Dangerous Drugs & Medical Devices
Drug Bot provides consumers with the latest news and
information on prescription drugs and medical devices.
Our staff can help you make sense of the complications
you are experiencing and help you find an attorney.
We will guide you through the legal process.
What We Offer
Drug Bot is here to provide you with the latest news involving dangerous drugs and medical devices on the market today. As you browse our site, please find detailed information regarding several medications and other products that have serious complications, as well as further instruction on how to protect your legal rights in filing a claim.
Nearly 70% of Americans were on at least one prescription drug, and more than half on two in 2013, a Mayo Clinic study found.
Given that information, coupled with the fact that Johnson & Johnson, the largest pharmaceutical manufacturer in the country, earned $67 billion in pharmaceutical sales during 2011, one might wonder how many people have suffered the serious and often life-threatening side effects of medications that were designed defectively.
It often takes months or even years for the harmful side effects of a drug to be flagged by the U.S. Food and Drug Administration (FDA), even though the federal agency has strict regulations in place to track adverse event reports filed by patients who took medications approved for sale on the U.S. market, as well as guidelines for approving new products. As a result, thousands, if not millions of unsuspecting drug users may be at risk for injury.
Each year, multi-billion dollar corporations like Merck & Co., Pfizer, Inc., Eli Lilly and Johnson & Johnson mass-produce droves of medications used by the U.S. population.
As people in the U.S. continue to suffer medical conditions that require treatment, more prescription drugs are approved by the FDA. Taking these medications may result in side effects, leading patients to file adverse event reports noting the injuries they allegedly experienced. In 2013, a statistic on the FDA Adverse Event Reporting System (FAERS)’s database showed that 711,232 complaints had been filed.
If the FDA determines there to be serious risk associated with a drug or medical device, the regulator may issue a Black Box Warning label on the product to warn about its potential harm to patients.
Type 2 diabetes medications part of a class referred to as incretin mimetics have been mentioned in several FDA complaints, for example. Despite their ever-growing popularity, incretin mimetics have received a lot of attention lately for their association with pancreatic cancer, pancreatitis and thyroid cancer, all of which were noted in an FDA alert issued in March 2013.
An antipsychotic medication marketed by the Johnson & Johnson subsidiary, Janssen has also been involved in public scrutiny related to its link to gynecomastia, a condition categorized by male breast growth, among other complications.
Safety issues involving a pair of medications used in dialysis have also been in the news lately, as patients report instances of sudden cardiac death, strokes, heart attacks, cardiovascular arrest and other catastrophic injuries. The acid concentrates were involved in a Class I recall by the FDA in June 2012 after the FDA determined these heart problems to be serious and possibly fatal.
The U.S. Food and Drug Administration (FDA) have recently begun to consider its protocol for approving certain medical devices on the U.S. market. For example, the thousands of complaint reports citing early device failure complications associated with metal-on-metal hips prompted the agency to FDA to propose new regulations in January 2013 that would require all metal hip manufacturers to submit new designs for pre-market approval. For products already on the market, manufacturers would need to conduct clinical studies in order to continue selling them. This would make metal-on-metal hip replacements ineligible to receive approval through the FDA’s 510(k) program.
Certain birth control IUDs may also be considered defective, given their alleged association with spontaneous migration away the uterine wall, and into other parts of the body. Adverse event reports noting uterine perforations, ectopic pregnancies, vaginal scarring and other complications have been filed with the FDA throughout the past several years.
According to thousands of lawsuits, a surgical material known as transvaginal mesh may be associated serious and life-altering complications that range from mesh erosion of the vaginal tissue, organ damage, chronic pain as well as pain during sexual intercourse and infection. These cases have been filed in separate U.S. federal and state litigations.
How the FDA Monitors Drugs, Medical Devices on the Market
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating all medical products sold in the U.S., which are devided into the following categories:
- Class I Devices: Products that are stamped as Class I, including tongue depressors and bandages, pose minimal risk to patients.
- Class II Devices: More complicated in design than devices in Class I, this category includes drugs and medical devices that may still pose risk to patients. This category belongs to 43% of all marketed devices, according to the FDA, and includes wheelchairs and X-ray machines.
- Class III Devices: Medical products part of this category carry the greatest risk to patients. Pacemakers and heart valves belong to the Class III category.
Class Action vs. Individual Lawsuits
A class action lawsuit is brought together by several plaintiffs who have filed similar claims against the same product. Individuals involved in class action suits may have suffered the same injuries from that product. This type of lawsuit is designed to divide financial losses equally between several members of a particular case. A multidistrict litigation (MDL) may coordinate a number of lawsuits in a single proceeding, where they will be overseen by a single judge. The decision of whether to centralize claims is determined by the U.S. Judicial Panel on Multidistrict Litigation (JPML), who must consider several factors before creating a federal proceeding.
- Dangerous Drugs. (June 2013) CBS News.com. Study Shows 70 Percent of Americans Take Prescription Drugs. Retrieved from: http://www.cbsnews.com/news/study-shows-70-percent-of-americans-take-prescription-drugs/
- Johnson & Johnson (January 2013) Johnson & Johnson 2012 Fourth-Quarter and Full-Year Results. Retrieved from http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=734718
- Drugs and Medical Devices. (December 2013) FAERS Reporting by Patient Outcomes by Year. Retrieved from: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm070461.htm