When Californians think about a product malfunctioning, they likely think of a household item not working or a vehicle failing. However, the realm of defective products expands much farther than that. Consumers are not just those that go to the store or purchase items online. They are also patients who require medical devices to aid them. And, just like any consumer trusting the product that they are using, they can unexpectedly experience harm and injury due to a defective medical device.
How common are defective medical devices? The Food and Drug Administration, or FDA, has made plans to ensure there are up-to-date safety and effectiveness features when it comes to medical devices. These plans came after a publication that brought light to medical device safety and the occurrence of defects in this market.
Based on these investigations, over 1.7 million injuries and roughly 83,000 deaths are allegedly linked to medical devices that have been reported to the FDA in the past decade. By modernizing the review process, the goal is to ensure safety and effectiveness and to pinpoint issues and defects before they can cause serious or even fatal harm to consumers.
The harm and damage caused by a defective medical device can be extensive and serious. Thus, it is imperative that consumers harmed by such a defect understand their rights and options. A product liability action could help one prove cause and liability. It not only seeks to hold a liable party accountable, but also help the injured consumer recover compensation for losses suffered.
Study: Hospitals often lack financial incentive to reduce medical errors
Medical professionals in Orange County have a responsibility to provide patients with the highest quality of care and the best outcomes possible. While hospitals must support this professional duty, they also must generate revenue to support ongoing operations. Unfortunately, these two goals are sometimes at odds. Research shows that hospitals often profit more from injury and other adverse patient outcomes than from successful treatment, which may create a problematic conflict of interests.
A 2013 study published in the Journal of the American Medical Association found that hospitals often profit from surgical errors, which generate additional revenue through prolonged patient hospital stays and corrective treatments, according to the New York Times. Researchers analyzed the records of 34,256 patients who had surgery in a Texas hospital in 2010. The study produced the following findings:
- Complications that should have been prevented affected 1,820 patients, with some patients suffering from more than one complication.
- On average, the patients who experienced complications had to spend 14 days in the hospital. This represented a fourfold increase over the length of time that other patients spent in the hospital.
- For each patient who suffered from complications, the hospital earned an extra $30,500 in revenue, on average.
The study’s authors note that the findings do not suggest hospitals intentionally make or allow errors to generate extra revenue. However, the fact that better performance is generally tied to financial loss may make it difficult for hospitals to make needed improvements to address the issue of medical malpractice.
There are a few potential solutions to this problem, according to the New York Times. Insurance companies could pay hospitals “bonuses” for providing a higher quality of care. Insurers could also stop paying for expenses associated with subpar care and resulting complications.
Sanctions in California
The use of financial sanctions to discourage poor hospital performance is a model currently being used to a limited extent in California. The state’s Department of Health Care Services has stopped reimbursing hospitals for treatment that Medi-Cal patients need after suffering from preventable errors. According to Southern California Public Radio, 85 hospitals have been penalized for errors made between July 2013 and August 2014.
These sanctions represent a step in the right direction, but they do not affect every hospital that has caused unnecessary harm. The DHCS only penalized 85 hospitals out of the 145 that reported mistakes. Since reporting guidelines leave room for interpretation, many hospitals may not report the full extent of preventable errors. Additionally, the DHCS only penalizes hospitals for errors affecting Medi-Cal patients; many hospitals may make mistakes that harm other patients without facing any sanctions.
Sadly, given the state of the current healthcare system, many patients may be affected by preventable medical errors. People who have suffered injuries or other harm because of substandard medical care should speak with a medical malpractice attorney about pursuing compensation for those injuries.
Jury awards $80 million to woman hurt by defective implant
When patients agree to have a medical device surgically implanted in their bodies, they trust that the surgeons know what they’re doing, and that the device is safe and will be effective. Indeed, when the only way to remove the device is through a second surgical operation, a patient must place a lot of faith in the people who created it. Unfortunately, sometimes medical device companies rush their products to market before they are ready, and patients are badly injured as a result.
This issue of trust is at the heart of long-running product liability litigation involving transvaginal mesh devices. Used primarily as a treatment for pelvic prolapse and stress urinary incontinence, the mesh products have been implanted in thousands of women. Unfortunately, medical professionals and government regulators have reported widespread problems with the devices.
In many cases, defects in the devices lead to serious health problems for the patients. Some of the mesh products erode, leaving jagged pieces of material inside the patient’s body. In particularly difficult cases, these pieces cut into internal organs, causing internal bleeding.
Many women have filed lawsuits against the designers and manufacturers of the mesh devices. Recently, a jury awarded $80 million to a woman who said her implant eroded, causing pain, infection and more. The jury found the device was defective and that Ethicon, a subsidiary of pharmaceutical giant Johnson & Johnson, had failed to adequately warn doctors and patients of its risks. As a result, the jury found the company should be held liable for $30 million in actual damages to the woman, and awarded her another $50 million in punitive damages to punish the company for what it found to be egregious behavior.
Medical device product liability cases are technically and legally difficult. It’s important for the injured and their families to get help from a lawyer with experience in product liability cases.
Why medical device defects slip through the regulatory cracks
The medical device industry faces some competing priorities that may be nearly impossible to resolve. These devices can make an important difference in patients’ lives, and so everyone wants them to be available quickly. However, medical devices can cause terrible problems if they are defective, and so everyone wants them to be safe. For that reason, the medical device industry is heavily regulated.
Unfortunately, sometimes the pressure to get a product to market overcomes the pressure to make sure the product is safe, and regulators are not able to discover problems until after the devices are already on the market, leading to patients getting hurt by defective products.
Recently, observers have been paying attention to the system through which regulators and the industry report potential problems with medical devices. Last year, an international team of newspaper journalists investigated worldwide problems in the reporting of problems with medical devices.
One problem it found in the United States involved the FDA’s database of incidents related to potential design defects in medical devices. The FDA maintains a system known as the Manufacturer and End User Facility Device Experience (or MAUDE) database. MAUDE is publicly available, allowing patients, doctors and others to learn about potential problems. However, until recently, the FDA also had another lesser-known system known as the alternative summary reporting database, which was available for certain medical device manufacturers. It was not publicly available.
Researchers found that hundreds of thousands of incidents were reported to the alternative database and not to MAUDE. Therefore, the public didn’t know about widespread problems involving breast implants, surgical staples and other devices. Apparently in response to the report, the FDA decided to close the alternative database this year.
When patients undergo any kind of medical procedure, they trust that they will get quality care and that the drugs and devices used will be safe. When a medical device is defective, and a patient is injured as a result, the injured can talk to an attorney with experience in product liability to learn about their options for pursuing compensation.
Why defective medical equipment remains on the market
As previously discussed on this blog, it is clear that some consumers suffer harm because a certain product was defected and entered the stream of commerce. Defects are not always clear, and they can occur when there are issues with the design, manufacturing and warnings. In some cases, even when a product has a known defect, this does not mean it will not cause harm to consumers. In fact, failures with a recall could be the reason why a consumer interacted with a certain product and suffered harm.
Individuals in California and elsewhere rely on medical equipment. These products are designed to assist those living with a medical condition; however, these products, like any other product on the market, could be defective. In fact, a recent survey found that many individuals in the U.S. are unaware that they are using medical devices or equipment that have been banned or recalled in other nations.
The biggest cause for this situation is that fact that this type of information is not often shared across borders. It is further purported that this problem could expand because there is an increasing demand for these products by the aging problems in conjunction with the push to get products on the market as quickly as possible. This leads to products that are defective to enter or remain on the market.
The losses caused by a defective product can be significant. An injured consumer not only suffers pain related to the injuries caused, but they are also likely to suffer financially, emotionally and mentally. The impact a defective product can be immense, which is why a products liability action may be an appropriate legal remedy. This civil suit not only proves harm and liability but also evaluates the damages suffered, helping the injured consumer recover compensation for their losses.