Robles Bush v. Thoratec Corporation

Filing 67

ORDER granting 55 Motion to Amend/Correct Complaint. Signed by Magistrate Judge Daniel E. Knowles, III on 4/9/12. (plh, )

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
DINA M. ROBLES BUSH

CIVIL ACTION

VERSUS

NO. 11-1654

THORATEC CORPORATION, ET AL.

SECTION "L" (3)
ORDER

On March 28, 2012, Plaintiff's Motion for Leave to File Second Supplemental and Amending
Complaint [Doc. #55] came on for oral hearing before the undersigned. Present were Marcia
Finkelstein on behalf of plaintiff and Mindy Patron on behalf of defendant. After the oral hearing,
the Court took the motion under advisement. Having reviewed the motion, the opposition, the case
law and thhe parties' arguments, the Court rules as follows.
I.

Background
This case arises out of the death of Pete Bush, a recipient of the Thoratec HeartMate II Left

Ventricular Assist System (“LVAS”), a surgically-implanted heart pump manufactured by defendant
Thoratec Corporation (“Thoratec”). According to the allegations in the petition, Mr. Bush had the
LVAS implanted on September 26, 2008, at the VA Hospital in Richmond, Virginia. On or about
October 24, 2008, the Food and Drug Administration issued a notice regarding the LVAS due to
issues with “wear and fatigue of the percutaneous lead connecting the [device] to the system
controller [which] may result in damage that could interrupt pump function, require re-operation to

replace the pump and potentially result in serious injury and death.”
Mr. Bush later returned to New Orleans with his wife, plaintiff Linda Robles Bush. He
visited the Heart Failure Department at Tulane University Medical Center (“Tulane”) from early
2009 through May 2010 to check the LVAS. Plaintiff alleges that Tulane did not inform Mr. Bush
of the notice issued regarding his implanted LVAS. On May 4, 2010, Mr. Bush’s LVAS ceased
functioning, allegedly resulting in his cardiac arrest and death. Plaintiff alleges that Tulane arranged
for an autopsy and that the LVAS was removed and sent to Thoratec for evaluation. Thoratec has
not disclosed the findings of that evaluation, but plaintiff alleges that the evaluation demonstrates
that the pump stopped due to the defect described in the FDA notice.
Plaintiff filed suit in the Civil District Court for the Parish of Orleans against defendants
Thoratec, a California citizen, and University Healthcare System, LLC, d/b/a Tulane University
Medical Center and Clinic, a Louisiana citizen. As to Thoratec, plaintiff alleges that Thoratec
misrepresented the safety of the LVAS and knew of the risk of failure that caused the decedent’s
death but failed to notify plaintiff or decedent of the dangerous defects. As to Tulane, plaintiff
alleged that Tulane failed to test the LVAS to detect damage as set forth in the FDA recall notice
and intentionally failed in a duty to inform him of the known defect. As to both, plaintiff alleges that
Thoratec and Tulane knowingly concealed defects from the FDA and concealed the results of an
autopsy analysis on plaintiff. On July 14, 2011, Thoratec removed to this Court. On October 24,
2011, the District Court denied plaintiff’s motion to remand and granted Tulane’s motion to dismiss.
[Doc. #40].
On November 29, 2012, the District Court granted Thoratec’s motion to dismiss and allowed
plaintiff to amend her complaint before December 19, 2011. Plaintiff did so, and Thoratec filed a

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motion to dismiss the amended complaint.
II.

The Parties' Contentions
A.

Plaintiff's Motion to Amend

Plaintiff seeks to amend her complaint for a second time based on evidence that she
discovered after she filed her amended complaint, evidence that she alleges she could not have
discovered earlier. After the deposition of Sabrina White, the LVAS coordinator at Tulane, and Dr.
Gundars Katlaps and Lisa Martin, the implanting surgeon and surgeon’s nurse/LVAS coordinators
at the VA Medical Center, respectively, plaintiff alleges that she discovered information to allege
a claim for failure to warn (1) how to tell patients about the LVAS defects and (2) how the hospitals
were to monitor for and detect damage to the percutaneous leads.
Citing Rule 15, plaintiff alleges that the amendment will not unduly delay the proceedings
given that the District Court only decided jurisdiction on November 29, 2011. Plaintiff also
contends that she has been “stymied” in her attempts to conduct discovery. Thoratec allegedly
refused to produce its investigative report, and the holidays delayed the deposition of White.
Plaintiff argues that she is in good faith and has attempted to move the case forward expeditiously.
She contends that she has not filed earlier amendments to cure the alleged deficiency, and this
amendment will not prejudice Thoratec.
Plaintiff also asserts that the amendment is not futile. Thoratec’s warning letter to hospitals
allegedly failed to define crucial terms such as “high” and “reduced.” According to plaintiff, Martin
and White stated that they monitored Mr. Bush’s levels differently. Plaintiff thus contends that
Thoratec’s instructions and training were confusing and inadequate.
B.

Defendant Thoratec's Opposition

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Thoratec contends that all of the information that plaintiff has now obtained was available
to her before the December 19, 2011 deadline to amend. Thoratec argues that all of the individuals
from whom she obtained the information were known to her before the deadline. Thoratec asserts
that plaintiff had over seven months – from the date of filing suit – to depose the individuals.
Thoratec also argues that plaintiff’s claims are still preempted, and the amendment is thus
futile. It notes that her new claims allege that Thoratec’s device correction should have included
different and/or additional instructions for medical providers. Thoratec thus contends that plaintiff
seeks to impose requirements that are “different from, or in addition to” the FDA’s requirements.
21 U.S.C. § 360k.
Thoratec further argues that plaintiff has repeatedly attempted to cure the deficiencies of her
complaint. It maintains that it will suffer prejudice by incurring the costs to defend against a new
complaint because allowing the amendment will only lead to a new motion to dismiss under Federal
Rule of Civil Procedure 12(b)(6).
C.

Plaintiff's Reply

Plaintiff argues that she has arduously pursued the claim. She consulted the attorneys only
days before prescription would have run, and, after counsel immediately requested Thoratec’s
investigative report, Thoratec refused to produce it. Plaintiff propounded discovery on Thoratec on
July 5, 2011 – after she had sued – and Thoratec allegedly did not respond to the discovery. Once
Thoratec had removed the case, plaintiff argues that it was against her best interests to engage in
discovery given the case law that holds that once plaintiff engages in discovery, she waives her right
to complain of removal.
Plaintiff also notes that after the District Court granted Thoratec’s motion to dismiss and

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allowed her to amend by December 19, 2011, she attempted to depose White, who was unavailable
until December 20, 2011. Plaintiff further maintains that she only learned of the importance of
Katlaps and Martin through exhibits to Thoratec’s motion to dismiss. When she noticed their
depositions, the VA Hospital objected and refused to produce them. Ultimately, plaintiff and the
VA Hospital reached a compromise, and Martin produced a declaration under 28 U.S.C. § 1746 that
responded to several of plaintiff’s questions. In sum, plaintiff contends that she consulted three
experts, sent two FOIA requests, propounded seven sets of discovery to parties and attempted to
depose White and the VA Hospital’s operating room manager.
Plaintiff maintains that the amendment is not futile. She alleges that Thoratec’s notices
violated Louisiana Revised Statutes §§ 9:2800.57 and Civil Code Article 2315, which mandate that
a manufacturer properly warn about a product defect. Plaintiff argues that the FDA regulations do
not regulate the specific substance of a manufacturer’s warning. Plaintiff notes that the FDA did
not become involved in the recall until two months after Thoratec issued it, thus evidencing that the
FDA does not regulate the substance of the warning that Thoratec issued. Citing Hughes v. Boston
Scientific Corp., 631 F.3d 762, 769-71 (5th Cir. 2011), plaintiff argues that her claims are not
preempted because she alleges that Thoratec violated FDA regulations.
III.

Law and Analysis
Federal Rule of Civil Procedure 15(a), which governs the amendment of pleadings, provides

that leave to amend pleadings “shall be freely given when justice so requires.” Fed. R. Civ. P.
15(a)(2). This, and other federal rules “reject the approach that pleading is a game of skill in which
one misstep by counsel may be decisive to the outcome and accept the principle that the purpose of
pleading is to facilitate a proper decision on the merits.” Conley v. Gibson, 355 U.S. 41, 48 (1957).

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Thus, Rule 15(a) evinces a liberal amendment policy and a motion to amend should not be denied
absent a substantial reason to do so. See Jacobsen v. Osborne, 133 F.3d 315, 318 (5th Cir. 1998).
However, leave to amend is by no means automatic. Addington v. Farmer's Elevator Mut.
Ins. Co., 650 F.2d 663, 666 (5th Cir. 1981). The decision to grant or deny a motion for leave to
amend lies within the sound discretion of the trial court. Id. As outlined by the Supreme Court,
courts in this circuit examine five considerations to determine whether to grant a party leave to
amend a complaint: (1) undue delay; (2) bad faith or dilatory motive on the part of the movant; (3)
repeated failure to cure deficiencies by amendments previously allowed; (4) undue prejudice to the
opposing party by virtue of allowance of the amendment; and (5) futility of the amendment.
Rosenzweig v. Azurix Corp., 332 F.3d 854, 864 (5th Cir. 2003) (citing Forman v. Davis, 371 U.S.
178, 182, (1962)). Absent any of these factors, leave to amend a complaint should be “freely given.”
Smith v. EMC Corp., 393 F.3d 590, 595 (5th Cir. 2004) (citing Forman, 371 U.S. at 182).
There is no evidence of undue delay here. The District Court only determined that it has
subject-matter jurisdiction in November 2011. Nor is there evidence of bad faith. While plaintiff
has amended her complaint before, she has only done so once, and that is not evidence of repeated
failure. While Thoratec argues prejudice, it only does so with regard to the costs of litigation, a
prejudice that all defendants must bear.
In addition, while Thoratec argues that the amendment would be futile, plaintiff’s reliance
on Hughes reveals that under the circumstances here, the issue is far from clear-cut. There, the court
held that “we are satisfied that Hughes's failure to warn claim is not expressly preempted to the
extent that it is based on Boston Scientific's violation of applicable FDA regulations requiring
accurate reporting of serious injuries and malfunctions of the HTA device. This claim does not

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impose additional or different requirements to the federal regulations, but is parallel to the federal
requirements.” 631 F.3d at 771. The Court can not say at this time that plaintiff’s new claims do
not fall under the protection afforded by Hughes.
IV.

Conclusion
For the foregoing reasons,
IT IS ORDERED that Plaintiff's Motion for Leave to File Second Supplemental and

Amending Complaint [Doc. #55] is GRANTED.
New Orleans, Louisiana, this 9th day of April, 2012.

DANIEL E. KNOWLES, III
UNITED STATES MAGISTRATE JUDGE

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