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A medical product known as intrauterine device (IUD) is a form of female contraceptive. This type of birth control is inserted into a woman’s uterus by a gynecologist and stays in the body for a few years until needing to be replaced. The procedure is non-invasive and only takes a few minutes. It can be appealing to many women due to its statistically high rate in preventing pregnancy, as well as its long-term use. An IUD prevents pregnancy by:
In some women, depending on the type of IUD, it may prevent the ovaries from releasing an egg. Additionally, there is a small chance that an IUD could slip out of place. This can happen at any time, but it is more common during the first three months. IUDs are most likely to come out during menstruation.
Women have complained to the Food and Drug Administration (FDA) of the serious health issues they experienced with IUDs. Reported complications include:
There are a few types of IUDs on the market currently. The variations in IUDs range in the physical size and the amount of hormones. Regardless of the type of IUD, there are rare, but serious health risks attached.
A number of medical devices received expedited FDA approval through the 510(k) premarket notification process. Typically, the FDA requires clinical trials to be conducted before a drug or medical device receives approval to be released to the public. However, through the 510(k) process, clinical trials are not required. The FDA will approve a drug or device if the manufacturer can prove a significant similarity to another drug or device that has already been approved.
Through the 510(k) process, a number of medical devices were released to the market with no trials or extended testing. This proved disastrous when several defective medical products caused unexpected side effects. Data was collected on high-risk medical devices that received 510(k) approval between 2005 and 2009. The data shows that more than 70 percent of these devices were later recalled due to safety concerns and reported side effects.
Pharmaceutical manufacturers are required to warn doctors of the non-obvious hazards that the product may cause and inform physicians how to avoid these hazards. Doctors are required to inform their patients of the possible risks of IUDs.
Additionally, doctors must ask if the patient has a copper allergy, Wilson’s disease, a bleeding disorder, is pregnant, has a sexually transmitted disease (STD) or pelvic infection, has had an abortion in the past three months, and if they have uterine cancer. These questions are necessary to ensure that the patient is a good match for an IUD, since there are health prerequisites.
Some side effects to be mindful of include:
It is important to contact a doctor if one is experiencing any concerning side effects.
Health care providers, such as physicians, are required to provide patients with a professional level of medical care. When health care providers breach this duty, they may be liable for medical malpractice. For example, a doctor may be liable if they inserted the IUD improperly or failed to disclose the risks and complications.
A victim may be able to bring a lawsuit under the following circumstances:
Under strict liability standards, a pharmaceutical company is legally responsible for injuries if the product had a defect when it left the manufacturer’s possession, and this defect substantially contributed to the plaintiff’s harm.
If there is a suspected manufacturing defect, evidence will be required. Evidence can come in the form of testimonies from the workers who constructed the devices, internal memos, and communications and forensic analyses of the defective IUDs. When the product causes an injury because of the way the product has been created, this may be a case of negligence. It is important to note that claims involving manufacturing defects must involve strict liability. This means the manufacturer had no intention to injure or had knowledge of the defect.
According to the strict liability doctrine, a person injured by a faulty or dangerous product can recover compensation from the maker or seller of the product without showing that the manufacturer or seller was actually negligent. To prove a claim, the product in question must have an unreasonably dangerous defect that caused the injury, and the defect must have been caused during the design, manufacturing, or shipping phase.
It is important to note if one is injured by a defective product and wishes to file a medical products liability claim, Pennsylvania uses the modified comparative fault standard. This means that the injured party cannot be found to be more than 50 percent responsible for the resulting injury. If the plaintiff is found to be more than 50 percent responsible, they may not recover damages.
Women who have experienced serious complications with their IUDs have filed lawsuits against the manufacturers. Many of the lawsuits have been combined into multidistrict litigation matters. This means that the lawsuits are not class actions, they are handled individually.
Most lawsuits are under the products liability law, meaning that manufacturers and sellers of medical devices have a duty to ensure their products are safe for patients. If a manufacturer or seller breaches this duty, they can be held liable for any injuries resulting from the defective medical device. The defect can be caused by a faulty product design, manufacturing defect, or a defect warning. One of the IUD manufacturers has an alleged design defect which causes women to suffer from adverse health consequences.
If a defective medical products liability claim is successful, the victims will be compensated and the producers or distributors will be encouraged to produce safer products. In the case that someone has suffered harm as a result of a defective product, a personal injury claim can be filed. The time in which the claim is filed is crucial. The sooner that a lawyer is contacted, the greater the chance of receiving compensation. Delaying can restrict the time for taking legal action due to the statute of limitations. After contacting a lawyer, a victim should let them know the type of IUD that was placed.
If you are suffering from a defective IUD, you need to contact a Philadelphia defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. A patient should not have to deal with the expenses related to a defective IUD, including medical expenses and lost wages. Our lawyers help secure financial compensation for victims of defective medical devices. If you are interested in consulting with a lawyer, contact us online or call us at 215-569-4000 for a free consultation. We have an office located in Philadelphia, and we proudly serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.