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.
Honorable Robert L. Vining, Jr. United States District Judge Northern District of Georgia Atlanta Division.
1. Description of Case:
(a) Describe briefly the nature of this action.
Plaintiff states: Plaintiff asserts strict liability, negligence, fraudulent concealment, breach of implied and express warranties, negligent misrepresentation, gross negligence, and joint and several liability claims against the Defendants. Plaintiff alleges injuries arising out of Plaintiff decedent's use of fentanyl. Plaintiff seeks pre-death pain and suffering, wrongful death, and punitive damages against the Defendants.
Defendant States: This is a wrongful death products liability action alleging Defendants' liability under theories of Strict Liability, Negligence, Breach of Warranty, and Negligent Misrepresentation.
(b) Summarize, in the space provided below, the facts of this case. The summary should not be argumentative nor recite evidence.
Plaintiff States: This is an original action filed in the United States District Court, Northern District of Georgia, Atlanta Division, in which Plaintiff alleges that, on or about April 24, 2007, Plaintiff's Decedent, Ronnie Stoyles, had a reaction to a prescription drug, Fentanyl. Ronnie Stoyles died as a result of his reaction to Fentanyl on April 24, 2007. The Fentanyl product used by Ronnie Stoyles was manufactured by Defendants. Plaintiff alleges strict liability, negligence, fraudulent concealment, breach of implied and express warranties, negligent misrepresentation, gross negligence, and joint and several liability claims against the Defendants. Plaintiff alleges injuries arising out of Decedent's use of Fentanyl. Plaintiff seeks pre-death pain and suffering, wrongful death, and punitive damages against the Defendants.
Defendants state: This case is in its infancy and Defendants (“Mylan”) has not had an opportunity to conduct discovery or meaningfully investigate Plaintiff's allegations. Consequently, Mylan's knowledge of the facts of this case is limited to the sparse factual allegations contained in Plaintiff's Complaint. Plaintiff's Complaint alleges that decedent Ronnie Stoyles was prescribed a fentanyl transdermal system (“FTS”) manufactured by Mylan. Plaintiff's Complaint does not reveal Mr. Stoyles' cause of death or provide any explanation as to how Plaintiff alleges that the product at issue caused Mr. Stoyles' death. Plaintiff's believe that Ronnie Stoyles was found dead on April 24, 2007 as a result of a reaction to Fentanyl.
At this early stage of litigation -and given the dearth of factual specificity contained in the Complaint -Mylan is unable to provide a meaningful summary of the facts of this case. Nonetheless, Mylan states that Defendant Mylan Inc. is a holding company and was not responsible for the development, manufacture and/or distribution of FTS and, therefore, all claims against Mylan Inc. should be dismissed with prejudice. Additionally, Mylan denies that Mr. Stoyles' alleged use of the product at issue caused or contributed in any way to his injury or death and/or Plaintiff's alleged harm. Mylan reserves the right to supplement this response.
(c) The legal issues to be tried are as follows:
Defendants state: At this early stage of litigation it is impossible for Mylan to exhaustively identify each and every legal issue that may arise at trial. Mylan hereby incorporates each of their affirmative defenses raised in their Answer. Based on the information currently available to Mylan, and without assuming the burden of production or proof on any matter where that burden properly belongs to Plaintiff, Mylan states that the following legal issues are likely to arise in this lawsuit:
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.
Plaintiff States the following Issues:
1. Whether Plaintiff suffered any injuries that were proximately caused by Plaintiff decedent's ingestion of fentanyl.
2. Whether Defendants breached a duty owed to Plaintiff.
3. Whether any negligence by Defendants proximately caused any alleged damages.
4. Whether Plaintiff assumed the risk of any harm suffered.
5. Whether the Defendants defectively designed their fentanyl products such that they proximately caused the alleged injuries suffered by Plaintiff.
6. Whether the requisite privity exists between each Defendant and Plaintiff to support Plaintiff' claims for breach of warranty.
7. If such privity exists, whether the drugs at issue in the Complaint were of merchantable quality.
8. Whether the Defendants misrepresented information about the drug at issue in the Complaint such that it proximately caused the alleged injuries suffered Plaintiff.
9. Plaintiff's damages.
10. Whether applicable statute of limitations, waiver, estoppel, or laches bars some or all of Plaintiff' claims.
11. Whether Defendants acted with wilful misconduct, malice, fraud, wantonness, oppression, or that entire want of care, which would raise the presumption of conscious indifference to consequences.
Plaintiff reserves the right to amend or supplement this report to the extent that discovery and investigation into this matter reveal additional legal issues for trial.
Defendants reserve the right to amend or supplement this report to the extent that discovery and investigation into this matter reveal additional legal issues for trial.
(d) The cases listed below (include both style and action number) are:
(1) Pending Related Cases: Mylan states that there are no Pending Related Cases. The Mylan defendants believe that each case related to its fentanyl transdermal system contains a unique set of facts, including but not limited to, the decedent's underlying health and medical condition, patch strength of FTS allegedly used, date ranges related to dates of death and pharmacological effect of FTS in conjunction with other drugs used by decedent.
Plaintiffs state the following as Pending Related Cases:
BARBARA E. BERRY, as Guardian ad Litem for Chelsea Berry, a minor; as personal representative of the Estate of Timothy Edgar Berry, decedent; AND Gina Miller, as Guardian ad Litem for Chelsea Berry, a minor; as personal representative of the Estate of Timothy Edgar Berry, decedent, v. MYLAN, INC., MYLAN PHARMACEUTICALS, INC. and MYLAN TECHNOLOGIES, INC., U.S. District Court for the Eastern District of California, Civil Action File No. 2:09-cv-01534.
BILL J. MOTLEY, Individually and as Personal Representative of the Estate of Karen A. Motely, Deceased v. MYLAN, INC., MYLAN PHARMACEUTICALS, INC. and MYLAN TECHNOLOGIES, INC., U.S. District Court, Southern District of Texas (Houston) Civil Action File No. 4:09-cv-01570
CANDACE GHOLSON and KRISTY GHOLSON v. MYLAN, INC., MYLAN PHARMACEUTICALS, INC. and MYLAN TECHNOLOGIES, INC., U.S. District Court, Northern District of California, Civil Action File No. 3:09-cv-2042
ARTHUR LAPAGLIA, Administrator of the Estate of other Joseph LaPaglia, v. MYLAN, INC., MYLAN PHARMACEUTICALS, INC. and MYLAN TECHNOLOGIES, INC., U.S. District Court, Northern District of Ohio (Cleveland), Civil Action File No.: 1:08-cv-3025
(2) Previously Adjudicated Related Cases: There are no previously adjudicated related cases.
2. This case is complex because it possesses one (1) or more of the features listed below (please check) :
(1) Unusually large number of parties
(2) Unusually large number of claims or defenses
(3) Factual issues are exceptionally complex
(4) Greater than normal volume of evidence
(5) Extended discovery period is needed
(6) Problems locating or preserving evidence
(7) Pending parallel investigations or action by government
(8) Multiple use of experts
(9) Need for discovery outside United States boundaries
(10) Existence of highly technical issues and proof
3. Counsel:
The following individually-named attorneys are hereby designated as lead counsel for the parties:
Plaintiff: C. Andrew Childers, Esq. Georgia Bar No. 124398 M. Brandon Smith, Esq. Georgia Bar No. 141418 Childers & Schlueter, LLP 260 Peachtree Street, Suite 1601 Atlanta, GA 30303 achilders@cbsfirm.com bsmith@candsfirm.com (404) 419-9500 (404) 419-9501 (facsimile)
Andrew G. Finkelstein, Esq. Kenneth B. Fromson, Esq. (Admitted Pro Hac Vice) kfromson@lawampm.com Marshall P. Richer, Esq. (Admitted Pro Hac Vice) mricher@lawampm.com Keith Altman, Esq. (Admitted Pro Hac Vice) kaltman @lawampm.com Finkelstein & Partners, LLP 1279 Route 300 PO Box 1111 Newburgh, NY 12551 Phone: (845) 562-0203 Fax: (845) 562-3492
OF COUNSEL FOR PLAINTIFF
Defendant: Brian K. Parker, Esq. (Admitted Pro Hac Vice) McGuireWoods LLP 625 Liberty Ave, 23rd Floor Pittsburgh, Pa. 15222 (412) 667-7907 bparker @mcguirewoods.com
4. Jurisdiction:
Is there any question regarding this court's jurisdiction?
If “yes,” please attach a statement, not to exceed one (1) page, explaining the jurisdictional objection. When there are multiple claims, identify and discuss separately the claim(s) on which the objection is based. Each objection should be supported by authority.
5. Parties to This Action:
(a) The following persons are necessary parties who have not been joined:
Not Applicable
(b) The following persons are improperly joined as parties:
Not Applicable
(c) The names of the following parties are either inaccurately stated or necessary portions of their names are omitted:
Not Applicable
(d) The parties shall have a continuing duty to inform the court of any contentions regarding unnamed parties necessary to this action or any contentions regarding misjoinder of parties or errors in the statement of a party's name.
6. Amendments to the Pleadings:
Amended and supplemental pleadings must be filed in accordance with the time limitations and other provisions of Fed.R.Civ.P. 15. Further instructions regarding amendments are contained in LR 15.
(a) List separately any amendments to the pleadings which the parties anticipate will be necessary:
Not Applicable at this time. The parties will supplement this if necessary.
(b) Amendments to the pleadings submitted LATER THAN THIRTY (30) DAYS after the Joint Preliminary Report and Discovery Plan is filed, or should have been filed, will not be accepted for filing, unless otherwise permitted by law.
7. Filing Times For Motions:
All motions should be filed as soon as possible. The local rules set specific filing limits for some motions. These times are restated below.
All other motions must be filed WITHIN THIRTY (30) DAYS after the beginning of discovery, unless the filing party has obtained prior permission of the court to file later. Local Rule 7.1A(2).
(a) Motions to Compel: before the close of discovery or within the extension period allowed in some instances. Local Rule 37.1.
(b) Summary Judgment Motions: within twenty (20) days after the close of discovery, unless otherwise permitted by court order. Local Rule 56.1.
(c) Other Limited Motions: Refer to Local Rules 7.2A; 7.2B, and 7.2E, respectively, regarding filing limitations for motions pending on removal, emergency motions, and motions for reconsideration.
(d) Motions Objecting to Expert Testimony: Daubert motions with regard to expert testimony no later than the date that the proposed pretrial order is submitted. Refer to Local Rule 7.2F.
Plaintiff States: The Parties have proposed specific dates and deadlines for the discovery of this matter given the complex nature and circumstances of it. These dates are specifically denoted in Subpart 10 of this Proposed Discovery Plan. The Parties therefore respectfully request this Court to adopt these proposed discovery dates and deadlines in the management of this case.
8. Initial Disclosures:
The parties are required to serve initial disclosures in accordance with Fed.R.Civ.P. 26. If any party objects that initial disclosures are not appropriate, state the party and basis for the party's objection.
The parties have served Initial Disclosures on July 10, 2009.
9. Request for Scheduling Conference:
Does any party request a scheduling conference with the Court? If so, please state the issues which could be addressed and the position of each party.
Defendant states: Neither party requests a scheduling conference at this time. The parties are working together to address scheduling issues in this lawsuit and anticipate submitting a proposed scheduling order by joint motion to the Court.
10. Discovery Period:
The discovery period commences thirty (30) days after the appearance of the first defendant by answer to the complaint. As stated in LR 26.2A, responses to initiated discovery must be completed before expiration of the assigned discovery period.
Cases in this court are assigned to one of the following three (3) discovery tracks: (a) zero (0)-months discovery period, (b) four (4)-months discovery period, and (c) eight (8)- months discovery period. A chart showing the assignment of cases to a discovery track by filing category is contained in Appendix F. The track to which a particular case is assigned is also stamped on the complaint and service copies of the complaint at the time of filing.
Please state below the subjects on which discovery may be needed:
Plaintiff States: Plaintiff anticipate that discovery will be needed regarding labeling history of Defendants' fentanyl products, communications between the Defendants and the FDA, internal procedures employed by Defendants to monitor adverse events related to their drug products, Defendants' knowledge of adverse events related to fentanyl, and other information relevant to Plaintiff' allegations against each defendant. This case involves complex factual and legal issues related to the cause of Plaintiff' injuries, the safety and efficacy of fentanyl and the adequacy of the warnings accompanying that prescription drug. The parties anticipate testimony from multiple experts regarding complex medical and pharmacological issues.
Defendant States: Defendants anticipate discovery will be needed on various subjects relating to the claims and defenses in this case including, but not limited to: the cause, manner and circumstances surrounding the death of Ronnie Stoyles; the medical care received and medical/drug history of Ronnie Stoyles; the damages sustained by Ronnie Stoyles' wrongful death beneficiaries; the educational and employment history of Ronnie Stoyles and other information necessary to evaluate the plaintiffs' damage claim; the evidence, if any, which exists to support the strict liability, negligence, breach of warranty and misrepresentation claims raised by the plaintiffs; Ronnie Stoyles' psychiatric care, if any, and his psychiatric condition, if any, at the time his death and prior thereto; the evidence which may exist to support plaintiffs' claims in this lawsuit; and the identity, scope and basis of any opinion testimony offered by plaintiffs to support their liability claims.
If the parties anticipate that additional time beyond that allowed by the assigned discovery track will be needed to complete discovery or that discovery should be conducted in phases or be limited to or focused upon particular issues, please state those reasons in detail below:
The parties have discussed the need for an additional six (6) months of discovery. The parties are aware that this case involves complex legal, factual, medical, and expert issues. The parties agreed that four (4) months is not an adequate amount of time to complete discovery and agree that an additional six (6) months (for a total of ten months) should be adequate. The parties propose a discovery schedule as follows:
Fact discovery cut-off date: May 10, 2010
Plaintiff's expert disclosures to be served by: July 12, 2010
Defendant's expert disclosures to be served by: August 12, 2010
Rebuttal Disclosure: September 13, 2010
Expert depositions to be conducted by: October 13, 2010
Recommended dispositive motion date: November 15, 2010
11. Discovery Limitation:
What changes should be made in the limitations on discovery imposed under the Federal Rules of Civil Procedure or Local Rules of this Court, and what other limitations should be imposed.
None at this time.
12. Other Orders:
What other orders do the parties think that the Court should enter under Rule 26(c) or under Rule 16(b) and (c) ?
It is anticipated that Defendants shall seek the entry of a Protective Order and Confidentiality order under Rule 26(c).
13. Settlement Potential:
(a) Lead counsel for the parties certify by their signatures below that they conducted a Rule 26(f) conference that was held on June 26, 2009, and that they participated in settlement discussions. Other persons who participated in the settlement discussions are listed according to party.
For plaintiff: Lead counsel (signature) : /s/: M. Brandon Smith
Of Counsel for Plaintiff:
Kenneth B. Fromson, Esq. (Admitted Pro Hac Vice) Marshall P. Richer, Esq. (Admitted Pro Hac Vice) Keith Altman, Esq. (Admitted Pro Hac Vice)
For defendant: Lead counsel (signature) : /s/ Brian K. Parker
Other participants:
Jennifer Cairns and Andrew Phillips
(b) All parties were promptly informed of all offers of settlement and following discussion by all counsel, it appears that there is now:
A possibility of settlement before discovery.
) A possibility of settlement after discovery.
A possibility of settlement, but a conference with the judge is needed.
No possibility of settlement.
(c) Counsel ( ) do or (_X_) do not intend to hold additional settlement conferences among themselves prior to the close of discovery. The proposed date of the next settlement conference is after the close of discovery.
(d) The following specific problems have created a hindrance to settlement of this case.
Not applicable.
14. Trial by Magistrate Judge:
Note: Trial before a Magistrate Judge will be by jury trial if a party is otherwise entitled to a jury trial.
(a) The parties (___ do consent to having this case tried before a magistrate judge of this court. A completed Consent to Jurisdiction by a United States Magistrate Judge form has been submitted to the clerk of court this day___, of 2009.
(b) The parties ( X ) do not consent to having this case tried before a magistrate judge of this court.
Upon review of the information contained in the Joint Preliminary Planning Report and Scheduling Order form completed and filed by the parties, the Court orders that the time limits for adding parties, amending the pleadings, filing motions, completing discovery, and discussing settlement are as stated above, except as herein modified:
IT IS SO ORDERED, this day of, 2009.
