Botox Manufacturer Must Pay for Brain Injuries Caused by "Off-Label" Use

The wrinkle reducer, Botox is approved by the FDA for very narrow uses only. But Allergan, its manufacturer, has promoted it to doctors all over the country for other uses, including muscle spasms. A doctor’s use of a drug for a purpose not approved by the FDA is often referred to as an “off-label” use. When a doctor used Botox “off-label” to treat Virginian Douglas Ray for hand tremors, it quickly led to brain damage. According to his wife, he now requires round-the-clock care and speaks very few words.

Botox is a purified form of the poison botulinum and is given as an injection. The drug is approved to treat “muscle stiffness” in the fingers and arms, “upper limb” spasticity, and chronic migraine headaches. Botox can migrate outside the injected muscles and cause side effects including botulism and severe autoimmune reactions with resulting brain damage.

Ray claimed Allergan did not properly warn his doctor about the risks of using the drug. A jury agreed, ordering Allergan Inc. to pay to Ray $12 million in compensatory damages and $200 million in punitive damages. This award by the U.S. District Court jury in Richmond, Va., was the largest penalty ever in a Botox injury case.

Botox is Allergan’s top-selling drug, with $1.42 billion in sales last year, or 29 percent of the drug maker’s revenue, according to data collected by Bloomberg.

This is not the first time the Botox manufacturer has had to pay penalties. In September of 2010, the federal government ordered Allergan to pay $600 million to settle civil and criminal allegations against the drug manufacturer for illegally marketing Botox for other uses. Allergan has also been accused of paying kickbacks to doctors and enticing them with all expense paid weekends to learn about off-label usage. 

Mike Danko Named California Trial Attorney of the Year Finalist

The Consumer Attorneys of California (formerly called The Trial Lawyers of California), named my partner Trial Attorney of the Year Finalist for 2009 in honor of our work for a brain injured client in the case of Burdett v. Teledyne Continental Motors.  The Trial Lawyers Association presented a video about the case at its annual convention awards dinner in San Francisco.

Jury Awards $2 Million to Golfer's Family

This week a San Diego jury found a golf course responsible for the death of a golfer who was killed after falling off an 80 foot cliff in a golf cart and awarded his family $2 million.  The golfer Edwin Payne tried to make a U-turn on the golf path but drove over a small inner curb, lost control of the cart on a slope veiled by trees, and eventually was catapulted over the cliff.  As discussed here, the property owner must  keep its property in a safe condition and warn of any unsafe conditions.The jury determined that the Pala Mesa golf course should have installed a higher curb and failed to warn him about the cliff behind the trees.  The award will be reduced by 30% because the jury assigned partial fault to Mr. Payne based upon the principle of comparative fault previously discussed here.

Pole Vaulter Awarded $8 Million for Spinal Cord Injuries

A Connecticut jury recently awarded $8,000,000 to a young man injured during warm ups for a USA Track and Field Junior Olympic Championship meet in 2002. High school senior pole vaulter Brandon White fractured his back at T5 and T10 levels and remains paralyzed from the chest down. Mr. White claimed that the beginning of the runway was obstructed by a batting cage. He sued the USA Track & Field Association/Connecticut for negligent supervision and for failing to provide a sufficient runway length. His sports and safety expert testified that the the usable runway was 25 feet short of the required USATFA length.

The USATFA defendant contended that Mr. White was instructed not to warm up until an official returned. It also claimed that Mr. White did not properly prepare for his vault attempt and should not have let go of the pole when he did. Mr. White’s waiver of all liability and express assumption of risk were excluded from evidence because Connecticut law disfavors these types of waivers.

The jury, without knowledge of the waiver and assumption of risk, determined that defendants were at fault for his injuries.  However, the jury determined that Mr. White was  nonetheless 20% to blame and so his award was reduced to $6,400,000. 

California law sets the bar higher for plaintiffs to prove their case.  California courts generally enforce waivers such as the one Mr. White signed.  Unless there were exceptional circumstances, he wouldn't have been permitted to bring his case to trial.