Plaintiff Sheli D. Milam Sams and Dr. Bradley Sams had Safeco Policy No. F335202 (“the Policy”) that included underinsured motorists (“UIM”) coverage. On February 13, 2021, Plaintiff was involved in an automobile accident in Colorado. The other driver, Semega Mahamadou, was at fault, and Mahamadou’s vehicle had an Allstate policy. Mahamadou’s Allstate policy had liability limits of $25,000 per person, and Allstate paid Plaintiff $25,000. Plaintiff’s sole formal doctor’s visit involved an x-ray in 2021. Dr. Charles Menendez interpreted the x-ray as showing a nondisplaced sternal fracture. Plaintiff’s husband provided treatment to her over the course of her recovery.
Defendant Safeco Insurance Company of Illinois (“Safeco”) sought to exclude or limit Sams’ designated experts, Dr. Charles Menendez and Plaintiff’s husband, Dr. Bradley Sams. Plaintiff argued that they acted as treating physicians.
Radiology Expert Witness
Charles Menendez is a board-certified radiologist who specializes in the general practice of radiology.
Bradley C. Sams received his medical degree and completed his residency training in obstetrics and gynecology at Louisiana State University Health Science Center. Sams is a member of the Mississippi Medical Association, the American College of Phlebology, and the American Association of Bariatric Physicians.
The parties contest whether Plaintiff properly disclosed her designated experts as treating physicians.
Plaintiff designated Menendez as a treating physician, so he was not required to provide a written report. But if a treating physician does not provide a written report, the physician’s testimony will be limited to opinions acquired based on the physician’s personal knowledge of the examination, diagnosis and treatment of a patient and not from information acquired from outside sources.
Menendez did not provide a written report, so any testimony he offers will be limited to be personal knowledge contained in his medical records and cannot come from information acquired from outside sources.
In contrast to Menendez, Sams’ disclosure as a treating physician did not satisfy Rule 26. A Plaintiff must provide more information than the treating physician’s facts, data, and symptoms he observed in his patients during treatment. Plaintiff provided no medical records from Sams which contain his expected testimony or a written report for that matter.
Alternatively, the Court determined that Sams admitted that he rendered no formal medical treatment to Plaintiff; this admission took Sams outside the scope of testifying as a treating physician, so he cannot satisfy Rule 26(a)(2)(C).
Held
The Court granted in part and denied in part Defendant Safeco Insurance Company of Illinois’ motion to exclude or limit the testimony of Charles Menendez and Bradley Sams.
Key Takeaway
A court considers the importance of the witnesses’ testimony. Because Sams did not render formal medical treatment to Plaintiff, his alleged expert testimony is not important. Besides, failure to properly disclose an expected expert’s testimony is grounds for prohibiting introduction of that evidence at trial.
Case Details:
Case Caption:
Sams V. Safeco Insurance Company Of Illinois
Docket Number:
1:24cv337
Court Name:
United States District Court, Mississippi Southern
Mikaznaaz Saiyed tragically passed away after giving birth at Swedish Covenant Hospital. She became unconscious during labor, and the delivery team had to perform an emergency C-section. Before long, she went into cardiac arrest, and the medical team rushed her to the intensive care unit. She passed away a few days later from a rare, life-threatening condition that sometimes occurs in pregnant women.
Her husband, Ahzar Saiyed, brought medical negligence claims against three Swedish Covenant entities, plus two members of the medical team. The United States later joined the case in place of the doctor and the midwife, because they worked for federally funded clinics.
Saiyed retained an expert, Dr. Martin Gubernick, to explain what went wrong in the delivery room. He issued a 24-page report that summarized how things unfolded in the hospital that day, including the medical care that Mrs. Saiyed received.
Gubernick addressed the cause of her injuries. He opined that the improper use of medications caused Saiyed to have uterine tachysystole, meaning excessive contractions. Gubernick believed that “her uterus was not given sufficient time to relax.” He also opined that the excessive contractions likely caused Saiyed to experience amniotic fluid embolism.
As Defendants see things, Saiyed cannot prove what caused the amniotic fluid embolism. They believe that the testimony of Gubernick is inadmissible under Daubert. And without his testimony, Saiyed cannot carry his burden of proof.
Obstetrics and Gynecology Expert Witness
Dr. Martin Gubernick is a board-certified obstetrician gynecologist with over forty years of experience in obstetrics and gynecology. Gubernick attended medical school at Northwestern University, and he did his residency at New York Hospital – Weill Cornell Medical Center in obstetrics and gynecology.
Defendants argued that Gubernick is unqualified to testify about amniotic fluid embolism. They basically identified a bunch of omissions in his CV. As Defendants pointed out, Gubernick has never published any medical literature on amniotic fluid embolism, and has never lectured on the topic. He has not researched that condition in particular. And he has never managed a labor and delivery involving a mother with amniotic fluid embolism.
However, Gubernick has loads of practical experience in delivery rooms. He has given drugs to induce labor, and is familiar with Cytotec and Pitocin, the two drugs at issue in this case. He has performed C-sections, monitored patients, and “overseen massive transfusions of blood products for conditions like amniotic fluid embolism.”
Gubernick has knowledge about amniotic fluid embolism, too. He is “familiar with amniotic fluid embolism including but limited to its pathophysiology, causes, treatments, and outcomes.” Gubernick is a physician trained in the area of pregnancy and childbirth. He has extensive experience with related drugs, procedures, and conditions. That experience gives him sufficient qualifications to take the witness stand.
Based on his report, Gubernick intended to explain to the jury what amniotic fluid embolism is, and how it happens. “Amniotic fluid embolism is a condition in which amniotic fluid (likely with fetal hairs, cells, and other material, etc.) enter the mother’s blood stream triggering what is akin to an allergic reaction. The amniotic fluid can leak into the mother’s blood stream, prompting mom’s body to ‘reject’, or ‘fight off’ what it senses is an attacker.”
Overall, Gubernick may not be an expert in amniotic fluid embolism per se. But he has substantial expertise in the area of pregnancy and childbirth. He has sufficient background and expertise to explain amniotic fluid embolism to the jury.
B. Methodology
Defendants believed that Gubernick lacked a basis to opine about what caused Saiyed to suffer an amniotic fluid embolism.
At bottom, Gubernick offered an opinion with two links in the causal change. He opined that Cytotec likely caused Saiyed’s uterine tachysystole (again, the excessive contractions). And he opined that the uterine tachysystole likely caused her amniotic fluid embolism.
Basically, the medication caused her uterus to go into overdrive, which led to a rupture. And the rupture caused a mixing of the fluid between the mother and the child.
Defendants took issue with both steps in the causal chain. A chain is only as strong as its weakest link. But here, each of the links is strong enough to get to a jury.
The first link is the connection between the medication and the medical condition. Gubernick opined that it is “well recognized” that Cytotec can lead to uterine tachysystole.” The Court found that Gubernick had a sufficiently reliable basis for reaching that conclusion. After all, the package insert itself warns physicians that a “major adverse effect of the obstetrical use of Cytotec is uterine tachysystole.”
A package insert doesn’t come out of nowhere. A package insert needs to receive the blessing of both the FDA and the drug manufacturer. And that approval comes after rigorous review and testing. Medical professionals kick the tires on anything said in a package insert because it affects how physicians use the medication with patients.
Gubernick based his opinion on the package insert, and the package insert reflected the understanding of the medical community. The whole point of a package insert is its reliability. It’s a go-to source for reliable information about how to use a drug, and what side effects might follow. Maybe a package insert is over-inclusive. But it doesn’t have to provide definitive gospel truth for an expert to rely on it.
The second link is the connection between the two medical conditions. Gubernick opined that the excessive contractions likely caused the amniotic fluid embolism. The Court held that Gubernick relied on the FDA-approved package insert, and he offered an explanation of how excessive contractions can lead to a rupture. That’s a sufficiently reliable basis to get in front of a jury. Any problems with his theory are best left for cross examination.
Held
Overall, the Court found that the opinions of Dr. Martin Gubernick pass muster under Daubert and Rule 702. Gubernick has the qualifications to give his opinions, and the opinions have sufficient indicia of reliability to get to a jury. Beyond that, the jury will have to figure it out.
Key Takeaway
An expert does not have to foreclose other possibilities when it comes to causation. And a Plaintiff doesn’t have to prove that negligence is the only explanation. Instead, an expert simply needs to offer an opinion that is sufficiently reliable to put before the jury. Basically, district courts stand guard and protect juries from unreliable experts. But once an expert offers a sufficiently reliable opinion, it is up to the adversary process to find the truth.
Elizabeth Reyes and her minor daughter G.T. sued the United States, Bronx Lebanon Hospital Center, BronxCare Health System, and two doctors over G.T.’s permanent medical conditions, which the Plaintiffs alleged were caused by mistakes made during Reyes’ labor and delivery and G.T.’s neonatal care.
The Bronx Lebanon Defendants filed a motion to preclude Plaintiffs’ obstetrics expert, Dr. Daryl K. Boffard; Plaintiffs’ anesthesiology expert, Dr. Alexander E. Weingarten; and Plaintiffs’ pediatric neurology expert, Dr. Louis N. Manganas. The United States filed a motion to preclude Drs. Boffard and Manganas.
Plaintiffs opposed these motions, and for the most part, they satisfied their burden to demonstrate the admissibility of their experts’ testimony under Rule 702 and Daubert. Despite their efforts, the Plaintiffs fell short in backing a few specific opinions.
Obstetrics and Gynecology Expert Witness
Dr. Daryl Keith Boffard, M.D., FACOG has been practicing Obstetrics and Gynecology Medicine in the New York metropolitan area since 1981 when he received his medical degree from the University of Medicine and Dentistry in Newark, NJ.
He was board certified by the American Board of Obstetrics and Gynecology in 1987. Following his residency, he has been the Medical Director at Jersey GYN Associates from 1987 to present date.
Dr. Alexander Eugene Weingarten, M.D., PC is a physician licensed to practice medicine and surgery in the state of New York and board certified in the medical specialty of anesthesiology.
He became board certified by the American Board of Anesthesiology in October of 1984 and has remained board certified ever since. He limits his practice to the field of anesthesiology. He received his medical degree from S.U.N.Y. Upstate Medical Center in Syracuse.
Dr. Louis Nicholas Manganas, M.D., Ph.D. is a pediatric neurologist who specializes in treating a wide range of neurological conditions in children, including hypoxic ischemic encephalopathy, intracerebral hemorrhage, central nervous system infections, developmental delays, and epilepsy.
After completing his clinical fellowship in Epilepsy at Yale, he joined the Department of Neurology at Stony Brook as faculty. He is currently the Chair of the Department of Neurology at the NYU Grossman Long Island School of Medicine.
First, Boffard opined that G.T.’s delivery process caused “cerebral palsy and hemiplegia.” The United States argued that Boffard isn’t qualified to offer an expert opinion on the causes of G.T.’s neurological conditions.
While Plaintiffs responded that “any person has the knowledge that having an interruption of oxygen for forty-five minutes can damage the brain,” and that “[t]here is nothing unreliable about Plaintiffs’ experts’ theories . . . that the failure to deliver or resuscitate . . . was a substantial contributing factor to the brain damage,” Boffard himself admitted that he’s “not qualified to offer an opinion as it relates to pediatric neurology.”
However, Boffard’s causation opinion goes beyond merely explaining brain damage; it focuses on specific pediatric neurological conditions that Boffard expressly stated he is not qualified to testify about. So while Boffard may testify that G.T.’s delivery caused brain damage, the Court excluded his opinion that the delivery process caused “cerebral palsy and hemiplegia and the sequelae of these conditions.”
Alexander Weingarten
Weingarten opined that “use of spinal anesthesia . . . was a substantial contributing factor to G.T.’s injuries, including brain damage.”
The Bronx Lebanon Defendants argued that Weingarten was not qualified to offer a causation opinion in the case. Plaintiffs’ only response was that Weingarten was qualified to opine on the standard of care, but this did not address Defendants’ concern about whether Weingarten was qualified to render an opinion about whether the use of anesthesia caused G.T.’s brain damage. Because Plaintiffs declined to meet Defendants’ critique head-on, the Court deemed this issue conceded. Therefore, the Court excluded Weingarten’s causation opinion.
Weingarten opined that the use of anesthesia “was a deviation from good and accepted medical practice.” The Bronx Lebanon Defendants argued that this opinion was “speculative and must be excluded” because Weingarten “based his opinions on someone else’s review of the records rather than his own.” Plaintiffs did not respond to this critique in their opposition brief. Consequently, the Court excluded Weingarten’s standard-of-care opinion.
Held
The Court granted in part and denied in part the Defendants’ motions to exclude the testimony of Plaintiffs’ experts Daryl K. Boffard and Alexander E. Weingarten.
Key Takeaway:
In this case, Plaintiffs declined to meet Defendants’ critique head-on. Numerous courts have held that a Plaintiff’s failure to address an issue in its opposition amounts to a concession or waiver of the argument.
Connie Thacker is one of tens of thousands of individuals who have filed suit against Ethicon for injuries after treatment with Ethicon’s pelvic mesh devices.
Plaintiff Connie Thacker filed a motion asking the Court to preclude defense expert Dr. John R. Wagner from offering testimony on certain subjects.
Obstetrics and Gynecology Expert Witness
Dr. John Raymond Wagner is board-certified in obstetrics and gynecology with a subspecialty board certification in pelvic floor medicine and reconstructive surgery.
He is a 1987-graduate of The Icahn School of Medicine at Mount Sinai in New York. While at Icahn, he was honored with the Alan F. Guttmacher Award as well as membership into the Alpha Omega Alpha Honor Medical Society.
Wagner’s testimony that certain risks of the Prolift and TVT-S devices are widely known by other surgeons
Thacker argued that Wagner’s testimony that certain risks of the Prolift and TVT-S devices are widely known by other surgeons was unreliable.
The parties anticipated that Wagner will testify that certain risks involved with using the Prolift and TVT-S devices were commonly known by other surgeons in his field (and thus did not need to be included in Ethicon’s product warnings).
While Thacker acknowledged that Wagner may properly opine on such risks as he understands them, she contended that he went too far by opining on what risks were commonly known by other surgeons. More specifically, Thacker argued that Wagner cannot testify as to what was commonly known by other surgeons because “Wagner did not conduct any empirical research or interview other physicians to verify the veracity of his opinion.”
Ultimately, the Court rejected Thacker’s argument and found that Wagner’s testimony that certain risks of the Prolift and TVT-S are widely known by other surgeons is reliable.
Wagner’s opinion regarding the common knowledge of pelvic surgeons was reliable because it was based on his medical training to become a pelvic surgeon—which is the same training regimen he represents is common to every pelvic surgeon. This training, along with his review of relevant medical literature, provided “appropriate validation,” for Wagner’s opinion concerning the common knowledge of pelvic surgeons and rendered his testimony reliable.
Wagner’s testimony regarding the properties of the mesh used in the TVT-S and Prolift
Thacker next argued that Wagner’s testimony regarding the properties of the mesh used in Ethicon’s devices was unreliable. Specifically, Thacker took issue with the reliability of Wagner’s opinion that the mesh involved “is a safe and effective material.” Thacker suggested that this opinion was unreliable because Wagner lacked the appropriate qualifications to form such an opinion: namely, she took issue with his lack of training in biomedical engineering, pathology, epidemiology, or medical device design.
The Court found that Wagner’s testimony regarding the properties of the mesh used in Ethicon’s devices was reliable due to Wagner’s “extensive clinical experience, combined with his review of peer-reviewed literature, qualifies [him] to opine on mesh’s reaction to and effect on the human body.”
Held
The Court denied the Plaintiff’s motion to exclude or limit the testimony of defense expert John Wagner.
Key Takeaway:
Wagner is more than qualified to opine on mesh’s reaction to and effect on the human body considering his extensive clinical experience, combined with his review of peer-reviewed literature. Wagner’s opinion regarding the common knowledge of pelvic surgeons is also reliable because it is based on his medical training to become a pelvic surgeon—which is the same training regimen he represents is common to every pelvic surgeon.
Please refer to the blogs previously published about this case:
Connie Thacker is one of tens of thousands of individuals who have filed suit against Ethicon for injuries after treatment with Ethicon’s pelvic mesh devices.
Thacker filed a motion asking the Court to preclude defense expert Dr. Salil S. Khandwala from offering testimony on certain subjects.
Obstetrics and Gynecology Expert Witness
Dr. Salil Siddhartha Khandwala is board-certified in obstetrics and gynecology with a subspecialty board certification in female pelvic medicine and reconstructive surgery. He has been in the practice treating women’s health issues since 2000.
He taught as an Assistant Professor in the Division of Urogynecology and Pelvic Reconstruction Surgery department at the University of Maryland from 1998-2002.
Khandwala’s testimony regarding degradation and contraction in the Ethicon mesh devices
Khandwala was expected to testify that Ethicon’s pelvic mesh devices do not degrade or contract. Thacker argued that this testimony should be excluded because it is unreliable. Thacker contended that Khandwala’s opinions are based on (1) his statement that he “does not believe,” in those issues with respect to Ethicon’s mesh devices; and (2) a flawed methodology.
However, Khandwala stated that his opinions on these subjects are based on his review of several studies and his own clinical experience using similar mesh devices. He also made several citations to scientific literature.
For example, with respect to his opinion on degradation, Khandwala stated that “I have never seen [degradation] in my personal experience using this sling in over 300 cases spanning a period of 10 years and recent published scientific literature has found that Prolene mesh in fact does not degrade [citation omitted].”
The Court found Khandwala’s opinions—that Ethicon’s pelvic mesh devices did not degrade or contract—to be reliable.
Khandwala’s testimony regarding mesh porosity and stiffness
Thacker suggested that Khandwala’s opinions on porosity and stiffness are unreliable because he “has never published on the porosity of mesh and has never personally examined the pore size of any of the Ethicon meshes absent observations with the naked eye.” Thacker argued that such gross examinations, on their own, are insufficient to render Khandwala’s opinions on porosity and stiffness reliable.
The Court held that Khandwala’s testimony, however, is not solely based on the occasional examination of Ethicon’s products. Rather, the portion of his report that Thacker challenges demonstrated that Khandwala’s testimony on this subject is based on his knowledge relating to the conditions of Ethicon’s mesh products in cases where they are correctly implanted.
And Khandwala’s knowledge on that subject was derived from both clinical and scholarly review. In fact, his expert report is replete with references to not only his own clinical experience as the basis for his knowledge relating to the conditions of Ethicon’s mesh products after implantation, but it also included numerous references to his review of relevant articles, studies, and other materials.
Held
The Court denied the Plaintiff’s motion to exclude the testimony of defense expert Dr. Salil S. Khandwala, M.D.
Key Takeaway:
Khandwala’s opinions regarding degradation and contraction did not rest on unsupported speculation or a flawed methodology. Basically, he stated that his opinions on these subjects are based on his review of several studies and his own clinical experience using similar mesh devices.
As a result, the Court broke no new ground in finding that Khandwala’s testimony was supported by appropriate validation and rested on a sufficient methodology.
Defendants CooperSurgical, Inc., Femcare, Ltd., and Utah Medical Products, Inc. manufacture and distribute birth control devices called Filshie Clips.
Filshie Clips are 3-5 millimeters wide and are laparoscopically placed on the fallopian tubes. Plaintiffs are individuals who had tubal ligation surgery in 2009 and 2010.
Plaintiffs Giovanna Bulox and Lorena Ahiri Merlo are sisters. Bulox underwent a tubal ligation procedure, choosing Filshie clips on July 13, 2010. Merlo underwent a tubal ligation procedure through the use of Filshie clips on July 21, 2009. Several years later, both sisters allegedly began to experience discomfort and pain.
In 2019, doctors removed two migrated Filshie Clips from Bulox’s body, one in her intestinal wall. Plaintiff Merlo had the same pain several years after her surgery, and in 2020, radiology showed the Filshie Clips migrated in her body. An attempt to remove them laparoscopically was unsuccessful; Merlo still has displaced Filshie Clips in her body. Plaintiffs sued Defendants for: (1) design defect; (2) manufacturing defect; (3) failure to warn; (4) strict liability; (5) negligence; (6) violation of consumer protection laws; (7) gross negligence; and (8) exemplary damages.
Defendants designated Dr. Janesh K. Gupta as a witness to assist their defense but Plaintiffs sought to exclude several of Gupta’s opinions, namely any opinion regarding: (1) Bulox’s medical condition; (2) Merlo’s medical condition; (3) the design and/or manufacture of Filshie Clips; (4) the adequacy of warnings promulgated with Filshie Clips; and (5) FDA regulations or how they apply to Filshie Clips.
Obstetrics and Gynecology Expert Witness
Dr. Janesh Gupta is an Honorary Professor of Obstetrics and Gynaecology at Birmingham Women’s and Children’s Hospital.
Gupta has published over 175 research papers in scientific journals, book chapters, reviews and books and over 100 lectures and presentations to learned societies in the fields of fetal medicine, benign gynaecology (including abnormal uterine bleeding, fibroids, endometriosis, endometrial hyperplasia), minimal access surgery, induction of labour and abortion. He has received grants from WellBeing of Women, Department of Health National Institute for Health Research (Health Technology Assessment), Medical Research Council and various industry partners.
Defendants designated Gupta as a witness to assist their defense because he is “an experienced English OB/GYN who has used the Filshie Clip for decades, has both written and reviewed published literature on the Filshie Clip, specifically on Filshie Clip migration, and has since 2012 served as the independent medical consultant for Femcare Ltd.—reviewing complaints and assisting with risk reviews and other studies of the Filshie Clips.”
The Parties Resolved Several Issues Raised in the Motion
Plaintiffs argued that Gupta is unqualified to testify about: (1) the injuries sustained by Plaintiffs because he never treated or examined Plaintiffs and did not review their medical records; and (2) Defendants’ FDA compliance because he does not practice medicine in the United States and possesses no knowledge of the FDA regulations or manufacturing or developing a medical device. Plaintiffs continued that Gupta’s opinions are unreliable and unhelpful because he is not an FDA expert yet offers opinions regarding what is a “serious injury” and “reportable event” according to FDA standards, and he did not form his opinions according to objective independent methodology.
However, Defendants explained that they did not intend to offer several of the objected-to opinions, making them moot. First, “Gupta did not intend to provide any specific testimony on Plaintiffs.” Second, Gupta provided no opinion on manufacturing or designing Filshie Clips, but rather he discussed how the design “physiologically accomplishes . . . female sterilization and result in migration,” and he also pointed out that Plaintiffs’ expert had no experience in designing medical devices. Based on the Court’s review, the above issues were denied as moot.
Third, Defendants have a separate FDA expert and did not intend to use Gupta as such—instead, Gupta discussed his own review of adverse event complaints as Defendants’ independent medical consultant.
Defendants clarified that “Gupta’s opinions . . . are really about his medical review of adverse event complaints in the context of FDA definitions.” Plaintiffs asserted that this clarification is insufficient because Gupta cannot offer the above testimony without also testifying about Defendants’ FDA compliance. But that is the exact same testimony that they stated that they intended to elicit from him. The Court held that this argument is insufficient for the exclusion of Gupta’s testimony.
Plaintiffs Failed to Carry their Burden To Exclude Gupta’s Testimony
Gupta May Testify About Reviewing Adverse Event Complaints
Plaintiffs argued that Gupta’s opinions regarding his review of reportable events are not backed by any independent methodology and therefore should be excluded. They argued that because Gupta lacked knowledge of the FDA and did not conduct independent research, he “relied only on his subjective interpretation of a definition of ‘serious injury’ provided to him by Femcare to make his determinations regarding serious injuries/reportable events,” which led to inconsistent findings. Plaintiffs also argued that Gupta rejected medical reports and made unfounded assumptions to discount patient reports of migration.
In his report, Gupta gave a detailed overview of his extensive medical experience and experience as a reviewer and of the applicable FDA regulations. Gupta first ascertained whether there was a serious injury in accordance to the regulatory body definitions and then determined whether there is a reasonable suggestion that the product may have caused the injury.
Gupta explained that that long-lasting chronic pain, the most common complaint with Filshie Clip migration, requires additional review due to the complexity of pain in the body, which for him, includes searching for additional physiological evidence in the medical history suggesting that the device caused or contributed to the reported problem. The Court held that Plaintiffs’ arguments are insufficient to exclude Gupta’s testimony as unreliable. Plaintiffs’ arguments largely relate to the bases of Gupta’s review decisions, not the underlying methodology, and are therefore more suitable for cross examination.
Gupta May Testify About Filshie Clip Warnings
Plaintiffs contended that Gupta’s opinions that the Filshie Clip instructions for use (“IFU”) are based on accurate and reliable data is unreliable and unsupported because these opinions are “based on his own erroneous understanding of the language included in the documents and a rate of incidence (0.13%) provided to him by Defendants and not based on any peer-reviewed science or accepted medical principles.”
The parties disagreed on the underlying facts of Gupta’s opinion that the Filshie Clip IFUs are based on accurate and reliable data. Without deciding the correctness of Gupta’s opinion, the Court found that his opinion is reliable: Gupta has extensive experience with implanting Filshie Clips and reviewing the IFUs—his testimony is based on this experience.
Held
The Court denied Plaintiffs’ motion to limit Defendants’ fact and expert witness, Dr. Janesh K. Gupta’s testimony.
Key Takeaways:
Unlike Plaintiffs’ contentions, Gupta has adequate knowledge of the applicable FDA regulations and has educated himself independently of Femcare’s provided material, citing to a wide body of literature in the field of chronic pelvic pain.
Gupta has employed his education and experience as a clinical expert who has implanted Filshie Clips for decades and counseled countless patients on the procedure. He also employs his own research, writing, and review of literature in reviewing the warnings for Filshie Clips to come to a conclusion as to whether they adequately warn of clip migration.
Please refer to the blog previously published about this case:
Defendants CooperSurgical, Inc., Femcare, Ltd., and Utah Medical Products, Inc. manufacture and distribute birth control devices called Filshie Clips.
Filshie Clips are 3-5 millimeters wide and are laparoscopically placed on the fallopian tubes. Plaintiffs are individuals who had tubal ligation surgery in 2009 and 2010.
Plaintiffs Giovanna Bulox and Lorena Ahiri Merlo are sisters. Bulox underwent a tubal ligation procedure, choosing Filshie clips on July 13, 2010. Merlo underwent a tubal ligation procedure through the use of Filshie clips on July 21, 2009. Several years later, both sisters allegedly began to experience discomfort and pain.
In 2019, doctors removed two migrated Filshie Clips from Bulox’s body, one in her intestinal wall. Plaintiff Merlo had the same pain several years after her surgery, and in 2020, radiology showed the Filshie Clips migrated in her body. An attempt to remove them laparoscopically was unsuccessful; Merlo still has displaced Filshie Clips in her body. Plaintiffs sued Defendants for: (1) design defect; (2) manufacturing defect; (3) failure to warn; (4) strict liability; (5) negligence; (6) violation of consumer protection laws; (7) gross negligence; and (8) exemplary damages.
Dr. Howard Sharp opined that the Filshie Clip was not the likely cause of Plaintiffs’ pain. Sharp was retained to “offer a differential diagnosis on the complex issue of the medical cause for Plaintiffs’ claimed injuries—in essence pain allegedly caused by a Filshie Clip that migrated.”
Plaintiffs argued that he should not be allowed to testify that factors other than migrated Filshie Clips were the cause of Plaintiffs’ pain because he has “openly acknowledged the absence of any alternative reason, evidence, or cause for the pain and subsequent injuries incurred by Plaintiffs,” and, therefore, they claim his opinion does not meet the standard for reliability.
Obstetrics and Gynecology Expert Witness
Dr. Howard Taylor Sharp is a tenured professor in the Department of Obstetrics and Gynecology at the University of Utah School of Medicine, where he has practiced for over 28 years. He currently serves as the Division Chief of General Obstetrics and Gynecology and Minimally Invasive Gynecological Surgery. Additionally, he is the Vice Chair for Clinical Activities in the department. He completed his residency in obstetrics and gynecology at the University of Utah in 1994, followed by a fellowship in minimally invasive gynecology at the Greater Baltimore Medical Center in Maryland in 1995.
Moreover, Sharp has research interests which include surgical complications, medical device efficacy and complications, and pelvic pain.
Plaintiffs did not question Sharp’s qualifications as an expert, but rather the reliability of his opinion.
Plaintiffs argued that because Sharp did not opine as to “what, other than Filshie Clip migration, caused Plaintiffs’ injuries,” his opinion is based on speculation and conjecture and is not tied directly to the evidence.
Basically, Plaintiffs contended that, by not suggesting a plausible alternative cause, Sharp’s opinion is unreliable, lacking a proper foundation, and could mislead the jury and invite speculation.
However, Sharp examined Plaintiffs’ medical histories and medical records, and reviewed Plaintiffs’ expert materials and materials related to clip migration, including clinical reports. Sharp utilized his years of specialized knowledge as a medical doctor, specifically as an obstetrician and gynecologist familiar with Filshie Clips and human physiology, as the basis of his opinion. The Court held that Sharp satisfies the requirements of Rule 702 and Daubert.
Regardless of whether Sharp’s opinion is correct or not, he has sufficiently articulated a basis for his opinion. That he did not physically examine both Plaintiffs is insufficient to show that his opinion should be excluded as unreliable.
The Court added that Sharp did provide alternative causes, namely, lengthy medical histories from both Plaintiffs containing other potential causes and in Bulox’s case, persistent complaints of pain before clip placement and after removal. The Court held that Plaintiffs’ complained-of deficiencies addressed Sharp’s credibility and not the reliability of his testimony.
Held
The Court denied Plaintiffs’ motion to exclude Dr. Howard Taylor Sharp’s opinion.
Key Takeaway:
Plaintiffs’ motion contains objections to the weight and not admissibility of Sharp’s testimony, which are objections best handled in vigorous cross-examination.
While Plaintiffs contended that Sharp’s opinion could mislead the jury and invite speculation by not suggesting a plausible alternative cause, the Court observed that Sharp examined Plaintiffs’ medical histories and medical records, and reviewed Plaintiffs’ expert materials and materials related to clip migration, including clinical reports. Moreover, Sharp did provide alternative causes, namely, lengthy medical histories from both Plaintiffs containing other potential causes and in Bulox’s case, persistent complaints of pain before clip placement and after removal.
The dispute in this matter stems from the prenatal care provided in January 2021 to Brittany S. Gobble by David P. Russell, M.D. at Bristol Gynecology and Obstetrics, P.C. (“BGO”) and Haley L. Akin, M.D. The Plaintiffs accused Haley Akin, M.D. of failing to make a diagnosis of severe pre-eclampsia during the hospitalization of January 16-17, 2021, insisting that Gobble should have been kept in the hospital. In other words, Defendants failed to properly diagnose and treat Gobble for severe preeclampsia which developed during her pregnancy and resulted in injuries to her minor child.
David Russell, M.D. saw Gobble in the office on January 18, 2021, the day following discharge from the hospital. Russell is accused of failing to send Gobble to the hospital that day.
Preeclampsia is described as “a disorder of pregnancy associated with new-onset hypertension” and “often accompanied by new-onset proteinuria.”
Both Plaintiffs and Defendants have now disclosed multiple expert witnesses who they intend to call at trial to address the claims that Plaintiffs have asserted against Defendants. One of these experts who has been disclosed by Plaintiffs is Jack Ayoub, M.D. (“Dr. Ayoub”), whose testimony Defendants sought prohibit.
Plaintiffs retained Ayoub to opine as to the standard of care for the diagnosis and treatment of patients with preeclampsia and preeclampsia with severe features.
Obstetrics and Gynecology Expert Witness
Jack Ayoub is board certified in obstetrics and gynecology, completed an obstetrics and gynecology residency training program at The George Washington University Medical Center in Washington, D.C., and has long been affiliated with both the American College of Obstetricians and Gynecologist and the American Board of Obstetrics and Gynecology. Ayoub founded Virginia Obstetrics & Gynecology, P.C. in July 2009 and currently serves as the CEO of that practice, while also having a surgery affiliation with Stone Springs Hospital Center in Dulles, Virginia.
Ayoub has delivered between 4,000 and 5,000 babies and in the process has routinely managed patients with and without prenatal issues, including diabetes, preeclampsia, and preeclampsia with severe features, among other conditions. While Ayoub presently delivers 5 to 8 babies a month, in the past he has delivered between 25 and 30 a month.
Ayoub’s testimony should be excluded because he is not an expert on preeclampsia
Defendants specifically advised that Ayoub is a sole practitioner who practices in the areas of ‘minimally invasive gynecologic procedures, including laparoscopy, heavy menstrual bleeding, fibroids, myomectomy, pelvic pain and endometriosis.”
Defendants noted that Ayoub has not published, written an abstract, or conducted bench research on preeclampsia or preeclampsia with severe features nor on hypertension in pregnancy. They further claimed that Ayoub testified that every person who completes a residency in obstetrics and gynecology is an expert on these topics. Finally, they noted that Ayoub’s lack of qualifications are demonstrated by the fact that he did not know the definition of a term pregnancy.
Ayoub has a long history of serving as a board-certified physician practicing in the field of obstetrics and gynecology. He has delivered numerous children and has been responsible for the care of the mothers who bore those children and has testified that in providing prenatal care he has frequently treated patients with diabetes and preeclampsia both with and without severe features. While Defendants assert that Ayoub spends most of his time handling gynecological matters at this juncture rather than practicing in the field of obstetrics, the question is whether Ayoub was qualified under Rule 702 at the time Gobble was treated by Defendants to opine as to the standard of care for the diagnosis and treatment of preeclampsia and preeclampsia with severe features. Given Ayoub’s education, training and experience, the Court finds that he possesses the qualifications necessary to offer expert testimony on these issues.
Ayoub’s opinions are unreliable and unhelpful as an initial matter because Ayoub provided an incorrect definition of a “term” pregnancy under ACOG guidelines
Defendants contended that Ayoub was wrong regarding the definition of a term pregnancy in opining as to when the minor child should have been delivered in accordance with the applicable standard of care. However, in reviewing Ayoub’s testimony it appeared that he is familiar with the ACOG standards addressing when a child should be delivered. In the Court’s reading of Ayoub’s testimony, he appeared to agree that it is generally preferable for delivery to wait until thirty-seven weeks in cases where a patient is experiencing preeclampsia.
Defendants argued that Ayoub’s opinions are unreliable because he has opined that the headache Gobble was experiencing while hospitalized supported a diagnosis of preeclampsia with severe features. They claimed that the idea that a headache is supportive of this diagnosis has been “generally rejected.”
Defendants pointed out that Ayoub opined that the fetal heart monitor tracing from that date fell into Category I, the best category under the ACOG classification system.
The Court held that Ayoub’s opinions simply diverge from those of Defendants and their experts. Plaintiffs have demonstrated that Ayoub’s opinions regarding when Gobble should have been delivered have a factual basis and are supported by applicable ACOG guidelines, just like the opinions of Defendants and their expert witnesses have a factual basis and are supported by applicable ACOG guidelines. In short, it comes down to which version of the facts should be accepted, which is a decision solely for a jury and not the Court. Resolving factual disputes is beyond the role of the Court as a gatekeeper.
Ayoub’s opinions should be excluded because he failed to consider Gobble’s comparative fault and was unfamiliar with the impact of maternal smoking on an unborn child
Defendants further attacked the opinions offered by Ayoub because Gobble smoked during her pregnancy, and he is not familiar with the toxins contained in cigarette smoke or whether those toxins pass the placenta. They further claimed that Ayoub did not properly consider Gobble’s comparative fault in causing her minor child’s injuries, i.e., her smoking and her failure to report to the hospital sooner on January 20, 2021, despite not feeling her baby move for several hours.
Defendants asserted that Gobble was given verbal and written instructions regarding counting her baby kicks when discharged from the hospital. On the other hand, Gobble had testified that Russell advised her that the baby’s movement would slow significantly as she got closer to her due date. Plaintiffs note that Ayoub has opined that Gobble should have been delivered while initially hospitalized and if she had been, there would be no issue regarding whether she appropriately monitored fetal movement. The Court found that once again, the issue here is not one of whether Ayoub’s opinions have a proper basis but instead of significant factual disputes, which are the province of the jury.
Held
The Court denied the Defendant’s motion to exclude the testimony of Jack Ayoub, M.D.
Key Takeaways:
Fed. R. Evid. 702 specifically provides that an expert may be qualified to testify by their “knowledge, skill, experience, training or education.” While it may certainly be a feather in an expert’s cap to have published or conducted research in the field in which they are offering expert opinions, nothing in Rule 702 requires it.
Significant factual differences between what Plaintiffs state that Gobble was told about fetal monitoring and what Defendants contended that she had been told are the province of the jury. When it comes down to which version of the facts should be accepted, it is a decision solely for a jury and not the Court. Resolving factual disputes is beyond the role of the Court as a gatekeeper.
Case Details:
Case Caption:
Gobble Et Al V. Bristol Gynecology And Obstetrics, P.C. Et Al
This matter arises out of a medical malpractice action filed by Plaintiffs Tyler Grenier, individually, and Jenna Grenier, individually and as next friend of J.A.G., a minor, (collectively “Plaintiffs”) against Defendant United States of America (“Defendant”) for alleged medical negligence at Tripler Army Medical Center (“Tripler”) related to the medical care by Defendant’s employees for prenatal care and labor of Plaintiff Jenna Grenier (“Jenna”), and the subsequent delivery of J.A.G.
Severe physical injuries sustained by Jenna Grenier and J.A.G. are alleged as well as the negligent infliction of emotional distress to Plaintiff Tyler Grenier (“Tyler”) and Jenna; Plaintiffs’ loss of filial consortium; and Tyler’s loss of spousal consortium.
In the instant motion, Defendant sought to exclude certain portions of opinions rendered by Plaintiffs’ expert witness, Dr. Adam Levy, M.D., because: his opinions regarding estimated fetal weight are unreliable; his opinions regarding Jenna’s operative delivery and using forceps resulting in excessive force are unreliable; his opinions about obtaining Jenna’s informed consent are unreliable; his opinions that Justin Pilgrim, D.O., and Asha Mada, D.O., were unqualified or incompetent are unreliable; his opinions that the medical care rendered to repair Jenna’s laceration injury are unreliable; and his opinions about the cause of the Minor Plaintiff’s injuries are unreliable and his deference on causation to a neonatologist acknowledged his lack of expertise.
Obstetrics and Gynecology Expert Witness
Dr. Adam Levy is a board-certified obstetrician gynecologist and has been a Fellow of the American College of Obstetrics and Gynecology since 1993. During his service in the Air Force he served as an OB/GYN specialist. He currently supervises and instructs residents in a high-risk pregnancy population labor and delivery.
Plaintiffs argued that Levy’s opinion that Defendant’s physicians failed to appreciate the risk for delivery complications because pre-delivery fetal growth was beyond the norm comports with accepted medical literature and therefore his opinion that the physicians who chose to deliver with forceps fell below the standard of care is reliable. As to Levy’s opinions regarding operative vaginal delivery, Plaintiffs argued that they are based on medical records and literature, and thus reliable.
Plaintiffs argued that Levy’s opinion that Jenna was not given a meaningful choice as to the method of delivery is “consistent with the modern standards of the medical community, his own deposition testimony, and thus [is] reliable and should not be excluded.” As to Levy’s opinions regarding the standard of care provided by Pilgrim and Mada in proceeding with forceps delivery, Plaintiffs pointed to his education, work and training in the area of high-risk obstetrics in a teaching hospital as qualifying him to render his opinions and submit that qualifications go to weight and not admissibility.
As to Levy’s opinion that the repair of the perineal laceration was done incorrectly, Plaintiffs submit that he is qualified to opine on the repair based on his education, training and experience. Plaintiffs submit that Levy’s opinions “regarding the traumatic birth being the cause of injuries to J.A.G. and his mother” are based on risks identified in medical literature and thus reliable.
Levy opined that “[t]he breaches of the standard of care of [J.A.G.] has caused brain damage” and that “cesarean delivery would have prevented both the newborn birth injuries and maternal injuries in this case.”
Levy’s opinions relate to the issue of medical standard of care
Defendant did not challenge Levy’s opinions as being irrelevant nor that he lacks qualification in the field of obstetrics and gynecology. The Court ruled that Levy’s opinions relate to the issue of medical standard of care. If he has misconstrued the medical records, or his analysis is otherwise shaky, then pointing out any such failures is appropriate for cross-examination and not exclusion where the expert’s qualifications and relevance of his opinions are not in issue. However, because Levy has deferred to a neonatologist as to the cause of the minor Plaintiff’s injuries, the Court believed that he is not qualified to render opinion testimony that the physicians’ breaches of the standard of care for the minor Plaintiff “has caused brain damage among the multitude of injuries that are currently being treated and will require further treatment far into the foreseeable future[,]” and that opinion is excluded.
As for his opinion regarding Jenna’s statements about whether she gave informed consent; the Court held the information to be factual because it did not require the assistance of an expert as required by Rule 702. The Court also excluded his opinion about Mada’s motivations. His conclusion that Jenna’s expressed desire for cesarean delivery was also ignored, was considered speculative at best.
Held
The Court granted in part and denied in part the Defendant’s motion to exclude the expert report and testimony of Dr. Adam Levy, M.D.
Key Takeaway:
Defendant did not challenge Levy’s opinions as being irrelevant nor that he lacks qualification in the field of obstetrics and gynecology. However, because Levy has deferred to a neonatologist as to the cause of the minor Plaintiff’s injuries, the Court believed that he is not qualified to render opinion testimony that the physicians’ breaches of the standard of care for the minor Plaintiff is the cause of brain damage.
This matter arises out of a medical malpractice action filed by Plaintiffs Tyler Grenier, individually, and Jenna Grenier, individually and as next friend of J.A.G., a minor, (collectively “Plaintiffs”) against Defendant United States of America (“Defendant”) for alleged medical negligence at Tripler Army Medical Center (“Tripler”) related to the medical care by Defendant’s employees for prenatal care and labor of Plaintiff Jenna Grenier (“Jenna”), and the subsequent delivery of J.A.G.
Severe physical injuries sustained by Jenna Grenier and J.A.G. are alleged as well as the negligent infliction of emotional distress to Plaintiff Tyler Grenier (“Tyler”) and Jenna; Plaintiffs’ loss of filial consortium; and Tyler’s loss of spousal consortium.
Plaintiffs sought to exclude certain portions of opinions rendered by Defendant’s expert witness, Dwight J. Rouse, M.D., because “they are not based on sufficient facts or data and they are not the product of reliable principles and methods.”
Obstetrics and Gynecology Expert Witness
Dwight J. Rouse is board certified in Obstetrics and Gynecology, and Maternal-Fetal Medicine. He is the Professor of Obstetrics and Gynecology at the Warren Alpert Medical School of Brown University and an actively practicing maternal fetal medicine attending at Women & Infants Hospital of Rhode Island.
Plaintiffs argued that, although Rouse’s testimony is relevant and his qualifications are not in issue, Rouse got a key fact wrong and thus any opinions relying on that wrong information should be excluded.
According to Rouse, “Grenier’s contention that she requested a cesarean delivery instead of operative vaginal delivery is at variance with the contemporaneous medical records. A low forceps delivery is what was performed and it was not foreseeable that mother or infant (or both) would suffer trauma. There is nothing in the medical record or the deposition testimony of the doctors or nurses to indicate that the forceps delivery was anything but easy and straightforward, or was performed in a manner outside the standard of care.”
Plaintiffs claimed that Rouse “cherry-picked one statement” and omitted relevant facts in medical records.
The Court held that Rouse’s opinions relate to the issue of medical standard of care and not causation based on epidemiological studies. If he has relied on a non-existent fact, has misconstrued the medical records, or his analysis is otherwise shaky, then pointing out any such failures is appropriate for cross-examination and not exclusion where the expert’s qualifications and relevance of his opinions are not in issue.
Held
The Court denied the Plaintiffs’ motion to strike the testimony of expert witness Dr. Dwight J. Rouse.
Key Takeaway:
Plaintiffs argued that, although Rouse’s testimony is relevant and his qualifications are not in question, Rouse got a key fact wrong. Therefore, any opinions relying on that incorrect information should be excluded. The Court held that Rouse’s opinions pertain to the issue of medical standard of care rather than causation based on epidemiological studies. Thus, highlighting any such errors is appropriate for cross-examination rather than exclusion, given that the expert’s qualifications and the relevance of his opinions are not in dispute.
Case Details:
Case Caption:
Grenier Et Al V. United States Of America
Docket Number:
1:22cv396
Court:
United States District Court for the District of Hawaii
