Science and Law
20th March 2014

8 Reasons Litigators Should Perform a FAERS Signaling Analysis

Even though the FDA Adverse Event Reporting System (FAERS) is not designed to establish a definitive causal link between a drug exposure and an adverse event, it is critical that you evaluate the information available on the drug or device at the center of your case.

8 Reasons Litigators Should Perform a FAERS Signaling Analysis

Even though the FDA Adverse Event Reporting System (FAERS) is not designed to establish a definitive causal link between a drug exposure and an adverse event, it is critical that you evaluate the information available on the drug or device at the center of your case. Here are 8 reasons why we recommend you perform a FAERS signaling analysis (i.e. evaluating or identifying signals using adverse event data):

1. Cast doubt on the plaintiff’s case. A rigorous analysis of FAERS may help to support the defense’s argument that no causal relationship exists between the drug and the adverse event in question. The data may also demonstrate that the company acted responsibly and exhibited an appropriate level of vigilance.

2. Identify red flags. If the FAERS data contains evidence of a safety signal, you need to be aware of it. You will need to determine when the signal occurred and how strong a disproportion was observed. This analysis can help determine the presence and strength of adverse drug reaction signals.

3. Anticipate your opponent’s arguments. Your client’s internal research provides value, but to fully prepare for your opponent’s claims, you will need to conduct an independent evaluation of the data.

4. Explore the Data. You may think that you understand the data based on the prior analyses that were done, but there could be a positive story embedded in the FAERS data that you and your client are not aware of. There are exploratory analyses that can be performed that might shed some light on specific signals.

5. Leverage case narratives. Case narratives offer insight that numeric data does not. The FAERS database includes case narratives that can further your understanding of the issues.

6. Identify missing reports. The published scientific literature will give you insight into the adverse events associated with the drug in question. Be sure to determine if any of these adverse event reports appear to be missing from the FAERS database. This information can be valuable to the defense since the results of the signaling analysis may change based on the additional data points.

7. Determine whether lawyers are submitting reports. Anyone can report an adverse drug event to FAERS. The system is not limited to patients and healthcare providers; even plaintiff lawyers can submit reports. By examining the FAERS data closely, you can determine whether reports were submitted by attorneys, which may skew the data.

8. Identify at-risk patients. If the signal seems to be valid (i.e. an association between the drug and the adverse event), a risk factor analysis using FAERS can help to identify patient and physician behaviors or actions that may increase the risk of an adverse event.

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