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Posts Tagged ‘medical’

Eleventh Circuit Rules Florida Strict Liability and Negligence Claims Not Preempted by the MDA

Posted on: February 12th, 2018

By: Robyn Flegal

A panel of the Eleventh Circuit determined in a February 8, 2018 published decision that a Florida district court erred when it ruled that a husband’s claims, brought against a medical device manufacturer after its Life Vest defibrillator failed to shock his wife’s heart, were preempted by federal law.

A defibrillator is worn by patients at risk of sudden cardiac arrest. It delivers a dose of electric current to the heart, depolarizing the heart muscle and ending dysrhythmia. The lower court dismissed the action in January 2017, ruling that the claims against the manufacturer were preempted by the Medical Device Amendment of the Food, Drug and Cosmetic Act. The FDA previously determined the Life Vest device was safe, and the district court agreed with the manufacturer that the allegations improperly contradicted the FDA’s prior approval of the product.

The Eleventh Circuit disagreed with the lower court’s ruling, deciding that the claims were not preempted. The court reasoned that the strict liability and negligence claims were not preempted by the federal regulations because the plaintiff alleged the defect was due to the manufacturer’s purported failure to comply with these regulations—which then caused a violation of Florida’s laws. The Court considered that a 2014 FDA warning letter put the manufacturer on notice that it was in violation of certain regulations. That letter can, now, serve as a basis for the plaintiff’s claims—even though the letter referred to shocks being delivered to patients who did not need them, as opposed to the failure to deliver shock to patients who needed them (as allegedly experienced by the plaintiff’s wife). The Court determined that the complaint’s references to the letter sufficiently stated a claim that was plausible on its face despite this disconnect between the warning letter and facts relating to the plaintiff’s wife’s use of the product.

Medical device manufacturers should be aware of the Eleventh Circuit’s ruling that claims of strict liability and negligence may not be preempted by the Medical Device Amendment. Such manufacturers should be particularly cognizant of this Eleventh Circuit decision where they have received an FDA warning letter.

For more information, please contact Robyn Flegal at [email protected].

D&O Insurance Policies Now Tailored to Health Care Organizations

Posted on: October 12th, 2012

By: Kelly Morrison

The new wave of insurance policies explicitly addresses antitrust and HIPAA concerns unique to the medical industry.

Please visit the following link for more information: D&O Insurance for Healthcare Organizations: Our Prescription for Better Coverage.

 

Electronic Medical Records – IT Guides for a New Frontier

Posted on: August 27th, 2012

By: Michael Eshman
It is clear that electronic medical records and exchanges are the wave of the future in healthcare. For better or worse, the electronic management and maintenance of files and records will transform the healthcare industry.

In December 2011, Georgia Health News reported on the medical revolution coming with online records and the statewide exchange Georgia is building with the help of a $13 million federal grant. In addition to the economic factors driving the change, in our prior blog post titled “Electronic Medical Records – Saving More Than Trees,” we noted that a recent Harvard study found medical malpractice claims dropped in Massachusetts after doctors began using electronic records. There are great rewards and incentives to adopt electronic medical records and to be part of the expanding record exchanges, both for the quality of care that can be provided to patients and for the economics and efficiency of practice management.

However, any practice using electronic medical records should lean heavily on trusted IT professionals to ensure the privacy and security of the records. As noted by Georgia Health News in the column linked above, the Ponemon Institute reports that the number of reported medical data breaches has increased by 32 percent since 2010.

In a recent brazen attack, hackers accessed the computer network of a small practice in Lake County, Illinois, but instead of merely stealing and reposting the records, they encrypted the records and posted a digital ransom note for payment in exchange for the password. It is unclear whether the records were backed-up, but if not, the hackers effectively held hostage the medical records of patients.

As more practices move to electronic records, and as medical record exchanges expand nationwide, the incidents of attempted hacks will likely increase, and it will fall to the practices and the administrators of the exchanges to manage the risk associated with maintaining and sharing electronic records. Electronic records and exchanges are part of the new frontier for medical providers, and there are great benefits to be gained from the advancements. But providers are wise to focus on the issues of data management and security and to lean on trusted IT professionals and risk managers for guidance.

Thoughts and questions are always welcome.