When filing their complaints, plaintiffs’ lawyers usually take the shotgun approach and throw in as many boilerplate allegations as they can think of.  Oftentimes, many of these claims are easily disposed of by way of a motion either to dismiss or to strike, or later on down the road through dispositive briefing.  But sometimes, certain allegations are made that raise eyebrows and leave even the most experienced litigator scratching her head.  In August of this year, Intuitive Surgical was named as a defendant in a case venued in Miami-Dade County, Florida, involving the da Vinci Si HD Surgical System.  See Seinfeld v. Intuitive Surgical, Inc., No. 2015-018171-CA-01. And this is one of those eyebrow-raising cases.

In the general allegations section of their complaint, the plaintiffs claim that certain defects in the da Vinci caused “an unnecessary hysterectomy, bowel injury, subsequent surgery, and damage to [plaintiff’s] urinary tract and genitalia.”  The complaint then goes on to allege two largely boilerplate counts sounding in negligent and strict liability design defect, manufacturing defect and failure to warn.

Sprinkled in among the allegations in those boilerplate counts are several claims that merit comment.  In their negligence count, the plaintiffs contend that Intuitive breached its duty of care by:

  • Negligently designing a training program and/or providing inadequate training to physicians prior to their use of the subject robotic surgical device on patients; and
  • Negligently designing a robotic surgical system that requires an excessive amount of training and use by a physician in order to become proficient in the use of the device.

In their strict liability count, the plaintiffs allege:

  • The subject robotic surgical device was defective in that its design requires an excessive amount of training and use by a physician in order to become proficient in the use of the device.

What makes these allegations so interesting is that plaintiffs in Florida cases involving medical devices typically allege that the manufacturer failed to adequately train the physician who used the device in question.  But such allegations generally don’t lead anywhere because Florida law does not recognize an independent cause of action for failure to train or instruct. See Rounds v. Genzyme Corp., No. 8:10-cv-2479-T-23TBM, 2011 WL 692218, at *3 (M.D. Fla. Feb. 18, 2011), aff’d , 2011 WL 3925353 (11th Cir. Sept. 8, 2011).  As explained in Rounds, such allegations are subsumed within the failure to warn claims:

Contrary to the plaintiffs’ assertion, the adequacy of the warning is both relevant to, and dispositive of, the plaintiffs’ “failure to train” claim. The difference between a “failure to train” and a “failure to warn” is semantic. The manufacturer … of a prescription product owes a duty to the doctor to provide adequate information about the risk associated with a product. The doctor …owes a duty to the patient to apprise himself of the risk associated with a product and to exercise judgment in both prescribing the product and informing the patient of the risk. The plaintiffs cannot overcome an unambiguous and adequate warning to [the doctor] and somehow attribute [the doctor’s] alleged negligence to the [manufacturer].

And so here, perhaps in an effort to get around this limitation, the plaintiffs are claiming that Intuitive should have designed a better training program for doctors. This argument likely won’t get too far because under Florida law, so long as a manufacturer provides an adequate warning to physicians of the possibility that the device may cause the injury alleged by the plaintiff, it does not have an affirmative duty to train or instruct physicians on how to use its device.  Rather, the physicians act as learned intermediaries and have a professional duty to exercise their independent judgment based on their education, experience and knowledge of their patients’ medical conditions and the device in question.  See Wolicki-Gables v. Arrow Int’l, Inc., 641 F. Supp. 2d 1270, 1286 (M.D. Fla. 2009) aff’d, 634 F.3d 1296 (11th Cir. 2011) (“It is the physician’s duty to inform himself of the qualities and characteristics of the products which he prescribes for his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product.”) (citing Buckner v. Allergan Pharmaceuticals, Inc., 400 So. 2d 820 (Fla. 5th DCA 1981)).

As for their second argument—that Intuitive should not have sold a product that requires an excessive amount of training—it remains to be seen how the plaintiffs will fare.  Though Florida law does not require the plaintiffs to plead a safer alternative design in proving their design defect claims, the availability of a safer alternative design is something that jurors can consider when applying the risk-benefit analysis in determining whether a complex medical device is defectively designed. See Hobart Corp. v. Siegle, 600 So. 2d 503, 505, at n.4 (Fla. 3d DCA 1992) (listing the factors to be considered by the jury when conducting the risk-benefit analysis).

It will be interesting to see whether the plaintiffs attempt to introduce any evidence of a safer alternative design that is capable of performing the same tasks as the da Vinci, yet requires less training.  And even if they choose not to offer such an alternative design, it will be quite instructive to see how the plaintiffs define the threshold that must be crossed in order for the required training to be deemed “excessive.”  The plaintiffs’ level of success in advancing this claim may well shape the playing field in this area of law, and contribute to our understanding of whether a medical device can in fact be too complex for its own good.

Ultimately, this case is also a good reminder to medical device companies that design records, even in the very early stages of defining desired product features, can be helpful (or harmful) if product liability claims later arise. A concise and thoughtfully written summary of design inputs can help explain why a device was necessarily complicated, but is not overly complicated, e.g., based on thought-leader feedback on prototypes or early market feedback. Conversely, cluttered, incomplete, or poorly drafted records may help a plaintiff convince a jury that better planning could have prevented serious injury.