Mihok v. Medtronic, Inc.

• Decision Date: 20 October 2016
• Docket Number: FSTCV146023001S
• Court: Connecticut Superior Court
• Parties: Michael Mihok v. Medtronic, Inc

Michael Mihok
v.
Medtronic, Inc

No. FSTCV146023001S

Superior Court of Connecticut, Judicial District of Stamford-Norwalk, Stamford

October 20, 2016

October 20, 2016, Filed

UNPUBLISHED OPINION

MEMORANDUM OF DECISION re MOTIONS TO STRIKE (#157.00 AND #163.00)

Kenneth B. Povodator, J.

Procedural Background

This proceeding is generally a product liability lawsuit, but as a result of the medical nature of the product, the ability to maintain the action at all is at the forefront of issues needing resolution. The plaintiff, as executrix of the injured party and in her own right claiming loss of consortium, has asserted six causes of action against the Medtronic defendants^[1] and three additional (if related) claims directed to Greenwich Hospital.

Plaintiff alleges that her late husband, Michael Mihok, was injured in 2012 by a failure of his InDura 1P Model 8709 Intrathecal Catheter, a Class III prescription medical device that is part of and used in conjunction with the SynchroMed® II Programmable Drug Infusion System (the " SynchroMed® II Infusion System"). The SynchroMed® II Infusion System is a Class III medical device that treats certain medical conditions by delivering medication (in this case, baclofen) via an implanted pump and catheter directly to the " intrathecal" area where fluid flows around the spinal cord.

The plaintiff does not appear to dispute--and seemingly agrees--that the Food and Drug Administration (" FDA") approved the SynchroMed® II Infusion System--including Mr. Mihok's Model 8709 catheter--under its Premarket Approval (" PMA") process, a rigorous standard for medical devices. Under the relevant statutes as interpreted by the U.S. Supreme Court, there is both express and implied preemption of most product liability claims that might otherwise arise under state law--there is a narrow scope of parallel claims that can be asserted without running afoul of the explicit statutory preemption and the related implied preemption.

The Medtronic defendants have moved to strike all of the claims directed to them, and defendant Greenwich Hospital also has filed a motion to strike all of the claims directed to it. In the Medtronic motion (which will be the framework for almost all of the discussion that follows), the defendant^[2] contends that the plaintiff's product liability claims against Medtronic are legally insufficient--barred--and therefore should be stricken because they are expressly preempted under 21 U.S.C. § 360k(a) (to the extent they are based on state law) and impliedly preempted under 21 U.S.C. § 337(a) (to the extent they are attempting to enforce federal law regarding the device). Medtronic also contends that the plaintiff has failed to state a sufficient claim under CUTPA, and her loss-of-consortium claim must be stricken because it is merely derivative of her barred substantive claims. As noted in footnote 2, Greenwich Hospital generally adopts the same arguments in its motion to strike.^[3]

The plaintiff contends that she has asserted a legally-sufficient product liability claim that successfully navigates the narrow channel between the legal Scylla and Charybdis created by the U.S. Supreme Court's analysis of federal statutory preemption of product liability claims under state law with respect to regulated medical devices (express and implied preemption), that her CUTPA claim is legally sufficient, and to the extent that her consortium claim depends on the viability of the product liability claim, that claim also should survive.

Further, the plaintiff raises procedural issues relating especially to the product liability claim. The court will address the procedural issues, after first reciting the factual background based on the allegations of the operative complaint (#154.00).

Factual Background

The defendant summarizes the factual history, as recited in the complaint, as follows:

" On December 11, 2006, Mr. Mihok underwent surgery to implant the SynchroMed® II Infusion System to control muscle spasticity caused by multiple sclerosis." (Compl ¶ 65-66.) " For several years, " the device worked " effectively, " " allowed Mr. Mihok to maintain his autonomy and independence, " and " improv[ed] Mr. Mihok's quality of life, both professionally and socially." (Id., ¶ 67.)

" On July 6, 2012, Mr. Mihok received a replacement SynchroMed® II pump due to the expected and impending expiration of the original pump's battery." (Id., ¶ 69.^[4]) The original catheter was disconnected from the expiring pump, which was explanted, and the new pump " was installed, tested and excellent initial flow of cerebrospinal fluid (CSF) was noted." (Id., ¶ 70.) The original catheter was re-sutured to the new pump and thereafter remained in Mr Mihok's body. (Id., ¶ ¶ 69-70.)

" Within two weeks of the replacement surgery, Mr. Mihok began experiencing drug withdrawal symptoms. (Id. ¶ 71.) On July 26, 2012, a pump study conducted at Stamford Hospital showed that the replacement pump was operating properly and exhibiting " good flow, " but " a large amount of fluid was noted in the cavity surrounding the pump." (Id. ) On September 7 2012, Mr. Mihok's doctor allegedly discovered that the original Model 8709 catheter implanted in December 2006 had fractured near the pump connection site. (Id., ¶ ¶ 69, 72.) To restore delivery of medication from the pump to Mr. Mihok's intrathecal space, his physician allegedly used a Model 8578 revision kit to attach a new, sutureless pump connector to Mr. Mihok's catheter. (Id., ¶ 73.) Following this catheter revision procedure, " regular administration of Baclofen was continued." (Id., ¶ 74.) Thus, the injuries alleged in this case stem solely from Mr. Mihok's Model 8709 catheter that was implanted in 2006, remained in Mr. Mihok's body when the pump was replaced in 2012, and was allegedly discovered to have fractured near the pump catheter port shortly thereafter. (Id., ¶ ¶ 14, 69, 72, 74.)"

The defendant goes on to assert that " [t]he Amended Complaint alleges no other problems with Mr. Mihok's pump or catheter."

Procedural Issues

As noted, the plaintiff directly raises some procedural issues, and others are implicated by the complaint itself.

The plaintiff's first procedural argument is that any issue of preemption cannot be raised at this time but can only be raised after a special defense is filed in which preemption is asserted. The court rejects the plaintiff's blanket contention that because preemption is a matter of defense that must be alleged by way of special defense, the issue cannot be raised by motion to strike. Identifying an issue that must be raised by special defense does not mean that it cannot be raised otherwise; it simply means that a defendant cannot rely upon a denial to raise the issue, and if not otherwise raised, it must be affirmatively asserted in a special defense; Practice Book § 10-50. Perhaps simplistically, the mere fact that it is a defense that must be alleged as a defense--later in the normal order of pleadings--does not preclude the issue being raised at an earlier stage of the proceedings.

There are a number of issues that properly are raised by special defense, but depending upon specific circumstances, can be raised by motion to strike. Thus, governmental immunity and the statute of limitations, when appropriate, can be raised and resolved via a motion to strike; see, e.g., Coe v. Board of Education, 301 Conn. 112, 116, n.4, 19 A.3d 640 (2011); Gordon v. Bridgeport Housing Authority, 208 Conn. 161, 171, 544 A.2d 1185 (1988). Similarly, other defenses often are raised by summary judgment, albeit on a different type of record, but without regard to whether a formal defense has been filed--there is no (current) requirement that a special defense be filed prior to assertion of a defense such as res judicata or collateral estoppel as a basis for summary judgment.

A less formalistic but practical approach to the " timing" of raising such issues, however, leads to a different and more substantial concern. Governmental immunity often, but not always, can be addressed by way of motion to strike, but that is dependent upon the nature of the allegations--it is more likely to be amenable to resolution by motion to strike if it involves an issue of existence or extent of duty. The same is true--and perhaps less often true--with respect to the statute of limitations, where the record must present a complete " timetable" to allow such a defense to be resolved on the pleadings, and indeed, some cases state that the plaintiff must effectively agree that the record is complete, before a statute of limitations " defense" can be resolved by way of motion to strike. Forbes v. Ballaro, 31 Conn.App. 235, 239-41, 624 A.2d 389 (1993). In other words, while the effectively absolute rule argued by the plaintiff does not exist, the ability to address defenses by way of motion to strike requires a more individualized and nuanced consideration of the nature of the defense and the completeness of the record (in a pleadings sense) for that purpose.

In the present case, the plaintiff has not conceded that the record is complete for purposes of this motion, and has contended that more extensive discovery is necessary in order to fully analyze the preemption claims asserted by the defendants. (The court notes that a number of cases cited by the defendant in its brief, including Mullin v. Guidant Corp., 114 Conn.App. 279, 287-90, 970 A.2d 733 (2009), were decided via summary judgment, i.e. on the basis of evidence actually presented to the court.) The court in this case initially deferred any action on the motions to strike until such time as some level of discovery was permitted, specifically for these purposes, but there is no suggestion that it was comprehensive, and the plaintiff contends that full discovery should be allowed prior to considering...