Mirena Iud Consent Form Bayer – According to Bayer, a 2D ultrasound can not determine whether the Mirena IUD has extended into the myometrium in full. But neither a standard of treatment nor a body of scientific evidence supports this opinion. The use of 3D ultrasound is predicated on Dr. Javitt’s belief that it is a standard of treatment. This finding is undisputed, but that does not imply that 2D ultrasonography is the norm.
The sufficiency of the Mirena label is relevant to Prof. Jarrell’s testimony.
Prof. Jarrell and Dr. Parisian are both myometrium and physiology specialists. However, there is a conflict of interest involving Prof. Jarrell and Dr. Parisian. She is not competent to express an opinion on pharmaceutical labeling in the US because she is a physiologist. Furthermore, neither the plaintiffs nor the defendants make the claim that Dr. Parisian is qualified to give testimony on the Mirena label.
According to Professor Jarrell’s testimony, the Mirena moniker was appropriate. She did not, however, suggest a more secure design. In her expert assessment, Jarrell did not suggest an alternative design. She simply voiced her view on how the label should be written. This runs counter to other experts’ testimony who were expert witnesses. Because of this, she needs to be thoroughly questioned by the other side and have evidence against her shown.
Dr. Wray’s evidence has no bearing on whether the Mirena label is adequate.
Despite the fact that the plaintiffs have provided a lot of evidence to back up their claims, the case’s merits are unaffected by Dr. Wray’s testimony regarding the suitability of the Mirena label. The FDA had plenty of time to research the safety of Mirena, including the dangers of implant migration brought on by perforation unrelated to implantation. The hazards that arise once the product is put on the market, however, were not addressed by the defendants.
The expert for a defendant must be qualified to testify. A qualified expert with the necessary education and experience should give testimony on the subject of the Mirena label’s suitability. The jury will need to hear from him or her on how the pertinent FDA rules and standards were met. The expert’s testimony doesn’t back up the plaintiffs’ claim that the Mirena label didn’t tell people about the risk of uterine perforation.
The sufficiency of the Mirena label is relevant to Dr. Feigal’s evidence.
Because Dr. Feigal’s thoughts on the suitability of the Mirena label are unrelated to the FDA’s requirements, the Court may decide to omit his testimony from the proceeding. But his testimony is relevant to the question of whether or not the Mirena label meets regulatory requirements, and the jury can learn from his knowledge of regulations.
Dr. Feigal is ineligible to provide testimony on secondary perforation and post-insertion migration. Even though he claims to be an expert on IUDs, his testimony does not demonstrate his particular understanding of uterine concerns and effects. He claimed in his testimony that he was unaware of the pre-and post-marketing alerts for other IUDs.
The sufficiency of the evidence is relevant to Dr. Feigal’s testimony.
The evidence of regulatory experts, Dr. David Feigal and Dr. Dena Hixon, is sought to be excluded by the plaintiffs. Plaintiffs contend that Dr. Feigal lacks the medical expertise necessary to testify as a witness and that his comments on the labeling and efficacy of Mirena are redundant. Plaintiffs further contend that Dr. Feigal’s views on the FDA’s perspective on the labeling of Mirena are unimportant to the validity of Bayer’s asserted compliance.
Given that Dr. Feigal had little prior experience with IUDs and that his testimony is dependent on research written by Goldstuck, which he did not have access to before the lawsuit, the plaintiffs seek to have Dr. Feigal’s testimony excluded. Thus, the intellectual rigor of Dr. Feigal’s testimony is lacking. Also, his ideas about what causes post-insertion migration are not based on the results of peer-reviewed studies, but rather on what he thinks.