Dangerous Drugs: News About Lawyers, Lawsuits, & Drugs Like Fentanyl, Reglan, and Phospho-soda

Lawsuit Against Makers of Phospho-Soda Filed in New York

This was filed July 14th of 2009:

47. Defendants, through their promotion, labeling and selling of Fleet Phospho-soda, falsely, deceptively and materially misrepresented to Mrs. Blackman and her physician that Fleet Phospho-soda was a safe product when, in fact, it was not. For example, Defendants expressly misrepresented to Mrs. Blackman on the Fleet Phospho-soda packaging that “[w]hen taken as directed,” Fleet Phospho-soda's “laxative action is gentle, virtually free from the likelihood of gastrointestinal discomfort, or irritation, and is safe for the age groups indicated.” Mrs. Blackman was in one of the “indicated” age groups at the time she used the Fleet Phospho-soda.

48. Additionally, despite their knowledge of the unsafe and dangerous nature of Fleet Phospho-soda, Defendants recklessly, negligently and knowingly failed to provide needed, accurate, and adequate information regarding the health hazards of Fleet Phospho-soda to those such as Plaintiff who would reasonably and foreseeably use the product. For example, Defendants failed to advise Plaintiff of the proper amount of water or other liquids to drink after taking the Fleet Phospho-soda and otherwise failed to advise her of the health risks and hazards associated with the use of Fleet Phospho-soda.

49. Defendants intended that consumers, including Mrs. Blackman, would rely on Fleet's omissions and misrepresentations regarding Fleet Phospho-soda and the dangers and health risks associated with the product.

50. Defendants' omissions and representations were negligently, recklessly or knowingly false and misleading as to Plaintiff, and were made with the intent of inducing Plaintiff into purchasing and using Fleet Phospho-soda.

51. Plaintiff believed and justifiably relied upon defendants' omissions and representations and was thereby induced into purchasing and using Fleet Phospho-soda.
Plaintiff's Use of Fleet Phospho-soda

52. Plaintiff Barbara Blackman purchased and used Fleet Phospho-soda on or about November 15, 2007 in preparation for a scheduled colonoscopy, which was performed the following day.

53. Plaintiff used Fleet Phospho-soda as directed and for the purpose and in the manner for which it was normally intended.

54. Plaintiff could not by the exercise of reasonable care discover the defective nature and perceive the dangers of Fleet Phospho-soda.

55. As a direct and proximate result of using Fleet Phospho-soda, Plaintiff was diagnosed with kidney failure on or about February 6, 2008. As a result of her injuries, Plaintiff had her right kidney removed on April, 11, 2008.

Technorati Tags: Phospho-Soda,Phospho-Soda lawsuit

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

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.

Technorati Tags: Phospho-Soda,Phospho-Soda lawsuit

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

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.

Technorati Tags: Fleet Phospho-Soda,Phospho-Soda,Phospho-Soda lawsuit

Expert Report in Fleet Phospho-Soda Lawsuit

This expert report discusses the actions that Fleet did and didn’t take with respect to Phospho-Soda and its association with kidney problems.  It comes from Bracey v. Fleet, and the expert is Suzanne Parisian.

31.) Dr. Caswell's statement to health care providers in his 2002 letter regarding post-marketing experience confirming the product as "safe and effective", incorrectly implies that Fleet Phospho-soda was approved for marketing by FDA through a New Drug Application (NDA) with a commitment for post marketing. He fails to more precisely inform health care providers that Fleet Phospho-soda, unlike competitor bowel preparation products marketed via approved NDAs, Fleet Phospho-soda remains on the market "grandfathered" as safe, able to support efficacy as an active ingredient with limited data and considered by FDA as "generally recognized as safe and effective"(GRASE). Despite the tome of the letter, Dr. Caswell was unaware when Fleet Phospho-soda had first become actively promoted for colon preparation. (Caswell April 5, 2006, Volume I testimony, page 124, lines 13-19). He indicated letter that there were only 40 USA based serious adverse events reported to Fleet from 1991 through 2001. However, Dr. Caswell was unfamiliar with the nature of those reports, unable to provide the types of procedures being performed when the events occurred, the dosing, type of populations involved or any other signal associated with possible increased risk. He also was unaware of methods of rehydration being used by patients in the adverse event reports. (Caswell April 5, 2006, Volume I testimony, page 125, lines 14-25).
32.) Fleet did not provide United States physicians with information described in the Australian Adverse Drug Reactions Bulletin, Vol. 16, No. 1 (February 1997) warning about the risks of electrolyte shifts with Fleet Phospho-soda. According to Dr. Caswell's testimony above, he considered the risks for electrolyte shifts with a single dose of Fleet Phospho-soda Solution as "known" since 1968. However, the Australian agency, unlike Dr. Caswell, felt that it was safety information which needed to be conveyed to health professionals in 1997. The Australian bulletin had been prepared by the Adverse Drug Reactions Advisory Committee (ADRAC) (Exhibit 122, CBFL-0000125-8). Heading 1. ELECTROLYTE DISTURBANCES WITH ORAL PHOSPHATE BOWEL PREPARATION.
In recent years, the use of oral sodium phosphate solution (Fleet Phospho-Soda Buffered Saline Laxative Mixture) as a bowel preparation for colonoscopy has become more common. Over the past 18 months, ADRAC has received three serious reports, two with fatal outcomes, highlighting severe electrolyte disturbances associated with this oral bowel cleansing solution. The product is available without prescription and can also be used as a laxative at a lower dose.....

Technorati Tags: Fleet Phospho-Soda,Phospho-Soda,Phospho-Soda lawsuit

Fleet’s Expert Witness Discusses The Association Of Acute Phosphate Nephropathy With Fleet’s Phospho-Soda Product

Fleet’s expert provides some good background information regarding Phospho-Soda and Phosphate Nephropathy, as well as other kidney troubles:

In March 2003, Dr, Glen Markowitz, a nephropathologist at Columbia University, reported to C.B. Fleet several cases of nephrocalcinosis that he thought might be associated with sodium phosphate use. I was invited by Sherrie Scott, RN to attend a meeting with Dr. Markowitz at Columbia University Hospital in New York City on April 11, 2003. In attendance were Ms. Scott and Joseph Kanapka, PhD from Fleet and Dr.'s Markowitz, Radhakrishnan and D'Agati from Columbia. We reviewed the clinical histories of the five cases of “acute nephrocalcinosis” that Dr. Markowitz had identified, including the dosing of sodium phosphate, hydration, concomitant medications, and selected histopathology. We were informed that all of the patients had been diagnosed after February 1, 2003. At the time of our meeting, the dosing intervals of sodium phosphate and hydration received during bowel preparation were unknown In four of the five patients who received their preparation at home. A main focus of Dr. Markowitz and his colleagues was whether there was an interaction between sodium phosphate and medications that can affect renal perfusion, including angiotensin converting enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB), and diuretics.

To date, a total of 27 cases have been reported in full manuscript form in the scientific literature, 25 of which were associated with oral sodium phosphate solution and two with sodium phosphate tablets. In addition, I am aware of additional cases reported in abstract form or reported directly to the pharmaceutical manufacturers or the FDA. Most of the subjects reported in the literature had normal renal function prior to ingestion of sodium phosphate. In the largest case series published, renal failure occurred between 1 day and 5 months after colonoscopy, with a median presentation 1 month following the bowel preparation.^[FN45] In 23 cases associated with sodium phosphate solution and reported in detail^[FN43],^[FN45],^[FN46],^[FN50], it is reported that one subject received an overdose of sodium phosphate while the other subjects took a split-dose regimen of 90-mL.

Technorati Tags: acute phosphate nephropathy,renal Failure,phospho-soda,phospho-soda lawsuit

Third Phospho-Soda Lawsuit Filed in Georgia

This is the third Phospho-Soda lawsuit filed in Georgia that I’m aware of.  This lawsuit alleges that phosphate nephropathy is a side effect of Phospho-Soda:

18. That Plaintiff administered to himself the Fleet Phospho-soda as directed.

19. Shortly thereafter, Plaintiff suffered severe kidney damage.

20. That Plaintiff is informed and believes that his kidney damage was caused by administration of the Fleet Phospho-soda that he was directed to administer to himself by his physician and which resulted in a physical ailment known as phosphate nephropathy.

This is a link to the first Georgia Phospho-Soda lawsuit I blogged about.  And this is a link to the second Phospho-Soda lawsuit.

Technorati Tags: Phospho-Soda,Phosphate Nephropathy,Phospho-Soda lawsuit,Fleet Phospho-Soda

Another Georgia Lawsuit Alleges Renal Failure Is a Side Effect of Fleet Phospho-Soda

This is the second Fleet Phospho-Soda lawsuit filed in Georgia that I’ve seen.  Here’s a link to the first Georgia Phospho-Soda  lawsuit. 

This lawsuit alleges that renal failure is a side effect of Fleet’s Phospho-Soda.

18. That Plaintiff administered to herself the Fleet Phospho-soda as directed on or about January 29,2008.

19. Shortly thereafter, Plaintiff suffered severe kidney damage.

20. That Plaintiff is informed and believes that her kidney damage was caused by administration of the Fleet Phospho-soda that she was directed to administer to herself by her physician and which resulted in chronic renal insufficiency.

Technorati Tags: Fleet Phospho-Soda,Phospho-Soda Lawsuit,Renal Failure,Colonoscopy

Fleet Phospho-Soda Lawsuit Filed in Georgia

The following lawsuit alleges that Fleet’s Phospho-Soda caused James Yearwood to develop nephrocalcinocis:

22. That Plaintiff is informed and believes that by February 2005, Defendant Fleet knew of risks of kidney failure associated with the use of Fleet Phospho-soda in geriatric patients, in patients treated with angiotensin receptor blocking medications, and in patients treated with diuretic medications.

23. That Plaintiff is informed and believes that despite knowing the risks to certain consumers, Fleet nevertheless heavily marketed directly to healthcare providers the utilization of Fleet Phospho-soda as a bowel cleanser prior to colonoscopy.

24. That Plaintiff is informed and believes that Fleet heavily marketed the utilization of Fleet Phospho-soda as a bowel cleanser prior to colonoscopy without fully warning or instructing of the risks to certain consumers, including but not limited to geriatrics, persons being treated with angiotensin receptor blocking drugs, or persons being treated with diurectic medications.

Technorati Tags: Fleet Phospho-Soda,Phospho-Soda,Phospho-Soda lawsuit,Nephrocalcinosis

Fleet’s Own Attorney Admitted That Phospho-Soda Causes Medical Problems

Below I’ve included the text of a Motion in Limine that Fleet filed in a Phospho-Soda lawsuit.  A Motion in Limine is a motion a party files before the trial in which the party asks the court to either allow or permit something from happening.

In this case, Fleet didn’t want the plaintiff to be able to show the jury statements that Fleet’s own attorney made in public:

In the DVD, Mr. Gunn states in part as follows:

I was trying a pharmaceutical case last month in California, and the company that I was trying it for has about 80 lawsuits pending over the product and several law firms that are representing them....The president of the company was telling me how much he was hoping I was going to use these other lawyers as resources. And I told him I wasn't, that they really didn't have anything to offer to me. They were too concerned with the medicine and the details, and that at the time of trial we're way beyond that... problem was the product did cause a problem so there really wasn't any point in talking about the medicine.

I’m not sure if the order was granted, but I bet it was.  Statements like this are generally kept out of court.

Defendant C.B. Fleet Company, Inc. (“Fleet”), by counsel, pursuant to this Court's Order entered December 11, 2008, hereby submits this Motion in Limine, showing the Court as follows:

I. INTRODUCTION

By way of this Motion in Limine, Fleet respectfully requests this Court to enter an order prohibiting the introduction into evidence and any reference to any statements made by Defendant's attorney Earl W. “Billy” Gunn at a Continuing Legal Education Seminar (“the seminar”). Fleet anticipates that Plaintiff will attempt to show the DVD of the seminar and/or illicit testimony related to the seminar in an effort to imply that Fleet admitted that the product at issue as defective. The fact is, however, that there is no evidence that Mr. Gunn's comment was in any way such an admission. Accordingly, any evidence of or testimony regarding the seminar is irrelevant to the issues at trial, and introduction of the DVD or testimony related thereto provides no probative value.

II. ARGUMENT

In order to be admissible at trial, evidence must be relevant to the case. Relevance requires that evidence have a tendency to “make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.” Fed. R. Evid. 401. Evidence that does not meet this test for relevance is not admissible. Fed. R. Evid. 402. In addition, relevant evidence should be excluded when any possible probative value of such “evidence” is substantially outweighed by the danger of unfair prejudice, confusion of the issues, misleading the jury, undue delay, waste of time, or needless presentation of cumulative evidence. See Fed. R. Evid. 403.

Expert Report in Phospho-Soda Lawsuit Explains How Product Causes Kidney Failure

The following expert report from a Phospho-Soda lawsuit filed in West Virginia explains how Phospho-Soda causes kidney failure.  The report also gives some of the regulatory history of the product.

The report is from Dr. Karen Kim, M.D., a professor at the University of Chicago Medical Center.

As per our conversation, I am providing my expert review on the File No.: 519-1042 (Burk v. C. B. Fleet Corporation). I am board-certified in internal medicine and gastroenterology. I have been a faculty member at the University of Chicago Medical Center for the past 12 years, where I am currently an Associate Professor of Medicine. During this tenure, I have had multiple roles including Director of the Colon Cancer Screening Program and Co-director of the GI Fellowship Program. Additionally, I am chair of the American Cancer Society (Illinois Division) Early Detection and Prevention Committee. I am actively involved in research on colorectal cancer screening uptake and in these capacities, have tremendous experience and expertise in gastroenterology, with a particular focus on colonoscopy for cancer screening. In addition, I teach colonoscopy to GI fellows and perform approximately 20-25 colonoscopies per week.

I have reviewed the medical records, depositions and case records provided by your office with regards to the claims brought by Walter Burk against the C. B. Fleet Company, Inc. Mr. Burk states that he drank the Fleets Phospho-soda preparation (FPS) on January 11, 2005 in order to cleanse his colon prior to a EGD/colonoscopy on January 12, 2005. Mr. Burk states that shortly after this ingestion, he sustained serious and permanent injury to his kidneys, as a direct and proximate result of drinking the FPS.

I have reviewed the following documents: Complaints, medical records, including all laboratory data, endoscopic records, inpatient and outpatient notes and medication lists and bowel preparation orders. I have reviewed the expert opinions of Drs. Levenson, Markowitz, Parisian, Blume and Moore. Additionally, I have reviewed the literature and product information provided by your office.

The opinions herein are rendered within a reasonable degree of medical certainty.

Case Summary

Mr. Burke was admitted for evaluation of chronic nausea and abdominal pain on January 10, 2005. He was seen in consultation by a gastroenterologist and was scheduled for a colonoscopy/EGD for evaluation of his symptoms. In the inpatient orders, he was prescribed a FPS prep the day before his procedures, to be taken at 1600 and again at 2100, in addition to a clear liquid diet. He underwent a combined EGD and colonoscopy on January 12, 2005, which revealed a hiatal hernia, gastritis, non-specific inflammation in the colon and a polyp. No intraoperative records were available for review. At the time of his admission, Mr. Burk was a 68 year old man with a history of hypertension, hyperlipidemia, diabetes, prostate cancer, pituitary adenoma, chronic nausea and abdominal pain and depression and was on norvasc, prozac, phenergan, nexium, alprazolam and carafate. His admission creatinine was 0.6 mg/dl. He was discharged from the hospital on January 13, 2005. Mr. Burk underwent another EGD with endoscopic ultrasound on 3/23/05, and was diagnosed with a benign leiomyoma. He had office visits with Dr. Newland on 7/18 and 7/27/05 for persistent complaints of nausea and abdominal pain and was found to be hypertensive. On 9/29/05, Mr. Burk was admitted for rectal bleeding, and he was found to have a serum creatinine of 7.4 mg/dl. A renal ultrasound on 10/1/05 showed echogenic kidneys without evidence of renal artery stenosis and a kidney biopsy on 10/3/05 was interpreted as severe nephrocalcinosis with prominent interstitial fibrosis and tubular atrophy. Since his diagnosis of acute and chronic renal failure, Mr. Burk required hemodialysis and was evaluated for possible renal transplantation.

Phospho-Soda Lawsuit Filed in Alabama

In April of 2009, Don Stagg filed a lawsuit against the manufacturer of Phospho-Soda.  It sounds like Mr. Stagg had a very bad experience with Phospho-Soda:

41. On September 25, 2007, Dr. Luttrell performed a colonoscopy on Mr. Stagg.

42. Two days following the colonoscopy exam, Mr. Stagg began to exhibit symptoms of acute renal failure including nausea, vomiting, dehydration, headache and fatigue.

43. On October 1, 2007, Mr. Stagg presented to St. Vincent's Hospital Emergency Room where he was diagnosed with acute renal failure secondary to Fleet Phospho-Soda.

A week after using the product, Mr. Stagg was diagnosed with acute renal failure.  What should have been a routine colonoscopy turned into a life-changing procedure.  If you or someone you know has been diagnosed with kidney problems after using Fleet Phospho-Soda, contact me and I’ll put you in touch with a Phospho-Soda attorney who will investigate your case.

Plaintiff, Don Stagg, by and through his attorneys, alleges as follows:

I. STATEMENT OF JURISDICTION AND VENUE

1. Plaintiff, Don Stagg, is a resident and citizen of Birmingham, Alabama and is over the age of nineteen.

2. Upon information and belief, Defendant C.B. Fleet Company, Inc., is a corporation existing under the laws of Virginia with its principal place of business in that state.

3. Upon information and belief, Defendant C.B. Fleet Holding Company, Inc., is a corporation existing under the laws of Virginia with its principal place of business in that state.

4. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §1332 (Diversity) in that the state of citizenship of the Plaintiff is different from the state of citizenship of the Defendants, and Plaintiff resides within this district.

5. Plaintiff alleges an amount in controversy in excess of $75,000.00 exclusive of interest and costs.

6. Venue is proper pursuant to 28 U.S.C. § 1391. The Defendants have sufficient minimum contacts with Alabama or otherwise intentionally availed themselves of the consumer markets within Alabama through the promotion, sale, marketing and/or distribution of its products in the state to render the exercise of jurisdiction by the Alabama courts permissible under traditional notions of fair play and substantial justice.

7. At material times hereto, the Defendants C.B. Fleet Company, Inc. and C.B. Fleet Holding Company, Inc. (hereinafter collectively referred to as the “Fleet”):

(a) were, and are, engaged in the business of the design, development, manufacture, production, processing, compounding, formulating, testing, sale, marketing, labeling, packaging, dosing, advertising, promotion, supply, releasing and/or distribution of Fleet Phospho-soda (“hereinafter “FPS” or “Phospho-soda”) in the United States and Alabama either directly or indirectly through third-parties or related entities;

b. were, and are, in the business of profiting from the design, development, manufacture, production, processing, compounding, formulating, testing, sale, marketing, labeling, packaging, dosing, advertising, promotion, supply, releasing and/or distribution of FPS;

c. conducted continuous and substantial business in the state of Alabama and,

d. acted and gained knowledge itself and by and through its various agents, servants, employees, and/or ostensible agents.

II. FACTUAL ALLEGATIONS

8. This action arises out of the manufacture, distribution, and sale for profit of an over-the-counter bowel cleansing drug known as FPS, which contains sodium phosphate.

9. Fleet promoted, distributed, and sold FPS as a “laxative, for the relief of occasional constipation” and “purgative, for use as part of a bowel cleansing regimen in preparing for surgery, x-ray, or endoscopic examination.”

10. A single forty-five (45) mL dose of FPS has long been used as a laxative to alleviate occasional constipation.

11. Forty-five (45) mL of FPS contains 8.1g of dibasic sodium phosphate and 21.6g of monobasic sodium phosphate.

Four People File Phospho-Soda Lawsuit in California

The following Phospho-Soda lawsuit gives a good amount of background information about the product, about its recall, and about the problems it can cause.  For example:

25. On December 11, 2008 the FDA responded to Fleet's June 2003 Citizen Petition seeking formal approval of doses ranging from 2 x 30mL to 2 x 45mL in 10 to 12 hours of FPS as a bowel cleanser prior to colonoscopy or other medical procedures. The FDA soundly rejected Fleet's petition. The FDA also stated that “[a]lthough the true incidence of acute phosphate nephropathy is unknown, it may occur in up to 1 in 1000 patients who receive OSP products and is probably under-recognized.” Additionally, the FDA explained that acute phosphate nephropathy can occur from ingesting oral sodium phosphate products even “in patients with no pre-existing health factors that would have put them at risk for developing kidney injury.” The FDA further stated that the product's warnings are currently inadequate; doctors and patients are not fully informed about the risks and inherent dangers of Phospho-soda, including acute phosphate nephropathy and death, and consequently the FDA revoked Fleet's OTC status for Phospho-soda when used as a bowel cleanser. Specifically, the FDA “concluded that the current labeling of OSP products does not adequately warn healthcare providers and patients about this serious event [acute phosphate nephropathy].” The FDA also required increased warnings for any oral sodium phosphate product sold as a bowel cleanser, including black-box warnings that Fleet previously refused to include on its Product packaging.

26. As of December 15, 2008, Fleet continued to actively maintain information located on its website (www.fleetlabs.com) promoting 2 x 45mL of Phospho-soda separated by 6 to 12 hours, and claiming that said dosing regimen is “safe” in patients without contraindications. As of the date of this complaint, Fleet maintains a “Q&A” document on its website stating that there is “nothing” wrong with the Product.

I’m always extremely skeptical when a company recalls a product and then claims there was nothing wrong with the product… especially when they haven’t returned the product to market.

Phospho-Soda Lawsuit Alleges that the Product Caused Nephrocalcinosis

Here’s a lawsuit filed in Georgia alleging that James Yearwood contracted nephrocalcinosis after using C.B. Fleet’s Phospho-Soda.  Nephrocalcinosis can cause renal failure that can either kill you or require you to undergo a kidney transplant.  This Phospho-Soda lawsuit doesn’t detail how long after using Phospho-Soda that the plaintiff was diagnosed with kidney problems.  Some of the Phospho-Soda lawyers I know have told me that it can be as little as sixty days from the date of use to the date of kidney problems.  If you used Phospho-Soda and would like me to put you in touch with a lawyer, contact me and I’ll do so.

COME NOW the Plaintiff, James Hubert Yearwood, and by and through the undersigned counsel file this Complaint and show as follows:

PARTIES

1. That Plaintiff is a citizen and resident of Tennessee.

2. That Plaintiff is informed and believes that C.B. Fleet Holding Company, Inc., (“Fleet Holding”) and C.B. Fleet Company, Inc., (“Fleet”) are corporations organized and existing under the laws of Virginia, where they are headquartered and have their principal place of business.

3. That Plaintiff is informed and believes that Fleet is a wholly owned subsidiary and instrumentality of Fleet Holding through which Fleet Holding at all relevant times herein did business in the State of Georgia.

4. That Plaintiff is informed and believes that Fleet and Fleet Holding are commonly owned, and operated, sharing corporate officers, shareholders and corporate location.

5. That Plaintiff is informed and believes that Fleet operates as part and parcel of Fleet Holding; that there is no true distinction between the two corporations and their activities.

6. That Plaintiff is informed and believes that Fleet and Fleet Holding are one corporate entity with no distinction between the two.

7. That Plaintiff is informed and believes that Fleet and Fleet Holding are responsible for the acts and omissions of their employees, agents, and contractors as if they were one corporate entity.

8. That in the alternative, Fleet is the alter ego of Fleet Holding; that Fleet is dominated and controlled by Fleet Holding, is subservient to Fleet Holding, manifests no separate interests of its own, and functions solely to achieve the goals of Fleet Holding (hereinafter, Fleet and Fleet Holding shall collectively be referred to as “Fleet”).

Lawsuit Filed in Colorado Against C.B. Fleet, the Manufacturer of Phospho-Soda

In December of 2008, the FDA issued an advisory alert regarding C.B. Fleet, the manufacturer of Phospho-Soda.  Phospho-Soda was a product used as a bowel purgative, often recommended to patients who were going to undergo a colonoscopy.  There have been many reports of individuals suffering permanent damage to their kidneys after using this product just one time.  Here’s the text of a Phospho-Soda lawsuit that was filed in Colorado in April of 2009.

PARTIES PLAINTIFF

1. Plaintiff Scott Lundy is a 58 year old male who, at all times relevant to the events described herein, was a resident of El Paso County, Colorado residing 12270 Jones Park Ct., Colorado Springs, Colorado 80921.

2. Plaintiff Mitzi Lundy is Scott Lundy's wife who, at all times relevant to the events described herein, has been married to and resided with Scott Lundy in El Paso County at 12270 Jones Park Ct., Colorado Springs, Colorado 80921.

PARTIES DEFENDANT

3. Defendant C.B. Fleet Company, Incorporated is a closely-held corporation that, upon information and belief, is incorporated in the State of Virginia, with its corporate headquarters located in Lynchburg, Virginia at 4615 Murray Place, PO Box 11349, Lynchburg, Virginia 24506.

JURISDICTION AND VENUE

4. The Court has subject matter jurisdiction pursuant to 28 U.S.C. §1332 (diversity jurisdiction). The amount in controversy exceeds $75,000.00 exclusive of interest and costs. There is complete diversity of citizenship between Plaintiffs and the Defendant. The Plaintiffs are residents of El Paso County at 12270 Jones Park Ct., Colorado Springs, Colorado 80921 and the Defendant is a Virginia corporation with its principal place of business in the State of Virginia.

5. Venue in this Court is proper pursuant to 28 U.S.C. § 1391 in that a substantial part of the events or omissions giving rise to the claims asserted herein occurred in this District, and Defendant is subject to personal jurisdiction in this District.

6. At all times relevant hereto, Defendant was the manufacturer, marketer, distributor and/or seller of Fleet Phospho-Soda oral saline laxative and is identified as follows:

a. Defendant C.B. Fleet Company, Inc., is a closely-held corporation that, upon information and belief, is incorporated in the State of Virginia, with its corporate headquarters located in Lynchburg, Virginia at 4615 Murray Place, PO Box 11349, Lynchburg, Virginia 24506.

7. At all times relevant to the Plaintiffs' Complaint, Defendant manufactured, promoted, distributed and sold for profit an Oral Saline Laxative product known as Phospho-soda(R). Defendant promoted, distributed, and sold Phospho-soda(R) as a “laxative, for the relief of occasional constipation” and “purgative, for use as a part of a bowel cleansing regimen in preparation for surgery, x-ray or endoscopic examination.”

8. At all times relevant hereto, the Defendant actually knew of the defective nature of its product as herein set forth, yet continued to design, manufacture, market, distribute and sell their product so as to maximize sales and profits at the expense of the general public's health and safety in conscious disregard for the foreseeable harm caused by this product. Defendant's conduct exhibits such an entire want of care as to establish that its actions were a result of fraud, ill will, recklessness, grow negligence or willful and intentional disregard to the Plaintiffs' individual rights, and hence punitive damages are appropriate.