Defective products, such as medical devices and dangerous drugs, cause thousands of injuries annually in the United States. Generally, all products produced and sold within the US are required to meet consumers’ ordinary expectations; thus, products with unexpected defects or dangers fail to meet these ordinary expectations.
As a result, different parties associated with the manufacture, marketing, or distribution of the defective products and dangerous drugs may be held liable for injuries arising as a direct or indirect result of their use. This is referred to as product liability.
In this article, we are going to focus on Dangerous drugs (with a specific focus on HUMIRA®) and defective devices, their effects on consumers as well as the legal recourse available to recover damages arising from their use. But first, let us look at product liability law.
What is Product Liability Law?
Product liability laws provide victims of dangerous and defective products with legal recourse for injuries suffered. In the US, these product liability laws are based on the premise that manufacturers and companies generally have a duty to protect their products’ consumers from potential hazards. This is because, in the past, courts have held that manufacturers tend to have more knowledge and insight about their products, so they bear any financial responsibility for injuries and damages that the defective products cause.
Types of Product Defects
There are three types of product defects identified by law that may cause consumer injury and give rise to supplier or manufacturer liability. These are:
- Design Defects: These are present in the product from the beginning, which is before its manufacture. Here, something in the product’s design is inherently unsafe.
- Manufacturing Defects: These occur in the course of the product’s assembly or manufacture.
- Marketing Defects: These refer to flaws in the way products are marketed such as insufficient warnings, improper labeling, or inadequate safety warnings.
HUMIRA® is a common prescription medicine that is used to moderate the signs and symptoms of several medical conditions including:
- Rheumatoid arthritis in adults. It can be used alone or with certain other medicines like methotrexate.
- Rheumatoid arthritis in adults. It can be used alone or with certain other medicines like methotrexate. Polyarticular juvenile idiopathic arthritis in kids aged two years and older.
- Psoriatic arthritis in adults.
- Ankylosing spondylitis in adults.
- Crohn’s disease in both adults and children aged six years and older.
- Hidradenit is suppurativa in individuals aged 12 years and older.
- Ulcerative colitis.
- Chronic plaque psoriasis in adults who are ready for phototherapy or systemic therapy.
- HUMIRA® is also used to treat non-infectious panuveitis (UV) in adults and kids aged two years and older.
HUMIRA®’s common side effects include reactions around the injection site such as pain, rash, swelling, bruising, redness, or itching; upper respiratory infections; rash; nausea; and headaches. It has also reportedly been linked to causing tuberculosis (TB); infections caused by fungi, viruses, and bacteria; as well as an increased chance of acquiring cancers or lymphoma in both adults and children.
After Using HUMIRA®, you should also watch out for (and report to your doctor) the following side effects:
- Hepatitis B infection if you carry the virus.
- Allergic reactions such as hives, troubled breathing, or swelling of your lips, mouth, eyes, and face.
- Nervous system problems like numbness, tingling sensations, weakness in your legs and arms, dizziness, and vision problems.
- Blood problems with symptoms like persistent fever, pale complexion, or bleeding and bruising easily.
- Heart failure.
- Liver problems.
- Immune reactions that may include lupus-like syndrome.
Examples of Other Drugs Associated with Serious Side Effects:
- Accutane: This is a prescription drug that is frequently used to treat some serious forms of cystic acne, which is a common form of skin disease. Despite its benefits, Accutane has been known to cause birth defects when used by pregnant women. Also, recent lawsuits claim that there is a link between the dug and suicidal or depressive behavior.
- Depo-Provera: This injectable contraceptive has been linked to several health risks. Women below the age of 35 who started using the drug within the last five years face a slightly increased risk of developing breast cancer. You also risk developing blood clots that can lead to a stroke or a pulmonary embolism by using the drug.
- Zoloft: This antidepressant drug is manufactured by Pfizer, and has been tied to several complications including birth defects, increased risk of suicides among young adults and children as well as serotonin syndrome (a brain chemical imbalance).
- Pradaxa: This blood-thinning drug is commonly prescribed to patients experiencing irregular heartbeats. Many patients have reportedly suffered from some form of bleeding-related injury after taking it.
- Risperdal: This refers to an antipsychotic drug that is used to treat mental health patients. Risperdal has faced numerous lawsuits due to its serious side effects while its manufacturer, Johnson & Johnson, has faced numerous criminal fines due to sales malpractices.
- Lipitor: This Pfizer product is used as an anti-cholesterol drug, but has been linked to liver damage and type two diabetes.
- Viagra: Despite being, perhaps, the most popular drug for treating erectile dysfunction on the market, Viagra has been linked to side effects such as priapism and sudden vision loss.
- Depakote: This is an anticonvulsant drug used for treating epilepsy, migraines, and bipolar disorder. However, it reportedly increases the risk of birth defects if taken by pregnant women.
- Yaz: This birth control drug from Bayer reportedly causes blood clots, strokes, heart attacks, and pulmonary embolisms.
- GranuFlo: This is a chemical solution that is used in kidney dialysis. It is manufactured by Fresenius and its improper use can lead to increased risk of patient heart attacks.
- Paxil: This antidepressant drug is manufactured by Glaxo Smith Kline. It has been linked to an increased risk of birth defects, serotonin syndrome, and increased suicide risks in young patients.
Why are Drugs Pulled from the Market?
Drugs are removed from the market when it is proven that their risks far outweigh their benefits. This often occurs when it is discovered that they contain a safety hazard that cannot be corrected, for example, if it is discovered that the drugs cause serious side effects when ingested that were not known during the approval period. A drug can also be pulled from the market if it is proven to be dangerous when combined with another drug.
Market withdrawals are not similar to recalls because, with the former, existing drugs that are already available on the market do not necessarily have to be returned to the manufacturer. Instead, they simply stop distributing the drug, which removes it from the market since its supply is cut off. On the other hand, a market recall requires all the drugs circulating in the market be returned to the manufacturer due to one of several reasons such as a defect.
Often, market withdrawals are business decisions whereby the manufacturer concludes that that drug has become unprofitable due to falling sales or increasing product liability lawsuits against it. Halting the supply of a drug to the market can remove it without attracting attention. However, the complete removal of a unique drug from the market could prove dangerous to you if you are dependent on it. So, decisions to have drugs removed from the market are taken prudently to avoid endangering the lives of consumers.
Pharmaceutical Drug Liability
Medicines and drugs are often at the center of product liability lawsuits. Drug manufacturers have a duty to ensure they have appropriately tested all their products before they are released into the market. The testing criteria used is developed by the United States Food and Drug Administration (FDA). The FDA testing criteria are considered industry standards; however, the fact that a drug was tested and licensed by the FDA does not absorb its manufacturer from liability to an injured party if it is defective.
Apart from over-the-counter drugs, almost all medical products usually have a ‘learned intermediary’ between the ultimate consumer and its manufacturer. This intermediary could be a pharmacist who fills a prescription, a doctor who prescribes the drug, or a nurse who instruct you on its proper use. As you can see, the lines of liability can become quite blurry, which is why you need the services of an experienced attorney to determine who is at fault when an injury occurs.
Unavoidably Safe Products
Prescription drugs that are considered ‘unavoidably unsafe products’ cannot be made totally safe no matter the amount of care taken during their manufacture. Therefore, although they may have some potentially harmful side effects, they are, nonetheless, beneficial to you. If these drugs are properly manufactured and appropriately accompanied by correct warnings, they commonly cannot form the basis of a product liability lawsuit.
The Manufacturer’s Duty to Warn
All drug manufacturers have a duty to warn consumers of potential side effects associated with the use of their products when side effects are proven to occur. However, they are not expected to warn consumers of unknown dangers. This duty is often discharged by the manufacturer when they provide your physician or pharmacist with all the necessary information.
The products liability law considers a drug manufacture an expert in their field, thus, they have a continuing duty to remain abreast of any knowledge regarding their products. They must also take reasonable and appropriate steps to update relevant medical professionals on potential side effects. There is no duty to warn unusually susceptible consumers of possible reactions. However, manufacturers have a duty to warn of rare reactions.
Defective Medical Devices
Dangerous and defective medical devices can lead to a product liability claim if you get injured while using it or if your loved one dies as a result. These devices may be faulty surgical instruments, pacemakers, prosthetics, or implants. Medical devices are closely monitored by the FDA; however, a product can still be defective in its design, marketing strategy, or manufacturing process.
A state lawsuit over a federally-approved medical device is likely to encounter stringent legal obstacles and receive increased national attention. Hence, all the more reason to hire professional legal services from an accomplished firm.
Below are some of the common high-risk medical devices available in the market:
- Transvaginal Mesh: These medical implants are used by women suffering from stress urinary incontinence or pelvic prolapse. Unfortunately, these implants have been linked to several serious and painful complications. One common complication is mesh erosion whereby the mesh starts deteriorating into sharp pieces that can lead to perforation of the nearby organs. In 2011, the FDA acknowledged that women who opt for a surgical mesh to repair their pelvic prolapse face an increased risk of suffering complications.
- Metal Hip Replacement: Liability for injuries that are caused by metal hip replacements is often placed on the manufacturer. However, the surgeon who performed the surgery that led to your injury may be culpable for medical malpractice. This refers to a situation where a health care provider (your surgeon) acts in a manner that falls below the care level practiced in the medical profession leading to injury. In this case, if your surgeon made an error during the surgery or even failed to inform you of all the risks inherent during the procedure, they become liable.
- LASIK Eye Surgery: LASIK surgery is commonly used to correct several types of problems associated with vision. Although it is normally successful, when something goes wrong you may have a claim against the manufacturer or surgeon - depending on who is liable. Equipment malfunction or its improper use may result in corneal damage. Furthermore, you may also suffer an injury of you were initially not a suitable candidate for the procedure.
- Robotic Surgery: Your surgeon may decide to use a robot during your surgery to allow for precise control. Robots help reduce the fatigue and stress experienced by surgeons during operations. Despite these achievements, there has been a growing number of lawsuits against surgery robots like the da Vinci manufactured by Intuitive.
- IVC Blood Clot Filter: These devices were designed to prevent dislodged blood clots from reaching the lungs. They, however, have been linked to a growing number of injuries and death complaints as well as product liability lawsuits.
- DePuy Hip Implants: These are a popular implant brand that is used in hip replacement surgeries. They have a high failure and patient injury rate, which has led to lawsuits and recalls.
- Stents: These are small metals or plastic tubes inserted permanently into a blood vessel. They are used to open arteries that have become too narrow because of atherosclerosis (plaque build-up). Drug-coated stents prevent arterial scarring and restenosis by slowly releasing drugs. The FDA continues to monitor all reports of adverse risks surrounding stents.
Seeking Product Liability Legal Help
If you, or a loved one, have been affected by a dangerous drug or a defective medical equipment, you could file a product liability lawsuit to help you get compensation for any injuries suffered. The entire process of filing and following up on a product liability suit is complex and often overwhelming to undertake alone. This is why it is prudent to seek the services of an attorney who is conversant with product liability law. At the very least, you should get a consult to see whether you have a strong case.
The Essence of Evaluating a Products Liability Case
Products liability cases can be quite long and tedious without a settlement. Thus, the process of case evaluation and strategy formulation will be essential throughout the case to assess where you are and the significance of any evidence obtained during discovery. An attorney must consider a multitude of factors surrounding your case before they can give you a final comprehensive assessment and evaluation. These include the contributory fault, liability admittance, sole proximate cause defense, or defending your case on damages only.
Determining the types and amount of injuries you have suffered is a crucial aspect of the case evaluation. You should estimate all your damages in advance, because, if you only suffered minimal injuries and financial losses, it may not be sensible to spend time and resources pursuing your claim.
Federal Laws Surrounding Product Liability
Product liability law is largely governed by state law. However, the federal government may decide to step in to preempt a certain product liability law area from state control to protect a group of manufacturers. This is because there exist specific federal law statutes that address specific product categories and industries.
What is a Class Action Case?
A class action refers to a lawsuit filed by a group of people who have suffered similar injuries as a result of using the same product or the actions of the same defendant. People seek justice through a class action suit when their injuries were caused by defective products such as dangerous drugs and medical devices.
The class action can be viewed as a vehicle used when several people have suffered similar or the same injuries. Often, many of the individuals attached to the class action suffered relatively minor injuries to pursue legal redress on their own. Suing as a class means consolidating resources including attorneys, defendants, witnesses, evidence, and any other litigation aspects. Further, if the number of people affected is high, it becomes impractical to file individual lawsuits.
In a class action, everybody who would be affected by the decision of the court is entitled to a notice of the start of the action. If you would like to join a class action after a notice, you are free to ‘opt-in’ and if not you can ‘opt out.’
What is a Mass Tort Action?
A mass tort refers to a single tort (a civil wrong that results in injury to someone else) that results in the injury of many victims; thus, it involves many plaintiffs suing either one or several negligent defendants. Often in mass tort cases, the plaintiffs sue based on injuries caused by a single or common product.
A mass tort is used when one or more of the legal criteria required for proceeding as a class action are not met. For instance, if each plaintiff in a group has many individual factual circumstances that are uncommon and that outweigh the common issues in the action. Only experienced attorneys have the resources and capacity to determine whether you should proceed as a class action or mass tort.
The Difference between Class Action and Mass Tort Cases
The major difference between class actions and mass torts is how, procedurally, the two plaintiff groups are treated. In a mass tort action, the plaintiffs are each treated as individuals. For example, during the case, each plaintiff’s facts must be established including the specific injuries or damages. Whereas class action cases treat the plaintiffs collectively as a class that is represented by a representative. Essentially, the court treats all members of the class as one plaintiff rather than separately.
Helpful Resources for a HUMIRA Lawsuit Near Me
If you or a loved one experience adverse side effects after using HUMIRA®, or any other dangerous drugs and defective medical devices, contact Consumer Alert Now at our business number (800) 511-0747. At Consumer Alert Now, we will help you evaluate your case and ensure that your legal rights are assessed and protected. We operate nation wide to ensure that our clients’ product liability or personal injury cases needs are met.