Fentanyl Patch Lawyer, Lawsuit, and Side Effect News

California Fentanyl Attorneys Allege Mylan Did Not Provide The FDA With Adequate Information

In June of 2004, attorneys representing the family of Timothy Berry filed a wrongful death lawsuit against Mylan Pharmaceuticals.  The lawsuit alleges that a defective Mylan fentanyl pain patch is responsible for the death of Timothy Berry.  Of particular interest is this passage in the lawsuit:

12. At the time the FDA approved the initial proposed labeling for the Patch, it did not have full knowledge of the dangers inherent in the use of the product, potential defects in the product or the nature and degree of the risks accompanying its intended use. Similarly, at the time the FDA approved revised labeling proposed by Defendants, it did not have full knowledge of the product defects and the dangers inherent in the use of the product or the nature and degree of the risks accompanying its intended use. The FDA lacked such information because Defendants failed to provide the FDA with existing evidence of product defects and the risks associated with fentanyl as such evidence was obtained or should have been obtained. For these reasons, the FDA has never had an opportunity to assess the current labeling for fentanyl in light of existing evidence. (Emphasis added.)

If in fact Mylan did conceal information from the FDA, it will probably come back to haunt them in the form of a large jury verdict and perhaps a large fine.

Mylan Sued in California Over Fentanyl Pain Patch

In May of 2009, Mylan was sued in the U.S. District Court for the Northern District of California.  The lawsuit was filed by the heirs of Philip Gholson, and the suit alleges that a defective Mylan fentanyl pain patch was responsible for the death of Philip Gholson.

17. The Defendants had a duty to exercise reasonable care in the design, manufacture, marketing, sale or distribution of the Patch into the stream of commerce, including but not limited to, a duty to assure that the Patch did not cause users to suffer from dangerous side effects, including death. The Defendants failed to exercise ordinary care in the design, manufacture, marketing, testing, approval, application for approval, inspection, sale, quality assurance, reporting to the FDA, quality control, and/or distribution of the Gholson Patch into interstate commerce in that the Defendants knew or should have known that the Patch created a high risk of dangerous side effects, including death.

18. More specifically, the Defendants' negligence in the design, manufacture, marketing, testing and sale of the Patch, includes but is not limited to their:

a. Providing misleading, inadequate, and/or insufficient warnings regarding the Patch;

b. Failure to use due care in designing and manufacturing the Patch;

c. Failure to use proper materials reasonably suited to the manufacture of the Patch;

d. Failure to provide to the FDA information or data relevant to the safety of the Patch;

e. Failure to obtain easily accessible information or data relevant to the safety of the Patch;

f. Not performing sufficient testing of the Patch to confirm or ensure it was safe for its intended use;

g. Failure to use due care to test and inspect the Patch to determine its durability and functionality for the purpose for which it was intended;

h. Failure to ensure the Patch is made without defects;

i. Failure to conduct adequate testing and post-marketing surveillance to determine the safety of the Patch;

j. Misrepresenting that the Patch is safe for use;

k. Inadequate or insufficient inspection for defects;

l. Inadequate and/or insufficient research into the safety of the product prior to sale;

m. Inadequate and/or insufficient monitoring or research regarding adverse events;

n. Failure to list death as an adverse event;

o. Failure to provide adequate training, knowledge or information to physicians, distributors, or sellers of the product;

p. Marketing the Patch for unsafe uses;

q. Failure to adequately warn individuals of the dangerous and lethal side effects of the product;

r. Formulating and designing the product;

s. Making the product;

t. Inspecting and testing the product; and/or

u. Packaging the product; and

v. Other and further particulars as will be proven at trial

19. The negligent, careless and reckless conduct of the Defendants, as alleged above, was a proximate cause of Decedent's death and the damages assured herein.

Mylan Files Response to Fentanyl Patch Lawsuit

One of the most frivolous legal documents I've ever seen is this response filed by Mylan in a fentanyl lawsuit.  Without knowing any facts at all about the case, Mylan asserts that no one was injured; even if they were injured, it wasn't because of the patch; if it was because of the patch, it's because the person had an underlying medical condition; even if the person didn't have an underlying medical condition, the person misused the patch; etc.

This is the sort of thing you'll be up against if you decide to file a fentanyl lawsuit.  Thankfully, my attorney friends know how to deal with this kind of conduct.  Let me know if you'd like me to put you in touch with them.

COMES NOW Defendants Mylan Inc. (erroneously named herein as Mylan, Inc.); Mylan Technologies Inc. (erroneously named herein as Mylan Technologies, Inc.) and Mylan Pharmaceuticals Inc. (erroneously named herein as Mylan Pharmaceuticals, Inc.) (“Mylan”) and hereby answer the Complaint (the “Complaint”) filed by Plaintiffs Walter Richardson, Michael Remeraz, Sam Bloom, Chriss Bloom and Stephanie Leewright (“Plaintiffs”) as follows:

I. GENERAL DENIAL

In accordance with the provisions of Code of Civil Procedure § 431.30(d), Mylan denies, generally and specifically, each, every and all allegations, statements, matters and purported causes of action contained in the Complaint, and the whole thereof, and without limiting the generality of the foregoing, deny, generally and specifically, that Mylan has engaged in any wrongful act or omission with respect to Plaintiffs and/or Plaintiffs' Decedent, or that Plaintiffs and/or Plaintiffs' Decedent has been damaged or injured in the manner or sums alleged, or in any way at all, as the result of any alleged wrongful act or omission on the part of Mylan.

Fentanyl Patch Lawsuit Filed Against Mylan in California

In March of 2009, Mylan was sued in the U.S. District Court for the Southern District of California.  The suit alleges that Mylan's fentanyl pain patches are defectively designed and manufactured, and were responsible for the death of Sandra Richardson:

11. This suit arises out of the wrongful death of Decedent due to the wrongful conduct of Defendants. Decedent was given a prescription for 100 mcg Mylan (fentanyl transdermal system) patches. Decedent was wearing one of these patches (the “Richardson Patch”) at the time of her death and it was the cause of her death. The Richardson Patch was designed, manufactured, marketed and/or distributed by Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc. (collectively, the “Mylan Defendants”). Mylan (fentanyl transdermal) patches also came in other sizes such as 25, 50 and 75 mcg. As referenced herein, the “Patch” shall refer to Mylan (fentanyl transdermal) patches of any size unless specified otherwise.

12. The Patch is a matrix patch containing the drug fentanyl. Fentanyl is an extremely dangerous drug that is at least 80 times stronger than morphine. Fentanyl is classified as a Schedule II controlled substance by the FDA and is generally used to relieve pain.

13. The Patch is applied by the patient and delivers fentanyl though the patient's skin. The Mylan Defendants design, manufacture, market and sell the Patch with the intention that it will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain level of fentanyl in the blood of the patient. In other words, if a Patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of fentanyl. Decedent never abused the Patch or used it inappropriately.

14. The Patch is unsafe for its intended or reasonably foreseeable use because it can and does cause lethal levels of fentanyl in patients.

15. Decedent was prescribed the Patch for pain. Decedent died on March 10, 2007.

CAUSES OF ACTION FIRST CAUSE OF ACTION: STRICT PRODUCTS LIABILITY

(By Plaintiffs against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc., and Does 1-100)

A. Strict Products Liability

16. Plaintiffs repeat and re-allege each and every consistent allegation contained in Paragraphs 1 through 15 and make such allegations a part hereof by reference.

17. The Mylan Defendants are liable under the theory of product liability. The Mylan Defendants at all times material hereto engaged in the business of designing, manufacturing, assembling, selling, marketing, and/or supplying the Patch, including the Richardson Patch. The Richardson Patch was in a defective condition at the time it was designed, manufactured, sold, and/or marketed by the Mylan Defendants and at the time it left the Defendants' possession that rendered the Patch unsafe for its intended or reasonably foreseeable use. Decedent was unaware of the defective condition of the Richardson Patch at the time she used the product in the manner and for the purpose which it was intended. The defective condition was a producing and legal cause of Decedent's death and the damages described herein. The Richardson Patch was in the control of the Defendants at the time the defect occurred. Further, the injury sustained by Decedent, fentanyl toxicity, was the exact type of injury that a defective Patch causes, The Richardson Patch reached Decedent without any substantial change in its condition. Because of the nature of ingredients or natural characteristics of the Richardson Patch, use of it involved substantial risk of injury. The exposure to risk of injury from the Richardson Patch outweighed any benefits from the product's use. Without limitation, the Richardson Patch was defective because it malfunctioned and did not perform as intended and designed.

Lawsuit Filed in California Against Maker of Generic Fentanyl Patch

Mylan, Inc. manufactures one of the most popular generic fentanyl patches.  The original fentanyl patch is called Duragesic, and uses a fentanyl gel.  The Duragesic fentanyl patch is referred to as a reservoir design, as it uses a reservoir of gel.  Mylan's patch uses a matrix design in which the fentanyl is in the adhesive that holds the patch on the body.  There is no reservoir of gel in a Mylan patch.

Even though the Mylan matrix fentanyl patch is arguably safer than the Duragesic patch, there have been many fentanyl lawsuits filed against Mylan.  This lawsuit alleges that the patch is defectively design and manufactured.

7. The Patch is a matrix patch containing the drug fentanyl. Fentanyl is an extremely dangerous drug that is at least 80 times stronger than morphine. Fentanyl is classified as a Schedule II controlled substance by the FDA and is generally used to relieve pain.

8. The Patch is applied by the patient and delivers fentanyl though the patient's skin. The Defendants design, manufacture, market and sell the Patch with the intention that it will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain level of fentanyl in the blood of the patient. In other words, if a Patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of fentanyl. Decedent never abused the Patch or used it inappropriately.

9. The Patch is unsafe for its intended or reasonably foreseeable use because it can and does cause lethal levels of fentanyl in patients.

10. Decedent was prescribed the Patch by Dr. Andrus for pain. Decedent filled the prescription in June 2007. Decedent was found dead on July 4, 2007. The cause of death listed on the death certificate is fentanyl toxicity.

CAUSES OF ACTION

FIRST CAUSE OF ACTION: STRICT PRODUCTS LIABILITY

(By Plaintiff against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc)

a. Strict Products Liability

11. Plaintiff repeats and re-alleges each and every allegation contained in Paragraphs 1 through 10 and makes such allegations a part hereof by reference.

12. The Defendants are liable under the theory of product liability. The Defendants at all times material hereto engaged in the business of designing, manufacturing, assembling, selling, marketing, and/or supplying the Patch, including the O'Sullivan Patch. The O'Sullivan Patch was in a defective condition at the time it was designed, manufactured, sold, and/or marketed by the Defendants and at the time it left the Defendants' possession that rendered the Patch unsafe for its intended or reasonably foreseeable use. Decedent was unaware of the defective condition of the O'Sullivan Patch at the time she used the product in the manner and for the purpose which it was intended. The defective condition was a producing and proximate cause of Decedent's death and the damages described herein. The O'Sullivan Patch was in the control of the Defendants at the time the defect occurred. Further, the injury sustained by Decedent, fentanyl toxicity, was the exact type of injury that a defective Patch causes. The O'Sullivan Patch reached Decedent without any substantial change in its condition. Because of the nature of ingredients or natural characteristics of the O'Sullivan Patch, use of it involved substantial risk of injury. The exposure to risk of injury from the O'Sullivan Patch outweighed any benefits from the product's use. Without limitation, the O'Sullivan Patch was defective because it malfunctioned and did not perform as intended and designed.

b. Manufacturing

13. More specifically, the O'Sullivan Patch was defective because of the existence of a manufacturing flaw that rendered the Patch unsafe for its intended or reasonably foreseeable use at the time it left the Defendants and such defect was a proximate cause of Decedent's death and the damages asserted herein. Without limitation, the O'Sullivan Patch was defective because it malfunctioned and did not perform as intended and designed.

Another Family Sues Watson Laboratories Over The Company’s Fentanyl Patches

Here is another fentanyl lawsuit filed in California against Watson Laboratories, Inc.  This one alleges that a defective 100 mcg/hr killed Melissa Mohammed.

6. At all times relevant hereto, Defendants designed, developed, manufactured, promoted, marketed, distributed, tested, warranted and sold Watson (fentanyl transdermal system) patches (“Watson Patches”) in interstate commerce and in the County of Orange, State of California. Furthermore, Defendants conducted substantial business in the County of Orange, advertised the Watson Patches in this county, received substantial compensation and profits from sales of the Watson Patches in this county, and made material omissions and misrepresentations and committed breaches of warranties in this county.

7. This suit arises out of the wrongful death of Decedent due to the wrongful conduct of Defendants. Decedent, while a patient of Dr. Marshall Millman, was given a prescription for 100 mcg Watson (fentanyl transdermal system) patches. Decedent was wearing one of these patches (the “Mohammed Patch”) at the time of her death and it was the cause of her death. The Watson Patch worn by Decedent at the time of her death was designed and manufactured by Defendant Watson Laboratories, Inc. The Mohammed Patch was marketed and distributed by Defendants Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Watson Pharma, Inc. shall hereinafter be collectively referred to as the “Watson Defendants.”

8. Watson (fentanyl transdermal system) patches also came in other sizes such as 25, 50, and 75 meg. As referenced herein, the “Patch” shall refer to Watson (fentanyl transdermal system) patches of any size unless specified otherwise.

9. The Patch is a multi-layer system containing a gel which has the drug fentanyl in it. Fentanyl is an extremely dangerous drug that is at least 80 times stronger than morphine. Fentanyl is classified as a Schedule II controlled substance by the FDA and is generally used to relieve pain.

10. The Patch is applied by the patient and delivers fentanyl though the patient's skin. The Watson Defendants design, manufacture, market and sell the Patch with the intention that it will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain level of fentanyl in the blood of the patient. In other words, if a Patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of fentanyl. Decedent never abused the Patch or used it inappropriately.

11. The Mohammed Patch was manufactured at the Watson Defendants' facility in Corona, California. The Mohammed Patch was made utilizing a reservoir design which means that the fentanyl gel is inserted into a reservoir between two of the patch's layers.

12. The Patch is unsafe for its intended or reasonably foreseeable use because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

13. Another design for Fentanyl patches existed at the time the Mohammed Patch was manufactured called the “matrix” design. At all relevant times, the Watson Defendants could have made fentanyl patches of a matrix design, as opposed to a reservoir design. The matrix technology cannot leak fentanyl. A sealed multi-laminate design could have also been used.

14. In 2008, the Watson Defendants recalled a lot of fentanyl patches because of leaking patches.

This is the second lawsuit in which the lawyer alleged that Watson manufactures its fentanyl patches in California.  The documents I’ve seen indicate the patches are manufactured in Salt Lake City, Utah.

Fentanyl Patch Lawsuit Filed Against Watson Laboratories, Inc.

Watson Laboratories, Inc., manufactures a generic fentanyl pain patch.  It is based on the reservoir design of the Duragesic patch, meaning it has a reservoir of fentanyl gel than can leak. 

7. This suit arises out of the wrongful death of Decedent due to the wrongful conduct of Defendants. Decedent, while a patient of Dr. Jeanne Myriam Axler, was given a prescription for 75 mcg Watson (fentanyl transdermal system) patches. Decedent was wearing one of these patches (the “Bristol Patch”) at the time of her death and it was the cause of her death. The Watson Patch worn by Decedent at the time of her death was designed and manufactured by Defendant Watson Laboratories, Inc. The Bristol Patch was marketed and distributed by Defendants Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Watson Pharma, Inc. shall hereinafter be collectively referred to as the “Watson Defendants.”

8. Watson (fentanyl transdermal system) patches also came in other sizes such as 25, 50, and 100 mcg. As referenced herein, the “Patch” shall refer to Watson (fentanyl transdermal system) patches of any size unless specified otherwise.

9. The Patch is a multi-layer system containing a gel which has the drug fentanyl in it. Fentanyl is an extremely dangerous drug that is at least 80 times stronger than morphine. Fentanyl is classified as a Schedule II controlled substance by the FDA and is generally used to relieve pain.

10. The Patch is applied by the patient and delivers fentanyl though the patient's skin. The Watson Defendants design, manufacture, market and sell the Patch with the intention that it will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain level of fentanyl in the blood of the patient. In other words, if a Patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of fentanyl. Decedent never abused the Patch or used it inappropriately.

11. The Bristol Patch was manufactured at the Watson Defendants' facility in Corona, California. The Bristol Patch was made utilizing a reservoir design which means that the fentanyl gel is inserted into a reservoir between two of the patch's layers.

12. The Patch is unsafe for its intended or reasonably foreseeable use because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

13. Another design for Fentanyl patches existed at the time the Bristol Patch was manufactured called the “matrix” design. At all relevant times, the Watson Defendants could have made fentanyl patches of a matrix design, as opposed to a reservoir design. The matrix technology cannot leak fentanyl. A sealed multi-laminate design could have also been used.

Paragraph 11 alleges that the patch is manufactured in Corona, California.  My information is that Watson manufactures their fentanyl patches at their Salt Lake City, Utah facility.  Not that it really matters – since Watson is headquartered in California, that’s a proper venue to sue the company.