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Helping People and Families

Who Were Injured By Dangerous Drugs or Defective Devices

Helping People and Families

Who Were Injured By Dangerous Drugs or Defective Devices

Defective Drugs & Defective Medical Devices Information & Lawsuits

consumer Alert Now is committed to providing information on high-risk and potentially harmful medical products and procedures by informing them of severe side effects , complications, medical conditions, and ways to take legal action. We’re here for people injured by medical devices and drugs that have serious complications.

Thousands of Americans turn to medical attention to relieve them of pain and suffering and improve their quality of life. Medications and implant surgeries can cure medical conditions, change and even save lives. While drugs, vaccines, biologics, and medical devices provide a benefit to many patients, when manufacturers cut corners where accuracy matters most, the result is compromised consumer safety. Medicines and various medical devices are not safe for everyone, not to mention that defective medical products can cause adverse effects and death. Deceptive marketing tactics and insufficient lab testing have cost thousands of patients their lives. As such, it’s crucial that consumers know the risks involved so they can make informed decisions about their health care.

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Types Of High-Risk Drugs

adrug is recognized as a substance that induces changes in the body and can be used to diagnose, treat, or prevent a medical condition. Every drug, vaccine, or biologic must be approved by the U.S Food & Drug Administration (FDA) before it can be used by the public. However, each drug has the potential to cause life-threatening and life-altering side effects and approval by the FDA does not guarantee safety. The testing done to establish a product’s safety is conducted on small groups before the drug is approved for sale. However, some problems are not discovered during the tests, only to be known when a product is used by a larger number of people. Failure by the drug manufacturer to adequately warn of the risks has left too many people suffering severe side effects and some have died.

Even with the FDA’s strict policies, standards, and guidelines for ensuring consumer safety with drugs considered high-risk, the processes can be slow-moving. It may take several years before the public is fully aware of the dangerous side effects of a drug. It can even take longer to remove a defective drug from the market.

Regardless of whether a drug is prescription or over the counter, it has the potential to cause side effects from minor headaches to severe kidney failure. According to the FDA, side effects are unwanted or unexpected reactions to a drug. In some case, the side effects are associated with all the drugs in a given class. As such, consumers must consider all potential side effects of a drug, even if the manufacturer claims rarity of the effect.

Important to note: Patients should consult a doctor before they stop taking a prescribed medication.

Vaccines

Vaccines

A vaccine is a product given to create immunity to a specific disease. Vaccine products are regulated by the Center for Biologics Evaluation and Research. These products contain germs that cause the disease they are designed to protect people against....
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Inactivated Vaccines Vs. Live Vaccines

Inactivated Vaccines Vs. Live Vaccines

Live vaccines are weakened or attenuated products made from viruses or bacteria. These products generate an immune response similar to natural infections but without symptoms or causing illness. A live vaccine is made from active but weakened disease...
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What To Do If You’ve Been Injured

A vaccine is meant to offer protection and a drug is meant to bring relief. As such, it’s even more devastating when the medicine ends up leaving them with a debilitating condition. Patients who have been can take several actions to help lessen the distress and help protect others from the same issue:

Report to the FDA

Consumers are encouraged to report adverse side effects to the FDA. The agency then evaluates the report to determine how serious how the case is.

File a Lawsuit

CDrug-injury lawsuits often target a company over design defects, manufacturing defects, or marketing defects. Some of the most common types of product liability lawsuits involve marketing defects, which are generally failure-to-warn defects.

File a Petition with National Vaccine Injury Compensation Program (VICP)

VICP is a government-regulated, tax-dollar-funded program that compensated individuals who’ve been injured by certain vaccines. The program covers 17 vaccines and anyone who’s been injured by one of those vaccines can file a petition. Also, petitions on behalf of disabled infants, children, infants, and deceased persons are accepted.

Defective Medical Devices

As research and technology advances, new developments are made every day in the medical industry, revolutionizing health care and improving the quality of life for people suffering health conditions. These developments also make life more convenient and easier for those who are in good health. Medical devices range from tongue depressors to stethoscopes, from syringes to artificial hearts, from pacemakers to robotic surgical instruments.

A medical device according to the FDA is an apparatus, an instrument, machine, implant, contrivance, implement, in vitro reagent, or other related objects intended for diagnosing mitigating, preventing, or treating medical conditions. FDA’s Center for Devices and Radiological Health (CDRH) oversees medical devices on the U.S market and also regulates thousands of medical device manufacturers and medical device facilities worldwide. The CDRH applies different levels of scrutiny on new products being introduced. For instance, a lower-level scrutiny process is applied on a new type of bedpan but a new heart valve must undergo an extensive process, including inspection of its manufacturing process and clinical and laboratory studies before it can be released to the market.

Most of the medical devices introduced in the U.S. are cleared through a lower-level process, which experts in the industry have criticized as extremely lax and failing to consider whether a new device is effective and safe for consumers. Medical devices, for the vast majority of the time, significantly improve and extend people’s lives. But sometimes, poor design and lax oversight may result in defective devices that can injure patients and even cause death.

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How Medical Devices Make it to the Market

This is the most rigorous process that the CDRH applies in scrutinizing new devices. PMA is generally meant for devices with the highest level of risk and includes laboratory tests and clinical trials. The CDRH can request additional data from the manufacturer about everything from shelf life to immunology and microbiology as well as discovered complications and adverse reactions. This is done to ensure that the device is effective and safe.

The vast majority of medical devices that have received expedited FDA approval and introduced onto the U.S. market are cleared through the 510(k) Premarket Notification Process (PMN). This controversial process does not require clinical trials or extended testing, instead, manufacturers provide information to the FDA showing that the particular device is substantially similar to another device that has already been approved and on the U.S market.

This approval process has proved disastrous when various high-risk medical devices caused adverse side effects and were later recalled due to safety concerns. The process has also been the subject of scathing criticism from experts who have called for reforms but little has changed, save for efforts to ensure that new devices come on the market with greater speed.

The CDRH allows the introduction of potentially risky devices that have the capacity to help patients with rare conditions or diseases that affectless than 8,000 people. This is done without the need to show the effectiveness of the device. Manufacturers of such devices have restrictions on their profit-making ability.

There is also another option that caters for less risky devices whichpose similarity to others already on the market. The approval process is referred to as De Novo and covers low to moderate risk devices where manufacturers provide a reasonable assurance of effectiveness and safety. De Novo is an evidence-based and risk-based approval process.

Defective or Dangerous
Medical Devices Recalls

When a device malfunctions or poses a danger, it may be recalled and removed from the market or corrected to meet the standards. A recall may be requested by the FDA or could be initiated by the manufacturer. The FDA considers a number of factors when requesting a recall, including how serious of a hazard the product presents and whether the use of the product is linked to injuries or disease. Recalls are classified into three classes, with Class 1 being the most serious, causing serious, adverse health consequence or death. Class 2 includes exposure to a device that could cause medically reversible or temporary adverse health consequences. Class 3 involves devices which violate the law but not likely to have adverse effects.

Examples of Dangerous Medical Devices
That Have Been the Subject of Recalls

  • Stryker Rejuvenate, ABG II and Accolade Modular-Neck Hip Stems
  • DePuy Orthopaedics' ASR Hip Resurfacing System and ASR XL
  • Acetabular System
  • The Zimmer Durom Cup Hip Implant
  • Kugel Composix Hernia Patch
  • Smith & Nephew Metal Liners
  • Medtronic Implantable Pain Medication Pump

Medical Device Complications And Drug Side Effects

medical devices and prescription drugs can come with unwanted complications and side effects, even with the approval of the U.S. Food and Drug Administration. Regulators, manufacturers and health care professionals have to weigh the benefits of a medical device or drug against the risks that it poses.

Severe side effects can range from infection, device failure to death. If there is a reported problem linked to a particular drug, the FDA can add warnings to the drug’s label and in rare cases request for a recall. The FDA refers to any unexpected or unfavorable medical occurrence linked to drugs and medical devices as “adverse events.” These include:

  • Disability

  • Hospitalization

  • Congenital Anomaly

  • A Life-Threatening Condition

  • Death

Medical devices and surgeries include some level of risk, from infection, minor bruising, or more serious such as device failure or a reaction to anesthesia. An infection can be simply treated with antibiotics or with a procedure as complex as another surgery to replace or remove a device. Adverse events from medical devices include death, organ damage, device migration, device breakage or failure, infection, perforation, and revision surgery.

Medical devices and prescription drugs may also have minor complications and side effects. Because most prescription drugs pass through the digestive system before they’re absorbed, nausea, diarrhea, and constipation become common side effects. Other common effects include pain, fatigue, drowsiness, skin reactions, irregular heartbeats, sweating, nasal irritation, and stomach upset. Conversely, minor complications involving medical devices include pain, swelling, numbness, mild allergic reaction, bruising, and redness.

Have You Experienced Severe Side Effects

Consumer Alert Now can connect you with attorneys who can review your case and let you know if you are eligible for a claim.

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Filing a Lawsuit with an Attorney

While some people opt to fight it out on their own, it’s always a smart decision to hire a product liability or mass tort attorney. This is a complex and changing area of law, and cases against medical device companies and Big Pharma can be complicated. As such, victims should also make sure that they get a competent and experienced legal team on their side to protect them.

A product liability lawyer can evaluate the case and the strength of the claim. They can explain the options and legal rights of the plaintiff in the event of a medical device or drug recall. The attorneys will draft a complaint and negotiate a settlement or take it to trial. Another way that lawyers help persons is by explaining the difference between filing a lawsuit as a mass tort or as a class action.

Class Action vs. Mass Tort

Mass tort litigation and Class action lawsuits are two ways a court can deal with large numbers of injured plaintiffs quickly and effectively. A class action is a type of legal action where an individual or small group of plaintiffs file a lawsuit on behalf of an entire group of injured people. This is done to reduce the number of cases that arise when many people are faced with the same problem. If the parties involved reach a settlement in a class action, a plan is developed by their lawyers for alerting potential members of the class and settling claims. The outcome of the single case applies to all members of the group and once the court approves the settlement, eligible class members are requested to submit a claim for a percentage of the settlement.

When consumers are injured on a large scale by defective products or defective drugs, personal injury claims can clog court dockets across the nation. And since dangerous drugs and medical devices can cause a wide range of side effects and complications for different people, all cases rarely fit into a single class. Mass tort litigation or Multidistrict Litigation (MDL), allows a single judge to oversee and administer similar cases. This involves grouping cases with common issues for all court processes. The court combines all information on investigations, evidence gathering, and discovery. Unlike a class action where class members share in the same verdict or settlement, compensation in MDL is based on the extent of the damages and injuries. Such cases are usually more complicated because of the lack of a standard predictable legal procedure.

Consumer Alert Now works with medical and legal experts to help consumers find answers to questions pertaining to medical device complications, prescription drug side effects, and related lawsuits. Through this website, consumers can get quality, accurate information to help them make informed decisions on their health care, connect with an experienced mass tort law firm, and share their drug and medical products stories. We are committed to keeping the public educated, informed, and safe from potentially harmful medical devices, products, drugs, and procedures by providing information of severe side effects, medical conditions, and ways to take legal action.

For the conditions and procedures you’ve endured, the medical devices implanted in your body, the prescription drugs you take, and the legal options you have, Consumer Alert Now is the go-to online resource for related information. We give patients a voice and serve as a watchdog on behalf of consumers. We adhere to a strict code of quality, accuracy, and integrity in providing and producing content on our website. Our sources include court documents, U.S. Food and Drug Administration reports, reputable news outlets, peer-reviewed medical journals, experts in the medical and legal field, and patients with first-hand experience.

Our team members have years of experience in medical and legal research and sift through complex government documents, medical journals, and court records to provide consumers with accurate, relevant medical information that is easy to understand. The expert writers at Consumer Alert Now draw on their research skills and expertise to find high-quality information and spread awareness.

Our writers are passionate about helping people injured by the negligence of pharmaceutical companies and other corporations. We give consumers a platform to get the resources they need, share their stories and take legal action against negligent companies. Our team members have completed health literacy training and hold memberships with professional organizations.

Defective Devices

Contact Consumer Alert Now for a Free Case Review

Drug and device manufacturers have a duty to create safe products and warn consumers about related risks. Unfortunately, they don’t always do that.

If you’ve been injured by a defective drug or medical device, Consumer Alert Now can connect you with lawyers in this field who can let you know if you have a case.

Contact Consumer Alert Now today at (800) 511-0747 or fill out our online contact form.

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