A streamlined FDA review pathway for medical devices that allows a manufacturer to gain market clearance without extensive clinical trials by proving their device is "substantially equivalent" to an legally marketed device already on the market.

A representative test trial selected from a larger pool of lawsuits within an MDL. Bellwether trials are tried before a jury to gauge how juries respond to evidence and arguments, providing crucial data that helps both plaintiffs and defendants evaluate the value of remaining cases and negotiate potential global settlements.

A test case in multidistrict litigation (MDL) used to gauge potential jury responses to issues common in other cases.

A court-ordered assessment deducted from individual plaintiff recoveries in an MDL to compensate the leadership attorneys (such as the PSC/PEC) for work performed and expenses incurred that benefited the collective litigation as a whole.

A payment arrangement commonly used in personal injury and mass tort litigation where the client pays no upfront legal fees. Instead, the law firm’s legal fees are structured as a percentage of the final financial recovery (settlement or verdict) secured for the client. If no recovery is made, the client owes no attorney fees.

The legal rule and framework used by federal judges to determine whether an expert witness’s scientific testimony and methodology are sound, scientifically valid, and admissible in court. Winning or losing a "Daubert challenge" can frequently decide the outcome of a mass tort litigation.

A product liability claim asserting that an entire line of products is inherently dangerous due to a fundamental flaw in its engineering or design, meaning the product remains unsafe even when manufactured flawlessly according to specifications.

A product liability legal theory asserting that a manufacturer or drug company failed to provide adequate warnings, instructions, or safety labels regarding known or foreseeable risks associated with using their product or pharmaceutical drug.

A product liability claim asserting that an individual item or specific batch of a product became dangerously flawed due to an error during the production, fabrication, or assembly process, causing it to deviate from the manufacturer's intended design.

While both involve large groups of injured individuals suing a common defendant, they differ fundamentally in structure. In a class action, thousands of individuals are grouped together into a single lawsuit represented by one representative plaintiff. In a mass tort, each individual plaintiff maintains their own separate, independent lawsuit with its own specific damages, even though the cases are consolidated for pretrial efficiency.

A federal legal procedure designed to speed up the handling of hundreds or thousands of complex, related cases. In a mass tort, lawsuits filed across the country that share common factual questions are temporarily transferred to a single federal district judge to streamline discovery and pretrial proceedings.

A core leadership group within a Multi-District Litigation (MDL), often appointed by the judge to work alongside or lead the Plaintiffs' Steering Committee. The PEC handles executive operational decisions, coordinates sub-committees, and manages litigation funding.

The stringent, scientific FDA review process required for high-risk (Class III) medical devices. Manufacturers must provide rigorous clinical data proving the safety and effectiveness of the device before it can legally be brought to the consumer market.

A small group of attorneys appointed by the presiding federal judge in a Multi-District Litigation (MDL). The PSC is responsible for managing the litigation on behalf of all plaintiffs, directing discovery, conducting depositions, and shaping overall case strategy.

A strict legal deadline established by state law that dictates the maximum window of time an injured individual has to file a lawsuit after an injury occurs or is discovered. Missing this deadline permanently bars the plaintiff from seeking legal compensation.

The legal right of a healthcare insurance provider (including private insurance, Medicare, or Medicaid) to demand reimbursement from a plaintiff’s final legal settlement for medical bills the insurer paid to treat injuries directly related to the lawsuit.