Orthodontic and third-party agreements: risks and concerns.

In recent times, there has been a growing number of companies on the internet offering orthodontics like braces, aligners, and other products that people can use at home. While the convenience is very appealing for patients, the same can’t be said about the risks and concerns that come with partnering with foreign-based aligner companies. With the recent demise of two overseas aligner providers, some dentists have not been able to continue patient care in the middle of a course of orthodontic treatment. This has resulted in patient complaints against dentists, who had no part in the companies’ collapse but are left to manage the fallout and develop a re-treatment plan with another aligner provider.

Another recent development is that patients are asking dentists to place attachments for “at-home, do-it-yourself” aligner treatment. Seeing that this is a complex issue, the ADAVB has approached their advisors at Meridian Lawyers to make general comments about the pitfalls for dentists undertaking either of these two types of treatment. Their advice is that the provision of aligners and/or attachments may make the dentist liable for any adverse treatment outcomes and possibly affect a dentist’s professional indemnity (PI) cover.

The ADAVB recommends that any member undertaking orthodontic treatment with third-party aligner providers familiarise themselves with the risks and ensure that they are not exposing themselves to additional liability, which may place them in a precarious position when defending a claim.

Major concerns 

Treatment plans by aligner companies are often computer-generated offshore with some input from a technician. Blindly following these plans may result in a compromised outcome and potentially irreversible damage. Orthodontists often make changes before a satisfactory plan is reached and may even further modify plans during treatment, depending on the progress. As the clinician, you’re responsible for the treatment and any adverse outcomes, not the aligner company that generated the treatment plan.

As a result, any claims by patients would most likely be against the dentist or the clinic. Contractual and duty of care considerations need to be taken into account. Even if the contract says the aligner company will cover your liability, that can’t be enforced. By Australian law, the dentist cannot delegate liability for treatment performed to another party. So, in the end, the problem comes back to bite the dentist.

Fault by association

A claim against the aligner provider would necessitate chasing shelf and overseas companies, making it almost

impossible for the patient. The patient will turn to the only person they can reach and direct the blame to – their dentist. It should be noted that at present, there are two class action claims in courts overseas against aligner providers, but these may take years to play out, and it’s unknown if they will be successful.

An insurer is not privy to the contracts dentists sign or warranties offered by aligner companies. This means warranties deflect back to the dentist and may not be covered under a professional indemnity policy. In Australia, health service providers cannot give warranties, so that part of the company’s “promise” is worthless unless it relates specifically to the aligners themselves (breakages, replacements, etc), not treatment outcomes. 

The issue with consent

Informed consent is potentially lacking as most dentists are utilising documents supplied by the aligner company, which in many cases, are not comprehensive enough to satisfy the Australian Code of Conduct requirements.

Less experienced dentists are often targeted to promote this type of orthodontic treatment as an easy treatment option to provide to patients. Patients seeking aligner treatment usually have high expectations, and it can be challenging to achieve the desired result using aligners only. 

Unaligned with Australian laws

While there is a high demand for DIY aligners, dentists should be mindful that undertaking treatments designed by a foreign company can bring more damage than good, especially as they don’t usually meet the standards set by

Australian authorities. Some examples of these breaches include:

> Against regulatory guidelines: advertising may not be compliant with Ahpra’s Code of Conduct because the company is based abroad.

> Products may not be TGA approved (as required in any PI policy): there is a high risk that the insurer may reject a claim when these devices are being used.

> Australian Privacy Principles (APPs) may be broken by sending confidential patient information overseas: if there is a breach of privacy, the insurer can deny cover as the policy wording indicates the dentists must abide by the APPs in how they store patient information. Foreign companies are not bound by the APPs, so a dentist must weigh the risks and inform the patient about the potential breach of confidentiality before undertaking treatment. In saying that, the risk

remains that an indemnity claim could still be denied.

> Companies may offer incentives or discounts, equipment, etc: these all need transparent disclosure under Ahpra’s regulatory framework. If you don’t disclose these on all advertising and patient material, you could be in breach of Ahpra

or TGA’s advertising standards and guidelines.

A professional indemnity policy is a contract between you and your insurer, and part of that contract is that you will abide by all regulatory requirements, and the issues mentioned above may expose you to a regulatory finding of

unsatisfactory professional conduct.

The ADAVB recognises that there are a lot of hidden issues that members are not familiar with. It’s strongly recommended that you consider your practice before agreeing to take on such treatments. ADAVB has provided some links to follow if you would like more information. You can also speak to your Account Manager or contact Guild Insurance at 1800 810 213 to review your policy for coverage and exclusions.

Australian Health Practitioner Regulation Agency (Ahpra) – Guidelines for advertising
Therapeutic Goods Administration – The Therapeutic Goods Advertising Code:  tga.gov.au/about-tga/legislation/legislationand- legislative-instruments/therapeutic-goodsadvertising- code

 

Office of the Australian Information Commissioner (OAIC) – Australian Privacy Principles: oaic.gov.au/privacy/australian-privacy-principles

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    Guild Insurance Limited ABN 55 004 538 863, AFS Licence No. 233 791.  This article contains information of a general nature only, and is not intended to constitute the provision of legal advice. Guild Insurance supports your Association through the payment of referral fees for certain products or services you take out with them    .

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