Griffin v. Medtronic, Inc.
| Decision Date | 11 January 1994 |
| Docket Number | Civ. No. S 93-60. |
| Citation | 840 F. Supp. 396 |
| Parties | Catherine W. GRIFFIN v. MEDTRONIC, INC. |
| Court | U.S. District Court — District of Maryland |
Jerome J. Seidenman, Kristen A. Brinster, Seidenman, Sutherland & Lynn, PA, Baltimore, MD, Carol A. Husum, Kalamazoo, MI, for plaintiff.
Benjamin R. Goertemiller, Howell, Gately, Whitney & Carter, Towson, MD, for defendant.
This is a products liability case, asserting numerous state-law based tort claims for injuries allegedly caused by defendant's implantable pulse generators and cardiac leads, commonly known together as "pacemakers." Both pacemakers allegedly failed after their sequential implantation in plaintiff, certain parts of the leads allegedly proved unremovable, and, it is also alleged, the consequences of these failed implantations have prevented plaintiff from properly employing her latest pacemaker to its fullest designed extent. The defendant now moves for summary judgment on the ground that plaintiff's claims are pre-empted by the so-called Medical Device Amendments of 1976 ("MDA") to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 et seq., particularly 21 U.S.C. § 360k. The plaintiff opposes summary judgment. No oral hearing is needed. Local Rule 105.6, D.Md.
This summary judgment motion presents only an issue of law, there being no facts material to the pre-emption question in dispute. Thus, defendant may prevail only in the event it demonstrates a clear entitlement to judgment in its favor as a matter of law. Fed.R.Civ.P. 56(c).
There is no question that the alleged injuries in this case are attributed to Class III Medical Devices, regulated under the MDA. Upon consideration, this Court has decided to follow the decisions of the First and Fifth Circuits, both of which have very recently addressed the question squarely presented in this case, viz., whether the MDA pre-empts state-law based causes of action in product liability cases involving regulated devices. Both circuits have said that such claims are pre-empted. See Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir.1993); King v. Collagen Corp., 983 F.2d 1130 (1st Cir.1993). It would serve no useful purpose for this Court to re-hash the thorough analyses of those Circuits here.
Plaintiff's attempts to distinguish these cases are unconvincing. Both cases took full account of the Supreme Court's latest pronouncements on federal pre-emption. Both squarely dealt with the cardinal issue in this case. Neither is inconsistent with prior case law in this Circuit or District, viz., Abbot v. The American Cyanamid Co., 844 F.2d 1108 (4th Cir.1988), and Callan v. G.D. Searle & Co., 709 F.Supp. 662 (D.Md.1989), in that those cases did not involve devices, but, rather, drugs. Both of those cases were decided before the Supreme Court's decision in the seminal case of Cipollone v. Liggett Group, Inc., ___ U.S. ___, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992), which especially calls into question the continued reliability of the discussion in Callan concerning § 360k.
Finally, plaintiff argues that, even if pre-emption were to be found by the Court, it should not extend to her fraud claim. To the extent that her claim mirrors the one discussed in King, 983 F.2d at 1139-40, this Court rejects it, for the same reasons as did the King court. To the extent that plaintiff makes the claim that defendant's fraud on the medical community, including prescribing doctors, entitles her to proceed, and ultimately to relief, she is barred by Maryland's requirement that fraudulent misrepresentations must be made to the plaintiff who is claiming injury from her reliance on those representations, not to...
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Ministry of Health v. Shiley
...LEXIS 3980 (E.D.Pa. February 25, 1994) (preempting claims where patient had heart valve removed to avoid fracture); Griffin v. Medtronic, Inc., 840 F.Supp. 396 (D.Md.1994) (involving pacemaker manufacturer); Reiter v. Zimmer, Inc., 830 F.Supp. 199 (S.D.N.Y.1993) (preempting strict liability......
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Fogal v. Steinfeld
...pacemaker lead, which also had not been subjected to any sort of FDA approval. Medtronic also relies on Mendes (supra); Griffin v. Medtronic, Inc., 840 F.Supp. 396 [U.S.Dist., D.Md., Jan. 11, 1994, Smalkin, J.], and Bollier v. Medtronic, Inc., 1993 WL 734843 [U.S.Dist., S.D.Tex., Oct. 27, 1......
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Talbott v. CR Bard, Inc., Civ. A. No. 94-10394.
...King. This court, however, agrees with the other district courts which have found their analysis to be correct. See Griffin v. Medtronic, 840 F.Supp. 396, 397 (D.Md.1994); Kemp v. Pfizer, 835 F.Supp. 1015, 1021-22 (E.D.Mich.1993); Michael, 1994 WL 59349, *9-10. 6 It is the distinction betwe......
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Duvall v. Bristol-Myers-Squibb Co.
...action to federal court on the basis of diversity of citizenship. The district court, noting its recent decision in Griffin v. Medtronic, Inc., 840 F.Supp. 396 (D.Md.1994) (holding that the MDA preempted state-law claims involving a medical device marketed after premarket approval), appeal ......
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Preemption of State Tort Claims Under the Medical Device Amendments
...at 1136 (fraud/misrepresentation claims preempted to the extent based on a failure to warn theory); see also Griffin v. Medtronic, Inc., 840 F.Supp. 396 (D.Md. 1994). 72. Michael, supra, note 21 (FDA imposed no requirements with respect to advertising/promotion of heart valve); Ministry of ......