Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)—S.D.N.Y.: ScarAway manufacturer awarded summary judgment in facial injury suit, (Aug 27, 2026)

By Chelsea N. Simms, Esq.

Without expert proof of causation, the consumer could not establish that brief contact with an over-the-counter silicone scar sheet caused skin, sensory, or nerve injuries.

The United States District Court for the Southern District of New York granted summary judgment on a strict products liability claim alleging injuries from ScarAway silicone scar sheets because the claim lacked proof that the product proximately caused the alleged injuries. Because the claimed reactions—including chemical burn, permanent skin damage, altered facial appearance, diminished sense of smell, and permanent nerve damage—presented complex medical causation questions beyond ordinary lay experience, the court required admissible expert testimony as to general and specific causation. The consumer submitted no expert report or other admissible expert evidence, and her testimony, recollections of statements allegedly made by medical providers, and asserted ability to draw conclusions from the sequence of events did not satisfy the evidentiary burden. Because she could not establish causation, the court entered summary judgment for the product manufacturer (McKenzie v. Perrigo, No. 22 Civ. 8720 (AEK) (S.D.N.Y. Aug. 25, 2026)).

In July 2019, a consumer sought treatment for facial injuries sustained during a fight with her boyfriend. On the suggestion of office staff at a dermatologist’s practice, the consumer applied ScarAway—an over-the-counter FDA Class-1 medical device containing medical-grade silicone—to the injury under her right eye. Before applying it, she did not independently research the product, read the warnings or instructions on the box, or seek clinical guidance. She kept the sheet on the injury for less than one minute and removed it after reporting immediate swelling and an attacking sensation. She washed her face with soap and water but did not seek medical care that day. The next day, after an internet search, she applied an unidentified acetone-containing product to the outer portion of her right cheek, away from the area where she had placed ScarAway. She later told a medical provider that the acetone may have burned the area further. In August 2019, she received diagnoses of a superficial wound abrasion, superficial burn, and hyperpigmentation. She then used Vaseline on the injury but declined to use a prescribed topical cream. At a follow-up visit four days later, the medical record reflected a 75 percent improvement because the scab on the right side of her face had resolved. She later sought care for hyperpigmentation and was advised to avoid sun exposure. She did not seek further treatment for injuries attributed to the incident until February 2022.

Causation. The court found that the events described by the consumer could not substitute for expert medical evidence. Her allegation that symptoms began immediately after application did not permit a reasonable jury to determine that the silicone sheet caused the full range of claimed conditions. Her account also included other possible sources of injury that required medical assessment, including the underlying traumatic facial injury and the later application of an acetone-containing product. She asserted that a physician in Jamaica told her silicone was in her skin and difficult to remove, but she produced no medical records or affidavit from that physician. She also recalled that a provider told her she had trigeminal nerve damage after reviewing an MRI report concerning her upper back following a motor vehicle accident. She supplied no evidence connecting any such nerve injury to ScarAway. In fact, she testified that no physician ever told her that ScarAway caused her skin injuries, and that she was never diagnosed with chemical burn, nerve damage, or an aggravation of bipolar disorder as a result of using ScarAway. These unsupported recollections did not establish either that the product was capable of causing the alleged conditions or that it caused them in her case. Her education, military service, and status as a licensed massage therapist likewise did not qualify her to give a causation opinion under Federal Rule of Evidence 702. The court explained that her assertions remained lay conclusions rather than reliable scientific or medical proof.

The manufacturer’s expert evidence reinforced the absence of a triable causation issue. A board-certified dermatologist reported that no evidence or feasible scientific explanation showed how less than one minute of contact with a silicone scar patch could damage the skin. The dermatologist found no causal connection between ScarAway and the reported skin changes and identified the traumatic injury and use of an acetone-based product as more likely causes, particularly if an open wound existed when ScarAway was applied. A board-certified neurologist found no objective evidence of facial nerve injury. The neurologist further concluded that any sensory complaints arising between 2019 and 2022 were not caused by ScarAway because they did not appear immediately after use, and that other causes of facial pain would require a separate diagnosis unrelated to the initial skin injury. The consumer offered no expert evidence to counter these opinions.

Finding that, without expert testimony on general and specific causation, no reasonable factfinder could determine that ScarAway caused the alleged injuries, the court granted the manufacturer’s request for summary judgment.

The case is No. 22 Civ. 8720 (AEK).

Judge: Krause, A.

Attorneys: Kellyann McKenzie, pro se. Vincent Robert Lodato (Sills Cummis & Gross P.C.) for Perrigo Co.

Companies: Perrigo Co.

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