If you have ever pulled an all-nighter for school or work you may know about Provigil and Nuvigil.
In recent times, these drugs that were initially developed to treat sleep disorders and improve awakeness have been the topic of much scrutiny. Some claim the manufacturers engaged with illegal and unethical tactics to promote drugs for off-label use, while others claim they caused serious side effects or risks that were not adequately disclosed.
The Allegations Against Provigil and Nuvigil
The allegations relating to Nuvigil and Provigil cases are complex and controversial and involve a wide range of legal claims and causes.
The defendants accused in these lawsuits include Teva Pharma, Mylan, as well as others. They are accused of engaging in a range of unethical and illegal practices in relation to the marketing, promotion, and distribution of Provigil, and Nuvigil.
These practices allegedly involve:
- Off-Label Promotion: The defendants claimed to have promoted the drugs in ways not approved by the FDA. For example, they are accused of promoting them for uses such as weight loss, cognitive enhancement, and athletic performance.
- Pay-For-Delay Schemes: The defendants were accused of entering into an agreement with generic drug manufacturers to delay the release of cheaper Provigil and Nuvigil versions.
- False or Misleading Advertising: The defendants face charges of making false or misleading claims about safety, efficacy, and risks associated with Provigil and Nuvigil to increase sales.
- Kickbacks & incentives: The defendants were accused of providing kickbacks & incentives to doctors and hospitals to prescribe Provigil & Nuvigil. This is in violation of antikickback legislation.
These allegations have been the basis of various legal claims in the Nuvigil and Provigil lawsuits.
- False Claims Act: This law allows individuals who have committed fraud against federal programs and contracts to sue on behalf of the government for damages. False Claims Act lawsuits were filed by several whistleblowers against the defendants alleging they engaged in off-label advertising and other fraudulent practices in relation to Provigil or Nuvigil.
- Antitrust Violations: The defendants have been accused of violating antitrust law by engaging in pay-for-delay schemes and other practices that limit competition and increase consumer prices.
- Consumer Protection Laws: The defendants have been accused of violating consumer protection laws in their state by making false and misleading statements about the safety and effectiveness of Provigil and Nuvigil. They are also accused of engaging in deceptive advertising practices.
- Personal Injury Claims: Individuals suffering injuries or harm after taking Provigil and Nuvigil could bring personal injury cases against the defendants. They would claim that they failed in their duty to warn of the risks and dangers related to the drugs.
Provigil & Nuvigil’s History
The origins of Provigil & Nuvigil can be traced back to the 1970s when researchers began studying the effects modafinil — the active ingredient found in both drugs — had on sleep and waking.
Cephalon began clinical trials in the 1990s for both drugs to test safety and efficacy. Provigil was approved by the FDA in 1998 for the treatment of Narcolepsy. This is a condition characterized by daytime fatigue and sudden sleep bouts.
Nuvigil was approved in 2007 as a newer form of the drug for the same indication. It is also approved for shift-work disorder and obstructive snoring.
Regulatory Actions and Investigations
In the cases of Provigil & Nuvigil, the FDA has taken a series of regulatory actions and conducted investigations regarding the marketing & promotion of these medications by their manufacturers.
Cephalon faced several investigations and lawsuits after the FDA issued its warning letter. In 2011, the Department of Justice brought a lawsuit against Cephalon, alleging it had engaged in illegal marketing practices and pay-for-delay schemes in relation to Provigil. Cephalon settled with the DOJ for $425 million in 2015.
These settlements show the seriousness and potential harms of Cephalon’s marketing and promotion practices. Provigil or Nuvigil are still important drugs to treat sleep disorders. It is crucial that they be used safely and ethically and that patients understand their risks.
Class Actions and Individual Lawsuits
There are typically two types when it comes to lawsuits regarding prescription drugs. These are class action lawsuits and personal lawsuits. In the case of Provigil/Nuvigil, a number of both have been filed against the defendants.
- Since the FDA approved Provigil in 1998, many individuals and groups have sued its manufacturer, Cephalon. (Teva Pharmaceutical Industries later acquired Cephalon). They claim the drug is causing severe side effects.
- In 2006, an individual or group filed a lawsuit alleging that Cephalon illegally slowed the release of generic Provigil versions by paying competitors. Cephalon agreed to pay $425m in 2008 to settle the lawsuit without admitting wrongdoing.
- Cephalon had been accused of paying four generic pharmaceutical manufacturers to delay the release of generic versions. Teva (which bought Cephalon in 2011) settled this lawsuit for $ 1.2 billion.
- Patients have also sued Provigil for serious side effects like Stevens-Johnson Syndrome. Stevens-Johnson Syndrome can be fatal. A woman filed a suit in 2012 claiming that Cephalon failed adequately to warn her of the risks related to Provigil. The lawsuit led to her developing Stevens-Johnson syndrome (SJS). The lawsuit has been settled out of court at an undisclosed price.
Legal Strategies and Arguments
Plaintiffs in the lawsuits brought against Cephalon/Teva alleged that Cephalon/Teva engaged, among other things, in illegal and anticompetitive conduct, such as paying out to competitors and delaying the release of generic versions of this drug. The plaintiffs say that this increased Provigil prices and prevented patients from accessing cheaper generic versions.
Plaintiffs have argued, in their individual lawsuits, that Cephalon/Teva has failed to adequately warn the patients of the risks related to Provigil/Nuvigil. This includes SJS as well as other severe side effects. They claim manufacturers knew or should know about the risks and failed to warn patients.
The defendants claim they acted legally and in their shareholders’ best interests. Cephalon/Teva denied any wrongdoing in the case of anti-competitive litigations. In the lawsuits filed by the manufacturers, they claim that their drugs were adequately warned about potential risks.
Why Hire an Attorney For a Provigil and Nuvigil Lawsuit? Consider These Reasons.
Are you considering filing a suit related to Nuvigil or Provigil? Hiring a lawyer will make a huge difference in your case.
Understanding the Complexity of Legal Process
Navigating legal proceedings can be challenging if you are unfamiliar with them. A lawyer with experience in Provigil/Nuvigil litigation can help you to understand the process and your choices. They can translate legal jargon into plain language and help you make informed choices about your case.
Expertise with Provigil/Nuvigil Lawsuits
A lawyer who is familiar with Provigil/Nuvigil litigation understands the nuances, complexities and uniqueness of these types of cases. They possess the expertise and know-how to identify and address the key legal concerns and build a strong argument on your behalf. They can also anticipate any challenges that might arise during the process of litigation, such as legal defenses by the defendants.
A lawyer can maximize your compensation if you suffered damages from Provigil or Nuvigil. They can estimate the value based on the extent and severity of your injuries, medical expenses, lost income, and pain. They can negotiate with the defendants, or their insurance company, to reach an agreement that adequately compensates your losses.
Deadlines for Filing
In legal proceedings, there is a strict deadline for filing lawsuits. If you miss your deadline, you might lose the right to compensation. A lawyer can assist you in meeting these deadlines.
Peace of Mind
A lawsuit can cause stress and overwhelm. Hiring a good lawyer can give you the peace of mind that professionals will handle your case. They can handle your legal case, allowing you to focus on your recovery.
Why Choose Husain Law + Associates — Houston Accident & Injury Lawyers, P.C.?
We know that dealing with the aftermath of a drug injury can be a stressful and overwhelming experience. We provide compassionate and personalized representation to our clients that meets their needs.
Here are some of the reasons you should choose our legal team:
- Experience: Our attorneys have years of experience handling Provigil/Nuvigil litigations and have successfully obtained millions of dollars of settlements for our clientele.
- Resources: Our resources are sufficient to investigate the case and present a compelling argument on your behalf. We work closely with top medical investigators and experts to uncover the evidence needed to make a convincing argument in court.
- Personalized Attention: At Husain Law + Associates — Houston Accident & Injury Lawyers, P.C. each client is treated as an individual, and we give personalized attention to their case. We will be there with you each step of the way to make sure you fully understand the legal procedure and your rights.
- No Fees Unless We Succeed: We only charge a fee if you win. This ensures that our firm is fully committed to fighting for your rights and securing your compensation.
Contact us Today
ContactHusain Law + Associates — Houston Accident & Injury Lawyers, P.C.if you or someone you love has suffered injury from using Provigil/Nuvigil. We offer free consultations. Let us fight on your behalf and help you receive the justice you deserve.
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