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.
- Green Development Risks
- A Question of Timing: Policy-Limit Demands and Insurer Bad Faith in Florida
- CUBI: Everything You Need to Know About Texas' Biometric Law and Beyond...
- Prejudgment Interest Starting as Early as the Time of Injury? At a Rate of 9% Interest? A Bill Sits on Illinois’ Governor’s Desk.
- Now That Vaccine Distribution Has Begun, What Issues Do Employers Face?
- Immunity From Liability For Healthcare Facilities and Healthcare Professionals in the Continuing Battle Against the Covid-19 Pandemic
- A National Approach to Biometric Privacy
- Remote Jury Selection by Video Conferencing
- Illinois Appellate Court Eliminates Key Defense to BIPA Claims
- Professional Liability
- Class Action
- Insurance & Reinsurance Litigation & Counseling
- Insurance Coverage
- Complex Commercial Litigation
- Cyber Risk & Liability
- Toxic Tort
- Professional Development
- Medical Negligence & Healthcare Liability
- Pharmaceutical & Medical Device Litigation
- Product Liability
- Construction Litigation & Counseling
- Social Media & Privacy
- Workers' Compensation
- Discrimination, Harassment & Hostile Workplace Claims
- Employment Litigation & Counseling