Federal Regulators Approve Smart Pill
November 14, 2017 | Pharmaceutical Litigation
MyCite tablets from Abilify may help doctors give better care to their patients, and they also has some interesting legal implications for dangerous drug cases.
The aripiprazole tablets, which the Food and Drug Administration has approved for treatment of manic depression and schizophrenia, have tiny ingestible sensors. When the patient swallows the tablet, the sensor delivers a signal to a wearable patch, which then transmits a signal to a smartphone. Furthermore, if the patient consents, a doctor can receive this data as well, so treating physicians know almost in real time whether or not the patient is taking medication as prescribed.
Some patients, including those with dementia, should not use ingestible medicine.
The FDA Approval Process
MyCite has a number of bugs; for example, the sensor may take up to two hours to transmit a signal to the patch. Nevertheless, the drug may meet a very significant need, as up to 50 percent of patients do not take their medication in accordance with their doctors’ orders.
This need was obviously not enough to convince FDA regulators that the smart pill was a good idea. Abilify originally asked for FDA approval back in 2015, and after almost a year, the agency refused to approve it, instead directing the drug maker to essentially go back to the drawing board. Such delays are commonplace, as on the average, it takes twelve years for the agency to approve a new drug.
At the same time, most new drug patents only last twenty years, and then, lesser-expensive generics often appear. So, drug companies usually have about eight years to charge full price for their medicines and recoup the billions of dollars that they spend during the development phase. The practical implications are significant:
- To boost sales, many companies encourage experimental off-label use. Typically, they hire doctors to conduct training seminars at vacation destinations, such as Aspen. Off-label use is generally legal, but it is very risky, and patients are not always fully apprised of these risks.
- Because the clock is ticking, the drug company cannot allow negative information to depress sales even for a few months. So, many companies suppress such data, and continue to sell drugs which they know, or should know, are dangerous.
It is negligent to take unnecessary risks in the name of higher profits or hide the facts for the same reason. Victims who suffer injury because of this behavior are entitled to financial compensation. Additionally, many jurors award substantial punitive damages in these cases, to send a firm message to the drug companies that such behavior is patently abusive.
Many dangerous drug cases involve strict liability instead of negligence. If the drug was defective, due to a design or manufacturing defect, the manufacturer is automatically responsible for damages, no matter how caution the company may have been.
Drugs and Contributory Negligence
Whenever possible in negligence cases, insurance company lawyers shift blame onto the victims. In dangerous drug cases, they often argue that the victims did not take the medication properly and therefore suffered injury. If the smart pill becomes widely available, that argument may lose all its force, because data would be available to conclusively refute claims of drug misuse.
Dangerous drugs often cause serious injuries. For a free consultation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. We handle dangerous drug and other mass tort cases on a nationwide basis.
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