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.
Plaintiff-TAUSHA LORI BOLES, individually, and as Personal Representative of the Estate of WANDA VAIL- and on behalf of all those entitled to recover for the wrongful death of Wanda Vail, hereby files her original petition and complains of Defendants-Mylan Laboratories, Inc.; Mylan Technologies, Inc.; Mylan Pharmaceuticals, Inc.; Mylan Bertek Pharmaceuticals, Inc.; and UDL Laboratories, Inc.
I.
DISCOVERY LEVEL
1.1 Plaintiff requests that the Court assign this case a Level 3 discovery control plan.
II.
PARTIES
2.1 Plaintiff Tausha Lori Boles is an individual residing in Benton County, Washingon and is a surviving child and Personal Representative of the Estate of Wanda Vail. She brings suit individually for the wrongful death damages she suffered as a result of her mother's wrongful death. As personal representative of Wanda Vail's Estate, she is bringing the Estate's survival claims. Tausha Lori Bales also brings suit for and on behalf of all those entitled to recover for Wanda Vail's death under the Texas and Washington Wrongful Death Act.
2.2 At the time of her death, Wanda Vail resided in Richland, Benton County Washington.
2.3 Defendant Mylan Laboratories, Inc. is a corporation organized under the laws of the State of Pennsylvania with its with its headquarters at 1500 Corporate Drive, Suite 400, Canonsburg, PA 19067. Mylan Laboratories is a global pharmaceutical company with market leading positions in generic pharmaceuticals, transdermal technology and unit dose packaged products Mylan Laboratories does routine and substantial business in the State of Texas. This Defendant does business in Texas and derives substantial revenues from its business activities in Texas but does not maintain a registered agent for service of process. Under Texas Civil Practice & Remedies Code § 17.044, the Texas Secretary of State is the agent for service of process on Mylan Laboratories because it is a foreign corporation that engages in business in Texas but does not maintain a regular place of business in Texas or a designated agent for service of process and this proceeding arises out of business done in Texas to which this defendant is a party and, also, because this defendant is required by statute to designate or maintain an agent for service of process and engages in business in Texas but has not maintained or designated a registered agent for service of process.
2.4 Defendant Mylan Technologies, Inc. is a corporation organized under the laws of the State of West Virginia and with its principal place of business in the State of Vermont. Mylan Technologies does routine business in and substantial business in the State of Texas. Under Texas Civil Practice & Remedies Code § 17.044, the Texas Secretary of State is the agent for service of process on Mylan Technologies because it is a foreign corporation that engages in business in Texas but does not maintain a regular place of business in Texas or a designated agent for service of process and this proceeding arises out of business done in Texas to which this defendant is a party and, also, because this defendant is required by statute to designate or maintain an agent for service of process and engages in business in Texas but has not maintained or designated a registered agent for service of process.
2.5 Mylan Pharmaceuticals, Inc. is a corporation organized under the laws of the State of Pennsylvania with its principal place of business in the State of West Virginia. Mylan Pharmaceuticals does routine and substantial business in the State of Texas. It may be served by serving its registered agent for service of process in Texas: Corporation Service Company d/b/a CSC Lawyers Inc., 701 Brazos Street, Suite 1050, Austin, Texas 78701.
2.6 Mylan Bertek Pharmaceuticals, Inc., is a Texas corporation with its headquarters in Sugar Land, Texas, that may be served by serving its registered agent for service of process in Texas, Corporation Service Company d/b/a CSC-Lawyers Incorporating Service Company, 701 Brazos, Suite 1050, Austin, Texas 78701.
2.7 UDL Laboratories, Inc. is an Illinois corporation with its headquarters in Illinois that may be served by serving its registered agent for service of process in Texas, Corporation Service Company d/b/a CSC-Lawyers Incorporating Service Company, 701 Brazos, Suite 1050, Austin, Texas 78701.
2.8 Mylan Laboratories is the parent company of the Mylan Technologies and Mylan Pharmaceuticals and Mylan Bertek Pharmaceuticals and UDL Laboratories, Inc., and collectively these companies are engaged in business of designing, manufacturing, marketing, distributing, selling, and otherwise placing into the stream of commerce the “Fentanyl Transdermal System” (referred to herein as the “Fentanyl Patch”) throughout the United States, including Texas. Accordingly, these parties will be referred to collectively as “Mylan” or “Defendants.”
III.
VENUE AND JURISDICTION
3.1 Venue is proper in Ft. Bend County under Texas Civil Practice & Remedies Code § 15.002(a)(1) because one of the Defendants is a Texas Corporation with its place of business is in Sugar Land, Ft. Bend County, Texas. Venue is also proper in Ft. Bend County under Texas Civil Practice & Remedies Code § 15.033 because this is a suit for breach of warranty against a manufacturer of consumer goods (fentanyl patches, a drug delivery system intended for personal use, and which Wanda Vail purchased and took for personal use), and Mylan Bertek Pharmaceuticals, Inc., is a Texas corporation with its headquarters in Sugar Land, Texas. Venue is proper as to Plaintiff's claims against all Defendants under Texas Civil Practice & Remedies Code § 15.005 because all of Plaintiff's claims arise from the same occurrence or transaction or series of occurrences or transactions, the injuries to and death of Wanda Vail.
3.2 This Court has subject matter jurisdiction over this civil action because Plaintiff seeks damages far exceeding the minimal jurisdictional limits of the Court.
3.3 The Court has specific and general personal jurisdiction over all Defendants because they purposely availed themselves of the privilege of conducting activities within Texas; they have substantial and continuous contacts with the State of Texas, generally and with respect to this action, to satisfy both general and specific minimum contacts; and exercising jurisdiction over them does not offend the traditional notions of fair play and substantial justice.
3.4 Although Plaintiff seeks damages far exceeding $75,000, federal courts lack jurisdiction over this case. There is incomplete diversity of citizenship, and Plaintiff's claims raise no question of federal law. Plaintiff expressly disavows any claims pursuant to federal law, treaties, or Constitution. Thus, removal to federal court would be improper. Removal would further be improper because one or more Defendants are Texas citizens.
IV.
BACKGROUND FACTS
4.1 On July 12, 2006, Wanda Vail died from a fatal overdose of the opioid fentanyl while using a defective fentanyl transdermal patch designed, manufactured, marketed, distributed, sold, and otherwise placed in the stream of commerce by Mylan.
4.2 The Fentanyl Transdermal System is the registered name for a transdermal patch which is available only by prescription. This patch contains fentanyl, a synthetic opioid that is up to one hundred times as strong as morphine.
4.3 The Fentanyl Patch is applied directly to the skin of the user, and is supposed to deliver this strong pain medicine at a regulated rate for up to seventy-two (72) hours. The Fentanyl Patch is supposed to be prescribed to relieve chronic moderate to severe pain, such as that which was suffered by Wanda Vail.
4.4 Defendants knew or had reason to know, prior to Wanda Vail's death, of the significant danger or risk that its patches could deliver a greater than stated amount of fentanyl or otherwise cause an excessive and deadly amount of fentanyl to enter the body of the person using the patch. Nevertheless, Defendants took no steps or insufficient steps to reduce those dangers and failed to advise consumers such as Stanley and Wanda Vail and her care givers of the significant risks involved.
CAUSES OF ACTION AGAINST ALL DEFENDANTS
V.
NEGLIGENCE
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.
VI.
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.
VIII.
STRICT LIABILITY: MARKETING DEFECT
8.1 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.
8.2 When it left the control of Defendants, the fentanyl patch was defective and unreasonably dangerous because it contained warnings insufficient to alert users such as Wanda Vail and her care givers of the dangers and risks associated with its use, including but not limited to the risk of overdose and death.
8.3 Defendants failed to give adequate warnings of such risks, which were known or by the application of reasonably developed human skill and foresight should have been known. Defendants further failed to give adequate instructions to avoid such dangers, which failure rendered the product unreasonably dangerous as marketed.
8.4 Defendants' failure to provide adequate warnings and instruction rendered its fentanyl patches dangerous to an extent beyond which that would be contemplated by an ordinary user with ordinary knowledge common to the community as to the product's characteristics.
8.5 Wanda Vail used the fentanyl patch for its intended and foreseeable purpose.
8.6 The defective marketing of Defendants' fentanyl patches directly and proximately caused Wanda Vail's death and Plaintiff's damages.
IX.
BREACH OF EXPRESS WARRANTY
9.1 Defendant expressly warranted to Wanda Vail and her care givers by and through statements made by these Defendants or their authorized agents or sales representatives, orally and in publications, package inserts and other written materials intended for physicians, medical patients, and the general public that their fentanyl patches were safe, effective, fit and proper for their intended use.
9.2 Defendant's breach of these express warranties proximately caused Wanda Vail's death and Plaintiff's damages.
X.
BREACH OF IMPLIED WARRANTY
10.1 At the time Defendants designed, developed, manufactured, marketed, sold, supplied and/or distributed their fentanyl patches, they knew of the use for which such patches were intended and implicitly warranted the patches to be of merchantable quality and safe and fit for its intended use.
10.2 Wanda Vail and her care givers reasonably relied upon the skill and judgment of Defendants as to whether their fentanyl patches were of merchantable quality and safe and fit for their intended, reasonably foreseeable and/or ordinary use.
10.3 In breach of the implied warranties given by Defendants, their fentanyl patches were neither of merchantable quality nor safe or fit for their intended, reasonably foreseeable and/or ordinary use because they were and are unreasonably dangerous and unfit for the intended, reasonably foreseeable and/or ordinary purpose for which they were to be used due to the defects described above.
10.4 Defendants' breach of implied warranty proximately caused Plaintiff's injuries and damages.
XI.
GROSS NEGLIGENCE
11.1 Defendants' conduct constitutes gross negligence, which was a proximate cause of Wanda Vail's death and Plaintiff's damages, for which Plaintiff is entitled to recover punitive damages. Defendants knew of the risks and dangers associated with the formulation, manufacture, and marketing of their fentanyl patches. Nevertheless, Defendants' concealed these risks and dangers and sold their patches for use by unsuspecting persons such as Wanda Vail.
DAMAGES
XII.
ACTUAL DAMAGES
12.1 As a result of the injuries to and death of Wanda Vail, her estate sustained survival damages including without limitation conscious physical pain and mental anguish suffered by her prior to her death as well as reasonable medical and funeral expenses.
12.2 As a result of the injuries to and death of Wanda Vail, her daughter Tausha Lori Boles has suffered wrongful death damages including without limitation past and future pecuniary loss, loss of companionship and society, mental anguish, and loss of inheritance.
12.3 Tausha Lori Boles further pleads, on behalf of all of persons entitled to recover for the wrongful death of Wanda Vail, if any, for all wrongful death damages recoverable under the Texas Wrongful Death Act.
XIII.
PRE-JUDGMENT AND POST-JUDGMENT INTEREST
13.1 Plaintiff seek pre-judgment and post-judgment interest at the maximum legal rate.
XIV.
EXEMPLARY DAMAGES
14.1 Because Defendants are guilty of gross negligence, they should have punitive damages assessed against them and awarded to Plaintiffs in an amount deemed appropriate by the jury.
XV.
JURY DEMAND
15.1 Plaintiffs request a jury trial and have paid the jury fee.
XVI.
CONDITIONS PRECEDENT
16.1 Pursuant to Rule 54 of the Texas Rules of Civil Procedure, all conditions precedent to Plaintiff's rights to recover herein and to Defendants' liability have been performed or have occurred.
XVII.
REQUEST FOR DISCLOSURES
17.1 Pursuant to Rule 194 of the Texas Rules of Civil Procedure, Plaintiff requests that each Defendant disclose, within 50 days of service of ther request, the information and material described in Rule 194.2(a) through (1).
XVIII
PRAYER
18.1 WHEREFORE, PREMISES CONSIDERED, Plaintiff prays that Defendants be cited to appear and answer herein, that their cause be set for trial before a jury, and that Plaintiff recover judgment of and from Defendants for actual and exemplary damages in such an amount as the evidence may show and the jury may determine to be proper, together with all interest, costs of suit, and such other and further relief to which Plaintiff may show himself to be justly entitled, whether at law or in equity.
