In our largest pharmaceutical case from 2016, Arnold & Itkin was honored to represent the Yount family against Johnson & Johnson for Risperdal, the infamous drug that causes gynecomastia in young boys. Our landmark case revealed that Johnson & Johnson knowingly and willingly withheld information about Risperdal's side effects for years, allowing thousands of boys nationwide to risk their emotional and physical health without their knowledge or consent. We were proud to hold Johnson & Johnson accountable alongside this family. Listen to Mr. Yount talk about his experience.
The medical device industry is highly competitive. Unfortunately, this means that many medical products are rushed to market without adequate testing or proper consideration of those who might be harmed by defects in the products. One way medical device makers have tried to take shortcuts into the market is through the 510(k) process in which they obtain FDA clearance by claiming their device is "substantially equivalent" in safety and effectiveness to another device that is already on the market or claiming that their device is being used for the same purpose. The actual use for the device, however, may have been misrepresented. State and federal law allows manufacturers, distributors, and sellers to be held fully accountable for design, manufacture, and marketing flaws.
What Is the Role of the FDA in Medical Recalls?
The FDA regulates almost every step of the process for development, manufacturing, testing, and marketing of medical devices and drugs. The FDA examines and reviews research and case studies relative to such products and offers or denies approval for medical devices and drugs.
The safety regulation of pharmaceutical products is extremely important due to the potential risk associated with unsafe products. The FDA will often continue to perform case studies even after approving a drug for sale.
If extended case studies reveal dangerous side effects or conditions which raise concern about a product's safety, the FDA may issue a warning or instruct the pharmaceutical company to strengthen the warning in the package labeling and inform medical providers about potential dangers. The FDA will issue a medical recall or instruct the pharmaceutical company to issue a medical recall of a product or drug if the danger to the public is found to outweigh the benefits derived from its use.
First approved in 1952, Acthar is an immune-system drug used in the treatment of infantile spasms, MS exacerbations, and other diseases and disorders. In 2014, a regulatory filing showed data for the first time the adverse events tied to the drug, including renal failure, abdominal pain, and even death.
Antidepressants / SSRI's
All across the nation, those who have been suffering from depression symptoms have turned toward antidepressants such as Zoloft in an attempt to find relief. These drugs, however, have not always been as safe as billed and have resulted in serious side effects to consumers.
This antipsychotic drug treatment has been on the market since 1994; doctors have connected Risperdal with a condition called gynecomastia, which causes males to develop breast tissue and milky white discharge due to the elevated levels of prolactin.
Since the early 1990s, Zoloft (manufactured by Pfizer) has been used to help treat the symptoms of depression. Classified as a SSRI, the drug was at the forefront of antidepressants on the market. It, however, has since been linked to several adverse side effects, such as serious birth defects.
Invokana is a relatively new form of diabetes medication that suppresses sugar from re-entering the bloodstream. Instead, it forces sugar through the kidneys--causing them to overload and shut down. Invokana has been linked to diabetic ketoacidosis, kidney failure, cardiac disorders, and fatal comas. It has also been linked to pancreatitis.
Talcum powder (commonly referred to as baby powder) is a common household hygiene product that women have been using for feminine hygiene for nearly a century. However, in 1971 researchers found talc particles on ovarian tumors--leading some to believe that talcum powder use is linked to cancer growth. Our firm has represented multiple women and families who were never warned about the dangers of talc use and suffered from severe and life-altering cancers--including ovarian cancer.
In recent years, our firm has become increasingly involved in highly complex multi-district litigation (MDL) cases and consolidated proceedings in state and federal court involving patients with common claims against pharmaceutical and medical device companies. In an MDL case, several hundred individual cases from across the country may be consolidated for pre-trial matters that include depositions, consultation with experts, requests for documents, and motions. Our law firm has been fortunate to serve on the plaintiffs' steering committee in several of these MDL cases.
We believe in taking an aggressive approach to representing our clients. Pharmaceutical companies and medical device manufacturers may have virtually limitless resources. It is crucial to fight fire with fire. We invest the resources it takes to deliver successful results. From the moment we become involved in a medical / pharmaceutical injury case, including MDL cases, we are geared towards taking the case to trial. That type of preparation has ultimately allowed us to negotiate fair and reasonable settlements, including several multi-million dollar awards.
If you have been injured by a dangerous or defective drug, it is in your best interests to get the involvement of a personal injury lawyer who you can trust to help you file a claim. Our firm has proven over the years that we can be trusted with some of the most complicated cases. In our careers, we have already tried more cases than most attorneys can say that they have tried in a lifetime. Want to know more about how we will be able to help you fight for maximum monetary compensation? Give our legal team a call today! We are standing by and ready to help you.
Arnold & Itkin represented a pregnant woman who experienced stomach pain and called Acadian Ambulances. The driver of the ambulance drove the ambulance into the back of a sugar cane truck causing the plaintiff's spine to be severed at T4 and for her to sustain serious brain injuries. We succeeded in obtaining a $117 million verdict for the mother, as well as her two daughters.
Attorneys from Arnold & Itkin LLP secured a unanimous jury verdict on behalf of our client who had suffered from the usage of Risperdal.
Arnold & Itkin has achieved a record settlement for a worker who was injured in a severe oilfield accident less than 2 years after the incident. His accident was a result of negligence from multiple parties--all of whom settled with our client only a week before trial. We are thrilled that our client will receive the medical care and future security he deserves.
Arnold & Itkin represented a construction superintendent who required a leg amputation after a crane collapse. At the time of the collapse, our client had been standing behind a safety fence 100 feet away when a fallen piece of crane equipment pinned him down. Our firm got him the largest award ever given in a case involving loss of limb, including $8.5 million in punitive damages.
Our client was a Houston-based investor who was cut out of a deal to acquire Honsador Lumber Corporation, one of Hawaii’s largest lumber suppliers. The jury found Key Principal Partners LLC and its parent Key Corporation guilty of breaching their fiduciary duties, interfering with Foreman's efforts to acquire the Honsador Lumber Corporation, and violating Hawaii's unfair competition statute. We won a massive $41 million verdict for the wrongdoing committed against our client.