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What You Need to Know About Dangerous Drugs & Devices

Numerous Americans seek medical attention to help reduce their pain and suffering and improve their quality of life. Prescription medication and implant surgeries, such as knee or hip implants, cannot only change but save lives.

However, pharmaceutical businesses and medical device producers cut corners where accuracy is essential— the safety of consumers. Inadequate laboratory screenings and ambiguous methods of marketing cost countless patients their lives.

Due to the injuries sustained or even loss of life, dangerous drugs, medical devices, and products have sparked countless recalls, safety warnings, and claims each year. In the United States, it is the obligation of the Food and Drug Administration (FDA) to protect the health of the public, guaranteeing the safety and efficiency of the nation's food, prescription and over-the-counter drugs, medical devices, cosmetics, tobacco, and other products.

In order for drugs and devices to be sold in the United States, the FDA has to approve them. Unfortunately, the FDA often improperly tests medications and devices prior to them being released to the public. Inadequate testing or misleading warning labels frequently dress up these products, causing patients to abuse specific drugs or medical devices unintentionally.

A defective drug is a non-prescription or prescription medication that can trigger physical, intellectual, psychological injury, or even death. A defective device is a faulty device that has malfunctions and can trigger severe damages or death to users. In some instances, these kinds of cases can be classified as "Mass Torts" in legal terms due to the large number of victims these drugs and devices adversely affect.

Common Defective or Dangerous Drugs

Pharmaceutical companies and drug manufacturers have the duty to produce safe medications and to organize all of the required tests to determine the safety of the drug before human use. Each of these businesses are required to include a warning label of any potential side effects on the packaging so that customers can make their own informed choice 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 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
  • and more

Throughout the years, medical research has supplied Americans with medications that can enhance our health and extend both our quantity and length of life. However, some medicines present a notable risk to consumers, causing serious injury as an outcome. Consumers who have been injured due to dangerous drugs can file a products liability claim versus any pharmaceutical company that has failed to test or produce drugs in the correct way. Below are some common dangerous drugs and the health risks they cause.

Accutane and Birth Defects

Accutane is a prescription drug that is often used as a last resort to treat forms of cystic acne. This drug is recommended to those who still suffer from cystic acne even after using other types of skin products and prescription antibiotics to treat their acne. While there are many advantages to Accutane, there have been proven results of abnormality when utilized by pregnant women. There have also been numerous lawsuits that claim to link this acne-treating drug to depressive or self-destructive (sometimes suicidal) behavior.

Depo-Provera

Depo-Provera is a contraceptive that is injected into the body that has been connected to various health risks. Females under the age of 35 who have taken the drug in the past five years may face a slightly greater danger of developing breast cancer. This drug also increases the threat of developing blood clots in users, possibly leading to pulmonary embolism or stroke. Although all medications have certain foreseeable side effects, drug producers still hold the duty to make their products as safe as possible for their designated users and notify them of any known threats they may pose.

Zoloft

Zoloft is a prescription medication to treat forms of anxiety and depression. This drug has been linked to many health problems, including increased risk of suicide, birth defects, bleeding issues (particularly when combined with aspirin, NSAIDs, or other drugs that affect bleeding), seizures, and a brain chemical imbalance called serotonin syndrome. While Zoloft does assist many users in its intended method, it can also cause severe damage to some.

Defective Medical Devices

Medical device manufacturers hold the same commitment to organize all of the required tests to determine the security of a device. They must also include any mandatory disclaimers on the machine to inform consumers of any side effects or issues the device may cause. If they fail to live up to their legal obligation of doing so, you or a loved one can suffer extreme injury or death.

There are two main categories of medical equipment 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
  2. Machines/devices intended to treat certain medical problems or are used in surgeries:
    1. Surgical robots (Da Vinci)
    2. Gastrointestinal scopes
    3. Birth control devices (Essure)
    4. IVC filters used to prevent blood clots (Cook & Bard)
    5. Power morcellators

Some defective medical devices, such as stents, surgical instruments, pacemakers, and prosthetics, can lead to a products liability claim. Although the FDA carefully monitors these devices, they can still be faulty in the design, production process, or perhaps in their marketing strategies. In some instances, state lawsuits over defective products that are federally approved face strict legal barriers and sometimes receive attention nationwide. Below are some common high-risk medical devices such as stents and defibrillators that are linked to product liability cases.

Metal Hip Replacement

Metal hip implants were created to take the place of the ball-and-socket joint of the hip in a more long-lasting method. Usually consisting of a mix of chromium and cobalt, these metal-on-metal implants were made to be more resistant but unfortunately have been linked to various severe health issues. These issues have resulted in numerous manufacturers withdrawing their devices from the market.

Transvaginal Mesh

Transvaginal mesh is a flexible patch that is placed into a woman's vaginal wall to reinforce its structure. It is generally utilized to correct two 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 physical activity. POP is the weakening of the pelvic muscles that allow the organs to slip out of place. Regrettably, TV mesh implantation has been connected to numerous severe complications, including the re-occurrence of POP or SUI, mesh erosion, and organ perforation.

Da Vinci Robotic Surgery

The da Vinci surgical system consists of multiple mechanical arms and a nearby console. Surgeons use these robots from a sitting position at the console, utilizing its HD, three-dimensional view system, and modern instruments to operate on their patients. Surgical robotics were produced for a variety of reasons, consisting of minimizing the threat of a shaking hand missing the mark, offering a clear line of sight to the operating location, and providing surgeons a method to operate from a seating position, so they are less tired by long-lasting surgical treatments. Unfortunately, patients have experienced complications after robotic surgeries, such as pierced organs and tissue, infections, and electrical burns. These issues have been linked to common mechanical issues, including malfunctioning of the arms, electrical problems, and control freezes.

CPAP/BiPAP Recall

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

CPAP and BiPAP devices made by Philips, such as the first-generation DreamStation, used polyester-based polyurethane foam (PE-PUR) to decrease the sound the device produced. Eventually, the PE-PUR foam can fragment into particles or release chemical gases that the user can possibly consume or inhale while sleeping. The particles are poisonous, sometimes carcinogenic, and present a serious risk to the user's health and life.

The risk is so serious that the FDA has classified the recall as Class I, the most extreme type of recall, and suggests that the device may possibly cause major injuries or 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 due to the foam breaking down into toxic particles and releasing chemicals. If this occurs, black debris can seep into the device's air pathways and unintentionally become inhaled or swallowed by the person using the device.

Philips has admitted that they have received lots of complaints from users about black debris and particles existing in their devices' airways.

According to the FDA, the shedding of the foam particles and chemicals can result in serious injury, which can be deadly, cause long-term impairment, and have a need for medical intervention to prevent irreparable injury. Adverse health impacts consist of considerable respiratory swelling and irritation that might directly result from the poisonous and carcinogenic impacts of chemicals produced by the devices being inhaled. Philips has also acknowledged that direct exposure and inhalation of these harmful chemicals can lead to headaches, inflammation, hypersensitivity, queasiness, and vomiting. Possible threats of exposure consist of unfavorable effects to the lungs, kidneys, liver, respiratory disease, and cancer.

Possible cancer brought on by degrading foam in these CPAP/BiPAP devices consists of:

  • 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 breathing injuries that these defective breathing machines 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 an enjoyed one has utilized one of the recalled devices, both the FDA and Philips recommend you do the following:

  • Make a consultation with your doctor ASAP: it is important to speak with your doctor prior to stopping or changing your current prescribed therapy. There are some circumstances where a ventilator supplies life-sustaining treatment, or treatment disruption is not acceptable, and the benefits of utilizing the device outweigh the dangers.
  • Explore other options: Consult your physician on other sufficient treatments for your condition. These could consist of: stopping the use of your device, using a device that is comparable but has not been recalled, and substitute treatments for sleep apnea.
  • No "Do It Yourself": Do not remove the foam and continue utilizing your recalled device. Removing the foam can potentially affect the device's performance and allow debris to seep into the device.
  • Use an inline bacterial filter: Philips advises this technique only if your physician considers it necessary to continue using the recalled device. However, the FDA believes there is no evidence that this is a safe and effective method of filter to decrease the risks. Although it might assist in filtering the hazardous particles, it does not reduce the outpouring of chemicals that the foam releases. Once again, this can also affect the device’s performance and actually increase the resistance of airflow through the device. If you choose this alternate form, the FDA recommends carefully monitoring your device for any increased build-up of debris and resistance-related problems of airflow after you change the filter.

Filing a Claim

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

If your injury occurred due to the malfunction of a medical device, a products liability case may be the better avenue to take, as it holds the product manufacturer or designer responsible for the injury. Medical malpractice cases may suffice in some cases where the negligence of the medical professional, for their unreasonable action or inaction, was the reason they suffered damage.

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

No matter what type of dangerous drug or device has harmed you, you deserve to have a knowledgeable attorney by 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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