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Plaintiffs’ Response to Defendant’s Motion to Strike Suzanne Parisian’s Testimony

Posted in Misc. Drugs

The plaintiffs in Burk v. Fleet responded to Fleet’s argument that Dr. Parisian should not be allowed to testify in the case:

Unless prohibited, Fleet is likely to attempt to take a position at trial that necessitates Dr. Suzanne Parisian's testimony. Fleet no doubt wants to point to an "empty chair" at trial to excuse its wrongful conduct in causing injuries to Walter Burk; the "empty chair" is FDA. Fleet, through the testimony of its employees and experts, wants to blame its careless, reckless and outrageous conduct – promoting a 2 x 45 mL dosing regimen of Fleet Phospho-soda despite the knowledge of the significant and deadly harm it posed – on FDA. Fleet wants to present a story to the jury in this case that it followed all applicable FDA regulations; and thus, Fleet did nothing wrong by promoting the product to consumers and physicians. Fleet wants to blame FDA and insist that FDA should have ordered Fleet to remove Phospho-soda from store shelves. And, since FDA did not take such action – until December 11, 2008 that is – Fleet will tell the jury it acted responsibly by promoting a 2 x 45mL regimen of Phospho-soda as a bowel cleanser to physicians and consumers. In an effort to bolster its story, Fleet now seeks to strike Plaintiffs' expert Dr. Parisian whose testimony will be necessary in assisting the jury in understanding critical issues in this case that Fleet seeks to interject. As set forth below, Fleet's Motion is meritless and as such, should be denied.

AND NOW, comes Plaintiffs, Walter A. Burk and Naomi Burk, by and through counsel, Jason A. Archinaco, Esq. and Robert A. Bracken, Esq. and the law firm of Pribanic & Pribanic, and file Plaintiffs' Response to Defendant's Motion to Strike Plaintiffs' Expert, Suzanne Parisian, M.D.

I. INTRODUCTION.

Unless prohibited, Fleet is likely to attempt to take a position at trial that necessitates Dr. Suzanne Parisian's testimony. Fleet no doubt wants to point to an "empty chair" at trial to excuse its wrongful conduct in causing injuries to Walter Burk; the "empty chair" is FDA. Fleet, through the testimony of its employees and experts, wants to blame its careless, reckless and outrageous conduct – promoting a 2 x 45 mL dosing regimen of Fleet Phospho-soda despite the knowledge of the significant and deadly harm it posed – on FDA. Fleet wants to present a story to the jury in this case that it followed all applicable FDA regulations; and thus, Fleet did nothing wrong by promoting the product to consumers and physicians. Fleet wants to blame FDA and insist that FDA should have ordered Fleet to remove Phospho-soda from store shelves. And, since FDA did not take such action – until December 11, 2008 that is – Fleet will tell the jury it acted responsibly by promoting a 2 x 45mL regimen of Phospho-soda as a bowel cleanser to physicians and consumers. In an effort to bolster its story, Fleet now seeks to strike Plaintiffs' expert Dr. Parisian whose testimony will be necessary in assisting the jury in understanding critical issues in this case that Fleet seeks to interject. As set forth below, Fleet's Motion is meritless and as such, should be denied.

II. ARGUMENT.

A. AN INDIVIDUAL MUST BE QUALIFIED AND PRESENT RELIABLE OPINIONS IN ORDER TO TESTIFY AS AN EXPERT AT TRIAL.

"The admissibility of expert testimony in a federal court sitting in diversity jurisdiction is controlled by federal law."' Humphries v. Mack Trucks, Inc., 1999 U.S. App. LEXIS 25522, *6 (4th Cir. 1999) (quotation omitted). Whether expert testimony should be admitted is governed by F.R.C.P. 702, which provides:
If scientific, technical or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.
F.R.C.P. 702.
Pursuant to F.R.C.P. 702, a district court must first determine whether an expert is qualified. "A witness's qualifications to render an expert opinion are liberally judged by Federal Rule of Evidence 702, which provides that a witness may qualify to give expert testimony based on knowledge, skill, experience, training, or education." United States v. Contreras, 1999 U.S. Dist. LEXIS 3724, *4 (4th Cir. 1999) (citing Kopf v. Skyrm, 993 F.2d 374, 377 (4th Cir. 1993)). "Where the expert's qualifications are challenged, 'the test for exclusion is a strict one, and the purported expert must have neither satisfactory knowledge, skill, experience, training nor education on the issue for which the opinion is proffered.' Kopf, 993 F.2d at 377 (quotation omitted).
Next, the district court must "act as 'gatekeepers' to 'ensure that any and all scientific testimony admitted is not only relevant, but reliable."' Workman v. Wal-Mart Stores East, L.P., 2007 U.S. Dist. LEXIS 97865, *17 (S.D.W.Va. 2007) (quoting Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993)). To determine reliability, the court must consider "'whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue."' Id. (quoting Daubert, 509 U.S. at 592).
When determining whether evidence satisfies the "scientific knowledge" prong, the Daubert court set forth factors that a district court should consider:
(1) whether a theory or technique can be or has been tested; (2) whether it has been subjected to peer review and publication; (3) whether a technique has a high known or potential rate of error and whether there are standards controlling its operation; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community.
Cooper v. Smith & Nephew, Inc., 259 F.3d 194 (4th Cir. 2001) (citing Daubert, 509 U.S. at 592-94). The United States Supreme Court subsequently noted, however, that the factors set forth in Daubert "were neither definitive, nor exhausitive." Id. (citing Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999)). "[T]he factors identified in Daubert may or may not be pertinent in assessing reliability depending on the nature of the issue, the expert's particular expertise, and the subject of his testimony." Workman, 2007 U.S. Dist. LEXIS 97865, at *18 (quoting Kumho Tire, 526 U.S. at 152).
In determining whether the second Daubert prong is met the district court must consider whether the testimony would be helpful to the trier of fact. United States v. Dorsey, 45 F.3d 809, 813 (4th Cir. 1995). To do so, "the Supreme Court warned that throughout an admissibility determination, a judge must be mindful of other evidentiary rules, such as FRE 403, which permits the exclusion of relevant evidence 'if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury."' Id. at 813 (quoting Daubert, 509 U.S. at 595). Typically, expert testimony will assist the trier of fact when it provides information beyond common knowledge. Daubert, 509 U.S. at 591.
Further, "[t]he Fourth Circuit Court of Appeals has provided additional guidance on how to evaluate the reliability of expert testimony when the opinion of the expert is based primarily on experience rather than science." Workman, 2007 U.S. Dist. LEXIS 97865, at *18 (citing United States v. Wilson, 484 F.3d 267, 274 (4th Cir. 2007)). "The Wilson court explained that a trial judge must 'require an experiential witness to explain how his experience leads to the conclusion reached, why his experience is a sufficient basis for the opinion and how his experience is reliably applied to the facts."' Id. at * 18-19 (quoting Wilson, 484 F.3d at 274).
Finally, it is well settled that the adequacy of an expert's knowledge goes to the weight of the testimony, not whether it is admissible. See, Humphries, 1999 U.S. App. LEXIS 25522, *14. Additionally, a party's argument attacking the lack of completeness of an expert's methodology goes to the weight of the evidence and not its admissibility. Kudabeck v. Kroger, 338 F.3d 856 (8th Cir. 2003).

B. DR. SUZANNE PARISIAN IS QUALIFIED TO RENDER THE OPINIONS THAT SHE IF OFFERING.

Dr. Parisian received her Medical Degree (M.D.) from the University of South Florida in 1978 and is Board Certified in Anatomic and Clinical Pathology. From 1991 to 1995, she served as a Commissioned Officer in the United States Public Health Service and achieved the rank of Commander. During this period, she was assigned to the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). Concurrently, she was also assigned clinical responsibilities at the Armed Forces Institute of Pathology (AFIP), Office of the Medical Examiner for the Armed Forces in Washington, D.C.
From 1991 to 1993, Dr. Parisian was a Medical Officer in the Office of Health Affairs (OHA), a staff office within the Center for Devices and Radiological Health, FDA. From March 1993 to December 1993, she was a Medical Officer in the Office of Device Evaluation (ODE), Division of Reproductive Abdominal, Ear, Nose and Throat, and Radiology, (DRAERD), FDA. From January 1994 through June 1995, she was Chief Medical Officer for DRAERD and ODE.
ODE, FDA is an Office responsible for the pre-marketing evaluation of product applications submitted by manufacturers to commercially market devices that are safe and effective within the United States. In ODE, Dr. Parisian participated in the review of marketing applications, including toxicology and biocompatibility data, as well as had the responsibility of training new medical officers and scientific reviewers in application and labeling review.
Dr. Parisian was an instructor in FDA's Staff College, instructing agency reviewers in the design and evaluation of clinical data submitted within pre-marketing applications. She was assigned primary responsibility for review of marketing applications and was required to teach all medical officers the process for evaluation and review as required by the Food, Drug and Cosmetic Act to support product marketing.
While in OHA, Dr. Parisian was a medical officer responsible for the review of mandatory adverse event reports submitted by manufacturers, as well as the review of voluntary reports submitted by health care providers, patients and others. At OHA, she was the primary clinician assigned responsibility for presiding over 162 health risk assessments. Health risk assessments are convened to advise FDA on the overall health risk of a product's performance issues, identification of public health safety issues, and to make recommendations to FDA regarding the subsequent regulatory actions that should be undertaken by FDA, health care providers, users groups and manufacturers in order to help protect the public's welfare.
Dr. Parisian's assignment at OHA specifically included safety issues involving cardiovascular and neurological products. In OHA, Dr. Parisian was required to review both prescription and over-the-counter labeling and promotions to determine the adequacy of instructions for use and warnings in relation to adequacy for the intended user populations. After moving to ODE, she continued to perform an additional 100 health risk assessments and trained medical officers as to the procedures for health risk assessment and health hazard evaluation. For FDA and post market surveillance, she participated with FDA's District Offices, Office of General Counsel, and the Office of Compliance in the review of manufacturing records, product complaints, adverse event reports, promotion and labeling obtained by FDA.
Dr. Parisian was the primary clinician involved in several of FDA's Major Corporate-Wide actions for which she received various citations and honors for her services for FDA, including Department of Health and Human Services and the Federal Government Employee of the Month. Dr. Parisian was sent by FDA as an official Agency representative to medical meetings and seminars to help identify and monitor medical device manufacturers and distributors for potential deviations from regulations governing promotional activities and labeling. At those interactions, she was required to provide official guidance as to the FDA's interpretation of Food and Drug Laws as they pertain to medical products and the role of manufacturers and health care providers.
One of her assigned responsibilities at FDA was to review the facts contained in product marketing applications, clinical trials, medical literature, animal toxicology, draft labeling, reports of post marketing experience in the United States and outside the United States, and available manufacturing documents and labeling that had been gathered by FDA or provided to FDA by the manufacturer or provided to FDA by another regulatory agency, and then to use the facts to make a clinical determination to a reasonable degree of medical certainty for FDA using the requirements and limitations of the FDCA as to the next course of action available to FDA to protect public health. Dr. Parisian was also required by FDA to advise and train other FDA employees regarding the facts of the case, the requirements or the Food, Drug and Cosmetic Act, and the clinical impact to the public. This was a process she was trained and required to perform for FDA. The health risk assessment process is described in 21 CFR 7 and is common to all FDA regulated products, drugs, devices, foods, biologics, and cosmetics.
During Dr. Parisian's tenure at FDA, she was involved as a medical officer with safety issues, physician warnings, labeling and Safety Alerts involving Combination Drug/Device products, a reviewing medical officer for Combination Biologics/Device products, and member of Interagency Working Committees.
After leaving FDA, and founding Medical Device Assistance, Inc., Dr. Parisian continued to provide information to individuals, manufacturers, and organizations outside FDA regarding FDA's requirements, Adverse Event Reporting, and OTC and prescription labeling of FDA-regulated products. In 1997, FDA requested she participate in a Panel of experts convened by FDA to comment on changes proposed in the requirements for medical device labeling. She continues to consult for manufacturers, lecture at conferences and seminars regarding FDA, premarket clearance, design of clinical trials and product labeling. She is also an online instructor for the Regulatory Professionals Association (RAPs). Dr. Parisian's activities with FDA regulated products have expanded to include drugs and biologies as well as pathology.
Dr. Parisian is the author of FDA Inside and Out, published May 2001, which is a book detailing the history and processes of all six centers of the FDA: food, drugs, biologics, animal products, cosmetic and National Toxicology Center. She is also a clinical instructor at the University of Arizona, College of Medicine, Phoenix Campus.
Defendant cannot dispute that Dr. Parisian is regarded as authoritative in the field of regulations, labeling and warnings as it relates to the FDA. Defendant would have this court believe that Dr. Parisian "has no professional experience applying FDA regulations to OTC drugs." See, Defendant's Motion at 9. This is simply untrue. In her report, Dr. Parisian states "[i]n OHA, I was required to review both prescription and over-the-counter labeling and promotions to determine the adequacy of instructions for use and warnings in relation to adequacy for the intended user populations." See, Parisian's Report at 2 attached as Exhibits 26-29 to Doc. No. 21. Furthermore, the health risk assessment process in which she was trained is common to all products regulated by FDA.
Defendant's motion should be denied as Defendant's improper attempt to restrict the jury's ability to learn about all information and facts relied upon by Dr. Parisian in providing her expert opinions. Dr. Parisian is a well-qualified individual who has vast experience in dealing with regulations, warnings and labeling as it relates to drug manufacturers. Her testimony will be both necessary and valuable in assisting the jury in understanding central issues in this case. Th
us, Defendant&#

39;s motion to strike Dr. Parisian's testimony must be denied.

II. UNDER DAUBERT, DR. PARISIAN'S TESTIMONY IS NOT ONLY RELEVANT BUT RELIABLE.

As set forth above, the Daubert standard requires the court to consider "'whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue."' Workman, 2007 U.S. Dist. LEXIS 97865, at *17 (quoting Daubert, 509 U.S. at 592).
Dr. Parisian's methodology is clearly stated within her report:
The procedure I have used to develop my opinions and prepare my expert report and declaration utilizes the same methodology and review process which I was trained to use for FDA to perform premarket, postmarket, clinical safety reviews and as well as health risk assessments. For 162 health risk assessments, I presided over a committee of FDA scientists drawn from all areas of the FDA, and after 1993, for an additional 100 health risk assessments, I was the only member of FDA involved in classification of public health risk. After 1993, as an FDA Chief Medical Officer, I became responsible for training other members of FDA in the process used to determine public health safety and risk.
The description of a health hazard evaluation for FDA-regulated products is 21 CFR 7.41. As FDA's medical reviewer, I made a determination based on scientific documentation, safety signals, and clinical training regarding any disease or injuries that could occur from the use of an FDA-regulated product. I made my determination to a reasonable degree of medical and regulatory certainty as to: 1) clinical conditions which could place humans at increased risk; 2) various subpopulations which may be placed at increased risk, for example, children, pregnant women, elderly, surgical patients; 3) degree of seriousness of the potential health hazard; 4) likelihood of occurrence of a risk; and 5) consequences, long-range and immediate, of the occurrence of the hazard.
See, Parisian's Report at 5-6. When considering the non-exhaustive factors identified in Daubert, it is clear that Dr. Parisian's methodology is sound. She has applied the training and methodology she not only learned, but also taught, at FDA. A methodology so reliable that it has been codified at 21 CFR 7.41.
This is precisely the type of case contemplated by the Fourth Circuit Court of Appeals in Wilson. The reliability of Dr. Parisian's testimony is primarily based upon her vast experience performing analysis similar to that which she performed in this case. Dr. Parisian's report in this case sets forth in great detail how her experience led to her conclusions, why that experience is sufficient basis for her opinion, and how her experience is reasonably applied to the facts present in this case. Dr. Parisian's testimony is reliable.
The majority of Fleet's motion is spent attacking the adequacy of Dr. Parisian's knowledge and the completeness of her methodology as it relates to the four basic opinions she has offered. These issues, however, go to the weight of the evidence rather than its admissibility. See, Humphries, 1999 U.S. App. LEXIS 25522, *14; Kudabeck, 338 F.3d at 861-62. Nonetheless, Plaintiffs will briefly address Fleet's argument relating to Dr. Parisian's four specific opinions.

1. Fleet recommended a dosing regimen for bowel cleansing to physicians for which it has no adequate safety support.

Dr. Parisian opines that Fleet recommended a dosing regimen for bowel cleansing to physicians for which it had no adequate safety support. See, Parisian's Report at 7-8. As a preliminary matter, this opinion has now been shown to be correct, i.e., FDA's action taken on December 11, 2008. Understandably, Fleet does not like this opinion and has attempted to attack it by discussing various issues – all of which go to the weight of Dr. Parisian's testimony rather than its admissibility.
First, Fleet points out that Dr. Parisian relies on a 2004 Tentative Final Monograph (TFM), which does not exist. Fleet is well aware that this was merely a typographical error as she stated in her deposition in another case:
Q. Can you direct me to a site for the 2004 tentative final monograph referenced in paragraph 25
A. I don't think — I think that is a typo. I think it should be the 1998 because I don't believe there is a 2004 tentative final monograph.
Next, Fleet argues that "Parisian attempts to substitute speculation for informed opinion when she suggests that when the FDA does finally issue a Final Monograph, Fleet will be barred from promoting the 2×45 mL professional use dosing to physicians." Defendant's Motion at 12. Dr. Parisian's opinion, however, has become fact. FDA informed Fleet that it will not include the 2×45 mL dosing regimen in any Final Monograph. See, letter from the FDA to Peter Reichertz, Esq. dated December 11, 2008, attached hereto as Exhibit 1. Further, FDA has warned consumers not to use Fleet Phospho-soda as a bowel cleanser. See, FDA Alert dated December 11, 2008 attached hereto as Exhibit 2. Indeed, any attempt by Fleet to offer an opinion to the contrary would now defy reality.
Fleet also insists that Dr. Parisian "fails to make any attempt to demonstrate that the specific risks relevant to Mr. Burk's use of FPS were not conveyed by Fleet to the medical community, including the doctors involved in Ms. [sic] Burk's treatment." Defendant's Motion at 12-13. Dr. Parisian's Report does, however, discuss the insufficiencies with regard to not only Fleet's failure to warn of the specific risks that Fleet knew could occur from using Fleet Phospho-soda, but also Fleet's failure to clearly convey the twelve-hour dosing regimen to physicians, a group that includes Mr. Burk's physician. See, Parisian's report at ¶¶ 19, 22-24, 27-32 and 36. Once again, Fleet's argument misses the point and goes to the weight to be afforded Dr. Parisian's opinion rather than its admissibility.

2. Fleet did not provide adequate warnings to physicians and patients about the risks of Fleet Phospho-soda.

Fleet argues that Dr. Parisian states in a "conclusory fashion that the inadequacy of Fleet's professional use warnings directly led to the injuries sustained by Mr. Burk." Defendant's Motion at 14. Fleet then points out that Dr. Parisian's report discusses a particular plaintiff from another case rather than Plaintiff Walter Burk. This is disingenuous. Pursuant to a standing agreement between counsel, certain expert reports, including that of Dr. Parisian, could be used in multiple cases. As such, the fact that Dr. Parisian's Report does not specifically discuss Mr. Burk is irrelevant. Furthermore, Dr. Parisian is a Board Certified in Anatomic and Clinical Pathology. Had Fleet truly wanted Dr. Parisian to analyze exactly how the inadequate warnings caused Walter Burk's injuries, it could have noticed her deposition. As stated earlier, Fleet had all opportunity to take Dr. Parisian's deposition, but clearly by design, chose not to do so, and instead opted to move to strike her testimony completely.
The fact is that Dr. Parisian has been deposed before and despite Fleet's statement that she "displays no knowledge of the potential causes of Mr. Burk's injury," see Defendant's Motion at 14, Dr. Parisian has laid out in detail how a chemical imbalance leading to injury can occur as a direct result of ingesting Fleet Phospho-soda:
What is it about that dosing regimen, 2 x 45 mL 10 to 12 hours apart is unsafe
A. Well, in terms of the 2 x 45 mL dosing what is unsafe, that is a big question. In terms of this type of a product one of the things you can create is a huge electrolyte shift in people. And you can change their fluid balance, particularly if you are dehydrated. In terms of people over 60, your renal function changes at 50. So you are talking about people with a reduced glomerular filtration rate, GFR rate. So you are talking about people that you are creating a massive electrolyte shift.
So that type of information is not being put forth in terms of the labeling. Physicians need to be concerned about these type of electrolyte shifts in patients. And the 2 x 45 mL has not been shown to be safe because of those electrolyte shifts. And that is why the FDA in '98 when they said they weren't going to approve that dose in such a short period of time, that was what their concern was. That in less than 24 hours if you give people a huge phosphate load in their GI trach, that you are going to create really large electrolyte imbalances.
Some patients can accept that. There are people that can have a large electrolyte imbalance. Say somebody who is perhaps 30 and has good kidney function, well hydrated, and they can take the shift. They can have changes in their electrolyte and their body can compensate, particularly phosphate. But in people who are older, after 50, starting to get around 60, that massive electrolyte shift can be a problem.
And so the issue is that this is a product that is over-the-counter. And Fleet has sold it with labeling that there are other opinions that we are going to discuss, that there is no real flag to tell a physician you need to watch out about the electrolyte shifts. And the issue is that the product is being used by GI doctors. This is a kidney problem. So it is a problem that may not even be noticed by the doctor who did the colonoscopy. Because when the person's kidneys shut down, maybe some people a week later or the next day or two weeks later, it may not be put together that the reason their kidney function had stopped is because of this huge electrolyte shift you have caused with the Fleet Phospho-soda.
So the first thing I would say is this tremendous electrolyte shift that you have created in certain patients that are not going to be able to handle that shift and compensate.
Q. And in terms of dealing with an electrolyte shift, can that be dealt with through proper hydration
MS. WHITE: Let me object. This is beyond the scope of her designation, but go ahead.
THE WITNESS: It is not just the electrolyte shift. It is also that you get these high phosphate levels in the kidney. So you can actually get injury directly to the kidney from the high phosphate load. And I am sure there is going to be probably nephrologists or pathologists talking about this.
But in terms of the mechanism, you create an electrolyte shift, yes, hydration helps on that. But you are not going to be able to address the phosphate injury that you can create in the kidneys. So there's other mechanisms. It is not just dehydration. It is not just that you are going to hydrate all people and they are going to be able to tolerate it if you give them adequate enough fluids. It is also the other mechanisms for creating the calcifications that you have in the kidneys and the phosphate. So it is a very complex scenario you have made in a very simple product that is supposed to only be used to get you ready to get a colonoscopy.
So it is in some ways by being an over-the-counter product without adequate labeling it is almost a wolf in sheep's clothing in that it looks like it is very innocuous, oh, it's Fleet's Phospho-soda, it's been around since the 1800s. But in reality it creates a tremendous change in each person's body who is receiving the product. And some bodies can tolerate that change better than others.
And the dosing is also very important. The space with which you give the person their time for their kidneys to recover, the 24 hours is crucial. Because if you only do it — if you dose products between six and 12 hours, you are not going to give that person's body time to compensate for the stress that you have put it under. So that is why the FDA repeatedly said yes, this dose is effective but where is the data to support that it is safe. And so that is what the issue is about this type of product. And that is the kind of information that physicians need to know before they prescribe it for patients. And that is the kind of — for my opinion that is the kind of information that is not being given to physicians to know how to prescribe it. And a GI physician is focused on getting a clean bowel. He may not think about the electrolyte shifts.
And also these people are also having general anesthesia, too, which has now changed the scenario. They are not allowed to have fluids after midnight. So you have changed the scenario. And so if you are going to offer it as a bowel prep product, you have to think about how can it be used safely in that type of a scenario. These patients after midnight are not going to have fluids as a rule. In terms of general anesthesia you can't have anything after midnight. So there is a lot of complexities here that are not being addressed that a physician needs to know about to determine whether this is the proper product for this patient or another product.
Fleet also argues that Dr. Parisian's opinions are based upon what she believes to be whether Fleet's behavior was moral or ethical. Defendant's Motion at 13. This is incorrect. Dr. Parisian's opinions are based upon Fleet's failure to comply with Good Manufacturing Practices and her vast experience in determining the adequacy of warnings. Thus, her opinion should not be stricken.

3. Fleet should have been aware of the potential risks for significant health consequences when it began to recommend the 2 x45 mL dose of Fleet Phospho-soda for bowel preparation.

Fleet seeks to exclude Dr. Parisian from testifying at trial because it believes that two of the studies that she cites in her report do not "fit" the facts of this case. Defendant's Motion at 14-16. Defendant argues that the Schneider study cited by Dr. Parisian does not "fit" because the "study did not address the effect of an acute phosphate load, similar to the dosages used for bowel cleansing, on humans." Defendant's Motion at 15. Fleet further argues that the Gonulsen study does not "fit" because it was published after Mr. Burk's ingestion of Fleet Phospho-soda in 2005. Defendant's Motion at 15.
Under F.R.C.P. 703 an expert may base their opinion upon facts or data, regardless of whether they are admissible, if "of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject." F.R.C.P. 703. As such, Dr. Parisian can rely on studies relating to Phospho-oda and adverse effects associated with ingestion of the Phospho-soda, even if such studies would not be admissible at trial. Further, Daubert does not render medical studies performed on animals as presumptively unreliable. See, United States v. Glover, 265 F.3d 337 (6th Cir. 2001). Moreover, Fleet's representatives themselves indicated that their "goal" was to dispute the nephrocalcinosis link with animal studies. See, email chain attached hereto as Exhibit 3. Remarkably, Fleet has now claimed / admitted that animal studies are insufficient.

4. Not only was it Dr. Parisian's opinion that Fleet had failed to demonstrate the safety and efficacy of two 45 or 30 mL doses over twelve hours reliable, but it is correct.

Defendant contends that Dr. Parisian's opinion that "'[t]here is no evidence' that Fleet has 'successfully demonstrate [sic] to FDA the safety and efficacy of administering two 45 mL or 30 mL doses over a twelve hour period for bowel cleansing as either a prescription or OTC product is merely speculation. See, Parisian's Report at 49. The accuracy of Dr. Parisian's opinion, however, was confirmed on December 11, 2008 when FDA informed Fleet that it would not include the double dose in the Final Monograph and that consumers should not use Fleet Phospho-soda as a bowel prep. See, Exhibits 1 and 2. What was also confirmed by FDA on December 11, 2008 was that Fleet's "expert" Robert Pinco who testified that the "FDA is on its way to agreeing the 2x 45 is generally recognized as safe and effective" was dead wrong. See portion of the deposition transcript of Robert Pinco, Esq., attached hereto as Exhibit 4. What cannot be overlooked by this Court is the fact that Fleet has never been able to show FDA that Phospho-soda was both safe and effective when used as a bowel cleanser and that Dr. Parisian's opinion is not just "not speculative", but it is correct.
For the reasons stated above, this Court should deny Defendant's Motion to Strike Plaintiffs' Expert Suzanne Parisian, M.D.