Prescription medication can only be purchased lawfully with a prescription from a medical expert.
A painkiller is a sort of prescription medication. A prescription pain reliever is intended to alleviate discomfort. However, when it causes harm to the person using the drug, it is considered a faulty product.
These types of medications and devices are often the subject of defective medicine claims when they cause injury.
Actiq is a narcotic pain medication that comes in the shape of a lollipop. Cephalon, Inc.’s Actiq lozenge element of the lollipop provides pain relief through the bloodstream. Individuals may use the medicine to relieve discomfort by placing it between their gums and cheeks. Actiq may also be administered by injection or transdermal patches.
The Actiq lollipop contains the active component fentanyl citrate. This active component has a high level of addiction. The narcotic is around 80 times stronger than morphine, a well-known and highly addictive painkiller.
The medicine was licensed by the FDA in 1998 to treat cancer patients’ extreme pain. Medical practitioners are also beginning to prescribe the narcotic lollipop for non-cancer pain.
The following are some of the drug’s side effects:
Yes. More than 100 individuals have died as a result of the drug’s terrible adverse effects. This alone suggests that the Actiq lollipop is a defective product.
A faulty product is any product that causes a person danger because of the following:
A design flaw is exactly what the term implies: a flaw in the design of a product.
If a product’s design is faulty, it indicates it is intrinsically problematic and will result in possible liability, regardless of how well the product is built or how effectively the buyer is informed about the product.
A manufacturing fault is, as the name implies, a flaw in the product’s production. A design may be excellent and entirely safe, but when the manufacturer creates the product, the product becomes dangerous.
Even though a product is developed and constructed flawlessly, certain goods may result in product liability lawsuits if a sufficient warning is not provided.
Furthermore, product liability lawsuits based on faulty warnings may involve a failure to adequately advise customers on how to utilize the device.
Product liability lawsuits arise when a producer or seller of a product or goods is held accountable for knowingly introducing a faulty product into the marketplace. It is critical to understand that any entity involved in any component of a product’s manufacture may be held accountable in the same way that a seller is.
A plaintiff must establish the following in order to win a case against the maker of Actiq lollipops:
Cephalon Inc. entered a guilty plea and paid over 400 million dollars to settle accusations that it promoted three medications for purposes not authorized by the FDA.
Former Cephalon workers launched the cases under the False Claims Act’s provisions.
According to the lawsuits, Cephalon participated in a plan to sell Actiq, Provigil, and Gabitril for unauthorized uses, which is in breach of the Food, Drug, and Cosmetic Act. This act requires a corporation to describe the planned uses of medication in its application to the Food and Drug Administration.
After authorization, the medicine cannot be advertised or publicized for “off-label” applications, which are any uses that are not listed in an application or authorized by the FDA.
The lawsuits claimed that because of Cephalon’s off-label promotions strategy, bogus payment claims were filed to government insurance programs, including the Federal Employee Health Benefits Program and Medicaid, which didn’t cover the off-label usage.
The US Justice Department also filed a criminal suit alleging that, between roughly January 2001-2006, Cephalon advertised the medications for purposes other than those authorized by the FDA.
Actiq was authorized by the FDA for use solely in opiate-tolerant cancer sufferers. Cephalon reportedly advertised the medicine for non-cancerous patients for sickle-cell discomfort problems, migraines, wounds, and in expectation of radiation therapy or swapping wound dressings between 2001 and 2006. Cephalon also marketed Actiq to individuals who weren’t opioid-tolerant.
Cephalon carried out its off-label advertising methods in several ways, including teaching its sales personnel to flout FDA-authorized label limits and push the pharmaceuticals for off-label applications.
The Actiq label, for example, indicated that the medication was intended for opiate-tolerant cancer sufferers with serious discomfort to be administered by oncologists or pain experts acquainted with opioids.
Cephalon directed Actiq salespeople to target doctors other than oncologists, mostly general practitioners. Actiq also marketed the medicine for various indications other than severe cancer pain.
Cephalon hired sales people and medical specialists to engage with physicians about the medications’ off-label applications. In contravention of the FDA’s rules, the corporation supported continuing medical education classes with millions in grants to encourage off-label usage of its medications.
As part of the solution to these allegations, Cephalon and the HHS Inspector General entered into a 5-year Corporate Integrity Agreement.
The agreement requires Cephalon to send physicians a letter informing them of the resolution, to post payments to physicians on its website, and to have its board of directors and top personnel regularly certify that the corporation complies with all relevant requirements.
The investigation was conducted by the Department of Health and Human Services Office of the Inspector General, the Justice Department’s Civil Division, the United States Attorney’s Office in Philadelphia, the FDA’s Office of Criminal Investigation, the Office of Personnel Management Office of Inspector General, and the Postal Service Office of the Inspector General.
Representatives from the Connecticut Attorney General’s Office and the National Association of Medicaid Fraud Control Units provided assistance.
Cephalon paid $375 million, plus interest, in a different civil settlement completed concurrently with the guilty plea agreement to settle False Claims Act accusations stemming from Medicare, Medicaid, and other federal programs claims, including the Every Employees Occupational Illness Compensation Program, the Federal Employees Health Benefits program, TRICARE, the Federal Employees Compensation Act Program, and the Postal Worker’s Compensation Program.
Delaware, California, Hawaii, Florida, Louisiana, Illinois, Nevada, Massachusetts, New Mexico, New Hampshire, Tennessee, Texas, Washington, D.C., and Virginia’s Medicaid programs split over 100 million dollars of the settlement.
Even when taken according to your doctor’s orders, Actiq may be hazardous, particularly in lollipop form. Contact a defective products lawyer if Actiq has damaged you or a loved one. The lawyer may bring a faulty product or wrongful death claim on your behalf and represent you in court.
16 people have successfully posted their cases
