Illinois Appellate Court Says the Learned Intermediary Doctrine Does Not Shield a Device Manufacturer from Liability When a Doctor is Deceived About a Device’s Prior Testing and Suitability


On Friday, October 30, the Appellate Court of Illinois, Second District, held that the Learned Intermediary Doctrine, which protects medical device manufacturers from liability if they provide physicians with proper warnings, does not shield product manufacturers from liability in situations where the physician is deceived about the subject device’s history of testing and suitability. 

The facts of the case are bizarre, to say the least. The Plaintiff allegedly suffered injuries to her left eye during a relatively routine cataract lens replacement procedure. Prior to the procedure, a sales representative for Defendant/Appellee Johnson & Johnson Surgical Vision, Inc. (“JJSVI”) allegedly brought a prototype lens injector device manufactured by another device company and showed it to the doctor prior to a day of surgical procedures. The Plaintiff alleged that the JJSVI sales rep knowingly misrepresented to the doctor that this prototype device had been approved by the Federal Food and Drug Administration and was being used by other physicians with great success. The doctor allegedly believed the JJSVI sales representative and used the prototype device on the Plaintiff that same day causing injury. 

During the pleadings stage, JJSVI filed a motion to dismiss arguing that it and its sales representative owed no duty to the Plaintiff because any alleged misrepresentation was made to the physician, not to the Plaintiff. The trial court agreed and dismissed the case based on the Learned Intermediary Doctrine. Plaintiff appealed.

The Learned Intermediary Doctrine states that when adequately informed physicians prescribe drugs or medical devices to patients, it breaks the chain of liability between the patient and the manufacturer. However, the doctor must have been properly warned of the risks of the drug or medical device for the Doctrine to apply.

In reversing the trial court’s ruling, the Second District stated that “when a manufacturer or its representative withholds crucial information about a drug or medical device, it has ‘breached its duty to warn the medical community because without this information, doctors could not provide appropriate and comprehensive medical advice for their patients.” citing Hansen v. Baxter Healthcare Corp., 198 Ill. 2d 420, 430 (2002). In reviewing the allegations, the Court decided that the JJSVI’s sales representative’s alleged misrepresentations were “no doubt…worse than a mere failure to warn.” (emphasis in the original). Because of this, JJSVI was not afforded the protections of the Learned Intermediary Doctrine.

The case is Plass v. Johnson & Johnson Surgical Vision, Inc. f/k/a Abbott Medical Optics, Inc., et al. 2020 Ill. App. 2d 190403-U, No. 2-19-0403. Appeal from the Circuit Court of DeKalb County, Illinois, Case No. 16-L-23.

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