NY Product Liability Lawyers Discuss Inappropriate FDA Financial Ties
When it comes to the approval or denial of mass marketed prescription drugs, most are concerned with the safety and efficacy of the particular item. However, for certain members of the FDA’s board of commissioners, financial incentives are a routine part of the process – and may be a contributing factor to certain approvals for drugs and medical devices.
According to a recent article published in the Wall Street Journal, financial ties between drug companies and FDA gatekeepers are becoming an increasing problem, primarily because of the natural concern over tainted decision making by those tasked with protecting American consumers from unsafe drugs and devices.
How the FDA approval process works
When a company seeks approval for a new drug, it must undergo weeks, months, or even years of clinical testing on the drug to ensure it is fit and proper for use by patients seeking treatment. From there, devices or medications are presented to a panel of doctors who make recommendations to the FDA as to whether the item should be approved for sale.
The problem herein lies with the reality that up to one third of all doctors sitting on these panels have received financial compensation from the companies presenting their products to the panel for approval. In fact, according to the Wall Street Journal’s compiled data, one-third of the 122 members sitting on cardiology, orthopedic, or gynecological panels had received some sort of incentive between 2012 and 2014, including cash, travel expenses or research grants.
While the FDA has the ultimate final say in the approval or denial of each drug or product, it often takes panels’ recommendations very seriously, aligning with panel recommendations in a “large majority” of cases.
Defective medical device lawsuits
The risk of patient harm due to improper financial ties is far from rhetoric, and real patients are experiencing injury and death as a result of medical devices and drugs that perhaps should have never been introduced to the American market. For example, the power morcellator device – which is used to conduct sensitive operations on the female reproductive organs during a hysterectomy or fibroid removal procedure – is increasingly linked with the subsequent onset of uterine cancer. In July, 2014, an FDA panelists opted to step down from his role as a gynecological product consultant – including consultation regarding the power morcellator device – after the FDA began inquiring into his financial relationship with the manufacturer of this product.
According to the FDA, performing paid work for a drug corporation does not necessarily disqualify a doctor from thereafter rendering an opinion about a certain drug or device. However, current ongoing paid consulting work for a certain device or drug would render that doctor ineligible to thereafter offer an opinion as a panelist – unless his or her expertise is not duplicable, in which case the FDA may offer a waiver.
Those who have been injured or lost a family member from a faulty hip implant or other dangerous medical product may have grounds for pursuing compensation in a defective medical device lawsuit. Damages recovered may include those for lost wages, medical expenses, diminished earning capacity, permanent disability and wrongful death.
New York product liability lawyers
Inappropriate financial ties – historically known as kickbacks – have a strong potential to sway a doctor’s opinion in favor of a certain drug or device, regardless of whether that device is considered completely safe for use.
If you were recently injured by a drug or medical product and would like to discuss your experience with a knowledgeable product liability attorney, we encourage you to contact The Sanders Law Firm right away by calling 888.711.2392.
Our principal offices are located in Manhattan, Long Island, Brooklyn, and Bronx, however we are part of a nationwide network of law firms available to handle your injury case, so call today! Resources
- Wall Street Journal, FDA Advisers financial ties not disclosed, https://www.wsj.com/articles/fda-advisers-financial-ties-not-disclosed-1418095981
- ABC News, Many FDA Drug Advisers tied to firms, https://abcnews.go.com/Health/story?id=117941