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.
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
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
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
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:
The two most popular types of Fentanyl patches are the reservoir design, and the matrix design. Immediately below is a diagram of the reservoir design:
As you can see, the reservoir patch gets its name from the fact that the fentanyl is contained in a reservoir. In Duragesic fentanyl patches and authorized generics such as
The following expert report from Swicegood v. Pliva, Inc. explains how Metoclopramide (generic Reglan) can cause movement disorders, such as Tardive Dystonia and Tardive Dyskinesia.
I noticed that Robert Gale is mentioned here as well. He’s the inventor of the Duragesic fentanyl patch; I’m not yet sure what involvement he has with Reglan / Metaclopramide.
What’s of particular interest to me is the fact that Robert Gale was deposed about the problems inherent with the Duragesic patch way back in 1996. Now that’s a deposition I’m going to try and get a hold of.
Way back in the 90’s, there hadn’t been as many problems or as much publicity about the Duragesic patch. You never know what Gale might have said under those circumstances.
Continue Reading Testimony from a Duragesic patch lawsuit from 1996
Here’s some expert testimony that touches on Robert Gale’s patent for the Duragesic fentanyl patch. This lawsuit dates back to 2000.
This is also actual trial testimony, not just deposition testimony.
Continue Reading Lawsuit Over Robert Gale’s Duragesic Patent
Interesting information regarding the development of ALZA and Mylan’s patches.
MARIO A. GONZALEZ having first been duly sworn, was examined and testified as follows:
COURTROOM deputy: Please take the stand, Dr.
THE COURT: Good afternoon, Dr.
THE WITNESS: Good afternoon, Your Honor.
MS. DAVIS: should I proceed, Your Honor?
THE COURT: Yes
DIRECT EXAMINATION BY MS. DAVIS:
Q. Good afternoon, Dr. Gonzalez.
A. Good afternoon.
Q. Would you please tell the court where you reside?
A. I live in Pembroke Pines, Florida.
Q. what is your present employment, Dr. Gonzalez?
A. Well as of a few weeks ago, I was President of Global Max Americas. ICON clinical is a large CRO. They announced that they are purchasing us, that they have purchased us. And I will – and that was my old job.
I will continue consulting as a pharmacoki neti ci st.
Q. Could you just explain what a CRO – you used that term – I'm not sure we are all familiar with that acronym.
A. CRO is abbreviation for a Contract Research organization. Global Max Americas was part of the Global Max Group which was a group of about 80 scientists doing consulting work and running clinical studies and helping companies develop products. And ICON is about 3,000, scientists so they are bigger than us. They made an offer we couldn't refuse. And we are being bought.
Q. Would you describe briefly to us your areas of expertise or the areas in which you perform consulting?
A. I'm a pharmacokineticist. I consult primarily in pharmacokinetics and other issues related to clinical pharmacology. Meaning pharmacology applied to humans and the effect of drugs in humans.
My work in pharmacokinetics has primarily focused on control release delivery systems, both oral and transdermal. So most of the consulting I do usually involves the drug that is not an immediate release product.
Q. So an immediate release would be something that goes in once and immediately gets dispersed through the body, as opposed to controlled release where the drug comes out over time?
A. That's right. A controlled release product is, as the name implies, the drug is being physical, chemically controlled by the dosage form. A transdermal system is a perfect example of that.
Q. And you mentioned pharmacokinetics. Could you define for us or describe for us what aspects of the study of drugs and how they operate is covered under the definition of pharmacokinetics?
A. Yeah. There is the little – a little acronym 1 we always talk about pharmacokinetics, ADMS. And it stands for absorption, distribution, metabolism and excretion. So pharmacokinetics is really the study of how drugs move around in the body, sort of a cocktail party description of the term.
And what we do is we basically use mathematics to describe the absorption, or how the drug distributes, or how it gets eliminated. Elimination is a combination of both metabolisms and excretion. Excretion meaning that the drug comes out of the body without being metabolized. For example, Fentanyl – 10 percent of a Fentanyl dose comes out unchanged in the urine. That's excretion.
Q. And what happens to the other 90 percent? Continue Reading Testimony of Mario Gonzalez in ALZA v. Mylan Fentanyl Patent Lawsuit