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Barbara Mack, As Administratrix of the Estate of v. Ventracor

March 9, 2011

BARBARA MACK, AS ADMINISTRATRIX OF THE ESTATE OF
WILLIAM A. MACK, JR., DECEASED, PLAINTIFF
v.
VENTRACOR, LTD., TRADING AND DOING BUSINESS IN THE UNITED STATES AS VENTRACOR, INC., ALSO KNOWN AS VENTRACOR; ROHINTON J. MORRIS, M.D.; MICHAEL A. ACKER, M.D.; ) MARIELL L. JESSUP. M.D.; THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA TRADING AND DOING BUSINESS AS UNIVERSITY OF PENNSYLVANIA ALSO TRADING AND DOING BUSINESS AS THE HOSPITAL OF THE UNIVERSITY OF ) PENNSYLVANIA ALSO TRADING AND DOING BUSINESS AS UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM; AND VENTRACOR, INC., DEFENDANTS



The opinion of the court was delivered by: James Knoll Gardner, United States District Judge

OPINION

This matter is before the court on the Motion to Remand and for Costs, Expenses, and Attorneys' Fees filed together with a memorandum of law *fn1 on behalf of plaintiff Barbara Mack, as Administratrix of the Estate of William A. Mack, Jr., deceased, on June 9, 2010. Defendants responded on July 7 and 9, 2010. *fn2

Plaintiff's reply was filed with permission on September 15, 2010. *fn3

Oral argument on plaintiff's motion was held before me on January 13, 2011.

For the reasons articulated in this Opinion, I grant in part and deny in part plaintiff's Motion to Remand and for Costs, Expenses and Attorneys' Fees.

Specifically, because I find that there is no federal question presented in this case, I grant plaintiff's motion to remand and remand this matter back to the Court of Common Pleas of Philadelphia County, Pennsylvania, for further proceedings. I also deny that portion of plaintiff's motion seeking costs, expenses, and attorneys' fees arising from an allegedly improper removal under 28 U.S.C. § 1447(c).

JURISDICTION

Defendants allege jurisdiction in this case based upon federal question jurisdiction pursuant to 28 U.S.C. § 1331.

VENUE

Venue is proper pursuant to 28 U.S.C. § 1391(b) because the events giving rise to plaintiff's claims allegedly occurred in Philadelphia County, Pennsylvania, which is located within this judicial district.

PROCEDURAL HISTORY

On February 4, 2009 plaintiff filed her initial complaint as a wrongful death and survival action in the Court of Common Pleas of Philadelphia County, Pennsylvania. The initial complaint did not contain a battery claim.

After numerous amendments, on February 19, 2010 plaintiff filed her Eighth Amended Civil Action Complaint in the Court of Common Pleas of Philadelphia County. The Eighth Amended Civil Action Complaint included a cause of action sounding in battery based upon a lack of informed consent because defendants allegedly violated multiple federal regulations.

On March 16, 2010, alleging federal question jurisdiction, defendants removed the case to this court, the United States District Court for the Eastern District of Pennsylvania. On March 26, 2010, plaintiff filed with this court a Notice of Voluntary Dismissal Pursuant to F.R.C.P. 41(a)(1)(A)(i), thereby dismissing her Eighth Amended Civil Action Complaint.

Plaintiff filed her current complaint, entitled Civil Action Complaint ("Complaint"), in the Court of Common Pleas of Philadelphia County, Pennsylvania on March 31, 2010. Plaintiff's Complaint includes a cause of action sounding in battery based upon a lack of informed consent pursuant to state statutory and common law. On May 10, 2010, defendants again removed this case by filing a Notice of Removal on the basis of plaintiff's battery claim, Count VIII of the state Complaint.

As noted above, on June 9, 2010, plaintiff moved to remand this action to the Court of Common Pleas of Philadelphia County, Pennsylvania, and defendants filed responses in opposition on July 7, 2010 and July 9, 2010. On July 7, 2010 plaintiff filed in the Court of Common Pleas of Philadelphia County a Praecipe to Reinstate her March 31, 2010 Civil Action Complaint.

PLAINTIFF'S COMPLAINT

According to plaintiff's current Complaint, the parties, claims and other allegations pertinent to plaintiff's motion to remand are as follows.

Parties

Plaintiff Barbara Mack is the Administratrix of the Estate of William A. Mack, Jr., deceased ("decedent"). Plaintiff is the widow of the decedent. Mr. Mack suffered from end-stage cardiac disease and was a participant in a human research study entitled Evaluation of the VentrAssistTM Left Ventricular Assist Device for Treatment of Advanced Heart Failure--Destination Therapy ("VentraAssist Study").

Defendant Ventracor, Inc., a global medical device company, sponsored the VentraAssist Study. It designed and manufactured the device ultimately implanted into Mr. Mack. *fn4 The Trustees of the University of Pennsylvania facilitated the study by entering into an Institutional Clinical Trial Agreement with Ventracor, Inc. *fn5 The surgical implantation of the device occurred at the Hospital of the University of Pennsylvania. Defendant doctors Rohinton J. Morris, M.D., Michael A. Acker, M.D., and Mariell L. Jessup, M.D. were the primary investigators conducting the VentraAssist Study.

Claims The ten-count Complaint filed on March 31, 2010 in the Court of Common Pleas of Philadelphia County by plaintiff Barbara Mack, as Administratrix of the Estate of William A. Mack, Jr., deceased, alleges products liability and medical malpractice claims brought against defendants under the Pennsylvania Wrongful Death Act *fn6 and the Pennsylvania Survival Act. *fn7

Specifically, Count I of plaintiff's Complaint is brought pursuant to the Restatement (Second) of Torts, § 402A as adopted in Pennsylvania state common law. *fn8 It alleges against defendant Ventracor, Inc. a cause of action for strict liability for the injuries and death suffered by plaintiff's decedent. Plaintiff alleges that Ventracor, Inc. is the manufacturer of a ventricular heart assist device implanted into the decedent.

Count II of the Complaint is a negligence claim under state common law. It is brought against defendant University of Pennsylvania and the defendant doctors who were involved in the clinical research study in connection with their supervision, use, and inspection of the device implanted in the decedent.

Count III is a strict liability cause of action pursuant to Section 402A of the Restatement (Second) of Torts as adopted in Pennsylvania state common law. Count III seeks damages for injuries to, and the death of, plaintiff's decedent. The claim is against the University of Pennsylvania, which allegedly distributed, marketed, sold, and implanted the device.

Count IV alleges negligence pursuant to state common law. Count IV is brought against defendant Ventracor, Inc. for the design, manufacture, and failure to warn of the risks, of the device implanted into the decedent.

Count V asserts causes of action against Ventracor, Inc. for breach of express warranty pursuant to 13 Pa.C.S.A. § 2313. It is based upon Ventracor's written materials, representations, and statements regarding the ventricular heart assist device.

Count VI alleges a cause of action against Ventracor, Inc. for breach of the implied warranty of fitness for a particular purpose pursuant to 12 Pa.C.S.A. § 2315. Count VI specifically alleges breach of an implied warranty that the device was suitable for implantation and use to support the decedent's circulation.

Count VII is a cause of action against Ventracor, Inc. for breach of the implied warranty of merchantability pursuant to 13 Pa.C.S.A. § 2314. Plaintiff bases Count VII upon Ventracor's alleged distribution of the device implanted into the decedent.

Count VIII is brought pursuant to state common law and the Medical Care Availability and Reduction of Error Act ("MCARE Act"). *fn9 It asserts a battery claim, under the Survival Act, against defendant doctors and the University of Pennsylvania for their failure to obtain the decedent's informed consent.

Count IX is a claim under the Survival Act for fraudulent misrepresentation against defendant doctors, the University of Pennsylvania, and Ventracor, Inc. In Count IX, plaintiff alleges that defendants fraudulently misrepresented to plaintiff's decedent that he retained legal rights in connection with his participation in the clinical research study.

Count X asserts a claim under the Survival Act against defendant doctors, the University of Pennsylvania and The Hospital of the University of Pennsylvania. In Count X, plaintiff alleges breach of a fiduciary duty owed the patient arising from the physician-patient and hospital-patient relationships, and which requires the physician and hospital to act in the best interests of their patient.

VentraAssist Study The VentrAssist Study evaluated the safety and efficacy of the VentrAssist LVA4, an implantable cardiac assist device designed and manufactured by Ventracor, Inc. *fn10 The device was in the earliest stages of approval by the United States Food and Drug Administration ("FDA"), and the study was performed pursuant to an FDA conditional Investigational Device Exemption ("IDE") under 21 C.F.R. § 812. *fn11

An IDE exempts a device on a conditional basis from the more rigorous requirements of premarket approval in order to foster research into useful devices intended for human use.

21 C.F.R. § 812.1. The device had not received premarket approval under 21 C.F.R. § 814. *fn12 Premarket approval occurs after the device has generated enough data on its safety and effectiveness during the IDE phase for the FDA to evaluate it and allow it to be sold and marketed on a routine basis. *fn13 See 21 C.F.R. §§ 814.1 to 814.126.

On April 27, 2008, Mr. Mack was admitted to the Hospital of the University of Pennsylvania because of his end-stage cardiac disease. *fn14 After determining that Mr. Mack was not a candidate for other routine therapies, he was recruited by the doctors at the Hospital of the University of Pennsylvania to participate in the VentraAssist Study on April 25, 2008. *fn15 Mr. Mack agreed to the procedure and signed the University of Pennsylvania Research Subject Informed Consent Form ("Consent Form") that day. *fn16

On April 29, 2008, Mr. Mack underwent surgical implantation of the VentrAssist model LVA4, along with the replacement of one of his heart valves, at the Hospital of the University of Pennsylvania. *fn17 ...


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