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Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 1 of 17 PageID 1
`
`UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF FLORIDA
`TAMPA DIVISION
`
`
`
`Plaintiff,
`
`ALFASIGMA USA, INC.
`
`
`
`v.
`
`WESTMINSTER
`PHARMACEUTICALS, LLC
`
`
`
`
`Defendant.
`
`
`
`
`Case No.
`
`COMPLAINT AND DEMAND FOR
`JURY TRIAL
`
`INJUNCTIVE RELIEF SOUGHT
`
`
`
`COMPLAINT
`
`Plaintiff Alfasigma USA, Inc. (“Alfasigma”) (formerly known as Nestlé
`
`Health Science-Pamlab Inc.) brings this Complaint against Defendant Westminster
`
`Pharmaceuticals, LLC (“Defendant”) and in support thereof, alleges as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`This is an action against Defendant for tortious interference with a
`
`settlement contract. In the August 26, 2014 Master Settlement Agreement and
`
`Mutual Release (“the Agreement”), Plaintiff settled a false advertising and unfair
`
`competition case it had filed against Virtus Pharmaceuticals, Inc. (“Virtus”),
`
`captioned Nestlé Health Science-Pamlab, et al. v. Virtus Pharmaceuticals, LLC,
`
`
`
`
`1
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 2 of 17 PageID 2
`
`Docket No. 9:12-cv-81202 (S.D. Fla.) (the “Virtus Litigation”). Mr. Louis Sanchez,
`
`the then-chief executive officer of Virtus, and Mr. Ryan Menendez, at that time
`
`Virtus’s Vice President, received significant benefits under the Agreement, and were
`
`bound by it. Messrs. Sanchez and Menendez subsequently joined Defendant
`
`Westminster. As he did with Virtus, Mr. Sanchez currently serves as Defendant’s
`
`Chief Executive Officer, while Mr. Menendez served as Defendant’s Senior Vice
`
`President of Business Development.
`
`2.
`
`Under the Agreement, Messrs. Sanchez and Menendez were released
`
`of all claims against them personally and, in exchange, agreed to refrain, until the
`
`end of 2024, from assisting any third parties from manufacturing, marketing, or
`
`offering for sale certain medical food products. Defendant, however, with
`
`knowledge of the Agreement and Messrs. Sanchez’s and Menendez’s duty to not
`
`provide assistance in launching the covered medical food products, induced them to
`
`breach the Agreement. With Messrs. Sanchez’s and Menendez’s assistance,
`
`Defendant launched competing medical food products, to Plaintiff’s ongoing injury.
`
`3.
`
`By inducing Messrs. Sanchez and Menendez to breach the Agreement,
`
`Defendant has intentionally and willfully interfered with Plaintiff’s contractual
`
`rights, and in so doing caused significant, ongoing, and irreparable injury to Plaintiff.
`
`Alfasigma brings this suit to stop Defendant’s ongoing interference with its
`
`
`
`
`2
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 3 of 17 PageID 3
`
`contractual rights, and to obtain compensatory and punitive damages for
`
`Defendant’s willful and intentional misconduct.
`
`II. PARTIES
`
`4.
`
`Plaintiff Alfasigma USA, Inc., formerly known as Nestlé Health
`
`Science Pamlab, Inc., is a Delaware corporation with its principal place of business
`
`at 4099 Highway 190 East Service Road, Covington, Louisiana 70433. A fully
`
`integrated pharmaceutical company founded over fifty years ago, Alfasigma
`
`specializes in the development, manufacture, sale, and distribution of medical foods
`
`throughout the United States.
`
`5.
`
`Defendant Westminster Pharmaceuticals, LLC is a pharmaceutical
`
`company which claims to distribute “generic drugs to pharmacies, hospitals, and
`
`trusted wholesalers and distributors across the country.” A limited liability company,
`
`Defendant is organized under Delaware law, and has offices in Tennessee and
`
`Tampa, Florida. Based on Defendant’s public filings, it has three members: Gajan
`
`Mahendiran, Amuda Mahendiran, and Vijay Patel.
`
`6.
`
`Defendant may be served with process through its Florida Registered
`
`Agent, Corporation Service Company, 1201 Hays St., Tallahassee, Florida 32301.
`
`
`
`
`3
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 4 of 17 PageID 4
`
`III.
`
`JURISDICTION AND VENUE
`
`7.
`
`This Court has diversity jurisdiction over this action pursuant to 28
`
`U.S.C. § 1332(a), as there is complete diversity of citizenship among the parties, and
`
`the amount in controversy exceeds $75,000, exclusive of interests and costs.
`
`8.
`
`For purposes of diversity jurisdiction, Alfasigma is a citizen of
`
`Delaware and Louisiana.
`
`9.
`
`As a limited liability corporation, Defendant shares the citizenship of
`
`its members. On April 6, 2021, Defendant filed its 2021 Foreign Limited Liability
`
`Company Annual Report with the Florida Secretary of State, representing that the
`
`address of all three of its members is 1321 Murfreesboro Pike, Suite 607, Nashville,
`
`Tennessee 37217. In addition, in a document filed on September 24, 2020, in the
`
`case captioned Jain et al. v. Nexgen Memantine, Inc. et al., Case No.: 8:20-cv-02263-
`
`VMC-JSS, (M.D. Fla. Sept. 24, 2020), Dkt. 34, Mr. Gahan Mahendiran represented
`
`that he is a resident of Virginia. Accordingly, and based on this publicly-filed
`
`information, Defendant is a citizen of Tennessee and Virginia. Accordingly, there
`
`is complete diversity between the parties.
`
`10. The exercise of personal jurisdiction over Defendant in Florida is
`
`proper as acts giving rise to Plaintiff’s cause of action have occurred in the state of
`
`Florida. In addition, Defendant is registered as a Foreign Limited Liability Company
`
`
`
`
`4
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 5 of 17 PageID 5
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`in Florida, and maintains corporate headquarters in Florida at 3450 Buschwood Park
`
`Drive, Suite 110, Tampa, Florida 33618.
`
`11. Venue is proper in this judicial district pursuant to 28 U.S.C. §
`
`1391(b)(2) because a substantial part of the events giving rise to Plaintiff’s claim of
`
`tortious interference alleged herein occurred in this District.
`
`IV. FACTUAL BACKGROUND
`
`A.
`
`Plaintiff’s Medical Foods
`
`12. Alfasigma specializes in the development of high quality medical
`
`foods—defined by federal law as foods that are “formulated to be consumed or
`
`administered enterally under the supervision of a physician and which [are] intended
`
`for the specific dietary management of a disease or condition for which distinctive
`
`nutritional requirements, based on recognized scientific principles, are established
`
`by medical evaluation.” 21 U.S.C. § 360ee(b)(3).
`
`13. Alfasigma markets and sells its medical foods throughout the United
`
`States. Alfasigma’s products include Deplin®, formulated to address the distinctive
`
`nutritional requirements of patients with depression or schizophrenia, and Metanx®,
`
`formulated to address the distinctive nutritional requirements of patients with
`
`diabetic peripheral neuropathy. Both Deplin® and Metanx® are formulated with a
`
`stable, pure, and crystalline form of L-methylfolate Calcium—the biologically
`
`active form of folate, which is critical for human health. Deplin® is formulated in
`
`
`
`
`5
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 6 of 17 PageID 6
`
`two strengths, with 15 mg of L-methylfolate Calcium and 7.5 mg of L-methylfolate
`
`Calcium. Metanx® is formulated with 3 mg of L-methylfolate Calcium, 35 mg of
`
`Pyridoxal-5´-Phosphate, and 2 mg of Methylcobalamin.
`
`14.
`
`In addition to marketing and selling its own brand-name medical foods,
`
`Alfasigma also supplies medical foods to a joint venture, which offers authorized
`
`generic versions of the original tablet forms of Deplin® and Metanx®, marketed
`
`under the names L-Methylfolate and Foltanx™ (the “Authorized Generics”). The
`
`Authorized Generics are sold throughout the United States.
`
`15. A “generic” is a pharmaceutical product that is both pharmaceutically
`
`equivalent to the brand name product—that is, formulated with the same active
`
`ingredients, in the same amounts, and with the same dosage form—and
`
`therapeutically equivalent—that is, has been shown to be bioequivalent to the brand
`
`name product such that it will have the same clinical effect and safety profile when
`
`administered to patients under the conditions specified in the label. The Authorized
`
`Generics—manufactured using the same ingredients and in the same facility as
`
`Deplin® and Metanx®—meet this demanding standard.
`
`16. Medical foods, including Deplin®, Metanx®, and the Authorized
`
`Generics, are often provided to patients through prescriptions written by their
`
`doctors and filled at a pharmacy. Generally, pharmacists presented with a
`
`prescription for a pharmaceutical product will consult a pharmaceutical information
`
`
`
`
`6
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 7 of 17 PageID 7
`
`database to determine if there is a generally less-expensive generic available for
`
`dispensing. If there is, the generic will be substituted in place of the brand name
`
`product actually prescribed. Unlike prescription drugs, however, the FDA does not
`
`make equivalency determinations
`
`regarding medical
`
`foods. Thus,
`
`the
`
`pharmaceutical database providers make the decision whether to assign the same
`
`database code—and thus “link” for substitution a generic product to a brand name
`
`product—based on information provided by the companies that are marketing the
`
`products.
`
`B.
`
`Plaintiff’s Lawsuit and Settlement with Virtus
`
`17. On October 29, 2012, Plaintiff brought suit against Virtus in Case No.
`
`9:12-cv-81202, in the United States District Court for the Southern District of
`
`Florida (the “Virtus Litigation”). The Virtus Litigation asserted claims of false
`
`advertising and unfair competition in connection with Virtus’s marketing of
`
`unauthorized, purportedly generic versions of Deplin® and Metanx® (among other
`
`products).
`
`18.
`
`In the Virtus Litigation, Plaintiff alleged that the products Virtus was
`
`advertising and selling as “generic” versions of Deplin® and Metanx® were in fact
`
`inequivalent and substandard, but nevertheless had been linked to Deplin®,
`
`Metanx®, and the Authorized Generics in pharmaceutical information databases.
`
`The Plaintiff further alleged that the advertising and sale of inequivalent products
`
`
`
`
`7
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 8 of 17 PageID 8
`
`injured Plaintiff both in terms of sales and reputation. Notably, even in its own
`
`motion practice, Virtus acknowledged that Messrs. Sanchez and Menendez had
`
`admitted during trial that Virtus had not tested its products for stability. Case No.
`
`9:12-cv-81202, Dkt. 352.
`
`19. The jury’s questions during their deliberations indicated they likely
`
`would have returned a plaintiff’s verdict. For example, a jury note to the Court
`
`during deliberations concerned the definition of “detriment”—an element of one of
`
`Plaintiff’s claims—and whether it was “considered a detriment if a consumer was
`
`mislead [sic] to purchase a product when the product was not what the consumer
`
`intended to buy?” Case No. 9:12-cv-81202, Dkt. 387 (Tr. Proceeding Aug. 26,
`
`2014), at 4:4-6.
`
`20. Virtus agreed to settle the litigation while the jury deliberated, resulting
`
`in the Agreement. See Case No. 9:12-cv-81202, at Dkt. 363 (Aug. 26, 2014)
`
`(“Parties announced settlement prior to verdict.”) One of Plaintiff’s objectives in
`
`resolving the Virtus Litigation was to prevent the advertising and sale of inequivalent
`
`products as “generic” versions of Deplin® and Metanx®. To this end, the Agreement
`
`provided that, until the end of 2024, the “Virtus Parties”—which includes Messrs.
`
`Sanchez and Menendez—would not “assist or attempt to assist” any “Third Parties”
`
`in “engag[ing] in any manufacture, use, sale, offers for sale, importation,
`
`distribution, advertising, promotion, or marketing of any such Third Party's product
`
`
`
`
`8
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 9 of 17 PageID 9
`
`given the same Database Code by pharmaceutical databases as any” of the products
`
`covered by the Agreement, including the “Tablet Product.”
`
`21.
`
`“Tablet product” is defined in the Agreement by reference to the
`
`database codes for the Authorized Generics of Deplin® and Metanx®.
`
`C. Defendant’s Chief Executive Officer and Senior Vice President of
`Business Development Are Bound by the Agreement
`22. Mr. Sanchez, Virtus’s Chief Executive Officer during the Virtus
`
`Litigation and at the time of the negotiation and execution of the Agreement,
`
`executed the Agreement:
`
`23. Along with Mr. Sanchez, the Agreement designated Mr. Menendez,
`
`then serving as Virtus’s Vice President, as the persons to receive notices for Virtus
`
`
`
`under the Agreement:
`
`
`
`
`9
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 10 of 17 PageID 10
`
`
`
`24. The Agreement provided significant consideration to both Messrs.
`
`Sanchez and Menendez, including releasing them personally from all claims by
`
`Plaintiff. In exchange, Messrs. Sanchez and Menendez were bound by the
`
`Agreement as among the “Virtus Parties,” further defined as “Virtus and its
`
`Affiliates,” which was defined to include persons, such as Virtus’s Chief Executive
`
`officer and Vice President, who had “the power to direct or cause the direction of
`
`the management and policies of” Virtus.
`
`25.
`
`In executing the Agreement, Mr. Sanchez expressly represented that he
`
`acted with actual authority to bind the Virtus Parties, specifically including himself
`
`and Mr. Menendez as Virtus’s “Affiliates.”
`
`D. Defendant’s Tortious Interference with the Agreement
`
`26. By 2020, Messrs. Sanchez and Menendez had both left their positions
`
`at Virtus and joined Defendant: Mr. Sanchez as Defendant’s Chief Executive
`
`
`
`
`10
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 11 of 17 PageID 11
`
`Officer, and Mr. Menendez as Defendant’s Senior Vice President of Business
`
`Development.
`
`27. At the time Messrs. Sanchez and Menendez joined Defendant as
`
`officers, Defendant had constructive knowledge and, upon information and belief,
`
`actual knowledge of the Agreement binding Messrs. Sanchez and Menendez.
`
`28. Due to their positions and roles with Virtus, Messrs. Sanchez and
`
`Menendez possess and, at the time they joined Defendant, possessed specialized
`
`knowledge
`
`regarding
`
`the development,
`
`formulation,
`
`ingredient sourcing,
`
`manufacturing, and marketing of purportedly generic versions of Deplin® and
`
`Metanx®.
`
`29. By the Fall of 2021, Defendant had begun manufacturing, advertising,
`
`promoting, distributing, marketing, offering to sell and selling medical foods in
`
`Tablet form marketed under the names L-Methyl-B6-B12 and L-Methylfolate
`
`Calcium (“Defendant’s Tablet Products”). Defendant advertises, promotes,
`
`distributes, markets, offers for sale, and sells these products as having the same
`
`ingredients and with the same strengths as the Authorized Generics. Defendant’s
`
`Tablet Products share the same Database Code as the Authorized Generics and are
`
`thus “linked” for substitution.
`
`30. Defendant aggressively advertises, promotes, distributes, markets,
`
`offers for sale, and sells Defendant’s Tablet Products nationwide, including in
`
`
`
`
`11
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 12 of 17 PageID 12
`
`Florida and in this judicial district. Defendant’s sale of these products have diverted
`
`sales away from the Authorized Generics, to Plaintiff’s injury, and have further
`
`caused price erosion.
`
`31. Upon information and belief, Defendant relied upon, and continues to
`
`rely upon, the assistance and direction of Messrs. Sanchez and Menendez,
`
`Defendant’s Chief Executive Officer and Senior Vice President of Business
`
`Development, in manufacturing, selling, offering for sale, distributing, advertising,
`
`promoting, and/or marketing Defendant’s Tablet Products.
`
`32. Upon information and belief, Defendant did not begin manufacturing,
`
`selling, offering for sale, distributing, advertising, promoting, and/or marketing
`
`Defendant’s Tablet Products until after Messrs. Sanchez and Menendez joined
`
`Defendant as its Chief Executive Officer and Senior Vice President Business
`
`Development.
`
`33. Upon information and belief, Defendant could not have manufactured,
`
`sold, offered for sale, distributed, advertised, promoted, and/or marketed
`
`Defendant’s Tablet Products without Messrs. Sanchez and Menendez assistance.
`
`34. Messrs. Sanchez and Menendez’s assistance to Defendant in its
`
`manufacture, sale, offering for sale, distribution, advertising, promotion, and/or
`
`marketing of Defendant’s Tablet Product constitutes a material and ongoing breach
`
`of the Agreement.
`
`
`
`
`12
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 13 of 17 PageID 13
`
`35. Despite having constructive (and, upon information and belief, actual)
`
`knowledge of the Agreement, Defendant induced Messrs. Sanchez and Menendez to
`
`breach the Agreement to provide their specialized knowledge regarding the
`
`development, formulation, ingredient sourcing, manufacturing, and marketing
`
`obtained with Virtus in order to assist and to continue assisting Defendant in
`
`manufacturing, marketing, selling, offering for sale, distributing, advertising,
`
`promoting and marketing Defendant’s Tablet Products.
`
`36. Defendant’s inducement of Messrs. Sanchez’s and Menendez’s breach
`
`of the Agreement was willful and/or reckless, and has continued despite notice from
`
`Plaintiff regarding the ongoing breach.
`
`37. Defendant’s interference with the Agreement, and its inducement of
`
`Messrs. Sanchez’s and Menendez’s breach of the Agreement have injured, and will
`
`continue to injure, Plaintiff. In addition to direct financial losses resulting from the
`
`loss of sales of the Authorized Generics, Defendant’s interference also has caused
`
`irreparable harm to Plaintiff through the loss of customers and the damage to its
`
`reputation.
`
`38. Plaintiff has retained the undersigned law firms of Carlton Fields P.A.
`
`and Shearman & Sterling LLP to pursue this matter on its behalf, and it is obligated
`
`to pay them reasonable attorneys’ fees and costs and litigation expenses associated
`
`with the prosecution of this matter.
`
`
`
`
`13
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 14 of 17 PageID 14
`
`COUNT I
`TORTIOUS INTERFERENCE WITH CONTRACT
`39. Plaintiff incorporates the allegations of the preceding paragraphs as
`
`though fully set forth herein.
`
`40. A binding and enforceable contract exists between Plaintiff and
`
`Defendant’s Chief Executive Officer, Louis Sanchez, and with Ryan Menendez,
`
`who served as Defendant’s Vice President of Business Relations. At all times
`
`relevant herein, Defendant had constructive knowledge and, upon information and
`
`belief, actual knowledge of this binding Agreement.
`
`41.
`
`In material breach of the Agreement, Messrs. Sanchez and Menendez
`
`assisted Defendant in its manufacture, sale, offers for sale, distribution, advertising,
`
`promotion, or marketing of Defendant’s Tablet Products.
`
`42. Defendant interfered with Plaintiff’s rights under the Agreement when
`
`it induced Messrs. Sanchez and Menendez to breach the Agreement by assisting
`
`Defendant in its manufacture, sale, offers for sale, distribution, advertising,
`
`promotion, or marketing of Defendant’s Tablet Products.
`
`43. Defendant did not act with any legal justification in interfering with
`
`Plaintiff’s Agreement, and Defendant was not acting under any privilege in its
`
`interference.
`
`44. As a result of Defendants’ tortious interference and the Plaintiff’s
`
`Agreement, Plaintiff has suffered, and unless such acts and practices are enjoined by
`
`
`
`
`14
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 15 of 17 PageID 15
`
`this Court, will continue to suffer, irreparable injury and damage for which it is
`
`entitled to relief.
`
`45. Plaintiff is entitled to an award of compensatory damages for
`
`Defendant’s tortious interference, in an amount which exceeds $75,000. Because
`
`Defendant has acted deliberately, intentionally, and/or grossly negligently, Plaintiff
`
`also is entitled to an award of punitive damages.
`
`V.
`
`JURY DEMAND
`
`Plaintiff demands a trial by jury of all issues so triable.
`
`VI. PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff respectfully prays for the following relief:
`
`A.
`
`The Court enter a judgment and order that Defendant, its agents,
`
`servants, employees, attorneys, successors and assigns, and all others in active
`
`concert or participation with them, be preliminarily and permanently enjoined from
`
`interfering with Plaintiff’s rights under the Agreement, and specifically that until the
`
`end of 2024, Defendant will not accept the assistance of its Chief Executive Officer
`
`Louis Sanchez or Ryan Menendez, who served as its Vice President of Business
`
`Development, in its manufacture, sale, offers for sale, distribution, advertising,
`
`promotion, or marketing of Defendant’s Tablet Products;
`
`B.
`
`The Court enter a judgment and order requiring Defendant to pay
`
`Plaintiff compensatory damages in the amount of Plaintiff’s actual and consequential
`
`
`
`
`15
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 16 of 17 PageID 16
`
`damages and any unjust enrichment by Defendant resulting from its tortious
`
`interference with Plaintiff’s Agreement;
`
`C.
`
`That the Court enter a judgment and order requiring Defendant to pay
`
`Plaintiff punitive damages for Defendant’s deliberate, intentional, and/or grossly
`
`negligent conduct which injured Plaintiff;
`
`D.
`
`The Court enter a judgment and order awarding Plaintiff its costs in this
`
`action, as well as awarding pre-judgment interest and post-judgment interest on any
`
`damages award;
`
`E.
`
`The Court enter a judgment and an order awarding Plaintiff such other
`
`and further relief as the Court deems just and equitable.
`
`
`
`Dated: March 28, 2022
`
`
`
`
`
`
`
`
`Respectfully submitted,
`CARLTON FIELDS, P.A.
`
`/s/ J. Coy Stull
`J. Coy Stull
`Florida Bar No. 15864
`Kai Su
`Florida Bar No. 1018977
`4221 W. Boy Scout Blvd., Suite 1000
`Tampa, Florida 33607-5780
`Tel. No.: (813) 229-4395
`Fax No.: (813) 229-4133
`Email: jstull@carltonfields.com
`Email: ksu@carltonfields.com
`
`
`-and-
`
`16
`
`

`

`Case 8:22-cv-00717 Document 1 Filed 03/28/22 Page 17 of 17 PageID 17
`
`
`SHEARMAN & STERLING LLP
`
`Saul Perloff (pro hac vice motion
`forthcoming)
`Lead Counsel
`Andre Hanson (pro hac vice motion
`forthcoming)
`Robert Rouder (pro hac vice motion
`forthcoming)
`Mary Catherine Amerine (pro hac vice
`motion forthcoming)
`300 W. 6th Street, 22nd Floor
`Austin, Texas 78701
`Tel. No.: (512) 647-1900
`Email: saul.perloff@shearman.com
`Email: andre.hanson@shearman.com
`Email: bob.rouder@shearman.com
`
`Attorneys for Plaintiff Alfasigma USA, Inc.
`
`17
`
`
`
`
`
`
`

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