FreeStyle Libre
OpenFILINGCausation
Plaintiffs allege two primary defect theories. First, the FreeStyle Libre adhesive contains isobornyl acrylate (IBOA), a known contact allergen that causes severe allergic contact dermatitis and chemical burns at the sensor application site. European regulatory authorities flagged IBOA concerns as early as 2019. Second, the CGM sensor produces inaccurate glucose readings — deviating significantly from actual blood glucose levels — causing patients to make dangerous insulin dosing decisions. The MARD (mean absolute relative difference) in real-world use exceeds the accuracy claimed in Abbott's marketing. FDA MAUDE database contains thousands of adverse event reports for sensor malfunctions, inaccurate readings, and skin injuries.
Defendants
| Entity | Role | Note |
|---|---|---|
| Abbott Laboratories | Manufacturer | FreeStyle Libre CGM system — sole defendant and manufacturer |
Litigation Timeline
Intelligence Signals
Salvia Cosmeceuticals, of India. The essential oil bottles contain methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The bottles for the products are not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Hisense Ltd., of Israel. The display or "parent" unit of the Max View baby monitors can overheat and/or spark when charging, posing a fire hazard to consumers.
Key Facts
- Status
- active
Geographic Exposure
Eligibility Criteria
- ✓Used Abbott FreeStyle Libre CGM system (any generation)
- ✓Experienced skin burns, allergic reaction, or severe dermatitis at sensor site
- ✓Received inaccurate glucose readings leading to medical emergency
- ✓Suffered hypoglycemic or hyperglycemic event due to device malfunction
- ✓Required medical treatment for injuries caused by device