Philadelphia PADCEV Lawyer
PADCEV (Enfortumab Vedotin-EJFV) is a prescription drug approved to treat bladder cancer in certain individuals, as well as urinary tract cancers in the renal pelvis, ureter or urethra. Unfortunately, it is now publicly known that PADCEV use carries a risk of serious and life-threatening conditions known as Steven-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS/TEN).
PADCEV was approved by the FDA in December 2019, but it wasn’t until July 2021 that the makers of PADCEV started carrying a warning on their packaging about the risk of SJS/TEN. It’s possible the drug maker knew of the risks of SJS/TEN yet continued to market it long before they made this information available to the public.
SJS/TEN are horrific diseases that nobody should be made to suffer, especially when they are already battling cancer and fighting heroically against another disease. If you or your loved one acquired SJS/TEN from PADCEV use, you might have a claim against the manufacturer or other responsible parties. The Philadelphia PADCEV lawyers at Green & Schafle can help you hold liable parties accountable to you for the harm they have caused and help you recover significant compensation to deal with the pain and complications of the disease their drug has inflicted on you.
What is PADCEV?
PADCEV was approved by the FDA in December 2019 to treat refractory bladder cancer and other urothelial cancers in patients who have already received immunotherapy and platinum-containing chemotherapy or who are who have received one or more prior therapies and are not able to receive a chemotherapy containing the medicine cisplatin. PADCEV is delivered via IV infusion for 30 minutes three times per month in 28-day cycles for as long as it is doctor-recommended.
The PADCEV website lists many serious side effects possible with use, including skin reactions, lung problems, neuropathy, hyperglycemia, vision problems and others. Most recently, PADCEV drug makers have added specific warnings about severe skin reactions in people treated with PADCEV, including admitting that some of these severe skin reactions have resulted in death. This information does not, however, explicitly reference Steven-Johnson Syndrome or Toxic Epidermal Necrolysis, commonly referred together as SJS/TEN.
What is SJS/TEN?
SJS/TEN is a severe allergic skin reaction that causes the epidermis to separate from the dermis so that a person’s outer layer of skin blisters and literally peels off the body. Needless to say, this condition is painful and life-threatening. Reactions can also affect linings in the mouth, nose, throat or genital area.
This condition is known as SJS when it covers less than ten percent of the body. If it covers over 30% of the body, then it is known as TEN. SJS and TEN can be considered together as related conditions along the same spectrum of disease.
In addition to the high risk of death from SJS/TEN, other serious problems that have been noted include:
- Lung problems and pneumonia
- Urinary problems
- Genital scarring
- Infections leading to organ failure or septic shock
By March 2021, the FDA was evaluating the need for regulatory action toward PADCEV for its risk of causing SJS/TEN. As of September 2021, the FDA was also evaluating the need for regulatory action toward PADCEV regarding serious risks of pancreatitis and pneumonitis.
Depending on where on the body the condition arises and how serious the reaction is, treatment can range from medications such as corticosteroids to treatment in a burn unit, skin grafts, and being placed on a ventilator. Preventing and treating infections and treating conditions in sensitive areas such as the eyes, genitals or lungs is crucial to preventing the worst outcomes of SJS, including death.
How Can Green & Schafle Help Users of PADCEV Who Contracted SJS/TEN?
Product manufacturers, including pharmaceutical drug makers, can be held strictly liable when they release dangerous or defective products onto the market. Product defects can be present in the design, manufacture, or marketing of the drug. In the case of PADCEV, the manufacturer could be liable for its failure to warn users or the risk of contracting SJS/TEN. Defective drug manufacturers can be liable for all the harm caused by their defective product, including medical bills, lost income, disability, pain and suffering, scarring and disfigurement, loss of quality of life, and more. In the case of death, Pennsylvania law allows immediate family members or the estate to sue to recover medical and funeral expenses as well as compensation for harm such as the loss of companionship and emotional distress. Punitive damages might also be available if it can be proven the manufacturer’s actions were particularly reckless or intentional.
It can seem daunting to try and go up against a pharmaceutical giant and prove that they failed to properly design, test or market their drug to the public. These cases are complicated, but they are not impossible to win. The attorneys at Green & Schafle have taken on difficult cases like these and recovered significant compensation for our clients through verdicts and settlements that hold the responsible parties accountable for their actions and help victims and their families deal with the harm done and recover as much as possible.
Legal Help With PADCEV Injuries From Dedicated Philadelphia Dangerous Drug Attorneys
If you or your loved one suffered from serious injuries like Stevens-Johnson Syndrome after taking PADCEV or other dangerous or defective drugs, call Green & Schafle in Philadelphia at 215-462-3330 for a free consultation. We’ll help you find out what went wrong and hold any responsible parties liable to you for your injuries and damages.