GOVERNMENT & LEGAL AFFAIRS
Throughout the healthcare community, the reuse of medical products designated by original equipment manufacturers as single-use devices (SUDs) remains a controversial topic. In the reprocessing practice, such SUDs are refurbished, resterilized, or reprocessed for additional use. The FDA list of products that are currently reprocessed and reused includes such devices as cardiac catheters, angioplasty balloon catheters, arthroscopic knee surgery blades, syringes, endotracheal tubes, trocars, drill bits, biopsy needles, and keratome blades.1
Promoters of this practice, including the reprocessing industry and hospitals, contend that patient safety is their first priority, and that such safety is ensured by the fact that reprocessed SUDs are more heavily regulated than most devices for patient care and treatment. Moreover, they argue that reusing SUDs provides significant cost savings to healthcare providersparticularly hospitals. And they also cite as a benefit the protection of the environment that results from reducing medical waste.
On the other hand, manufacturers take the position that reusing SUDsparticularly those that pierce human skin or enter the bloodstreamposes enormous risks to patients, including infection and other injuries. These critics argue that the perceived increase in patient risk from improperly reprocessed SUDs overrides all of the potential benefits of SUD reuse, and they support the general notion that devices labeled for single use are meant for just that--one use. In recent years, patient advocacy groups have joined the manufacturing community in supporting these positions.
The debate over SUD reuse has generally focused on patient safety and cost savings. Meanwhile, little consideration has been given to the legal ramifications of this practice, and particularly to the liability exposure of those entities in the chain of manufacturing, reprocessing, and end-user utilization. This article examines the regulatory background of SUD reuse, the potential liability of manufacturers with regard to this practice, claims that may be asserted by a patient injured by a reprocessed SUD, and the defenses available to manufacturers.
FDA's authority to regulate medical devices extends over several thousand products ranging from adhesive bandages, tongue depressors, and urinary catheters to complex implantable defibrillators and cardiac stents. The agency classifies all such products into one of three classes according to their degree of risk. Class I encompasses those devices with the lowest category of risk, Class II those of intermediate risk, and Class III those of highest risk.2
FDA's authority also extends to the regulation of reprocessed devices, a category of products that emerged in the 1970sat virtually the same time that the medical device industry first became regulated. Until well into the 1990s, however, FDA's exercise of its authority over reprocessed devices remained minimal. The agency merely required that entities reprocessing SUDs be able to confirm that the devices could be safely cleaned and sterilized, that their technical features would remain intact, and that they could be used safely and effectively after reprocessing.3
This relatively hands-off approach was conducive to the emergence of a reprocessing industry, and was naturally supported by those who believed that reprocessing successfully produced safe and effective devices while enhancing the bottom line. With the goal of reducing spiraling healthcare costs, hospitals and later third-party contractors began reprocessing a wide variety of medical devices.
Manufacturers criticized the increased adoption of reprocessing, pointing to growing concern about the safety and efficacy of reprocessed SUDs. In spite of questions about the motives of manufacturers, FDA eventually heard the appeal for greater regulation of reprocessed devices and determined to take action.
Increased Regulation. In November 1999, FDA proposed a series of steps toward updating its policy regarding SUD reprocessing.4 These steps included four major activities.
- Developing a list of commonly reprocessed SUDs.
- Developing a list of factors to determine the degree of risk associated with reprocessing devices.
- Using the factors to categorize reprocessed devices into three categories of risk (high, moderate, and low).
- Developing priorities for the enforcement of premarket submission requirements for hospital and third-party reprocessors based on the risk category to which the reprocessed device was assigned.
At the beginning of 2000, following a public comment period, FDA published two companion draft guidances titled Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme and Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.5, 6
In response to the publication of these two draft guidances, FDA received a number of written comments.7 Although the comments expressed strong support for the agency's decision to actively regulate hospital and third-party reprocessors, they also raised concern about the burden that would be placed on hospitals. Commenters observed that the new requirements would represent an extra financial burden on hospitals, and they questioned whether hospital personnel had the experience needed to comply with the proposed reprocessing and premarket submission requirements. Questions were also raised regarding the viability of the scheme proposed for assigning a reprocessed device to a particular risk category.
In June 2000, the United States General Accounting Office (GAO) reviewed the practice of reprocessing, focusing on the extent of the practice, associated health risks, cost savings, and the role of FDA in SUD reprocessing oversight.7 The GAO found that "the evidence suggests that some SUDs can be safely reprocessed if appropriate cleaning, testing, and sterilization procedures are carefully followed," and that "SUD reprocessing [was] seen as safe by many associations representing healthcare professionals." Many healthcare professionals told the GAO that they believed an important reason "manufacturers market devices with a single-use label (is) because of the economic benefits of doing so" and not because the devices were incapable of being reprocessed and reused.
Regarding the economic impact, the GAO reported that "substantial cost savings can be achieved by reprocessing SUDs." This was evidenced by the fact that "independent reprocessing firms charge hospitals approximately one-half the price of a new device for a reprocessed device, while the in-house cost of reprocessing some devices can be less than 10% of the price of a new device." In practical terms, this could mean a savings of between "$200,000 to $1,000,000" annually for hospitals, for example, "with active cardiology services . . . reusing electrophysiology catheters."
In August 2000, FDA increased its ovesight of reprocessed SUDs.6 Essentially, all the regulatory requirements that were then applicable to manufacturers, including premarket submission requirements, became applicable to reprocessors. For example, FDA dropped its proposal for classification of reprocessed SUDs as a result of concern about subjective differences in interpreting the criteria. Instead, the agency decided to use the device classification scheme already in use for all medical devices. A phased-in implementation was also proposed in order to provide hospitals and third-party reprocessors with time to learn the new requirements and develop the programs necessary for compliance.
MDUFMA and Beyond. In passing the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Congress mandated additional requirements for SUD reprocessors.8 This legislation attempted to address concerns that had previously been raised regarding reprocessed SUDs. Before marketing their devices, for example, manufacturers of most medical products are required to submit a premarket notification (510(k)) and obtain FDA clearance. However, certain devices are exempt from this requirement. MDUFMA required that reprocessors provide 510(k) premarket review and validation data even if the devices in question had previously been 510(k)-exempt.
Manufacturers of other 510(k) devices were required to provide cleaning, sterilization, and functional performance data to demonstrate that the SUD in question would remain substantially equivalent after reprocessing. The goal was to ensure that users would be confident that a reprocessed SUD would have the same characteristics as the original, and that reprocessing would provide the necessary sterility.
The goal of greater vigilance with regard to the risk of infection and inadequate performance also prompted changes in the postmarket monitoring of device-related adverse events. MDUFMA required FDA to modify the MedWatch mandatory and voluntary reporting forms to facilitate reporting when an adverse event involved a reprocessed SUD. Compulsory reports to FDA, the manufacturer, and the reprocessor are required from healthcare facilities in cases of death or serious injury if a reprocessed device is involved. Once such a report is received, FDA is to initiate an investigation and undertake the necessary follow-up actions such as the issuance of a public health notification.
According to Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health (CDRH), from October 22, 2003, through December 13, 2005, the FDA database recorded 176 reports of death, serious injury, or device malfunction involving reprocessed SUDs.9 However, FDA's analysis of these reports failed to demonstrate "a clear causative link between a reprocessed SUD and subsequent patient injury or death."
As of August 1, 2006, reprocessed SUDs are required to prominently and conspicuously bear the name, abbreviation, or symbol of the reprocessor on the device itself. In September 2006, CDRH's Schultz concluded his statement to the House of Representatives Committee on Government Reform by stating that "FDA believes that reprocessed SUDs that meet FDA's regulatory requirements are as safe and effective as a new device."
Although no cases have been reported in which a patient has brought suit alleging injury from a reprocessed SUD, it is only a matter of time before such a suit is instituted. Such a suit is an unavoidable consequence even for the most diligent manufacturer, even one that has an aggressive risk management program in place.
When such a case arises, a plaintiff allegedly injured by a defective medical device will typically sue all entities involved, particularly those with the deepest pockets, seeking potential recovery from as many sources as possible. It can be expected that a plaintiff alleging to have been injured from a reprocessed SUDsomeone, for example, who developed an infection after a physician used such a device during a surgical procedurewill sue the physician, the hospital where the surgery was performed, the reprocessor (which in some instances could be the hospital), and the SUD manufacturer. It is unlikely that the manufacturer will be the sole entity sued.
Virtually similar claims will be asserted against all defendants, and additional claims for medical malpractice and lack of informed consent (i.e., for not informing the patient that the device was one which was reprocessed) will be brought against the physician or healthcare provider and, in some cases, the hospital. The availability of claims and the precise elements that a plaintiff needs to prove vary significantly by state, and this general discussion of claims is not intended to imply that all causes of actions may be available to all plaintiffs.
In the event a manufacturer is sued, the company's counsel should carefully examine the laws of the applicable jurisdiction. The claims expected to be seen are as follows.
Negligence. Negligence claims could be based on a host of alleged breaches of duty to the consumer by the manufacturer. However, it can be expected that the claims will be very similar to those that serve as the basis for the strict liability claimfailure to warn, manufacturing defect, or design defect. In some states, negligence and strict liability claims against product manufacturers are identical. Negligent testing and inspection of the product before placing it on the market could also reasonably be asserted. While manufacturing and design defect claims are premised as such, failure to warn claims require evidence that adequate instructions for use and warnings as to the dangers of the product were not provided.
Strict Liability. Strict liability claims, based in many instances on the Restatement of Torts (a legal treatise discussing tort law, including product liability), generally require the injured plaintiff to prove the product was in a defective condition and unreasonably dangerous for its intended use, that the defect existed when it left the particular defendant's control, and that the defect was the cause of the injury. In some jurisdictions, every entity in the chain of distribution (manufacturer, component part manufacturer, distributor, and so on) may be held strictly liable for the defective product.
Breach of Warranty. Claims for breach of express and implied warranties emanate in many states from the Uniform Commercial Code (uniform act governing commercial practices and transactions). A manufacturer creates an express warranty when it represents its product's qualities to induce purchase, and is in breach when the product does not conform as warranted. Implied warranties are breached when the product was not "fit for the ordinary purposes for which such goods are used." Plaintiffs asserting this claim will argue that the SUD was not of merchantable quality after, for example, an SUD breaks due to the stress of multiple uses and cleanings.
Unfair Trade Practices. Increasingly, injured plaintiffs are seeking recovery for alleged violations of state consumer protection and unfair trade practice statutes. These statutes generally prohibit unfair methods of competition and unfair or deceptive trade practices, and a successful plaintiff may be permitted to recover attorneys' fees and costs, and double or treble damages.
Fraud. Fraud claims, or those based on misrepresentation, will contend that the defendant falsely and fraudulently acted with intent to deceive, misrepresent, and conceal. Specifically, that the manufacturer concealed the fact that the SUD had previously been used and reprocessed, and did not make the patient aware of its previous use.
Availability of Defenses
When the inevitable lawsuit arises, it will likely result from the use during a surgical procedure of an SUD that has not been properly or thoroughly resterilized and transmits infection to the patient, or an SUD that, after being reprocessed numerous times, becomes fragile and breaks during a procedure, causing patient injury. These scenarios may result through no fault of the manufacturer, which needs to advance as many defenses as practicable.
In addition to the generally asserted defenses (for example, statute of limitations), the manufacturer has available some other sound defenses to protect itself from liability. However, as a cautionary note, not all states recognize each of these defenses, in whole or in part.
Learned Intermediary Doctrine. This doctrine provides generally that a prescription drug or medical device manufacturer that adequately warns and instructs the physician--the learned intermediary--about the risks of the product may have satisfied its duty to warn, and will not be liable to the injured patient. For the manufacturer that can effectively argue that the physician was fully informed of the risks and benefits of using the device on a single patient only, this might be a summary judgment winning defense.
Spoliation of Evidence. Manufacturers may be completely absolved of liability when the reprocessed SUD has been disposed of or is otherwise unavailable for testing and inspection. Some states take the drastic remedy of dismissing the case against a defendant when the alleged defective product has not been preserved and the defendant, as a result, is unable to test it or conduct an inspection to prepare a defense. As a first order of business, any manufacturer sued or on notice that a suit is likely, should have counsel issue a preservation order so that the party in possession of the device maintains it for the litigation.
Subsequent Product Modification or Alteration. Manufacturers may escape liability for negligence or strict liability claims if they can successfully argue that the SUD was modified or altered after it left the manufacturer's possession and control, and that the modification was the cause of the plaintiff's injury. Since this defense has not been tested in the context of reprocessing, it remains questionable whether the reprocessing itself could arguably be deemed a subsequent modification or alteration.
Preemption. Preemption is a legal concept that provides that federal laws and regulations take precedence over state laws and regulations in the same area. Because of the difficulty involved in determining the scope of potentially conflicting federal and state laws, courts have historically differed on the application of the preemption principle. Congress included in the medical device amendments to the Federal Food, Drug, and Cosmetic Act the requirement that a state may not impose "any requirement" that is "different from, or in addition to, any requirement, applicable . . . to the device" under federal law.10
In 1996, in Medtronic v. Lohr, the Supreme Court ruled that there was no preemption of certain state-law tort suits where the device at issue had been cleared by FDA under the 510(k) process.11 The case arose from the implantation of a Medtronic pacemaker that subsequently failed, allegedly causing injury to the plaintiff. The plaintiff's physician contended that a defect in the pacemaker lead was the likely cause of the failure. An action was brought in state court alleging negligence and strict liability. The case made its way to the Supreme Court, which had to decide whether a federal statute, the Medical Device Amendments of 1976, preempted a state common law negligence action against the manufacturer of this allegedly defective medical device.
The Supreme Court's ruling permitted the plaintiffs to proceed with their claims. The impact of this decision is that, at least in the case of certain state court claims, a manufacturer may not avail itself of the preemption defense for devices cleared pursuant to the 510(k) process. For example, it would appear that if the legal claim involves the manufacturing process approved by FDA, then it is likely to be preempted. If, however, the claim is that the manufacturer acted in a negligent manner in the manufacturing process (i.e., there was a manufacturing defect), preemption is not likely to be a defense.
Another process by which a manufacturer obtains market clearance is FDA's premarket approval (PMA) process, which involves scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. It remains unclear whether manufacturers of PMA-approved devices have a viable preemption defense, because the Supreme Court has not yet had the opportunity to consider the issue. Based on language in the Medtronic v. Lohr ruling, some courts have held that there is preemption for some state claims.
Whether the original manufacturer of a reprocessed SUD has a viable preemption defense in state court actions may depend upon whether the SUD was originally a PMA-approved device or a device cleared pursuant to a 510(k) application. Until the Supreme Court considers the issue, jurisdictions will differ regarding the availability of the preemption defense for PMA-approved devices.
Implications of Device Recalls, Withdrawals, and Discontinuances. In the normal course of business, circumstances may arise leading to an FDA recall of an SUD, or a decision by the manufacturer to voluntarily discontinue or withdraw the device from the market. Since reprocessors are required to comply with FDA regulations, a manufacturer would expect that the reprocessor would keep itself abreast of when a particular device is removed from the market. However, that may not always be the case. To minimize liability from reuse of an SUD after the date of a recall, withdrawal, or discontinuance, the manufacturer should send a notice similar to a 'Dear Doctor' letter to any entity it knows to be reprocessing the particular device.
Shifting Liability. Manufacturers should consider other parties in the chain of distribution from whom it would be appropriate to seek contribution (partial reimbursement) or indemnity (full reimbursement). Good business practices may discourage a manufacturer from attempts to shift liability to their customersthe hospitals and physicians who purchase their SUDsas an unwise business decision; nevertheless, that is certainly a position that should be fully evaluated. Additionally, members of one reprocessors' trade organization maintain minimum amounts of insurance coverage in the multi-million-dollar range, and that insurance may provide coverage for the manufacturer.
To the benefit of medical device manufacturers (and perhaps as a result of strong lobbying efforts), and despite FDA's recent assurances that reprocessing is a safe practice, some states are aggressively pursuing legislation that absolves manufacturers of liability when a reprocessed SUD is used. And some states are even imposing statutory obligations upon physicians to inform patients that the device to be used during a procedure had been used on another patient and was reprocessed.
In Utah, the potential liability of a manufacturer for the effects of reprocessing critical single-use medical devices, defined as those intended to directly contact normally sterile tissue . . . or physically connected to a device to make such contact, and for the "safety and effectiveness of the reconditioned or reprocessed critical single-use medical device" is shifted to the reprocessor.12
In Illinois, after its general assembly concluded that the reuse of SUDs was "linked to cases of patient infection, chemical injury, and mechanical failure," the state enacted a statute permitting only those entities that are registered with and regulated by FDA, or a state licensed hospital, to reprocess.13
Bills are also pending in Virginia and Massachusetts, proposing that a reprocessed SUD may not be used without the patient's written consent. In Virginia, in addition to providing that a reprocessed SUD may not be used by a healthcare provider on any patient without that patient's written consent, there would be a ban on the use of reprocessed single-use needles or syringes. The Virginia bill further provides that the SUD reprocessor or reconditioner "shall be liable for the safety and effectiveness of a reprocessed single-use device," and the healthcare provider may also be liable if he or she fails to obtain the required informed consent. Most importantly, Virginia law would absolve the manufacturer from liability for the "use, safety, or effectiveness" of a reprocessed SUD unless it specifically and expressly consented to the use of that reprocessed device.14
In Massachusetts, although the law would require the healthcare provider to obtain a patient's written consent for use of a reprocessed SUD, the pending bill does not propose to shift liability to the SUD reprocessor.15 However, both Massachusetts and Virginia propose that failure of the reprocessor or healthcare provider to comply with the bills' requirements is "prima facie evidence that the reprocessing of the device alone has rendered" the reprocessed SUD "unreasonably dangerous and unfit for its intended use." Also, in both states' proposed legislation, remedies available under the respective statutes are not exclusive of other remedies, which may be pursued against the reprocessor or healthcare providers.
In New Jersey, a patient advocacy group is pushing for legislation banning the use of reprocessed SUDs altogether. It will not be long before other states follow suit in enacting legislation that shifts liability away from the manufacturer, requires physicians to obtain written patient consent that a reprocessed device is going to be used, or bans their use altogether.
Although legal research has revealed no reported lawsuits in this area, it is only a matter of time before the plaintiffs' bar moves forward. Shortly after last year's Washington Post series exposing the dangers of reprocessing, some plaintiffs' firms posted the articles on their Web sites. Efforts by patient advocacy groups, strong lobbying by manufacturers, and additional negative publicity for the reprocessing industry are bound to lead to litigation.
No one is too remote to be sued. All entities in the stream of commerce could be targeted and are potentially liable. Given the adverse publicity exposing the potential dangers of the practice of reprocessing SUDs and the pending legislative activity on the informed consent issues, FDAeven though it has found this practice to be safe and effectivemay become more aggressive in regulating the reprocessing industry to the benefit of the manufacturers. While a few states have shielded manufacturers from liability for reprocessed SUDs, this does not necessarily protect them from all causes of action.
In addition to the recommendations already addressed, manufacturers should undertake early risk-management efforts, including regulatory compliance plans and heightened awareness of areas of vulnerability. By monitoring MedWatch reports that involve reprocessed SUDs, for example, manufacturers can take a first step toward recognizing and minimizing their potential liability.
1. "List of Single-Use Devices Known to Be Reprocessed or Considered for Reprocessing (Attachment 1)," in
CDRH Home Page [online] (Rockville, MD: FDA, Center for Devices and Radiological Health, 2005 [cited 22
March 2007]); available from Internet: www.fda.gov/cdrh/reuse/fr-attachment1.html.
2. "Reuse of Single-Use Devices," in CDRH Home Page [online] (Rockville, MD: FDA, Center for Devices and
Radiological Health, 2006 [cited 22 March 2007]); available from Internet: www.fda.gov/cdrh/reuse.
3. JM Wood and GF Heyman, "Reuser Friendly: A Review of the Regulation of and the Product Liability
Regarding the Reuse of Single-Use Medical Devices," Tort and Insurance Law Journal 37 (2001): 41-78.
4. "FDA's Proposed Strategy on Reuse of Single-Use Devices," Federal Register, 64 FR: 59782-59783 (November 3, 1999).
5. Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme, Guidance for Industry and FDA Reviewers (Rockville, MD: FDA, Center for Devices and Radiological Health, 2000 [cited 22 March 2007]); available from Internet: www.fda.gov/cdrh/reuse/1156.pdf.
6. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Guidance for Industry and for FDA Staff (Rockville, MD: FDA, Center for Devices and Radiological Health, 2000 [cited 22 March 2007]); available from Internet: www.fda.gov/cdrh/reuse/1168.html.
7. Single-Use Medical Devices: Little Available Evidence of Harm from Reuse, but Oversight Warranted (Washington, DC: United States General Accounting Office, 2000 [cited 22 March 2007]) available from Internet: www.gao.gov/new.items/he00123.pdf.
8. Medical Device User Fee and Modernization Act of 2002, P.L. 107-250, (October 26, 2002).
9. "Statement of Daniel Schultz, MD, Director CDRH, before the Committee on Government Reform, September 26, 2006" in CDRH Home Page [online] (Washington, DC: FDA, Center for Devices and Radiological Health, 2006 [cited 22 March 2007]); available from Internet: www.fda.gov/cdrh/Reuse/testimony-092606.html.
10. 21 USC 360k(a).
11. Medtronic v. Lohr, 518 U.S. 470 (1996).
12. Liability of Reprocessor of Single-Use Medical Devices, UCA 78-11-28, enacted 2005 General Session, eff. 5/2/05.
13. Single-Use Surgical Devices, 410 ILCS 620/16 5, eff. 1 January, 1998.
14. Re-use of certain medical devices manufactured from a single use; civil penalty, Virginia House Bill No. 768, to amend Code of Virginia by adding Sections 32.1-135.3 and 54.1-2403.00 (2006), continued to 2007 in Health, Welfare and Institutions.
15. An Act Relative to a Patient's Right to Know of the Re-Use of Certain Medical Devices Manufactured for a Single Use, Senate Bill No. 1321, (26 January, 2005) newly drafted as An Act Relative to a Patient's Right to Know of the Re-Use of Certain Medical Devices Manufactured for a Single Use, Senate Bill No. 2433 (21 March, 2006).
Caryn M. Silverman is a partner and Bernard H. Maister is a special counsel in the law firm of Sedgwick, Detert, Moran & Arnold LLP (New York City).