Products Liability Law Daily Wrap Up, WARNINGS ISSUES—MEDICAL DEVICES—D. Conn.: Connecticut product liability claim against Novo Nordisk for alleged insulin pen “backflow” survives dismissal, (Feb 13, 2025)

By Justin Marcus Smith, J.D.

Although the hospital could proceed with its product liability claim because it was not pleading “commercial” damages, negligence claims failed because it only alleged financial injury, and dismissed claims would have to be amended as CPLA “sub-claims.”

The Connecticut Product Liability Act (CPLA), Conn. Gen. Stat. §52-572m et seq., did not bar a hospital from bringing a product liability claim against Novo Nordisk, Inc. (Nordisk) in connection with alleged “backflow” from re-use of Novo Nordisk insulin pens, held the federal district court in New Haven, Connecticut. The hospital’s alleged out-of-pocket costs and settled losses in making third parties whole in an earlier class action were not excludable under the CPLA as “commercial” within the meaning of §52-572n(3). However, the hospital failed to allege a requisite physical injury to support claims of negligence. The failure to plead negligence also eliminated any possibility that Nordisk acted recklessly as well as the hospital’s calls for punitive damages or indemnification. The CPLA was ordinarily an exclusive remedy, but the court elected to consider certain UCC merchantability claims as CPLA “sub-claims.” Among these, only the implied warranty of merchantability claim survived because the court could not decide, at this stage, whether the pens were defective if used as instructed. The court also instructed that any repleading of claims dismissed without prejudice would have to be asserted as defective product sub-claims with the CPLA providing the cause of action (Griffin Health Services Corp. v. Novo Nordisk Inc., No. 3:24-cv-01045-JCH (D. Conn. Feb. 10, 2025)).

Background. A Connecticut -based hospital services corporation (hospital) sued pharmaceutical manufacturer Novo Nordisk, Inc. (Nordisk), in connection with the use of Nordisk multi-dose insulin pens. The pens consisted of a disposable needle and reusable insulin cartridge. When hospital staff re-used the pens, they were allegedly prone to “backflow” whereby blood cells contaminated the insulin cartridge. The hospital alleged that it treated more than 3,100 patients with the pens from 2008 to May 2014 and ultimately found itself at the wrong end of a patient class action about the backflow contamination problem. The hospital said it settled the suit for about $1 million and incurred additional costs to test patients for exposure to blood-borne illnesses and for responding to a Connecticut Department of Public Health investigation.

The hospital accused Nordisk of failure to warn. The hospital alleged that medical publications and news outlets began reporting about backflow problems with insulin pens, like the pens at issue here, in 2008. The hospital said the FDA had even issued a warning. There may have also been a class action lawsuit against Nordisk about the danger of sharing its insulin pens. The court declined to take judicial notice of certain hospital exhibits at this stage of the litigation; however, it footnoted that a preliminary review of the exhibits did not appear to support the hospital’s claim that Nordisk failed to warn adequately or failed to instruct about the proper use of the pens.

The hospital also claimed Novo Nordisk violated provisions of the Connecticut Product Liability Act (CPLA), Conn. Gen. Stat. §52-572m et seq., and fraudulently misrepresented the safety of its insulin pens. The hospital also sought indemnification for costs incurred as a result of Nordisk’s allegedly tortious actions. consequential damages.

Commercial loss. As to the count of claimed sale, manufacture, or distribution of a defective product, the court concluded the hospital could seek damages stemming from the costs it incurred reimbursing patients for injuries, if any, caused by Nordisk’s pens. Nordisk argued that the CPLA, Conn. Gen. Stat. §52-572n, barred this claim because, as between commercial parties, commercial loss caused by a product is not harm and is not recoverable in a product liability claim. The pertinent issue Nordisk raised here was whether the hospital’s alleged losses were commercial within the meaning of §52-572n(3).

The court found this case was analogous to a Connecticut Supreme Court case that allowed a claim for damages under the CPLA for costs incurred remedying damage done to third party property in Sylvan R. Shemitz Designs, Inc. v. Newark Corp., 291 Conn. 224 (2009) (Shemitz). The Shemitz court found the “commercial loss” exclusion under the CPLA did not apply to costs incurred by a commercial party in repairing or replacing a defective product or repairing property damage caused by a defective product. The instant hospital likewise sought damages for costs incurred in remedying personal injuries to third parties. The court commented that the CPLA applies with equal force to personal injuries and property damage. It was also of “no moment” that hospital’s damage claim stemmed from damage to third-party property.

Negligence claims. The court said that courts generally treat separately asserted claims, like the negligence claims here, as theories of liability arising under a single CPLA claim. Although exposure to risk of injury would be sufficient to allege actual injury if a sub-clinical injury has occurred, the first problem the court saw with the various negligence claims was that the amended complaint failed to allege that any person sustained a physical injury, rather than just a financial injury. This pleading defect required dismissal of count 1, negligence, as a sub-claim under count 4, sale, manufacture, or distribution of a defective product. The court dismissed count 1 without prejudice.

Turning to the negligent misrepresentation count, the court noted that the amended complaint did not allege anything about representations Nordisk made, if any, about the safety of using the insulin pens on multiple patients. This omission also called for dismissal, without prejudice. However, turning to count of gross negligence, the court analyzed that gross negligence was not a separately cognizable theory of liability. The court dismissed the gross negligence claim with prejudice.

Punitive damages. Inasmuch as the amended complaint failed to adequately allege a claim for negligence, that knocked-out any possibility that Nordisk acted recklessly in failing to place warning labels on the pens. And, by extension, that also eliminated the prayer for punitive damages.

Indemnification. The same reasoning applied to indemnification. The hospital could not pursue a claim for indemnification coextensive with its failure to plead a claim of negligence. The court dismissed the indemnification claim accordingly and without prejudice.

Fraudulent misrepresentation. The court dismissed count seven, fraudulent misrepresentation, without prejudice because it said it could not find any allegations in the amended complaint that Nordisk expressly claimed a single insulin pen could be safely used on multiple patients.

UCC. The hospital asserted three claims under the Uniform Commercial Code (UCC). Nordisk argued these UCC claims violated the CPLA. It also argued the warranty claim aspects ought to be dismissed for inadequate pleading. The court noted that at least some courts have dismissed UCC claims when the plaintiff also brought CPLA claims, and the court reached the same conclusion in this case. Shemitz made clear that the CPLA was an exclusive remedy for product liability claims, except, as already discussed, claims seeking compensation for “commercial loss,” not a bar to the CPLA action here. The hospital could not bring separate UCC claims and a CPLA claim. Even so, the court reasoned the hospital could bring well-pleaded UCC causes of action “as a basis for a product liability ‘sub claim’”.

Viewing the UCC claims as sub-claims, and turning first to whether the hospital perfected a pleading of breach of the implied warranty of merchantability, the court declined to consider, at this stage of the litigation, whether the pens were defective if used as instructed. The parties’ arguments interposed an issue of fact. The court accordingly denied Nordisk’s motion to dismiss the CPLA “sub-claim” for breach of implied warranty of merchantability. By extension, the court also declined to dismiss the incidental and consequential damages. However, it remarked that incidental and consequential damages was not a cause of action and the hospital should re-plead it as a remedy.

Last, the court found that the count of implied warranty of fitness for a particular purpose was inadequately pleaded. That was so because the amended complaint did not allege that Nordisk was aware that the hospital intended to sue the insulin pens for the “particular purpose” of administering one pen to multiple patients.

The case is No. 3:24-cv-01045-JCH.

Judge: Hall, J.

Attorneys: David J. Robertson (Heidell, Pittoni, Murphy & Bach, LLP) for Griffin Health Services Corp. d/b/a Griffin Hospital. Emily Ballard Marshall (DLA Piper LLP) for Novo Nordisk Inc.

Companies: Griffin Health Services Corp. d/b/a Griffin Hospital; Novo Nordisk Inc.; Novo Nordisk US Commercial Holdings Inc.; Novo Nordisk US Holdings Inc.; Novo Nordisk Pharmaceutical Industries, LP; Novo Nordisk Pharmaceutical Industries, Inc.

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