Each year in the United States, millions of medical device units are recalled by the U.S. Food and Drug Administration (FDA). Each year, more medical devices are recalled than ever before. This is a concerning trend.
Many device models, including IUD birth control devices, are put to market under a pre-approval process and not properly tested, putting women at risk of serious injury. According to plaintiffs and attorneys, birth control IUD devices may only be recalled after they are known to cause serious health problems or targeted by lawsuits.
The Lyon Firm is taking cases involving Mirena, Essure and Paragard IUD injuries.
The Lyon Firm has successfully represented women throughout the country in complex IUD device litigation, working with medical specialists and engineers to determine the root cause of birth control device failures.
Thousands of women have had their lives adversely affected by birth control devices that were marketed as safe, but ultimately caused serious injuries or complications. Devices like Essure permanent birth control, Mirena IUD and Paragard IUD have allegedly disrupted he lives of women, leading to a series of medical device defect lawsuits. Those who have suffered can contact an attorney to review their unique case.
In 2020, lawsuits have been filed against Teva Pharmaceuticals, targeting the manufacturer for reported injury and complications of their Paragard intrauterine medical device (IUD). Paragard is a plastic T-shaped birth control device with a copper wire coil. Recent litigation has alleged that Paragard may break or become dislodged upon removal, potentially leading to damage to the surrounding tissue and organs. Other women have reported uterine pain and infection.
Plaintiffs’ legal complaints include claims for negligence, violation of consumer protection laws, strict liability design defect, strict liability manufacturing defect, and a failure to warn. Attorneys involved in the litigation claim that Teva “knew or should have known that Paragard can and does cause serious harm to individuals who use it, due to the risk of the Paragard’s arm breaking upon removal.”
Women have reported that upon device removal, part of the IUD may break, forcing doctors to remove the part in unexpected procedures. Some plaintiffs have undergone more than one invasive procedure to successfully remove the IUD. A plaintiff in Illinois claims that “Paragard is inherently dangerous and defective, unfit and unsafe for its intended use.”
Paragard complications may include:
The Paragard is a hormone-free IUD designed to be implanted into a woman’s uterus as a long-term, but reversible, form of contraception. Marketing for the device says it is more than 99 percent effective at preventing pregnancy for up to 10 years. Complications have been reported well before that ten year mark.
The device was first approved by the Food and Drug Administration (FDA) in 1984, and functions by continually releasing small amounts of copper into the uterus—believed to prevent sperm from reaching the egg, and preventing pregnancies. The IUD also causes changes in the lining of the uterus to help reduce the risk of fertilization.
Some common side effects after IUD insertion can include:
In the last ten years the FDA has received over 1,500 reports of device complications, and in many instances the device failed before the end of its expected lifespan. Women have needed painful corrective surgery and have suffered health complications as a result.
Joe Lyon is an experienced medical device defect attorney investigating birth control complications and Paragard IUD injury cases. The Lyon Firm has handles cases involving Mirena IUD and Essure Birth Control Injury.
The popularity of the Essure birth control device led to a wave of settlements for injured women before it was discontinued, and the Paragard IUD appears to be headed for the same fate. Similar to Essure, CooperSurgical’s Paragard IUD is designed to be clinically inserted to prevent pregnancy. Paragard has a limited life span, however, and when the device is removed, it may lead to injury Compensation may be available for damages that can include medical expenses, lost wages, and pain and suffering.
Following an injury, women may consider pursuing legal action. The Lyon Firm will review each case carefully by discussing the following factors:
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients. Birth control devices, including IUDs, must be 100 percent safe for use or legal action will be necessary to create a safer medical marketplace.
If you have suffered an injury due to a defective birth control device, you may have a viable claim. When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.
A medical product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:
(1) Manufacturing/ Construction Defect:
These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials.
As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.
(2) Defective design and/or formulation:
Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.
Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product.
(3) Failure to warn or inadequate warning or instruction associated with the product:
All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning.
The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.
There has not been a recall issued for the Paragard IUD, but other IUD models have been recalled, and many injuries reported.
There are no links with metal toxicity, however several other IUD injuries have been reported.
Our Firm will help you find answers to difficult questions. The Lyon Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered.
Experience: Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.
Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.
Defective birth control products on the market present safety and health hazards for women across the world. Cheap and defective products may pose severe health risks. The manufacturers of medical devices have a duty to foresee potential injury and properly design and test products before they are released.
Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in illness or injury can lead to lawsuits filed by plaintiffs and their Cincinnati IUD Injury lawyer.
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law.
Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.
Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.