Court: District Court, C.D. California; November 7, 2017; Federal District Court
Anita Laux filed a lawsuit against Mentor Worldwide, LLC on December 29, 2015, in Ventura County Superior Court, which was later removed to the United States District Court for the Central District of California on February 12, 2016. The current matter involves Defendant's Motions to Exclude the expert opinions of Dr. Susan Kolb, Dr. Pierre Blais, and Dr. Arthur Brawer, which the Court has granted.
The facts indicate that Mentor Worldwide manufactures saline-filled inflatable breast implants. Laux underwent surgery on December 30, 2005, to have these implants inserted. Following the surgery, she reported various health issues, including body pain, respiratory congestion, fatigue, and numbness. In May 2014, tests indicated the presence of biotoxins from mold and debris within the implants. Subsequently, Dr. Kolb removed the implants on May 23, 2014, finding them to be leaking. Dr. Blais later examined the implants and concluded they had defective valves leading to bilateral leaks, which he asserted caused Laux significant health problems, including biotoxin disease and autoimmune disorders.
Laux's lawsuit claims injuries stemming from the Defendant's manufacturing defects, negligence, and breach of warranty, with Dr. Kolb, Dr. Blais, and Dr. Brawer designated as expert witnesses to establish the causal link between the injuries and the defective implants. Following discovery, the Defendant moved to exclude the experts' opinions on August 4, 2017. The Court will evaluate each motion individually.
Federal Rule of Evidence 702 establishes a "gatekeeping" role for trial courts to ensure that scientific testimony is relevant and reliable, as reinforced by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc. The proponent of expert testimony must demonstrate its admissibility by a preponderance of the evidence. Expert testimony is admissible if the witness is qualified and the testimony meets four criteria: (a) it aids in understanding the evidence or determining a fact, (b) it is based on sufficient facts or data, (c) it arises from reliable principles and methods, and (d) the expert has applied these methods reliably to the case facts. The Daubert decision outlines four factors for assessing reliability: (1) whether the theory can be tested, (2) whether it has undergone peer review, (3) the known or potential error rate, and (4) its general acceptance in the relevant scientific community. The Supreme Court later clarified that these factors are flexible and intended to assist rather than constrain the analysis of expert testimony.
Defendant seeks to exclude Dr. Susan Kolb's testimony on the grounds that she lacks qualifications as a biotoxin expert under Rule 702, her differential diagnosis is unreliable, and her opinions do not meet the Daubert reliability standards. Plaintiff counters that Dr. Kolb is a recognized expert in breast implants. The Court concurs with Defendant, ruling that Dr. Kolb is unqualified to assert that Plaintiff suffers from biotoxin disease allegedly caused by mold in Mentor Saline Breast Implants. Dr. Kolb's background is primarily in plastic surgery, having graduated from Washington University and completed her residency at Wilford Hall Medical Center. Although she is certified in plastic and reconstructive surgery, she lacks formal training in immunology, mycology, and infectious diseases, which are pertinent to her proposed testimony. Her diagnosis of biotoxin disease is based solely on clinical experience with over 500 patients rather than published medical literature. The Court concludes that her qualifications do not extend to the areas of mold and biotoxins, rendering her testimony inadmissible.
Defendant challenges the reliability of Dr. Kolb's differential diagnosis methodology, which is a process used by medical practitioners to determine the most likely cause of a patient's symptoms by eliminating potential causes. Key steps include compiling a list of possible causes and ruling them out, as supported by case law. Defendant argues that Dr. Kolb's diagnosis is flawed because she did not adequately rule out environmental mold exposure as a cause of the biotoxin disease diagnosed in Plaintiff. Dr. Kolb typically tests for "TGF beta 1" to assess biotoxin levels but did not perform this test for Plaintiff, relying instead on Plaintiff's assertion of no mold exposure. This reliance is questioned because Plaintiff had previously communicated about mold exposure in her mother's home. Dr. Kolb's conclusion that Plaintiff's symptoms were solely due to defective implants contradicts this earlier statement, raising concerns about the thoroughness and reliability of her differential diagnosis.
Dr. Kolb's failure to test for TGF beta 1 undermines her ability to objectively rule out environmental exposure, particularly regarding mold. The inconsistencies between her diagnosis and the Plaintiff's claims about mold exposure raise significant concerns about the reliability of her differential diagnosis and the underlying data. The selective use of facts does not adhere to scientific standards, as noted in relevant case law, which emphasizes that a differential diagnosis must consider all potential causes to be reliable. The Court concludes that Dr. Kolb inadequately accounted for the possible impact of environmental mold on the Plaintiff, rendering her methodology unreliable. Moreover, Dr. Kolb's theories lack testing, peer review, or acceptance within the scientific community. Her diagnosis of biotoxin disease relies solely on her prior experiences and is not supported by specific evidence regarding mold presence in the Defendant's breast implants. Additionally, the literature she referenced is primarily non-peer-reviewed and has been excluded in other legal contexts. Ultimately, Dr. Kolb's conclusions connecting the Plaintiff's symptoms to biotoxin disease are unsupported by scientific literature, leading the Court to determine that the Plaintiff has not met the burden of proving the admissibility of Dr. Kolb's testimony. Consequently, the Court grants the Defendant's Motion to Exclude Dr. Kolb's expert opinions.
Defendant seeks to exclude the opinions of Plaintiff's expert, Dr. Pierre Blais, as articulated in his "Failure Analysis Report," arguing that he is not qualified to comment on microbiological organisms or faulty breast implant valves due to his background as a chemist without formal training in microbiology, pathology, or engineering. In his deposition, Dr. Blais acknowledged his lack of education in microbiology but claimed competency in identifying debris in breast implants based on his collaboration with microbiologists. The Defendant references prior cases where courts excluded Dr. Blais' similar opinions, citing a district court's finding that Blais' report was filled with unqualified medical conclusions and lacked sufficient scientific literature. The Court concurs that Dr. Blais lacks the necessary expertise to identify microbiological organisms and that his methodology is unreliable, noting he did not test the implants or establish a scientific basis linking the injuries to Defendant's products. His examination of the implants involved merely visual observation, and he failed to provide measurements or access to the valve design specifications, relying instead on outdated documents and memory. Thus, the Court concludes that Dr. Blais' methodology is questionable and insufficiently rigorous to be deemed reliable.
Dr. Blais has not published any theories on bacterial or fungal colonization of saline implants in peer-reviewed literature, with the defendant asserting that existing literature contradicts his claims. Although Dr. Blais attempted to publish his theories, both attempts were rejected by editors who deemed the issue resolved. Consequently, the Court concludes that Dr. Blais' theories regarding the Plaintiff's breast implant valves lack support from peer-reviewed research, deeming his opinions unreliable. Previous court cases have similarly discredited Dr. Blais' testimony, citing his lack of qualifications and reliance on untested knowledge.
The defendant also seeks to exclude the opinions of Dr. Arthur Brawer, arguing that his expert report does not meet Federal Rule of Civil Procedure 26 requirements and is unreliable under Daubert standards. Specifically, Dr. Brawer's report allegedly fails to provide a complete statement of his opinions, the basis for them, the facts he considered, a list of prior cases where he testified, and his compensation details. The report primarily summarizes the Plaintiff's medical history without adequately supporting his assertion of "breast implant toxicity." The Court agrees with the defendant's assessment, concluding that Dr. Brawer's report does not satisfy the requirements of Rule 26.
Defendant seeks to exclude Dr. Brawer's opinions as unreliable under the Daubert factors, arguing his report lacks a clear methodology and fails to substantiate his claim of "breast implant toxicity" with scientific evidence. The report does not identify the toxic substance involved or establish a causal link to injury, rendering his conclusions unsupported. The Court concurs, noting that Dr. Brawer's assertions amount to mere personal opinions without a scientific foundation, aligning with precedents that allow courts to dismiss expert testimony lacking a sufficient analytical basis. Additionally, under Federal Rule of Civil Procedure 37, non-compliance with information requirements prohibits the use of such testimony unless justified. Since the Plaintiff does not claim justification for Dr. Brawer's report non-compliance, and given the Court's gatekeeping role under Federal Rule of Evidence 702 and Daubert, it finds Dr. Brawer's report fails to meet necessary scientific standards. Consequently, the Court grants Defendant's motion to exclude Dr. Brawer's expert report.
The Court grants the Defendant's motions to exclude the expert opinions of Dr. Susan Kolb, Dr. Pierre Blais, and Dr. Arthur Brawer. The Plaintiff's opposition, filed on September 11, 2017, is treated as a response to these motions. The Court emphasizes the leniency granted to pro se litigants regarding procedural rules. It notes that Dr. Kolb lacks qualifications in relevant fields such as rheumatology or mycology and admitted uncertainty about mold toxicity. Additionally, prior cases have found Dr. Shoemaker's methodologies insufficient under the Daubert standard, leading to the exclusion of his opinions. Dr. Blais' report is critiqued for reiterating his autoinflation theory without substantial evidence. The Court also mentions that Dr. Brawer's opinions are excluded under Daubert, and therefore does not consider the Defendant's argument regarding the inability to depose Dr. Brawer due to the Plaintiff's former counsel's actions.
