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.
AND NOW, come the parties, by their respective counsel and hereby submit this report pursuant to Rule 26(f) and 16(b) of the Federal Rules of Civil Procedure. The parties submit the following:
1. Counsel for the Parties
In accordance with Rule 26(f) and this Court's Order of June 22, 2009, the parties have participated in the conference to develop a discovery plan and submit this joint report. The parties are represented by the following counsel:
(a) For Plaintiffs
Michael E. Heygood, Esq.
Charles W. Miller, Esq.
Heygood, Orr & Pearson
2331 W. Northwest Highway, 2nd Floor
Dallas, TX 75220
(b) For Defendants
Clem C. Trischler, Esq.
Pietragallo Gordon Alfano Bosick & Raspanti, LLP
One Oxford Centre, 38th Floor
Pittsburgh, PA 15219
Brian P. Johnson, Esq.
Johnson, Spalding, Doyle, West & Trent, L.L.P.
919 Milam, Suite 1700
Houston, TX 77002
2. Brief Statement of the Nature of the Case
(a) Plaintiffs' Statement:
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.
There are various dosage sizes of the Patch. As you can see from the below table (that is included in the package insert that comes with the Patch), depending upon the dosage, the Patch should deliver a fentanyl level between 0.3 ng/ml and 2.5 ng/ml.
Dose
Mean (SD) Time to Maximal Concentration Tmax (hr)
Mean (SD) Maximal Concentration CIMX (ng/mL)
Fentanyl Transdermal System 12 mcg/hr
27.5(9.6)
0.3(0.2)
Fentanyl Transdermal System 25 mcg/hr
38.1(18.0)
0.6(0.3)
Fentanyl Transdermal System 50 mcg/hr
34.8(15.4)
1.4(0.5)
Fentanyl Transdermal System 75 mcg/hr
33.5(14.5)
1.7(0.7)
Fentanyl Transdermal System 100 mcg/hr
36.8(15.7)
2.5(1.2)
Stephen Gortat was wearing a 100mg fentanyl patch at the time of his death. As a result, as set forth above, the patch was suppose to deliver 2.5 ng/ml of fentanyl to him. However, upon autopsy his fentanyl level was 33 ng/ml -- over 13 times the expected dosage.
It is universally agreed that too great of a concentration of fentanyl in a person's bloodstream is lethal. In 2007, the U.S. Food and Drug Administration issued a Public Health Advisory saying this very thing.
Basalt, the leading toxicology treatise in the United States, which is the accepted gold standard reference for medical examiners around the country, sets forth that fentanyl becomes lethal at 3.0 ng/ml in the bloodstream.
Plaintiff will demonstrate to the Court and the jury that Stephen Gortat died as a result of his fentanyl patch, which was manufactured and marketed by the Defendants, giving him an improper lethal dose of fentanyl. As a result, Plaintiff will demonstrate to the Court and the jury that the Defendants are legally liable for all damages associated with the wrongful death of Stephen Gortat.
(b) Defendants' Statement:
This claim involves the use of an FDA-approved pharmaceutical product, Mylan's Fentanyl Transdermal System (MFTS), which was developed, manufactured, distributed and sold by Mylan Technologies Inc. (“MTI”) and Mylan Pharmaceuticals Inc. (“MPI”). As with any pharmaceutical product, the manufacture and marketing of this product is controlled by the Food, Drug and Cosmetic Act (“FDCA”). Pursuant to statutory authority conferred on the Food and Drug Administration (“FDA”), MTI and MPI began to market the MFTS only after obtaining FDA approval of the drug. As part of the approval process, MTI submitted an Abbreviated New Drug Application (“ANDA”) which the FDA evaluated. At the conclusion of the evaluation process, FDA determined that the MFTS was safe and effective in the management of persistent, moderate to severe chronic pain when the drug was used in accordance with its approved labeling.
The Mylan Defendants will demonstrate that no basis exists to challenge FDA's finding that the MFTS is a safe and effective drug product. The Mylan Defendants will demonstrate that the strict liability, negligence, product misrepresentation and warranty claims raised in the plaintiffs' Complaint lack merit since the drug product in question was properly formulated, manufactured in accordance with good manufacturing practices, and reasonably safe when properly used and prescribed. Further, the Mylan Defendants acted reasonably and properly in the development, manufacture, distribution and sale of this drug and were not negligent in any respect.
The Mylan Defendants will demonstrate that the remaining claims raised in the plaintiffs' Complaint lack merit because: (i) the MFTS was safe and effective when properly used and properly prescribed (ii) the FDA approved labeling provided with this prescription drug product was adequate to warn the prescribing physician of the possible risks associated with the product; (iii) the product was safely and properly formulated, manufactured, distributed and sold; (iv) the design of the MFTS was state-of-the-art; and (v) the MFTS was safety and properly formulated, manufactured, distributed and sold, and no deficiency, defect or malfunction existed in the MFTS which caused or contributed to the death of Stephen Gortat. Moreover, the scientific evidence will show that the post-mortem blood levels relied upon by Plaintiffs to suggest that fentanyl was delivered at an unsafe rate is inherently unreliable.
The Mylan Defendants complied with the FDCA and the regulations established by the FDA for the manufacture, distribution and sale of this product.
3. Any Challenge to Jurisdiction or Venue
The parties do not challenge personal or subject matter jurisdiction in the United States District Court for the Northern District of Texas.
Moreover, the parties do not anticipate any challenge to venue in the United States District Court for the Northern District of Texas, Dallas Division.
4. Pending or Contemplated Motions
There are no Motions currently pending before this Court.
The parties do anticipate the filing of Motions for Summary Judgment, Daubert Motions and other motions in Limine. The proposed time for the filing of those motions is outlined in the discovery plan which is incorporated in support of this Rule 26(f) Report.
5. Any Matters Which Require Conference with the Court
At this time, the parties do not anticipate the need for a conference with the Court.
6. Likelihood that Other Parties Will Be Joined
Without some initial discovery, it is impossible to predict whether other parties will be joined to this action.
The discovery plan proposed by the parties includes the deadline for the joinder of third parties. That proposed deadline is December 1, 2009.
7. Discovery Plan
The parties have conferred upon the discovery issues presented by this case, including a potential discovery plan and set forth such as follows:
(a) The parties have agreed to make their Initial Disclosure as required by Fed. R. Civ. P. 26(a)(1) by August 14, 2009.
(b) The parties have agreed that any Third Party Complaint shall be filed by December 1, 2009.
(c) The parties have agreed that plaintiff shall make all expert disclosures required by Rule 26 of the Federal Rules of Civil Procedure no later than February 15, 2010.
(d) The parties have agreed that the defendants shall make all expert disclosures requires by Rule 26 of the Federal Rules of Civil Procedure no later than March 30, 2010.
(e) The parties have agreed that all discovery in this matter shall be completed by May 31, 2010.
This is a complex case and the parties agree that discovery in this case should extend until May 31, 2010. Plaintiff intends to seek discovery on various subjects relating to the claims and defenses in this case including, but not limited to:
(1) the design, manufacture, and sale of the Mylan fentanyl pain patches;
(2) FDA investigations relating to the Mylan fentanyl pain patches,
(3) FDA inspections of the plants where Mylan fentanyl pain patches are manufactured;
(4) correspondence between the FDA and Mylan regarding the Mylan fentanyl pain patches, including production thereof and the warnings and package inserts related thereto;
(5) known or suspected defective Mylan fentanyl pain patches;
(6) known or claimed deaths or injuries from the use of Mylan fentanyl pain patches;
(7) expected or anticipated fentanyl levels from the use of the Mylan fentanyl pain patches, including studies related thereto;
(8) lawsuits and claims claiming death and/or injury from Mylan fentanyl pain patches;
(9) all correspondence and/or communications with doctors or other medical providers regarding Mylan fentanyl pain patches;
(10) the package inserts for the Mylan fentanyl pain patches, including their anticipated purpose;
(11) all marketing materials related to the Mylan fentanyl pain patches;
(12) all warnings given to patients, medical care providers and/or the public regarding the Mylan fentanyl pain patches;
(13) the cost of production of the Mylan fentanyl pain patches;
(14) the financial condition of the makers and marketers of the Mylan fentanyl pain patches;
(15) all medical studies ever performed or relied up by the Defendants in the manufacture and marketing of the Mylan fentanyl pain patches;
(16) all information and/or documentation the Defendants have ever obtained from ALZA or one of its related companies regarding fentanyl and/or Duragesic;
(17) the relationship and respective responsibilities between the makers and markets of the Mylan fentanyl pain patch and the makers and marketers of the Duragesic pain patch;
(18) the internal discussions and documentation of the defendants regarding the above matters;
(19) the evidence which may exist to support Defendants' defenses in this lawsuit; and
(20) the identity, scope and basis of any opinion testimony offered by the Defendants to support their defenses in this lawsuit.
Defendants intend to seek discovery on various subjects relating to the claims and defenses in this case including, but not limited to:
(1) the cause, manner and circumstances surrounding the death of Stephen Gortat, including, without limitation, his autopsy and toxicology results;
(2) the medical care and medical history of Stephen Gortat, including, without limitation, the medical treatment and medications used and/or prescribed by him prior to his death;
(3) the damages sustained by Stephen Gortat's wrongful death beneficiaries;
(4) the educational and employment history of Stephen Gortat and other information necessary to evaluate the plaintiff's damage claim; and
(5) the cause, manner and circumstances surrounding Stephen Gortat's death;
(6) the evidence, if any, which exists to support the strict liability, negligence, breach of warranty and misrepresentation claims raised by the plaintiff;
(7) the decedent's psychiatric care, if any, and his psychiatric condition, if any, at the time his death and prior thereto;
(8) the evidence which may exist to support Plaintiff's claims in this lawsuit; and
(9) the identity, scope and basis of any opinion testimony offered by plaintiff to support his liability claims.
The parties agree that the discovery limits imposed by the Federal Rules of Civil Procedure should apply to this case.
Following the completion of discovery, the parties propose the following deadlines with respect to pretrial motions:
(a) Motions for Summary Judgment - June 15, 2010;
(b) Response(s) and Brief(s) in Opposition to Motions for Summary Judgment - July 15,2010;
(c) Reply Brief(s) and Response to Summary Judgment Oppositions - July 30, 2010;
(d) Daubert Challenges - June 15, 2010;
(e) Response(s) and Brief(s) in Opposition to Daubert Challenges -- July 15, 2010;
(f) Reply Brief(s) and Response to Daubert Oppositions -- July 30, 2010;
(g) Remaining pretrial motions in limine to be filed in accordance with the Court's trial scheduling order
8. Statement of Counsel
Counsel for both parties have read the Dondi decision, 121 F.R.D. 284 (N.D. Texas 1988) and counsel have read and are familiar with the District's Civil Justice Expense and Delay Reduction Plan as amended in May 2002.
9. Requested Trial Date
The parties believe that this case will be trial ready in October 2010.
It is anticipated that the trial of this matter will take ten (10) days. A jury trial has been demanded by both plaintiffs and defendants.
10. Consent to Trial by Magistrate
The parties do not consent to trial before the Magistrate Judge.
11. Prospects for Settlement
The parties believe that it is premature to evaluate the case for settlement, and impossible to predict the prospects for settlement.
Thus far, no settlement discussions have taken place, although the parties are agreeable to a mediation following the conclusion of fact discovery.
12. Agreement with Respect to Mediation
The parties are agreeable to mediation and propose to mediate the matter at the conclusion of fact discovery which is proposed to conclude on May 31, 2010.
