A patient filed a lawsuit against the physician, product manufacturer, and pharmacy chain. She may have also filed against the information technology firm that handled the capability to print out the patient information sheet at the pharmacy as a supplement to the medication labeling.
Facts About Monograph Lawsuit
There is a woman in a western state who got an anticonvulsant medication and experienced adverse effects because of its interaction with another medication. The result was complete blindness, along with severe and painful scarring from Stevens-Johnson syndrome.
According to the woman and her husband’s statement, the medication has a significant risk of causing SJS and associated epidermal necrolysis. The patient acknowledged that the monograph, a summary of the package insert information, and a relevant patient medication guide by the FDA were supplied when the medicine was dispensed.
However, the woman claimed the monograph was written in nontechnical language, so it needed to be more understandable for patients and caregivers. The monograph was a written supplement to the oral counseling patients receive from pharmacists when the medication is dispensed.
There was a major difference between package inserts and medication guides that are reviewed and approved by the FDA. However, the patient information sheet for monographs must be reviewed and approved by the FDA.
Furthermore, a federal statute recognizes unofficial documents as part of self-regulation action plans designed to improve patient access to helpful information and medications.
In 2005, the pharmacy explained that the database of information sheets could print out a 5-section version or an 8-section version. The shorter version omitted the section with these headings: before Using this medication, overdose, and additional information.
The software company revised the software in 2005; therefore, the abbreviated version could not be printed at the pharmacy. This medication chain told the information technology contractor that it wished to use only the abbreviated 5-section version. So, the software company complied with the request after receiving a release of liability and agreement from the chain.
According to facts, the product container contained some warnings about drug interactions and complications because of coexisting health conditions. The plaintiff received one of the versions that omitted a Black Box warning that had been in before using this medication section and stated that ‘serious and sometimes fatal rashes have occurred with the use of this medication.
Monograph lawsuit alleged negligence by the software company, which used the abbreviation of information. However, in response to this lawsuit, the firm’s attorney motioned to the trial court that the lawsuit would be dismissed. These trials denied that motion, and the software company appealed to a state court of appeals.
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Court Trail
The court agreed that the trial court should not be dismissed before trial. A jury would have to answer several questions. First, the court focused on the IT firm’s reprogramming of its software to allow the pharmacy chain to distribute the abbreviations. A 5-section monograph that omitted from the black box warnings.
In addition, the court differentiated the case from an earlier one in which it was ruled that a software firm had no legal duty extending to a patient who received a medication monograph through the software firm.
So, evidence in court indicates that the IT firm knew that enabling the software to print out the more abbreviated form of the document could place patients at risk. The court pointed out an acknowledgment in the 2005 agreement between the pharmacy chain and IT firm in the release of liability document, which shows the full 8-section version to avoid harm rather than the 5-section version. This is all about the monograph lawsuit facts and figures.