Off Label Drug Promotions: Who Wins and Who Loses

In drug litigation, one of the common claims is that drug or device manufacturers failed to adequately warn of risks of the drug or device, and that the manufacturer simply failed to tell the whole truth.  By simply turning on your television you are subjected to a seemingly nonstop onslaught of advertizing for drugs and devices that will end your pain, restore your energy, enable you to do activities you have not done in years, and give you a fantastic sex life.  If the ads work, the consumers are “asking your doctor about” whatever new drug is the subject of the current slick campaign.

When the drug or device use results in injuries, one of the standard defenses relied on by the drug and device manufacturers is the Learned Intermediary Doctrine, which in simplest terms says, we warned the doctor who possesses superior knowledge and we don’t have to warn the consumer.

But a typically overworked doctor with a limited time to see patients, visit the hospital, attend conferences, fight with insurers over payments, and keep abreast of literature, etc., MUST rely on the drug and device manufactures with their vastly superior knowledge and resources to simply truthfully tell them the risks as well as the benefits.

One of the dirty little secrets is off label use, where someone uses the drug for a potential condition that is not stated on the label.  Drug companies seek to expand their market through these procedures which are clearly improper.  It is profitable to do this as market share expands, by doctors being urged to expand prescriptions to currently non-labeled uses but for which marketers ensure doctors are supported by research and experience.

But what happens to the manufacturers when they are caught?   Here are some recent examples;

On October 19, 2011 Abbott Laboratories ($ABT) has set aside $1.5 billion for a potential off-label marketing settlement with the U.S. Justice Department.  According to reports Abbott pushed Depakote (approved for treatment of seizures) for autism, sexual compulsions, agitated and aggressive patients amongst other conditions.

Read more: Abbott Earmarks $1.5B for Off-Label Depakote Settlement

Other recent settlements include Johnson and Johnson paying $81 million for claims regarding Risperadal (J&J, feds reach deal on one Risperdal charge) and, Pfizer’s $2.3 billion settlement of claims of improper promotion of Bextra and other drugs for unapproved uses.

Who loses?

Consumers, who used the drugs, were injured, and receive nothing of these settlements.  Instead they are going through the court processes to hold companies liable for their conduct, and where the company likely will claim if any fault exists, it was that of the doctor, who has superior knowledge, and to whom warnings were given, or it is the fault of the consumer who has some pre existing or unique anatomical condition that caused their injury.

Amazingly, the manufacturers contend, based on the Learned Intermediary Doctrine, they have no obligation to tell the consumers the whole truth.

Attorneys at The Brandi Law Firm have long been involved in drug and device litigation, from the Dalkon Shield, Phen fen, Vioxx, Avandia, Yaz, to POP ( pelvic organ prolapse) surgeries from Transvaginal mesh, bladder cancer from Actos, femur fractures from Fosamax, to toxic poisoning and revisions from De Puy ASR metal on metal hip implants.  For more information contact Thomas Brandi at The Brandi Law Firm Website.