On August 18, the Federal Drug Administration approved flibanserin, known in the media as the “female Viagra.” It’s the first time the FDA has approved a drug addressing “generalized hypoactive sexual desire disorder” in premenopausal women.
Soon after the FDA approval, Canadian company Valeant Pharmaceuticals bought the maker of flibanserin, Sprout Pharmaceuticals, for $1 billion. If everything goes the way the company hopes, the drug, sold under the brand name Addyi, will be a cash cow like Viagra, which generated $1.685 billion in sales for Pfizer in 2014 alone.
It looks like a winner. What could go wrong?
The potential problem with the ‘female Viagra’
Like Viagra, Addyi is meant to increase libido. Unlike Viagra, it is meant to be taken daily rather than a few hours before a sexual encounter. While Viagra works by increasing blood flow to the penis and is effective for the majority of men who take it, flibanserin works by affecting the neurotransmitter serotonin. In trials, it worked for just 10 percent of women who took it.
So, not only might Addyi not work as intended for many women, but the drug might also be dangerous, as it is strongly contraindicated with alcohol. Side effects from this interaction may include a drop in blood pressure and fainting. Since for many women a romantic evening and a glass of wine go hand in hand, this risk could pose a real problem for patients who want the benefits of flibanserin but don’t want to give up alcohol indefinitely.
But what happens if you take Addyi—or any other pharmaceutical drug—and have an adverse reaction? Can you sue your doctor or the FDA? What do you need to make a solid case? We spoke to attorney Mark L. Taylor at Powers Taylor in Dallas, Texas, to find out.
If I have a bad reaction to a drug, whom can I sue?
Can I sue the pharmaceutical company who produced it?
“Most pharmaceutical lawsuits filed are against the manufacturer of the drug for failing to warn the consumer about possible harmful side effects,” says Taylor. “This type of claim would be a product liability claim and is often pursued by a large group of people against the drug manufacturer or company.”
Can I sue the doctor who prescribed it or the pharmacy that dispensed it?
According to Taylor, “It is technically possible to sue your doctor for prescribing a drug or your pharmacist for not explaining the warnings, but these claims are much more difficult. Pursuing a claim against your doctor or pharmacist would be considered a medical malpractice lawsuit.
“To win a medical malpractice lawsuit involving a prescribed drug, you must be able to prove that the health care provider knew about harmful side effects that were not included with the drug’s warnings and ignored facts that would indicate the patient was at high risk for that particular side effect. Doctors and pharmacists typically do not have access to that information. So, while it is possible to sue your doctor or pharmacist, it is not very common.”
You may have more luck if your physician or pharmacist did not follow FDA procedures. In order to prescribe or dispense flibanserin, your physician or pharmacist must assess how likely it is the patient will actually abstain from alcohol, and he or she must be certified through the FDA’s risk evaluation and mitigation strategy program. If you can show that your health care professional failed to do these things, you may have a stronger case.
Can I sue the FDA for approving it?
No. The FDA is protected by “sovereign immunity.”
“While the FDA is tasked with protecting the public, this governmental body is immune from private lawsuits for injuries caused by drugs that it approved,” says Taylor.
What to know before suing over an adverse drug reaction
In successful medical malpractice and product liability claims, compensation can be large, but winning these kinds of cases isn’t easy. Taylor explains why.
“In order to bring a lawsuit against any of the parties mentioned above, you would have to successfully prove 1) that you used a defective or dangerous drug, 2) that you were injured by that drug, 3) that the drug was defective or you were not warned about any dangers, and 4) that the defective drug or the failure to warn you of possible dangers caused your injuries.
“The first priority should always be your health. Make sure that you take care of any medical issues or injuries that have occurred due to a drug reaction. Once you have taken care of any immediate medical needs, you should find an attorney and ask for a consultation. There is normally a statute of limitations within which a case must be filed (in Texas, for example, it is 2 years), and it is important to allow enough time for your attorney to research your case and file the lawsuit. Product liability cases involving pharmaceutical drugs can be very complex and may involve multiple liable parties.”
Do you need legal advice?
If you’ve had an adverse reaction to a drug, speak with an attorney in your state to get advice. You may want to proceed with a lawsuit, or you may decide it’s not worth your time, money, and effort.
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