Defective Medical Devices and the False Claims Act
By: Joel M. Androphyi
Federal and state laws require medical devices shipped and sold in the United States to be safe, effective, and reliable, and to perform as represented and to specifications. Medical device manufacturers are subject to mandatory and stringent controls over product design, manufacture, process changes, rework, specifications, specifications changes, and quality control.1
Federal manufacturing standards require manufacturers to follow “current good manufacturing practice.”2 Medical device manufacturers must, among other requirements, establish and maintain procedures to control the manufacture of a medical device to ensure that the finished device conforms to approved design.3 Similarly, rejected and/or reprocessed devices and components must be subject to reprocessing procedures that ensure that the device or component meet approved specifications.4 Changes to any specification must be subject to controls as stringent as those applied to the original device. Medical device manufacturers must control all manufacturing processes to ensure that the finished device conforms to all specifications.6
Manufacturers of medical devices are also required to prepare and implement satisfactory quality assurance programs, and to ensure that their finished products and components are safe and effective and perform as intended.7 Finished devices must be subject to inspection and testing procedures that assure that the device specifications are satisfied. Manufacturers must also maintain records that demonstrate that a device was manufactured in accordance with device specifications, productions specifications, and quality assurance procedures and specifications.9
To further ensure that medical devices are not adulterated, defective, unsafe, and/or ineffective, manufacturers and importers are required to maintain complete records and reports. Written and oral complaints concerning the failure, quality, performance, safety, or effectiveness of a device must be investigated, and records of the investigation, evaluation, conclusions, and follow-up must be maintained.10 Similarly, an investigation must also be conducted if a device or its components fail to meet performance specifications.11 A written record of the investigation, evaluation conclusions, and follow-up must also be made and maintained.12
Medical device manufacturers are also subject to mandatory reporting obligations to the FDA.13 Manufacturers must report to the FDA when they are aware of information that reasonably suggests that a medical device may have caused or contributed to a serious injury or death.14 They are also required to report device malfunctions to the FDA that could cause of contribute to a serious injury or death if they were to recur.15
Reportable events must also be investigated, and the cause of each event must be evaluated, documented, and reported.16 A “reportable event” is a death or serious injury, and for a manufacturer, includes events that result from device failure, malfunction, improper or inadequate design, manufacturer, labeling, or user error that may cause or contribute to a death or serious injury.17
Federal law requires that a device manufacturers take full responsibility for product recalls and assure that recalls are successful.18 FDA guidelines classify medical device recalls by the severity of the potential consequences. Class 1 recalls are required when a defective product could predictably cause serious health problems or death; Class II recalls are required when a product might cause a temporary health problem, or pose only a slight threat of a serious nature; and Class III recalls are required when the products are unlikely to cause adverse health reactions, but violate FDA regulations.
- See, e.g.: 21 C.F. R. § 820.1 et seq.
- See 21 C.F.R. § 820.30.
- See 21 C.F.R. § 820.30(i).
- See 21 C.F.R. § 820.70.
- See 21 C.F.R. § 820.5.
- See 21 C.F.R. § 820.75.
- See: 21 C.F.R. §§ 820.180 to 820.186.
- See 21 C.F.R. § 820.198.
- See: 21 C.F.R. §§ 803.1 et seq.
- See 21 C.F.R. § 803.50.
- See 21 C.F.R. § 821.1.
iAuthor of treatise, Federal False Claims Act and Qui Tam Litigation, Law Journal Press (2010), research source of the issues discussed in this article.
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