Defective Drugs & Medical Devices
To improve our health and quality of life we rely on a variety of medications and medical products. However, some of these drugs and medical products may have been defectively manufactured and as a result may be unsafe and harmful. These medical products may pose dangerous risks or injury. Manufacturers of drug and medical devices have a legal duty to make a safe product, test their products, meet FDA standards and approvals for their products (prior to entering the market) and to issue the appropriate warnings for any risks associated with their products. Physicians and pharmacists also have a duty to relay manufacturers' warnings to their patients or consumers when it is necessary and appropriate to avoid consumer injuries.
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Medications must approved by the FDA to be sold in the United States. Products approved by the FDA, yet used for unapproved purpose may be unsafe and carry dangerous risks. The timely, cost-effective resolution of defective medical products often calls for an attorney who is experienced in handling these matters and dedicated to providing personal service. Contact our firm today to schedule a consultation and case evaluation with a defective drug and medical device attorney.
Below, we have provided some general information about unsafe prescription drugs and defective medical devices. For more information or to schedule a case evaluation with one of our attorneys, please contact us online or by telephone at 8oo-322-8300.
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Frequently Asked Questions about Drugs and Medical Devices:
Q: Who is liable for harm suffered from prescription drugs?
A: Depending on the facts of your case, liable parties can range from drug and medical device manufacturers, to your treating physician, to the pharmacy that dispensed the medication.
Q: How can I find out if a medication I have been prescribed is dangerous?
A: Always ask your physician questions you have about medications he or she prescribes you. Also ask your pharmacist about possible risks and instructions on how to take your medications. If you are already taking a medication and would like to make sure it is still safe, check with the FDA Web site or the MedWatch Web site for updates on dangerous drugs.
Medications must approved by the FDA to be sold in the United States. Products approved by the FDA, yet used for unapproved purpose may be unsafe and carry dangerous risks. The timely, cost-effective resolution of defective medical products often calls for an attorney who is experienced in handling these matters and dedicated to providing personal service. Contact our firm today to schedule a consultation and case evaluation with a defective drug and medical device attorney.
Drugs and Medical Devices – An Overview
The costs of defective drugs and medical devices are great. Having defective drugs and medical devices on the market can lead to significant health risks in consumers. Risks can cause serious injury, disabilities and hospitalization. In some cases, injuries lead to more intensive surgeries than were originally necessary to correct the damage caused by the defect. Some harms caused by defective prescription drugs and medical devices also cause death. Fatal injuries caused by defects have been on the rise the past decade. This increase has lead to drugs being pulled off the markets, class action lawsuits, safety concerns and liability issues; we want to know who to blame.
Defective Drugs
When a consumer receives a prescription for medication from his or her physician he or she would likely believe that drug is safe. However, safe does not necessarily mean harmless. According to the US Food and Drug Administration, "safe" means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. A defective drug is one whose potential risks offset its anticipated benefits. Likewise, a defective drug is one whose potential risks outweigh its possible benefits to the consumer.
Defective Medical Devices
Medical devices are used to ease pain, help with disabilities and save lives. However, when these devices are flawed they may cause serious injury and death. Some medical device defects may include faulty design or insufficient manufacturing quality and are considered instruments used for treatment, diagnosis or prevention of disease or injury. The FDA categories of devices are complex and widely varied and many of the adverse effects of medical devices are preventable.
Legal Duty of Manufacturer
We all rely on medications and medical products to help gain a higher quality of life or better health. However, not all drugs or medical products are helpful. Some may have been defectively manufactured or may be unsafe. These medical products may pose dangerous risks or injury. Drug and medical device manufacturers have a legal duty to make a safe product, test their products, meet FDA standards and approvals for their products (prior to entering the market) and to issue the appropriate warnings for any risks associated with their products. Likewise, physicians and pharmacists have a duty to relay manufacturers' warnings to their patients or consumers when it is necessary and appropriate to avoid consumer injuries. If you have been injured by a drug or a medical device, you may be entitled to compensation for your injury.
What Can You Do?
Manufacturers, physicians and pharmacists may be held liable for certain drug and medical device defects, but ultimately you are responsible for your own health. Keep yourself aware and knowledgeable of your medical treatment. You are accountable for taking your prescription correctly, taking the right dosage and not abusing your medications.
Suits to watch for: These are some of the new cases which seem headed toward major mass tort litigation.
Several weeks ago a major recall of hip implants, potentially involving some 90,000 devices, was announced by DePuy Orthopedics, a division of Johnson & Johnson. The defect leading to the recall is that the implant loosens, causing pain and ultimately needs to be replaced. The extremely high rate of failure (up to 13%!) led to the recall, somewhat belatedly, in that t his problem has been known to DePuy for several years.
The high failure rate has been attributed to the design of the hip components. For one thing, being metal on metal, small pieces of metal are released into surrounding tissue, preventing the device from boding firmly with natural bone. The symptoms of the defect are pain on weight bearing or walking.
What a recall means is that people with one of these devices still in them will need to be monitored closely and ultimately may need hip revision surgery. Others have already had an expensive and painful replacement, and are due recompensation.
The good news here is that this is not a device where the preemption created by the Riegel decision applies; it was approved under the less demanding 501(k) process.
These are nearly identical birth control pills which utilize a dangerous fourth generation progestin, drospirenone. There is evidence of an increased risk of clots forming in the veins of women who are taking these hormones. The serious side effects we are handling involved pulmonary embolism, deep vein thrombosis and stroke.
Cup fails to bond with hip resulting in severe pain and replacement
Users develop inflammatory bowel disease, Crohn's Disease, ulcerative colitis
Drugs and Medical Devices Resource Links
The FDA is the main federal agency charged with drug and medical device safety. The FDA's Web site includes news, product reports and approvals, safety alerts and recalls.
This Web site contains the FDA safety information and adverse event reporting program used by consumers to report defective drugs or medical devices or to check the status of medical products.
Breast Implants on Trial
From PBS's Frontline, this Web site includes news, documents, studies and other information related to breast implant defects and litigation.
The Institute for Safe Medication Practices is a nonprofit organization devoted to medication safety and serving health care providers and consumers.
this Web site offers regulatory information and news on drugs, biologics, medical devices and pharmaceuticals.
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