Stepped Up Regulation of Lab-Developed Tests Has Products Liability Implications

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Significant advances in science, and particularly in genomic medicine, have catapulted lab-developed tests (LDTs)–diagnostic tests designed, manufactured, and used in the same laboratory–past the benign uses they fulfilled decades ago. When LDTs were used with relative infrequency and often for a crucial segment typically neglected by in vitro diagnostic (IVD) manufacturers–namely, rare diseases–they received lax oversight from the FDA under what the Agency deems its “enforcement discretion.”

Now though, in the wake of well-publicized disasters like Theranos and the realities of both (1) the huge cost incentives to use these “home brew” tests over FDA approved tests that can cost as much as ten or twenty times as much; and (2) the transformative effect of genomic testing advances which have meant LDTs are now employed to test everything from birth defects to ovarian cancer, the FDA has undertaken to significantly step up its oversight and require pre-market approval for many such LDTs.

According to the first of three draft guidance documents on the Agency issued on the subject in the last two years, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), it proposes a risks-based oversight strategy under which those tests the wrong result or interpretation of which would have the greatest implications for patient mortality or morbidity would receive the most stringent oversight and have to obtain pre-market approval prior to their use.

This stepped-up oversight isn’t merely burdensome to labs making LDTs; it has real products liability implications. For one thing, a company’s misstep with the FDA in the form of an enforcement action or inspection is often either an initial attractant or a catalyst for plaintiffs’ attorneys. Knowing that these kind of regulatory missteps are helpful at trial to paint a picture of a non-compliant, careless manufacturer, plaintiffs’ attorneys may seek grounds for suits after learning of a company’s FDA trouble.

Additionally, standards and regulations are useful to products liability plaintiffs in establishing a standard of care, one hurdle of a negligence case (the next being showing that the defendant deviated from that standard of care). The more detailed and complex the regulations, the easier it is to find some lapse in consistency with them.

LDT makers must be quick to recognize the burdens of their new regulatory environment and adapt accordingly. Quality assurance/regulatory affairs personnel should be hired or engaged as soon as possible to avoid regulatory and products liability consequences.


FDA Update: News, Products, & Guidance Documents

Courtney A. Stevens, Esq. | Loss Control |Medmarc Insurance Group

The FDA has had a busy first quarter, and this post provides a brief run-down of some of the more news-worthy items coming out of the Agency since the dawn of 2016.

New Guidances

Data Integrity

Last week, the FDA released a draft guidance titled Data Integrity and Compliance with CGMP. Noting that the Agency had seen a growing number of cGMP violations involving data integrity, it sought to provide further clarity and detail to the data-related cGMP requirements. The guidance largely takes the form of a question and answer dialogue, posing and answering questions like:

  • Is it acceptable to only save the final results from reprocessed laboratory chromatography?
  • Is the FDA investigator allowed to look at my electronic records?
  • How does FDA recommend data integrity problems identified during inspections, in warning letters, or in other regulatory actions be addressed?

In answering the last question with regard to the kind of corrective action a company should demonstrate in the wake of a data-related cGMP violation, the Agency restated its oft-articulated position that is not specific to data problems, saying: “FDA encourages you to demonstrate that you have effectively remedied your problems by: hiring a third party auditor, determining the scope of the problem, implementing a corrective action plan (globally), and removing at all levels individuals responsible for problems from cGMP positions.

Interoperable Devices

On January 26, 2016, the FDA released a draft guidance document titled Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. As interoperability (accidental and intentional) of medical devices has been a headache not only for regulators, but for products liability, this guidance was of particular interest.

This the first guidance on the topic of interoperability that the FDA has published, and its real focus on the design controls and considerations important in interoperable products. As its impetus, the FDA noted that “the failure to establish and implement appropriate functional, performance, and interface requirements during product development may lead to the exchange of inaccurate, untimely, or misleading information[,] device malfunction, including the failure to operate, and can lead to patient injury and even death.”

The device highlights the following items:

  • Designing systems with interoperability as an objective;
  • Conducting appropriate performance testing and risk management activities; and
  • Specifying the functional, performance, and interface characteristics in a public manner such as labeling.

New App

The FDA has teamed up with the Federal Trade Commissionmobile medical app (FTC) in the production of a new interactive tool mobile app developers. The tool goes through several questions about the processes and purposes of the developer’s prospective app, and helps the developer determine the regulatory framework under which its product will likely be scrutinized. The tool can be found and tested here.

New Products Approvals and Clearances

The Agency had a busy last couple of months, approving and clearing numerous drugs and devices. A few of particular note are provided below.

  • On April 8, the FDA’s Center for Veterinary Medicine (CVM) began the process of rescinding approval of a swine drug in light of new evidence that the drug may leave trace amounts of a carcinogenic residue. (FDA News Release | April 8, 2016.)
  • On April 7, the FDA approved the marketing of the first tissue containment system for use with certain laparoscopic power morcellators. “Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.” (FDA News Release | April 7, 2016.)
  • On March 30, the FDA granted an investigational new drug application for a test screening blood donations for presence of the Zika virus. (FDA News Release | March 30, 2016.)