Over the past year, a number of surprising facts have emerged about serious and potentially life-threatening risks posed for consumers.
From commonly used medical devices that are now known to spread cancer to faulty auto parts used in millions of vehicles that appear to be the cause of dozens of deaths and serious injuries. This is the annual list of the Top 10 Consumer Risks uncovered or highlighted in 2014, as chosen by the AboutLawsuits.com editorial staff:
1. Power Morcellators
Over the past few years, a medical device known as a power morcellator has become increasingly popular for treatment of symptomatic uterine fibroids, allowing doctors to perform a minimally invasive, laparoscopic hysterectomy or myomectomy, where the uterus or uterine fibroids are cut up and removed through a small incision in the abdomen.
Although tens of thousands of women underwent uterine fibroid morcellation each year, over the course of 2014, it has become widely acknowledged within the medical community that these controversial devices pose an unreasonable and potentially deadly risk of spreading aggressive cancerous tissue, leading to a diagnosis of leiomyosarcoma, endometrial sarcoma or other uterine cancer following a hysterectomy or uterine fibroid removal.
Late last year, a couple from Boston, consisting of two prominent doctors, began a campaign calling for a ban on power morcellation, after the wife had previously undiagnosed cancer spread throughout her body.
An FDA investigation has confirmed that about 1 out of every 350 who undergo power morcellation for uterine fibroids have unsuspected sarcoma contained within their uterus, which doctors are unable to detect or diagnose prior to the surgery. When the morcellator is used, there is no way for surgeons to contain this cancerous tissue, causing the contained cancer to quickly spread and disseminate to other areas of the body, reducing the likelihood for long-term survival and diminishing the woman’s overall quality of life.
In April, the FDA issued a safety warning urging doctors not to use power morcellators for uterine fibroid removal surgery. Then in November, the agency required a black box label warning on the devices, and contraindicated them for use in most uterine fibroid procedures.
As more women and families learn about the issue, a growing number of power morcellation cancer lawsuits are being filed against manufacturers of these devices, alleging that they were marketed and sold without adequate warnings for consumers and the medical community.
2. General Motors Ignition Switch Recall
In early 2014, it was discovered that millions of different General Motors vehicles may have defective ignition switches, which could cause vehicles to suddenly shut off if heavy key chains are used or if he ignition is jarred, such as may occur in an accident. This could cause drivers to lose control of their vehicles or prevent airbags from deploying, resulting in more serious injury or death.
Hundreds of accidents, injuries and deaths have now been linked to the GM Ignition switch problems, and information has emerged that the auto maker has known about the risk for years, yet failed to take earlier steps to correct the problems or warn consumers.
In February, the auto maker issued a series of ever-expanding recalls affecting more than 2.5 million small vehicles worldwide, including certain Pontiac, Chevy and Saturn cars. However, over the following months, as focus increased on the safety of GM vehicles, more than 10 million GM vehicles were ultimately recalled due to ignition switch problems.
After acknowledging that GM officials knew about the problem for more than a decade, congressional investigations have been launched and class action lawsuits have been filed.
The problems also resulted in ongoing litigation, with GM setting up a victim’s settlement fund, which has already acknowledged that payments will be made for more than 30 wrongful deaths associated with the recalled GM vehicles.
3. Testosterone Drug Heart Problems
This year started off with heightened concerns within the medical community about the safety of popular testosterone replacement therapy medications, such as Androgel, Testim and other “Low T” treatments used by millions of men throughout the U.S., following the publication of a study in the Journal of the American Medical Association (JAMA) in November 2013, which found that certain users may face an increased risk of heart attack, stroke and sudden death.
In January 2014, a follow up study was published in the medical journal PLoS One, which reinforced those concerns, finding that side effects of testosterone drugs may double the risk of heart attacks for younger men with pre-existing heart disease and older men, regardless of any prior health conditions.
Throughout this year, the FDA has been investigating testosterone drug heart risks, convening a panel of outside advisors to review the available evidence and issue recommendations about regulatory actions that should be taken to protect consumers.
In September, the FDA Panel called on the agency to force testosterone makers to conduct new clinical trials and research to determine the extent of the problem. The experts also recommended that the popular “Low T” drugs be restricted to men who have an actual medical need, finding that the vast majority of men receiving prescriptions in recent years were given the medicals for natural, age-related testosterone declines.
There are now hundreds of Androgel lawsuits, Testim lawsuits, Axiron lawsuits, AndroDerm lawsuits and other Low T drug lawsuits being filed on behalf of men throughout the the United States who suffered a heart attack or other injury, alleging that the manufacturers have recklessly promoted the drugs without adequately warning about the potential risks.
4. Takata Airbag Recalls
It was a bad year for cars, with the number of recalls this year obliterating all previous records before the year was even half over. By year’s end, more than 60 million vehicles had been recalled, and a large number of them were due to defective airbags manufactured by Takata Corp.
The airbags have been found to overinflate, rupturing and firing deadly shrapnel into their vehicles. The damage is so traumatic that police and emergency medical personnel have mistaken the injuries for violent stabbings and shootings.
The extent of the airbag problems is so widespread that 10 different auto manufacturers have issued recalls, affecting more than 10 million vehicles, to have the airbags replaced.
Federal investigators have questioned the actions of Takata and Honda, the auto company most affected by the recalls. Honda now admits it failed to report numerous problems with the airbags, and Takata has admitted to conducting secret tests on the airbags after problems surfaced years ago.
Amid a growing number of lawsuits against both companies, federal regulators have demanded that most Takata airbag-equipped vehicles be recalled. Takata has refused, but auto manufacturers have increasingly complied, with tens of thousands, and sometimes hundreds of thousands, of vehicles being recalled every week.
5. Viagra Melanoma Skin Cancer
In April, a study was published by Harvard researchers that tied the wildly popular erectile dysfunction drug, Viagra, to an increased risk of melanoma, a deadly form of skin cancer.
The researchers found that men taking Viagra were up to 84% more likely to be diagnosed with melanoma than men who do not take the little blue pill.
The revelations have led to more investigations into the potential Viagra side effects, further increasing concerns about the use and promotion of the drug as a “lifestyle” drug instead of for the reason it was developed: to treat a very real medical condition.
While further research into the cancer risk is likely to continue to be a focus in 2015, many expect that Pfizer may face potential Viagra melanoma lawsuits over their blockbuster medication.
6. Antibiotic Peripheral Neuropathy Risk
Although the FDA first warned that the class of popular antibiotics known as fluoroquinolones, which include Levaquin, Cipro and Avelox, were linked to a risk of peripheral neuropathy in August 2013, this year was marked by a series of studies that appear to reinforce the agency’s findings and highlight the inadequacy of warnings provided by the drug makers for years.
While prior warnings provided with Levaquin, Avelox and Cipro indicated that the antibiotics may cause peripheral nerve damage, the drug makers suggested that the side effects were rare and often go away after the medications are no long used. However, several studies have confirmed that the antibiotics may cause permanent peripheral neuropathy, leaving users with nerve problems that continue for years and possibly the rest of their lives.
Some say the drugs’ side effects, particularly the side effects of Cipro, may explain an illness known as Gulf War Syndrome, which afflicts military veterans of the first Gulf War with nerve damage and other problems. Cipro was widely disseminated among the soldiers to prevent infections.
7. Transvaginal Mesh Litigation
The number of vaginal mesh lawsuits being pursued by women throughout the United States has continued to skyrocket throughout 2014, with more than 70,000 claims currently being pursued against makers of transvaginal mesh and bladder sling products used in recent years for treatment of pelvic organ prolapse and stress urinary incontinence.
Complications from vaginal mesh have caused women to suffer painful and debilitating injuries when the mesh eroded through the vagina, caused infections and other injuries.
Over the course of this year, a series of early trial dates were held throughout the country to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation. While the manufacturers have had limited success in a few select cases, they have also been hit with several multi-million dollar damage awards, including some with punitive damages designed to punish the companies for their actions in connection with the design and sale of the products.
With little movement towards vaginal mesh settlements, the U.S. District Judge presiding over the litigation has grown increasingly frustrated and been preparing hundreds of cases to be ready for trial to begin by 2015. However, with the entire federal court system typically only conducting a few thousand trials nationwide each year, the litigation could be a major topic for years to come.
8. Xarelto Bleeding
The blood thinner Xarelto overtook its competitor Pradaxa this year in sales, becoming the most successful of the new breed of blood thinners designed to prevent strokes due to atrial fibrillation. However, along with that crown, Xarelto also surpassed Pradaxa in the number of adverse event complaints filed with the FDA.
Like Pradaxa, Xarelto was designed to replace the older blood thinner warfarin (also sold under the brand name Coumadin). But all blood thinners carry an increased risk of bleeding problems, which warfarin addresses by having a reversal agent, vitamin K, which can quickly counteract the anticoagulant effects.
The new drugs Xarelto, Pradaxa, and a third new blood thinner, Eliquis, all lack a reversal agent, meaning that doctors have no approved means of stopping a Xarelto bleeding event. This has reportedly led to hundreds of deaths and severe injuries of patients who essentially bled out because doctors had no drug to give them to stop the process.
The makers of Xarelto and other new novel anticoagulants are now racing to develop reversal agents. But critics say they should have done that before the drugs hit the market, and Bayer and Johnson & Johnson now face a growing number of Xarelto bleeding injury lawsuits.
9. Talcum powder ovarian cancer
For years, there have been suspicions that the use of talcum powder on women’s genitals increases the risk of ovarian cancer. This year, however, Johnson & Johnson was hit with two class action lawsuits, and a growing number of individual lawsuits, by women who say they were diagnosed with ovarian cancer because of their use of its Baby Powder and Shower-to-Shower products.
The talcum powder lawsuits have uncovered decades of research dating back into at least the 1970s which tied the use of talc to an increased risk of ovarian cancer. However, women have never been formally warned about the risks.
Recent research published this year has also determined that talcum powder bears some disturbing similarities to asbestos, raising questions as to whether it has similar long-term health problems.
10. Actos Litigation
In 2014, evidence has emerged that suggests Takeda Pharmaceuticals and Eli Lilly withheld information about the risk of bladder cancer from Actos, their popular diabetes drug.
During the first trial in the federal court system, where several thousand Actos lawsuits are currently pending, the drug makers were hit with a landmark $9 billion verdict in April, after a judge determined that there was deliberate and systematic destruction of evidence in an attempt to cover up the drug’s link to bladder cancer.
While the judge presiding over the case did reduce the judgment to just $37 million, she did so reluctantly, calling for the Supreme Court to allow such large punitive damage awards that can be sufficient to punish massive, multinational corporations that commit wrongdoing.
Takeda and Eli Lilly continue to face thousands of claims unless Actos settlement agreements are reached in 2015 to resolve the litigation.