A federal court jury in Vermont returned a $6.5 million verdict in favor of the parents of a 6-year-old boy with cerebral palsy who suffered seizures after receiving off-label Botox treatment for his mild muscle spasticity. The jury determined that the defendant, Allergan Inc., negligently promoted the off-label use of Botox to treat muscle spasticity in children at unsafe high doses and failed to sufficiently provide the little boy’s parents and his health care providers with information about the drug’s known risks and dangers, such as seizures, side effects and harmful immune responses.
The jury did find, however, that Allergan had not violated the Vermont Consumer Fraud Act by deceptively promoting Botox for its off-label use in children with muscle spasticity. The jury awarded the Drakes $2.5 million in compensatory damages and $4 million in punitive damages. The trial strategy for the plaintiffs was to put the CEO of Allergan and the company’s ethics on trial in this case.
The parents filed suit in 2013 against the pharmaceutical company after their son, who had mild spasticity in his legs, began having seizure-like episodes requiring hospitalization after a Vermont doctor injected him with Botox. The Drakes said: Prior to his Botox injections, J.D. could walk, feed himself, brush his teeth and speak. He had no history of seizures.
Dr. Scott Benjamin injected almost 7 u/kg of Botox into the boy’s calves in April 2010. Two days after the injections, the child’s complained of pain and his walking became more and more unstable. The doctor injected him again in May with almost twice as much Botox. The next day, the boy began vomiting and had trouble breathing and speaking, in addition to having seizure-like symptoms. He was rushed to the emergency room and diagnosed with an allergic reaction to Botox.
Since then, the boy has continued to have seizures and has developed a chronic, life-threatening immune response. The maximum safe dose for Botox, which has never been approved by the U.S. Food and Drug Administration to treat pediatric spasticity, is 8 u/kg. The FDA denied to approve the drug for that indication because Allergan couldn’t show it was effective at safe doses.
Allergan has continued to promote the off-label use of Botox to treat children. The majority of Botox sales are for off-label indications. It was alleged in the complaint:
The FDA made clear to Allergan in 2009 that it was free to warn physicians about the maximum safe dose for children, but to date Allergan has failed to make that information public. Instead of warning, Allergan continues to sponsor ‘medical education’ activities and dosing schedules that encourage physicians to use unsafe doses higher than 8 u/kg.
Allergan pled guilty to off-label promotion of, among other indications, pediatric spasticity, and agreed to pay $600 million in civil and criminal penalties to the United States government in 2010. Allergan never disclosed information about side effects or seizures in warnings, promotional or marketing materials. Instead, it had a corporate plan to illegally promote the off-label use of Botox by physicians. In addition to promoting Botox at doctors’ conferences, Allergan established and funded two organizations for the express purpose of promoting off-label use of Botox. Allergan has publicly stated that Botox is a miracle drug and has often compared it to penicillin. Side effects are rarely mentioned and consistently understated.
Pharma Manufacturing reports that the FDA has
posted a warning letter stating that management at
Valeant Pharmaceuticals failed to properly oversee a
contract manufacturer that supplied it with Sculptra
Aesthetic (injectable poly-L-lactic acid). In particular, the
FDA found no evidence that anyone at Valeant had
reviewed and approved the vendor’s deviation report
after the manufacturer stopped production to fix
problems affecting drug quality. The article says that the
FDA “wants to see evidence Valeant has taken steps to
improve its monitoring of CAPAs and review of supplier
deviation reports.” However, Valeant is confident it can
resolve the issues raised and has already divested
Sculptra Aesthetic as part of a deal with Nestle’s
Galderma unit.
Sculptra Aesthetic, a facial injectable that is marketed to smooth wrinkles. The product competes with Juviderm, which is sold by Allergan. Valeant is trying to buy Allergan, which also sells Botox, for $53 billion in conjunction with Pershing Square Capital Management.
Nonetheless, the letter raises the possibility that Allergan and its supporters may use the agency warning to support their argument that Valeant cutbacks focus too heavily on areas other than marketing, which may jeopardize R&D or patient safety. Earlier this week, the Allergan board reiterated that the Valeant offer is “grossly inadequate and substantially undervalues” Allergan.
We asked Valeant for comment and will update you accordingly. [UPDATE: Shortly after we posted, Valeant released a statement that says, in part, the warning letter "pertains to the management of Valeant's contract manufacturers, rather than Valeant's own internal manufacturing." A Valeant spokeswoman adds that Sculptra Aesthetic was sold shortly after the inspection.]
