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Lew v. Medtronic, Inc.

United States District Court, Central District of California

December 16, 2014

Jerome Lew
Medtronic, Inc. et al.



Before the Court is a Motion for Leave to Amend Complaint, Join Parties and Remand ("Joinder Motion") filed by Plaintiff Jerome Lew. (Joinder Mot., Doc. 8.) Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, "Medtronic") filed an Opposition, and Plaintiff replied. (Joinder Opp'n, Doc. 17; Joinder Reply, Doc. 21.) Also before the Court is a Motion to Dismiss Plaintiffs Complaint filed by Defendants. (Dismiss Mot., Doc. 14.) Plaintiff filed an Opposition, and Defendants replied. (Dismiss Opp'n, Doc. 19; Dismiss Reply, Doc. 20.) The Court finds this matter appropriate for decision without oral argument. Fed.R.Civ.P. 78(b); CD. Cal. R. 7-15. Accordingly, the hearing on the Motion, set for December 19, 2014, at 2:30 p.m., is VACATED. For the reasons stated below, the Court GRANTS Plaintiffs Joinder Motion, and DENIES Defendants' Motion to Dismiss as moot. The Court REMANDS this case to Los Angeles Superior Court, Case No. SC123264.


On November 14, 2014, Plaintiff Jerome Lew filed the present Joinder Motion, seeking to join Jeffrey C. Wang, M.D. and The Regents of the University of California pursuant to Federal Rule of Civil Procedure 20(a) and 28 U.S.C. § 1447(e). (Joinder Mot. at 1.) Lew alleges that Dr. Wang is an employee of The Regents and a clinical instructor and orthopedic surgeon at UCLA Medical Center. (Notice of Removal, Ex. 1, "Compl., " ¶ 32, Doc. 1-1.) Dr. Wang performed a spinal surgery procedure on Lew at The Regents' UCLA Medical Center in Santa Monica, California. (Id. ¶ 47.) Lew also requests that, if the Court permits Lew to file a First Amended Complaint ("FAC") and add Dr. Wang and The Regents as defendants, the Court remand this action because Lew, Dr. Wang, and The Regents are all California residents and complete diversity will be destroyed. (See Joinder Mot. at 1.; Compl. ¶¶ 2-8.)

A. Factual History

Lew alleges in his Complaint that, on or about March 31, 2009, Lew consulted Dr. Wang regarding numbness and pain in both of his hands. (Id. ¶ 43.) Dr. Wang diagnosed Lew with "cervical stenosis and cervical myelopathy with herniated disk at C4-C5 and C5-C6, and degenerative disk disease." (Id.)

On May 11, 2009, Lew underwent spinal surgery. (Id. ¶ 47-48.) Dr. Wang performed an "anterior C5 vertebrectomy and corpectomy, and C4-C6 anterior interbody fusion" at The Regents' UCLA Medical Center in Santa Monica, California. (Id. ¶ 47.) Lew describes the surgery as follows:

Dr. Wang removed the central portion of the C5 vertebral body and used a vertebral body replacement device to fill the space where the C5 was partially removed. Then he inserted the Infuse®-soaked absorbable collagen sponge and bone from the C5 vertebra into the cervical corpectomy cage with the intention that it would stimulate bone growth over time in order to "fuse." (Id. ¶ 48.)

Lew contends that the Infuse® Bone Graft used during his surgery was designed by Medtronic for only "anterior approach lumbar spine surgery." (Id. ¶ 12.) On July 2, 2002, Infuse® was approved through the premarket approval process by the United States Food and Drug Administration ("FDA") "for use at a single level in the lower region of the spine (L4 through SI) with a lumbar fusion containment cage to treat degenerative disc disease." (Id. ¶ 13.) Lew alleges that the FDA approval was later expanded to permit the use of Infuse® at another level in the lower region of the spine (L2 through SI), but that Infuse® has never been approved for use in the cervical spine (the region of the spine that was the subject of Lew's spinal surgery). (Id. ¶¶13-19.)

According to the Complaint, on July 1, 2008, "the FDA issued a Public Health Notification ("Safety Alert") to healthcare practitioners about complications from the use of. . . Infuse® [] in the neck or cervical area of the spine . . . with some reports of life-threatening and fatal events." (Id. ¶ 21.) Lew alleges that Medtronic, Dr. Wang, and The Regents were aware of the July 1, 2008 FDA Safety Alert, but still performed the surgery on Lew using Infuse®. (Id. ¶ 24.) Lew contends that he was unaware that Infuse® had not been approved by the FDA for the type of cervical spine surgery that was performed on him. (Id. ¶ 28.)

Lew alleges that Dr. Wang had a financial relationship with Medtronic by which he would receive royalties for products manufactured by Medtronic, including those used during spinal surgery. (Id. ¶¶ 33-34.) Lew further contends that Medtronic paid Dr. Wang "to consult on development of products, including attending product design meetings for Medtronic" and for Dr. Wang's research on Medtronic's medical devices, including the Infuse® product. (Id. ¶¶ 35-37.) Lew alleges that the "cervical corpectomy cage and Infuse® product" that Dr. Wang used during Lew's surgery were manufactured and provided by Medtronic, and that a sales representative from Medtronic was in the operating room during Lew's surgery. (Id. ¶ 48-49.)

According to the Complaint, Dr. Wang never informed Lew of Dr. Wang's financial relationship with Medtronic or that Dr. Wang intended to use Medtronic's products during Lew's spinal surgery. (Id. ¶ 44.) Lew alleges that he believed that his surgery would consist of only "an autograft from bone harvested from his own body during the surgery" and was never informed that Infuse® would be used. (Id. ¶ 46.) As a result, Lew alleges that he did not consent to "a corpectomy or removal of his C5 vertebra, " "replacement of the partially removed C5 vertebra with a corpectomy cage, " or "use of the Infuse® product." (Id. ¶¶ 50-52.) Lew also alleges that he "did not consent to a multi-level surgical procedure. He only consented to a single C5-6 procedure." (Id. ¶ 53.) Further, according to Lew, "[n]either Medtronic nor Dr. Wang nor The Regents disclosed to [Lew] that an unapproved or uncleared cervical corpectomy cage would be implanted during his surgery." (Id. ¶ 61.) Based on these facts, Lew contends that Medtronic and Dr. Wang "were experimenting with the use of rhMBP (Infuse®) in the cervical spine. Medtronic provided the Infuse® and cervical corpectomy cage, Dr. Wang provided the patient/human subject, Mr. Lew, and The Regents allowed the uncleared/unapproved cervical corpectomy cage to enter its hospital and be implanted in Mr. Lew." (Id. ¶ 60.)

Lew alleges that, in March 2011, he underwent a Computerized Tomography ("CT") scan that revealed "evidence of bony overgrowth present around and outside the corpectomy cage, " and that subsequent radiology studies "revealed evidence of bony overgrowth posteriorly from the cage entering into the canal and compressing the cord." (Id. ¶ 63.) According to Lew, "[e]xcessive bony overgrowth is one of the known, inherent dangers associated with the improper use of the Infuse® bone graft, and one of the primary reasons it is not approved for use in the cervical spine." (Id. ¶ 65.) On September 5, 2012, Lew underwent "a cervical laminectomy and bilateral neural foraminotomies" to attempt to correct the significant bony overgrowth. (Id. ¶ 64.) However, despite this second surgery, Lew "continues to suffer from chronic nerve damage as a result of the surgery." (Id. ¶)

B. Procedural History

On September 18, 2012, Lew served Dr. Wang, The Regents, and other healthcare providers with Notices of Intention to Commence Action letters pursuant to California Code of Civil Procedure § 364. (Joinder Mot., Ex. 2, "§ 364 Notices, " Doc. 8-1.) Under § 364 "[n]o action based upon the health care provider's professional negligence may be commenced unless the defendant has been given at least 90 days' prior notice of the intention to commence the action." Cal. Civ. Proc. Code § 364(a).

On September 21, 2012, Lew filed a complaint in Orange County Superior Court against Medtronic, based on the same underlying facts at issue in the present Joinder Motion. (Joinder Mot., Ex. 3, "First Medtronic Complaint, " Doc. 8-1.) Lew's First Medtronic Complaint alleges that "[o]nce the 90-day wait period [pursuant to § 364] expires without resolution, [Lew] intends to amend his complaint to name Dr. Wang [and The Regents] as [] defendant[]." (Id. ¶ 57-58.) However, on October 16, 2012, prior to the expiration of the 90-day wait period, Medtronic removed the First Medtronic Complaint to federal court based on diversity. (Joinder Mot., Ex. 4, "First Removal, " Doc. 8-1.)

On October 26, 2012, and October 29, 2012, Lew and Medtronic signed an agreement entitled "Tolling Agreement." (Joinder Mot., Ex. 5, "Tolling Agreement, " Doc. 8-1.) The Tolling Agreement provides that Lew "will voluntarily dismiss without prejudice the Complaint... in exchange for Medtronic's agreement to toll or suspend the running of any and all statutes of limitations that may apply to the claims asserted in the Complaint as of September 21, 2012." (Id. ¶ 6.) Further, the Tolling Agreement states that if Lew "files a lawsuit concerning a claim that was tolled by this Tolling Agreement, [Lew] shall file such lawsuit only in the federal district where he is domiciled or where he had Infuse® implanted during a surgery." (Id. ¶ 9.) After signing the Tolling Agreement, Lew and Medtronic stipulated to a dismissal without prejudice of all claims asserted in the First Medtronic Complaint. (See Joinder Mot., Ex. 6, Jerome Lew v. Medtronic, Inc. et ah, Order for Dismissal Without Prejudice, Case No.: SACV 12-01788 JST (MLGx), Doc. 8-1.)

On December 19, 2012, after the California Code of Civil Procedure § 364 90-day waiting period had expired, Lew filed a complaint in Orange County Superior Court against Dr. Wang, The Regents, and other healthcare provider defendants, based on the same underlying facts as the First Medtronic Complaint and the Joinder Motion at issue here. (Compl. 6.; Joinder Mot., Ex. 7, "Wang/Regents Action, " Doc. 8-1.) The parties stipulated to a change of venue and the Wang/Regents Action was transferred to Los Angeles Superior Court on March 8, 2013. (Joinder Mot., Ex. 8, "Transfer, " Doc. 8-1.) On October 1, 2014, the parties stipulated to allow Lew to file a second amended complaint ("SAC") to include only Dr. Wang and The Regents as defendants. (Compl. 6; Joinder Mot., Ex. 12, "SAC, " Doc. 8-1.)

On September 22, 2014, Lew provided Medtronic with notice that it intended to end the Tolling Agreement. (Joinder Mot., Ex. 11, "Tolling Agreement Notice, " Doc. 8-1.) On October 16, 2014, Lew filed the present action in Los Angeles Superior Court against Medtronic. (Compl.) When Lew filed the present action against Medtronic in state court, Lew also filed a Notice of Related Case, identifying the Wang/Regents Action as an action that "involves the same parties and is based on the same or similar claims, " "arises from the same or substantially identical transactions, incidents, or events requiring the determination of the same or substantially identical questions of law or fact, " and "is likely for other reasons to require substantial duplication of judicial resources if heard by different judges." (Joinder Mot., Ex. 13, "Notice of Related Case, " Doc. 8-1.) Lew contends that it always intended to consolidate the present action and ...

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