Pinsonneault v. St. Jude Med., Inc., Civil Nos. 12–1717
| Citation | 953 F.Supp.2d 1006 |
| Decision Date | 18 June 2013 |
| Docket Number | 12–2396 (PJS/JSM).,12–1785,Civil Nos. 12–1717 |
| Parties | Richard J. PINSONNEAULT, Plaintiff, v. ST. JUDE MEDICAL, INC. and Pacesetter, Inc., St. Jude. Joseph D. Houlette, Plaintiff, v. St. Jude Medical, Inc. and Pacesetter, Inc., Defendants. Gary Rouse, Plaintiff, v. St. Jude Medical, Inc. and Pacesetter, Inc., Defendants. |
| Court | United States District Courts. 8th Circuit. United States District Court of Minnesota |
OPINION TEXT STARTS HERE
Yvonne M. Flaherty, Lockridge Grindal Nauen PLLP, Minneapolis, MN, for Richard J. Pinsonneault.
Charles S. Zimmerman, Genevieve M. Zimmerman, Jason P. Johnston, Ronald S. Goldser, Zimmerman Reed, PLLP, Minneapolis, MN, for Joseph D. Houlette.
Daniel E. Gustafson, Karla M. Gluek, Gustafson Gluek PLLC, Minneapolis, MN for Plaintiffs.
Andrew E. Tauber, Mayer Brown LLP, Rebecca K. Wood, Robert D. Keeling, Sidley Austin LLP, Washington, DC, Brian W. Thomson, Blake Shepard, Jr., Leonard Street and Deinard, PA Minneapolis, MN, Daniel L. Ring, Mayer Brown LLP, Maja C. Eaton, Sidley Austin LLP, Chicago, IL, for Defendant St. Jude Medical, Inc.
The above matters came on before the undersigned in Civil No. 12–1717 (PJS/JSM) upon Plaintiff's Motion to Amend Complaint [Docket No. 48]; in Civil No. 12–1785 (PJS/JSM) upon Plaintiff's Motion to Amend Complaint [Docket No. 30]; and in Civil No. 12–2396 (PJS/JSM) upon, Plaintiff's Motion to Amend Complaint [Docket No. 29].
Daniel E. Gustafson, Esq., Yvonne M. Flaherty, Esq. and Amanda M. Williams, Esq. appeared on behalf of plaintiffs Richard J. Pinsonneault and Gary Rouse; Genevieve M. Zimmerman, Esq. appeared on behalf of plaintiff Joseph D. Houlette; and Andrew E. Tauber, Esq., Rebecca K. Wood, Esq., and Blake Shepard, Jr., Esq. appeared on behalf of defendants St. Jude Medical, Inc. and Pacesetter, Inc.
The Court, being duly advised in the premises, upon all of the files, records, and proceedings herein, and for the reasons stated on the record at the hearing and the Memorandum below, now makes and enters the following Order.
IT IS HEREBY ORDERED that:
1. Plaintiffs' Motions to Amend Complaint [Civil No. 12–1717 (PJS/JSM) Docket No. 48], [Civil No. 12–1785 (PJS/JSM) Docket No. 30], and [Civil No. 12–2396 (PJS/JSM) Docket No. 29] are GRANTED as it relates to the additional factual allegations and changes to existing factual allegations set forth in the proposed First Amended Complaint, and DENIED as it relates to proposed Counts V and VI.
2. Plaintiffs shall serve and file their First Amended Complaints, consistent with this Order, on or before June 24, 2012.
3. Defendants shall respond to the First Amended Complaints in a manner that is consistent with the Federal Rules of Civil Procedure.
MEMORANDUMPlaintiffs Richard J. Pinsonneault, Joseph D. Houlette, and Gary Rouse (collectively referred to herein as “plaintiffs”) commenced individual actions against St. Jude Medical, Inc. and Pacesetter, Inc. (collectively referenced as “St. Jude”) claiming injury as a result of alleged defects in the Riata leads manufactured and distributed by St. Jude, which are attached to medical devices used to treat heart conditions, including implantable cardiac defibrillators. See Complaint, ¶¶ 1–2, 8–11 [Docket No. 1].1 Plaintiffs were implanted with a Riata lead, which allegedly ultimately failed and injured them. Id., ¶¶ 6, 7. The alleged defects pertaining to the Riata leads include among several claimed defects, the increased risk of abrasion of the lead wires or electrical conductors, causing the lead wires to protrude through the insulation and preventing proper functioning of the medical devices. Id., ¶¶ 35–37.
On December 15, 2010, St. Jude published a “Dear Doctor” letter, regarding various Riata lead models, indicating an insulation abrasion rate of 0.47% over nine years of use. Id., ¶¶ 42, 43. No voluntary recall was issued at this time. Id., ¶ 45. On November 28, 2011, St. Jude issued a second “Dear Doctor Letter,” advising that it had increased the insulation abrasion rate from its 2010 rate of 0.47% to 0.63%. Id., ¶ 47. No voluntary recall was issued at this time. Id.
On December 21, 2011, the FDA issued a Class I Recall of the Riata leads. A Class I Recall is defined as a situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death. Id., ¶¶ 48, 49. Specifically, the issue involved failures associated with lead insulation abrasion on the St. Jude Riata and Riata ST Silicone Endocardial Defibrillation leads. Id., ¶ 50.
Plaintiffs asserted a claim of strict liability based on allegations that the Riata leads contain a manufacturing defect because the actual manufacture of the leads differed from the specifications set forth in the pre-market approval application (“PMA”) that was submitted to the FDA and the conditions for approval set by the FDA. Id., ¶¶ 59–62. In addition, plaintiffs asserted a claim for negligence in manufacturing. The basis of this claim was that St. Jude breached its duty to manufacture the Riata leads consistent with the PMA and the Conditions of Approval, which led to their injuries. Id., ¶¶ 65, 66. Further, plaintiffs claimed that St. Jude is culpable under theories of negligence per se based on its alleged failure to abide by applicable Federal Regulations, and under res ipsa loquitur. Id., ¶¶ 67–78.
Plaintiffs' are now seeking to amend the Complaint to add the following claims for relief against St. Jude:
COUNT V
94. Plaintiff hereby incorporates by reference all preceding paragraphs as if fully set forth herein.
95. Defendants have a duty to provide ongoing warnings and instructions regarding safety hazards associated with the Leads.
96. Defendants breached this duty by failing to, inter alia, provide timely and adequate reports regarding safety hazards and/or potential defects associated with the Leads.
97. Defendants also breached this duty by failing to conduct adequate risk analyses, tests, and investigations regarding safety hazards and/or potential defects associated with the Leads.
98. As a direct and proximate result of Defendants' negligence, Plaintiff was injured as described herein.
COUNT VI
99. Plaintiff hereby incorporates by reference all preceding paragraphs as if fully set forth herein.
100. Defendants expressly warranted to Plaintiff by and through Defendants and/or their authorized agents or sales representatives, in publications, package inserts, the internet, and other communications intended for physicians, medical patients, and the general public, that the Leads were safe, effective, fit and proper for their intended use.
101. In allowing the implantation of the Leads, Plaintiff and his physicians relied on the skill, judgment, representations, and express warranties of Defendants. These warranties and representations were false in that the Leads were not safe and were unfit for the uses for which they were intended.
102. Through sale of the Leads, Defendants are merchants pursuant to Section 2–314 of the Uniform Commercial Code.
103. Defendants breached their warranty of the mechanical soundness of the Leads by continuing sales and marketing campaigns highlighting the safety of its product, while it knew of the defects and risk of product failure.
104. As a direct and proximate result of Defendants' wrongful conduct, Plaintiff has sustained and will continue to sustain severe physical injuries and/or death, loss of companionship and society, severe emotional distress, mental anguish, economic losses and other damages for which he is entitled to compensatory and other relief in an amount to be proven at trial.
See Affidavit of Yvonne M. Flaherty in Support of Plaintiffs' Motion for Leave to Amend the Complaint [Civil No. 12–1717 (PJS/JSM) ], Exs. A, B (Proposed First Amended Complaint), ¶¶ 94–104.2
The proposed amended complaints also seek to add facts regarding: when St. Jude received approval to market the predecessor to the Riata Leads (the original PMA), as well the fact that St. Jude submitted, and the FDA approved, 14 supplements to the PMA that alter the design and manufacture of the leads; additional supplements to the Riata Series leads; inspections conducted by the FDA in 2009 of defendants' manufacturing facility in Sylmar California, which revealed deficiencies in violation of 21 C.F.R. § 803, et seq., in the handling of complaints, failing to follow procedures for the product design of the leads, failing to include information that was reasonably known to the manufacturer, failing to timely make Medical Device Reporting (“MDR”) submissions, failing to define the procedures for implementing corrective and preventative actions, failing to review sampling methods for adequacy of their intended use, failing to perform design reviews at appropriate times, failing to perform a complete risk analysis, failing to establish procedures for the validation, verification, review, and approval of design changes before their implementation, and failing to resolve discrepancies noted at the completion of design verification; an October 17, 2012 inspection by the FDA of St. Jude's manufacturing facility in Sylmar California that revealed additional deficiencies; a FDA order issued in 2012, requiring St. Jude to collect clinical data related to the potential for premature insulation failure in the Riata Leads and to conduct a three-year post market surveillance study to address concerns related to premature insulation failure; and a January 2013 study published in the Heart Rhythm Journal, which indicated that St. Jude had advised that the rate of cable externalization was 24% in the Riata 8fr Leads, 9% in the Riata ST 7fr Lead, and that the Riata Leads fail more often than other brands. See Proposed First Amended Complaint, ¶¶ 4, 19, 23, 27, 28, 30, 39, 41–46, 71–72.
To continue reading
Request your trial
-
Mize v. Mentor Worldwide LLC
...the FDA had discretion to not include those reports in the database. ( 21 C.F.R. § 803.9(a) ; see also Pinsonneault v. St. Jude Medical, Inc. (D. Minn. 2013) 953 F.Supp.2d 1006, 1016 [adverse events not "automatically" made public].) But because the FDA regularly publishes such information ......
-
Aaron v. Medtronic, Inc.
...Because the state-law duty to warn is "not genuinely equivalent to a duty imposed by the FDCA" (Pinsonneault v. St. Jude Med., Inc. , 953 F.Supp.2d 1006, 1016 (D.Minn.2013) ), Plaintiffs' "allegations that Medtronic failed to report adverse events to the FDA do not state a parallel claim." ......
-
Glover v. Bausch & Lomb, Inc.
...v. Medtronic, Inc. , 293 F. Supp. 3d 129, 183–84 (D.D.C. 2018) (applying District of Columbia law) ; Pinsonneault v. St. Jude Medical, Inc. , 953 F. Supp. 2d 1006, 1015 (D. Minn. 2013) (applying Minnesota law). In none of these cases, however, did the court confront a state product liabilit......
-
Waltenburg v. St. Jude Med., Inc.
...duty to warn was not equivalent to the federal duty to properly issue reports to the FDA. See Pinsonneault v. St. Jude Med., Inc., 953 F.Supp.2d 1006, 1015 (D.Minn.2013). Contrarily, the Ninth Circuit, in an en banc decision also handed down last year, found that the plaintiffs' negligent f......