Cause Of Action Denied For Violation Of FDA Regulations

Product Liability

In the case of Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd. (Fla. 2d DCA Case Number 2D15-2495), summary judgment was granted in favor of the surgery center because Florida does not recognize a private right of action for violation of FDA regulations.

Facts Of The Case

Mrs. Wolicki-Gables suffered from chronic neck and pain and her doctor recommended the surgical insertion of a pain pump system.  The pain pump was manufactured by Arrow International, Inc. and was a Class III medical device that was approved through the Premarket Approval Process (PMA) of the Food and Drug Administration (FDA).

Despite the surgical insertion of the pain pump, Mrs. Wolicki-Gables’ pain continued.  Subsequent testing revealed that a tube connected to the pain pump was leaking and that the medication was not being delivered in an effective manner.  The doctor recommended a revision surgery in which the tube connector was removed.

Prior to surgery, Mrs. Wolicki-Gables signed an informed consent form and handwrote on the form that she wanted the old pump back and stated that she did not want technical support from the manufacturer present during her surgery (as is common with surgeries to remove ineffective medical devices).  Despite her requests, the doctor performed surgery with the company representative present and replaced the bad tube connector.  After surgery, Mrs. Wolicki-Gables’ husband requested the tube connector but the company representative refused to allow him to have it saying that it was company policy to take it for testing.

The pain pump worked for a couple of weeks until Mrs. Wolicki-Gables was taken to the hospital with transverse myelitis, or a severe inflammation to the spinal cord.  The pain pump also become infected and was removed.  Shortly thereafter, the plaintiffs learned that Arrow International had tested the connector, claimed to find no defects, and had destroyed the part in compliance with company policies.

Mrs. Wolicki-Gables then sued for product liability claims.  A federal judge found that all of her claims were pre-empted by the Medical Devices Amendment (MDA) to the Federal Food,  Drug, and Cosmetic Act (FDCA).  Thereafter, Mrs. Wolicki-Gables filed a second lawsuit against the surgery center for spoliation of evidence claiming that the surgery center was responsible for the loss of the tube and bring a “permissible parallel claim” against Arrow International for negligent design and manufacturing under Florida law (as opposed to federal law).  Again, the trial judge granted summary judgment in favor of the defendants.

Legal Analysis

The Court went on for several pages analyzing the details of the law on this claim before stating that “an MDA parallel claim is much like a unicorn-existing in legend, but elusive in reality.”  While claims alleging a failure to comply with the federal standards which were established through the premarket process are not preempted, Florida law does not give rise to a private cause of action absent a clear legislative intent to do so.  As such, the plaintiffs’ “parallel claim” had to fit a “narrow gap” in the law that was “analogous to Goldilocks’ porridge” for which the Florida Legislature has just not considered.

Commentary On Legal Analysis

How would you like to litigate a case for several years and take an appeal only to be told that your case is like a mythical “unicorn” and “Goldilocks’ porridge”?  This should be a shocking legal result to a casual observer because no one would be able to predict this sort of outcome to a lawsuit.

The attorneys for the plaintiffs in this case were extraordinarily brilliant to sue under the “color of law” but ended up effectively denied justice due to the overall politicized nature of federal law.  This is a prime example of how lobbying in Washington effects us all in ways that we cannot even imagine until a member of the taxpaying public suffers a loss.  Meanwhile, the Washington lobbyists who help shape the laws are motivated by millions of dollars from mega corporations to stack the deck in their favor.  For that matter, I would say that overwhelming majority of attorneys have no idea what a “parallel claim” is.  However, I think that all of us know that the public is supposed to have a cause of action to sue the manufacturer of a dangerous product.  Our government is supposed to be a government by the people and for the people rather than for the money.

Contact A Lakeland Product Liability Attorney For Help With Your Case

If you have a case for a defective medical device, you should contact a Lakeland, Florida product liability attorney to discuss your case.  Cases against medical device manufacturers are some of the toughest personal injury cases because the law surrounding whether you can sue or not can be exceedingly complex.  For professional legal help, contact us to schedule your free consultation today.


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May 26, 2017