Talbott v. CR Bard, Inc., Civ. A. No. 94-10394.

• Decision Date: 23 August 1994
• Docket Number: Civ. A. No. 94-10394.
• Citation: 865 F. Supp. 37
• Parties: Linda TALBOTT, et al., Plaintiffs, v. C.R. BARD, INC., David Prigmore and John Cvinar, Defendants.
• Court: U.S. District Court — District of Massachusetts

865 F. Supp. 37

Linda TALBOTT, et al., Plaintiffs, v. C.R. BARD, INC., David Prigmore and John Cvinar, Defendants.

Civ. A. No. 94-10394.

United States District Court, D. Massachusetts.

August 23, 1994.

COPYRIGHT MATERIAL OMITTED

Jeffrey A. Newman, James Ponsetto, Jeffrey S. Beeler, Newman, Heineman & Itzkowitz, Boston, MA, for Linda Talbott, Judith K. Gastel.

Jeffrey A. Newman, Jeffrey S. Beeler, Newman, Heineman & Itzkowitz, Boston, MA, for Helen M. Wilson.

Francis C. Lynch, Daryl J. Lapp, Maria A. Patrizio, Palmer & Dodge, Boston, MA, for C.R. Bard, Inc.

Robert D. Keefe, Michael F. Zullas, Hale & Dorr, Boston, MA, for David W. Prigmore.

William H. Kettlewell, Dwyer & Collora, Boston, MA, for John Cvinar.

MEMORANDUM AND ORDER

WOLF, District Judge.

Eunice Beavers died after a heart catheter which was being used in a procedure intended to enhance her health and extend her life malfunctioned and allegedly caused her death. In a criminal case before this court, the manufacturer of the heart catheter, C.R. Bard, Inc. ("Bard"), pled guilty to charges that it conspired to defraud the United States Food and Drug Administration ("FDA") concerning a number of its various types of heart catheters, and to many claims of filing false statements with the FDA and shipping adulterated heart catheters. After accepting a binding plea agreement between Bard and the United States government, the court imposed on Bard criminal and civil fines totaling $61 million, and other penalties. See United States v. C.R. Bard, Inc., 848 F.Supp. 287 (D.Mass.1994). In addition, six employees of Bard are now being prosecuted criminally.

This civil case, alleging wrongful death and other causes of action under state law, has been brought by Mrs. Beavers' heirs against Bard and two members of its management who are also defendants in the pending criminal case. Arguing that federal law preempts all of the state law claims in this case, the defendants moved to dismiss, pursuant to Fed.R.Civ.P. 12(b)(6), for failure to state a claim upon which relief can be granted. A hearing on the motion to dismiss was held on August 5, 1994.

For the reasons set forth below, the court finds that all of the plaintiffs' claims are preempted. More specifically, the court finds that the relevant statute, 21 U.S.C. § 360k(a), expressly preempts all causes of action concerning the Bard heart catheter at issue here because the device was subject to comprehensive regulation by the FDA; there is no private right of action to enforce the FDA's standards; and permitting litigation of any of plaintiffs' state law claims would present the statutorily prohibited risk that Bard would be subject to requirements different than, or in addition to, the FDA requirements.

As applied in this case, the express preemption provided by 21 U.S.C. § 360k(a) manifests a decision by Congress to replace completely the private rights of action usually available under state law with civil and criminal enforcement by the federal government when thoroughly regulated devices, such as Bard's heart catheter, are at issue. This judgment represents a permissible decision by Congress that the public interest will best be served by relying exclusively on the FDA to strike the proper balance between reasonably assuring safety and promoting innovation with regard to new devices that have the potential both to enhance and to injure human health.

This is a particularly poignant case in which the heirs of a woman who died during angioplasty are being found not to have the right to seek compensation for the damages they have undoubtedly suffered. The government has vigorously enforced the applicable criminal and civil laws. Nevertheless, this decision may cause some, including those who enacted the law, to question whether complete preemption of private rights of action is the most fair and effective means of balancing the legitimate, competing interests of promoting innovation and reasonably assuring the safety of complex medical devices. It is axiomatic, however, that the courts must faithfully give effect to the intentions of Congress when they are clearly expressed by statute, as they have been in this case. Defendants' motion to dismiss, therefore, must be granted.

I. The Facts.

In considering a motion to dismiss, a court must take all of the allegations set forth in the complaint as true and must draw every reasonable inference in favor of the plaintiff. Watterson v. Page, 987 F.2d 1, 3 (1st Cir.1993); Monahan v. Dorchester Counseling Center, Inc., 961 F.2d 987, 988 (1st Cir.1992). Plaintiffs' complaint, therefore, may not be dismissed for failure to state a claim "unless it appears beyond doubt that the plaintiffs can prove no set of facts in support of their claims which would entitle them to relief." Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 101-02, 2 L.Ed.2d 80 (1957).

For purposes of resolving this motion to dismiss, the following alleged facts are accepted as true. The statements of the applicable law in this section are not in dispute.

Defendant C.R. Bard, Inc. is a New Jersey corporation. Plaintiffs' Second Amended Complaint ("Second Am. Compl.") ¶ 3. Its USCI Division maintains offices and manufacturing facilities in Massachusetts. Id. Defendant David Prigmore, a citizen of Massachusetts, was the Group Executive Vice President in charge of Bard's USCI Division. Id. ¶ 1. Defendant John Cvinar, also a citizen of Massachusetts, was President of the USCI Division. Id. ¶ 2.

Eunice Beavers was a citizen of Missouri, where she died on December 28, 1988. Plaintiff Linda Talbott, a daughter of Mrs. Beavers, is the Administratrix of the Estate of Eunice Beavers and is a citizen of Missouri. Id. ¶ 4. Plaintiffs Judith K. Gastel and Helen Marie Wilson are also daughters of Eunice Beavers, and citizens of Missouri. Id. ¶¶ 5-6.

In 1980 Bard, through its USCI Division, began to distribute a Swiss heart catheter known as the Gruentzig dilation catheter. Id. ¶ 9. Under federal law, the manufacturer of a heart catheter must demonstrate to the FDA that there is reasonable assurance that its device is safe and effective for human use prior to its distribution. 21 U.S.C. §§ 360c(a)(1)(C); 360e. The distribution of any heart dilation catheter incorporating new designs, materials, or manufacturing changes that affect the safety or the effectiveness of the device requires FDA approval of a premarket approval supplement. 21 U.S.C. § 360e(f); 21 C.F.R. § 814.39. Clinical human testing of an unapproved medical device cannot be performed without FDA authorization granting an Investigational Device Exception ("IDE"). 21 U.S.C. § 360j(g). Federal law requires that manufacturers promptly notify the FDA of any deaths, serious injuries, or certain malfunctions experienced during, or as a result of, the use of heart catheters. 21 U.S.C. § 360i(a); 21 C.F.R. § 803.1(a)(2).

Plaintiffs allege from about 1987 through about 1990, certain individuals within both Bard and its USCI Division began willfully to ignore FDA notification and approval requirements established to ensure the safety and effectiveness of heart catheters by, among other things, failing to report that Mini Profile catheters were experiencing balloon deflation malfunctions while inside patients' coronary arteries. Second Am.Compl. ¶¶ 17-18. Plaintiffs further allege that the defendants, beginning in about 1987, distributed for experimental testing and full scale distribution redesigned versions of its heart catheters without the required FDA approval. Id. ¶ 19. Plaintiffs do not allege, however, that a redesigned catheter was used in the angioplasty procedure during which Mrs. Beavers died.

Plaintiffs allege that in about February 1988 Bard knew that its Mini Profile catheters, manufactured by its USCI Division, had a propensity to fail to deflate in patients' coronary arteries, and that this malfunction could result in death. Id. ¶¶ 24-25. On about March 8, 1988, Bard filed allegedly fraudulent, misleading and inaccurate documentation with the FDA seeking approval to distribute for human use the Mini Profile catheter. Id. ¶ 26.

The FDA approved distribution of the three lumen¹ Mini Profile catheter on May 24, 1988. Second Am.Compl., Ex. A, at 31, ¶ 70. From July 1988 through about November 1988, Bard received at least twenty-eight complaints from physicians and others that Mini Profile catheters were failing during use, but Bard did not notify the FDA or recall the product. Id. ¶¶ 28-30. Rather, allegedly in response to the deflation problem, Bard redesigned its heart catheters and sold them without FDA approval. Id. ¶ 31. The redesigned catheters had two, rather than three, tubes. Id., Ex. A, at 33, ¶ 77.

On December 28, 1988, Eunice Beavers underwent a percutaneous transluminal coronary angioplasty procedure with a Mini Profile catheter which failed to deflate, allegedly causing Mrs. Beavers' death. Id. ¶¶ 31-32. The catheter used was the FDA approved Bard three lumen Mini Profile. Id., Ex. A, at 34, ¶ 82.

On or about January 19, 1989, Bard filed a Medical Device Report notifying the FDA that Eunice Beavers had died while undergoing angioplasty with a Mini Profile catheter. Id. at 34. Plaintiffs allege Bard falsely and fraudulently stated in the Report that whether the incidence of faulty deflation was occurring with greater frequency or severity than described on the device's labelling was "unknown." Id.

On February 15, 1990, the FDA ordered a recall of the Mini Profile catheter. Id. ¶ 41.

At no time did the defendants notify Eunice Beavers' family or physicians of the Mini Profile's deflation problems. Id. ¶ 36. It was not until about November 1993, when survivors of Eunice Beavers were contacted by a newspaper reporter in connection with the criminal case against Bard, that Mrs. Beavers' family learned that the Mini Profile catheter was used in the procedure which resulted in her death, and was implicated in the...