Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)—D. Conn.: Novo Nordisk stuck with products liability claims involving insulin pens, (Jul 30, 2026)

By Jeffrey H. Brochin, J.D.

Disputed facts remained regarding warnings, training, product risks, and the adequacy of information provided to hospital staff.

A federal District Court in Connecticut has denied in part the Motion for Summary Judgement filed by Novo Nordisk, Inc. (Novo Nordisk or Manufacturer) in a products liability lawsuit brought by Griffin Health Services Corp. (Griffin or Hospital) regarding Novo Nordisk’s insulin pens. The lawsuit alleged that Novo Nordisk failed to provide any warnings during the period 2008-2014 as to the dangers of multi-patient use of a single pen. Although Novo Nordisk argued that the Learned Intermediary Doctrine applied and that they therefore had no duty to warn an end-user, the court ruled that because Griffin obtained the insulin pens directly from Novo Nordisk—and not from an intermediary—warnings should have been made to Griffin. However, the court granted the motion with regard to the indemnification claims (Griffin Health Services Corp. v. Novo Nordisk, Inc., No. 3:24-cv-01045-JCH (D. Conn. July 24, 2026)).

Lack of multi-patient use warning. Novo Nordisk designs, manufactures, and distributes prefilled, disposable insulin delivery devices (pens) approved by the FDA, that Griffin used at its hospital. During the period 2008-2014, the pens did not contain any warnings as to the risk of backflow of biological materials and risk of bloodborne infections if an insulin pen was used on more than one patient. Novo Nordisk only placed a “For Single Patient Use Only” warning label on their insulin pens after the FDA required Novo Nordisk to do so in February 2015, which was almost one year after Griffin Hospital discovered that members of its nursing staff had used insulin pens on multiple patients.

Following the discovery in May 2014 that Novo Nordisk’s insulin pens were shared between different patients, the Connecticut Department of Public Health (CDPH) conducted an investigation into the incident. CDPH investigators reviewed the education materials provided to hospital staff by Novo Nordisk and concluded that the information “failed to indicate that insulin pens were intended for single patient use only.” CDPH also interviewed hospital staff and identified at least 12 nurses who reported they had not been instructed that insulin pens were single patient use only. Griffin filed suit alleging, among other claims, failure to warn, design defect, negligence, and breach of implied warranty of merchantability. Presently before the court were Novo Nordisk’s Motions for Summary Judgement.

Wrongful conduct rule. Novo Nordisk argued that Griffin’s suit should be barred by the wrongful conduct doctrine. Because Connecticut prohibits recovery for injuries sustained as a direct result of intentional or knowing participation in an illegal act, Griffin should not recover. Novo Nordisk cited multiple statutes in support of that argument, including that Griffin’s wrongful conduct arose from giving one patient’s prescription medication to another patient, which is against federal and state law, as well as hospital policy.

However, the court rejected that argument, noting that the Hospital was not seeking to recover from an illegal activity in which it participated; rather, the claim was premised on the harm caused by Novo Nordisk’s lack of information provided through training and the inadequate warning on the insulin pen product. The court ruled that the statutes cited were not applicable to the facts of the instant case, and they denied the motion based on that doctrine.

Design defect claim. Novo Nordisk argued that Griffin had not provided any evidence, expert or otherwise, relevant to the issue of whether the insulin pens were defectively designed. Griffin’s own witnesses (two doctors) testified that the alleged risk of backflow was probably zero and the risk was never proven. Furthermore, Connecticut applies the modified consumer expectation test where the product involves complex designs, and according to Novo Nordisk, the failure to establish the several essential elements of that test warranted summary judgment. However, the court found that a reasonable jury could find that Griffin was unaware of any risk, and that Novo Nordisk failed to warn or train users on the dangers of contamination. Accordingly, Griffin was not required to prove there was a feasible alternative design, and summary judgment on the design defect claim was therefore denied.

Learned intermediary doctrine. The court next examined the Motion for Summary Judgement as to the failure to warn claim. Novo Nordisk asserted that Griffin must establish: (1) the likelihood that the product would cause the harm suffered; (2) the ability of the product seller to anticipate at the time of manufacture that the expected product user would be aware of the product risk, and the nature of the potential harm; and (3) the technological feasibility and cost of warnings and instructions. In addition, Novo Nordisk argued that, under the “learned intermediary doctrine,” the manufacturer of a prescription pharmaceutical or medical device is not required to provide a warning to the ultimate consumers; instead, the doctrine provides that adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly.

The court rejected this argument, observing that insulin pens are medical devices and therefore inherently unsafe devices. A manufacturer of such inherently unsafe products can avoid liability under the CPLA for injuries that they cause only if the products are properly prepared and accompanied by proper directions and warnings. Although generally, a manufacturer's duty to warn of dangers associated with its products pertains only to known dangers and runs to the ultimate user or consumer of those products, the Connecticut Supreme Court has recognized an exception to this general rule regarding warnings related to prescription drugs and medical devices. The exception, known as the learned intermediary doctrine, provides that adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly. But here the court found the doctrine to be inapplicable because Griffin had purchased the pens directly from Novo Nordisk, with no intermediary involved. Because a genuine dispute of material fact existed as to whether Novo Nordisk provided any warnings at all, the learned intermediary doctrine could not resolve the Motion for Summary Judgment.

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

Judges: Hall, J.

Attorneys: David Alexander Dayya (Murphy & Bach LLP) for Griffin Health Services Corp. Lesley P. Chuang (DLA Piper LLP) for Novo Nordisk Inc.

Companies: Griffin Health Services Corp.; Novo Nordisk Inc.

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