Plaintiffs’ Consolidated Motion to Remand and Brief in Support

Hughes, et al. v. Myland, Inc., et al.

Description: Heygood, Orr & Pearson filed this brief on behalf of nineteen groups of plaintiffs whose fentanyl patch cases had been removed to federal court from the Pennsylvania Court of Common Pleas by the defendant drug companies. The defendants argued that their removal was proper because Mylan, Inc. (one of the defendant drug companies and a Pennsylvania resident) had been fraudulently joined in the action. Thus, according to defendants, the Pennsylvania citizenship of Mylan, Inc. could be ignored, and the case was properly removable because none of the other defendants were Pennsylvania residents. In this brief, Heygood, Orr and Pearson argued that the drug-company defendants’ removal was procedurally improper and that the case should be remanded back to the state court in Pennsylvania. Heygood, Orr and Pearson also explained that Mylan, Inc. was a proper defendant because of its involvement in the design and development of the Mylan fentanyl patch. The federal court agreed with the plaintiffs and sent the case back to the Pennsylvania Court of Common Pleas.


IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SHELLY HUGHES, et al.             Plaintiffs,v.

 

MYLAN, INC., et al.

              Defendant.

 

CIVIL ACTION NO. 11-05543
NANCY MORENO, et al.              Plaintiffs,v.

 

MYLAN, INC., et al.

              Defendants.

 

CIVIL ACTION NO. 11-05544
ANDREA BOWEN, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05545
MARY JO WALL, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05546
AMY DORAN, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

                Defendants.

 

CIVIL ACTION NO. 11-05547
MARILYN APPLE, et al.               Plaintiffs, v.

 

Mylan, INC., et al.

               Defendants.

CIVIL ACTION NO. 11-00548
LISA CROYLE, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

CIVIL ACTION NO. 11-05549
TERRY REESE, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05550
PATRICIA HOLK, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05551
MICHELLE HOBBS, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05552
COLLEEN GRIGSBY, et al.                Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05553
CHANTE NEWMAN, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05554
EVELYN REGENER, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05555
SHANNON MORRISON, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05556
ASHLEY BROADDUS, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05557
WILLIAM PHELPS, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05558
STEVEN SHEMELIA, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants.

 

CIVIL ACTION NO. 11-05559
KATIE TISCH, et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendants

  

CIVIL ACTION NO. 11-05560
GLENDA A. MAXWELL et al.               Plaintiffs,v.

 

MYLAN, INC., et al.

               Defendant.

CIVIL ACTION NO. 11-05617

PLAINTIFFS’ CONSOLIDATED MOTION TO REMAND AND BRIEF IN SUPPORT

INTRODUCTION

These nineteen cases should be remanded to state court because (1) none of the cases were properly removed pursuant to 28 U.S.C. § 1446(b); and (2) even if Defendants had complied with the removal statute, Defendants have failed to carry their heavy burden of persuasion of showing that Mylan, Inc. is fraudulently joined in these actions.  No one disputes that these cases were not removable when first filed, a fact recognized by this Court when it remanded six of them earlier this year.   Pursuant to 28 U.S.C. § 1446(b)’s “voluntary rule,” the only way these cases could have become removable is if Plaintiffs had voluntarily withdrawn their claims against Mylan, Inc. (a Pennsylvania defendant), at which point Defendants would then have had thirty days to file removal papers.  The problem is that Plaintiffs have never withdrawn their claims against Mylan, Inc., and these cases are thus still nonremovable.

Defendants first incorrectly seize on the United States Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), to claim that these cases have become removable because Plaintiffs’ warnings claims against Mylan, Inc. are no longer valid.  The Mensing decision, however, does not constitute a “voluntary” act of Plaintiffs that would trigger the thirty-day period of § 1446(b), and federal case law is clear that a subsequent development in the law (such as the Mensing decision) cannot make a case removable.  Moreover, even if Mensing had somehow made these cases removable, Defendants’ removal would be untimely because they removed these cases almost seventy-five days after the Mensing decision, well outside the thirty-day window of § 1446(b).

Defendants also make the incredible claim that these cases have become removable because Plaintiffs voluntarily withdrew their claims against Mylan, Inc. when they filed their Long Form Complaint in the Pennsylvania Court of Common Pleas on August 15, 2011.  Plaintiffs do not understand how Defendants could possibly interpret their Long Form Complaint in such a manner, as the Long Form Complaint did not withdraw a single allegation against Mylan, Inc.  The only difference between Plaintiffs’ Long Form Complaint and their prior pleadings is that there are additional allegations of misconduct against Defendants, including Mylan, Inc.  Because Plaintiffs have not withdrawn their claims against Mylan, Inc., through the Long Form Complaint or any other document, these cases are still not removable.

Even if this Court were to ignore Defendants’ noncompliance with § 1446(b), Defendants still come nowhere close to satisfying the demanding standard for showing that Mylan Inc. has been fraudulently joined, a standard that requires Defendants to show that Plaintiffs’ claims are essentially “a clear legal impossibility.”  (January 19, 2011, Remand Order at 5 (internal quotation marks and citation omitted), attached to the Declaration of John Chapman as Exhibit 1.)  Despite Defendants’ claims to the contrary, Plaintiffs continue to have valid warnings claims against Mylan, Inc. because the Mensing decision was far more limited than Defendants would lead this Court to believe.  Moreover, to the extent there is any doubt about the scope or applicability of Mensing to Plaintiffs’ warnings claims, such doubt must be resolved in favor of Plaintiffs at the remand stage.

Finally, even if this Court were to resolve all questions about Mensing in favor of Defendants and construe the opinion as barring all of Plaintiffs’ warning and warranty claims, Plaintiffs still have claims against Mylan, Inc. for design and manufacturing defect, claims indisputably beyond the scope of Mensing.  These claims are supported by evidence that Mylan, Inc. obtained FDA approval of the Mylan fentanyl patch’s matrix design, oversaw studies concerning the design, and performed the critical quality control process of reviewing adverse event reports for any evidence of product defect.  In sum, Defendants’ removal of these cases is neither procedurally nor substantively proper, and they should all be remanded to the Philadelphia Court of Common Pleas. 

BACKGROUND[1]

            These wrongful death actions involve the Mylan fentanyl pain patch.  Plaintiffs generally bring claims of strict liability and negligence based on defective design, manufacture, and warnings, as well as warranty claims.  All of these actions were filed in the Philadelphia Court of Common Pleas pursuant to a Mass Tort Program, a type of coordinated proceeding.  The most recent of these actions was filed on July 26, 2011.[2]

Defendants first removed six of these cases on or about November 16, 2010, asserting that Mylan, Inc. (a Pennsylvania defendant) had been fraudulently joined and that, as a result, its citizenship should be disregarded.[3]  After extensive briefing, this Court remanded all six of the cases, concluding that Defendants had failed to carry their burden of showing that Plaintiffs’ claims against Mylan, Inc. were “practically a clear legal impossibility.”  (January 19, 2011, Remand Order at 5-6, Chapman Decl. Exhibit 1.)  After remand, the cases were consolidated pursuant to the Philadelphia Court of Common Pleas’ Mass Tort Program, and they proceeded in the ordinary course of litigation.

On June 23, 2011, the United States Supreme Court issued its decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed the issue of state-law, failure-to-warn claims against manufacturers of generic pharmaceutical products.  On or about July 20, 2011, Plaintiffs sought leave to file a long form complaint in order to refine their claims against Defendants in light of Mensing, as well as to more generally create a master complaint from which all subsequently filed complaints could be based.

On August 15, 2011, Plaintiffs filed their Original Master Long Form Complaint (the “Long Form Complaint’).  Critically, the Long Form Complaint did not withdraw a single allegation against any defendant, including Mylan, Inc.  (For reasons set forth below in Part III.B, Plaintiffs’ warnings claims were unaffected by the Mensing decision.)  The only difference between Plaintiffs’ Long Form Complaint and their prior pleadings is that the Long Form Complaint contains additional allegations against Defendants.  On September 2, 2011, Defendants removed these cases.


 

ARGUMENT AND AUTHORITIES

I.          Defendants bear the burden of showing that they have strictly complied with the removal statute’s procedural requirements.

 

A removing party bears the burden of proving that jurisdiction exists.  Boyer v. Snap-On Tools Corp., 913 F.2d 108, 111 (3d Cir. 1990).  As a general matter, removal statutes are “strictly construed against removal and all doubts should be resolved in favor of remand.”  Id. (quoting Steel Valley Auth. v. Union Switch and Signal Div., 809 F.2d 1006, 1010 (3d Cir. 1987)).  In addition, “doubts as to the procedural propriety of removal should be resolved in favor of remand.”  Laney v. Independence Blue Cross, No. 06-4175, 2007 U.S. Dist. LEXIS 68407, at *8-9 n.9 (E.D. Pa. Sept. 17, 2007) (emphasis in original);    Syngenta Crop Prot., Inc. v. Henson, 537 U.S. 28, 32 (2002) (“[S]tatutory procedures for removal are to be strictly construed.”).

  1. A.                A case that is not originally removable can only become removable by voluntary action of the plaintiff.

 

If a case is not removable at the initial pleading stage, then a defendant may later remove it only if the defendant files removal papers “thirty days after receipt. . . of a copy of an amended pleading, motion, order or other paper from which it may first be ascertained that the case is one which is or has become removable.”  28 U.S.C. 1446(b).  Courts are without any authority to expand the thirty-day time period.  The Knit With v. Aurora Yarns, No. 09-5981, 2010 U.S. Dist. LEXIS 22592, at *31 (E.D. Pa. March 11, 2010).

In addition, § 1446(b) has been interpreted as imposing what is known as the “voluntary rule,” which provides that “an action which is nonremovable when commenced can become removable only by voluntary act of plaintiff.”  In re Asbestos Products Liability Litigation, No. 11-02626,  2011 U.S. 53432, at *5 (E.D. Pa. May 16, 2011) (surveying authority) (emphasis added); Rubino v. Genuardi’s, No. 10-6708, 2011 U.S. Dist. LEXIS 9735, at *14-19 (E.D. Pa. Jan. 31, 2011); Cook v. Pep Boys- Mannie, MoeJack, Inc., 641 F. Supp. 43, 45 (E.D. Pa. 1985);  Abels v. State Farm Fire & Casualty Co., 694 F. Supp. 140, 143 (W.D. Pa. 1988) (“‘[I]f, . . . apart from fraudulent joinder, plaintiff states a nonremovable case in his initial complaint, involuntary changes will not make the case removable; they must have been brought about by the voluntary act of the plaintiff.’”) (quoting 1A J. Moore, B. Ringle & J. Wickler Moore’s Federal Practice, para. 0.168 [3.-5-6] at 597 (2d Ed. 1987)).[4]   The reason for the voluntary rule is two-fold:

First, it contribute[s] to judicial economy, because after an involuntary removal, the plaintiff may appeal the dismissal in state court, and success on appeal would lead to the reinstatement  of the non-diverse party, destroying federal jurisdiction and compelling remand to the state court. Second, it recognizes the general principle of deference to the plaintiff’s choice of forum. Allowing removal only when the plaintiff voluntarily dismisses a defendant ensures that the plaintiff will not be inappropriately forced out of state court without his consent.

 

Graver, 2011 U.S. Dist. LEXIS 53432, at **5-6 (quoting Greco v. Beccia, 2001 U.S. Dist. LEXIS 2647, 2001 WL 121887 at *2 (M.D. Pa. Feb. 13, 2001)); see also First Star Savings Bank v. Am. Title Ins. Co., No. 94-3716, 1994 U.S. Dist. LEXIS 12350, at*8 (E.D. Pa. August 29, 1994) (recognizing that the voluntary rule requires a voluntarily dismissal because “[i]n such cases the plaintiff has created diversity by his voluntary act and is deemed to have relinquished his right to control the choice of forum”).  Here there was no voluntary act by Plaintiffs that make these cases removable.

B.        A subsequent development in case law cannot make a case removable.

A corollary to the voluntary rule is that a change in the law that has the effect of eliminating a plaintiff’s claims against a non-diverse defendant does not make a case removable.  See Commonwealth v. Tap Pharmaceuticals Products, 415 F. Supp. 2d 516, 527 (E.D. Pa. 2005); (rejecting notion that a recent Supreme Court decision in an unrelated case is an “order or other paper” under 28 U.S.C. § 1446(b) that makes a case removable);  Bumpers v. Community Bank of Northern Virginia, No. 03-1380, 2008 U.S. Dist. LEXIS 5107, at *7-8 (W.D. Pa. Jan. 24, 2008) (“A decision by the United States Supreme Court in an unrelated case is, however, not an “order or other paper” that can render a case  removable pursuant to 28 U.S.C. § 1446(b).”)[5]  This is because as a general rule, an “other paper” must be generated within the specific state court proceeding that was removed in order to provide grounds for removal under § 1446(b). See Tap Pharmaceuticals Products, 415 F. Supp. 2d at 527; Rynearson v. Motricity, Inc., 626 F. Supp. 2d 1093, 1097 (W.D. Wash. 2009); Hawaii v. Abbott Laboratories, Inc., 469 F. Supp. 2d 842 (D. Hawaii, 2006).

II.        These cases are not removable pursuant to 28 U.S.C. § 1446(b) because Plaintiffs have not voluntarily withdrawn their claims against Mylan, Inc.

 

A.           The United States Supreme Court’s decision in PLIVA, Inc. v. Mensing does not make these cases removable and, even if it had, Defendants’ removal would be untimely.

 

Defendants assert that these cases are removable because Plaintiffs no longer have “colorable” warning claims against Mylan, Inc. after the United States Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  (See  Notice of Removal at 7-9.)  As a result, in Defendants’ opinion, Mylan, Inc. is now fraudulently joined.  Setting aside the fact that Plaintiffs do in fact still have valid warnings (and design and manufacturing) claims against, Mylan, Inc., see infra Parts III.B and III.C, Defendants’ argument fails for the simple reason it is foreclosed by black-letter federal law.   Even if Mensing had invalidated every single one of Plaintiffs’ claims against, Mylan, Inc., these cases are still not removable under 28 U.S.C. § 1446(b) because a subsequent development in case law cannot make a case removable.  See supra Part I.B.

Moreover, even if this Court were inclined to accept Defendant’ invitation to ignore black-letter law and consider the Mensing decision to be a triggering event under 28 U.S.C. § 1446(b), Defendants’ removal would be untimely.   Mensing was decided on June 23, 2011; Defendants removed these cases on September 2, 2011, well outside the thirty days mandated by § 1446(b).   Simply put, Mensing does not make these cases removable under any circumstances.

B.        Plaintiffs have never voluntarily dismissed their claims against Mylan, Inc.

 

Under Pennsylvania law, discontinuance pursuant to Pa. R. Civ. P. 229 “is the exclusive method of voluntary termination of an action, in whole or in part, by the plaintiff prior to the commencement of trial.”[6]  First Star Savings Bank v. Am. Title Ins. Co., No. 94-3716, 1994 U.S. Dist. LEXIS 12350, at *9 (E.D. Pa. August 29, 1994) (remanding case because, at the time of the removal, the parties had not fully complied with Pa. R. Civ. P. 229(a)); Hutton v. Temple University, 703 F. Supp. 391, 392 (E.D. Pa. 1989) (remanding case even though Plaintiff had entered into a joint tortfeasor release with the non-diverse defendant because as of the date of the removal, the plaintiff had not filed a discontinuance of record).   Because it is undisputed that no Rule 229 discontinuance has ever been entered in any of these cases, there is no basis for concluding that Plaintiffs have voluntarily terminated their claims against Mylan, Inc., and the Court can end its analysis here.  See First Star Savings Bank, 1994 U.S. Dist. LEXIS 12350, at**8-9; Hutton, 703 F. Supp. at 392.

Defendants nevertheless urge this Court to ignore the lack of a Rule 229 discontinuance and examine Plaintiffs’ Long Form Complaint, claiming that it “signal[s] a dramatic shift in the theories of liability pursued in this litigation.”  (Reese Notice of Removal at 3 (Dkt 1).)  Defendants go so far as to suggest that Plaintiffs’ Long Form Complaint effectively abandons all failure-to-warn allegations against Mylan, Inc.  (Id.  at 5.)  To the extent the Court is even willing to consider Defendants’ request (which it should not), the Court will find that Defendants have misled the Court as to the contents of Plaintiffs’ Long Form Complaint.

It is unclear how Defendants can claim the Long Form Complaint abandoned failure-to-warn claims against Mylan, Inc. when the Long Form Complaint did not withdraw a single failure-to-warn allegation against Mylan, Inc.[7]  Below is a table comparing failure-to-warn allegations from Plaintiffs’ original complaints with allegations from the Long Form Complaint.

COMPARISON OF PLAINTIFFS’ WARNING ALLEGATIONS

Reese Complaint[8]

Long Form Complaint

The Mylan Defendants failed to provide sufficient warnings or instructions about the foreseeable dangers associated with normal and foreseeable uses of the Patch to Decedent’s doctor.  (Reese Compl. ¶ 78.) The Mylan Defendants failed to provide sufficient warnings or instructions about the foreseeable dangers associated with normal and foreseeable uses of the Patches to Decedents’ doctor.  (Long Form Comp. ¶ 77.)
Plaintiff further asserts that these Defendants had actual or constructive knowledge that a percentage of the patches they placed into the stream of commerce were defective and posed a significant danger to anyone who used these patches, yet failed to take adequate or timely actions to ensure that potential users or distributors of these patches were advised of the defect and warned not to use the patches.  (Reese Compl. ¶ 42.) Plaintiffs further asserts that these Defendants had actual or constructive knowledge the Patches they placed into the stream of commerce were defective and posed a significant danger to anyone who used these Patches, yet failed to take adequate or timely actions to ensure that potential users or distributors of these patches were advised of the defect and warned not to use the Patches.  (Long Form Compl. ¶ 38.)
Defendants acted together, with a common profit motive, in failing to adequately or appropriately disclose material information relating to the defects in the Patch.  (Reese Compl.¶ 43.) Defendants acted together, with a common profit motive, in failing to adequately or appropriately disclose material information relating to the defects in the Patch.  (Long Form Compl. ¶ 39.)
The above described defects in the product were well known to each of the defendants on and prior to September 2008. Despite such knowledge, the defendants failed to act, to properly warn or to protect Decedent and other Patch users from deadly harm.  (Reese Compl. ¶ 51.) The above described defects in the product were well known to each of the defendants on and prior to the Decedents’ deaths.  Despite such knowledge, the defendants failed to act, to properly warn or to protect Decedents and other Patch users from deadly harm.  (Long Form Compl. ¶ 46.)
The Defendants, in wanton, reckless, grossly negligent and indefensible disregard of the public safety — and that of Decedent— failed adequately and appropriately to warn of the true and, known to the Defendants, deadly risk posed by the Patch.  (Reese Compl. ¶ 52.)

The Defendants, in wanton, reckless, grossly negligent and indefensible disregard of the public safety — and that of Decedents— failed adequately and appropriately to warn of the true and, known to the Defendants, deadly risk posed by the Patch.  (Long Form Compl. ¶ 47.)
Defendants each grossly, negligently, wantonly and recklessly failed to apprise the FDA, the prescribing medical professionals and the public of the lethal risk of “fentanyl toxicity” and fentanyl death the Patch presented due to inherent and customary manufacturing defects and imperfections in the product.   (Reese Compl. ¶ 53.) Defendants each grossly, negligently, wantonly and recklessly failed to apprise the FDA, the prescribing medical professionals, the holder of the RLD, Duragesic, and the public of the lethal risk of “fentanyl toxicity” and fentanyl death the Patches presented due to inherent and customary manufacturing defects and imperfections in the product.  (Long Form Compl. ¶ 48.)
Despite knowing of these defects prior to the date Decedent used the patch in question, the Defendants took inadequate steps to advise physicians, hospitals, nursing homes and other health care providers of the possibility of defects occurring in other patches and of the significant danger to users of the Patch.  (Reese Compl. ¶ 63.) Despite knowing of these defects prior to the date Decedents used the Patches in question, the Defendants took inadequate steps to advise physicians, the holder of the RLD, Duragesic, hospitals, nursing homes and other health care providers of the possibility of defects occurring in other Patches and of the significant danger to users of the Patches.  (Long Form Compl. ¶ 58.)
Despite knowing of the defects prior to the date Decedent used the patch in question, the Defendants took inadequate steps to advise physicians, hospitals, nursing homes and other health care providers of the possibility of defects occurring in other patches and of the significant danger to users of the Patch.  (Reese Compl. ¶ 70.) Despite knowing of the defects prior to the date Decedents used the patches in question, the Defendants took inadequate steps to advise physicians, hospitals, nursing homes, the holder of the RLD, Duragesic, and other health care providers of the possibility of defects occurring in other Patches and of the significant danger to users of the Patches.  (Long Form Compl. ¶ 65.)
Despite having actual notice of these defects prior to the date Decedent used the patch in question, the Defendants took inadequate steps to advise consumers, including Decedent of these defects, the risk posed by similar defects and the significant dangers presented to those using a defective Patch.  (Reese Compl. ¶ 71.) Despite having actual notice of these defects prior to the date Decedents used the Patches in question, the Defendants took inadequate steps to advise consumers and, including Decedents of these defects, the risk posed by similar defects and the significant dangers presented to those using defective Patches.   (Long Form Compl. ¶ 66.)
The Mylan Defendants knew that its Patches could, under foreseeable circumstances, present dangers to Decedent and other foreseeable users of the Patch.  Therefore, the Mylan Defendants had a duty to take reasonable care to provide warnings about the foreseeable dangers associated with using the Patch adequate to safeguard the health of the foreseeable population of consumers who would be exposed to the Patch. Without limitation, the Mylan Defendants failed to provide adequate warnings and/or instructions to Decedent’s doctor regarding the following risks:

  1. The risk of death from the proper use of the Patch;

 

  1. The risk that patients would receive potentially lethal fentanyl levels—far exceeding the levels the Patch was designed to deliver—while properly using the Patch;

 

  1. The risk of death from fentanyl’s narrow therapeutic index.  There is a small interval between therapeutic and toxic fentanyl levels.  The Mylan Defendants failed to provide sufficient warnings about the risks associated with fentanyl’s narrow therapeutic index;

 

  1. The risk of potentially fatal fentanyl overdoses caused by defectively manufactured Patches; and

 

  1. The risk of patient fentanyl overdoses and deaths caused by the use of fentanyl with other drugs.

 

(Reese Compl. ¶ 77.)

The Mylan Defendants knew that their Patches could, under foreseeable circumstances, present dangers to Decedents and other foreseeable users of the Patches.  Therefore, the Mylan Defendants had a duty to take reasonable care to provide warnings about the foreseeable dangers associated with using the Patches adequate to safeguard the health of the foreseeable population of consumers who would be exposed to the Patch. Without limitation, the Mylan Defendants failed to provide adequate warnings and/or instructions to Decedents’ doctors regarding the following risks:

  1. The risk of death from the proper use of the Patches;

 

  1. The risk that patients would receive potentially lethal fentanyl levels—far exceeding the levels the Patches were designed to deliver—while properly using the Patches;

 

  1. The risk of death from fentanyl’s narrow therapeutic index.  There is a small interval between therapeutic and toxic fentanyl levels.  The Mylan Defendants failed to provide sufficient warnings about the risks associated with fentanyl’s narrow therapeutic index;

 

  1. The risk of potentially fatal fentanyl overdoses caused by defectively manufactured Patches;

 

  1. The risk of patient fentanyl overdoses and deaths caused by the use of fentanyl with other drugs;

 

  1. The risk of death from using the Patch on compromised skin;

 

  1. The risk of death from using Patches that have been exposed to heat;

 

 

  1. The risk of death from using Patches on areas of skin that have been shaved; and

 

  1. The risk of death from using Patches on skin that has had soaps, lotions, or oil applied to it.

 

(Long Form Compl.¶ 71.)

 

The Mylan Defendants’ negligent failure to provide such adequate warnings or instructions to Decedent’s doctor was a factual and proximate cause of Decedent’s death and the damages claimed herein.  (Reese Compl. ¶ 79.) The Mylan Defendants’ negligent failure to provide such adequate warnings or instructions to Decedents’ doctors was a factual and proximate cause of Decedents’ deaths and the damages claimed herein.  (Long Form Compl. ¶ 77.)
Defendants took inadequate steps to . . . notify users, consumers and physicians of this danger.  (Reese Compl. ¶ 84.) Defendants took inadequate steps . . . to notify users, consumers, physicians, and the holder of the RLD, Duragesic, of the aforementioned dangers.  (Long Form Compl. ¶ 84.)
Said acts and omissions of the Defendants include but are not limited to negligent design, manufacture and/or distribution of the Patch and failure to adequately warn of known adverse effects inherent in the use of Patch and to remove defective fentanyl-delivery systems from sale to consumers in a timely manner.  (Reese First Am. Compl. ¶ 91.) Said acts and omissions of the Defendants include but are not limited to negligent design, manufacture and/or distribution of the Patches and failure to adequately and effectively warn of known adverse effects inherent in the use of Patches and to remove defective fentanyl-delivery systems from sale to consumers in a timely manner.  (Long Form Compl. ¶ 91.)

 

As the above table shows, the Long Form Complaint contains all of the same failure-to-warn allegations as the original complaints, which, as set forth below in Part III.B, are valid under Mensing.  The only difference between the Long Form Complaint and the prior complaints is that the Long Form Complaint has additional allegations of misconduct against Defendants, including Mylan, Inc.

C.        A request to “refine” a complaint is not a voluntary withdrawal of claims. 

            Based on correspondence Defendants have submitted to this Court, Plaintiffs anticipate that Defendants will argue that Plaintiffs have withdrawn their claims against Mylan, Inc. because the Long Form Complaint is the result of Plaintiffs seeking leave to “refine” their complaints in light of PLIVA v. Mensing.  (See September 14, 2011 letter to the Honorable Judge Joyner (raising this argument), Chapman Decl., Ex. 3.)  It appears that Defendants are requesting that the Court ignore the plain language of the Long Form Complaint (and its comprehensive allegations against Mylan, Inc.), and simply presume that Plaintiffs’ use of the word “refine” constituted a withdrawal of their claims against Mylan, Inc.  Defendants’  assertion lacks any basis in law or common sense.

First, Plaintiffs’ request to “refine” a complaint is not a withdrawal of their claims.  The word “refine” means “to make more fine, subtle or precise,” which is exactly what Plaintiffs’ Long Form Complaint does with regard to all of Plaintiffs’ claims, including their warnings claims. See Dictionary.com, http://dictionary.reference.com/browse/refine (last visited September 15, 2011).  Second, in order for a document to make a case removable, it must be “unequivocally clear and certain that federal jurisdiction lies.”  See Efford v. Milam, 368 F. Supp. 2d 380, 385 (E.D. Pa. 2005) (internal quotation marks omitted).  Defendants cannot seriously claim that Plaintiffs’ request to “refine” their claims unequivocally makes clear that Plaintiffs are withdrawing their claims against Mylan, Inc.  Third, even if Plaintiffs’ request to “refine” their complaints did somehow constitute a withdrawal of their claims against Mylan, Inc., then Defendants’ removal is still untimely.  The request to “refine” Plaintiffs’ complaints was made at a July 20, 2011, Case Management Conference.  (See Chapman Decl., Ex. 3.)  Defendants did not remove these cases until September 2, 2011, well beyond the thirty days set forth in 28 U.S.C. § 1446(b).  In short, any suggestion that Plaintiffs withdrew their claims against Mylan, Inc. when they sought to “refine” their complaints is meritless.  Because Plaintiffs did not voluntarily withdraw their claims against Mylan, Inc. removal was improper.

  1. III.             Even if Defendants had complied with the procedural requirements for removal, they still cannot show that Mylan, Inc. has been fraudulently joined.

 

As set forth above, there has been no triggering event under § 1446(b) that would start the thirty-day clock for removal and, as a result, removal of these cases was procedurally improper.  However, even if this Court were to put aside Defendants’ failure to meet the procedural requirements of removal, these cases should still be remanded because Defendants have failed to show that Mylan, Inc. was fraudulently joined such that its citizenship should be disregarded.

  1. A.                Defendants bear a heavy burden of persuasion to show that Mylan, Inc. has been fraudulently joined.

 

A removing party who claims that a defendant has been fraudulently joined bears a “heavy burden of persuasion.”  Boyer v. Snap-On Tools Corp., 913 F.2d 108, 111 (3d Cir. 1990) (quoting American Standard v. Steel Valley Auth., 484 U.S. 1021, 108 S. Ct. 739, 98 L. Ed. 2d 756 (1988)).  To show that a defendant has been fraudulently joined, a removing party must establish by clear and convincing evidence that “there is no reasonable basis in fact or colorable ground supporting the claim against the joined defendant, or no real intention in good faith to prosecute the action against the defendant or seek a joint judgment.”  Boyer, 913 F.2d at 111 (quoting Abels v. State Farm Fire & Casualty Co., 770 F.2d 26, 32 (3d Cir. 1985)); Texas Eastern Transmission Corp. v. The Fidelity & Cas. Co. of New York, 1995 U.S. Dist. LEXIS 14811, at *24 (E.D. Pa. Oct. 4, 1995).  In making this assessment, the district court considers all allegations in the plaintiff’s complaint to be true.  In re Briscoe, 448 F.3d 201, 217 (3d Cir. 2006) (“In so ruling [on fraudulent joinder] the district court must assume as true all factual allegations of the complaint.”) (quoting Batoff v. State Farm Ins. Co., 977 F.2d 848, 851-52 (3d Cir. 1992)).  Moreover, a district court must “resolve all contested issues of substantive fact in favor of the plaintiff.”  Boyer, 913 F.2d at 111.  And “any uncertainties as to the current state of controlling substantive law” are resolved in favor of the plaintiff.  Id.; see also Brown v. Jevic, 575 F.3d 322, 326 (3d Cir. 2009).   

As the United States Court of Appeals for the Third Circuit has explained, “[i]f there is even a possibility that a state court would find that the complaint states a cause of action against any one of the resident defendants, the federal court must find that joinder was proper and remand the case to state court.”  Boyer, 913 F.2d at 111.  (quoting Coker v. Amoco Oil Co., 709 F.2d 1433, 1440-41 (11th Cir. 1983).)  Put another way, the joinder is not considered fraudulent unless the claims against the non-diverse defendant are “wholly insubstantial and frivolous.”  In re Briscoe, 448 F.3d at 218.

  1. B.                 Plaintiffs continue to have valid warnings claims against Mylan, Inc. after PLIVA v. Mensing.

 

In its January 19, 2011, remand order, this Court found that Plaintiffs had colorable failure-to-warn claims against Mylan, Inc. because Plaintiffs had submitted evidence that Mylan Technologies, Inc. “effectively outsourced its labeling and regulatory responsibilities to Mylan, [Inc.].”  (Remand Order at 7.)  That order applies with the same force today, as Plaintiffs continue to have valid warnings claims against Mylan, Inc.

1.         Mensing is more limited in scope than Defendants would have this Court believe. 

 

In Mensing, the Supreme Court ruled that the plaintiffs’ state-law failure-to-warn claims brought against manufacturers of generic drugs were preempted by the federal regulatory scheme governing such drugs.  Specifically, the Mensing plaintiffs alleged that the defendant generic drugs manufacturers violated their state-law duty to warn by failing to change their FDA-approved labeling to strengthen the warnings about certain risks.  The Supreme Court ruled that such a claim was preempted because, unlike brand-name drug manufacturers, generic drug companies could not use FDA’s “Changes Being Effected” [“CBE”] process to change their labels independently, without prior FDA approval, nor could they send so-called “Dear Doctor” letters to physicians to provide them with warnings of a new risk that was not reflected in FDA-approved labeling.  131 S. Ct. at 2575-2576.  The Court concluded that such actions by the generic drug manufacturers would violate the requirement that the generic labeling be the same as the labeling for the reference listed drug (“RLD”).  Id.  at 2578.  Because state law required the defendants to take an action that federal law prohibited, the Court concluded that the plaintiffs’ claims were preempted on the basis of impossibility.  Id. at 2581.

By its terms, the Court’s preemption ruling in Mensing is, at best, applicable only to failure-to-warn claims that require that a plaintiff prove that a generic drug manufacturer was required to alter the content of the FDA-approved labeling by seeking FDA action.  Moreover, as will be discussed more thoroughly below, the decision is explicitly limited to claims arising before the enactment of the Food and Drug Administrative Amendments Act [“FDAAA”] of 2007.  The result is that Mensing did not purport to foreclose (or even address) a number of warnings claims, including

●   failure to warn arising from the duty to effectively communicate warnings;

 

●  failure to warn arising after enactment of the Food and Drug Administrative Amendments Act [“FDAAA”] of 2007;[9]

 

●    failure to suspend sales until labeling could be revised to include adequate warnings;     and

 

  • failure to secure prompt labeling revisions by advising the reference listed drug (“RLD”) holder of the inadequacies in its existing RLD labeling.

 

Below, Plaintiffs explain why each of these claims is valid against Mylan, Inc.  To the extent there is any uncertainty as to the scope or effect of Mensing, such uncertainties must be resolved in the favor of Plaintiffs at this stage.  Boyer, 913 F.2d at 111; Jevic, 575 F.3d at 326.

 


 

2.         Plaintiffs have valid warnings claims based on Mylan, Inc.’s failure to effectively communicate warnings.

 

Under general principles of products liability law, most states impose a two-pronged duty to warn on manufacturers that includes the requirement that 1) their warnings must be adequate; and 2) their warnings must be effectively conveyed to the relevant parties.[10]  See, e.g., Taurino v. Ellen, 397 Pa. Super. 50, 58 (1990) (“We recognize . . . a manufacturer of a prescription drug may be shown to be negligent despite the fact that adequate warnings were given to the prescribing physician. Negligence may be shown where, for example, the manufacturer employs detail men who instruct physicians on the use of the drug and who are proven to have promoted the product in such a way as to encourage the physicians to ignore the warnings or where the manufacturer knows its warnings are being widely ignore and does nothing about it.”); Incollingo v. Ewing, 444 Pa. 263, 288 (Pa. 1971) (“Action designed to stimulate the use of a potentially dangerous product must be considered in testing the adequacy of a warning as to when and how the product should not be used; if detail men are an effective means of selling a product and explaining its nature, a jury could find that they also afforded an effective medium of conveying a warning.”).   Some states describe this duty in terms of requiring that a manufacturer make all reasonable efforts to ensure that an adequate warning is given.[11]

The Court in Mensing focused only on the issue of the substantive adequacy of the warning and held the particular failure-to-warn claim preempted because the generic defendants could not change their labeling without prior FDA approval.[12]  See Mensing, 131 S. Ct. at 2572-2574.  Mensing, therefore, does not address this second, efficacy of communication, prong of state duties to warn.  As a result, if it is pleaded and demonstrated that a generic drug manufacturer failed to effectively communicate information already appearing in its FDA-approved labeling to the appropriate person, and that such information would have altered either the decision of a physician to prescribe the drug or the decision of an individual to take the drug, Mensing would not preempt that failure-to-warn claim against that manufacturer.

Plaintiffs’ Long Form Complaint contains numerous allegations regarding Mylan, Inc.’s failure to effectively warn about the risks associated with its product.

  • In addition, Defendants failed to adequately and effectively communicate the risks disclosed in its product labeling, including the risk of death from hypoventilation.  Upon learning of the adverse events patients were suffering using their product, Defendants should have disseminated the approved product labeling and emphasized the precautions that should be taken, and the risks associated with, using the Patch.  (Long Form Compl. ¶ 72.)

 

  • Defendants were also required to ensure that the existing labels were effectively communicated to physicians and patients.  An adequate warning requires both proper language describing the nature and rate of the risk, the nature of the harm that might be encountered and the ways to avoid that harm.  In order to be an adequate warning, the drug prescriber and user must be made aware of those warnings – requiring effective communication of the warnings.  Printing a label, yet never distributing the label to the physician and patient, is not sufficient to warn the user of the danger.  Defendants had many different ways to ensure that the actual warning language was effectively communicated to physicians and patients – both through proper delivery of the existing RLD label, along with other FDA approved means of communication that did not require language different from the RLD label.  Defendants failed to deliver the label, or to otherwise effectively communicate the warnings in the label, to physicians and patients.  (Long Form Compl. ¶ 74.)

 

  • Defendants breached their duty to effectively communicate warnings to the medical community generally, Plaintiffs’ physicians, Plaintiffs, and/or other foreseeable users of the Patches similarly situated, in that they failed to:

 

  1. ensure that warnings they disseminated or relied on to be disseminated to the medical community, Plaintiffs’ physicians, or to the Plaintiffs and other foreseeable users similarly situated, were actually and effectively communicated to physicians and patients;

 

  1. Failure to keep abreast of knowledge regarding the safety of the Patch  and to properly research, test and market the Patch, review all adverse drug event information (ADE) related to the use of Patch and report to the FDA, physicians (and/or to the public) significant data regarding efficacy or safety of the drug;

 

  1. periodically review all medical literature pertaining to fentanyl patch use and effects and report to the FDA, physicians (and/or to the public) significant data concerning deaths resulting from use in the ordinary course of treatment; and

 

  1. Engage in responsible testing, research, and pharmacovigilance practices regarding the Patch.  (Id. ¶ 75.)

 

3.         All of the warnings claims against Mylan, Inc. that this Court previously found to be valid survived Mensing because all of the decedents in these cases died after the enactment of the FDAAA.

 

In Mensing, the Supreme Court explicitly limited its preemption analysis, stating that the decision “[r]efer[s] exclusively to the pre-2007 statutes and regulations and [we] express no view on the impact of the FDAAA.” 131 S. Ct. at 2574 n.1.   All of the decedents in these nineteen cases died well after the FDAAA was enacted on September 27, 2007, and thus all of Plaintiffs’ failure-to-warn claims are governed by the new regulations.

The Mensing Court acknowledged that, according to the FDA, generic drug manufacturers were required to propose stronger warning labeling to the extent changes were needed.  The Court found, however, that once the FDA received such a request for a change, it could only “work with” the brand-name manufacturer of the drug to implement the stronger warning.  The Court characterized the requirement placed on a generic drug manufacturer as asking “the FDA for assistance in convincing the brand-name manufacturer to adopt a stronger label.”  131 S. Ct. at 2577.  Central to the Court’s holding was the fact that, if a generic manufacturer requested a stronger warning for the labeling of its drug, the FDA would have to undertake negotiations with the branded manufacturer in order to implement such a change.[13]

By contrast, under the provisions added by the FDAAA in 2007, the FDA now has the authority to order labeling changes for any prescription drug.[14]  The passage of the FDAAA thus removes at least one of the discretionary impediments identified by the Mensing Court in finding impossibility preemption: the need to negotiate with the manufacturer of the RLD in order to strengthen the warning contained in the RLD label.

In addition, the language of the Food, Drug & Cosmetic Act [“FDCA”] states that if the FDA discovers that a drug is unsafe or ineffective after it has received marketing approval, the agency “shall, after due notice and opportunity for hearing to the applicant, withdraw approval” of the drug.[15]  The Supreme Court has construed this provision as requiring the FDA to prevent the marketing of any drug or device where the “potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit.”[16]  The Court stated that the FDCA does not permit any “remedial discretion” once it is evident that a drug or device is misbranded.  Id. at 136.   Instead, the FDA is required to take action once it receives notification that a drug presents a safety hazard to the public.  As a result, the two areas that the Court in Mensing identified as being rife with discretion, therefore making it impossible for generic drug manufacturers to comply with both federal and state law, are no longer open to speculation.

The result is that deaths after the enactment of the FDAAA are governed by the impossibility-preemption framework the Court established in Wyeth v. Levine,  555 U.S. 555 (2009) where FDA action and the exercise of its discretion was still required because FDA had the option to reject a label change the manufacturer had already implemented under CBE regulations.  Because the level of discretion was so low in Levine, the Court concluded that failure-to-warn claims are preempted only if the manufacturer could show by clear evidence that FDA would not have approved the labeling change at the time.[17]  That standard should govern post-2007 Mylan fentanyl patch claims.  In any event, until the Court rules on post-2007 regulations, Mensing does not bar post-2007 failure-to-warn claims against generic drug manufacturers, and all of Plaintiffs’ warnings claims against Mylan, Inc. are still valid.

4.         Plaintiffs have claims against Mylan, Inc. for failing to suspend sales until labeling could be revised to include adequate warnings

As stated above, the Court’s preemption ruling in Mensing is, at best, applicable only to failure-to-warn claims that require that a plaintiff prove that a generic drug manufacturer was required to alter the content of the FDA-approved labeling by seeking FDA action.  In Mensing, the plaintiffs did not advance, and the Supreme Court did not consider, the argument, referenced by the underlying Eighth Circuit decision, that generic drug manufacturers could not show impossibility preemption because federal law merely permitted them to sell generic drugs but did not require that they do so.[18]  Rather than sell an inadequately-labeled, dangerous drug to unsuspecting patients and uninformed doctors, these manufacturers, at the very least, retained the independent ability to suspend their drug sales until FDA acted and they could change their labeling.  They could even have exercised their First Amendment right to issue a press release or other communication to explain the reason for the suspension. These completely independent actions on the part of the generic drug manufacturers themselves could have avoided the sale of fentanyl patches without an adequate warning without conflict with federal law.  Thus, where a generic drug defendant cannot conclusively show that it was impossible for it to have temporarily suspended sales of its generic drug until the FDA allowed it to make a change to its labeling, it cannot show that failure-to-warn claims against that manufacturer are preempted. Plaintiffs have pled this precise theory of liability against Mylan, Inc. as follows:

Despite knowing of the defects prior to the date Decedents used the patches in question, the Defendants took inadequate steps to advise physicians, hospitals, nursing homes, the holder of the RLD, Duragesic, and other health care providers of the possibility of defects occurring in other Patches and of the significant danger to users of the Patches.  Defendants could have (and should have) suspended sales of their inadequately-labeled and, therefore, misbranded drug until their product’s label was revised to warn of these significant dangers.  Defendants acted with deliberate indifference to the consequences to patients using the product of their failure to do so.

 

(Long Form Compl. ¶ 65.)

  1. 5.                  Plaintiffs have valid claims against Mylan, Inc. for failing to advise the reference listed drug (“RLD”) holder of the inadequacies in its existing RLD labeling.

 

Yet another issue left open by the Supreme Court is whether a generic manufacturer could fulfill its state-law duties without offense to federal law by advising the RLD holder of the need to update and/or revise its label.  When Mylan, Inc. received information that, if not included in the labeling, rendered the label inadequate, Mylan, Inc. could have bypassed the FDA altogether and taken the safety information warranting a label change directly to the RLD holder (Duragesic).  Under federal regulations,[19] upon receipt of such information, the RLD holder would have been required to make a labeling change to include it.  Under CBE regulations even the Supreme Court acknowledges are applicable to generics, immediately upon the mandatory label change they independently initiated, the generic drug manufacturers would have been able to change their labeling to match it.[20]  Plaintiffs’ Long Form Complaint pleads this type of claim against Mylan, Inc.

 

  • Further, the defendants knew and did not disclose these risks and safety information to the holder of the Reference Listed Drug (“RLD”), Duragesic, or advise such holder of the deficiencies and inadequacies of the product’s labeling.  (Long form Compl. ¶ 46.)

 

  • Defendants took inadequate steps to ensure that these products were safe, to ensure that additional defective products were not designed, manufactured or distributed, and to notify users, consumers, physicians, and the holder of the RLD, Duragesic, of the aforementioned dangers.  (Id. ¶ 84.)

 

As shown above, Plaintiffs continue to have warnings claims against Mylan, Inc. after the Mensing decision.  Because this Court has already ruled that such claims are colorable in light of the evidence that Defendants “effectively outsourced its labeling and regulatory responsibilities to Mylan, Inc.,” this Court should remand the cases.   (Remand Order at 7.)

  1. C.                In addition to warnings claims, Plaintiffs have design and manufacturing defect claims against Mylan, Inc.

 

Defendants take a myopic view of Plaintiffs’ Long Form Complaint when they suggest that Plaintiffs have brought only warnings claims against Mylan, Inc.; Plaintiffs also have design and manufacturing defect claims against the company.  Defendants’ assertion that Mylan, Inc. is not the entity that actually manufactured or distributed the product is of no consequence because courts consistently recognize the doctrine of negligent undertaking pursuant to § 324A of the Restatement (Second) of Torts.  See, e.g.,  Sheridan v. NGK Metals Crop., Civ. Action No. 06-5510, 2008 U.S. Dist. LEXIS 40926, at *8 (E.D. Pa. May 22, 2008) (citing  Cantwell v. Allegheny County, 483 A.2d 1350, 1353 (Pa. 1984)).  Under this doctrine, “[o]ne who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to protect his undertaking, if (a) his failure to exercise reasonable care increases the risk of such harm or (b) he has undertaken to perform a duty owed by the other to the third person, or (c) the harm is suffered because of reliance of the other or the third person upon the undertaking.”  Sheridan, 2008 U.S. Dist Lexis. 40926 at *8 (quoting § 324A of the Restatement (Second) of Torts).   As discussed below, Mylan, Inc. voluntarily undertook critical duties with regard to the design and manufacture of the Mylan fentanyl patch and, at this stage, such evidence is sufficient to establish that Plaintiffs’ claims are colorable.

1.         Plaintiffs’ design defect claims are colorable because the evidence shows that Mylan, Inc. worked to obtain FDA approval of the Mylan fentanyl patch’s matrix design and oversaw studies concerning the design.

 

As part of its oversight over the regulatory affairs of its subsidiaries, Mylan, Inc. assisted with obtaining FDA approval of the Mylan fentanyl pain patch’s matrix design pursuant to the ANDA process.[21]  (See Deposition of Frank Sisto 7:13-8:6, 14:10-14:22, 33:12-34:13, Chapman Decl. Ex. 2.)  The ANDA for the Mylan fentanyl patch was significant because the original innovator used a reservoir design whereas the Mylan fentanyl patch uses what is known as a matrix design, a design Defendants claim is safer than the original reservoir design.  (Deposition of Michael Houghton 41:4-41:23, Chapman Decl., Ex. 4.)  Mylan, Inc. collected the information necessary to assemble the ANDA, submitted the information and the product applications to the FDA, and then coordinated with those agencies to obtain approval of the ANDA.  (See Dep. of Sisto 7:18-8:8.)   Pursuant to that process, Mylan, Inc.’s regulatory department was involved in designing studies related to the Mylan fentanyl patch to ensure FDA requirements were met.  (See Deposition of Andrea Miller 62:4-62:7, Chapman Decl., Ex. 11.)  For example, Andrea Miller, Mylan, Inc.’s vice-president of REDACTED, oversaw a study of the safety of using product overlays with the Mylan fentanyl patch, a study that was performed to demonstrate the relative safety of the matrix design over the original innovator’s reservoir design patch.  (Id. 63:7-68:3.)  Defendants’ documents also show that John O’Donnell, a Strategic Scientific Advisor at Mylan, Inc., participated in meetings with the FDA involving studies related to the Mylan fentanyl patch and regularly received product forecasts.[22]  Frank Sisto, Mylan, Inc.’s former corporate vice president of regulatory affairs and global head of regulatory affairs, testified that Mylan, Inc. has been working on a fentanyl patch to be used for a longer period of time (seven days as opposed to three days).  (Id. 43:6-43:13.)  Because this evidence shows that Mylan, Inc. participated (and continues to participate) in the design process for the Mylan fentanyl patch, Plaintiffs have colorable design claims against the Mylan, Inc.

2.         Plaintiffs allege manufacturing defect claims against Mylan, Inc., and the evidence supports those claims.

 

            Plaintiffs’ Long Form Complaint alleges that the Mylan fentanyl patches used by the decedents were defective in that that they delivered an excess amount of fentanyl to the decedents’ bloodstreams.  (See, e.g., Long Form Compl. ¶ 31.)  Moreover, Plaintiffs specifically allege that Defendants knew about these manufacturing defects:

Prior to the time the Patch in question was manufactured and distributed, the Mylan Defendants knew or should have known that numerous patients had received lethal doses of fentanyl while using the Patch as prescribed because . . .

 

c.         The Mylan Defendants received information from the FDA’s adverse event reporting system indicating that patients had received lethal fentanyl levels while using the Patch as prescribed; . . .

 

f.          The Mylan Defendants received information through their pharmacovigilance activities, as insufficient as they were, indicating that patients had died from fentanyl overdoses with lethal blood fentanyl levels while using the Patch as prescribed.

 

(Long Form Compl. ¶ 30.)

This Court has previously ruled that Plaintiffs have colorable claims against Mylan, Inc., for its negligence in rendering regulatory and compliance services for its subsidiaries, including the monitoring of adverse event reports associated with the Mylan fentanyl patch.[23]  (See Remand Order at 7-8, Chapman Decl., Ex. 1.)  Mylan, Inc.’s negligence in this regard supports not only Plaintiffs’ warnings claims, but also their manufacturing claims, because the adverse event reporting system is a quality control system by which Defendants monitor and investigate potential product defects.  (See Remand Order at 7 (recognizing that “pharmaceutical manufacturers have a continuing obligation to investigate and report adverse events associated with products after obtaining FDA approval”).)

For example, Andrea Miller, Senior Vice President of Global Regulatory Affairs at Mylan, Inc., testified that in response to a report of an adverse event Mylan, Inc. initiated a review of literature involving the phenomenon of postmortem redistribution, a possible explanation for why patients were REDACTED with unexpectedly high fentanyl levels after using the Mylan fentanyl patch.  (Deposition of Andrea Miller 36:3-41:1, Chapman Decl., Ex. 11.)  Ms. Miller explained that the review was “part of our evaluation, we evaluate the product.  Found no defect with the product, no causative relationship to a product.”  (Id. 40:5-9.)  By voluntarily undertaking this monitoring function on behalf of Mylan Technologies, Inc., the manufacturer of the Mylan fentanyl patch, Mylan, Inc. undertook a critical quality control process on behalf of its subsidiary and is thus liable under a manufacturing defect theory.

  1. D.                This Court and two other federal Pennsylvania Courts have rejected Defendants’ argument that Mylan, Inc. is merely a passive holding company.

 

In addition to losing the argument before this Court earlier this year, Defendants have twice raised and lost the argument that Mylan, Inc. was fraudulently joined in a product liability case due to its purported holding company status.  See Kuresa-Boon v. Mylan Pharmaceuticals, Inc., Civ. No. 08-1452, 2008 U.S. Dist. LEXIS 62042 (E.D. Pa. Aug. 13, 2008); Dambaugh v. Mylan Bertek Pharmaceuticals, Inc., Civ. No 07-1132, 2007 U.S. Dist. LEXIS 83830 (W.D. Pa. Nov. 13, 2007).[24]  In both of these cases, the courts considered and rejected Mylan, Inc.’s claim of fraudulent joinder.

In Kuresa-Boon, this Court concluded that the plaintiff’s allegations that Mylan, Inc. was involved in the marketing and promotion of the relevant pharmaceutical product – allegations nearly identical to those at issue here – defeated Mylan, Inc.’s claim that it had been fraudulently joined.  2008 U.S. Dist. LEXIS 62042, at *7.

First, the court concludes that Plaintiffs have pled a sufficient independent cause of action against defendant Mylan Laboratories based upon Mylan Laboratories’ independent actions involving, but not limited to, the marketing and promotion of phenytoin. There is a reasonable basis in fact or colorable ground supporting this claim against Mylan Laboratories. The court determines that there is a possibility that a state court would find that Plaintiffs’ Complaints state a cause of action against Mylan Laboratories separate and apart from any allegations of alter ego liability. . .

Specifically, Plaintiffs’ Complaints state, with particularity, that all defendants were involved in the marketing of phenytoin, either by express assent or by conduct, and that all defendants had information from internal and external sources regarding the safety of the drug at issue but refused to provide adequate warnings or implement a system to collect and report the number of adverse events. . . . The Complaints are expansive enough to include the representations made by Plaintiffs’ counsel during oral arguments that Mylan Laboratories’ Medical Director made a public statement to the journal ‘Neurology’ that ‘Mylan’  was engaged in monitoring and recording phenytoin adverse events reported to the pharmacovigilence database. (See also Pls.’ Ex. 1, Letter from Medical Director of Mylan Laboratories to journal Neurology, March 15, 2005 4-8.)

Id.  

The Kuresa-Boon court also noted that the plaintiffs had produced to the court “public statements and public filings that suggest that Mylan Laboratories was engaged in activities normally attributed to a pharmaceutical company: the manufacture and marketing of prescription drugs. (See Pls.’ Ex. 3, Press Release ‘Mylan Receives Approval for Extended Phenytoin Sodium Capsules, USP, 100 MG’, December 29, 1998; Pls.’ Ex. 7, Mylan Laboratories Form 10-k filing (stating that ‘We obtain new generic products primarily through internal product development.’))”  Applying well-established fraudulent joinder principles, the Court concluded that “whether these statements are an admission or a non-legal use of the corporate ‘we’ is a matter for a trial court, and is not a factual dispute that can be resolved here.”  2008 U.S. Dist. LEXIS 62042, at *7.

In Dambaugh, Mylan, Inc. again lost is fraudulent joinder argument.  There, as here, Mylan, Inc. submitted an affidavit stating that it “was not in the business of manufacturing, promoting, selling, or distributing the drug.”  2007 U.S. Dist. Lexis 83830, at *2.  The court, however, held that Mylan, Inc. failed to satisfy its “heavy burden” to show fraudulent joinder because “the affidavit does not conclusively demonstrate the entire pertinent universe of Mylan Labs’ involvement with the distributing subsidiary and the drug.”  Id. at *5.  The court stated that “[u]nder these circumstances and at this stage in the litigation, to allow this affidavit to defeat Plaintiff’s Complaint and create federal jurisdiction would go far beyond the ‘limited look’ permitted by our Court of Appeals, and subvert the limited role of both judge and removal procedure.”  Id.  Simply put, Defendants have failed to show that Mylan, Inc. is merely a passive holding company.


 

CONCLUSION AND PRAYER

As set forth above, these cases are not removable pursuant to 28 U.S.C. § 1446(b)’s voluntary rule because Plaintiffs have not voluntarily dismissed their claims against Mylan, Inc. Defendants’ removal of these cases is further improper because Defendants have failed to show that Mylan, Inc. is fraudulently joined in these cases.  Plaintiffs respectfully request that the Court grant Plaintiffs’ Consolidated Motion to Remand, remand the cases to the Court of Common Pleas of Philadelphia County, and grant Plaintiffs such other and further relief to which they may show themselves to be justly entitled.

Respectfully submitted,

 

FELDMAN & PINTO

 

/s/ Rosemary Pinto

Rosemary Pinto, Esquire

Attorney I.D. No. 53114

1604 Locust Street, 2R

Philadelphia, PA  19103

Telephone (215) 546-2604

Facsimile (215) 546-9904

Email:  rpinto@feldmanpinto.com

 

 


 

Admission pro hac vice to be sought for:

 

James Craig Orr, Jr.

Texas Bar No. 15313550

Michael Heygood

Texas Bar No. 00784267

Eric D. Pearson

Texas Bar No. 15690472

Charles W. Miller

Texas State Bar No. 24007677

Heygood, Orr & Pearson

2331 W. Northwest Highway, 2nd Floor

Dallas, TX 75220

214-237-9001 (office)

214-237-9002 (fax)

 

 

CERTIFICATE OF SERVICE

 

I hereby certify that the foregoing was filed this 21st day of September, 2011 using the Court’s CM/ECF system which will generate an electronic copy of same to the below counsel of record:

 

Christopher A. Iacono, Esq.

Pietragallo Gordon Alfano

Bosick & Raspanti, LLP

1818 Market St., Ste 3402

Philadelphia, PA 19103

 

Clem C. Trischler, Esq.

Pietragallo Gordon Alfano

Bosick & Raspanti, LLP

The Thirty-Eight Floor

One Oxford Centre

Pittsburgh, PA 15219

 

/s/ Rosemary Pinto

 

 


[1]           Because this Court is already familiar with these cases, Plaintiffs provide only an abbreviated background of Plaintiffs’ claims.

 

[2]           That case is Holk v. Mylan, Inc. currently docketed in this Court as No. 2:11-cv-0555-BMS.

 

[3]           Defendant Mylan, Inc. has corporate headquarters in Pennsylvania and does not dispute that it is considered a citizen of Pennsylvania for jurisdictional purposes.  These cases are thus not removable pursuant to 28 U.S.C. § 1446(b)’s forum defendant rule, which provides that “a defendant may not remove a case from state to federal court where defendant is a citizen of the state in which the action is brought and diversity of citizenship jurisdiction is the basis of the court’s subject matter jurisdiction.”  Papadopoulous v. Mylonas, No. 11-4163, 2011 U.S. Dist. LEXIS 100539, at *13 (E.D. Pa. Sept. 6, 2011).  In addition to the forum defendant rule, several of the decedents in these cases were Pennsylvania citizens at the time of death, which destroys diversity jurisdiction as to those particular cases.  See, e.g., Reese v. Mylan, Inc., No. 2:11-cv-05550; Tisch v. Mylan, Inc., No. 2:11-cv-05560.

 

[4]           Though the United States Court of Appeals for the Third Circuit has never squarely address the voluntary rule, every district court within the Third Circuit, including the Eastern District of Pennsylvania, as well as every federal appellate court that has addressed the issue has adopted the rule.  Graver, 2011 U.S. Dist. LEXIS 53432, at **5-9 (surveying authority).

 

[5] See Webb Equipment Co., No. C10-5128, 2010 U.S. Dist. LEXIS 49705, at *8  (W.D. Wash April 20, 2010) (rejecting argument that recent Supreme Court decision regarding corporate citizenship reopens removal window under § 1446(b); Morsani v. Major League Baseball, 79 F. Supp. 2d 1331, 1333-34 (M.D. Fl. 1999)  (decision in an unrelated case is not an “order or other paper” under § 1446(b); “plain language of the statute . . . implies the occurrence of an event within the proceeding itself”); Metropolitan Dade County v. TCI TKR of South Florida, 936 F. Supp. 958, 959 (S.D. Fl. 1996) (Federal Communications Commission opinion not “other paper” under § 1446(b) that triggered thirty-day period); Lozano v. GPE Controls, 859 F. Supp. 1036, 1038 (S.D. Tex. 1994) (judicial opinion in an unrelated case is not “other paper” under § 1446(b)); Kocaj v. Chrysler Corp., 794 F. Supp. 234, 236 (E.D. Mich. 1992) (Sixth Circuit opinion on ERISA preemption in unrelated case is not “other paper” under § 1446(b); “[statutory] language plainly refers to items served or otherwise given to a defendant in a state court case”); Coman v. Int’l Playtex, Inc., 713 F. Supp. 1324, 1327 (N.D. Cal. 1989) (new federal law removing ability to plead Doe defendants is not “other paper” triggering removal window); Johnson v. Trans World Airlines, Inc., 660 F. Supp. 914, 917 (C.D. Cal. 1987) (right to remove does not emanate from subsequent development of case law); Phillips v. Allstate Ins. Co., 702 F. Supp. 1466, 1468 (C.D. Cal. 1989) (“[V]irtually every court which has considered the question of what suffices as a removal triggering “paper” has concluded that the term does not include intervening statutory or case law changes.”); Holiday v. Travelers Ins. Co., 666 F. Supp. 1286, 1289 (W.D. Ark. 1987) (recent Supreme Court decisions not “other paper” under § 1446(b)); Hollenbeck v. Burroughs Corp., 664 F. Supp. 280, 281 (E.D. Mich. 1987) (decision in unrelated case is not “other paper” under § 1446(b), as the ‘other paper’ language focuses on voluntary actions of the plaintiff, not factors beyond the plaintiff’s control); Johansen v. Employee Benefit Claims, Inc., 668 F. Supp. 1294, 1296-97 (D. Minn. 1987) (based on the statutory language, “other paper” should be interpreted to refer to documents generated within the state court litigation, and not an extraneous decision in another case); Gruner v. Blakeman, 517 F. Supp. 357, 360-61 (D. Conn. 1981) (subsequent decision in a related case did not constitute “order or other paper”); see also Wright, Miller and Cooper, 14C Federal Practice and Procedure § 3732, p. 310 (West 1998) (“[T]he publication of opinions by other courts dealing with subjects that potentially could affect a state court suit’s removability or documents not generated as a result of state court litigation are not recognized as ‘other paper’ sources for purposes of starting a new thirty-day period under Section 1446(b)”); Green v. R.J. Reynolds Tobacco Co., 274 F.3d 263, 266 (5th Cir. 2001) (recognizing that “[m]ost other courts to address the issue have found court decisions in unrelated cases not to constitute “orders” or “other papers” under § 1446(b) and not to be grounds for removal.”). 

 

[6]           Rule 229 requires either (1) a court order; or (2) consent of all parties before an action may be discontinued as to less than all defendants.

[7]           As set forth below in Part III.B, there are a host of reasons why Mensing does not preempt Plaintiffs’ warnings claims.

 

[8]            The allegations are from the First Amended Complaint filed in Reese v. Mylan, Inc., currently docketed as No. 2:11-cv-05550, a true and correct copy of which is attached as Exhibit 12 to the Chapman Declaration.

[9] The “Food and Drug Administrative Amendments Act of 2007” [Pub. Law 110-85] was enacted on September 27, 2007.  Title IX of the FDAAA, inter alia, added numerous sections to 21 U.S.C. § 355, approval of New Drugs, and added 21 U.S.C. § 355-1, Risk Evaluation and Mitigation Strategies.

 

[10] See also Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 853 (10th Cir. 2003); DeGidio v. Centocor Ortho Biotech, Inc., 2010 U.S. Dist. LEXIS 118406 *12 (N.D. Ohio Nov. 5, 2010) “[m]eans to convey the warning must be adequate”); Bearden v. Honeywell Int’l, Inc., 2010 U.S. Dist. LEXIS 28331 *10, n. 3 (M.D. Tenn. Mar. 24, 2010) (adequacy of warning is determined, in part by “means used to convey the warning”); Alvarez v. Gen. Wire Spring Co., 2009 U.S. Dist. LEXIS 6878 *22 (M.D. Fla. Feb. 1, 2009) (“a warning may be defective . . . as a result of its location and the manner in which the warning is conveyed”); Rimbert v. Eli Lilly & Co., 577 F. Supp. 2d 1174, 1192 (D.N.M. 2008); Reece v. Astrazeneca Pharms., LP, 500 F. Supp. 2d 736, 749 (S.D. Ohio 2007) (warning may be unreasonable in its factual content, its expression of the facts, or the method or form in which it is conveyed); In re Meridia Prods. Liability Litig., 328 F.Supp.2d 791, 812 (N.D. Ohio 2004) (among other things, “the means to convey the warning must be adequate”); Golod v. Hoffman La Roche, 964 F. Supp. 841, 853 (S.D.N.Y. 1997) (in determining if a warning is adequate, court must consider several factors, including whether the warning is accurate, clear, consistent on its face, portrays with sufficient intensity the risk involved in taking the drug, and its form and manner of expression); Wilson v. Johns-Manville Sales Corp., 107 F.R.D. 250, 256 (S.D. Tex. 1985); Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 179 (Tex. 2004) (“‘adequate warnings and instructions’ means warnings and instructions that are given in such form that they could reasonably be expected to catch the attention of the reasonably prudent person in the circumstances of the use of the product in question”); Evridge v. Am. Honda Motor Co., 685 S.W.2d 632, 636 (Tenn. 1985); Ross v. Jacobs, 684 P.2d 1211, 1214 (Okla. App. 1984) (“[m]eans to convey the warning must be adequate”); Richards v. UpJohn Co., 625 P.2d 1192, 1196 (N.M. Ct. App. 1980) (“the means to convey the warning must be adequate. In other words, the drug manufacturer must bring the warning home to the doctor”).

 

 

[11] See, e.g., N.C. Gen Stat. Ann. § 99B-5 (stating that liability for failure to warn may be found where a manufacturer “failed to take reasonable steps to give adequate warning or instructions or to take other reasonable action under the circumstances”).

 

[12] The Court read the pleadings in Mensing narrowly to include only state-law allegations that, if true, “required the Manufacturers to use a different, safer label.”  131 S. Ct. at 2574.

[13]          Id. at 2578.  As Justice Thomas later explained: “[i]f the FDA decided there was sufficient supporting information, and if the FDA undertook negotiations with the brand-name manufacturer, and if adequate label changes were decided on and implemented, then the Manufacturers would have started a Mouse Trap game that eventually led to a better label on generic metoclopramide.”  Id.

 

[14]          21 U.S.C. § 355(o)(4).

 

[15]          21 U.S.C. §§ 255(e)(1)-(3); see also Food and Drug Administration v. Brown and Williamson Tobacco Corp., 529 U.S. 120, 133 (2000).

 

[16]          Brown and Williamson Tobacco Corp., 529 U.S. at 133, quoting United States v. Rutherford, 442 U.S. 544, 556 (1979).

 

[17]          Levine, 129 S. Ct. at 1198.

[18]          131 S. Ct. at 2587 n.8 (Sotomayor, J., dissenting) (stating that the issue was not and need not have been considered); see Mensing v. Wyeth, Inc., 588 F.3d 603, 611 (2009) (“the generic defendants were not compelled to market metoclopramide.  If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product”); see also Levine, 129 S. Ct. at 1210) (Thomas, J. concurring) (FDA approval of a warning does not give manufacturers the unfettered right to sell the drug with the same warning forever);  Geier v. American Honda Motor Co., 529 U.S. 861, 873, 120 S. Ct. 1913, 146 L. Ed. 2d 914 (2000) (describing “a case of impossibility” as one “in which state law penalizes what federal law requires”);  Bartlett v. Mut. Pharm. Co., 759 F. Supp. 2d 171, 200 (D.N.H. 2011) (“Federal law did not require Mutual to sell sulindac.  Nor, for that matter, did state law require Mutual to stop selling it, or to redesign it. . . So it was not ‘impossible’ for Mutual to comply with both federal and state law”.  Cf. Barnett Bank of Marion County, N.A. v. Nelson, 517 U.S. 25, 31, 116 S. Ct. 1103, 134 L. Ed. 2d 237 (1996) (explaining that impossibility pre-emption arises if the federal law said, ‘you must sell insurance,’ while the state law said, ‘you may not’)).

[19]          See 21 C.F.R. § 201.57(e).

[20]          See Mensing¸131 S. Ct. at 2575 (deferring to the FDA’s interpretation of the CBE regulation “to allow changes to generic drug labels only when a generic drug changes its label to match an updated brand name label or to follow the FDA’s instructions”).

 

[21]             Generic drugs may be applied for via an Abbreviated New Drug Application (“ANDA”).

[22]          See, e.g., FDA Meeting Minutes, MYLAN-4669, Chapman Decl., Ex. 5; October 8, 2002, Email, MYLAN-0000100623,Chapman Decl. Ex. 6.  Some of the documents prior to October of 2007 refer to Mylan Laboratories, Inc., but this is the same entity.  Mylan, Inc. was formerly known as Mylan Laboratories, Inc. until October of 2007, when it changed its name.

 

[23]          Documents, show for example, that Peter B. Bottini, Executive Director of Product Safety Risk Management at Mylan, Inc., was involved in assessing adverse event reports related to the Mylan fentanyl pain patch, formulating risk management strategy for the patch, and filing reports with the FDA related to the patch.   (See, e.g., December 14, 2004, e-mail, MYLAN-148122, Chapman Decl., Ex. 7; June 28, 2006, e-mail MYLAN-25598, Chapman Decl., Ex. 8; June 13, 2005, e-mail Mylan-174570, Chapman Decl., Ex. 9.)  Moreover, it is clear that a host of Mylan, Inc. employees were responsible for overseeing the Surveillance Plan for the patch, which involved assessing safety data for purposes of FDA reporting.  (See August 10, 2005, E-mail, Mylan-158606, Chapman Decl. Ex. 10.)

 

[24]           In both cases, Mylan, Inc. was referred to by its previous name, Mylan Laboratories, Inc.  The company officially changed its name from Mylan Laboratories, Inc. to Mylan Inc. on October 2, 2007.  (Cuthbertson Aff. ¶ 5, Exhibit B to Notice of Removal).