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Lessons Learned From the Intuitive Surgical Lawsuits: Physician Learning Curves

BooksAs I noted last month, surgeon training is one of the issues that was debated in the various product liability lawsuits that were filed against Intuitive Surgical in recent years.  This begs the question: How much training should a surgeon complete before being handed the keys to a surgical robot?… Continue Reading

Lessons Learned From the Intuitive Surgical Lawsuits: The Benefits of Partnering With Independent Educational Firms

appleThough a number of companies manufacture and sell surgical robots in the United States, Intuitive Surgical has been the primary target of product liability lawsuits in recent years. Around 100 such claims have already been filed and at least 700 more are believed to have been placed on the back burner pursuant to a tolling … Continue Reading

Shielding Intellectual Property from 3-D Printing’s Paradigm Shift

Medical toolIt’s not hard to imagine a time in the not-too-distant future when physicians start using 3-D printing technology to produce tools for their robotic surgery systems that are based on existing copyrighted models but customized to address patient-specific needs. But what happens when the copyright holders of those existing models start attributing depressed bottom lines to … Continue Reading

Aubin v. Union Carbide—A Year Later

hammerIn January, I posted regarding the impact of the Florida Supreme Court’s decision in Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015).  In that post I explained that even after Aubin, the consumer expectations test should not be applied in all design defect strict product liability cases because it is still up … Continue Reading

Will the Rise of the Machine Mark the Fall of Med Mal?

SurgeonsRecently, James Ryan Morales from HealthAim reported on a new study at Children’s National Medical Center in Washington involving the Smart-Tissue Autonomous Robot (STAR) Project. In the study, a supervised autonomous robot performed soft-tissue surgery on a pig’s bowel, demonstrating that robots can now perform surgical operations with very minimal human supervision. It is, therefore, … Continue Reading

Five Steps Robotic Manufacturers Can Take to Limit Liability When Using 3-D Printing

3-D PrinterClinical robotics and other emerging technologies are profoundly reshaping the way in which medicine is practiced.  One of those technologies, additive manufacturing—also known as 3-D printing—is helping usher in a new era of innovation and customization unlike anything that we have ever seen.  But with this promising innovative technology also come many novel challenges, as … Continue Reading

Following Aubin v. Union Carbide, Will Complex Medical Device Manufacturers Face an Uphill Battle in Defending Against Strict Liability Design Defect Claims in Florida?

Medical SnakesIn Florida, there are two tests that a jury may apply in determining whether a product is defectively designed under a strict liability theory: the “consumer expectation test” and the “risk-utility test.”  Plaintiffs usually prefer the consumer expectation test because it is generally easier for them to prove, while defendants prefer the “risk-utility test.”  Late last … Continue Reading

As New Players Enter the Robotic Surgery Field, the Legal Implications are Limitless

Industry Insights BannerVarun Saxena from Fierce Medical Devices recently reported that partners Johnson & Johnson and Google are designing their own robotic surgery devices, which “will compete with Intuitive in general surgery arenas, which include hernia repair and colorectal surgery.”  The Johnson & Johnson endeavor was formed in collaboration with Google’s Verily Life Sciences and will operate … Continue Reading

Can a Complex Medical Device Require Too Much Training?

Medical booksWhen 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 … Continue Reading
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