Most companies highlight the benefits of their products. If there are downsides, they rarely, if ever, mention them in a commercial. Pharmaceutical firms, on the other hand, list lots of horrific complications, including death, in TV commercials. Have you ever wondered why? Could it be in part because such warnings reduce the risk that you could sue the drug company?
Why Do Drug Companies List So Many Side Effects?
Imagine watching a TV commercial for the latest and greatest electric vehicle. Beautiful people are seen driving a fast car along a gorgeous mountain road.
They are having a great time, but then the announcer warns about the possibility of brake and steering failure, untimely air-bag deployment or collisions. Finally, you would be shocked to hear a warning that the vehicle might catch on fire and explode while you were driving.
Not surprisingly, automobile manufacturers might be reluctant to air such commercials. It could be hard to sell a vehicle with so many potential problems.
Why Are Drug Companies OK with Long Lists of Terrible Side Effects?
Prescription drug commercials are different! They almost always contain long lists of potential side effects. Some of these are devastating or even deadly.
For example, ads for the very successful and extremely expensive rheumatoid arthritis medicine, Enbrel, contain a frightening series of warnings.
Here they are:
“Enbrel may lower your ability to fight infection. Serious, sometimes fatal events including infections, tuberculosis, lymphoma, other cancers, nervous system and blood disorders, and allergic reactions have occurred. Tell your doctor if you’ve been someplace where fungal infections are common or if you’re prone to infection, have cuts or sores, have hepatitis B, have been treated for heart failure or if you have a persistent fever, bruising, bleeding or paleness. Don’t start Enbrel if you have an infection like the flu.”
Why List So Many Scary Side Effects?
Could it be so you can’t sue the drug company?
Why would a drug company include a very long list of adverse reactions in its commercials? On the one hand, the FDA requires pharmaceutical manufacturers to disclose both the benefits and risks of prescription medications.
On the other hand, we suspect that drug companies welcome the opportunity to quickly run through more adverse reactions than anyone can remember. Why would they do that? What does a long list of warnings have to do with an inability to sue the drug company?
The Abilify (Aripiprazole) TV Commercial:
You have to watch this Abilify commercial to appreciate how cartoon characters and a cartoon pill make it seem like a wonderful solution for depression.
Then comes the long list of scary side effects:
“Abilify is not for everyone.
Call your doctor if your depression worsens or if you have unusual changes in behavior or thoughts of suicide…
Elderly dementia patients taking Abilify have an increased risk of death or stroke.
Call your doctor if you have high fever, stiff muscles and confusion to address a possible life threatening condition or if you have uncontrollable muscle movements, as these can become permanent. High blood sugar has been reported with Abilify and medicines like it and in extreme cases can lead to coma or death.
Other risks include increased cholesterol, weight gain, decreases in white blood cells which can be serious, dizziness on standing, seizures, trouble swallowing, and impaired judgment or motor skills.”
The Art of Distraction:
Drug companies have perfected the art of distraction.
As you listen to this long list of scary side effects for Abilify, the cartoon woman interacts with her cartoon work colleagues. Then we see her serving lemonade to her smiling cartoon family at a backyard barbecue. Why worry about drug side effects when the cartoon characters are having a good time?
A few years ago, researchers studied consumer responses to televised commercials (Nature Human Behavior, Oct. 9, 2017). They found that including more frequent but less severe problems along with really serious ones:
“…dilutes consumers’ judgements of the severity of the side effects.”
During many prescription drug commercials there is often a disconnect between pictures and words. While the voiceover speeds through the side effects, people on the screen may be having the time of their lives, playing, smiling and socializing. There is often a catchy tune, dancing and frequently, at least one adorable child or dog.
If You Are Harmed or Killed By a Medicine, Why Can’t Your Family Sue the Drug Company?
There may be another reason that drug companies embrace long lists of adverse reactions. We’re speculating, but we suspect that the lawyers for pharmaceutical manufacturers appreciate the cover such disclosures provide.
If someone is harmed, but the company can show it warned patients ahead of time, the risk of litigation may be lowered. We are not lawyers, so please do not take our word for this.
We imagine, however, that if a drug company warns in a TV commercial that its medication can cause kidney failure, heart attack, stroke, cancer or death, it would be hard to sue for damages if such an outcome occurs. Pharmaceuticals may be categorized legally as “unavoidably unsafe products.” So, if the official prescribing information or a TV commercial warns about a potentially dangerous or lethal drug outcome, it can be very hard for a family to sue the drug company.
In other words, if the manufacturer offers “adequate” warnings about side effects, even people who suffer serious or lethal harm may not have a legal leg to stand on.
Warnings That May Be Ignored:
Statins and Rhabdomyolysis:
Check out the official prescribing information for atorvastatin (Lipitor).
Under the heading WARNINGS AND PRECAUTIONS it says:
“LIPITOR may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including LIPITOR.”
Tens of millions of people take statins every day. Even a rare adverse reaction will affect some patients.
CHL shares a shocking story of muscle weakness and rhabdo in this comment:
“My mother took Lipitor for almost a year. Rhabdomyolysis may be rare indeed, but my mother GOT it. She went to take a bath, and was so weak she was unable to get out of the bathtub – for over eight hours. She sat in the tub, cold, weak, and without the body strength to get out.
“When my sister could not reach mom via phone, she got a neighbor to enter mom’s home with an extra key. Mom is not ‘big’. She is 5’4″ tall, 125 lbs, and had been in relatively good health. If she had been in that tub 2 more hours, the emergency room doctor said she would have died. Mom spent a week in the hospital before she was strong enough to return home.
“Lipitor caused her illness. She stopped taking the statin, but the drug did enough muscle damage that she has never been the same. Her muscle strength is gone, she tires easily, and she can no longer do the things she once did with ease.”
Crystal is a nurse and shares her story of atorvastatin:
“I became a diabetic after being on atorvastatin for several years. Won’t touch the stuff now. I am an RN and have been caring for my husband since I discovered that he had a low grade rhabdomyolysis from severe whole body cramps secondary to statins that ruined his kidneys. I’ve managed to keep him at chronic kidney disease III until this year.”
Amiodarone and Lung Toxicity:
Amiodarone is “indicated” for life-threatening recurrent irregular heart rhythms. In the black box warning it states:
“Amiodarone hydrochloride is intended for use only in patients with the indicated life- threatening arrhythmias because its use is accompanied by substantial toxicity.
Amiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baselinechest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone hydrochloride therapy is initiated.
Repeat history, physical exam, and chest X-ray every 3 to 6 months.
Amiodarone hydrochloride can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue amiodarone hydrochloride if the patient experiences signs or symptoms of clinical liver injury.”
It’s pretty clear that the pharmaceutical manufacturers that make amiodarone are warning patients and physicians that the drug carries potentially life-threatening risks. If something bad happens, it is unlikely that a family can sue the drug company, because they were, in theory, warned of the risks.
Kathy describes her father’s death:
“My dad recently died after going into the hospital for pneumonia. It was discovered he had lung disease from taking the drug amiodarone. He was on a respirator for a few weeks, but never pulled through. My mother says they were never warned about this drug nor were they advised to have his lungs checked periodically. He was such a healthy man before this. Does the FDA keep track of deaths resulting from taking this drug? Have there been any lawsuits from people who have died taking this drug?”
A doctor may face litigation for not providing adequate information, but I doubt that the family could sue the drug company because of the warning in the prescribing information.
Risperdal (Risperidone) and Dementia:
Risperidone is an anti-psychotic medication indicated for schizophrenia. The black box warning states:
“WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL® is not approved for the treatment of patients with dementia-related psychosis.”
A tragic death reported by E.N.
“Risperidone killed my mother. She was in her mid-eighties and in assisted living. The psychiatrist on call put her on Risperdal [risperidone] because she was ‘argumentative.’
“My mother was also a type 2 diabetic and had been on oral meds for that condition for over 20 years. She was only on Risperdal for a short time, maybe two months, when she tested very high for sugar one day. She was given an injection of insulin that evening and not checked on for several hours. At that time, she was “unresponsive” and taken to the hospital where she died a short time later, never having regained consciousness.
“The doctor said she died of natural causes. In researching her meds, I came upon the information about Risperdal being dangerous for diabetics.”
When FAILURE to Warn DOES Allow A Family to Sue the Drug Company:
In 2021, Johnson & Johnson (J&J) settled roughly 9,000 Risperdal cases to the tune of about $800 million. Why? Thousands of men complained that this medication caused gynecomastia (excessive growth of breast tissue). Why would J&J spend so much money to settle all these cases?
The lawyers for all these men accused the drug company of not warning about gynecomastia. The company did try to overturn a “failure-to-warn” case in Pennsylvania.
FIERCE Pharma, a publication that reports on the pharmaceutical industry, reported this outcome (Nov. 26, 2019):
“Despite J&J’s efforts to get a 2016 Risperdal verdict against the drugmaker—worth $70 million in actual damages—tossed out, a Pennsylvania appeals court upheld the decision in a new opinion (PDF).
“The court also sent the case back to a lower court to consider punitive damages, meaning the company could face more damages from the case.
“The case stems back to a 2013 lawsuit from Andrew Yount and his mother alleging J&J’s Risperdal caused him to develop breasts, a condition called gynecomastia.
“The appeals court said it found no ‘reversible error’ in the original award. The plaintiff was four-and-a-half years old when he was originally prescribed the med, ‘and he has never since known life without gynecomastia.’”
I know this is complicated and confusing. Here’s my non-legal take on when you can and when you can’t successfully sue a drug company for damages caused by a medication. If a drug company warns about the side effects you experience, you are facing a very steep uphill battle. That warning could be during a TV commercial or in the official prescribing information.
If you have watched any direct to consumer (DTC) prescription drug commercials on television, you know that there can be a long litany of scary side effects, including death! If you have ever checked out the official prescribing information for most medications, you know that the list can be much longer.
If you or someone you love experiences one of those adverse reactions, you will have a hard time finding a law firm that is willing to take your case. Now do you understand why drug companies do not mind very long lists of scary side effects?
If, on the other hand, you experience a side effect that is not in the official prescribing information or listed on a TV commercial, you might have a case. Of course, a law firm would have to be able to prove your adverse reaction was in fact caused by the medicine. That can also be an uphill battle.
The bottom line is that patients and their families find it extremely difficult to sue the drug company. So, what is the take home message from this post?
- Find out about the most serious and most common complications of any medicine you take.
- Ask your doctor and pharmacist what to do if such an adverse reaction occurs.
- Learn if you should stop the drug suddenly or phase off it gradually.
- Discover if there are any complications that are so serious you should go immediately to an emergency department.
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Please share your own story about drug side effects in the comment section below.