Failure to Warn of Side Effects: Ropinirole and Impulse Control Disorders
As medical negligence solicitors, we regularly act for patients who have suffered avoidable harm because they were not properly warned about material risks associated with their treatment. Ropinirole, a dopamine agonist commonly prescribed for Parkinson’s disease and Restless Legs Syndrome, has been at the centre of a growing number of cases where patients were not advised of the risk of serious behavioural side effects, including impulse control disorders. Where warnings are omitted or inadequate, and harm follows, a legal remedy may be available.
What Ropinirole Is Prescribed For
Ropinirole is a dopamine agonist that mimics the action of dopamine in the brain. It is widely used to alleviate symptoms associated with low dopamine levels, notably in Parkinson’s disease and Restless Legs Syndrome. When prescribed appropriately and with adequate monitoring, it can be effective in improving motor symptoms and quality of life. However, the benefits must be balanced against known risks, and patients must be given clear, tailored information to make an informed decision.
Known Risks and Adverse Effects
In addition to common minor side effects, there is well-documented concern—both clinically and in the public domain—about Ropinirole’s association with impulse control disorders. These may present as compulsive spending, gambling, high-risk behaviours, and problematic sexual behaviours. For some patients, these behaviours escalate and cause profound social, financial, and psychiatric harm. Crucially, these risks are not theoretical; they are recognised, foreseeable, and require careful counselling before treatment begins and vigilant review thereafter.
The Legal Duty to Warn and Obtain Informed Consent
Clinicians owe a duty to take reasonable care to inform patients of material risks and reasonable alternatives before prescribing medication. The Supreme Court’s decision in Montgomery v Lanarkshire Health Board makes clear that patients must be told about risks that a reasonable person in their position would likely find significant, as well as any particular concerns a specific patient has. This duty applies to pharmacological treatments no less than surgical procedures, and it includes risks of behavioural and psychiatric side effects where they are known or reasonably foreseeable.
The High Court decision in Kennedy v Frankel illustrates these principles in the context of Ropinirole. Mrs Kennedy, treated for Parkinson’s disease, developed an impulse control disorder and later psychosis while on Ropinirole. She experienced severe financial and personal consequences, including relationship breakdown and unfounded accusations flowing from her condition. The Court found that the treating clinician failed on two occasions to advise her of the risks posed by Ropinirole, breaching the duty to warn and rendering him liable for the resulting loss.
At the same time, case law such as Khan underscores that a failure to warn, by itself, is not sufficient to establish liability. The claimant must also prove causation—that had proper advice been given, they would have declined or altered treatment, and that the medication more likely than not caused the harmful behaviours. In practice, this often requires expert medical evidence, contemporaneous records, and careful analysis of the patient’s decision-making and symptom timeline.
Pathways to Redress
Where a patient has suffered harm linked to Ropinirole and was not adequately warned or monitored, several legal routes may be considered.
Clinical negligence claims focus on whether the prescribing clinician or Trust fell below the standard of a reasonably competent practitioner by failing to warn of material risks, failing to discuss reasonable alternatives, or failing to monitor and act on emerging red flags. The claimant must establish breach of duty, causation, and loss on the balance of probabilities, supported by expert evidence.
Product liability claims may be available where a medicinal product is considered unsafe due to inadequate warnings or instructions under the Consumer Protection (Northern Ireland) Order 1987. This imposes strict liability in appropriate circumstances, typically requiring an assessment of the product’s safety expectations and the adequacy of its risk information.
Informed consent claims, post-Montgomery, centre on whether a patient was given the information a reasonable patient in their position would consider significant, including the risk of impulse control disorders and the availability of alternative treatments or dose adjustments. The omission of a known or foreseeable risk can amount to a breach of the duty to inform.
If a claim succeeds, compensation may cover physical and psychiatric injury, financial losses such as gambling debts or uncontrolled spending, treatment and care costs, and related consequential losses, including relationship and housing impacts where causally connected. Generally, claims must be issued within three years of the date of knowledge of the injury, although the Court retains a discretion to extend this in limited circumstances.
How We Can Assist
Specialist legal advice at an early stage is crucial. A proper assessment will examine prescribing decisions, documentation of consent, the timing and nature of behavioural changes, steps taken to monitor and respond to side effects, and the financial and personal consequences. Where the evidence supports a breach of duty and causation, we will pursue the fullest recovery available, including interim funding where appropriate and expert-led rehabilitation planning.
If you or a family member has experienced unexpected behavioural changes, financial harm, or psychiatric injury that may be linked to Ropinirole, we can provide clear, compassionate, and experienced representation. Please contact enquiries@paduffy.com or phone us to discuss your options in confidence.