Botox Sued for Promoting Off-Label

Pretty much everyone has heard of Botox, the miracle drug that swept the nation for its cosmetic celebrity. In the 1990s and early 2000s, Botox was everywhere. Manufacturers of the drug were doing so well that they actually ran out in 1997, as they couldn’t keep up with production. The popularity of the drug, and the money it brought in, gave everyone involved something to smile about (if their face wasn’t paralyzed).

Botox is used to smooth wrinkles for a younger look, of course. But, it started out as something entirely different. Botox began has a more general, more traditional medical treatment before it ever reached its celebrity status and now that train is coming full circle. But there’s a catch, today’s FDA guidelines are strict about the promotion of drugs for unintended uses, and no one is quite feeling the backlash like the manufacturer of Botox.

The drug we now know as Botox is actually made up of botulinum toxin type A, a strand of bacteria that acts as a neurotoxin. It was discovered and researched throughout the 1800s in an attempt to learn about foodborne illnesses. Later, research for weaponizing the drug discovered its muscle-paralyzing effects, which then translated into treatment for disorders in which overactive muscles were involved. From there, its cosmetics wonderments were discovered and the drug was off.

But since that time, Botox has faced some issues over its safety and its illegal promotion, costing the company near a billion dollars in lawsuits.

Botox Gains Popularity for Off-Label Uses

When a drug is submitted to the FDA for approval, it must send with it a list of its intended uses. If the drug is approved, then it’s only approved for those uses. However, that does mean that doctors can’t prescribe the drug for other reasons that they see fit. This is perfectly legal and very common (about 1 in 5 prescriptions). It’s called off-label prescribing. But it does have its risks.

When off-label uses result in good outcomes, they are published in journals or presented at conferences in an effort to spread the information to other physicians and to increase the profits of the manufacturer. The pharmaceutical company then conducts their own studies in an effort to gather data and get the new uses approved by the FDA.

This is how Botox got approved for a whole list of ailments; it’s currently approved to treat everything from migraines to overactive bladder. But because it is legal, doctors commonly prescribe the drug to patients for other uses that they think are beneficial but not necessarily supported by the FDA.

As mentioned, this is perfectly legal for doctors to do. What is not legal is for the manufacturer to promote the drug for uses that have not been approved. This is exactly how Botox got into hot water and cost themselves millions.

Botox Gets Back to Its Roots as a Poison

One of the off-label uses for Botox is in the treatment of spasticity associated with cerebral palsy in children. This treatment, like some other off-label uses, exposes the patient to more of the neurotoxin than the FDA approves. This has been linked to serious medical problems, including hospitalization and death. The dangers arise when this high dose of Botox move from the injection site into unintended areas of the body, causing interference with vital bodily functions such as breathing and swallowing. The drug is designed to paralyze nerves, after all. When Botox is used as the FDA approves, the quantiles are too small for this to be possible.

Because of the risks of Botox causing respiratory failure and death, the drug was mandated to carry the FDA’s black box warning—the strongest warning of its kind.

This warning turned reality when a doctor prescribed the drug to a young child with cerebral palsy. The dose was too high; the 6-year-old boy began suffering seizures.

The family sued and the case went in front of a federal court in Vermont. There, the manufacturer of the drug, Allergan, was put on trial.

The federal jury decided that Allergan Inc. had to pay $6.5 million to the parents of the boy, but not just for his injuries. The real reason for the verdict was in the promotion of the drug.

The jury determined that Allergan negligently promoted the off-label use of Botox at unsafe doses and failed to sufficiently provide the patient’s parents and his health care providers with information about the drug’s known risks and dangers.

Before the injection, the boy only had mild spasticity in his legs. But after the doctor delivered the high doses, he began having seizure-like episodes requiring hospitalization.

The boy’s doctor injected him with almost 7 u/kg of Botox. Soon after, the boy began to complain of discomfort. He was then injected again with almost twice as much Botox. The next day, he began vomiting and having trouble breathing and speaking. Then the seizure-like symptoms began. He was later diagnosed with an allergic reaction to Botox.

The boy still suffers from seizures and has developed a chronic, life-threatening immune response from the high dose injection.

The jury awarded the Drakes $2.5 million in compensatory damages and $4 million in punitive damages.

There’s Plenty of Lawsuits

In 2008, 15 patients sued Allergan claiming that the company failed to warn of the drug’s dangers. The case involved four deaths from the off-label use of Botox. Later in 2008, a consumer group called Public Citizen linked 16 deaths to the drug.

In 2010, a lawsuit was filed by a woman after she suffered traumatic brain injuries, movement disorders, and dementia for the use of Botox. Her case settled out of court in October 2011.

In May 2010, Allergan was sued after a patient suffered from botulism poisoning after using the drug to treat wrinkles. Allergan was found negligent because they had known about potential botulism dangers but had denied the connection in promotional materials to doctors and patients.

In September 2010, Allergan settled a wrongful death lawsuit on behalf of a woman who died after receiving injections for shoulder pain.

In a later trial, it was exposed that Allergan had sent European regulators a letter in 2007 that contained warnings about Botox’s potentially deadly side effects. It had failed to do so in the U.S. market.

In May 2012, a man settled with Allergan for $60.5 million after he was diagnosed with Guillain-Barre Syndrome due to Botox injections for back pain.

From Costing Big to Not Illegal

The illegal and blatant promotion of Botox for off-label uses eventually cost the company $600 million dollars to resolve its criminal and civil liability. The resolution included a criminal fine and forfeiture totaling $375 million and a civil settlement with the federal government and the states for $225 million.

However, what the company paid so dearly for (the promotion, not use, of off-label prescriptions) is now beginning to change.

Before, this type of thing brought on legal liability, criminal charges, penalties under the False Claims Act, and misbranding actions by the FDA. In recent years, however, the trend as turned toward protection for commercial speech in matters of healthcare.

The argument pushes for citizens to have a right to know about a use for a drug that might be effective in helping them.

Recently, the FDA and Amarin Corporation (a pharmaceutical company) reached a settlement that permits the company to engage in truthful and non-misleading promotion of their fish oil capsule for an off-label use. Though the settlement only applies to this one case, it marks a significant change in FDA policy on off-label drug promotion.

Dolman Law Group

The controversial drug and its stirring with the FDA has brought to light a gray area of truth, liability, and constitutional rights. Should companies be stopped from promoting a drug for uses the FDA doesn’t support? Or do consumers have a right to know if a drug can also help cure them, even if that’s not why it was made? It’s an argument that cost Botox millions and now may prove to be shifting in the other direction.

Either way, drug companies do commit shady dealings in an everlasting pursuit of greater profits. Bad drugs are manufactured and hurt people all the time. When defective medication cost an innocent person their health or life, those responsible deserve to be held accountable. Dolman Law Group is an award-winning personal injury firm in Clearwater, Florida who specializes in Defective Drug accountability.

If you or a loved one has been injured by negligence—no matter what the cause—contact us today for a free case evaluation. We look forward to working with you.

Dolman Law Group
5435 Main Street
New Port Richey, FL 34652
(727) 853-6275