Defective Medical Device Attorneys Warn of Need to Expand Regulations to Ensure Public Safety
Do the latest regulatory advancements go far enough?
Almost ten years ago, the defective medical device lawyers from Parker Waichman LLP called for increased governmental oversight for medical devices and diagnostic machines. We observed that numerous medical devices, such as two different versions of Stryker’s hips implants, heart defibrillators manufactured by Medtronic, and certain Composix® Kugel® Mesh patches, manufactured by C.R. Bard subsidiary Davol Inc., caused thousands of people to suffer serious and even life-threatening injuries.
Since then, many other medical devices and treatments have failed, causing numerous people to suffer. Medical devices such as DePuy’s metal-on-metal hip implants, Bayer’s Essure birth control device, and Medtronic’s Infusion insulin pump have been linked to severe complications. There countless other devices subject to recall by the U.S. Food and Drug Administration (FDA) since we first discussed the problem in 2008. Fortunately, new global regulations will supplement the FDA regulations.
Medical Devices In The News
Parker Waichman LLP – A National Defective Medical Device Law Firm
Parker Waichman LLP is a national defective medical device law firm based in New York. Parker Waichman’s defective medical device attorneys have earned the reputation as warriors for justice on behalf of those who have fallen victim to the medical device industry, which is more concerned with growing its bottom line then guaranteeing the safety of its customers. You can turn to Parker Waichman for aggressive representation if you or a loved one suffered complications or unintended side effects from defective medical devices.
The Call for a More Rigorous Regulatory Scheme
In 2008, researchers from the University of California at San Francisco argued that medical devices did not have sufficiently stringent regulations to guarantee patient safety. These researchers found that new medications went through more rigorous testing and analysis before receiving FDA approval when contrasted with medical devices. (For clarity, a medical device is an implement that can be implanted such as a knee or hip or is a machine, which somehow assists the body to perform its natural functions.)
The researchers did not stop at suggesting what to do though. Rather, they offered a suggestion that could make medical devices safer even after the FDA granted approval. The researchers proposed that a review of the device’s technology could improve the efficacy and safety of medical devices. To be effective, the technology review must be completed by an independent body of researchers and scientists. Otherwise, the review might be fraught with conformational biases and other imperfections, which call into question the accuracy and the credibility of the results.
An independent review of the technological utility of the latest medical devices approved by the FDA would allow physicians to make the best judgments for patient care. As it stands right now, physicians have scant, few resources at their disposal other than what the manufacturer provides. Some medical devices receive peer review but others might be subject to recall by the FDA, and in those instances, the physician will have unbiased empirical data on which he or she could base a decision made in the best interest of their patient’s health.
Part of the problem is the process by which the FDA approves new medical devices. Typically, only 100 or so of the latest medical devices receive the same scrutiny that a new medication would from the FDA. Medical device manufacturers can rely on an expedited process to obtain approval for their latest device when the item functions similar to a device previously approved by the FDA. Thus, the medical device manufacturer can get fast approval if it bases its design on another previously approved medical device. The FDA dispenses with rigorous review and permits these items to go to market. The process is essentially a rubber stamp and is not the surest method of protecting patients, but it does facilitate the growth of the business.
The FDA places too high of reliance on its after-market recall protocols to ensure public safety. Device manufacturers have an obligation to initiate a voluntary recall if they learn of a malfunction of one of their medical devices. Additionally, physicians and surgeons can start a recall procedure if they learn about a medical device defect. For manufacturers, this is like calling a penalty on you. It is not the most palatable thing to do and can substantially cut into their bottom line. However, letting the issue go might actually be costlier.
Should FDA Approval be the Beginning and not the End of the Process?
The researchers from the University of California suggest that FDA approval should be the first step toward the lawful use of medical devices. They posit that FDA approval as it stands is highly restricted and limited. By contrast, further evaluation by independent agencies of medical devices after the FDA approves the design and function would allow physicians to learn about potential limitations of the device. The additional review will allow doctors to have a thorough understanding of the possible side effects from use of the device and have a better understanding of how long the device will last before replacement is required.
The idea is to prevent human recipients of these devices from becoming test subjects. Realistically, the only method of testing that can provide accurate results and expectations for the performance of these new devices is of prolonged use. To that end, the patients become lab rats. For most people, that is unacceptable. The University of California researchers opined that this result could be avoided by submitting devices for supplemental testing by entities such as the California Technology Assessment Forum (CTAF). The CTAF is a group of medical experts from various medical disciplines that will review a proposed device and critique it with an eye toward improving patient safety. The CTAF conducts meetings that are open to the public and emphasizes the completely transparent nature of its investigations.
Independent review boards like the CTAF can help with providing patients information of which they might not otherwise avail themselves. Independent review boards can distill data and produce it in terms that the general public can understand. With the current state of the information delivered by the FDA, it is readily available from their website, but it is very complicated and difficult to understand. Independent boards would have only one purpose, and that is to give patients peace of mind knowing that the devices they consent to use will make them healthier people.
New Global Compliance Requirements Might Pick Up Where the FDA Leaves Off
In March of 2019, the new global compliance requirements will take effect. These 2016 revisions will add risk management to every element of medical device manufacturer’s quality assessment systems according to ISO 13485. For those who are unfamiliar, the ISO program is the International Organization for Standardization. The ISO is used worldwide as a uniform set of standards governing the use of many manufacturing industries, including medical devices.
ISO 13485, according to the Organization, is an internationally agreed-upon set of standards. These standards ensure that all devices manufactured to meet the minimum requirements for quality. The standard applies to companies who design, produce, install, and maintain medical devices. Certification entities can use these criteria in an auditing process as well.
ISO 13485 was updated to respond to the demands of the marketplace. The 2016 update incorporates the latest technological advances as well as the regulatory mandates and quality management obligations. To that extent, the Organization revised the ISO 13485 to respond to increased demands for risk management and emphasize “risk-based decision making” during the manufacturing process of medical devices.
What Impact, if any, Will the Upgrade to ISO 13485 have on the Medical Device Industry?
The upgrades to ISO 13485 will require medical device manufacturers to incorporate risk-management best practices into every aspect of the manufacturing process as well as the overall supply chain. This is a departure from past requirements. As a result, medical device manufacturers are left scrambling to bring their processes into compliance. The upgrade aims to increase internal and external visibility and transparency of data and clinical trials.
While adherence to ISO compliance regulations is voluntary, compliance with FDA and European manufacturing regulations is not. Under the newest FDA regulations, medical device manufacturers must comply with stricter Premarket Notifications. The more stringent requirements imposed by the amended FDA regulations focus on device companies showing that their new product is not only safe for use by patients but can efficiently treat the condition for which the manufacturer designed the product. European regulations try to reach the same degree of certainty for which the FDA strives.
Updated regulations which impose stricter requirements will have a negative impact on smaller device manufacturers. Larger medical device manufacturers will have no problem absorbing the costs that will flow from the necessity of conducting lengthier studies and more expensive studies to satisfy the new regulations. Smaller to mid-sized companies will find compliance financially trying because compliance will be much costlier because of the duration and frequency with which trials must be conducted. It remains to be seen whether burdensome compliance requirements will force smaller companies to abandon projects that could benefit many patients.
Outdated technology continues to support the medical device application process. Manufacturers submit approvals via email and maintain processes on paper instead of on computer-based systems. Many of these systems are based on the company’s internal needs, which thwart the trend toward opening up the manufacturing processes to outside observation and scrutiny. The effect of this clandestine method of developing medical devices is that there is less oversight from agencies whose sole mission is to ensure the safety of the public. As a result, the FDA must try to bring device manufacturers into line with a standard method of operation that is industry wide.
The antiquated method of maintaining documentation prevents adequate risk assessment. There is a growing need to increase the visibility of documents, results of clinical trials, and follow-up analysis. The FDA issued 121 warning letters and 3,525 requests for inspection of devices. Those numbers have significantly increased over the last ten years.
The older systems that the medical device manufacturers use require months to reprogram when regulations change. With paper documents spread out all over the place and older computer manufacturing and tracking software, the auditing process is very difficult and complicated. As a result, companies will begin to invest in newer technologies so that they can comply with regulatory mandates.
Technological advances allow for ease of assimilation with the latest regulatory mandates. Merely hiring people to fill in the gaps will not suffice. Making additional hires will increase the overhead incurred by the device manufacturers. Instead, eliminating paper files will facilitate the tasks researchers must complete when conducting clinical trials. Furthermore, more regulatory requirements mean that some functions will need to be outsourced to other companies. Notwithstanding, the obligation to comply with regulations, no matter how arduous or extensive remains with the device manufacturer.
A number of medical device manufacturers are turning to cloud-based technologies to maintain clear communication among their internal components and external collaborators. This should encourage ease of regulatory compliance. An additional benefit of storing documentation on the cloud is that regulators can locate and review the literature with greater convenience and transparency.
Whether the new regulations will make medical devices safer and help patients combat the physical ailments from which they suffer remains to be seen. The philosophy behind increasing the rigor of complying with an increased number of regulations should increase safety. That is no guarantee.
Defective Medical Devices Continue to find Their Way onto the Marketplace
If the medical device you received fails to work correctly or causes severe side effects of which you were not aware, you might be entitled to financial compensation from the device manufacturer. The defective medical device attorneys with Parker Waichman LLP have the experience you need to help you recover damages for your injuries.
Just replacing the defective device is not always the best answer to the problem. Many devices require surgical implantation like replacement hips, knees, and pacemakers. Replacement surgery is fraught with danger. Every time a person undergoes surgery, they face possible risks such as infection, adverse reaction to anesthesia, taking opiates to reduce or block pain, painful rehabilitation, lost work, and time away from home if inpatient rehabilitation is needed. Furthermore, a patient could suffer tremendous blood loss from surgery. Additionally, surgical complications could result in cardiac arrest, stroke, and even death. To compound matters, every time a person has surgery, they face the specter of falling victim to medical malpractice. Therefore, it is plain to see that replacement surgery is not always the best option.
Compensation for medical device failures is based on the legal theory of products liability. Each state has its own statutory scheme relating to products liability. However, there are many similarities among the various states. There are three theories of products liability recognized by courts. They are:
- Manufacturing defects. A manufacturing defect is concerned with the manufacturing process which produces a defective product. The entire production line could be faulty, or the flaws could be limited to a specific lot created during a particular period.
- Design defects. Design defects relate to the method and manner in which the manufacturer drew up the plans for the device, the nature and quality of the parts the manufacturers use, and the way in which the components were designed to work together.
- Failure to warn. Medical device manufacturers owe their customers a duty to warn them about the possibility of the occurrence of side effects. Manufacturers must inform patients about the potential of side effects so the patient can make an informed decision about his or her healthcare. Sometimes this theory of recovery is referred to as defective marketing.
What Damages are Available to Collect in a Defective Medical Device Case?
It is important to note that every case is different from every other. One cannot simply claim that because one person received an award, that means they should also receive an award or receive the same amount of compensation. Cases involved people, and by our nature, we have various differences from the specific injuries victims suffered from the particular defect involved and the magnitude of the recovery. Other cases can be guidelines but, as our defective medical device attorneys understand, every case turns on the specific facts.
There are, however, particular types of damages each person can claim in their defective medical device litigation. The damages a plaintiff can lawfully clam will be determined by the circumstances and specific losses the plaintiff suffered and the particular law that governs their claims. For example:
- Medical expenses. Each person is entitled to recover medical expenses they incurred relating back to the defective medical device. Medical expenses do not necessarily have to be limited to compensation for the replacement cost. They can be compensation for doctors visits, therapies designed to treat complications suffered by the patient caused by the device, medication, travel expenses, and any other charge that was directly caused by the defective medical device or is related to the defective medical device.
- Future medical costs. The medical device manufacturer could be held liable for future medical costs associated with repair or replacement of their defective component. Future medical expenses include physical therapy, inpatient rehabilitation, doctors visits, medication, accommodations made to one’s home relating to the care of the patient’s condition caused by the defective device, and could even include compensation for medical malpractice claims.
- Lost wages. Lost wages and recovery for loss of economic opportunities are inter-related. Compensation for lost wages is compensation for the time you missed from work because of the medical care you needed for your defective device. Compensation for lost wages can include sick time, vacation time, and personal days you took to deal with your defective medical device.
- Loss of economic opportunity. Loss of financial opportunity includes loss of future wages but also comprises recovery for missing out on the chance to get a promotion or was out of work and missed a raise, or, if you are a salesperson who must travel, for example, you could receive compensation for any commissions on which you missed out.
- Pain and suffering. Compensation for pain and suffering pertains to the loss of quality of life you felt because of another’s misdeeds. For instance, if your defective artificial knee kept you from playing golf, or prevented you from playing with your children or grandchildren, then the quality of your life is diminished in a meaningful way. Even just the inconvenience of suffering in pain day to day takes a toll on a person’s psyche. That also deserves compensation.
- Punitive damages. Punitive damages may be appropriate in certain circumstances. The court could assess punitive damages against a device manufacturer who committed fraud or committed another intentional act that caused harm to an individual. Whether a court may assess punitive damages in a given situation is governed by the law of the state in which the plaintiff filed the claim.
- Plaintiffs typically can recover the costs of the litigation, which can be very expensive. Parker Waichman will advance the costs of the litigation to you, so you need not dig into your own pocket to pay for expenses like expert witnesses, copying medical records, paying for deposition transcripts, and the like.
Statute of Limitation on Defective Medical Device Claims
Most states have a three-year statute of limitations, however, some states have a shorter limitation within which to file your claims. You should consult with your attorney to determine the proper time frame. Missing that date will prevent you from recovering damages for your defective medical device claim.
Why Choose Parker Waichman LLP?
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Our Medical Device Defect Lawyers Are Ready to Discuss Your Claim Today
Parker Waichman LLP will evaluate your claim in a free, no-obligation consultation. Contact our defective medical devices litigation firm today to learn more about how we can start working to help you recover compensation for your loss. Parker Waichman LLP’s defective medical device attorneys aggressively pursue companies who fail to keep their customers safe. Contact Parker Waichman LLP today by filling out our online form or by calling 1-800-YOURLAWYER (1-800-968-7529) if you or a family member is a victim of a defective medical device.
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