Fentanyl Patch Lawyer, Lawsuit, and Side Effect News

Lawyers in Texas File Sue Mylan, Alleging Defective Fentanyl Patch Responsible For Individual’s Death

On August 13th of 2009, Texas lawyers filed the wrongful death lawsuit of Boles v. Mylan Laboratories in the U.S. District Court, Southern Division, of Texas.  This fentanyl lawsuit alleges that one of Mylan’s matrix fentanyl patches caused the death of Wanda Vail.

STRICT LIABILITY: DESIGN DEFECT

6.1 At all pertinent times, Defendants were engaged in the business of designing, manufacturing, marketing, testing labeling, selling, distributing, and placing fentanyl patches into the stream of commerce, including the fentanyl patch Wanda Vail was using at the time of her death.

6.2 When it left the control of Defendants, the design and formulation of the fentanyl patch rendered it defective and unreasonably dangerous in that it was prone to deliver a dangerous overdose of fentanyl.

6.3 The fentanyl patch reached Wanda Vail in the condition expected and intended by Defendants.

6.4 Wanda Vail used the fentanyl patch for its intended and foreseeable purpose.

6.5 There were safer alternative designs and formulations other than the one used, which were economically and technologically feasible and would have prevented or significantly reduced the risk of injury in question.

6.6 The defective design of Defendants' fentanyl patches directly and proximately caused Wanda Vail's death and Plaintiff's damages.

VII.

STRICT LIABILITY: MANUFACTURING DEFECT

7.1 At all pertinent times, Defendants were engaged in the business of designing, manufacturing, marketing, testing, labeling, selling, distributing, and placing fentanyl patches into the stream of commerce, including the fentanyl patch Wanda Vail was using at the time of her death.

7.2 When it left the control of Defendants, defects in the manufacture of the fentanyl patch rendered it defective and unreasonably dangerous in that it was prone to deliver a dangerous overdose of fentanyl.

7.3 Wanda Vail used the fentanyl patch for its intended and foreseeable purpose.

7.4 The defective manufacture of Defendants' fentanyl patches directly and proximately caused Wanda Vail's death and Plaintiff's damages.

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.

Fentanyl Lawsuit Filed in Texas Against Mylan

The family of Wanda Vail has filed a lawsuit in Texas against Mylan, the manufacturer of a generic fentanyl patch.  The lawsuit seeks punitive damages:

5.1 Defendant committed acts of omission and commission, which collectively and severally constituted negligence, which was a proximate cause of the death of Wanda Vail and Plaintiff's damages.

5.2 Defendants owed Wanda Vail the duty to exercise reasonable care in the designing, manufacturing, marketing, testing, labeling, distributing, selling, and placing into the stream of commerce fentanyl transdermal patches. Defendant further owed the duty to exercise ordinary care to prevent users such as Wanda Vail from suffering overdoses of fentanyl when using such patches as directed for their intended purpose. Defendants breached these duties and proximately caused Wanda Vail's death and Plaintiff's damages.

5.3 Defendant's conduct constituting negligence includes without limitation:

a. failing to remove their fentanyl patches from the market when they knew or should have known of the likelihood of overdose and serious injury to its users;

b. continuing to market and sell their fentanyl patches when they knew or should have known of the likelihood of overdose and serious injury to its users and without providing sufficient post-sale warnings;

c. failing to use ordinary care in the designing, manufacturing, marketing, testing, labeling, selling, distributing, and placing into the stream of commerce fentanyl patches so as to prevent and minimize the likelihood of overdose and serious injury to its users;

d. failing to include with their fentanyl patches proper warnings regarding the significant dangers and risks of overdose and serious injury;

e. failing to adequately monitor and respond to reports of defects in and overdoses associated with the use of their fentanyl patches;

f. negligently misrepresenting and concealing the risks and dangers involving Defendants' fentanyl patches, on which Wanda Vail and/or her care relied to her detriment.

Mylan’s Lawyers Raise 29 Issues In Fentanyl Patch Lawsuit

In a joint preliminary report filed in a Georgia fentanyl patch lawsuit, Mylan’s attorneys raised the following 29 legal issues:

1. Whether a product at issue was the specific and proximate cause of the injuries Plaintiff claims to have sustained.

2. Whether there was a legal duty to conform to a standard of conduct raised by the law for the protection of others against unreasonable risks of harm breached by Mylan and, if so, whether that breach was the specific and proximate cause of the claimed injury.

3. The amount of Plaintiff's claimed damages.

4. Whether Plaintiff's claims are barred in whole or in part by Plaintiff's comparative and/or contributory negligence.

5. Whether Plaintiff's claims should be reduced by any comparative or contributory negligence of third parties.

6. Whether Plaintiff's claimed injuries were the sole, proximate and direct result of intervening and superseding causes that were not within the control of Mylan, including without limitation, pre-existing or subsequent medical conditions, causes, or injuries that are unrelated to and not attributable to Mylan.

7. Whether Plaintiff's claimed injuries were caused by the alteration, unintended use, abuse, misuse, and/or modification of the product referred to in Plaintiff's Complaint in an unforeseeable manner by parties outside the control of Mylan.

8. Whether Plaintiff's claim for punitive damages is in contravention of Mylan's' rights guaranteed under the due process clause of the Fifth and Fourteenth Amendments to the United States Constitution, the excessive fines clause of the Eighth Amendment to the United States Constitution, the double jeopardy clause of the Fifth Amendment to the United States Constitution, and other provisions of the Constitutions of the United States and the State of Georgia.

9. Whether Plaintiff's claims are barred in whole or in part by Mylan's compliance with applicable state, federal, and local laws and regulations.

10. Whether Plaintiff assumed the risk of any harm suffered.

11. Whether Plaintiff's claims are barred, in whole or in part, by express or implied preemption.

12. Whether Plaintiff's claims are barred by the doctrine of primary jurisdiction.

13. Whether Plaintiff failed to take reasonable steps to mitigate damages.

14. Whether punitive damages would be improper in this case because Mylan's conduct does not meet the standard for imposing punitive damages.

15. Whether Plaintiffs alleged injuries were caused by a pre-existing, intervening, or superseding cause.

16. Whether Plaintiff's claims are barred, in whole or in part, by Plaintiffs own fault and/or negligence.

17. Whether the fault of those for whom Mylan is not responsible, including Plaintiff, should be used to reduce any recoverable damages herein in proportion to the degree or percentage of fault attributable to them, in accordance with the law.

18. Whether Plaintiff's claims are barred by the express and/or implied assumption of the risks, if any, inherent in the alleged use of the product or products at issue.

19. Whether some or all of Plaintiff's claims are barred by the learned intermediary doctrine.

20. Whether Plaintiff's claims are barred by the applicable statute(s) of limitations.

21. Whether Plaintiffs have failed to join all necessary and indispensable parties.

22. Whether Plaintiff's claims are barred, in whole or in part, under the applicable state law because FTS was subject to and received pre-market approval by the Food and Drug Administration under 52 Stat. 1040, 21 U.S.C. § 301.

23. Whether Plaintiff lacks the legal capacity to bring this lawsuit either on her own behalf or the behalf of the decedent's estate.

24. Whether Plaintiff's claim for pain and suffering is barred because decedent's death was instantaneous and/or there is no evidence the decedent exhibited consciousness of pain.

25. Whether Plaintiffs fraud claim fails for failure to plead fraud with the specificity required by Georgia law or the Federal Rules of Civil Procedure.

26. Whether Plaintiffs breach of warranty claims fail because there was no privity of contract between decedent and Mylan.

27. Whether Plaintiff's breach of warranty claims fail because a wrongful death action may not be predicated on a breach of warranty arising from the sale of goods.

28. Whether Plaintiffs implied breach of warranty of fitness for a particular purpose claim fails because decedent relied on a learned intermediary to select the subject product and because decedent did not rely on the skill or knowledge of Mylan.

29. Whether Mylan Inc. is a holding company without any legal responsibility for the development, manufacture and/or distribution of FTS and, therefore, should be dismissed with prejudice.

Mylan is fighting hard not to be found liable for designing or selling a defective fentanyl patch.  As of this date, no cases against Mylan have gone to trial yet.

Report Filed in Texas Fentanyl Lawsuit

Many courts require the parties in a lawsuit to file a report that sets out their individual positions in the litigation, proposed deadlines, and other legal issues.  This one was filed in July of 2009 in a lawsuit against Mylan Pharmaceuticals.

This is a wrongful death lawsuit seeking money damages against the Defendants for the death of Stephen Gortat, who died on May 12, 2007 while wearing a fentanyl pain patch manufactured and distributed by the Defendants.

Fentanyl is the strongest pain medicine on the market today. It is 100 times stronger than morphine and is classified as a Schedule II controlled substance by the DEA.

The fentanyl pain patch is a time release system which contains the drug fentanyl (“Patch”). The Patch is applied by the patient (usually every three days) and delivers fentanyl though the patient's skin. It is designed, manufactured, marketed and sold with the intention that the Patch will release a certain amount of fentanyl for absorption 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 but instead should receive a therapeutic amount of fentanyl that will help relieve pain. However, if the patch malfunctions and delivers too much fentanyl, it is most likely fatal.

Note that Mr. Gorat died in May of 2007, and that the trial won’t be before October of 2010.  If you’re considering filing a lawsuit on behalf of a deceased loved one, be aware that the process does take several years to come to completion.

Fentanyl lawyers file wrongful death lawsuit against Mylan Pharmaceuticals

In July of 2009, the family of Kathie Christy filed a wrongful death lawsuit against Mylan Pharmaceuticals, the maker of a generic fentanyl pain patch:

8. This suit arises out of the wrongful death of Decedent due to the wrongful conduct of the Mylan Defendants. Decedent, while a patient of Rebecca Talley, M.D., was given a prescription for 100 mcg Mylan (fentanyl transdermal) patches. Decedent was wearing one of these patches (the “Christy Patch”) at the time of her death and it was the cause of her death. The Christy Patch was designed, manufactured, marketed, and/or distributed by 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.

9. 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.

10. The Patch is applied by the patient and delivers fentanyl through 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.

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

12. Decedent was prescribed the Patch by Dr. Talley for pain. Decedent filled the prescription in July 2007. Decedent was found dead on July 30, 2007. Decedent had a fatal blood fentanyl concentration at the time of her death.

The lawsuit alleges that the Mylan patch in question had a manufacturing defect at the time it left Mylan’s factory.  It also alleges that Mylan’s design – called a Matrix design – is defective.

Mylan Sued in Georgia Over Fentanyl Pain Patch Death

In April of 2009, a lawsuit was filed in the U.S. District Court for the Northern District of Georgia against Mylan.  The lawsuit was filed by the surviving family of Ronnie Stoyles, who the lawsuit alleges was killed by a defective Mylan fentanyl pain patch.

35. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

36. Defendants knew or should have known that the Patch created a high risk of unreasonable, dangerous side effects, including that proper use of the Patch can cause death, but the Mylan Defendants failed to communicate to the FDA, Decedent, Decedent's physicians, distributors, pharmacists, and/or the general public, that proper use of the Patch could cause serious injury and/or death. Defendants instead communicated to all such persons/entities that the Patch was safe for use. Specifically, Defendants' misrepresentations include, without limitation, a representation that the Patch would produce a maximum fentanyl blood concentration that was much lower that the fentanyl concentration found in Decedent's blood at the time of his death and a representation that the Patch was safe for use and a representation that the Patch can be used with other medications.

37. Therefore, Plaintiff brings this cause of action against the Defendants under the theory of negligent misrepresentation for the following reasons:

a. Defendants failed to provide true and accurate information, warnings and instructions as set forth herein;

b. Defendants, individually, and through their agents, representatives, distributors and/or employees, negligently misrepresented material facts about the Patches in the course of their business in that they made such misrepresentations when they knew or reasonably should have known of the falsity of such misrepresentations. Alternatively, the Defendants made such misrepresentations without exercising reasonable care to ascertain the accuracy of these representations;

c. The above misrepresentations were made to the FDA, Decedent, Decedent's physicians, pharmacists, as well as the general public;

d. The Defendants intended to induce others to rely on their representations, including, without limitation, Decedent, physicians, and pharmacists;

e. Decedent and others, including, without limitation, Decedent's physician(s) and her pharmacist(s), justifiably relied on the Defendants' misrepresentations; and

f. Consequently, Decedent's use of the Patches was to his detriment. The Defendants' negligent misrepresentations were a direct and proximate cause of the Decedent's death, his physical and mental pain and anguish and respiratory arrest prior to his death, and the damages claimed herein.

Lawsuit Filed in Ohio Against Mylan Over Their Fentanyl Pain Patch

Mylan was sued in Ohio in May of 2009 over the death of Joseph LaPaglia.  The lawsuit alleges that Mylan designed, manufactured, and marketed a defective fentanyl patch, and that the defective patch killed Joseph LaPaglia.

23. Plaintiff incorporates by reference the consistent allegations of the preceding paragraphs.

24. Pleading further and without waiver of the foregoing, the LaPaglia Patch was defective under Ohio Revised Statute §2307.76 because it lacked adequate warnings and instructions. Specifically, the LaPaglia Patch was defective due to inadequate warnings and/or instructions because: (a) the Mylan Defendants knew or, in the exercise of reasonable care, should have known about the risk that the Patch could cause a fentanyl overdose and (b) the Mylan Defendants failed to provide the warnings and/or instructions that a manufacturer exercising reasonable care would have provided concerning that risk, in light of the likelihood that the Patch could cause a fentanyl overdose. These risks were not open or obvious or a matter of common knowledge. The Mylan Defendants' failure to provide adequate warnings and/or instructions to Decedent, his doctor, his pharmacist, or other healthcare providers was a proximate cause of Decedent's death and the damages described herein.

25. Alternatively, the LaPaglia Patch was defective due to inadequate post-marketing warnings or instructions because, at a relevant time after it left the control of the manufacturer, the Mylan Defendants: (a) knew or, in the exercise of reasonable care, should have known about a risk that the Patch could cause a potentially fatal fentanyl overdose is associated with the Patch and (b) the Mylan Defendants failed to provide the post-marketing warnings or instructions that a manufacturer exercising reasonable care would have provided concerning that risk, in light of the likelihood that the Patch could cause a fentanyl overdose. These risks were not open or obvious or a matter of common knowledge. The Mylan Defendants' failure to provide adequate warnings and/or instructions to Decedent, his doctor, his pharmacist, or other healthcare providers was a proximate cause of Decedent's death and the damages described herein.

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.

Another Motion to Compel Filed Against Mylan in a Fentanyl Patch Lawsuit

Mylan is again attempting to play "hide the ball" by refusing to turn over important information relating to their fentanyl pain patches.  Every time the plaintiff is forced to file a motion to compel, it (a) increases the plaintiff's costs, and (b) delays the proceedings.  It's therefore in Mylan's best interests to force the plaintiff to have to file numerous motions to compel.

These nineteen requests relate to the testing, studies, and analysis of “Mylan Products.” Plaintiff defines “Mylan Products” as “any of the transdermal fentanyl patch system products designed, manufactured or distributed by Defendants.” The Mylan Defendants' testing of the transdermal fentanyl patch systems and the results of that testing is critical information that is likely to lead to admissible evidence relating to Plaintiff's negligence and product liability claims. As other courts have noted, in product liability actions this type of testing and clinical trial data “is likely to lead to evidence relating to the design, manufacture, and implantation of [the product] that will be relevant to plaintiffs' allegation that the [product] is defective.” See Timberlake v. Synthes Spine Co., Civil Action No. V-08-4, 2008 U.S. Dist. LEXIS 44256, at *7-8 (S.D. Tex. June 4, 2008); See also In re Prempro Prods. Liab. Litig., MDL Docket No. 4:03-CV-1507-WRW, 2006 U.S. Dist. LEXIS 24931, at *11-15 (E.D. Ark. Mar. 20, 2006) (compelling disclosure of the “meeting minutes and reports of any ... committees ... that relate to the ... clinical trials”); Groundberg v. Upjohn Co., 137 F.R.D. 365, 367 (D. Utah 1991) (overruling objections to the production of the raw data of drug protocol reports used to record the reaction of persons given the medication used in a clinical trial).

Plaintiff has limited these requests to testing and studies of transdermal fentanyl patch systems, the product at issue in this case, and thus the Requests are not overly broad or unduly burdensome. Moreover, due to the nature of the case, these requests are limited in time to a reasonable period. Mylan Inc. announced final FDA approval for its fentanyl transdermal system on January 28, 2005. Thus, obtaining documents relating to the testing, studies and analysis of fentanyl transdermal patches will not require Mylan to comb through decades of documents. Most of the testing will have been done within the last five years. Accordingly, these requests are narrowly tailored to lead to evidence directly related to Plaintiff's claims, and production should be ordered. See FED. R. CIV. P. 26(b).

The Mylan Defendants assert that no documents can be produced without a protective order. Plaintiff disagrees. Plaintiff believes the vast majority of the documents sought by Plaintiff are not “trade secret[s] or other confidential research, development, or commercial information” subject to protection under Federal Rule of Civil Procedure 26(c)(1)(G). Certainly, the Mylan Defendants have the burden of justifying the confidentiality of each and every document sought to be covered by a protective order, which they have not done. See Cipollone v. Liggett Group, Inc., 785 F.2d 1108, 1122 (3rd Cir. 1986.) Accordingly, the Mylan Defendants should be required to produce documents responsive to these requests, and seek protection only for “trade secret or confidential research, development, or commercial information” protected by Rule 26(c)(1)(G).[FN2]

Mylan Sued In Texas Over Their Fentanyl Patch

In May of 2009, Mylan was sued in the United States District Court for the Southern District of Texas.  The lawsuit alleges that Mylan's fentanyl patch is responsible for the death of Karen Motley:

6. This suit arises from the wrongful death of Decedent, due to the wrongful conduct of Defendants. On or about May 27, 2008, Decedent Karen A. Motley, age 60, was given a prescription for a 50 meg Mylan (fentanyl transdermal system) patch by her physician, Kelly Maedo, M.D., for treatment of chronic back pain. Decedent was wearing the patch (the “Motley Patch”) at the time of her death and it was the cause of her death. The Motley Patch was designed, manufactured, marketed and/or distributed by Defendants. Mylan (fentanyl transdermal system) patches come ins such strengths at 25, 50, 75, and 100 meg. As referenced herein, the “Patch” shall refer to Mylan (fentanyl transdermal system) patches of any size unless specified otherwise. Mylan, MTI and MPI shall hereinafter be together referred to as the “Mylan Defendants.”

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 through 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 the fentanyl. Decedent never abused the Patch or used it inappropriately.

9. The Patch is unreasonably dangerous because it can and does cause lethal levels of fentanyl in patients.

10. Prior to and at the time of the manufacture of the Motley Patch, the Patch Defendants knew that they were producing defective patches that leaked. Prior to and at the time of the manufacture of the Motley Patch, the Patch Defendants knew that they were producing defective patches that would produce levels of fentanyl in patients above the intended and designed level. Prior to and at the time of the manufacture of the Motley Patch, the Patch Defendants knew or should have known that they were producing defective patches that were killing and/or injuring patients.

11. Despite the foregoing, the Patch Defendants, with reckless and/or intentional disregard for the safety of patients, continued and continue to this day to manufacture fentanyl patches that kill patients because of the massive revenue being generated by their sale.

12. The Patch is unreasonably dangerous because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

13. On May 30, 2008, while using the Patch as prescribed, Decedent died from the toxic effects of fentanyl.

Motion to Compel Filed Against Mylan in Fentanyl Patch Lawsuit

After someone sues a fentanyl patch manufacturer, he or she is entitled to inspect documents in the possession of the manufacturer.  The process in which both sides exchange information is called, appropriately enough, "discovery."  Many of the fiercest legal battles are fought over discovery.  Mylan is fighting very hard not to have to reveal information about their fentanyl patches.  Because of Mylan's efforts to keep things secret, the plaintiffs in this case have had to file a motion to compel, which asks the court to order Mylan to produce the documents:

REQUEST NO. 11: Any and all documents related to the maximum concentration of serum fentanyl intended to be delivered through use of Mylan Products.

REQUEST NO. 12: Any and all documents related to the concentration of serum fentanyl intended to be delivered through use of Mylan Products.

REQUEST NO. 22: Any and all documents submitted to the FDA in connection with efforts to obtain FDA approval of any Mylan Products or the labeling for same.

REQUEST NO. 82: All documents that set forth the process by which decisions were made as to which Mylan Patches, or lots or batches of patches, were accepted or rejected at the Mylan Facility during the period January 1, 2003 to the present.

REQUEST NO. 126: Copies of any and all documents or written communication provided or sent by you to the FDA in connection with its investigation referenced in the FDA's July 15, 2005 Public Health Advisory regarding fentanyl transdermal patches.

REQUEST NO. 148: All Batch Records related to the lot or batch of the patch(es) the subject deceased had on at the time of his or her death.

REQUEST NO. 149: All Batch Records related to the three lots manufactured immediately prior to the lot of the patch(es) the subject deceased had on at the time of his or her death.

Without these documents, it will be very difficult for the plaintiff to win.  No wonder Mylan wants to keep them secret.

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.