Status of Medical Device Reprocessor/Refurbisher Liability

Courtney S. Young, Esq. |Senior Attorney, Medmarc Risk Management

Status of Reprocessor Liability

The recent pressures to drive down the cost of medical care have given way to a practice of using medical devices (even so-called “single-use devices”) a greater number of times, on a greater number of patients, before disposing of them. To accomplish this, hospitals are increasingly using reprocessors to sterilize and re-validate their devices between uses. Although device reprocessing is nothing new, the increase in demand has largely altered the general practice from one in which hospitals sent its devices to a reprocessor and got those exact units back after reprocessing, to one in which the reprocessor provides the hospital with the same model of devices that the hospital submitted but not necessarily the same specific units submitted. This allows for a faster turn-around time.  In this process, the reprocessor may often re-serialize the devices and alter the labels, warnings, or instructions for use, hopefully to account for any additional precautions medical personnel must need to take in light of the manner of reprocessing.

FDA Regulation

Medical device refurbishing is an interesting area right now as it has recently become a focus for FDA and a potential subject of new regulation. Last Spring, the FDA sought industry feedback on proposed definitions including repair, refurbish, remanufacture, recondition, and remarket. At the same time, the Agency also solicited answers to questions about the risks and failure modes introduced as a result of performing these activities on medical devices, and whether the risks were different depending on who performs the activities (hospitals, OEMs, third parties). Thus far, though over 200 comments were submitted in response to these questions, there has not been any further movement from the FDA in this area. Many have speculated that when the Agency does take action, it will likely be to bring refurbishers under the same oversight scheme as reprocessors of single-use devices.

Kapps v. Biosense Webster, Inc.

Although the presence of reprocessors in the chain of distribution presumably has products liability implications for the original-equipment manufacturers (OEMs), few cases have addressed the issue of strict products liability for manufacturers when a device malfunctions after it has been reprocessed or refurbished. The most recent case that really explored this issue was Kapps v. Biosence Webster, 813 F.Supp.2d 1128 (D.Minn. 2011), a case that came out of the Federal District Court of Minnesota in 2011. Though several years old now, the Court’s analysis provides some valuable insights into distinctions that may be important in deciphering products liability apportionment between OEMs and reprocessors. It’s easy to extrapolate that similar reasoning would apply to refurbishers.

In Kapps, the plaintiff was an atrial fibrillation patient that underwent a procedure in which doctors used a “lasso catheter” that had been reprocessed.  During the surgery, the lasso portion of the catheter separated and remained entangled in the plaintiff’s mitral valve. It was eventually able to be removed by the doctors, but the damage that was sustained to the plaintiff’s mitral valve in the process necessitated additional open-heart surgery and replacement of his damaged valve with a prosthesis.

The plaintiff brought the usual products liability claims—manufacturing defect, warning defect, design defect, breach of warranty, and negligence—against both the OEM and the reprocessor.

The Court held:

  1. Plaintiff cannot rely on res ipsa loquitor to establish the OEM’s liability for manufacturing defects.

Res ipsa loquitur is a doctrine used in negligence and products liability actions when the plaintiff has incurred some harm, but obvious difficulties may make too difficult for the plaintiff to prove the exact origin of the cause of harm. In order to utilize res ipsa, plaintiffs (generally) must first establish both that (1) the accident—here, the defect in the product—is the kind that would usually be caused by negligence; and (2) that the defendant had exclusive control over the instrumentality that caused the accident—here, the manufacture and composition of the device.  In disallowing the plaintiff to rely on res ipsa against the OEM, the Court relied on the fact that at the time of injury, the reprocessed device could not be said to have been in the same condition it was when it left the OEM’s control. In effect, the second prong was not satisfied as the OEM did not have exclusive control over the condition of the catheter once the reprocessor was used.

  1. Claims against the reprocessor are viable under theory of res ipsa loquitor.

In contrast, because the reprocessor did have exclusive control over the condition of the catheter as it was at the time of the injury, the Court held that res ipsa loquitur could be applied to the negligence claim against the reprocessor.

  1. An OEM that markets its device as single use will be immunized against the claim that it nonetheless should have foreseen and warned that a reprocessor might ignore the single-use instructions.

In Kapps, the OEM of the catheter has specifically labeled the device, and included in its instructions for use, that it was intended for single use only. Nonetheless, the plaintiff claimed that the OEM should have foreseen that the catheter would likely still be reprocessed despite such instructions, and warned accordingly of the dangers of reprocessing. The Court rejected this claim.

  1. Reprocessor carried a manufacturer’s duties to warn and to provide a defect-free product, because it acted (a) replaced the OEM’s instructions for use and product serial numbers with its own; (b) warranted the functionality of the reprocessed device; and (3) marketed the product as its own equivalent to the OEM’s.

The reprocessor responded to the warning-defect allegations of the plaintiff’s by asserting that the duty to warn should lie only with the OEM. The Court did not find this argument compelling, and instead held that the reprocessor in these circumstances indeed had the same duty to warn as an OEM has.

Kapps can provide helpful guidance for OEMs and reprocessors alike.  For OEMs, it may be reassuring that they may not be strictly liable for manufacturing defects after the their device has been reprocessed, but they must be careful to include warnings and instructions for reprocessing and its dangers if in fact their device is not designated for single use only. Reprocessors should be mindful of enlarging their own products liability when they mix, re-serialize, and alter the warnings and labels of an OEM’s devices.

State Statutes

In the years since Kapps, courts haven’t been asked to reconsider the issue of reprocessor/refurbishers liability hasn’t come before the courts again, so it’s the best indication we’ve got as to how courts are likely to treat reprocessor liability going forward. That said, several states aren’t waiting for the courts to decide, and some have enacted statutes specifically deeming reprocessors and refurbishers to have the same liability with respect to a defective device as original manufacturers. See, e.g., Utah’s statute, U.C.A. 1953 § 78B-4-505. Liability of reprocessor of single-use medical devices.

Conclusion

The safest course for reprocessors and refurbishers of medical devices is probably to assume that they may stand in the shoes of the OEM if something goes wrong with the device they process. In doing so, they should implement a quality management system and undertake the same robust risk management practices of which successful OEMs make use.

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