What You Need to Know About Dangerous Drugs & Devices

What You Need to Know About Dangerous Drugs & Devices

October 29, 2021

Many Americans look for medical attention to help reduce their pain and suffering as well as improve their quality of life. Prescription medication and implant surgeries such as knee or hip implants can change and even save lives.

However, pharmaceutical companies and medical device producers cut corners where accuracy is crucial—the security of their consumers. Insufficient laboratory testing and deceiving marketing strategies cost countless patients their lives.

Because of the injuries sustained or perhaps loss of life, dangerous drugs, medical devices, and products have caused thousands of recalls, safety warnings, and lawsuits every year. In the United States, it is the obligation of the Food and Drug Administration (FDA) to protect the public’s health, ensuring the security and efficacy of the country's food, prescription, and over-the-counter drugs, medical devices, cosmetics, tobacco, and other products.

For drugs and devices to be sold in the United States, the FDA has to approve them. Regrettably, more times than not, the FDA improperly tests medications and products before they are released to the public. Insufficient testing or deceptive warning labels typically dress up the products, causing patients to inadvertently abuse certain drugs or medical devices.

A defective drug is an over-the-counter or prescription medication that can cause physical, intellectual, emotional injury, or perhaps death. A defective device is a defective device that has malfunctions and can trigger extreme damages or death to users. In some cases, these kinds of cases can be categorized as "Mass Torts" in legal terms due to the fact of massive amount of victims these drugs and products negatively affect.

Common Defective or Dangerous Drugs

Pharmaceutical businesses and drug producers have the responsibility to produce safe medications and to arrange all of the required tests to determine the safety of the drug prior to human use. Each of these companies is required to put a warning label of any possible adverse effects on the packaging so that customers can make their own informed decision to use, or not use, the prescribed medication.

If, or when, a manufacturer fails to do so, you can suffer severe medical or physical consequences or, even worse, death.

A few of the most common defective or dangerous drugs that have affected our clients are:

  • Accutane
  • Actos
  • Baycol
  • Digitek
  • Elmiron
  • Farxiga
  • Granuflo
  • Invokana
  • Lipitor
  • Nexium
  • NuvaRing
  • Opioids
  • Paxil
  • Prilosec
  • Protamine
  • Raptiva
  • Rezulin
  • Serevent
  • Sulfate
  • Steroid Injection
  • Testosterone
  • Trasylol
  • Tylenol
  • Zofran
  • Zoloft
  • & more drugs

If you do not see the drug that hurt you on the above list, it does not imply that you do not have a claim.  

Over the years, medical research study has offered us medications that can improve our health and extend both our quantity and length of life. However, some medications constitute a significant threat to customers, causing serious injury as a result. Consumers who have been hurt due to dangerous drugs can submit a product liability claim against any pharmaceutical business that has failed to test or produce drugs in the correct way. Below are some common dangerous drugs and the health threats they cause.

Accutane and Birth Defects

Accutane is a prescription drug that is used as a last resort to treat types of cystic acne. This drug is prescribed to those who still suffer from cystic acne even after utilizing other types of skin products and antibiotics to treat their acne. While there are lots of benefits to Accutane, there have been proven results of abnormality when used by pregnant females. There have likewise been many lawsuits that claim to link this acne-treating drug to depressive or suicidal behavior.

Depo-Provera

Depo-Provera is a contraceptive that is inserted into the body that has been linked to various health risks. Women under the age of 35 who have taken the drug in the previous five years may face a somewhat higher risk of developing breast cancer. This drug also increases the risk of developing blood clots in users, possibly resulting in pulmonary embolism or stroke. Although all medications have certain foreseeable negative effects, drug producers still hold the obligation to make their items as safe as possible for their intended users and inform them of any recognized risks they may cause.

Zoloft

Zoloft is a prescription medication to treat types of depression and anxiety. This drug has been linked to numerous health problems, including increased danger of suicide, birth defects, bleeding issues (specifically when paired with aspirin, NSAIDs, or other drugs that impact bleeding), seizures, and a brain chemical imbalance called serotonin syndrome. While Zoloft does help numerous users in the way it is intended, it can also cause extreme harm to some.

Defective Medical Devices

Medical device manufacturers hold the same commitment to arrange all of the required tests to determine the safety of a device. They should likewise include any required disclaimers on the device to inform consumers of any adverse effects or concerns the device may cause. If they fail to do so, you or a loved one can suffer extreme injury or death.

There are two primary categories of medical devices that can cause patient injuries.

  1. Defective joint replacement parts like:
    1. Hip implants (DePuy/Pinnacle/ASR)
    2. Knee implants (Zimmer Persona Knee)
    3. Modular Redapt Femoral
  1. Machines/devices that are meant to treat specific medical problems or are used in surgical treatments:
    1. Surgical robotics (Da Vinci)
    2. Gastrointestinal scopes
    3. Contraception devices (Essure)
    4. IVC filters utilized to prevent blood clots (Cook & Bard)
    5. Power morcellators

If you do not see the specific medical gadget that damaged or hurt you on the above list, it doesn't imply that you do not have a claim.

Some defective medical devices, such as stents, surgical instruments, pacemakers, and prosthetics, can result in products liability claims. Although the FDA carefully monitors these devices, they can still be flawed in the design, production process, or even in their marketing methods. In some circumstances, state lawsuits over malfunctioning products that are federally authorized face rigorous legal barriers and in some cases receive nationwide attention. Below are some common high-risk medical devices such as stents and defibrillators that relate to product liability cases.

Metal Hip Replacement

Metal hip implants were produced to replace the ball-and-socket joint of the hip in a more resilient method. Normally consisting of a combination of chromium and cobalt, these metal-on-metal implants were made to be more resistant; however, they have been connected to numerous severe health problems. These issues have resulted in many producers withdrawing their devices from the market.

Transvaginal Mesh

Transvaginal mesh is a versatile patch that is placed into a women’s vaginal wall to reinforce its structure. It is generally used to correct two different conditions: stress urinary incontinence (SUI) and pelvic organ prolapse (POP). SUI is the loss of bladder control due to a cough, sneeze, laughter, workout, or any other rigorous activity. POP is the diminishing of the pelvic muscles that allow for the organs to slip out of place. Sadly, TV mesh implantation has been connected to many complications, consisting of the re-occurrence of POP or SUI, mesh erosion, and organ perforation.

De Vinci Robotic Surgery

The da Vinci surgical system consists of multiple mechanical arms and a console nearby. Surgeons use these robotics from a sitting position at the console, using its high definition, three-dimensional view system, and modern instruments to operate on their patients. Surgical robots were developed for a variety of reasons, consisting of combating the inaccuracy of a shaking hand, offering a clear view to the operating location, and offering surgeons a way to operate from a seating position so they are less fatigued by lengthy surgeries. Sadly, patients have complained of issues after robotic surgery, such as pierced organs and tissue, infections, and electrical burns. These complications have been connected to common mechanical issues, consisting of malfunctioning of the arms, electrical problems, and control freezes.

CPAP/BiPAP Recall

In June 2021, Philips, a Dutch medical device producer, recalled countless of its breathing machines. These machines, used to treat sleep apnea, include CPAP (Continuous Positive Airway Pressure) and Bi-Level PAP (Bilevel Positive Airway Pressure) devices, along with ventilators that were made between 2009 and April 2021.

CPAP and BiPAP devices manufactured by Philips, such as the first-generation DreamStation, use polyester-based polyurethane foam (PE-PUR) to reduce the sound the device produces. With time, the PE-PUR foam can fragment into particles or release chemical gases that the user may ingest or inhale while sleeping. The particles are toxic, often carcinogenic, and present a serious threat to the user's health and life.

The risk is so severe that the FDA has categorized the recall as Class I, the most extreme type of recall, and shows that the device may possibly cause major injuries and even death.

Philips is recalling the following devices:

  • *DreamStation ASV
  • *DreamStation ST, AVAPS
  • *DreamStation CPAP, Auto CPAP, BiPAP
  • *DreamStation GO CPAP, APAP
  • A-Series BiPAP V30 Auto Ventilator
  • A-Series BiPAP A40
  • A-Series BiPap A30
  • C Series ASV, S/T, AVAPS
  • Dorma 400, 500 CPAP
  • E30 (Emergency Use Authorization)
  • Garbin Plus, Aeris, LifeVent Ventilator
  • OmniLab Advanced+ In-Lab Titration Device
  • REMStar SE Auto CPAP
  • SystemOne ASV4
  • SystemOne (Q series)
  • Trilogy 100 Ventilator
  • Trilogy 200 Ventilator

These Philips devices are being recalled because of the foam breaking down into harmful particles and releasing chemicals. If this occurs, black debris can permeate into the machine's air pathways and unknowingly become inhaled or swallowed by the person utilizing the machine. Philips has admitted that they have received many complaints from users about black debris and particles being present in their machines' airways.

According to the FDA, the shedding of the foam particles and chemicals can cause severe injury, which can be deadly, cause long-lasting impairment, and have a need for medical intervention to avoid irreversible injury. Negative health impacts consist of considerable respiratory inflammation and irritation that may directly result from the toxic and carcinogenic effects of chemicals produced by the producers being inhaled. Philips has likewise acknowledged that exposure and inhalation of these hazardous chemicals can cause headaches, irritation, hypersensitivity, nausea, and vomiting. Possible hazards of exposure include negative impacts to the lungs, kidneys, liver, respiratory disease, and cancer.

Potential cancer caused by degrading foam in these CPAP/BiPAP devices include:

  • Bladder Cancer
  • Brain Cancer
  • Breast Cancer
  • Kidney Cancer
  • Laryngeal Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Lymphoma
  • Multiple Myeloma
  • Nasal Cancer
  • Nasopharyngeal Cancer
  • Papillary Carcinoma
  • Prostate Cancer
  • Rectal Cancer
  • Stomach Cancer
  • Testicular Cancer
  • Throat Cancer
  • Thyroid Cancer

Serious respiratory injuries that these malfunctioning breathing devices can cause consist of:

  • Acute Respiratory Distress Syndrome (ARDS)
  • Chemical Poisoning
  • Chronic Asthma
  • Chronic Bronchitis
  • Heart Attack
  • Interstitial Lung Disease
  • Kidney/Renal Disease
  • Liver Damage
  • Lung/Pulmonary Damage
  • Lung/Pulmonary Disease
  • Pleural Effusion
  • Pulmonary Fibrosis
  • Recurring Pneumonia
  • Respiratory Failure
  • Sarcoidosis
  • Severe Ear, Nose, or Throat Inflammation requiring medical intervention

If you or a loved one has used one of the recalled devices, both the FDA and Philips suggest you do the following:

  • Make an appointment with your physician ASAP: make certain that you speak with your physician prior to stopping or altering your current prescribed treatment. There are some instances where a ventilator supplies life-sustaining treatment, or treatment interruption is not appropriate, and the advantages of using the machine exceed the risks.
  • Contemplate other options: Consult your physician on other appropriate treatments for your condition. These might include: stopping the use of your machine, utilizing a machine that is comparable however has not been recalled, and substitute treatments for sleep apnea.
  • No "Do It Yourself": Do not remove the foam from your device and continue using it. Removing the foam can possibly impact the machine's performance and allow toxic particles to enter the device.
  • Use an inline bacterial filter: Philips advises using this method only if your doctor deems it essential to continue using the recalled device. However, the FDA believes there is no proof that this is a safe and effective way of filter to lower the risks. Although it may assist in filtering the harmful particles, it does not reduce the profusion of chemicals that the foam releases. Again, this can impact the performance of the device and increase the resistance of airflow through the device. If you choose this alternate form, the FDA suggests closely monitoring your device for any increased accumulation of debris and resistance-related problems of airflow after you change the filter.

Filing a Claim

When an individual suffers an injury from an unsafe drug or medical device, a medical malpractice or product liability claim may be an appropriate method to seek settlement for your sufferings.

If your injury occurred due to the malfunction of a medical device, a products liability case may be the better strategy, as it holds the product manufacturer or designer accountable for the injury. Medical malpractice cases may work in other cases where the carelessness of the physician, for their unreasonable action or inaction, was the reason they suffered damage.

Suppose you have been injured due to a prescription medication that had risks you were not informed of. In that case, it is best to file a products liability case to hold the pharmaceutical business responsible for selling a dangerous drug without the proper warning.

No matter what kind of unsafe drug or device has harmed you, you are worthy of having an experienced legal representative on your side. Such drugs and devices can trigger serious physical damage, psychological pain, medical costs, the inability to work, and even death.

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