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Medication Package Inserts – Medical Malpractice?

02-11-2019 12:05 PM CET | Politics, Law & Society

Press release from: Crowson Law Group

All prescription medications come with a package inserts in them that provides detailed information about the medication, the conditions that it treats, the potential side effects as well as possible drug interactions, dosing and other important information. Unfortunately, most people, including doctors, assume that this information is more of a legal document that is written in order to protect the drug manufacturers. As a result, they fail to take the time to review the document before prescribing the medication to the patient. Where a physician prescribes medication without consulting the prescribing information and the patient experiences an adverse reaction to it this could result in a medical malpractice lawsuit.

One article stated two medical malpractice cases involving package inserts; “A 6 year old boy was diagnosed with attention deficit/hyperactive disorder (ADHD) and was prescribed and amphetamine and methylphenidate at 50mg/day. His dose was gradually increased to 200mg after he did not adequately respond to the lower dose. The boy collapsed at school and was rushed to the hospital, where he went into cardiac arrest and died. According to the package insert, it warned against exceeding a dose of 2.5 mg/kg in children. It also recommended performing an electrocardiogram before starting the drug, and before any dose increase. When the boy collapsed in school, he was taking 8 mg/kg, which is 3 times higher than the recommended dose.”

“An 18 year old boy had suffered episodes of depression and anxiety at the prospect of losing his grandmother. He had also become dehydrated. He was given a prescription of quetiapine XR, of which his health insurance switched to quetiapine IR. After taking the medication for 11 days, he came home from school and fell asleep on a reclining chair. The next morning, his mother was unable to wake him up and he is now in a vegetative state. According to the package insert, patients who are dehydrated should not take the medication. In fact, this was mentioned 5 times in the package insert.”

The above examples show how important it is for each and every health care provider to review the package insert and documentation before prescribing any medication to their patients. The package insert and documentation gives reasoning behind the prescribing decision. By providing such a warning regarding the medication the company that manufactures the medication absolves themselves from liability in such cases. However, physicians and healthcare providers who fail to read the package insert and documentation have breached their duty of care to their patients and in the above two cases resulted in severe injury and death to the patients. Thus their failure to review the package documentation and insert rises to the level of medical malpractice and they open themselves to lawsuits.

If you or a loved one has suffered injury as a result of a healthcare professional failing to review the package insert you may have a medical malpractice lawsuit. For legal advice and representation on Alaska medical malpractice cases contact a law firm that specializes in medical malpractice matters.

About Crowson Law Group

The Crowson Law Group is a law firm of renowned professionals who focus on medical malpractice matters. For representation by Anchorage Alaska attorneys who focus on medical malpractice cases, contact Crowson Law Group today.

Company: Crowson Law Group
Address: 637 A St. , Anchorage, AK 99501
Phone: (907) 677-9393
Website :

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