July 2009

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…..

Continue Reading Expert Report in Fleet Phospho-Soda Lawsuit

Expert Witness Suzanne Parisian gave this testimony in an Ortho-Evra lawsuit entitled Arbino v. Johnson & Johnson.

Q. Where does it say it's similar? It just says it contains an estrogen and a progestin.
A. Called a combination hormonal contraceptive. As you know, those have been on the market since 1960. So, the information that you're asking me in one sentence may be lost on them, because they have been using and prescribing combination hormonal contraceptives, and this is being represented to them as a combination hormonal contraceptive.
So, you are asking what would every physician, board certified OB-GYN see when they see that, and I think that you cannot take it out of context. This is being provided to them as a product that is approved by the FDA and is a combination hormonal contraceptive.
So, it may be lost on when you take that sentence out of context and try to say that all OB-GYNs would know there's no information about this product as a transdermal because, obviously, it is now being provided to them as approved.
Also, it's been provided to the FDA as comparable to an oral contraceptive in terms of allowing bridging of data
So, it's not a clear-cut sentence taken out of context and what would be interpreted by all OB-GYNs.
Q. How about the sentence that starts the next paragraph The use of combination hormonal contraceptives is associated with increased risks of several serious conditions, including myocardial infarction, thromboembolism, stroke, hepatic neoplasia and gallbladder disease. And then it continues.
Any reason to doubt that a board certified OB-GYN, in 2001 or 2002, didn't know that combination contraceptives, for at least thirty-five or forty years, were associated with an increased risk of myocardial infarction?
MS. PARFITT: Objection Again, she can't get behind the minds of every board certified OB-GYN. I object to the form of the question
Doctor, if you can respond to the question, okay.
A. Again, the terms are not clear-cut, because you are talking about to an OB-GYN who has used combination hormonal oral contraceptives since 1960, and then you are taking it out of context, because if you look at the paragraph above, you just said that there is no epidemiological data, and then you are coming back here talking about birth control pills. We are switching between transdermal and birth control pills.
So, that second paragraph is providing information that a board certified OB-GYN and a family practitioner, they are not the only ones who prescribe — OB-GYNs are not the only ones who prescribe birth control pills.
Okay. So, you're talking about family practitioners. You're talking about general practitioners. You're talking about nurse practitioners. You're telling them that this product is of the same risk as an oral contraceptive.
Now, if you know from the data, that's not necessarily true, because up in the paragraph above it, they say there's no data to tell you if this actually performs like an oral contraceptive.
So, in some ways, the second paragraph is speaking specifically about the history of oral contraceptives.
Q. Is there any reason to doubt that anyone, board certified OB-GYN, family practitioner, didn't know in 2000 that there's an increased risk of thromboembolic events associated with hormonal contraception?
MS. PARFITT: Objection The question was just asked, and she gave a very detailed response to the question.
I think in light of the fact we got a late start today, we need to start to move forward and not ask the questions twice.
Q. (By Mr. Winter) You can answer the question, Doctor. That was not the question I asked before.
A. You're talking apples and oranges. Yes, there has been a history, and this is the class labeling. There has been a history of increased risks of oral contraceptives.
Having gone through all the documents and seen even corporate documents, we know, sitting here today, that the company knew that this product did not perform as a birth control pill. But they're actually using class labeling for a birth control pill and telling physicians and all the people who prescribe it from state to state, that this has an increased risk which is associated with birth control pills.
There's never been a transdermal contraceptive product, and that's not what's stated there. It states that they are talking about class labeling, that birth control pills have an increased risk of several serious conditions.
So, if I was a physician who was prescribing a birth control pill, I would see that, and I would read that as being consistent with oral contraceptives, which, as we know, is what the FDA was told, that this product was consistent with an oral contraceptive.

Continue Reading Testimony of Suzanne Parisian Concerning the Ortho-Evra Patch

Fleet certainly hopes so:

Six months after pulling two laxative drugs off drug store shelves, Lynchburg-based C.B. Fleet has collected thousands of cases of the products and is considering ways to put the drugs back on the market.

Meanwhile, 38 lawsuits against the pharmaceutical company were consolidated last week into one federal court so pretrial work can continue smoothly. The lawsuits allege that the drugs C.B. Fleet recalled have caused serious kidney damage.

Chris McDaniel, chief scientific officer for C.B. Fleet, said the company continues to assert that the recalled drugs are safe when used as directed. C.B. Fleet wants to sell them again if it can ensure that they would be used correctly, he said.

The drugs in question use a formula that C.B. Fleet has made in Lynchburg for more than 100 years. Fleet Phospho-soda is a laxative, and Fleet Phospho-soda E-Z Prep Bowel Cleansing System is a double dose of the laxative used to clean the intestines before a colonoscopy.

Source: C.B. Fleet says its laxatives are safe | Lynchburg News Advance

All of the Phospho-soda lawsuits I’ve seen indicate to me that the product should stay in Fleet’s warehouse and not come back to market.

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This one is a mouth patch, and it isn’t supposed to be used as a substitute for the Duragesic patch or the other generic fentanyl patches.

The U.S. Food and Drug Administration on Thursday formally approved Onsolis, Raleigh-based BDSI's mouth patch that delivers the painkilling drug fentanyl to cancer patients suffering severe “breakthrough pain” that doesn't respond to other medications.

Onsolis is manufactured by Aveva Drug Delivery Systems of Florida and marketed under license from BDSI (Nasdaq: BDSI) by Meda Pharmaceuticals. With FDA approval of Onsolis, BDSI is due about $27 million in milestone payments, which Sirgo said would be directed to the company's drug pipeline.

The company also is developing the product BEMA Buprenorphine, a form of painkilling drug buprenorphine that is often given intravenously to treat chronic pain. Like Onsolis, the product uses the company's BEMA technology, which delivers drugs through mucous membranes in the mouth via a small patch.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

Source: FDA approval pumps $27M into BDSI pipeline – Triangle Business Journal:

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Johnson & Johnson, the makers of the Duragesic fentanyl patch reported that sales for the patch are down 12.3% worldwide from this quarter last year.

Duragesic Sales Down

One has to wonder if all of the Duragesic recalls and bad press over the various lawsuits has eaten into sales.  Note that U.S. sales are down much more than global.

Here’s a link to the PDF reporting J&J’s earnings.

I wish them the best of luck.  I also wish that they’ll send me any documents they obtain from the Canadian subsidiaries they plan on suing.

EDMONTON — The last time Ellen Robb spoke with her brother, he was doing chores and laundry at home, optimistic that with his chronic back pain under control, he would soon be back at work as an electrician.

Four days later, after many unanswered phone calls, Robb found Doug Hoy dead on his apartment floor, barefoot as if he were on his way to get his laundry basket across the hall.

Months later, a toxicology report revealed Hoy’s blood had three times the safe amount of fentanyl, Robb said.

Fentanyl is an opiate 80 to 100 times as strong as morphine, and approved for use as a pain medication in Canada and the United States.

Hoy had been prescribed the fentanyl patch to treat his severe chronic back pain after another powerful opiate, OxyContin, failed to bring relief.

Now, Robb and her family have taken steps to launch a class-action lawsuit against five pharmaceutical companies, alleging the companies that design, test and distribute fentanyl patches were negligent in warning people about the risks of breathing problems or death, as well as severe weakness, drowsiness and confusion.

Source: Family of dead Alta. man seeks class-action lawsuit against drug-makers

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.

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

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.

Continue Reading Third Phospho-Soda Lawsuit Filed in Georgia

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.

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

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.

Continue Reading Fleet Phospho-Soda Lawsuit Filed in Georgia