffs allege such self-tests are not accurate, and provide for the seeker a false and misdirected sense of need.
Plaintiffs assert that TRT advocates and proponents misrepresented the health risks of TRT for healthy men, including an increased risk for testosterone stroke, and testosterone heart attack. Testosterone has been seen to foster an over-production of red blood cells, or a thickening of the blood, which can lead to blood clots and in rare cases, testosterone death in otherwise healthy men.
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