Defective Medical Device Lawyers Fighting For Your Health And Safety
More than a decade ago, the defective medical device lawyers at Parker Waichman LLP called for increased governmental oversight of medical devices and diagnostic machines. We observed that numerous medical devices, such as two different versions of Stryker’s hip implants, heart defibrillators manufactured by Medtronic, and certain Composix Kugel Mesh patches, manufactured by C.R. Bard subsidiary Davol Inc., had 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. Many of such devices have been recalled by the U.S. Food and Drug Administration (FDA).
Today, new FDA regulations should help to address these issues, but that won’t protect those who have already suffered injuries due to defective medical devices. If you have been harmed by a device that was supposed to help improve your health, call us. We can provide a free case evaluation to determine if you should pursue a legal claim for compensation.
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 a machine that somehow assists the body to perform its natural functions.)
Medical device manufacturers can rely on expedited approval for their latest device when the item functions similarly to a device previously approved by the FDA. The FDA dispenses with rigorous review in these cases and permits the items to go to market. The researchers proposed that the FDA approval should be the first step toward the lawful use of medical devices, not the last step. The next step, they suggested, should be a review of the device’s technology by an independent body of researchers and scientists. Further evaluation after the FDA’s initial approval would allow physicians to learn about potential limitations of the device and have a thorough understanding of the possible side effects from use of the device. It would also determine how long the device will last before replacement is required.
The FDA has been working on changes to its processes in recent years, but it still has a ways to go to update how it approves these potentially life-saving or life-destroying devices.
Global Compliance Requirements Pick Up Where The FDA Leaves Off
In 2019, new global compliance requirements took effect that added risk management to every element of a medical device manufacturer’s quality assessment systems according to ISO 13485. The International Organization for Standardization’s guidelines are used worldwide as a uniform set of standards governing the use of many manufacturing industries, including the making of medical devices.
ISO 13485 was updated to incorporate the latest technological advances as well as regulatory mandates and quality management obligations. 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.
While adherence to ISO compliance regulations is voluntary, compliance with FDA and European manufacturing regulations is not. More stringent requirements imposed by amended FDA regulations focus on device companies showing that their new product not only is safe for use by patients, but can efficiently treat the condition for which the manufacturer designed the product. One challenge to this move is that some device manufacturers maintain antiquated systems that make it more difficult to expose their documentation to public oversight. There is a growing need to increase the visibility of documents, results of clinical trials, and follow-up analyses, and companies will need to invest in newer technologies so that they can comply with regulatory mandates.
Whether the new regulations will make medical devices safer and help patients combat the physical ailments from which they suffer remains to be seen, but it would appear to at least be a step in the right direction.
Defective Medical Devices Continue To Find Their Way Onto The Marketplace
Even with advances in government oversight, defective and dangerous medical devices are still sold and used every day. 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’s manufacturer. The defective medical products lawyers at Parker Waichman 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, like replacement hips, knees, and pacemakers, require surgical implantation, and replacement surgery is fraught with danger. Every time a person undergoes surgery, they face possible risks such as infection, adverse reactions to anesthesia, and needing to take opiates to reduce or block pain, as well as the potential for painful rehabilitation, lost work, and time away from home if inpatient rehabilitation is needed. Additionally, surgical complications could result in cardiac arrest, stroke or even death. To compound matters, every time a person has surgery, they face the specter of falling victim to medical malpractice.
Grounds For A Defective Medical Device Lawsuit
Compensation for medical device failures is based on the legal theory of product liability. Courts typically recognize three types of arguments in a product liability case: manufacturing defects, design defects, and failure to warn.
- Manufacturing Defects: A manufacturing defect is concerned with the manufacturing process that 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 have a duty to warn customers about possible side effects so the patient can make an informed decision about their health care.
Defective Medical Devices Our Lawyers Have Sought Compensation For
What Damages Are Available To Collect In A Defective Medical Device Case?
It’s important to note that every case is different, so you can’t assume that the results of your case will be the same as someone else’s. But generally, a defective medical device lawyer can help you to secure both economic and non-economic damages. Some examples of things you may be compensated for through defective medical device litigation include:
- Medical Expenses: Each person is entitled to recover medical expenses they incurred because of the defective medical device. Medical expenses do not have to be limited to compensation for the replacement cost; they can also include compensation for doctor visits, therapies designed to treat complications caused by the device, medication, travel expenses, and any other expense that was directly caused by 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 can include physical therapy, inpatient rehabilitation, doctor visits, medication, accommodations made to one’s home, and even compensation for medical malpractice claims.
- Lost Wages: Compensation for lost wages makes up for the time you missed from work because of medical care you needed due to the 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 economic opportunity includes the loss of future wages as well as costs like missing out on the chance to get a promotion or a raise.
- 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 has been diminished in a meaningful way. Even just the inconvenience of suffering in pain day after 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 that committed fraud or another intentional act that caused harm to an individual. Whether a court may assess punitive damages in a given situation is governed by state law.
- Legal Costs: Plaintiffs typically can recover the costs of medical device litigation, which can be quite 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 so forth.
Statutes Of Limitations On Defective Medical Device Claims
Most states have a three-year statute of limitations, but some states have a shorter time frame in which you must file your claim. It’s important to consult a knowledgeable defective medical device attorney to make sure that your case is timely, as missing the deadline can prevent you from recovering damages, even if you have a solid basis for your defective medical device claim.
Why Choose Our National Defective Medical Device Law Firm?
Parker Waichman’s defective medical device attorneys have earned a reputation as tenacious advocates 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. Our defective medical device law firm is in New York but handles cases all across the country, earning accolades along the way. When you need an aggressive defective medical device lawyer to seek justice on your behalf, you’ll have a strong ally in Parker Waichman.
You don’t just need to take our word for it, though. The legal community has spoken, bestowing numerous honors on our firm, including:
- A 9.8 (out of a perfect 10) rating by AVVO
- A listing in Best Lawyers
- Lawdragon’s highest ranking of “5 Dragons”
- An “AV Preeminent” peer-review rating from Martindale-Hubbell
