Misc. Drugs

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I don’t always post FDA alerts, but when one involves possible fatalities, I do.

[Posted 10/16/2009] American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose

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Do you subscribe to FDA warning alerts?  Well, if not, you should.  Because if you did you’d get informative emails like this one:

Audience: Neurological healthcare professionals, patients

[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.  Tysabri was approved by the FDA for the treatment of

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The FDA is investigating that very question:

FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32

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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.

Continue Reading Lawsuit Against Makers of Phospho-Soda Filed in New York

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.

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