Roughly half of Parkinson’s patients suffer from frightening extracampine hallucinations (EH). Unusually high dopamine levels are usually responsible. In many cases, these hallucinations of animals or deceased individuals are extremely unsettling and almost debilitating. Parkinson’s hallucinations often touch almost every sensory nerve. Patients do not simply see things that are not there. These patients sometimes see, hear, taste, and smell things that are not there.
Despite the nature and scope of the problem, there was no effective EH treatment until the Food and Drug Administration hastily approved Nuplazid in 2016. By 2017, sales eclipsed $125 million. Nuplazid’s maker, San Diego-based Acadia Pharmaceuticals, expects sales to double in 2018. But there are serious concerns about the drug’s effectiveness, and more importantly, its safety.
Congress created the FDA’s controversial expedited approval avenues to essentially short-circuit the agency’s mission. Instead of taking the time necessary to help ensure safety and effectiveness, industry insiders can take advantage of legal loopholes to rush potentially unsafe drugs to market. If the FDA process fails to protect patients, aggressive and experienced Napoli Law attorneys take up the slack. We fight for maximum compensation in these cases. Furthermore, we have the resources to assist you. Victims of bad drugs can trust Napoli Law to serve as a strong voice both in the courtroom and at the negotiating table.
What is Nuplazid?
Nuplazid (Pimavanserin) is an oral medication. At $100 per dose, it can easily cost Parkinson’s patients $30,000 a year. Nuplazid is also a very powerful drug. Because EH affects so many different senses, the medicine must affect both the brain and the senses in a number of different ways.
Some common side effects include:
- Chest pain,
- Weight change,
- Confusion, and
- Arrhythmia (irregular heartbeat).
Depending on the patient, these mild to moderate side-effects usually dissipate once the body adjusts to the medicine.
The potential serious side effects of this powerful medication are what really concerns doctors and other researchers. These serious and possibly fatal side effects include:
- Peripheral Edema: Excessive fluid accumulation is commonly associated with various forms of heart disease, including hypertension and congestive heart failure. The fluid causes excess pressure on the veins, and often on the heart itself. PE can also lead to Peripheral Neuropathy (permanent nerve damage).
- QT Interval Prolongation: This condition, which is also known as Long QT syndrome (LQTS), is essentially a very serious arrhythmia. Many LQTS patients have almost no symptoms until serious heart problems suddenly occur. People with a family history of this condition are especially prone to Nuplazid-induced LQTS.
- Dyspnea: Shortness of breath may be either sudden or chronic. Chronic dyspnea is much more common in Nuplazid exposure cases.
- Angioedema: In some cases, Pimavanserin causes excessive swelling that is much worse than hives. The swelling is very common in the bronchial passages, throat, and larynx. So, Angioedema patients often have a hard time eating and breathing. In some cases, this condition may be life-threatening.
Other potential side effects include severe rashes, excessive fatigue, throat tightness, and urinary tract infections. So far, Nuplazid has been linked with over 240 deaths. That’s an astronomical number of potential fatalities, given the fact that Pimavanserin has only been available since 2016.
The FDA Approval Process
On average, new drugs spend about a dozen years in the approval pipeline. This area has been a bone of contention for years. Safety advocates claim that the time delay helps ensure that new drugs are safe.
Meanwhile, industry lobbyists have loudly complained that the process is too long. A new drug patent usually lasts twenty years. The clock begins ticking when the drug is discovered and not when it is available for sale. So, drug makers may have only about eight years to recoup their extensive development costs, which could exceed $2.5 billion, and show a healthy profit.
Congress eventually listened to well-paid lobbyists as opposed to safety advocates and revised the approval process. But rather than addressing the issue directly, lawmakers sidestepped the question. They created two controversial approval shortcuts.
- Breakthrough Therapy: If the drug is effective at treating a serious condition and there are no current alternatives, the FDA often approves it with almost no questions asked. Many considered the InFuse Bone Graft to be a breakthrough therapy. In 2016, the FDA approved Nuplazid based on one clinical trial that included a mere 200 patients. Only a fraction of these individuals actually received the drug; the rest received a placebo.
- 510(k) Approval: If a device is “substantially similar” to one that is already on the market, the FDA offers expedited approval. But the process is very subjective. Furthermore, there is no guarantee that the first device or drug was safe. Many dangerous hip implants received 510(k) approval.
Even the normal approval process does not ensure safety. The FDA receives a substantial part of its budget from the pharmaceutical and medical device industry. Furthermore, by the time the slow-moving FDA issues a recall, many people have already been seriously injured.
Your Claim for Damages
These claims are very complex. They are theoretically easy to win, but very difficult to win in practice.
The burden of proof in these tort cases is usually a preponderance of the evidence, a legal term which means “more likely than not.” If the scales of justice tip ever so slightly in the plaintiff’s favor, the plaintiff prevails on that particular element. This is the lowest standard of proof in the law.
These cases almost always require expert witnesses. To evaluate these witnesses, New York courts use the more well-established Frye standard. Generally, their opinions must only be reasonable in order for them to testify before the jury. Other states used the more intense Daubert standard.
However, pharmaceutical and medical device companies have nearly unlimited resources. They hire top professional witnesses who testify that the device or drug is entirely safe. Furthermore, these cases are based on inductive reasoning (a limited amount of information) as opposed to deductive reasoning (a large body of data).
Therefore, to obtain fair compensation in these cases, victim/plaintiffs need tenacious and highly-skilled attorneys.
In its short time on the market, Nuplazid has been linked to hundreds of fatalities. For a free consultation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. We do not charge upfront legal fees in dangerous drug cases.