Erm, apart from the punitive damages this is pretty much any product liability suit. If you make life-critical systems and your product fails you are getting sued out the wazoo - which is why many products will specifically state that they are not to be used in life-critical systems.
Most mechanical equipment is not reviewed on a case-by-case basis by a regulatory industry; however aircraft incidents are. Aircraft products - meaning any product that is used on an aircraft, right down to the bolts attaching the overhead bins - are expected to be serviceable in "expected conditions of flight". If they are not, the manufacturer is subject to compensatory and even punitive damages [1].
Manufacturers can even be liable for their design decisions, unless the design decisions are specifically constrained by regulations. Obtaining product certification is a strong indicator that a product is compliant, but it may nevertheless expose the manufacturer to liability [2]. These are obviously difficult standards to meet, but they are appropriate when life-critical systems are in question.
[1] http://www.dailyreportingsuite.com/products-liability/news/_...
[2] http://www.mondaq.com/unitedstates/x/429650/Aviation/FAA+Wei...
> In response to the third and final question, the FAA explains that because an aircraft type certificate embodies the FAA's determination that an aircraft, engine, or propeller design complies with federal standards, it can play an important role in determining whether a manufacturer breached a duty owed to the plaintiff. The type certificate does not create a per se bar to suit, but ordinary conflict preemption principles apply to the particular design-defect claim. According to the FAA, the type certificate will preempt a state tort suit only where compliance with both the certificate and the claims made in the tort suit "is a physical impossibility" or where the claims "stand as an obstacle to the accomplishment of the full purposes and objectives of Congress."7
> Where the FAA has expressly approved the specific design aspect that a plaintiff challenges, that claim would be preempted. On the other hand, where the FAA has left a particular design choice to a manufacturer's discretion, and no other conflict exists, the type certificate does not preempt a design-defect claim. In other words, where the FAA has not made an affirmative determination with respect to the challenged design, and has left that design aspect to the manufacturer's discretion, the claim would proceed by reference to the federal standards of care found in the Act and its implementing regulations.
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> The difficulty in applying the FAA's views on preemption to product claims lies in the fact that aircraft design specifications rarely require a specific design, but are instead couched in terms of performance or safety outcomes. For example, the certification standards for a stall warning system in a Part 23 aircraft requires "a clear and distinctive stall warning, with the flaps and landing gear in any normal position, in straight and turning flight" by a system "that will give clearly distinguishable indications under expected conditions of flight."9 A type certificate issued for a Part 23 aircraft would presumptively mean the FAA determined that the aircraft complied with these standards at the time the design was certified. However, would the type certificate preclude all product liability claims based on a defective stall warning system? What if the certification was actually wrong and the system did not comply with the standard when the FAA already said that it did? Can this type of claim actually be litigated or is it preempted?
> Additionally, what if the claimed defect was that the stall warning system did not provide a warning when operated outside certification limits such as weight, speed, or center of gravity? Are these conditions outside the "expected conditions of flight" and therefore no federal standard exists? The FAA's Letter Brief to the Third Circuit in Sikkelee does not provide clear answers in the context of product liability litigation. Courts will continue to struggle with deciding these difficult issues in the future.