New York family awarded $6.75 million in Botox lawsuit
MINEVILLE, New York— Mild redness, irritation and fever were the side effects that Lori and Kevin Drake were warned about when their son, Joshua, received therapeutic Botox treatments.
After receiving injections of the drug to treat muscle spasms in his legs, the 7-year-old New York boy developed epilepsy and now requires daily medication and constant observation to monitor for seizures.
Joshua’s parents sued the drug manufacturer, California-based Allergan, and were awarded a $6.75 million verdict in U.S. District Court in Burlington, N.Y., on Thursday.
Beyond the monetary gains, the Drakes hope the trial raises awareness among parents and medical officials for what they say is a deadly lack of information regarding the risks of “off-label” Botox treatments not approved by the Food and Drug administration.
“It’s about our son and it’s about all of the other children that are out there whose families don’t know,” Lori Drake said.
Having been born with mild cerebral palsy, Joshua had mobility difficulties at an early age, she said.
Regular physical therapy helped treat his condition, and he continues to walk without the need for specialized equipment, Drake said.
A persistent muscle spasm that affected Joshua’s balance led his parents to consult a podiatrist who recommended the Botox treatment.
Being told of the potential benefits and seemingly mild side-effects of the treatment, the Drakes placed their trust in medical professionals who they believed had been informed on the correct use of the drug.
Yet during the trial, it was shown that Allergan officials had recommended physicians use dosages well above the levels found to be safe in clinical trials.
“When they trained these people, they trained them in very high dosages because they were trying to, obviously, sell their product. The more doctors used, the more product was sold,” Drake said.
One Allergan animal study cited by the family in their original complaint set the safety limit at 8 units per kilogram of a patient’s weight. The dose administered to Joshua in 2012 contained 12 units per kilogram.
Phone messages and an email sent to Allergan by the Associated Press last week drew no immediate response.
Joshua’s injections were administered by a doctor at the University of Vermont Medical Center in Burlington, though Drake noted that the family did not seek litigation against the doctor or the hospital on the grounds that they had been misinformed by Allergan on details about the Botox treatment.
Returning home from the 2012 treatment, Joshua experienced a range of side-effects starting with vomiting and building to facial swelling, severe mucus buildup and seizure activity.
He was brought to his local pediatrician before being sent to the University of Vermont Health Network, Champlain Valley Physicians Hospital, and finally being transferred and stabilized back at the University of Vermont Medical Center.
“He’d never experienced a seizure or anything like that ever until immediately after the injection,” Drake said.
In the months following that first hospitalization, Joshua experienced multiple severe seizures until being prescribed a daily medication in February 2013 that seemed to control them.
But even with the medication, he still requires constant surveillance by an adult trained to watch for seizure symptoms and administer treatment.
Making sure a trained and trusted adult is always available can be a challenge when trying to let their son enjoy the average elementary-school lifestyle, Drake said.
“He can’t go on the bus from school to a birthday party or a friend’s house or any of those things that a 7- or 8-year-old would be able to do,” she said.
The Drakes hope that, along with putting pressure on Allergan to provide complete information about Botox treatments to both patients and physicians, the trial encourages parents to be more vigilant in researching and understanding the treatments and medications recommended for their children.
“You’re putting your child’s health and, quite frankly, their life, in someone else’s hands,” she said.
Rowe writes for the (Plattsburgh) Press-Republican.