July 2009

A reader brought to my attention that all of Mylan's fentanyl patches are made in Vermont, not West Virginia.  Therefore, no matter if the allegations that West Virginia employees bypassed safety mechanisms are true, that could in no way have any bearing on the safety of the Mylan fentanyl patch.

Hopefully, no similar conduct occurred on the fentanyl line in Vermont.

What's next in the saga of Mylan, the fentanyl patch manufacturer whose employees allegedly bypassed quality controls? 

NEW YORK, July 29 (Reuters) – Mylan (MYL.O), the world's No. 3 generic drugmaker, said on Wednesday that it had reshuffled its management after a report on its quality controls sparked volatility in its share price.

Heather Bresch, formerly chief operating officer, is being promoted to the position of president, and Rajiv Malik will take on the role of chief operating officer, the company said. Most recently, Malik headed global technical operations, overseeing quality and regulatory affairs, among other areas.

Source: Reuters

Not sure what to make of the fact that the individual who was chagred with "overseeing quality and regulatory affairs" got a promotion out of this… but then again, the allegations are that employees hid defects from the quality control department.

Yesterday, I blogged about the allegations that Mylan employees knowingly bypassed safety procedures to boost production.  Today, there's another story worth blogging about:

According to a press release issued by Mylan, the plant has been cleared of any problems by the Food & Drug Administration following a visit to the facility by agency officials on Monday. But in its statement the FDA’s assistant commissioner for compliance policy, Steven Solomon, said the investigation is not over.

“This investigation involves allegations of compliance violations that the FDA takes very seriously,” Solomon wrote. “The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue.”

Source: FDA, Mylan, at odds over status of probe at W.Va plant

I'm sure Mylan would like the investigation to be over, but I for one am relieved that the FDA is continuing to look into these allegations.  Many of the products made at this West Virginia plant, like Mylan's fentanyl patch, can be deadly if not manufactured according to specifications.

Considering how many lawsuits have already been filed against Mylan alleging their fentanyl patch is defective, I can't help but wonder if the safety procedures were skipped on the fentanyl line…

I’ve just launched www.findtherightzicamlawyer.com, which will archive the many documents and court filings related to lawsuits against the makers of Zicam.  Zicam was recalled from the market because the FDA had received well over 100 reports of people losing their sense of smell after using Zicam.

Zicam is a homeopathic remedy, meaning its makers didn’t have to undergo the same rigorous tests that makers of prescription drugs have to.  One of the active ingredients in Zicam is a form of zinc, and zinc has been clinically proven to kill the cells in your nose that detect smell.

If you think you lost all or part of your sense of smell, you might want to check the website out.  And as always, don’t hesitate to contact me if you’d like me to put you in touch with an attorney to discuss a Zicam lawsuit.

My name is Justinian Lane, and I’ve been writing about dangerous and defective drugs since 2003.  In fact, one of the reasons I went to law school is because two of my family members both needed liver transplants after receiving a contaminated batch of prescription drugs.  I graduated from Michigan State University College of Law in May of 2010 and am currently awaiting the results of the July 2010 bar exam.

One of the reasons I started this blog was so that I could share information with the public that drug companies won’t.  For that reason, I often post documents filed in prescription drug lawsuits.  There is no better way for patients, doctors, and the rest of the public to find out the hidden dangers of prescription medication than to read the documents produced in drug lawsuits.

I also talk a lot about the law of defective drugs at this blog.  None of this information is offered as or should be considered as legal advice.  Legal advice only comes when you hire a licensed attorney and he or she examines your case in detail.  I may even discuss a case that sounds *just like* your case, but that doesn’t mean it is.  If you think you need legal advice, contact me and I’ll put you in touch with a top-notch drug attorney who can help you.

Please also feel free to contact me if you have questions, contacts, suggestions, or criticisms for me.  Or, if you don’t like using forms, you can email me at justinian AT justinian DOT us.

 And don’t worry – I’ll never sell your contact information, and no one will ever contact you without your permission.

When I read the following article this morning, the first question I had was whether these Mylan employees overrode quality control guidelines for the Mylan fentanyl patch:

MORGANTOWN, W.Va. — Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.

Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.

But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

Source: http://www.post-gazette.com/pg/09207/986516-28.stm#ixzz0MT8ZvQJB

The article doesn't specifically mention the Mylan fentanyl patch, but it doesn't exclude it, either.  I'm glad that Mylan management took the initiative to launch an investigation, but I'm disturbed that overriding the quality control mechanisms was apparently as simple as "right-clicking" the red screen.

Many people refer to Windows crashes as "The Blue Screen of Death." If Mylan employees knowingly released defective fentanyl patches, perhaps we should start talking about "The Red Screen of Death," as a defective patch can certainly kill someone.  In fact, many lawsuits have been filed over deaths attributed to Mylan fentanyl patches already.

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

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.

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

To say that Dr. Parisian doesn’t approve of Johnson & Johnson’s conduct with respect to the Ortho-Evra patch would be an understatement.

104. J&J disregarded its duty and obligations as a pharmaceutical manufacturer, ignored forty-years of oral contraceptive history and science, failed to utilize good scientific methods and appropriate evaluation of its pre-clinical safety signals for design, development, testing and marketing of ORTHO EVRA. J&J's scientists in 1996, had calculated that a 20cm2 patch should be loaded with 60 mcg of EE to deliver a nominal 20 mcg EE per day based on EE skin flux of 0.04 mcg per cm2 per hour. The EE delivery values had been based on PK characteristics of ORTHO CYCLEN OC and were aimed at obtaining a steady state range of 40-50 pg/ml (Audett, 7/23/07, p 254, I. 18-20). However, J&J's development team subsequently made a determination to increase patch EE adhesive loading to 75 mcg to increase the delivery of EE. After increasing the systemic EE delivery for the patch, J&J disregarded the safety signal of increased reporting of thrombotic events during the Phase 3 clinical trials as well as disregarded a February 20, 1998 Leiden-Site report to Dr. Shangold of unacceptable estrogenic side effects suggesting high systemic EE delivery from J&J's clinical investigator Dr. Peter Van der Ark (POE 04854048). J&J also disregarded the coagulation results of CONT-006 (APPENDIX 6 30,109,178,198, 222-225). Furthermore, during its pre-NDA negotiations with the FDA, J&J failed to adequately inform the FDA that as early as 1998 it had been aware of safety signals of increased reports of pulmonary emboli greater than anticipated for a 35 mcg OC. After obtaining the FDA's NDA approval, J&J continued to elect not to provide its own clinical experts , key opinion leaders ("KOL"), physicians and patients with adequate warnings about increased systemic EE delivery and reporting of VTE in its clinical trials in its original ORTHO EVRA label, and communications (APPENDIX 6 ¶ 283-288). J&J was aware that, unlike ORTHO EVRA being sold in the United States, J&J's EVRA patch sold outside the US was loaded with 60mcg of EE. EVRA, and also unlike ORTHO EVRA, had been able to support EE bioavailability to a 35 mcg CILEST OC (NRGEEP-POI-1025) as well as bioavailability to historical data for J&J's clinical trial lot 10607. J&J's actions regarding its follow-up of the safety of increased EE delivery of ORTHO EVRA has shown a disregard for ensuring patient safety and a disregard for its own duty to sell safe and effective products. Such actions by J&J have directly contributed to the injuries and deaths of healthy young women who elected to use ORTHO EVRA for prevention of unintended pregnancy.

Continue Reading Dr. Suzanne Parisian’s Expert Report in an Ortho Evra Lawsuit