In 2016, the United States Food & Drug Administration (FDA) recalled more than 8,000 defective products and issued more than 14,000 warning letters about possible serious side effects associated with legal products. A large percentage of these actions involved dangerous drugs. Since the FDA both approves new drugs and acts as a consumer watchdog, its bureaucrats often hesitate to take action against drugs that they only recently declared to be safe. So, by the time the agency finally takes adverse action, the dangerous drug has usually already injured thousands of people. Even worse, the FDA almost never initiates unilateral Class III recalls, so dangerous drugs may remain on the shelves and enter the bloodstreams of unsuspecting victims. This is where the need for New York pharmaceutical litigation attorneys come in.
To be blunt, these cases are difficult to win, because the big pharma companies have almost unlimited resources with which to fight these claims. But at Napoli Shkolnik, PLLC, our pharmaceutical lawyers have nationwide resources of our own. More than that, we have a determination to stand up for victims of injustice and we aggressively go after companies that callously put profits before people. If you or a loved one has been injured by a dangerous drug in New York or elsewhere, your best move is to contact Marie Napoli or one of our other experienced pharmaceutical lawyers.
Filing a Claim for Damages
A defective drug is a prescription medication that causes physical, emotional, or psychological injury to a patient. When the risks associated with a drug are not made known by the pharmaceutical company that manufactures the drug, then the company may be held liable for any damages a patient suffers as a result of taking the drug.
In addition to filing a dangerous drug lawsuit for harm caused by a defective medication directly against the drug’s manufacturer, other parties who may be held liable include:
- The doctor who prescribed the medication;
- The hospital where the prescription was written;
- The pharmacist who filled the medication; and
- The pharmacy where the prescription was filled.
To better establish damage claims, our pharmaceutical lawyers partner with some of the top experts in their fields. These brave individuals sometimes testify on behalf of victims at great personal risk to their careers, because they share our passion for justice. Furthermore, from a technical standpoint, these witnesses have considerable freedom to share their opinions in New York courtrooms.
Because the injuries associated with dangerous drugs and dangerous devices are often substantial, compensation is usually substantial as well. Additionally, juries often award significant punitive damages in these cases, to punish the company and deter future wrongdoing.
The Dangerous Drug System
A little over a hundred years ago, any company could sell any product to any person for any reason, regardless of its possible effects on health and safety. As an example, one large drug maker bottled and sold heroin in the late 1800s, marketing it as a children’s cough suppressant to Hispanic households.
Thankfully, the environment changed in 1906, when President Theodore Roosevelt signed the Pure Food and Drug Act. The Chemistry Bureau, a special division of the Department of Agriculture, enforced the law until 1927, when Congress created the Food, Drug, and Insecticide Organization, which later became the FDA.
The government approves many new drugs and devices through the expedited, no-questions-asked 510(k) fast track. In short, if a new drug or device is substantially similar to an existing product, the FDA rubber stamps it. However, there is no guarantee that the compared-to product is safe.
But a major shake-up took place within the FDA in 1997, just as the first opioid pain relievers became available and drug makers started using polished television ads to pitch their products directly to consumers. Now, the agency is no longer the safety watchdog it once was. In fact, in 2017, the prescription drug industry provided three-fourths of the FDA’s budget.
Dangerous pharmaceutical Drug attorneys in new york
At Napoli Shkolnik, PLLC, we represent victims of dangerous drugs and also defective medical devices, because, in terms of the legal elements, the foundation of damage claims, and the injuries involved, these cases are very similar. Pharmaceutical litigation lawyers help protect victims of pharmaceutical wrongdoing.
Many times, the origins of these claims go back many years. For example, in the 1940s and 1950s, many doctors prescribed Diethylstilbestrol, a synthetic estrogen, to their patients who faced pregnancy complications. But this drug created a generation of DES daughters who were permanently infertile. Many of the drug’s adverse effects linger into third-generation DES granddaughters.
Other issues, such as the opioid epidemic, are more recent occurrences. As mentioned earlier, Oxycontin, Percocet, and other prescription painkillers first appeared in the 1990s, and over subsequent years, they became even more powerful and addictive. However, the dangerous drug manufacturers largely turned a blind eye to these dangers and blamed the victims when they almost inevitably became addicted to these products.
Our docket also includes device litigation, such as defective hip implants. The all-metal cup and socket joint is prone to early failure, largely because the artificial joint’s movement releases tiny metal fragments into the patient’s bloodstream, causing severe metal poisoning infections. Moreover, there is emerging evidence that the cheap metals in some Stryker hip implants may cause dementia and other serious illnesses.
In many of these cases, the manufacturers conceal known product dangers to boost sales, primarily because it costs over $1 billion to put a new drug through the FDA’s approval process and manufacturers are desperate to boost product sales in any way possible. The Infuse Bone Graft is a good example, as there is considerable evidence that the device manufacturer sponsored events that encouraged doctors to use highly experimental methods and that Medtronic also manipulated safety reports.
Much like opioid pain relievers, Taxotere is an example of a well-intentioned drug that was too powerful to use safely. Like most other chemotherapy drugs, docetaxel targets and kills rapidly dividing cells, a category that includes both cancer tumors and hair. That’s why most breast cancer patients lose their hair as they undergo treatment. But Taxotere is so powerful that it causes permanent alopecia, or permanent hair loss. This condition is emotionally crippling for women, especially those who see hair regrowth as evidence that their disease is in full remission.
If a drug or device has dangerous side effects, the manufacturer is strictly liable for the victim’s damages, regardless of the company’s good intentions.
Talcum powder is a good example of this idea. After all, few things are more benign than dusting the body with talcum powder to control body odor. But talcum powder contains asbestos-like particles that migrate up a woman’s fallopian tubes and cause cervical cancer, one of the most aggressive forms of this deadly disease. There is also evidence that links talcum powder to mesothelioma.
Along the lines of Johnson & Johnson and other talcum powder makers, device designers and engineers created the Bair Hugger Warming Blanket almost exclusively for personal comfort. Most hospital and clinics are very cold. The low temperature helps keep the air sterile and the staff alert, but it is often uncomfortable for recovering surgical patients. So, the Bair Hugger Warming Blanket uses a vacuum pump to collect air from near the floor, heat it, and then heat the blanket. But the air near the floor is often full of dangerous bacteria, which multiplies in the warm air and then settles inside the patient’s healing wounds, causing staph and other infections.
One final category of dangerous drugs and devices are those that use extraordinary power to combat illnesses and conditions that are more bothersome than dangerous. For example, the transvaginal mesh combats pelvic organ prolapse in women, a condition that’s very painful but not very serious. Over time, the mesh mixes with soft tissues, causing infection. One surgeon compared the emergency removal process with separating chewed bubble gum from matted hair.
Similarly, testosterone supplements are designed to treat lethargy and other “male menopause” symptoms. If this condition even exists, it can hardly be described as life-threatening. But the heart problems that “low T” supplements cause are very real. In fact, researchers had to prematurely cancel one study, because a test subject developed dangerous cardiac issues.
These drugs and devices are just a small sampling of the cases that our pharmaceutical lawyers routinely handle on a nationwide basis. If you or a loved one was injured by a dangerous drug or hazardous medical device, you can count on the aggressive pharmaceutical lawyers at Napoli Shkolnik PLLC to not only arrange for the medical treatment you need at no upfront cost, but to also fight for your rights in court.
Partner with Tenacious Attorneys
Dangerous drug cases are not for faint-hearted attorneys, but are for Marie Napoli and some of the other aggressive and experienced pharmaceutical lawyers at Napoli Shkolnik, PLLC. We do not charge upfront legal fees in negligence cases. You may have questions about pharmaceutical litigation and what is involved, and we would be happy to answer them. Call the Napoli Shkolnik, PLLC pharmaceutical defense litigation law firm or follow this link to contact us today.