Question

Case Study: Medical Product Liability
What are the limits on medical product liability cases under federal law? FACTS: On May 10, 1996, the plaintiff underwent a percutaneous transluminal coronary angioplasty, intended to dilate his right coronary artery, which had been found to be “diffusely diseased” and “heavily calcified.” The physician used an Evergreen balloon catheter, which is specifically contraindicated for patients who have “diffuse or calcified stenosis.” During the procedure, the physician first attempted to remove the calcium deposits in the plaintiff’s artery with a Rotoblator device, and then unsuccessfully inserted several different balloon catheters. The physician ultimately inserted the Evergreen balloon catheter into the patient’s artery and inflated the device several times , up to a pressure of 10 atmospheres. The device label for the Evergreen balloon catheter specifies that it should not be inflated beyond the “rated burst pressure” of 8 atmospheres. On the final inflation, the balloon catheter burst, and the plaintiff began to rapidly deteriorate. He developed a complete heart block, lost consciousness, was intubated and placed on advanced life support, and was rushed to the operating room for emergency coronary bypass surgery. The plaintiff survived, but according to his complaint suffered “severe and permanent personal injuries and disabilities.” The patient filed suit against the manufacturer, alleging strict liability; breach of implied warranty; and negligent design, testing, inspection, distribution, labeling, marketing, sale , and manufacture.1 The Evergreen balloon catheter entered the market pursuant to the Food and Drug Administration’s (FDA) premarket approval process in the mid-1990s. The warning and contraindications for use of the catheter were clearly noted on the product information label.
Case Study Questions 1. What is the FDA premarket approval process? 2. How does the FDA’s premarket approval process affect lawsuits that allege injuries
caused by defective medical devices? 3. What does a plaintiff have to prove to win a case against the manufacturer of a
premarket-approved medical device?

Answer 1

QUESTION:

1. What is the FDA premarket approval process?

2. How does the FDA’s premarket approval process affect lawsuits that allege injuries
caused by defective medical devices?

3. What does a plaintiff have to prove to win a case against the manufacturer of a
premarket-approved medical device?

ANSWER:

1. What is the FDA premarket approval process?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

1. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

2. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices.

3. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval.

4. PMA is the most stringent type of device marketing application required by FDA.

5. The applicant must receive FDA approval of its PMA application prior to marketing the device.

6. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended uses.

7. The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.

8. The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval of Medical Devices. A Class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act and may not be marketed.

9. PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices.

10. Device product classifications can be found by searching the Product Classification Database. The database search provides the name of the device, classification, and a link to the Code of Federal Regulations (CFR), if any. The CFR provides the device type name, identification of the device, and classification information.

11. If it is unclear whether the unclassified device requires a PMA, use the three letter product code to search the Premarket Approval (PMA) database and the 510(k) Premarket Notification database. These databases can also be found by clicking on the hypertext links at the top of the product classification database web page. Enter only the three letter product code in the product code box. If there are 510(k)’s cleared by FDA and the new device is substantially equivalent to any of these cleared devices, then the applicant should submit a 510(k).

12. A new type of device may not be found in the product classification database. If the device is a high risk device (supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury) and has been found to be not substantially equivalent (NSE) to a Class I, II, or III [Class III requiring 510(k)] device, then the device must have an approved PMA before marketing .

13. Data Requirements:A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device.

14. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of PMA application. If a PMA application lacks elements listed in the administrative checklist, FDA will refuse to file a PMA application and will not proceed with the in-depth review of scientific and clinical data.

15. If a PMA application lacks valid clinical information and scientific analysis on sound scientific reasoning, it could impact FDA's review and approval.

16. PMA applications that are incomplete, inaccurate, inconsistent, omit critical information, and poorly organized have resulted in delays in approval or denial of those applications.

17. Manufacturers should perform a quality control audit of a PMA application before sending it to FDA to assure that it is scientifically sound and presented in a well-organized format.

18. Technical Sections: The technical sections containing data and information should allow FDA to determine whether to approve or disapprove the application. These sections are usually divided into non-clinical laboratory studies and clinical investigations.

2. How does the FDA’s premarket approval process affect lawsuits that allege injuries
caused by defective medical devices?

THE SENTINEL INITIATIVE

According to FDA, Sentinel aims to develop and implement a proactive system that will complement existing systems that the agency has in place to track reports of adverse eventslinked to the use of its regulated products.

POSTMARKETING SURVEILLANCE AND THE NATIONAL EVALUATION SYSTEM FOR HEALTH TECHNOLOGY (NEST)

Because the premarket review process cannot be designed to completely ensure the safety of all devices before they enter the market, it is essential to have a strong surveillance system that monitors the safety of medical devices. When a problem is identified with a particular medical device, various corrective actions can then be implemented. Corrective actions might include changing the device labelling and instructions for use, improving user training, continued study of the device problem via post market surveillance, or removal of the device from the market if appropriate.

SOURCES FOR DETECTING POTENTIAL PROBLEMS WITH MEDICAL DEVICES:

1. Medical Device Reporting (MDR). FDA annually receives several hundred thousand reports of confirmed or possible medical device related malfunctions, serious injuries, and deaths. Limitations of this passive surveillance system include incomplete, inaccurate, and/or delayed data reporting; underreporting of events; and lack of information on the total number of devices on the market in clinical use.

2. Medical Product Safety Network (MedSun). FDA receives about 5,000 higher quality reports each year on device use and adverse outcomes from a network of 280 U.S. hospitals. The network can be used for targeted surveys and clinical research and has specialty sub networks that focus on particular device types , laboratories , or patients

3. Post-Approval Studies. Such studies may be ordered by FDA as a condition of approval for a PMA device. These studies are typically used to assess device safety, effectiveness, and/or reliability including longer-term, real-world device performance.

4. Post market Surveillance Studies. FDA may order a manufacturer of a Class II or Class III device to conduct a 522 study (FFDCA Section 522) if failure of the device is reasonably likely to have serious adverse health consequences, if it is expected to have significant use in pediatric populations, or if it (1) is intended to be implanted for longer than one year or (2) has life-supporting or life-sustaining use outside a device user facility. Approaches used in 522 studies vary widely and may include nonclinical device testing, analysis of existing clinical databases, observational studies, and, rarely, randomized controlled trials.FDA Discretionary Studies. In addition to those mentioned above, FDA conducts its own research to monitor device performance, investigate adverse event signals and characterize device-associated benefits and risks to patient subpopulations. Sources of privacy-protected data for these studies include national registries, Medicare and Medicaid administrative and claims data, data from integrated health systems, electronic health records, and published scientific literature.

5. Other Tools. Identified in the appendix of the September 2012 FDA report.

ADVERSE EVENT REPORTING

The Safe Medical Devices Act of 1990 required FDA to establish a system for monitoring and tracking serious adverse events that resulted from the use or misuse of medical devices.193 Medical Device Reporting (MDR) is one mechanism that FDA uses to identify and monitor significant adverse events involving medical devices.

Device manufacturers are required to report to FDA (1) within 30 calendar days of acquiringinformation that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health issue.195 User facilities, such as hospitals and nursing homes, are also required to report deaths to both the manufacturer, if known, and FDA within 10 working days.196 User facilities must report serious injuries to the manufacturers (or FDA if the manufacturer is unknown) within 10 working days.

COMPLIANCE AND ENFORCEMENT

Compliance requirements apply to both the premarket approval process and post market surveillance. When a problem arises with a product regulated by FDA, the agency can take a number of actions to protect the public health. Initially, the agency tries to work with the manufacturer to correct the problem on a voluntary basis. If that fails, legal remedies may be taken, such as asking the manufacturer to recall a product, having federal marshals seize products, or refusing imported products that are in violation of the FFDCA. If warranted, FDA can ask the courts to issue injunctions or prosecute individual company officers that deliberately violate the law. When warranted, criminal penalties, including prison sentences, may be sought. Section 516 of the FFDCA gives FDA the authority to ban devices that present sub stantial deception or unreasonable and substantial risk of illness or injury. Section 518 enables FDA to require manufacturers or other appropriate individuals to notify all health professionals who prescribe or use the device and any other person (including manufacturers, importers, distributors, retailers, and device users) of any health risks resulting from the use of a violative device, so that these risks may be reduced or eliminated. This section also gives consumers a procedure for economic redress when they have been sold defective medical devices that present unreasonable risks. Section 519 of the act authorized FDA to promulgate regulations requiring manufacturers, importers, and distributors of devices to maintain records and reports to assure that devices are not adulterated or misbranded. Section 520(e) authorizes FDA to restrict the sale, distribution, or use of a device if there cannot otherwise be reasonable assurance of its safety and effectiveness. Stricted device can only be sold on oral or written authorization by a licensed practitioner or under conditions specified by regulation.

3. What does a plaintiff have to prove to win a case against the manufacturer of a
premarket-approved medical device?

The plaintiff has to file a product liability complaint against The Evergreen balloon catheter manufacturer based on The Safe Medical Devices Act of 1990.

Following points are to be emphasised with all documents of surgery.

According to that:

1. Device manufacturers are required to report to FDA (1) within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health issue.195 User facilities, such as hospitals and nursing homes, are also required to report deaths to both the manufacturer, if known, and FDA within 10 working days.196 User facilities must report serious injuries to the manufacturers (or FDA if the manufacturer is unknown) within 10 working days.

When a problem arises with a product regulated by FDA, the agency can take a number of actions to protect the public health.

1. Initially, the agency tries to work with the manufacturer to correct the problem on a voluntary basis.

2. If that fails, legal remedies may be taken, such as asking the manufacturer to recall a product, having federal marshals seize products, or refusing imported products that are in violation of the FFDCA.

3. If warranted, FDA can ask the courts to issue injunctions or prosecute individual company officers that deliberately violate the law. When warranted, criminal penalties, including prison sentences, may be sought.

4. Section 516 of the FFDCA gives FDA the authority to ban devices that present sub stantial deception or unreasonable and substantial risk of illness or injury.

5. Section 518 enables FDA to require manufacturers or other appropriate individuals to notify all health professionals who prescribe or use the device and any other person (including manufacturers, importers, distributors, retailers, and device users) of any health risks resulting from the use of a violative device, so that these risks may be reduced or eliminated.

This section also gives consumers a procedure for economic redress when they have been sold defective medical devices that present unreasonable risks.