Every year, thousands of people are harmed by dangerous drugs and medical devices. All too often, medications are not subjected to adequate testing prior to coming to market, and their side effects don’t become apparent until they have been used to treat thousands of patients. Medical devices can also be subject to inadequate testing, as well as manufacturing and design defects. Either case can result in untold numbers of injuries and deaths, as well drug and medical device recalls, and massive litigation as their victims seek compensation for the harm caused by faulty medical products.
Millions of people take prescription medications, confident that these products have been fully tested for dangerous side effects. Unfortunately, this is not always the case. Every year, pharmaceutical companies issue recalls or are hit with fines or lawsuits over medications that have caused serious harm to untold numbers of patients. Though the U.S. Food & Drug Administration (FDA) frequently issues warnings and orders drug companies to add new information to their products’ labels regarding newly discovered side effects, this action often does not occur until thousands of people have suffered life-threatening injuries from potential complications.
Over the past several years, a number of potentially dangerous drug classes have created controversy. These include:
- Atypical Antipsychotic Medications: This class of medications, which was supposedly associated with fewer side effects than older antipsychotics, has been the subject of mounting concerns as their use has increased, particularly among children. Risperdal, an atypical antipsychotic marketed by Johnson & Johnson, is now the subject of litigation because of its potential to cause gynecomastia (excessive breast growth) in men and boys.
- Contraceptives: Over the years, a variety of birth control pills, patches and devices have been the subject of litigation because of potentially dangerous side effects. These include the Mirena IUD, which plaintiffs claim can cause uterine perforations and other injuries due to a propensity to spontaneously migrate from its proper position in the uterus, even when the IUD has been correctly inserted by a doctor.
- Dialysis Drugs: In 2012, Fresenius Medical Care recalled its GranuFlo and NaturaLyte dialysis concentrates after they were linked to hundreds of cases of cardiac arrest. Since then, more than 1,700 lawsuits have been filed on behalf of dialysis patients who allegedly suffered heart attacks, strokes, sudden cardiac death, and other serious injuries related to the medications.
- Testosterone therapies: In 2014, the FDA began investigating heart risks potentially associated with AndroGel and other prescription testosterone replacement therapies. Within months of the FDA’s announcement, dozens of testosterone lawsuits had been filed in U.S. courts, and many additional claims were expected.
Dangerous Medical Devices
Most consumers assume that medical devices are put through rigorous human testing before they can be used in patients. But in fact, one FDA approval program known as 510(K) clearance allows devices to come to market without any human testing whatsoever, just so long as a manufacturer can show that the product is similar in design to another device that was previously granted pre-market approval by the FDA. Critics have argued that this program has allowed numerous dangerous devices to come to market, including transvaginal mesh and metal-on-metal hip implants,and cause debilitating and permanent injuries in thousands of people.
Dangerous medical devices that have raised concerns in recent years include:
- Metal-on-Metal Hip Implants: Approved through the FDA’s 510(k) clearance program, metal hip implant components manufactured by DePuy Orthopaedics, Biomet, Inc., Stryker and Wright Medical Technologies have all been named in lawsuits that allege the devices caused painful and debilitating complications to the people who received them. While such hip devices were supposed to be more durable than those made from other materials, data indicates that they are prone to failure within just a few years of implantation.
- Transvaginal Mesh: Surgical mesh products used in the transvaginal repair of pelvic organ prolapse and stress urinary incontinence have been linked to serious complications, including chronic pain, mesh erosion, and organ damage, that have changed the lives of thousands of women. These devices were also brought to market via the FDA 510(k) clearance program, and are now the subject of tens of thousands of lawsuits. Companies involved in this litigation include American Medical Systems, Inc., Boston Scientific, Corp., C.R. Bard, and Ethicon, Inc.
- Power Morcellators: These devices are used to cut up tissue and remove it through a small abdominal incision during laparoscopic hysterectomies and fibroid removal surgeries. However, morcellation has raised concerns that it could promote the spread of undetected uterine cancer cells throughout a woman’s peritoneal cavity. In April 2014, the FDA issued an alert to discourage the use of power morcellators in gynecological surgeries, as the spread of these cancers can greatly reduce a woman’s chances of long-term survival.