No Financial Bias Exception to Dangerous Medical Device Warning Failure, Court Rules

When it comes to the dangers of medical devices or medications, the learned intermediary doctrine holds manufacturers responsible to describe the known risks to doctors, who in turn interpret those risks to patients. Patients then rely on the interpretations of their physicians to make informed medical choices. One effect of this, however, is that the manufacturer’s duty to warn of possible danger is to the physician who provides the medication, conducts the surgery or oversees treatment – not to the general public. drug and medical device litigation Florida

But what if the doctor in question is receiving some sort of financial benefit from the manufacturer for prescribing or using a particular drug or device?

Recently, the U.S. Court of Appeals for the Eleventh Circuit weighed a request by plaintiffs to create a “financial bias exception” to the intermediary rule in a Florida product liability lawsuit stemming from a vaginal mesh injury. However, finding no such precedent or even discussion of it in previous decisions, the court declined to do so.

Transvaginal Mesh Injuries

Surgical mesh is a sort of screen-like material that can be used to reinforce tissue or bone. It is sometimes used to treat women with pelvic organ prolapse (POP) or stress urinary incontinence (SUI). With POP, pelvic organs shift downward and bulge out of the vagina when the pelvic floor muscles and tissue are too weak to hold the organs in place. Organs that can be subject to prolapse can include the uterus, vagina, rectum, bladder and urethra (though it’s most often the bladder). Aging and childbirth are risk factors. SIS occurs when weakening of the pelvic muscles results in certain activities increasing pressure on the abdomen resulting in incontinence.

There have been more than 100,000 transvaginal mesh injury lawsuits filed alleging complications due to erosion and infection, including pain, bleeding, organ perforation, recurring prolapse and autoimmune problems. The U.S. Food & Drug Administration halted all sales of transvaginal mesh for POP in 2019, saying medical device manufacturers failed to show the benefits outweighed the risks.

Florida Product Liability Learned Intermediary Doctrine Challenge 

In the recent case of Salinero v. Johnson & Johnson, Ethicon, Inc., plaintiff underwent surgery in Florida in 2012 to address POP. After the implant of surgical mesh manufactured by defendants, she suffered a host of health problems, ultimately requiring her to have the implant removed. In their federal lawsuit, she and her husband alleged Ethicon and its parent company failed to warn them of the dangerous health consequences of the mesh product.

Defendants successfully moved for summary judgment citing Florida’s learned intermediary doctrine as a complete defense, effectively breaking the chain of causation in this product liability lawsuit. They note their duty to warn was to the physician, not the patient.

Plaintiffs countered, however, that the learned intermediary doctrine shouldn’t apply here because the doctor in this case had, “a long-standing financial relationship with both defendants.” Therefore, they couldn’t reasonably expect the physician to accurately communicate the risk of this medical device to them. In effect, they were asking the court to create a financial bias exception to the learned intermediary doctrine.

As longtime Palm Beach medical malpractice lawyers and product liability attorneys, we see this as a perfectly reasonable exception. However, the court may have been legally correct in its decision, as this is an issue perhaps best addressed by the legislature (responsible for creating the laws), rather than the courts (responsible for interpreting them).

The 11th Circuit ruled that it was bound to follow the decisions of Florida courts. In this case, the doctor made clear he knew about the implant risks and stood by his professional decision to recommend the mesh to his patient. Therefore, inadequate warning could not be considered the proximate cause of plaintiff’s injuries, as the learned intermediary doctrine barred the failure to warn claim.

This does not mean patients who suffer injury due dangerous medical devices or drugs are without remedy. It is important, however, for them to consult with an attorney experienced in medical device and drug litigation in Florida.

Contact the South Florida personal injury attorneys at Halberg & Fogg PLLC by calling toll-free at 1-877-425-2374. Serving West Palm Beach, Miami, Tampa, Orlando and Fort Myers/ Naples. There is no fee unless you win.

Additional Resources:

Salinero v. Johnson & Johnson, Ethicon, Inc., April 21, 2021, U.S. Court of Appeals for the Eleventh Circuit

More Blog Entries:

Florida Arbitration Agreements Increasingly Common in Health Care, Jan. 21, 2021, Palm Beach Medical Device and Drug Litigation Blog

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