Dangerous Drugs: News About Lawyers, Lawsuits, & Drugs Like Fentanyl, Reglan, and Phospho-soda

A Myriad of Mylans – Who to Sue in a Fentanyl Case?

I just generically refer to “Mylan” when I mean any one of several Mylan companies.  The best information I’ve seen so far about which Mylan is which comes from their own in-house litigation counsel, Brian Cutherbertson.  He filed a three page affidavit on August 13th of 2009 in the case of Boles v. Mylan.  In it, he details the corporate makeup of Mylan:

5. There is no entity presently operating under the name Mylan Laboratories, Inc. In October, 2007, Mylan Laboratories Inc. officially changed its name to Mylan Inc. ("Mr').

6. MI is a holding company incorporated under the laws of the Commonwealth of Pennsylvania, with its principal place of business at 1500 Corporate Drive, Canonsburg, PA 15317.

7. MI is a shareholder of companies involved in the production of quality generic and specialty pharmaceutical products.

8. MTI is a wholly owned subsidiary of MI and is a corporation organized and existing under the laws of the State of West Virginia with its principal place of business in St. Albans, Vermont.

9. On January 28,2005,M TI received approval from the federal Food and Drug Administration (" FDA") for the manufacture of the Mylan Fentanyl Transdermal System ("MFTS''). A true and correct copy of the FDA approval letter issued on January 28,2005, is attached to this Affidavit as Exhibit No. 1.

10. Pursuant to an Abbreviated New Drug Application submitted by MTI, FDA issued approval for MTI's manufacture of the MFTS concluding that the product was safe and effective when used in accordance with its approved labeling.

11. Since obtaining FDA approval on January 28, 2005, MTI has manufactured the MFTS at its production facilities in St. Albans, Vermont. Distribution of the MFTS is handled through MPI, another wholly owned subsidiary of MI. MPI is a West Virginia corporation with its principal place of business in Morgantown, West Virginia.

12. I understand that the Original Petition filed on behalf of plaintiff in this matter claims that Ms. Vail died on July 12, 2006, allegedly as a result of complications stemming from her use of the MFTS.

13. The MFTS was, at all times, developed, formulated, and manufactured by MTI. Since FDA approval of the product, MPI has been the entity responsible for the distribution and sale of the MFTS.

14. The Original Petition alleges, at paragraph 2.8, that MI, MTI, MPI, Mylan Bertek Pharmaceuticals, Inc. ("MBP"), and VDL Laboratories, Inc., are collectively " engaged in [the] business of designing, manufacturing, marketing, distributing, selling, and otherwise placing into the stream of commerce the [MFTS]." This allegation is incorrect.

15. MBP is a registered Texas corporation that is a wholly owned subsidiary of MI. However, MBP ceased all operations in June of 2005.

16. Thus, while MBP exists as a registered Texas corporation, it has no offices, employees, manufacturing facilities, warehouse, or sales staff in Texas or elsewhere. Moreover, MBP was never involved in any aspect of the design, manufacture, marketing, distribution, or sale of the MFTS.

17. Because the operations of MBP ceased in 2005, this entity absolutely was not involved in the development, manufacture, distribution, or sale of the pharmaceutical product allegedly used by Plaintiff's Decedent in 2006.

18. The final entity named in the Original Petition is VDL Laboratories, Inc. VDL Laboratories Inc. is an Illinois corporation with its principal place of business in the State of Illinois. Like MTI, UDL Laboratories, Inc. had no role or involvement in any aspect of the design, manufacture, marketing, distribution, sale, or supply of the MFTS.

If there are any typos in the above, blame my OCR software, not Mr. Cuthbertson.

Hopefully this document will help plaintiffs’ attorneys figure out which corporate entity to sue in a fentanyl lawsuit.

New Documents From Fentanyl Lawsuits

These documents pertain only to generic fentanyl patch lawsuits, not against the makers of the brand-name Duragesic patch.

• Mylan’s Lawyers Raise 29 Issues In Fentanyl Patch Lawsuit
  • They left out the kitchen sink, surprisingly.
• Report Filed in Texas Fentanyl Lawsuit
  • This report sets out the positions of the parties.
• Fentanyl lawyers file wrongful death lawsuit against Mylan Pharmaceuticals
  • Mylan has yet to face a jury trial, but they’ve been sued by many families of individuals who died of fentanyl toxicity while wearing a Mylan patch.
• Mylan Sued in Georgia Over Fentanyl Pain Patch Death
  • There are several lawsuits pending against Mylan in Georgia.

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

 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.  In this Duragesic lawsuit, Gale refuses to answer a key question about the safety the patch.
• How’s this for maintenance: ALZA had to shut the Duragesic production line down because a terrycloth towel was jammed into one of the nozzles.  If not for Duragesic lawsuits like this, these documents would never see the light of day.
• Here’s information from a Duragesic lawsuit dating all the way back to 1996.
• Not every lawsuit over the Duragesic patch is a personal injury lawsuit.  Here’s trial testimony from a Duragesic patent infringement lawsuit.
• Additional testimony from a patent lawsuit.
• Still more goodies from a lawsuit between ALZA and Mylan over the development of Mylan’s “matrix” patch.
• A Duragesic lawsuit filed prior to the 2008 recall.
• The deposition of Sanjay Panda, an ALZA executive.  In this deposition, he talks quite a bit about the manufacturing process at ALZA’s Vacaville plant.
• The deposition of the Chief Medical Examiner for Broward County sheds some light on how fentanyl toxicity is determined as a cause of death.
• Expert witness Mark Prausnitz, Ph.D., testifies on behalf of the plaintiff in a Duragesic wrongful death lawsuit.
• The deposition of a toxicologist in the Hendelson Duragesic lawsuit.  That trial ended in a multimillion dollar verdict for the plaintiff.
• Plaintiff’s motion in limine regarding Duragesic studies performed by the defendants.
• As usual, the defendants in a Duragesic fentanyl lawsuit don’t want the jury to see evidence of other defective fentayl patches.
• Robert Middleberg, Ph.D., testified on behalf of the plaintiff in the Dicosolo lawsuit.  That Duragesic trial ended in a big win for the plaintiffs.
• Here’s the deposition of Duragesic defense expert Bruce Goldberger, Ph.D.
• Prausnitz again, this time in the Dicosolo Duragesic lawsuit.
• Here’s a copy of a fentanyl lawsuit filed in New York, alleging a defective Duragesic patch killed Charles Addison.
• Watson Pharmaceuticals is the defendant in this fentanyl lawsuit.  They make a patch that competes with Duragesic.
• And now Mylan is the defendant in this Georgia fentanyl lawsuit.
• Mylan has been getting sued a lot recently.  Here’s a Mylan fentanyl lawsuit, and their answer to it.
• Scorched Earth litigation means discovery battles.  This discovery battle is going on in a Mylan lawsuit.
• Robert Gale, inventor of the Duragesic fentanyl pain patch, gave this deposition in the Discolo lawsuit that was a big loss for the patch maker.
• Here’s the expert report of Michael Kaufman, a witness who determined a defective Duragesic patch was responsible for the death of James Adams.
• And now here is Kaufman’s deposition from the same Duragesic lawsuit.
• One of the issues in any fentanyl lawsuit in which someone died is the issue of postmortem redistribution.  Rather than let me explain it, why not read an expert’s opinion?
• ALZA makes generic fentanyl patches on the same machines that make the Duragesic patches.  No surprise, then, that there have been lawsuits against generic fentanyl patch manufacturers.  Sandoz is the defendant in this one.
• Ever see a motion for summary judgment?  Now you can say you have; this one comes from a Duragesic lawsuit.
• Now we’ve got the first amended complaint from the Duragesic lawsuit filed over Charles Addison’s death.
• The complete text of another Duragesic lawsuit.
• Another lawsuit alleging that Duragesic is defectively manufactured and defectively designed.
• How good is the quality control at the Duragesic factory?  Read this report and judge for yourself.
• $750 an hour doesn’t buy you a good spell checker, apparently.
• When I saw this Duragesic “test,” the first words that came to my mind were “junk science.” 
• An FDA Warning Letter sent to the maker of the Duragesic patch.
• The guy in charge of making Duragesic doesn’t know if fentanyl is dangerous.
• A little background information about the Duragesic patch.
• Courtesy of Google Earth, an overhead shot of the factory where Duragesic is made.
• Just how many autopsies did this Duragesic lawyer buy?
• The makers of the Duragesic patch would probably prefer it if you didn’t read this Establishment Inspection Report filed by the FDA after the Duragesic recall.
• FDA Medwatch reports show many problems with the Duragesic patch.
• What’s the Bodolay I?  It’s the machine responsible for many defective Duragesic patches.
• Deposition of David Chullino shows that fentanyl inspectors were supposed to examine 4 patches per second!
• The deposition of ALZA executive Suneel Gupta gives a wealth of valuable information about the Duragesic lawsuits the company is facing.
• Was keeping defective Duragesic patches off the market a high, or a low priority?

I may have a few more documents pertaining to fentanyl or Duragesic side effects, but that ought to keep you busy reading for a loooong time.

Technorati Tags: Duragesic,Fentanyl,discovery documents,pharmaceuticals

Testimony from a Duragesic patch lawsuit from 1996

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.

Technorati Tags: Duragsic,Fentanyl,Duragesic lawsuit,fentanyl lawsuit

Deposition of ALZA Executive Regarding Manufacturing Process at Vacaville Duragesic Plant

This deposition is of Sanjay Panda, an executive with ALZA.  During this Duragesic lawsuit, Panda testified as to how the Duragesic fentanyl patch is manufactured at the Vacaville Duragesic factory.  I believe I’ve already posted this in PDF format, but here it is in text format.

Technorati Tags: Duragesic,Duragesic patch,fentanyl,fentanyl patch lawsuit,fentanyl lawsuit,Duragesic lawsuit

THE VIDEOGRAPHER: Good morning. My name is Michael Barber, and I am a videographer associated with Barkley Court Reporters located at 222 Front Street, Suite 600, San Francisco, California, 94111.

The date is October 23rd, 2006. The time is 9:21 a.m.

This deposition is taking place at the Barkley Court Reporters office at 1435 River Park Drive, Suite 502, Sacramento, California 95815, in the matter of Judith Davis versus Johnson & Johnson, et al., Case No. 505 CV 2910C10 GRJ.

This is the videotape deposition of Sanjay Panda being taken on behalf of the plaintiff.

Counsel, would you please identify yourselves for the record and state whom you represent.

MR. ANGWIN: Ed Angwin for the plaintiffs.

MR. HARVEY: Todd Harvey for plaintiffs.

MR. ZELLERS: Michael Zellers for the defendants.

THE VIDEOGRAPHER: Thank you. Would the court reporter please swear in the witness.

(Whereupon, the witness was sworn.)

MR. ZELLERS: Mr. Angwin, before we start, I would like to note that this deposition is considered by the defendants as being confidential and subject to the protective order.

We also have agreed that this deposition is being taken in a number of cases which the court reporter will note in the transcript.

One last thing: All objections except as to form are reserved.

MR. ANGWIN: Thank you. And we understand and we will be using certain documents which have been produced subject to the protective order, and we will treat them accordingly.

Also, for the sake of not having to depose Mr. Panda five times, we are taking this in the case of Debra Evans, Dorothy Hart, Lee Hendelson, and Joseph Pinedo, and the court reporter is going to designate those in the record.

EXAMINATION

BY MR. ANGWIN:

Q. Mr. Panda, I understand you have been deposed before; is that correct?

A. That's true.

Q. You are familiar with the process?

A. True.

Q. Okay. You understand I am going to ask you a series of questions. If you can answer them, answer them. I don't want you to guess. I don't want you to state things unless you know them. And also if you have -- if you feel a question I ask Is unclear, you are welcome to ask me to rephrase it or else you are welcome to take a break whenever you want to or confer with your counsel.

A. Thank you.

Q. Can you please state your full name for the record.

A. Sanjay Panda.

Q. Mr. Panda. And, Mr. Panda, where do you 09:23A reside?

A. Sacramento.

Q. Sacramento, California?

A. North of Sacramento. Yuba City.

Q. Where are you currently employed?

A. Alza Corporation.

Q. In what city is that in?

A. Vacaville, California.

Q. Okay. Did you review any documents or other materials in preparation for this deposition?

A. No. I was traveling. I did not get time.

Q. It's my understanding you have been deposed previously.

A. Yes.

Q. Did you review documents prior to those depositions?

A. Yes.

Q. And I believe you testified as to what those were. Since those depositions and this deposition, have you reviewed any documents which relate to the 2003/2004 time frame or any of the lots that are involved in the five cases we are here about today?

A. No.

Q. Have you also given trial testimony in any cases relating to Duragesic patches?

A. No.

Q. Have you given testimony by affidavit or sworn statement in any cases involving Duragesic patches?

A. No.

Q. When you previously testified, which cases was that in?

A. I don't recall the cases. I think -- believe one was Thompson case, but I don't recall.

Q. That was the Thompson case, the Texas case?

A. (Witness nods head).

Q. Would that be the one where Fletch Tramble (phonetic) deposed you? Does that sound familiar?

MR. ZELLERS: If you know.

Deposition of Chief Medical Examiner for Broward County in Duragesic Lawsuit

Here’s the deposition of Dr. Joshua Perper, the Chief Medical Examiner for Broward County, Florida.  Because he works for the county, he wasn’t a witness for either the plaintiff or the defendant.  But read his deposition and decide for yourself which side his testimony helped more.

Technorati Tags: Duragesic,Duragesic lawsuit,fentanyl,fentanyl lawsuit

JOSHUA A. PERPER, M.D. was called as a witness by the Defendants and, having been first duly sworn, was examined and testified as follows:

DIRECT EXAMINATION

BY MR. AUCIELLO:

Q. Doctor, will you state your name for the record, please?

A. Joshua A. Perper, P-E-R-P-E-R.

Q. Sir, what is your present position?

A. I am chief medical examiner for Broward County.

Q. Doctor, I'll show you a document that we have just received that we will mark Defendant's Exhibit 1, which I believe is a curriculum vitae (handing).

(Thereupon, the said document was marked as Defendant's Exhibit No. 1 for identification.)

THE WITNESS: That's my curriculum vitae.

BY MR. AUCIELLO:

Q. Doctor, it's a very voluminous curriculum vitae. We won't go through it in detail, but just in a shorthand fashion, can you tell us about your education?

A. Okay. I have the foreign medical education. I have a medical degree from the Medical School of Hebrew University. I have a law degree from the law school of the same university. I have a master of science in forensic medicine from Johns Hopkins University.

More than 30 years I have been engaged in the practice of pathology and forensic pathology. From 1967 to 1972, I was an Associate Medical Examiner at the Office of the Chief Medical Examiner in Baltimore, Maryland. In 1972 to 1980, I was the Chief Forensic Pathologist for the Coroner of Allegheny County, Pittsburgh, Pennsylvania. From 1988, except for a few months, till 1994 I was the elected coroner for Allegheny County. From 1994 to the present, I am the Chief Medical Examiner for Broward County.

I am licensed to practice medicine in the State of Florida and I have active licenses in Pennsylvania and Washington, D.C.

I'm Board certified in anatomical and surgical and forensic pathology. I am a member of various medical associations. I used to be the chairman of the State Board of Medicine in Pennsylvania, both which regulates and analyzes physicians.

And in Pittsburgh, during my stay in Pittsburgh, I was clinical professor of pathology and a clinical professor of epidemiology and public health at the University of Pittsburgh.

And I was also for short time an adjunct professor of law at Duquesne University.

And in Florida I am a clinical professor of pathology and epidemiology at the University of Miami. I'm also clinical professor of pathology and epidemiology and public health at Nova University.

I wrote several books or chapters in books, approximately seven or eight, and I have more, about 120, publications in the field of pathology and forensic pathology.

Q. Doctor, I have your publications here in your CV. Would you characterize any of them as being primarily about issues in toxicology?

A. No, but there are toxicology-related subjects.

Q. Do you consider yourself an expert in toxicology, also?

A. No. However-- No, I'm not a toxicologist. However, I know about the action of drugs involved and the interpretation of results in toxicology.

Q. Not just in this autopsy that we are going to talk about, how is toxicology done here at Broward County? Is it sent to an independent lab or is it done here?

A. Well, no. Well, both. In other words, it depends on the type of analysis. Most of the tests are done in our office. We have a Department of Toxicology, and Doctor Schueler is the chief toxicologist; therefore, if you have any questions which relate to the technical or to the scientific significance of the testing, he is certainly qualified to answer that.

Now, in certain cases, if there are drugs which we do not encounter them commonly or we don't have a method for them, because of that reason they might be sent to an outside lab.

MR. AUCIELLO: I'll show you right now a document we will mark as Exhibit 2 (handing).

(Thereupon, the said document was marked as Defendant's Exhibit No. 2 for identification.)

BY MR. AUCIELLO:

Q. I'll ask you if you can identify it (handing)

A. Yeah. This is my autopsy report in this case. And, in addition to that, I can see something else. You have some other number of records from the file--

Q. From your file; correct?

A. Yes.

--which include the investigation report by our medical examiner investigating, Linda Krivjanik; - she is still with us - a telephone note in relation to a telephone call which was received from the mother, Maxine Heller; a narrative information which comes from Transportation Service which is used in the evening hour or so, as people who take the information when somebody dies; a diagram of the body of the deceased;--

Q. This all relates to the autopsy of--

A. Just a moment. I'm not done.

--a list of the deceased's clothing and effects; the morgue intake receipt; Broward Removal Services form in which they indicate whom they transported to the office and the identification of the person. And then I believe there's a copy of prescription forms. And then there's a contact documentation from Adam Hendelson who want to speak as fast as possible with--

Q. Did you mean to say, Doctor, Lee Hendelson called instead of Adam Hendelson?

A. He called, yes. That's basically all.

This is yours; right (handing)?

Q. Yes. That will be the exhibit.

Doctor, did you do the autopsy on Adam Hendelson?

A. Yes.

Q. Is it your practice that you will do it personally or will you supervise someone else?

A. I do it personally.

Q. Did anyone assist you in the autopsy?

Plaintiff’s Motion in Limine Regarding Duragesic Studies

This motion was filed by the plaintiff, and asked the court to exclude evidence of studies performed by the manufacturers of the Duragesic patch.  The plaintiff presented evidence that the studies were too unreliable to go before a jury.

Technorati Tags: Duragesic,Duragesic lawsuit,fentanyl,fentanyl lawsuit

Motion in Limine regarding other evidence of defective Duragesic patches

In every Duragesic or fentanyl lawsuit, two things will happen:

First, the plaintiff will discover evidence of other people injured by the fentanyl patches.  This evidence will come in the form of FDA reports, internal company reports, and perhaps even other lawsuits.

Second, the defendants will file a motion in limine that asks the court not to let the jury see that information.

This is just one of the many tricks that defendants in product liability lawsuits such as this pull.  Thankfully, I know several former defense lawyers who used to represent companies in lawsuits like this one.  Now, they represent injured people and know first hand what they’ll be up against.  If you’d like me to put you in touch with a Duragesic lawyer, just contact me and I will.

Defendants Johnson & Johnson, Janssen Pharmaceutica Products, L.P., and ALZA Corporation hereby move for an Order excluding from trial all evidence relating to other incidents, adverse event reports, and product complaints involving Duragesic, the product at issue in this case. More specifically, Defendants move to exclude Plaintiff's Exhibit Nos. 62-70, 72-73, 84, 87, 103-104, 109, 112, 163, 165, 193, 208-210, 214-215, 217, 220-221, 228-229, 237, 246, 249-250, 257, 269, 272, 309-311, 394-400, 403, 453, 464-465, 468-474, 479-502, 505-509, 514-516, 539-541, 543, 545-557, 562-580, 583-584, 595-596, 602-652, 671-672, and 682-702 and any other document, testimony or argument relating to other incidents, adverse event reports, and product complaints involving Duragesic. Such evidence is inadmissible because these reports and complaints (1) are hearsay within hearsay, (2) reflect incidents that did not occur under reasonably similar conditions to those involved in this case, (3) are not relevant to the determination of the facts at issue in this action, and (4) are unfairly prejudicial to Defendants and confusing to the jury. Such evidence is therefore inadmissible under Federal Rules of Evidence Rules 401, 402, 403, and 802.
I. FACTS

The product at issue in this case is Duragesic, a prescription pain patch that delivers medication through the skin of the user. Duragesic is manufactured by defendant ALZA Corporation and distributed by defendant Janssen Pharmaceutica Products, L.P. Fentanyl, the active ingredient in Duragesic, is a generic opioid analgesic that is contained in a gel mixture inside each patch.

In 1996, Plaintiff's son, Adam Hendelson (“Decedent”), suffered a broken pelvic bone and other injuries from a severe car accident. In the following years, he developed a number of physical problems related to the car accident injuries, including arthritis and degenerative disk disease in his back. As his physical symptoms progressed, Decedent began taking an increasing variety of pain medications and anti-depressants. Decedent was found dead in his apartment in the early morning hours of December 17, 2003, at the age of 28. His death was ruled to be a result of a combined drug overdose. A variety of prescription and over-the-counter medications were found in Decedent's blood, but the medical examiner concluded that Decedent died from excessive amounts of three particular medications: Celexa, (citalopram, an antidepressant), Remeron (mirtazapine, an antidepressant), and fentanyl, the active ingredient in Duragesic. See Broward County Medical Examiner Autopsy Report, attached as Exhibit A.
II. THE PRODUCT REPORTS

As the manufacturers/distributors of Duragesic, a prescription drug, Defendants are required by federal law to record every adverse event and product complaint they receive. See 21 C.F.R. § 314.80. Adverse events (which involve patient injury) and product complaints (which do not involve injury) are reported to Defendants from third parties, generally healthcare providers, plaintiffs' attorneys, patients, and caregivers/family members. When Defendants receive a report of an adverse event from a third party, the information relayed to Defendants is entered onto certain forms that are then forwarded to the relevant departments within the company for follow-up. The forms are also forwarded to the FDA at certain intervals that are regulated by law.

Discovery Battle in Fentanyl Lawsuit Against Mylan Pharmaceuticals

Several fentanyl attorneys who have sued Mylan Pharmaceuticals and Mylan Technologies have asked the court to order the production of many documents related to the design, manufacture, and distribution of Mylan fentanyl pain patches:

Plaintiff Monica Cunningham, as personal representative of the estate of John E. Edmonson, and on behalf of the Wrongful Death Beneficiaries of John E. Edmonson (“Plaintiff”), by and through her undersigned attorneys files this Motion to Compel Production of Documents Related to (1) Communications with Governmental Agencies, (2) Inspections of Facilities, (3) Recalls, (4) Batch Records, (5) Operating Procedures, (6) Product Returns, (7) Plaintiff, and (8) Intended Fentanyl Concentrations. Pursuant to Local Rule 3.01(j), Plaintiff requests oral argument on this motion and estimates the Court will need thirty minutes to hear the Motion.

I’m not surprised at all that the fentanyl attorneys representing Mylan are refusing to hand these documents over without a protective order.  Similar documents produced in Duragesic lawsuits have shown fentanyl manufacturers to have shoddy manufacturing plants and lackluster quality control.  At this point, I haven’t seen any documents produced from a Mylan fentanyl patch lawsuit.  I can’t wait for some to be made available, and when they are, I’ll post them here.

Defendants’ Motion for Summary Judgment in Adams Duragesic Fentanyl Patch Lawsuit

In virtually every fentanyl lawsuit, the lawyers for the defendant are going to file what’s called a Motion for Summary Judgment with the court.  A Motion for Summary Judgment asks the court to decide that the case should not go forward to a jury, but should instead be “thrown out.”  Because any fentanyl lawyer or Duragesic lawyer who represents an injured person will have to respond to one of these, I posted this one. 

I.INTRODUCTION

The independent medical examiner in this case determined that James Adams (“Adams”) died of a heart attack and also suffered from what is known as a “fatty liver.” These two conditions are unrelated to either the product at issue in this case, Duragesic, or the drug it delivers, fentanyl. Merely because Adams was wearing a Duragesic patch at the time of his heart attack, Adams's wife, Plaintiff Linda Adams, filed a wrongful death product liability lawsuit against Defendants Johnson & Johnson (“J&J“), ALZA Corporation (“ALZA “), Janssen, L.P. (now known as Ortho-McNeil-Janssen Pharmaceuticals, Inc.) (“OMJPI”), and Hook-SupeRx, L.L.C. (“Hook-SupeRx”) (collectively referred to as “Defendants”).[FN1] ALZA and OMJPI manufacture and distribute Duragesic, a prescription pain patch that delivers fentanyl transdermally through the skin of the person to whom it is applied. Hook-SupeRx is the owner and operator of the CVS pharmacy that filled the prescription at issue.

    FN1. CVS Pharmacy #6386, CVS 6386 IL, L.L.C., Hook-SupeRx, Inc., and CVS Corporation were also initially named as defendants. The latter three defendants were never served and CVS Pharmacy #6386 is not a legal entity capable of being sued. (Notice of Removal, ¶4, at 2.)

The two counts of Plaintiffs complaint raise negligence and strict liability product liability claims which, under Illinois law, both require expert testimony of a defect. Defendants are entitled to judgment as a matter of law on both counts because Plaintiff presents no testimony, expert or otherwise, that the patches worn by Adams were defective in any way. Without expert testimony of a defect, Plaintiff cannot avoid summary judgment by relying on circumstantial evidence to establish a non-specific defect because there is a reasonable secondary cause for this injury, there is no “smoking gun” evidence of a defect, and any alleged defect is outside the common knowledge of jurors. Shawgo v. General Motors Corp., 2007 WL 2301315 at * 6 (S.D.I1, August 09, 2007, Judge Murphy). (Ex. 1.)

In addition to the lack of expert testimony, the negligence claims found in Count I fail as a matter of law because Plaintiff has no evidence that Defendants were negligent in the manufacture, design, sale, or labeling of the Duragesic(R) patches used by Adams. Defendants are also entitled to summary judgment on the strict product liability claims found in Count II because Plaintiff has not identified either a manufacturing expert, a design expert, or a warnings expert to support these claims. Specifically, Plaintiff's manufacturing defect claims fail by virtue of the absence of any evidence related to the manufacture of the patches worn by Adams. Her design defect claim suffers from a lack of evidence that an alternate design would have prevented Adams's death. Moreover, her design defect claim is barred by Illinois's adoption of comment k to Restatement §402A regarding “unavoidably unsafe” products like Duragesic(R). Defendants are further entitled to summary judgment on the failure-to-warn claims because the prescribing physician was sufficiently apprised and adequately warned of the risks of Duragesic(R). Additionally, Plaintiff's state tort law claims based on design defect and failure to warn are preempted by federal law. Finally, the strict product liability count against Hook-SupeRx should be dismissed as a matter of law because it has, pursuant to 735 ILCS 5/2-621, certified the correct “identity of the manufacturer of the product which allegedly caused the injury.”

Thus, for these reasons, this Court should grant summary judgment in Defendants' favor.

More Information About the Quality Control Procedures at the Duragesic Plant

An expert witness report from a Duragesic lawsuit explains why so many Duragesic fentanyl patches from 2003 and 2004 had safety problems.  Apparently, the problem was that employees were expected to visually inspect 240 patches per minute.  I’ve written about that before.  What I just discovered was that as early as March of 2002, there was an electronic quality control system available that supposedly could have eliminated the need for employees to visually inspect the patches:

11. Do the batch records and documents demonstrate that the defendants failed or refused to take appropriate and necessary corrective and preventative action to ensure that the Duragesic patches released to consumers in 2003 - 2004 periods were safe?

Opinion: Yes

Rationale: The company knew that there were critical defects present in the product that were inherent to, and directly traceable to, the design of the product, yet they produced and released product for years without changing the design to assure that the product was safe. The company knew that the production process was incapable of consistently producing product but they kept trying to minimize the problems by inspecting and segregating pockets of each lot rather than stopping production and re-designing the process.

FDA would term the company’s actions, as they have in similar situations with many other companies, as "testing into compliance" - repeated testing of the product until a satisfactory test result is obtained. Further, according to the company’s qualification report (DUR2 082575) dated March 2002, the company had available a qualified "Electronic Vision Inspection System" that could have been used to detect critical patch defects. For reasons that cannot be ascertained from the evidence made available to me, this device was not in operation during this time period, and not in operation for this specific batch of Duragesic.

Untrained operators were required to perform visual inspection of patches as they exited the Bodolay machine at a speed of 14,400 units/hour (equivalent to 240 patches exiting the machine each minute). The electronic vision inspection system was designed (DUR2 082576) to 100% inspect, detect, and reject patches with:

¯ Seal flaws, including gel within the seal
¯ Seal width within tolerance limits
¯ The presence of gel within the system

In my opinion, if the electronic vision system had been used during this time, and in particular for the manufacture of 0327192, it is likely that the widespread and obvious defects leading to the company’s recall of Duragesic patches would have been caught during manufacture and defective patches, rejected, and hence not released to market.

I know that at some point in time the company did implement the “Electronic Vision Inspection System,” but I don’t know how effective it has been in spotting defects like the “classic stringer leaker” and other common defects with Duragesic patches.  Considering that each defective patch can lead to a wrongful death, I hope the new system is really 100% effective.  Otherwise, there will be more Duragesic lawsuits filed.

Here’s a link to more information about this expert report, including the full report in PDF format.

Janssen Warned By FDA About Misleading Claims

Here’s the text of a letter sent by the FDA to Janssen about the Duragesic patch back in 2004.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration Rockville, MD  20857

TRANSMITTED BY FACSIMILE
Ajit Shetty, M.D. CEO Janssen Pharmaceutica, Inc. 1125 Trenton-Harbourton Road Titusville, NJ 08560-0200
RE: NDA # 19-813
Duragesic® (fentanyl transdermal system) CII

MACMIS # 12386
WARNING LETTER
Dear Dr. Shetty,
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a professional file card (DR-850) for Duragesic® (fentanyl transdermal system) submitted by Janssen Pharmaceutica, Inc. (Janssen) under cover of Form FDA 2253.  The file card makes false or misleading claims about the abuse potential and other risks of the drug, and includes unsubstantiated effectiveness claims for Duragesic.  The file card thus misbrands the drug under Section 502(a) of the Federal Food, Drug, and Cosmetic Act (Act) 21 U.S.C. 352(a).  By suggesting that Duragesic has a lower potential for abuse compared to other opioid products, the file card could encourage the unsafe use of the drug, potentially resulting in serious or life-threatening hypoventilation.
Background
According to the approved product labeling (PI), Duragesic is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours.  Duragesic is indicated in the management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be managed by lesser means such as acetaminophen-opioid combinations, non-steroidal analgesics, or PRN dosing with short-acting opioids.  The Indications and Usage section of the PI states: "Duragesic should not be used in the management of acute or postoperative pain because serious or life-threatening hypoventilation could result (see BOX WARNING and CONTRAINDICATIONS)."  The boxed warning and contraindications sections further discuss the risk of serious or life-threatening hypoventilation.  This risk is also addressed in the warnings and precautions sections of the PI.
Duragesic has the potential for abuse. The Drug Abuse and Dependence section of the PI states, in pertinent part:
Fentanyl is a Schedule II controlled substance and can produce drug dependence similar to that produced by morphine.  DURAGESIC® (fentanyl transdermal system) therefore has the
Ajit Shetty Page 2 Janssen Pharmaceutica, Inc. NDA 19-813
potential for abuse. Tolerance, physical and psychological dependence may develop upon
repeated administration of opioids.
False or Misleading Safety Claims
The file card presents the prominent claim, “Low reported rate of mentions in DAWN data,” along with Drug Abuse Warning Network (DAWN) data comparing the number of mentions for Fentanyl/combinations (710 mentions) to other listed opioid products, including Hydrocodone/combinations (21,567 mentions), Oxycodone/combinations (18,409 mentions), and Methadone (10,725 mentions).  The file card thus suggests that Duragesic is less abused than other opioid drugs.
This is false or misleading for two reasons.  First, we are not aware of substantial evidence or substantial clinical experience to support this comparative claim.  The DAWN data cannot provide the basis for a valid comparison among these products. As you know, DAWN is not a clinical trial database.  Instead, it is a national public health surveillance system that monitors drug-related emergency department visits and deaths.  If you have other data demonstrating that Duragesic is less abused, please submit them.
Second, Duragesic is not as widely prescribed as other opioid products. As a result, the relatively lower number of mentions could be attributed to the lower frequency of use, and not to a lower incidence of abuse. The file card fails to disclose this information.
The information from the Drug Abuse and Dependence section of the PI, which appears in a footnote on the opposite page of the spread (entitled “Favorable side-effect profile”) is not sufficient to make the claim truthful and non-misleading.  The footnote does not substantiate the claim. Nor does it set forth qualifying information about the frequency of prescribing of the compared opioids.  
In addition, on the page entitled “Favorable side-effect profile,” the file card presents the claim, “Minimizes the potential for local GI side effects by avoiding GI absorption,” along with a table entitled, “Adverse experiences in patients with cancer,” that shows a 14 percent rate of constipation with Duragesic and a 0 percent discontinuation rate because of constipation.  This combination of text and graphics is false or misleading, in that it suggests that Duragesic is associated with less constipation, nausea, and vomiting than oral opioids, which are absorbed by the GI tract.  We are not aware of substantial evidence or substantial clinical experience to support this comparative claim.

Unsubstantiated Effectiveness Claims
The file card states, on page four, “Demonstrated effectiveness in chronic back pain with additional patient benefits.” The referenced study,1 conducted by Simpson et al., is inadequate to support this claim, because it was an open-label, single-arm trial with no control group.  We are not aware of substantial evidence or substantial clinical experience to support this claim.
On pages 4 and 5, the file card includes the claims, “86% of patients experienced overall benefit in a clinical study based on: pain control, disability in ADLs, quality of sleep,” “All patients who experienced overall benefit from DURAGESIC would recommend it to others with chronic low back
1 Simpson RK Jr, Edmondson EA, Constant CF, Collier C.  Transdermal fentanyl as treatment for chronic low back pain. J Pain Symptom Manage.  1997; 14:218-224.
Ajit Shetty Page 3 Janssen Pharmaceutica, Inc. NDA 19-813
pain,” “Significantly reduced nighttime awakenings,” and “Significant improvement in disability scores as measured by the Oswestry Disability Questionnaire and Pain Disability Index.”  To support these claims, the file card again cites the Simpson et al. trial.  For the reasons noted above, this uncontrolled study is inadequate to support such claims.  We are not aware of substantial evidence or substantial clinical experience to support these claims.
On pages 6 and 7, the file card includes the claims, “Long-term effects: 12-month open-label study,” “Significant improvement in physical functioning summary score,” and “Significant improvement in social functioning,” along with figures illustrating these claims.  To support these claims, the file card cites a study2 conducted by Milligan et al. This open-label, uncontrolled study is not adequate in design to show an analgesic effect.  The data from this study are not substantial evidence or substantial clinical experience to support such outcomes claims.  We are not aware of substantial evidence or substantial clinical experience to support these claims.
On pages 8 and 9, the file card includes the claims, “Improved patient outcomes: Open-label, crossover comparison study,” “Significant improvement in physical functioning summary score,” and “Significant improvement in social functioning,” along with figures comparing data for Duragesic and sustained release oral morphine.  To support these claims, the file card cites the study3 conducted by Allan et al.. An open-label study cannot minimize bias in the reporting of subjective response in the SF-36, a general healthcare questionnaire.  It is therefore not sufficient to support the cited claims.  We are not aware of substantial evidence or substantial clinical experience to support these claims.
Finally, the file card prominently presents the claims, “1,360 loaves…and counting,” “Work, uninterrupted,” “Life, uninterrupted,” “Game, uninterrupted,” “Chronic pain relief that supports functionality,” “Helps patients think less about their pain,” and “Improvements in physical and social functioning.”  These outcome claims are misleading because they imply that patients will experience improved social or physical functioning or improved work productivity when using Duragesic.  Janssen has not provided references to support these outcome claims.  We are not aware of substantial evidence or substantial clinical experience to support these claims. 

Conclusions and Requested Actions
The file card makes false or misleading safety claims and unsubstantiated effectiveness claims for Duragesic. The file card thus misbrands Duragesic in violation of the Act. 21 U.S.C. § 352(a).
DDMAC requests that Janssen immediately cease the dissemination of promotional materials for Duragesic the same as or similar to those described above.  Please submit a written response to this letter on or before September 17, 2004, describing your intent to comply with this request, listing all promotional materials for Duragesic the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Because the violations described above are serious, we request, further, that your submission include a plan of action to disseminate truthful, non-misleading, and complete information to the audience(s) that received the violative promotional materials.  Please direct your response to me at the Food and Drug Administration, Division of Drug
2 Milligan K, Lanteri-Minet M, Borchert K, et al. Evaluation of long-term efficacy and safety of transdermal fentanyl in the treatment of chronic noncancer pain. J Pain.  2001;2:197-204. 3 Allan L, Hays H, Jensen N-H, et al.  Radomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain.  BMJ.  2001;322:1154-1158 Ajit Shetty Page 4 Janssen Pharmaceutica, Inc. NDA 19-813
Marketing, Advertising, and Communications, HFD-42, Rm. 8B-45, 5600 Fishers Lane, Rockville, MD 20857, facsimile at 301-594-6771.  In all future correspondence regarding this matter, please refer to MACMIS # 12386 in addition to the NDA numbers.  We remind you that only written communications are considered official.  
The violations discussed in this letter do not necessarily constitute an exhaustive list.  It is your responsibility to ensure that your promotional materials for Duragesic comply with each applicable requirement of the Act and FDA implementing regulations.
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
Sincerely,
{See appended electronic signature page}
Thomas W. Abrams, RPh, MBA Director Division of Drug Marketing, Advertising, and Communications
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/

Thomas Abrams
9/2/04 04:32:52 PM

A Terrycloth Towel Stopped the Duragesic Production Line During Lot 0307377

Duragesic production records produced in a Duragesic fentanyl patch lawsuit reveal that on one occasion, the Duragesic production line was shut down due to a “terrycloth towel jammed in” part of the Bodolay 1 production machine.  The picture below is a screenshot taken from page 90 of the PDF records.

According to these records, no one should have received any patches from lot 0307377.  If you did, you should contact me immediately by using the button to your right. 

If you think your injuries or the death of a loved one was caused by a defective Duragesic or generic fentanyl patch, you should also contact me.  I can put you in touch with competent, caring Duragesic lawyers who will work hard to investigate your claim and recover as much money as possible for you.  There have been several multimillion dollar jury verdicts in fentanyl lawsuits, and those lawsuits have established that defective patches were introduced into the market.

Here are the Duragesic production line records in PDF format.

An Interesting Motion to Compel in a Duragesic (Fentanyl) Lawsuit

ALZA and Ortho-McNeil-Janssen Pharmaceuticals are the primary defendants in many Duragesic lawsuits.  ALZA invented the Duragesic Fentanyl patch, and they later were purchased by Ortho-McNeil-Janssen.  In one of these fentanyl patch lawsuits, the plaintiff’s attorney obtained numerous autopsy reports of people who died due to fentanyl toxicity.  The attorney then showed those reports to the forensic pathologist and toxicologist in this case.  ALZA and OMJ want to see those autopsy reports, but the plaintiff’s attorney doesn’t want to give them to the defendants for several reasons, including the fact that the attorney paid a lot of money to buy these reports.

Supposedly, there are “thousands” of autopsy reports.  This is interesting for a couple of reasons.  First, it’s interesting to see the plaintiff fight not to turn them over, since it’s usually a defendant who doesn’t want to turn over information.  But more importantly, I wonder if there really have been thousands of deaths due to fentanyl and Duragesic patches.  I’ve only heard a ballpark estimate that 100 Duragesic lawsuits have been filed.  If there really are thousands of people who died from using the Duragesic patch, there should be at least several hundred lawsuits.  Of course, ALZA and OMJ would likely disagree with me on that.

At any rate, the motion from the Duragesic lawsuit is available here in PDF format.

FDA Inspection Report Shows Problems at Duragesic Fentanyl Patch Factory

The quality of the photocopy is a little low, but the FDA’s Establishment Inspection Report (EIR) for the Duragesic Fentanyl patch factory in Vacaville, California sheds some light on (a) why there needed to be a recall of so many defective fentanyl patches, and (b) why so many people died from defective patches.  This document was produced during the discovery process in a Duragesic lawsuit.  If it weren’t for fentanyl lawyers finding documents like this, the public might never have known why so many patches had to be recalled.

Here’s the entire Establishment Inspection Report from this fentanyl lawsuit in PDF format.

FDA Medwatch Reports Show Many Problems With Duragesic Fentanyl Patches

The FDA compiles reports of all adverse events associated with prescription drugs.  The reports for the Duragesic fentanyl patch shows lots of adhesion problems and leakage problems.  Duragesic lawyers obtained this document during discovery in a Duragesic fentanyl patch lawsuit.

The FDA Medwatch reports for the Duragesic fentanyl patch are available here in PDF format.

Information About Bodolay 1 Fentanyl Machine Explains Cause of Patch Defects

During the discovery process in a Duragesic lawsuit, fentanyl lawyers obtained a copy of the attached document explaining how the Bodolay 1 machine made Duragesic patches.  As the document reveals, the Bodolay 1 machine wasn’t the most reliable machine in the world.

Here’s the document relating to the Bodolay 1 Duragesic fentanyl patch machine.