Court: Louisiana Court of Appeal; March 27, 2006; Louisiana; State Appellate Court
An appeal was filed by plaintiffs Aliene Sumráll Packard and Kenneth C. Packard against a trial court's judgment that granted summary judgment in favor of defendant Dr. Bruce Razza, dismissing their medical malpractice claim. The claim centered on a spinal fusion performed by Dr. Razza in 1991, alleging he failed to inform Mrs. Packard that the Luque spinal fixation plate system was not FDA-approved. Plaintiffs contended that the device was defective and that Dr. Razza's breaches of the standard of care included two unsuccessful lumbar surgeries, requiring an additional surgery to remove the device, which resulted in permanent injuries.
Mrs. Packard's supplemental petition indicated that a subsequent surgery in 1999 by Dr. David Baron to remove the device led to an infection, necessitating multiple hospitalizations. Defendants asserted that the claims regarding the 1991 surgery were filed too late under La. R.S. 9:5628, but the trial court denied this exception. However, this decision was reversed by an appellate court, only to be reinstated by the Louisiana Supreme Court.
Dr. Razza's motion for summary judgment was granted by the trial court, leading to this appeal. The case history reveals that Mrs. Packard had chronic spinal issues exacerbated by multiple automobile accidents and underwent several surgeries, including the initial surgery in 1991. She became aware of the lack of FDA approval for the Luque plates in 1995 after seeing a television program, which prompted her to file suit. Prior to the 1991 procedure, she signed consent forms acknowledging the risks and authorizing the use of the fixation device.
The document outlines the essential elements of informed consent regarding proposed medical procedures, specifically focusing on the nature, risks, and potential consequences of the treatment options discussed with Mrs. Packard. Key points include:
1. **Informed Consent**: The proposed procedures were thoroughly explained, including the associated risks and the possibility that the desired outcomes may not be achieved. The potential future need for surgical removal of the internal fixation devices was also highlighted.
2. **Alternative Treatments**: All feasible alternative treatments were presented to Mrs. Packard, and she was given ample opportunity to discuss her condition and treatment options with her doctor, Dr. Razza.
3. **Documentation of Consent**: A 1991 consent form was signed by Mrs. Packard, indicating her understanding of the procedures and her satisfactory resolution of any questions.
4. **Surgical History**: Dr. Razza provided testimony regarding the necessity of two surgeries in 1991 and 1993 for spine stabilization. The first involved decompression with pedicle screws, while the second addressed pain relief after an accident and included the removal and re-implantation of the plate and screws, which he explained as part of a sterilization process.
5. **Device Information**: Dr. Razza clarified that the internal fixation device used was elective and not FDA-approved, but it was commonly utilized in spinal surgeries. He believed it offered the best chance for a successful outcome.
6. **Mrs. Packard's Testimony**: Mrs. Packard recounted that during her initial surgery discussion, she was not informed about the hardware being implanted or given a choice regarding its use. By the second surgery, she was aware of the screws but was not informed of their FDA status, nor did she request their removal.
7. **Subsequent Medical Issues**: After learning about the unapproved status of the screws, Mrs. Packard later opted to have them removed in 1999, during which she contracted an infection that led to multiple surgeries and significant lifestyle impairment.
The record reflects a complex interplay of informed consent, surgical practices, and subsequent medical complications resulting from the procedures.
Mrs. Packard filed a lawsuit in Colorado against Dr. Razza and is involved in a class action against pedicle screw manufacturers. She claims she was not informed that the pedicle screws used were not FDA-approved, stating she would have avoided them had she known. Dr. Wheaton Williams, an expert in infectious diseases, treated her for a postoperative lumbar wound infection in March 2001 and noted a long history of back pain, with a chronic infection stemming from spinal hardware removal in March 1999. He diagnosed her with vertebral osteomyelitis, acknowledging a higher infection risk associated with implants, but stated he was not qualified to assess the standard of care for orthopedic surgeons.
It is undisputed that Mrs. Packard signed consent forms that did not disclose the FDA status of the screws. A dispute exists regarding whether Dr. Razza verbally informed her about this during a consultation. The case centers on whether this information is a 'material fact' that would prevent summary judgment. Summary judgment can be granted only if there's no genuine issue of material fact. The summary judgment process aims for a fair and efficient resolution of cases. Material facts are those that could significantly impact the plaintiff's legal claims. Informed consent requirements are outlined in La. R.S. 40:1299.40, which mandates that consent forms must detail the procedure's nature, purpose, and associated risks, and confirm that all questions were satisfactorily answered before signing.
Consent is presumed valid unless proven otherwise due to misrepresentation of material facts. Evidence cannot alter the authorization for procedures outlined in written consent. In informed consent cases, the plaintiff must demonstrate a causal link between the doctor's actions and the damages claimed. This includes establishing that the doctor's breach of duty caused the damages and that a reasonable patient would not have consented if fully informed of the risks. In the cited case, the written consent explicitly stated the use of specific medical devices and associated risks. The plaintiff's injury was unrelated to the procedure and resulted from an elective surgery performed six years later by a different doctor, not due to any failure of the device or breach of care standards. The issue of whether the patient was informed about the FDA status of the device was deemed insufficient to deny summary judgment for the doctor. The trial court's judgment was affirmed.
