In 2015, Parker Waichman LLP hopes for increased testing, safety, and efficacy in the processes and marketing used by the medical device industry so consumers may be assured of receiving safe, effective devices that underwent upright development, research, and promotion.
Parker Waichman, a national law firm that has long dedicated its practice to assisting individuals who have been harmed by defective medical devices is asking the medical device industry to make some needed changes as we approach 2015. Specifically, Parker Waichman seeks improvements in the ways in which medical device makers develop, test, inspect, and market their products, as well as how they go about receiving approval for medical devices.
Among other issues, an increase in transparency is sought, as well as accountability from the medical device community, with the end result being that patient welfare becomes what it always should have been: The number one priority, above and beyond approval and marketing activities, and activities that lead to increased profits.
Financial relationships that take place between the medical device industry and the health care community have led to growing controversy. Parker Waichman, and other critics of the practice, point out that these relationships may lead to conflicts of interest, which may ultimately and disproportionately impact both research findings and prescribing practices. More significantly, the results of these types of business practices may lead to patients becoming secondary, or lesser, priorities in their own health care decisions. This may result in long-term, debilitating, life-threatening, and fatal injuries that leave patients poorly represented and in need of financial, medical, and legal assistance.
Some of the injuries and damages Parker Waichman has seen have been associated with the ways in which medical devices are developed, tested, approved, marketing, sold, and used; these injuries are often irreversible. In some cases, multiple additional surgeries are required and full recovery is still not possible. In some cases, injuries have been fatal. We hope to see this trend reverse and seek full and appropriate development and testing on medical devices, not simply the practice of pushing devices through via federal loopholes such as the 510(k) that enables a fast-tracked approval route for medical devices when any given medical device is simply similar to a previously approved device.
In some cases financial relationships have impacted how medical studies have been presented with advertising highlighting a device’s benefits, while downplaying its negative reactions. In some cases, medical device makers have paid actual healthcare professionals and facilities for the use of their images in advertising for specific medical devices. In some cases, adverse effects were hidden in reports or minimized in promotional devices.
We urge the medical device community to ring in the new year with the promise of improving its processes and with the assurance that it will develop medical devices ethically and with a long-term, broad focus on the patient. We seek a medical device industry that is efficacious and intensely ethical, that creates safe products that do not cause patient harm, injury, the need for additional surgeries, or the need to bring legal action to simply receive appropriate health care. We hope for a medical device industry that is free of kickbacks, financial exchanges, and a biased risk-to-benefit ratio.
Controversial consultative relationships between medical device makers and the health care community should be a scandal of the past. We should learn from these mistakes and understand that these relationships may encourage doctors who receive benefits, perks, and payments to promote medical devices to patients and peers, and to prescribe these devices to, implanting them in, patients’ bodies.
Study funding is expensive and challenging, as is the business of putting in place proper checks and balances. When appropriate research is conducted and processes are transparent, accountability and work ethics are in place, saving consumers, drug makers, the insurance industry, the medical industry, and the government big money that is lost today in costly and all-too-routine litigation.
In the new year, we at Parker Waichman, are asking the medical device industry to strengthen accountability, consider the patient the number one priority, conduct required research before seeking approval from federal regulators by way of regulatory loopholes, and to always consider safety before profits. We hope the medical device industry will voluntarily go beyond the minimal requirements, make fundamental changes, set higher and respectable business and medical standards, and help us ensure consumers are appropriately protected when seeking medical treatment.
“Patients and physicians rely on safe and effective medical treatments,” says Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “Patients and doctors need to know whether, and to what extent, certain types of treatments may be dangerous.”
Patients who are injured following the use of potentially dangerous medical devices may be entitled to compensation, Parker Waichman points out.
Parker Waichman LLP offers free lawsuit consultations to victims of medical device injuries and side effects. For more information concerning probiotic side effects, please visit the firm’s Defective Medical Device page. Free case evaluations are also available by calling 1-800-LAW-INFO.