By Nicholas Kaster, J.D.
The patient admitted that B&L did not sell Besivance in a defective condition, preventing her from maintaining a viable strict liability claim against the company. Without a strict liability claim, she could not rely upon any presumption that B&L knew that off-label use of Besivance could cause injury.
A patient’s negligence action against Bausch & Lomb (B&L) for a physician’s off-label use of its drug Besivance in treating the patient following a photorefractive keratectomy (PRK) procedure for nearsightedness failed to survive summary judgment. In affirming a state trial court, the Kentucky Court of Appeals ruled that the patient could not present prima facie evidence of foreseeability. There was no evidence suggesting that B&L knew or should have known that the use of Besivance in PRK was associated with any adverse effects, the appellate court concluded (Stiens v. Bausch & Lomb Inc., December 11, 2020, Goodwine, P.).
In 2011, B&L began marketing a new drug, Besivance, for ophthalmological use. Besivance is a topical antibiotic shown to prevent a wide range of bacterial infections of the eye. On January 19, 2012, the patient’s doctor used Besivance as the patient’s prophylactic and postoperative antibiotic following her PRK for nearsightedness. Following her surgery, the patient suffered irreparable damage to her left eye, impairing her vision.
Ophthalmologists use various antibiotics as postprocedural prophylactics to prevent ensuing infections following PRK and other refractive surgeries. However, Besivance was not approved for use as a prophylactic under the Federal Food, Drug, and Cosmetic Act (FDCA). Use for any purpose other than what is approved under the FDCA is "off-label." The evidence is in agreement that in refractive eye surgeries, off-label use of antibiotics for infection prevention is the standard of care.
In February 2013, the American Society of Cataract and Refractive Surgery issued an alert jointly with a peer-reviewed study that certain topical medications, Besivance in particular, should not be used intraoperatively during LASIK and PRK due to the adverse effects of its adhesive component.
Trial court proceedings. On July 24, 2014, the patient filed suit against B&L, asserting a variety of product liability claims under the Kentucky Products Liability Act (KPLA). After extensive motion practice and a multitude of discovery issues, on July 30, 2018, the trial court entered an order granting summary judgment to B&L on the last remaining claim, which was based in negligence.
The trial court found that because the patient chose to forego pursuing a claim under the FDCA, she could not be permitted to allege that B&L engaged in off-label promotion in violation of that statute. Therefore, the trial court excluded all testimony regarding off-label promotion. B&L moved to exclude three articles about the use of Besivance in PRK and related testimony. The trial court excluded the articles and related testimony as irrelevant and unduly prejudicial.
In granting the motion for summary judgment, the trial court held that the patient lacked the evidence to support a prima facie negligence claim. The court held that even in the light most favorable to her, she had failed to present sufficient evidence of foreseeability and causation.
Foreseeability. On appeal, the patient argued that B&L should have foreseen that an injury could result from the "off-label" and untested use of a pharmaceutical product and, thus, B&L should have warned of unknown risks and tested the product for its marketed purpose. B&L countered that it had no duty to prevent unforeseen risks caused by its product under negligence law and that the patient failed to present evidence suggesting that B&L knew or should have known there were risks associated with that particular use of its product.
To recover under a claim of negligence, a plaintiff must present evidence that: (1) the defendant owed a duty of care to the plaintiff; (2) the defendant breached its duty; and (3) the breach proximately caused the plaintiff’s damages. The Kentucky Supreme Court has held that "so far as foreseeability enters into the question of liability for negligence, it is not required that the particular, precise form of injury be foreseeable-it is sufficient if the probability of injury of some kind to persons within the natural range of effect of the alleged negligent act could be foreseen." Such risk must be foreseeable based on what the tort feasor knew or should have known at the time of the accident rather than what might be deemed foreseeable in hindsight.
Each of the claims made by the patient under the KPLA was founded in negligence and required evidence of foreseeability, the court explained. The patient admitted that B&L did not sell Besivance in a defective condition, thus preventing her from maintaining a viable strict liability claim against B&L. Without a strict liability claim, she could not rely upon any presumption that B&L knew that off-label use of Besivance could cause injury.
The Kentucky Supreme Court has previously provided clarification as to the difference between negligence and strict liability under the KPLA. Negligence depends on what a prudent manufacturer, by the exercise of ordinary care, actually should have discovered and foreseen, whereas strict liability depends on what the manufacturer would have anticipated had it been (but regardless of whether it actually was or should have been) aware of the condition of and potentialities inhering in the product when the company put it on the market. Where one is actual, the other is postulated.
Even under Kentucky products liability law, the elements of negligence remain the same, including foreseeability, the court explained. The KPLA imposes upon manufacturers a duty to test their products for risks that they or the medical community "had a reasonable basis to suspect" might exist. However, Kentucky courts do not require manufacturers to lead scientific research into the forays of cutting-edge medical advances. A manufacturer’s liability for failure to warn follows only if it knew or should have known of the inherent dangerousness of the product and failed to accompany it with the quantum of warning adequate to guard against the inherent danger.
Here, the patient cited case law in an effort to demonstrate that B&L had a duty to warn of potential risks that could arise when using Besivance. However, the cases cited by the patient all turned on the presence of evidence that the drug manufacturers had actual knowledge of reported risks or dangers associated with the use of their pharmaceutical products. Additionally, more recent case law reaffirms that warnings must be given for off-label use only when there is empirical evidence of harm that is known by the manufacturer.
In this case, the court noted, there simply was no evidence suggesting that B&L knew or should have known that the use of Besivance in PRK was associated with any adverse effects. Following the trial court’s evidentiary holdings, the patient was left with no evidence suggesting that B&L knew or should have known that there could be risks associated with Besivance use at all. The patient argued that B&L had a duty to notify physicians of any additional side effects discovered from its use. While this was an accurate statement of law, the court stated, there had not yet been evidence to suggest that using Besivance in PRK could be dangerous.
While the patient’s injury was undoubtedly lamentable, the court said, it could not hold that B&L had a duty to warn of or test for risks without any reason to suspect that there could be risks associated with this particular use of Besivance. Given the lack of specific evidence that B&L had prior knowledge that its product posed a risk to patients when used for infection control following surgery, the patient argued that the court should infer that B&L’s promotion of its product for an off-label use without prior testing was a sufficient basis upon which to predicate foreseeability of harm. However, given that Kentucky does not prohibit the off-label promotion and marketing of drugs, the court did not believe that it was appropriate to extend the law of negligence in this regard.
The patient had not established an industry or company standard for off-label promotion outside of the FDCA against which B&L’s promotion of Besivance could be weighed, the court determined. If the patient wanted to rely upon FDCA regulation of off-label promotions, she should have brought a claim under the FDCA, the court noted.
After the trial court excluded much of the testimony regarding the use of Besivance, the patient was unable to identify any admissible evidence tending to show that B&L knew or should have known that her doctor’s decision to use Besivance in PRK might lead to medical complications. Therefore, the court held that the patient failed to meet her prima facie burden of proof, making summary judgment the appropriate result. Accordingly, the Kentucky appeals court affirmed the trial court’s order in favor of B&L.
The case is No. 2018-CA-1762-MR.
Attorneys: Thomas K. Herren (Law Offices of Herren & Adams LLP) for Karin J. Stiens. John L. Tate (Stites & Harbison, PLLC) for Bausch & Lomb Inc.
Companies: Bausch & Lomb Inc.
MainStory: TopStory DrugsNews WarningsNews CausationNews KentuckyNews
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