There are More Out There: Da Vinci Robot Surgical Injuries

Despite the numerous complaints already being filed against California-based Intuitive Surgical, Inc., maker of the Da Vinci Surgical System, it turns out that surgical injuries are actually being underreported. This was concluded by Johns Hopkins researchers who put together court records and news articles to come up with the true picture of the situation with da Vinci robot lawsuits in particular and the reporting mandate in general.

The Food and Drug Administration (FDA) routinely requires medical device manufacturers and drug companies to report all adverse occurrences relating to their product in order to ensure public health and safety. However, the study shows that because there are no real repercussions from the FDA when companies fail to faithfully report these adverse events, there is no motivation to do so. This means that in general when a product or device is shown to have serious side effects or defects the FDA only gets to hear about it from the victims themselves when extensive damage has already been done.

Because there are no warnings issued to the public, most people are unaware of the risk they are taking in patronizing these products or devices, which are in large part inadequately tested. Coupled with marketing strategies which entice consumers already primed to favor the newest technology, manufacturers are set up to make huge profits which would be compromised if adequate testing is carried out. This applies to consumer products as well, but medical devices and products have the potential for serious if not fatal harm.

Until the FDA’s reporting mandate acquires a more punitive personality, the only recourse for those who suffer injury or harm from the use of these devices or products is in civil court. And because the da Vinci surgical system is a wholly new category of medical device, litigation is likely to be highly complex. It would be necessary for those suffering from surgical injuries to engage a product liability lawyer well-versed in the arena of robot-assisted surgical devices such as the da Vinci system.

Products Liability and the Omnibus Tort Reform Act in Wisconsin

Major changes have been made to the civil laws on products liability in Wisconsin under the Omnibus Tort Reform Act of 2011 that will affect how manufacturers will be held accountable when it comes to design or manufacturing defects. Previously, Wisconsin was a strict liability state with no cap on punitive damages. The reforms have made it more difficult for plaintiffs to recover damages from manufacturers, sellers and distributors. However, according to the website of Habush Habush & Rottier S.C. in Rhinelander ®, this should not prevent product defect victims from addressing the problem and seeking compensation for injuries.

The new laws on tort liability now require that in order for a plaintiff to recover damages for injuries sustained due to a defect in a product’s design, it must present an alternative design for the product with which the injury would not have happened. This is the reasonable alternative design test which is in wide use in the US. A plaintiff claiming unawareness of the risks of using the product may only file for damages if there was inadequate or no warning or instructions included with the product. This is in direct contrast with the previously prevailing rule where it did not matter if there were instructions or warnings; as long as the plaintiff claims he or she did not know, the manufacturer may still be held liable.

Other conditions codified in the tort law include a statute of repose (after which a manufacturer may no longer be held liable, typically 15 years), a punitive damages cap ($200,000 or double the amount of compensatory damages, whichever is higher), limited market share liability, comparative negligence features and statutory defenses for manufacturers.

The new laws do make Wisconsin more attractive for manufacturers, but it also makes it more difficult for consumers to seek compensation for injuries they may sustain from a defect in the product’s manufacturing or design. The new law makes it even more imperative to have competent legal representation which will undertake the task of proving that a manufacturer breached its duty of care to its customers.