One of the most promising drugs to come along in recent years is also one of the most dangerous. For many years, the Food and Drug Administration overlooked Lemtrada’s (Alemtuzumab’s) serious side effects, characterizing these situations as one-off oddities. But recent reports connected Lemtrada with “permanent disability and even death.” The FDA finally responded with a black box warning regarding possible strokes and aortic dissections (blood vessel tears).
Further complicating matters, aortic dissection and stroke are two of the most commonly misdiagnosed conditions in the United States. Today’s doctors often diagnose conditions with very little evidence. The Lemtrada-cardiac disease connection is quite new, so many doctors may not be fully aware of the risk.
In complex situations like this one, many lawyers are over their heads. But the experienced attorneys at Napoli Law know what to do. We have the resources and savvy to handle both medical misdiagnosis and dangerous drug cases on a nationwide basis. First, we connect victims with the medical assistance they need. Next, we work hard to develop the dangerous drug claim. Then, we never stop fighting for you.
What is Lemtrada?
Genzyme, a division of pharmaceutical giant Sanofi, spent billions of dollars developing Lemtrada in the 1980s and 1990s. The company touted the drug as an effective treatment for B-cell chronic lymphocytic leukemia patients who had not responded to other therapies. Lemtrada uses antibody proteins to boost the immune system and strengthen bone marrow. The FDA approved Lemtrada in 2001.
Almost immediately, regulators received reports of side-effects. Rather alarmingly, it soon became clear that Lemtrada not only repressed B-cells, it also repressed T-cells, which are important to the immune system. T-cell suppression often leads to a serious autoimmune disease. But rather than see these problems as red flags, the FDA essentially ignored them.
Lemtrada sales were brisk, but not brisk enough to satisfy corporate shareholders. So, Genzyme scientists announced that Lemtrada could suppress, and even reverse, the effects of multiple sclerosis (MS). The FDA was skeptical and initially denied approval. But when the company threatened a lawsuit, and the FDA backed down. American doctors began prescribing Lemtrada to MS patients in 2014.
Lemtrada is so powerful that it overwhelms the blood vessels in the head, potentially causing strokes and aortic dissections. Hundreds of cases have been reported since the expanded approval. Perhaps most disturbingly, many victims experience initial symptoms within one to three days after they receive their first dose of Lemtrada.
Dangerous Drug Claims
The mad dash for profits, a large number of victims, and a government watchdog agency seemingly asleep at the wheel are common ingredients in most dangerous drug cases.
As mentioned, drug companies spend billions bringing new drugs to market. But that’s only part of the story. Congress also recently reduced the length of new drug patents. So, these companies have little time to sell lots of product. Cost-savings shortcuts, even if they put people at risk, are not uncommon. Sadly, it’s also standard practice to bury negative information about the drug so sales will not be affected.
This environment creates thousands of victims. These families are usually completely unaware of the risk, so a serious illness or wrongful death blindsides them.
Admittedly, the Food and Drug Administration is in a tough position. It’s hard for anyone to admit they made a mistake and if it recalls a drug that it previously approved, the FDA is doing just that. As a result, there must be rampant serious side effects before the FDA takes any action. Even then, the response is usually requiring an additional warning or encouraging a voluntary recall. Meanwhile, more and more people get hurt.
Legally, this combination of factors places dangerous drug claims in the same legal category as hazardous chemicals and other environmental tort claims. Drug makers are strictly liable for damages in these situations. Victim/plaintiffs need only prove cause. Establishing cause is a bit easier in New York than in some other jurisdictions. Court standards for allowing experts to share their opinions with jurors are more victim-friendly in the Empire State.
In both dangerous drug and medical misdiagnosis cases, damages usually include compensation for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering. Additional punitive damages may be available as well. Jurors award these damages if there is clear and convincing evidence that the tortfeasor (negligent actor) intentionally disregarded a known risk.
Medical Misdiagnosis Issues
Punitive damages are also common in medical negligence cases. The doctor-patient relationship is one of the most sacred ones in the law. Patients depend entirely on their doctors for all information about, and treatment of, their conditions. Because of this high duty, high damage awards are common.
Misdiagnosis is also incredibly costly. Many conditions, like aortic dissections, get much worse if they are not addressed immediately. The same is true of strokes. Any hypoxia (lack of oxygen) to the brain can cause a permanent brain injury.
Doctors only listen to their patients for an average of eleven seconds before they redirect or interrupt them. Moreover, most doctors see as many patients as possible in order to maximize revenue. As a result, listening to the patient’s symptoms or researching the patient’s condition is frequently minimized, if it is done at all.
Unfortunately, misdiagnosis is common in many cases. Doctors often misdiagnose strokes as migraine headaches or alcohol intoxication; aortic dissections are often dismissed as mild heart attacks. Other commonly misdiagnosed conditions include:
- Lyme Disease,
- Heart attacks, and
- Celiac Disease.
If the doctor’s diagnosis and/or treatment fell below the standard of care, the doctor may be liable for damages. As mentioned, that standard of care is very high.
Misdiagnosis claims often involve third-party liability. According to the respondeat superior rule, the clinic, practice group, hospital, or other entity which employed the doctor is usually responsible for damages.
Complex Lemtrada injuries may involve multiple types of legal claims. For a free consultation with an experienced dangerous drug attorney in New York, contact Napoli Shkolnik PLLC. Home and hospital visits are available.