The legal and ethical importance of ensuring consumer product safety cannot be understated. At the federal level, the Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA), the Department of Transportation, and even the Department of the Treasury work to oversee the regulation of both voluntary and mandatory standards of product safety. Needless to say, ensuring a reasonable level of product safety is not only inherently ethical but also required by law.
In order to determine whether a new product, medical device, or pharmaceutical is safe, its manufacturer generally runs its own internal testing and control processes. Yet, how can a company be certain that the results of such tests are valid and unbiased, and that all aspects of the product have been considered? To confirm that their data is reliable and that their product is safe and effective, companies typically turn to third party product testing.
Third party product testing is a quality control (QC) process that allows for an independent company (a third party) to test for any and all product quality and safety issues that may pose a risk of harm to the public. Third party testing also seeks to verify that the product complies with the mandates of all relevant regulatory agencies.
Although companies generally run their own QC processes in-house, third party product testing is crucial in that it provides unbiased information from an outside source. In this way, both the manufacturer and regulatory agencies can be certain that the results were not manipulated. The manufacturer then also has peace of mind knowing that a fresh set of eyes has reviewed its product for anything that may have been missed and that their product is safe to sell to the public.
Pharmaceutical manufacturers and other companies that operate laboratories generally seek third party testing to ensure strict compliance with regulatory requirements. In addition to examining the finished product, a third party analysis of the development process can help labs identify procedural errors, malfunctioning equipment, maintenance-related issues, and possible corrections for them.
On the flipside of identifying safety issues and other negative aspects, independent product testing helps to validate the effectiveness of the product itself. In the case of medications, third party product testing can identify contaminants and heavy metals as well as confirm the potency and reliability of the product.
Some independent testing companies also focus on the implementation of the product; for example, testers might watch a field employee install a product to make sure that the process of installation goes smoothly and does not create any additional hazards.
Another benefit of using an independent testing company or laboratory to evaluate a product is that these dedicated testing organizations tend to have testing-focused facilities with specialized equipment that the manufacturer may not otherwise have access to. The testing staff in such facilities are also specifically trained and experienced in product testing and/or laboratory assays, providing a level of expertise that in-house QC can’t always offer.
Although third party analysis is not always possible, it is always recommended to obtain when applicable. Additionally, it’s important for manufacturers to avoid becoming complacent and use only one testing company for long periods of time. By working with different firms, a company’s products can be evaluated and shown to be safe and effective by a variety of independent analysts, thereby lending further credibility to the results.
Simply put: Third party testing is one of the most important elements of ensuring the delivery of a safe product.
Even if a company performs internal quality control on its products and is fairly confident in its safety, skipping third party testing can be incredibly dangerous. If some aspect of the product is unsafe upon release to the general public, a lack of third-party testing could mean that consumers could be injured or made seriously ill, creating a public health disaster.
According to independent testing provider ICSA Labs, one of the most common reasons companies give for not obtaining third party certification is a shortness of budget.1 Unfortunately, it’s difficult to illustrate to companies a return on investment as a result of third party testing, which makes it hard to argue for the funds required. This, of course, is a poor reason not to go ahead with testing.
ICSA Labs also stated in a 2009 report that approximately 96% of all products they tested failed on the first certification attempt.2 Although not all testing companies have the same standards, the example of ICSA’s stringent certification requirements and high initial failure rate serves to illustrate the way in which independent testing can push manufacturers to refine a product and develop one of even better quality.
From a consumer perspective, the potential ramifications of an unsafe product or medication can be incredibly damaging—even fatal. In the case of recent PPI lawsuits (regarding proton pump inhibitor drugs like Nexium and Prilosec), attorneys argued that the pharmaceuticals’ manufacturers did not warn patients and medical professionals that there might be an increased risk of kidney damage, renal failure, and even ischemic stroke.
As a result, say the lawyers, patients with acid reflux issues were prescribed a medication that may have worsened their health due to a lack of awareness or physician monitoring.
Another example of a major failure in product safety is the transvaginal mesh lawsuit, in which lawyers argued it has caused such complications and side effects as pain during intercourse, lower back pain, erosion of vaginal tissue, vaginal bleeding, urinary problems, perforations of the bowel or bladder, chronic vaginal draining, and more.
The transvaginal mesh, which is typically used to help correct conditions like pelvic organ prolapse and stress urinary incontinence, was also involved in several cases where pelvic organ prolapse repair resulted in death. Since then, the mesh has been reclassified as a “high-risk” medical device. Unfortunately, many consumers have already had to pay the price for what may have been an oversight in company safety testing.
The potential of a product to do harm to its user stands above and beyond all legal reasons to validate a product through third party testing. The one thing that should be most important to any manufacturer should be the health and safety of the individuals who use their products, regardless of how much it might cost. Companies that ignore this aspect due to such budgetary concerns always run the risk of user harm. In such cases, affected consumers are well within their rights to seek compensation for their damages.
Since 1987, Saunders & Walker P.A. has been fighting for consumer justice in cases of medical malpractice, harmful drugs (e.g., Nexium side effects and Prilosec side effects), dangerous medical devices, food poisoning, product liability, and more.
If you or someone you know has been injured, made ill, or otherwise negatively affected as a result of an unsafe product or medication, it’s time to hire a pharmaceutical lawyer. If you’ve incurred medical bills or lost income due to the repercussions of a dangerous product, you are entitled to receive financial compensation to cover your expenses and recoup some (if not all) of your losses.
Whatever the case, the experienced attorneys of Saunders & Walker P.A. will listen to your concerns, work with you to develop your case, and fight for your consumer rights in court. To learn more about our areas of practice or set up an appointment for a completely free case evaluation, contact us today at 1-800-748-7115.