Experimental Treatments Show Promise and Risk for Cerebral Palsy Patients
Children with cerebral palsy have one of several neurological disorders that permanently affect body movement or muscle coordination. The problem is not with the actual muscles; rather, it’s with the part of the brain that controls the muscle movement. Treatments for cerebral palsy include:
- Physical and occupational therapy
- Speech therapy
- Medications aimed at controlling seizures, muscle spasms and pain
- Braces or orthotic devices
- Communication aids
Sometimes, surgery is recommended to release tight muscles.
Over the past ten years, a new type of therapy has emerged which uses Botox injections to treat children with a particular type of cerebral palsy involving “spasticity.” Spasticity causes muscle stiffness and tightness that interferes with voluntary movements (like walking). Several videos have surfaced showing young children with cerebral palsy walking for the first time after receiving Botox injections to treat spasticity in their legs.
What the videos don’t show, however, are the risks of using Botox in this “off-label” manner. Doctors routinely prescribe medications for off-label uses, and we want doctors to have the ability to use their knowledge, experience and judgment to decide how best to use a medication for an individual patient. But doctors must know when a particular use of medication is “off-label,” and doctors must know of the risks associated with such uses.
Pharmaceutical companies are not allowed to market drugs for off-label uses. If a company knows a use is off-label, its representatives are not allowed to pitch that use to doctors as if the use has been cleared by FDA. Likewise, if the manufacturer is aware of risks associated with off-label uses of its products, it should share those risks. Doctors need to know when a use of medication is off-label as well as what potential side effects may exist so that they can assess the risks and benefits of the off-label use with their patients. This is especially true when the patient is a child with cerebral palsy.
A federal jury in Vermont recently decided to hold a large pharmaceutical company responsible for failing to properly share this type information about one of its products in the case of Drake v. Allergan, Inc. The court decided in November to hold Botox manufacturer Allergan responsible for its off-label promotion of Botox when a child suffered epileptic seizures after receiving Botox injections. In this case, the jury determined that Allergan had committed two major violations of Vermont’s consumer protection act. First, by marketing Botox for use in children at unsafe doses; and secondly, by failing to provide doctors and patients with full information about the risks and dangers known to the company.
If your child has experienced any serious medical problems as a result of receiving Botox injections to treat spasticity related to cerebral palsy, you may be entitled to compensation.
Call 1 800 YOST LAW (967-8529) for help. There is no fee or expense unless you recover.
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