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Fleet’s Motion to Strike Dr. Suzanne Parisian’s Testimony

Posted in Misc. Drugs

This comes from the Phospho-Soda lawsuit Bracey v. Fleet.

Parisian's apparent last and fourth "opinion" is that "[t]here is no evidence that Fleet INDs have 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. See Exhibit "N", at ¶ 72. Parisian does not suggest that the FDA has acted on any studies submitted by Fleet since 1998 and found them deficient in any manner. Her opinion is no more than an observation that the FDA has all of this under advisement.
This opinion fails to offer any scientific analysis that requires expert testimony, is conclusory and usurps the role of the trier of fact. Thus, it should be excluded. See Reyes v. Wyeth Labs., 498 F.2d 1264, 1289 (5th Cir. 1974) ("Expert witnesses appear to assist in the court's decision-making process, not to control it.").
Dr. Parisian acknowledges elsewhere in her Report that FDA approved the prescription drug Visicol, which is a 90 mL equivalent of sodium phosphate in tablet form. The manufacturers of Visicol were permitted by FDA to rely on pre-existing studies based on oral sodium phosphates solution's "long history as a safe oral medication and grandfathered drug." See Exhibit "N", Parisian Report at ¶¶ 39, 45. Yet, Parisian chooses not to address her implicit opinion that the studies submitted to support Visicol's approval do not also demonstrate the safety of Phospho-soda. This contradictory, selective analysis is not helpful to the jury, is clearly unreliable and falls far short of permissible expert testimony.

C.B. Fleet Holding Company, Inc. and C.B. Fleet Company, Inc. ("Fleet"), defendants, through undersigned counsel, submit this memorandum in support of their Motion for the entry of an Order excluding the testimony of Plaintiffs' expert, Suzanne Parisian, M.D.

I. INTRODUCTION

Plaintiff Timothy Bracey, at the direction of his surgeon Dr. David Treen, ingested two 45 mL (1.5 fl. oz.) doses of Fleet(R) Phospho-soda(R) [FN1] (hereinafter, "Phospho-soda") in preparation for colon surgery on June 21, 2004. Plaintiff claims he sustained renal failure as a result of the Phospho-soda he took in accordance with written instructions provided to him by Dr. Treen [FN2].

FN1. Phospho-soda is an over-the-counter laxative for the relief of occasional constipation manufactured by defendant C.B. Fleet Company, Inc. The product also has a separate and distinct "professional use". As an over-the-counter product with a professional use, it is directed by or prescribed by doctors at typically higher doses than the consumer use, as part of a bowel cleansing regimen used in preparation for surgery, x-ray, colonoscopy, or other medical procedures.

FN2. Plaintiff did not rely upon any instructions, warnings or representations made by Fleet in taking the Phospho-soda in preparation for his surgery.

While Plaintiffs bring this action against Fleet pursuant to the Louisiana Products Liability Act ("LPLA"), the crux of Plaintiffs' allegations sound in failure to warn physicians or "professional users" who prescribe Phospho-soda as a bowel purgative prior to medical procedures, such as the surgery at issue in this case. [FN3]

FN3. Plaintiffs also claim that Phospho-soda was defectively designed but fail to offer any evidence or identify any expert to support this claim.

Fleet Phospho-soda is an over-the-counter (hereinafter, "OTC") laxative product that also has a separate and distinct use as a bowel cleanser subject to professional labeling. The Food and Drug Administration ("FDA") requires that such professional labeling is only to be directed toward physicians or other healthcare specialists for use in their bowel cleansing regimens as they deem fit. While the FDA has yet to issue a Final Rule regarding professional dosing instructions, Fleet has continued to adhere to the Tentative Final Monograph (hereinafter, "TFM") by providing healthcare providers with warnings in the Physician's Desk Reference ("PDR"), on its website, through information provided in the mail and other professional labeling. See 50 Fed. Reg. 2124 (Jan. 15, 1985); Exhibit "A"; Exhibit "F".

Suzanne Parisian, M.D. has been ostensibly disclosed to opine on Fleet's regulatory status and the warnings provided to physicians and consumers. In short, Dr. Parisian is not qualified to testify in this case. While Dr. Parisian spent four years at FDA dealing with medical devices, she has no experience with pharmaceutical drug safety or labeling. Her training and experience is limited to medical devices, which does not translate into expertise in pharmaceutical products. See Exhibit "N", Parisian Report at ¶ 15.

Dr. Parisian's report seemingly offers "four opinions" that generally focus on Fleet's warnings, dosing and marketing of Phospho-soda for use as a bowel cleanser, although she also appears to offer an opinion that the labeling and warnings directly caused Plaintiff's injuries. While the expert report goes on for over 100-pages, it is nearly impossible to capture what Dr. Parisian's opinions are in this case as a general matter or how these opinions impact on any liability issue. Moreover, she articulates no methodology throughout her disordered and lengthy expert report, and offers no support for her contentions. This renders her opinions unreliable, and not suitable for expert testimony. See Hopkins v. NCR Corp., 1994 U.S. Dist. LEXIS 17273, at *47-48 (D. La. 1994) ("If the expert evidence submitted is not reliable, it should not be accepted as admissible evidence.")

A. Regulatory History

Fleet Phospho-soda occupies a somewhat unique regulatory status among pharmaceutical products: it is an OTC laxative product that also has a professional use indication for bowel cleansing. It has been used since 1893 for relief of occasional constipation. The recommended adult dose for laxative use is 20 to 45 mL. The OTC label, as required by 21 C.F.R. § 201.307, specifically states that consumers are not to use more than 45 mL (1.5 ounces) in a 24 hour period: "Do not use more unless directed by a doctor." Id.

In 1985, a tentative final monograph (hereinafter, "TFM") was published by FDA for OTC laxative products. This proposed rule contained a "professional labeling" section, for labeling which was to be "provided to health professionals (but not to the general public)." 50 Fed. Reg. 2124,2157 (Jan. 15, 1985). The FDA reiterated this position in 1998, specifically directing that the contraindications, precautions and other warnings contained in the professional labeling be directed to health care professionals only, and that professional use warnings are not to be placed on the consumer packaging:

The agency notes that the comment stated that a summarized version of the professional labeling will appear on the product's retail package. Professional labeling is labeling provided to health professionals but not to the general public. Therefore, a summarized version of this professional labeling should not appear on the retail package.

63 Fed. Reg. 27886, 27888 (May 21, 1998). In accordance with the FDA directive, Fleet did not place warnings regarding the use of its product as a bowel cleanser on the Phospho-soda package. Fleet published its professional labeling in the Physician's Desk Reference for prescription drugs ("PDR"), attended conferences circulating professional labeling, and medical literature, distributed "Dear Doctor" letters and provided information on the healthcare provider side of its website. See Exhibit "A"; Exhibit "F".

In 1993, Fleet submitted a Citizen's Petition to the FDA requesting an amendment to the TFM to include a two x 45 mL dose within the professional labeling directed to physicians. See "B". The FDA responded in March, 1996 by stating that, while studies demonstrate the efficacy of two 45 mL doses separated by 10 to 12 hours, there was insufficient data to determine that the dosing regimen was generally recognized as safe. The Agency suggested that this dosing regimen may be suitable for professional labeling only, and invited Fleet to submit additional safety data in connection with a Citizen's Petition to add the dosing regimen to the professional labeling section of the Monograph when finalized. See Exhibit "C", at pg. 11.

The FDA issued a final rule limiting container size of OTC laxatives to 90 mL (3.0 fl. oz.) in response to reports of adverse events due to overdosage. See 63 Fed. Reg. 27836 (May 21, 1998). The FDA also required the consumer product label to state that "taking more than the recommended dose [45mL] in 24 hours can be harmful" and "Do not use more unless directed by a doctor." See id.

On the same day, the proposed rule to amend the TFM for consumer labeling and professional labeling to be directed toward physicians only was published. The proposed professional labeling did not include a maximum dose a physician was to use for such prescribed use of the product See 63 Fed. Reg. 27886 (May 21, 1998). The proposed professional labeling was subsequently withdrawn by the FDA in December, 1998, with the intention to re-propose it at a later time. See 63 Fed. Reg. 67817 (Dec. 9, 1998). To date, FDA has not re-proposed a TFM to include professional labeling and there is no Final Monograph for OTC laxatives other than the final rules noted herein that the FDA did promulgate. Consequently, there is no binding indication as to what professional use dosing is permitted.

In September 2001, FDA published a Science Background Paper on the safety of oral sodium phosphate solution. The Agency advised that serious electrolyte disturbances had been reported in connection with the use of the product, usually at more than 45 mL during a 24-hour period. In contraindicated or at-risk patients, [FN4] electrolyte shifts could result in symptomatic dehydration, renal failure, metabolic acidosis, tetany and death. See Exhibit "D".

FN4. Those "at risk" included patients with congestive heart failure, ascites, renal insufficiency, dehydration, debility, gastrointestinal obstruction, gastric retention, bowel perforation, colitis, megacolon, ileus, inability to take adequate oral fluid, taking diuretics or other medications that affect electrolytes. See Exhibit "D".

The FDA's information was echoed in a May, 2002 Dear Healthcare Provider letter voluntarily communicated by Fleet. Fleet stated that Phospho-soda can be safely and effectively used as a bowel-cleansing agent, and warned against use in contraindicated patients, and to use with caution in at-risk patients. In accordance with the FDA warning, Fleet advised physicians:

• Fleet Phospho-soda should not be used in patients with: Megacolon, Kidney Disease, Congestive Heart Disease, Bowel Obstruction(s), or Ascites.

• Fleet Phospho-soda should be used with caution in patients with: Impaired Renal Function, Heart Disease/Failure, Acute Myocardial Infarction, Unstable Angina, Pre-existing Electrolyte Disturbance or Increased Risk of Electrolyte Disturbance; and in patients taking drugs that prolong the QT interval.

• Patients with an increased risk of electrolyte disturbance include those with: Gastrointestinal Obstruction, Gastric Retention, Bowel Perforation, Colitis, or Ileus; or who are: Dehydrated, Debilitated, unable to take adequate fluid, or taking diuretics or other medications that affect electrolytes.

See Exhibit "F" (emphasis in original). Finally, Fleet explained that, in all patients, it is important to recommend additional clear fluids by mouth to prevent dehydration.

Importantly, Fleet specifically noted that electrolyte disturbances are more likely to occur where more than 45 mL (1.5 fl. oz.) of the product is taken in less than a 24-hour period. These shifts can result in "acidosis, tetany, cardiac arrhythmias, dehydration, renal failure, hypovolemia, and, in rare cases, death in patients in whom the use of oral sodium phosphates is contraindicated or in patients at-risk." See Exhibit "F" (emphasis in original). Moreover, Fleet stated that the reported serious adverse experience rate was 1.5 per million doses sold between 1991 and 2001, and while this is a very low rate, in general it is known that adverse events are underreported. See Exhibit "F".

A primary method of communicating warnings to physicians is through the PDR. Fleet voluntarily submits professional labeling and dosing information in this publication. See Exhibit "A". The pertinent warnings in effect prior to Mr. Bracey's surgery are as follows:

Do not use in patients with megacolon, gastrointestinal obstruction, ascites, congestive heart failure, kidney disease or in children under 5 years of age;

Use with caution in patients with impaired renal function, heart disease, acute myocardial infarction, unstable angina, pre-existing electrolyte disturbances, increased risk for electrolyte disturbances (e.g., dehydration, gastric retention, bowel perforation, colitis, ileus, inability to take adequate oral fluid, concomitant use of diuretics or other medications that affect electrolytes), with debilitated or elderly patients or with patients who are taking medications known to prolong the QT interval.

In at risk patients, including elderly patients, consider obtaining baseline and post-treatment sodium, potassium, calcium, chloride, bicarbonate, phosphate, blood urea nitrogen and creatinine values, and consider using the lower end of the dosage range.

There is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium; consequently hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia, and acidosis may occur.

Additional fluids by mouth are recommended with all bowel cleansing dosages. See Exhibit "A" (emphasis added); see also Oliveira, Mechanical Bowel Preparation for Elective Colorectal Surgery: A Prospective. Randomized, Surgeon-Blinded Trial Comparing Sodium Phosphate and Polyethylene Glycol-Based Oral Lavage Solutions. Dis Colon Rectum, 40(5):585-591 (May 1997).

In March, 2003, Fleet was contacted by Dr. Glen Markowitz, a nephropathologist associated with Columbia College of Physicians & Surgeons, who reported a new finding of five cases of calcium phosphate deposition or "nephrocalcinosis" in the tubules of the kidneys on biopsies of patients with recent history of colonoscopy preceded by sodium phosphate. In response, Fleet endeavored to meet with Dr. Markowitz and his colleagues to discuss these findings and further investigate the purported association between Phospho-soda and renal complications. See Exhibit "G", at pgs. 136-37.

Fleet submitted the information learned through Dr. Markowitz and subsequent investigation to the FDA, and requested a meeting to discuss these findings in November and December, 2003. See Exhibit "H"; Exhibit "I". The FDA granted this request, and Fleet met with representatives from the Division of Gastrointestinal and Coagulation Drug Products, and the Division of Over the Counter Products on January 14,2004. The cases of nephrocalcinosis5 were presented along with information Fleet had obtained through a commissioned world-wide epidemiological study illustrating the very low adverse event rate. Fleet also presented its on-going and future clinical studies, both human and animal, and specifically asked for the FDA's input as to its plan and further investigation. See Exhibit "J".

FN5. Nephrocalcinosis in this context is now more typically referred to as "Acute Phosphate Nephropathy" (hereinafter, "APhN") and the terms are used interchangeably.

The June, 2004 professional labeling was appropriate to warn of potential risks involved in ingesting Phospho-soda. Fleet had regularly updated and clarified its Phospho-soda labeling as knowledge of potential adverse events expanded and as evidence of potential misreading of instructions, accidental abuse or misuse of the product warranted. See Exhibit "P", Jones Report at pg. 15. Bowel preparation by their nature induce diarrhea, therefore physicians are aware of the potential for dehydration. Additionally, there is a risk of dehydration particularly in cases as in this one where the patient is anesthetized for a long period of time as part of a surgical procedure. See Exhibit "Q", Wishner Report at pg. 3. Finally, as plaintiffs treating physician Dr. Treen testified, he was aware of the risks, particularly dehydration, which is a known risk. See Exhibit "U", at pgs 71- 72.

B. Pertinent Medical History

Plaintiff Timothy Bracey is a 51 year-old man with a medical history of significant heart disease, including aortic stenosis, aortic insufficiency and Wolff-Parkinson-White syndrome. On February 2, 2004, plaintiff was diagnosed with acute diverticulitis with a perforated colon. See Exhibit "K", at Bates 214. Plaintiff underwent a partial colectomy and a diversion colostomy and had a somewhat complicated post-operative course. See Exhibit "K", at Bates 35, 56 and 408-409.

After a few months of recuperation, the June 22,2004 surgical colostomy reversal at issue in this case was scheduled. Prior to this surgery Plaintiff was referred for a colonoscopy to ensure the colon was prepared to withstand the procedure. See Exhibit "T", at pg. 51. Gastroenterologist Dr. Rian Tanenbaum conducted a pre-colonoscopy physical examination and the colonoscopy was performed by his partner on June 14, 2004. See Exhibit "L", at Bates 14. Prior to undergoing the colonoscopy, Plaintiff was directed by Dr. Tanenbaum to use Fleet Phospho-soda as a bowel cleanser to prepare the bowel for the procedure by removing fecal matter from the colon. The bowel preparation instructions provided to Plaintiff directed that 90 mL6 of Fleet Phospho-soda split in two 45 mL doses, separated by three hours and followed by eight ounces of water. Additionally, the patient was instructed to take two bisacodyl – or Dulcolax – tablets. [FN7] See Exhibit "V". The colonoscopy was normal, the procedure was uncomplicated by any untoward event and Plaintiff was cleared for the surgical colostomy reversal. See Exhibit "L", at Bates 7.

FN6. 90 mLs is equivalent to 3.0 fl. oz.; 45 mLs is equivalent to 1.5 fl. oz.

FN7. Notably, the bowel preparation instructions provided to Plaintiff by his physician did not remotely comport with any Fleet recommended instructions.

Plaintiff was scheduled to undergo colostomy reversal just one week later, on June 21,2004. Pre-operative labs from June 15,2004 noted the high-normal creatinine of 1.2. See Exhibit "K", at Bates 154. Another bowel cleansing was required prior to this surgery. This time, the bowel preparation instructions provided by Dr. Treen instructed that two 1 1/2 fl oz. of Fleet Phospho-soda be taken in separated by five hours in the afternoon the day before the procedure. Each dose was to be followed by eight ounces of clear liquid, and an additional three glasses of clear liquid prior to midnight. [FN8] See Exhibit "W".

FN8. While the hydration indicated by Dr. Treen's instructions are similar to Fleet recommended dosing, Fleet did not recommend dosing intervals of less than six hours for any professional use. Moreover, in 2004, when requested, Fleet provided physicians with bowel preparation instruction sheets indicating that the two doses be split between ten and twelve hours a part. Fleet has not specifically recommended a surgical bowel cleansing dose.

During and immediately following the operation, Plaintiff experienced over twelve hours, possibly up to 24-hours, of sustained and unaddressed hypotension and hypovolemia [FN9] because of inadequate fluid replacement and management beginning pre-surgery, as well as blood loss during and after the surgery. See Exhibit "M", Carey Report at 1-2; Exhibit "R", at pg. 23. Laboratory findings the day after surgery revealed, among other abnormalities, an elevated creatinine [FN10] and Plaintiff was diagnosed with acute renal failure as a result of this hypotension and hypovolemia.

FN9. Hypotension refers to abnormally low blood pressure that if not aggressively treated may lead to hypovolemia or reduced blood flow to critical organs including the kidneys.

FN10. Creatinine, a breakdown product of muscle, is measured in the blood to determine proper kidney function. An elevated creatinine may reveal that kidney function has decreased or is otherwise abnormal.

Plaintiff was eventually treated with fluids to replace the volume loss and raise his blood pressure. Blood transfusions were required due to significant blood loss during the procedure as well as bleeding from continued post-operative diarrhea. See Exhibit "K", at Bates 56. Although Plaintiff was suffering from acute renal failure, the ACE-I and NSAID, drugs known to hasten the effects of renal failure, were continued until consulting nephrologist, Dr. Miguel Molina, ordered them to be held in light of the Plaintiff's condition.

During this hospital course, Plaintiffs' treating nephrologists diagnosed acute tubular necrosis ("ATN") secondary to hypotension and hypovolemia (loss of blood volume), exacerbated by an ACE-I (Lisinopril) and NSAIDs (Arthrotec and Voltaren). See Exhibit "K", at Bates 40,45,54-56; Exhibit "R", at pg. 81-82. His creatinine peaked at 4.9 on June 28, 2004 and steadily decreased to a current range of 1.7 to 2.1. See Exhibit "K", at Bates 154.

Qualified medical experts for the defense have submitted reports supporting Plaintiffs' own treating physicians' conclusions, that Plaintiff sustained renal failure as a result of a significant bout of ATN. The risk of such renal failure is not specific to any one bowel cleansing regimen prior to surgery. Indeed, as indicated by the hospital chart and Plaintiffs' own physicians, significant volume depletion with the presentation of pre-surgical diarrhea from any bowel preparation, fasting prior to surgery, the effects of anesthesia, hypotension, hypovolemia in the setting of significant abdominal surgery together with Plaintiff's medical history, put the Plaintiff had a heightened risk of developing acute renal failure. Against this backdrop, Plaintiff progressed to mild chronic renal failure and it is clear from both clinical and experimental data that complete recovery of renal function following ATN does not always occur. See Exhibit "M", Carey Report.

III. ARGUMENT

A. Plaintiffs Bear The Burden Of Establishing Admissibility Under Daubert

District courts have broad discretion to exclude improper expert testimony under Daubert v. Merrill Dow Pharms., Inc., 509 U.S. 579 (1993) and Rule 702 of the Federal Rules of Evidence. See Pipitone v. Biomatrix, Inc., 288 F.3d 239.244-45 (5th Cir. 2002). The proponent of expert testimony bears the burden of establishing admissibility by a preponderance of the evidence. See Bouriaily v. United States, 483 U.S. 171, 175-76 (1987); Nugent v. Hercules Offshore Corp., 2000 U.S. Dist. LEXIS 5082, at *5 (E.D. La. Apr. 14,2000). The trial court acts as a gatekeeper to ensure that the scientific evidence is valid and relevant. See Knight v. Kirby Inland Marine. Inc., 482 F.3d 347,355 (5th Cir. 2007); In re Vioxx Products Liability Litigation, 414 F. Supp. 2d 574, 580 (E.D. La. 2006); Wilson v. Woods, 163 F.3d 935, 937 (5th Cir. 1999).
Rule 702 governs the admissibility of expert testimony. It 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 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.
Fed. R. Evid. 702 (2007). In Daubert, the Supreme Court identified non-dispositive factors to aid this analysis:
(1) whether a theory has been or can be tested or falsified; (2) whether the theory or technique has been subject to peer review and publication; (3) whether there are known or potential rates of error with regard to specific techniques; and (4) whether the theory or approach has "general acceptance."
Daubert. 509 U.S. at 593-94.
"The focus of the Daubert inquiry should be on the methodology used, not on the conclusions reached." Walker v. Yellow Freight Sys., Inc., 1999 U.S. Dist. LEXIS 15012, at *18 (E.D. La. 1999). Any analytical gap can be a sufficient basis to exclude testimony. See In re: Vioxx Products Liability Litigation, 414 F. Supp. 2d 574,579 (E.D. La. 2006). Consequently, a step in the expert's analysis that renders the opinion unreliable – whether that step changes a methodology or misapplies the methodology – causes that testimony to be inadmissible. See Curtis. 174 F.3d at 670-71 (quoting In re: Paoli R.R. Yard PCB Litigation. 35 F.3d 717, 745 (3d Cir. 1994)); Chambers v. Exxon Corp., 661 F. Supp. 2d 661, 663 (M.D. La. 2000) aff'd 247 F.3d 240 (5th Cir. 2001). "[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert." General Elec. Co. v. Joiner. 522 U.S. 136, 146 (1997); Moore v. Ashland Chemical Inc., 151 F.3d 269, 277 (5th Cir. 1998); Black v. Food Lion. Inc., 171 F.3d 308, 311 (5th Cir. 1999) (quoting Kumho Tire v. Carmichael. 526 U.S. 137, 157 (1999)).
Beyond proper qualifications and reliability, the proffered expert's testimony must be helpful to the trier of fact. In other words, the testimony must "fit" the facts of the case and not usurp the jury's primary role as evaluator of evidence. See Daubert. 509 U.S. at 591; Kirkland v. Marriott Int'l Inc., 416 F. Supp. 2d 480, 483 (E.D. La. 2006); Nugent. 2000 U.S. Dist. LEXIS 5082, at *7. The Fifth Circuit has articulated additional factors which are applicable to pharmaceutical products:
(1) whether the expert's opinion is based on incomplete or inaccurate dosage or duration data; (2) whether the expert has identified the specific mechanism by which the drug supposedly causes the alleged disease; (3) whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion; (4) whether the expert has adequately accounted for alternative explanations; and (5) whether the expert proposes to testify about matters growing directly out of research he or she has conducted independent of the litigation.
In re Vioxx Products Liability Litigation. 414 F. Supp. 2d at 579.
Fleet submits for all the reasons that follow that Dr. Parisian's Expert Report fails to meet the requirements set forth by Rule 702 and Daubert. See Nugent, 2000 U.S. Dist LEXIS 5082, at *18. Accordingly, her testimony should be excluded.

B. Dr. Parisian is Not Qualified to Render An Opinion in this Matter

Plaintiffs have proffered Dr. Parisian to testify on FDA OTC drug regulation, warnings, labeling and causation. As demonstrated herein, she is completely unqualified to render any of the opinions she attempts to set forth in her report. Under Rule 702, an expert must possess sufficient "knowledge, skill, experience, training or education" in order to present admissible opinions. Fed. R. Evid. 702 (2007). When testimony is presented by an unqualified expert, it must be excluded. See Mahonev v. Pilgrim's Pride Corp., 2007 U.S. Dist. LEXIS 1678, at *2 (W.D. La. Jan. 9, 2007).

1. Dr. Parisian is Not Qualified to Offer and Opinion Concerning FDA OTC Regulations

Plaintiffs have failed to establish Parisian's expertise in pharmaceutical products, much less OTC drug regulation. While she earned a medical degree in 1978, she has not practiced medicine for over 15 years. According to her Curriculum Vitae, she served at the Center for Devices and Radiological Health (hereinafter, "CDRH") and the Armed Forces Institute of Pathology, Office of the Medical Examiner between 1991 and 1995. Since 1995, she has operated Medical Device Assistance, Inc., which primarily serves Plaintiffs' counsel in litigation support. See Exhibit "N", Parisian Report at ¶¶ 1-15.
Although Dr. Parisian may have experience in FDA's regulation of medical devices, she does not have any non-litigation, professional or practical experience regarding the regulation of OTC drugs at the FDA or elsewhere. Her four years of employment at the FDA were restricted to the CDRH. In contrast, regulation of drugs – including OTC drugs – within the FDA is handled by the Center for Drug Evaluation and Research ("CDER"). She has no professional experience applying FDA regulations to OTC drugs. See Lillebo v. Zimmer, 2005 U.S. Dist. LEXIS 2563, at * 12-13 (D. Minn. Feb. 16, 2005) (stating, "Parisian is a pathologist who spent nearly four years working for the FDA. Her first two years were spent advising the FDA on health risks presented to patients by medical devices and providing clinical support on medical device issues … Her last two years were spent reviewing premarket activities and applications for medical devices").
Under the FDA structure, experience under one Center does not translate into expertise of another. See Richard Merrill, FDA Regulatory Requirements as Tort Standards. 12 J.L. & POL'Y 549, 555 (2003) (stating, Medical devices … are subject to a different set of regulating requirements than applies to drugs"). To the extent she claims to have some incidental experience with OTC drugs at the FDA, incidental experience is insufficient to qualify her as an expert. See In re: Diet Drugs Products Liability Litigation. 2001 U.S. Dist. LEXIS 1174, at *21 (E.D. Pa. Feb. 1, 2001).

2. Dr. Parisian is Not Qualified to Offer an Opinion Concerning Adequacy of Warnings or Labeling

Moreover, Parisian is not a gastroenterologist or other physician who utilizes bowel purgatives in preparation for medical procedures, and is wholly unqualified to provide an opinion as to the risk/benefit analysis such physicians undertake before prescribing such products. As a non- practicing physician who never practiced internal medicine, a sub-specialty or surgery, she cannot provide any informed opinion as to the adequacy of Fleet labeling from the actual standpoint and knowledge of the physicians using the products. She is therefore unqualified to form a reliable opinion as to the dosing, labeling or warnings appropriate for Phospho-soda. In re Diet Drugs. 2001 U.S. Dist. LEXIS 1174, at *27-28 (disqualifying plaintiffs expert regarding accuracy of warnings labels, the medical significance of adverse event reports, and the drug's risks, as he had no experience in the pertinent specialties of cardiology, pathology, pulmonology or toxicology). Physicians are not entitled to a blanket qualification for medically-related testimony. See Alexander v. Smith & Nephew. P.L.C., 98 F. Supp. 1276, 1281 (N.D. Okla. 2000).
Dr. Parisian, while arguably an expert in the field of medical devices, cannot be held out to be an expert in the field of drugs. Therefore, her expert opinion must be excluded in this case.

C. Dr. Parisian's Opinions are Not Reliable and Must be Excluded under Daubert [FN11]

FN11. Any discussion of Parisian's expert opinions is seriously hampered by the extraordinary length of the opinion (almost 140 pages to convey 4 opinions), as well as the repetitive and confusing structure of it.

1. Opinion #1 on Dosing and Warnings is Unreliable

In her first opinion, Dr. Parisian appears to fault Fleet for recommending to physicians a dosing regimen for bowel cleansing that has no adequate support for safety. She goes on to state that Fleet "has failed to adhere in its marketing, OTC and professional labeling and promotions, to the dosing regimen for Phospho-soda specified in FDA's 2004 Tentative Final Monograph (TFM) for GRASE Oral Sodium Phosphate Laxative for bowel preparation." There are two fundamental problems with Parisian's opinion.
First, she focuses on the recommended dosing that Fleet shares with physicians who are using the product for bowel cleansing in preparation for colonoscopy, and ignores the fact that this use of the product was for bowel cleansing in advance of a surgical procedure, not colonoscopy. Fleet does not make any specific recommendation with respect to dosing in such circumstances. Moreover, there is no suggestion in the record that plaintiff's physicians relied on any dosing recommendation from Fleet. Indeed, the directions that they provided to plaintiff in the use of this product bore little resemblance to any recommendations on dosing from Fleet.
As discussed in part III.B., supra, Parisian is not a gastroenterologist and is not qualified to opine on what a gastroenterologist requires to be fully informed about a particular drug. Importantly, Dr. Parisian does not articulate how the 2004 PDR, Dear Doctor Letters and other labeling information were inadequate to warn a gastroenterologist. Her statements regarding Fleet's alleged failure to provide adequate labeling, warnings, dosing instructions, methods for rehydration and conveyance of health risks are entirely unconnected to the facts of this case. She fails to make any attempt to demonstrate that the specific risks relevant to Mr. Bracey's use of Phospho-soda were not conveyed by Fleet to the medical community, including the doctors involved in Mr. Bracey's treatment. Without this conceptual nexus, her opinions are meaningless and should not be admitted.
Second, there is no such document titled "FDA's 2004 Tentative Final Monograph." See Exhibit "O", Pinco Report at ¶ 45. There was a Tentative Final Monograph published by the FDA in 1985, and amended in 1998, but the TFM does not contain any restrictions on dosing for professional use. Parisian implies and insinuates that Fleet has acted improperly in promoting the professional use of two doses of 45 mL of Phospho-soda within a 24-hour period, even though such dosing is at the express direction of a doctor. However, the FDA is and was fully aware that physicians prescribed, and continue to prescribe, Phospho-soda for bowel cleansing using a two x 45 mL dose. In September 2001 and May 2006, the FDA issued "Backgrounders" pertaining to Phospho-soda and did not prohibit the professional dosing or limit Fleet's ability to provide information to healthcare providers on the use Phospho-soda for bowel cleansing. See Exhibit "D"; Exhibit "E". It was and is within the FDA's authority to reclassify Phospho-soda as a prescription drug or prohibit dosing in excess of the OTC laxative labeling, but the Agency has not done so. See Exhibit "O", Pinco Report at ¶ 40; 21 U.S.C. § 352 (authorizing the FDA to deem drugs misbranded).
Parisian's opinion is not based on an interpretation of FDA regulations or on experience applying the regulations to OTC drugs. She acknowledges that there are no regulations concerning OTC professional labeling, and that FDA does not mandate prior approval of professional labeling for OTC drugs. See Exhibit "N", Parisian Report at ¶ 18-19, 54. Indeed, she fails to state how Fleet has contravened any laws, rules or regulations. In fact, OTC manufacturers are only bound legally by a final monograph, not a tentative final monograph. See Exhibit "O", Pinco Report at ¶ 45; See 50 Fed. Reg. 2124,2125 (Jan. 15, 1985) (notifying that the conditions addressed in the monograph become effective 12 months following publication of the final monograph in the federal register).
Dr. Parisian acknowledges that FDA has not issued a Final Monograph. See, e.g., Exhibit "N", Parisian Report at ¶ 25. In any event, as Mr. Pinco states, Fleet has adhered to the requirements of the 1998 TFM, including the direction that "a summarized version of th[e] professional labeling should not appear on the retail package." See Exhibit "O", at ¶¶ 33, 45; 63 Fed. Reg. 27886, 27888 (May 21, 1998); see also 50 Fed. Reg. 2124, 2157 (Jan. 15, 1985). She 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 x 45 mL professional use dosing to physicians. This very suggestion underscores the flaws in her "analysis" for it demonstrates that there is currently no legal impediment to the professional use of 2 x 45 mL of Phospho-soda. Whether that remains true at some point in the future is a matter to be decided by the FDA, not Parisian. Accordingly, her "opinion" on this point is without scientific basis and should be excluded. See In re: Meridia Products Liability Litigation. 328 F. Supp. 2d 791, 806 (N.D. Ohio 2004) ("[t]he more subjective an expert's inquiry, the more likely the testimony should be excluded as unreliable.").
In fact, Dr. Parisian's lengthy report and testimony is littered with irrelevant information, which should be excluded by the Court. Dr. Parisian refers to the warnings provided with other sodium phosphate products, Visicol and OsmoPrep. See Exhibit "N", Parisian Report at ¶¶ 46-49, Visicol and OsmoPrep are prescription drugs, subject to different regulations and FDA oversight. Dr. Parisian cannot demonstrate how her discussion of these two products "fits" into the case, involving as it does a different product. Daubert. 509 U.S. at 591.
Similarly, Dr. Parisian's discussions within "Opinion #1" of the following: (1) Fleet AccuPrep, (2) Phospho-soda's "grandfathered" status, and (3) the conduct of foreign agencies. See Exhibit "N", Parisian Report at ¶¶ 20-33; 38. Plaintiff did not use AccuPrep, thus it is wholly irrelevant. Moreover, Fleet has no duty to advise healthcare professionals that Phospho-soda is a "grandfathered" drug. To the extent Dr. Parisian insinuates that Fleet has attempted to circumvent FDA requirements or requests based on the fact that it has a "grandfathered" status, she fails to put forth any evidence. Lastly, Fleet is not required to adhere to the requirements of foreign regulatory entities. The FDA has never required notices such as those provided by the Canadian and Australian regulatory agencies.
The opinions collectively grouped as Parisian's Opinion #1 are unsupported, and consist of her personal, subjective beliefs. This kind of testimony is unreliable under Daubert. and should be excluded. See Nugent. 2000 U.S. Dist LEXIS 5082, at *5 ("The aim is to prevent expert testimony based merely on subjective belief or unsupported speculation."); Kirkland v. Marriott Int'l. Inc., 416 F. Supp. 2d 480,483 (E.D. La. 2006) (noting that Daubert aims to exclude expert testimony based merely on subjective belief or unsupported speculation).

2. Opinion #2 on Marketing and Corporate Intent is Inadmissible

Dr. Parisian's second opinion focuses on allegedly unethical marketing practices by Fleet insofar as Fleet is alleged to have provided inadequate warnings to consumers or physicians on the appropriate use of Phospho-soda. See Exhibit "N", Parisian Report at ¶¶ 51-58. She again implies that Fleet has somehow acted inappropriately by marketing this OTC product for professional use in the absence of a final monograph. This, she contends, has been possible due to a "unique favorable regulatory set of circumstances." See id. ¶ 51. Further, she believes that because of the regulatory status of the product, Fleet has sought to gain market-share while failing to perform adequate testing.
To the extent that the Opinion No.2 is duplicative of Opinion No. 1, it is inadmissible for the same reasons, which are incorporated herein by reference. OTC drug manufacturers, such as Fleet, are permitted to market and sell products prior to issuance of a Final Monograph. See Exhibit "O", Pinco Report, at ¶ 30-32.
Parisian states in conclusory fashion that the inadequacy of Fleet's professional use warnings directly led to the injuries sustained by Bracey. She does not address Bracey's condition before, during or after the procedure at issue in this litigation, and displays no knowledge of the potential causes of Bracey's injury. [FN12] She similarly utterly fails to demonstrate what information Fleet should have conveyed to Bracey's doctors that would have been sufficient to avoid Bracey's injury. This opinion is particularly inappropriate insofar as Bracey's doctors have testified as to their awareness of the risks that Parisian claims were not conveyed by Fleet. Parisian claims that Fleet has failed to perform any adequate testing of the appropriate dosing of Phospho-soda, yet she does not mention or evaluate the numerous studies that have been submitted by Fleet to the FDA since 1998. Instead, she attempts to substitute her judgment for the judgment of the FDA. As Mr. Pinco has noted in his opinion, had the FDA believed that the warnings provided were inadequate, it would have taken action by reclassifying sodium phosphate as a Category III (insufficient data) ingredient. See Exhibit "O", Pinco Report at ¶¶ 24-28; 40- 41.

FN12. Fleet hereby incorporates by reference the Motion In Limine to Exclude the Expert Opinion of Dr. Brown, filed this same date

Moreover, Fleet's state of mind and motives underlying its business decisions are outside the scope of expert testimony and should be excluded as speculative. For example, she states that Fleet provided inadequate warnings "in an attempt to gain the colonoscopy preparation market share as an OTC product" and "instituted a complex multi-tiered marketing strategy" that failed to provide "full disclosure of information that would allow [physicians and consumers] to make an informed determination regarding risk vs. benefit…." See Exhibit "N", Parisian Report at ¶¶ 51-53. These personal opinions concerning her view of what behavior is moral or ethical are not admissible. See In re Baycol Products Litigation. 495 F. Supp. 2d 977, 1001 (D. Minn. 2007) (finding that "[p]ersonal views on corporation ethics and morality are not expert opinions" and excluding an expert from testifying about his "personal views as to whether Bayer acted ethically, irresponsibly or recklessly").

3. Opinion #3 on Renal Studies Does Not "Fit" this Case

As her Opinion No. 3, Parisian contends that Fleet should have predicted what Dr. Markowitz and his colleagues discovered in 2003, that calcium-phosphate deposition can occur upon an isolated load of an oral sodium phosphate based laxative, even though there had been no case reports to support such knowledge over the prior 100 years in which the product has been in use. As support for this position, she cites two studies: Schneider, P., Contribution to the phosphate-induced nephropathv in the dog. Comparative light and electron microscopic investigations on the proximal tubule after oral application of K2HPO4. Na2HPO4, and NaCl. Exp. Pathol. 19:53-65 (1981) and Gonlusen, G., Renal Failure and Nephrocalcinosis Associated with Oral Sodium Phosphate Bowel Cleansing. Clinical Patterns and Renal Biopsy Findings. Arch Pathol. Lab. Med. 130:101-06 (Jan. 2006).
The articles Parisian cites, however, describe scientific processes that are too dissimilar to the facts of this case to be relevant. See Cano v. Everest Minerals Corp., 362 F. Supp. 2d 814, 851 (W.D. Texas 2005) (finding that the failure to consider both positive and negative associations in the literature is not reliable methodology). Both publications are extrapolated beyond the methods and conclusions articulated, creating an analytical gap that science has not filled. Her opinions are simply unreliable and not relevant to this case. See Pipitone v. Biomatrix. Inc., 288 F.3d 239, 244 (5th Cir. 2002).
In Schneider, high doses of sodium phosphate were administered to dogs over a period of 9 and 22 weeks to determine the effect on the kidney. It did not address the effect of an acute phosphate load, similar to the dosages used for bowel cleansing. Id. The analytical gap in her opinion and in scientific knowledge renders this study inapplicable to this case. In other words, it does not "fit", as the dosages, intervals and methods are simply not comparable. See Daubert. 509 U.S. at 591; Moore, 151 F.3d at 277 (excluding expert opinion based on animal studies that were too dissimilar to the facts of the litigation).
At her deposition, Dr. Parisian could not explain why she relied on this study and its relevance to the litigation at bar:
Q. And in paragraph 63, you talk about the dog study some more. Did you review the dog study?
A. I reviewed that article because that's the only thing that's really available. The reason that article was being brought up in the way I put it in here was because it was 1981. So the type of information that would have been known about the risk of phosphate in terms of an animal model and producing renal disease….
Q. And what other, if any, other animal studies have you reviewed regarding phosphate sodium?
A. I am trying to remember if there are other animal studies listed in here. We've kept — I think that was the primary one that I discussed, but I don't recall if that was the only one. If there are other animal studies, they would be in here, and some of the medical literature would cite — would cite that, but nothing really. That was the best study that focused on the effects of phosphate on the kidney in an animal model.
See Exhibit "S", at pg. 171.
Parisian cannot even articulate what it is that Fleet failed to do that would have made any difference in this case whatsoever. There is no support in the medical literature that reports a clinical study, animal or otherwise, that an intake of a high phosphate load over a 24 hour period from any source actually induced renal damage from calcium phosphate deposition or nephrocalcinosis. Dr. Parisian is unable to articulate any scientific opinion correlating the relationship between this animal study and Fleet's warnings regarding use of Phospho-soda. Dr. Parisian does nothing more than a lay person could suggest: "the animal study has the words 'phosphate' and 'nephropathy' in the title, so it must be relevant."
Gonulsen is simply a single case report that was not even published until after Bracey sustained his injury. Moreover, it describes of a patient whose renal biopsy revealed nephrocalcinosis following use of oral sodium phosphate solution in preparation for a colonoscopy, which the authors concluded induced renal failure. Id. Whether or not the case report is instructive on the existence of nephrocalcinosis, it simply has no bearing on Parisian's opinion that Fleet should have known of the potential injury of nephrocalcinosis before alerted to this condition by Markowitz in 2003. To the extent that Parisian relies on the case study in support of her assertion that Fleet failed to provide sufficient warnings and thereby directly caused Bracey's injury, Parisian has presented no qualifications to enable her to offer an opinion on medical causation. [FN13] Mr. Bracey did not undergo a renal biopsy and his clinical course, including surgery, was entirely different than the one described in this case report, therefore a diagnosis of nephrocalcinosis cannot be made. Again, the causation analysis in Gonulsen does not "fit" the facts of this non-biopsy surgical case and offers further proof that Dr. Parisian's methods are unreliable. Daubert, 509 U.S. at 591; In re Vioxx Products Liability Litigation. 414 F. Supp. 2d at 579.

FN13. Fleet addresses in detail why there is insufficient evidence that Bracey has nephrocalcinosis, or acute phosphate nephropathy in the Motion in Limine to Exclude the Expert Opinion of Dr. Brown.

Parisian's opinions concerning the animal and other studies should be excluded as they are not relevant and she cannot demonstrate how Fleet's failure to include such studies in its labeling breached a duty to the physician or the consumer. Dr. Parisian fails to explain the relevance of these articles to this case. See Joiner, 522 U.S. at 144-45 (explaining, "[t]he issue was whether these experts' opinions were sufficiently supported by the animal studies on which they purported to rely. The studies were so dissimilar to the facts presented in this litigation that it was not an abuse of discretion for the District Court to have rejected the experts' reliance on them"). Merely declaring that Fleet failed to act responsibly does not make it so. See In re Breast Implant Litigation, 11 F. Supp. 2d 1217, 1234 (D. Colo. 1998) (an expert does not establish a fact merely by proclamation).

4. Opinion #4 on Fleet's IND Application is Irrelevant

Parisian's apparent last and fourth "opinion" is that "[t]here is no evidence that Fleet INDs have 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. See Exhibit "N", at ¶ 72. Parisian does not suggest that the FDA has acted on any studies submitted by Fleet since 1998 and found them deficient in any manner. Her opinion is no more than an observation that the FDA has all of this under advisement.
This opinion fails to offer any scientific analysis that requires expert testimony, is conclusory and usurps the role of the trier of fact. Thus, it should be excluded. See Reyes v. Wyeth Labs., 498 F.2d 1264, 1289 (5th Cir. 1974) ("Expert witnesses appear to assist in the court's decision-making process, not to control it.").
Dr. Parisian acknowledges elsewhere in her Report that FDA approved the prescription drug Visicol, which is a 90 mL equivalent of sodium phosphate in tablet form. The manufacturers of Visicol were permitted by FDA to rely on pre-existing studies based on oral sodium phosphates solution's "long history as a safe oral medication and grandfathered drug." See Exhibit "N", Parisian Report at ¶¶ 39, 45. Yet, Parisian chooses not to address her implicit opinion that the studies submitted to support Visicol's approval do not also demonstrate the safety of Phospho-soda. This contradictory, selective analysis is not helpful to the jury, is clearly unreliable and falls far short of permissible expert testimony.

CONCLUSION

Parisian does not present reliable and relevant testimony. She is unqualified to give testimony in an OTC pharmaceutical case, and the opinions she renders are subjective and, at times, irrelevant. Parisian states that she used the same methodology to formulate her expert opinion in this case that she employed while working in medical devices at the FDA CDRH. See Exhibit "N", Parisian Report at ¶ 13. She fails, however, to describe the methodology used at the CDRH to evaluate medical devices and further fails to demonstrate how her methodology to review medical devices is applicable and relevant to the review of OTC drugs. See Nugent. 2000 U.S. Dist LEXIS 5082, at * 18. Moreover, the majority of her lengthy and vague 138-page expert report merely reiterates the product and regulatory history of Phospho-soda and laxatives in general. The only analysis proffered is subjective and conclusory. This kind of testimony will not assist the trier of fact and is unreliable under Daubert. As the Court stated in Moore:
The subject of an expert's testimony must be scientific knowledge. The adjective 'scientific' implies a grounding in the methods and procedures of science. Similarly, the word 'knowledge' connotes more than subjective belief or unsupported speculation … In short, the requirement that an expert's testimony pertain to 'scientific knowledge establishes a standard of evidentiary reliability."
Moore. 151 F.3d at 275 (internal citations omitted). Therefore, Parisian's opinions must be excluded.