Doctors strive to give their patients the best care possible, using their skills and expertise to deliver an outcome the patient is satisfied with. However, there are occasions when the patient may believe the care provided is substandard, and this could result in a clinical negligence claim. The matter of who is at fault may get more complicated when the claim involves a product, such as drugs, prostheses, dressings, and devices, as who would the fault lie with? Medical Protection looks at how a patient can claim compensation in such a situation, and how it can impact on the clinician.
Under product liability law, a claim can be made against the supplier of a product if it is of substandard quality, by poor design, manufacture, or otherwise. A product might be found to be substandard if it does not fulfil either claims made by the manufacturer or the reasonable expectations of a consumer. The ‘supplier’ includes the person who, effectively, sold the product to the patient, but also the manufacturer and any intermediate distributor.
Some doctors might feel this is a niche legal issue that does not apply to them, but whenever the ownership of a product passes from the doctor to the patient, it becomes relevant. An example of this could be in the specialist private sector where the clinician owns a stock of prostheses or devices that are passed to patients. A claim for a faulty product can usually be passed from the provider back to the manufacturer, who should have insurance to deal with such an issue. However, there are pitfalls where the doctor might be personally vulnerable.
Consent not informed
Products may have an intrinsic imperfection, which could lead to problems for patients, but is not considered a defect in law. For example, breast implants may rupture or leak even when in their optimum undamaged state at implantation. Failure to warn of risks that might be important to the patient could lead to a claim in negligence if the risk eventuated, rather than a claim under product liability law. The judgment in Montgomery[1] means doctors need to be careful to discuss the patient’s particular concerns.
Not used for expected purpose
Manufacturers market products and consumers use the products with a reasonable expectation as to how they are intended to be used. If a doctor uses a product for a purpose that lies outside that normal expectation, then a claim might be pursued if the product fails, and harm ensues. For example, the femoral component of a hip prosthesis might be designed to work with a particular acetabular component. If a different acetabular component is used, the prosthesis fails, and the patient suffers harm as a result. In this case, the manufacturer might well try to defend a product liability claim against them. This is on the basis that the product was not used with a compatible component, in the hope of passing any liability to the clinician.
Creation of a new product
Similarly, if a product is altered before it is used, the manufacturer might say it is no longer their product. This might happen where, for example, two topical creams are mixed before dispensing, or where the integrity of a slow-release medication device is altered (a patch cut or a tablet crushed). If the new product causes any harm, the original manufacturer might claim that the person who created the ‘new’ product is liable, as they altered the original product.
Manufacturer in liquidation
It hit the headlines when PIP implants were found to be made to a poor standard, and surgeons who owned the prostheses before effectively selling them to patients were caught up in the product liability litigation[2]. However, where the surgeon merely implanted prostheses that were sold by a clinic or hospital, they were outside the chain of product liability. The manufacturer was successfully prosecuted and went into liquidation.
Conclusion
Doctors need to be aware about the pitfalls in the use of medical products and that they could be held liable if found to be supplying substandard products. Modifying a product before use, using a product for a purpose for which it was not designed, and using components together to form a new product, might mean the doctor is seen by some to be ’stepping into the shoes of the manufacturer’ of the product, and if so, liability for a problem in the product might not be passed up any supply chain. Practices should ensure they have adequate cover for product liability, which is a matter that falls outside of healthcare indemnity, as well as that provided by Medical Protection.
Any members subject to a claim should contact Medical Protection as well as their insurers for further advice about product liability.
[1] https://www.medicalprotection.org/uk/articles/new-judgment-on-patient-consent
[2] https://www.itv.com/news/2021-05-20/pip-breast-implant-scandal-heres-what-you-need-to-know