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.

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.

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.

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.