The Cranial Technologies lawsuit picture has two sides. The company itself is the plaintiff in intellectual property cases it has brought against competing helmet makers, and its flagship product, the DOC Band, has been at the center of separate insurance-coverage lawsuits filed by families against insurers that refused to pay for treatment. Cranial Technologies has not been the defendant in any major reported product or consumer suit.
Patent Suit Against Ottobock and Active Life
On March 29, 2023, Cranial Technologies sued German medical-device maker Ottobock SE & Co. KGaA and its U.S. distributor, Active Life LLC, in the U.S. District Court for the Central District of California.1Justia. Cranial Technologies Inc v Ottobock SE and Co KGAA et al The complaint alleges that Ottobock’s MyCRO Band cranial helmet and its iFab manufacturing system infringe five Cranial Technologies patents covering methods for automatically selecting the shape and trim lines of a cranial remodeling device and for producing custom helmets using 3D printing.2Knobbe Martens. Cranial Technologies Sues Ottobock for Infringement of Cranial Remodeling Patents It was the first time Cranial Technologies had sued either defendant.
Ottobock and Active Life moved to dismiss the indirect and willful infringement claims. The court denied that motion, finding that Cranial Technologies had adequately alleged the defendants knew about the patents as of the filing of the complaint, which was enough to sustain the willfulness and indirect infringement claims.3Bloomberg Law. Cranial Technologies v Ottobock The case remains active on the Central District of California docket.1Justia. Cranial Technologies Inc v Ottobock SE and Co KGAA et al
Copyright Suit Against Alcam Medical
In January 2024, Cranial Technologies filed a separate action against Alcam Medical Orthotics and Prosthetics in the same California district, this time alleging copyright infringement rather than patent infringement.4PACER Monitor. Cranial Technologies Inc v Alcam Medical Orthotics and Prosthetics The case was assigned to Judge Jesus G. Bernal.5Law360. Cranial Technologies Inc v Alcam Medical Orthotics and Prosthetics
It did not last long. Cranial Technologies voluntarily dismissed the suit without prejudice on March 1, 2024, roughly five weeks after filing.4PACER Monitor. Cranial Technologies Inc v Alcam Medical Orthotics and Prosthetics Because the dismissal was without prejudice, refiling remains possible. The public docket does not explain whether the parties settled privately or the company simply chose not to pursue the claim.
Insurance Coverage Lawsuits Over the DOC Band
The most consequential litigation involving Cranial Technologies’ product has been brought by families, not by the company. Insurers have often classified cranial helmet treatment for positional plagiocephaly as cosmetic and denied coverage, prompting appeals and lawsuits.
In Bynum v. Cigna Healthcare of North Carolina (2002), the U.S. Court of Appeals for the Fourth Circuit called Cigna’s denial of DOC Band coverage “objectively unreasonable” and an “abuse of discretion,” rejecting the insurer’s cosmetic characterization. The court also noted that Cigna had a “financial self-interest in defining ‘cosmetic’ in a broad manner” given the rising volume of such claims.6South Carolina Court of Appeals. James v State of South Carolina Employee Insurance Program, Opinion No. 4182
Four years later, the South Carolina Court of Appeals affirmed in James v. State of South Carolina Employee Insurance Program (2006) that DOC Band treatment for an infant with plagiocephaly and torticollis was medically necessary to prevent potential functional problems such as jaw misalignment. Both the state employee insurance program and Blue Cross Blue Shield of South Carolina had denied the claim.6South Carolina Court of Appeals. James v State of South Carolina Employee Insurance Program, Opinion No. 4182
In 2008, Blue Cross Blue Shield settled a class action after being accused of refusing to pay for hundreds of cranial helmets used to treat infant skull deformities. The terms of the settlement do not appear to have been publicly disclosed.7Fox 5 NY. Investigation: Insurance Companies Denying Cranial Helmets for Infants With Flat Head Syndrome
Coverage is still uneven. Cranial Technologies says roughly 70% of insurance providers offer some form of DOC Band coverage, with actual reimbursement depending on the policy and the child’s diagnosis.8Cranial Technologies. Navigating Insurance
Why These Disputes Keep Arising
The insurance litigation persists because the underlying medical question is contested. Some research supports helmet therapy: a 2015 study in Plastic and Reconstructive Surgery analyzing more than 4,300 infants reported a 94% correction rate with helmets, compared with 77% for conservative treatment such as repositioning and physical therapy.9American Society of Plastic Surgeons. Study: Conservative Treatment Normalizes Head Shape in Most Infants With Skull Flattening10National Library of Medicine. Cranial Helmet Therapy for Positional Plagiocephaly11Evidence-Based Interventions. Helmet Therapy for Treatment of Positional Plagiocephaly/Brachycephaly in Children The American Medical Association has taken the position that correction of facial anomalies and congenital deformities is a functional medical necessity rather than cosmetic care.6South Carolina Court of Appeals. James v State of South Carolina Employee Insurance Program, Opinion No. 4182 Without a settled clinical standard, insurers can lean on studies questioning efficacy while families and clinicians cite evidence of real benefit.
About the Company Behind the Cases
Cranial Technologies was founded in 1986 and is the leading U.S. provider of custom cranial orthotics, with more than 100 clinics and over 500,000 patients treated.12Cranial Technologies. Cranial Technologies Its DOC Band is a custom-fitted helmet for infants between 3 and 18 months of age. The company holds more than 34 patents covering its cranial remodeling products and manufacturing processes, with more pending, and states on its website that it “expects others to respect” its intellectual property, a posture consistent with its recent enforcement filings.13Cranial Technologies. Intellectual Property