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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Monthly Archives: July 2009

Mylan Changes Management After Damaging Report About Quality Control

Posted in Duragesic / Fentanyl

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,… Continue Reading

FDA Contradicts Mylan's Position Regarding Investigation

Posted in Duragesic / Fentanyl

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… Continue Reading

New Website Launched Dealing With Zicam Lawsuits

Posted in DangerousDrugs.US, Misc. Drugs

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… Continue Reading

About Dangerous Drugs

Posted in Uncategorized

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… Continue Reading

Did Mylan Employees Knowingly Release Defective Fentanyl Patches?

Posted in Duragesic / Fentanyl

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…. Continue Reading

Lawsuit Against Makers of Phospho-Soda Filed in New York

Posted in Misc. Drugs

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… Continue Reading

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

Posted in Misc. Drugs

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… Continue Reading

Expert Report in Fleet Phospho-Soda Lawsuit

Posted in Misc. Drugs

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… Continue Reading

Will Fleet Phospho-Soda Return to the Market?

Posted in Misc. Drugs

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… Continue Reading

New Fentanyl Patch Approved, But It Isn’t a Substitute for Duragesic

Posted in Duragesic / Fentanyl

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… Continue Reading

Duragesic Fentanyl Patch Sales Down

Posted in Duragesic / Fentanyl

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. 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…. Continue Reading

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

Posted in Misc. Drugs

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… Continue Reading

Third Phospho-Soda Lawsuit Filed in Georgia

Posted in Misc. Drugs

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… Continue Reading

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

Posted in Misc. Drugs

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… Continue Reading

Fleet Phospho-Soda Lawsuit Filed in Georgia

Posted in Misc. Drugs

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… Continue Reading

Welcome PharmaGossip Readers

Posted in DangerousDrugs.US

I’m honored that PharmaGossip linked here, and I wanted to say hello to the PharmaGossip readers.  As you’ll be able to see from looking around the blog, I’m posting as many documents as I can from pharmaceutical lawsuits, both patent and product liability.  Tax dollars go to fund the courts, and as such, these documents… Continue Reading

Documents from Fentanyl & Duragesic Lawsuits Available as of July 15th, 2009

Posted in Duragesic / Fentanyl

 As I keep adding to the stockpile of documents produced in generic fentanyl patch lawsuits and Duragesic lawsuits, I’ll post a monthly update as to what’s available.  Here’s what I have posted so far: Copy of a fentanyl lawsuit filed against Mylan Pharmaceuticals in California. A deposition of Robert Gale, the inventor the Duragesic patch. … Continue Reading

Memorandum From the Department of Health and Human Services Regarding Metoclopramide (Reglan) and Tardive Dyskinesia

Posted in Reglan / Metoclopramide

This memo from Health and Human Services was produced during the discovery process of a Metoclopramide lawsuit.  The memo was filed with the court in 2005, so it presumably is older than that. The Division of Neuropharmacologic Drug Products requested an AERS review of cases of movement disorders and neuroleptic malignant syndrome relating to metoclopramide… Continue Reading