Black Box Warnings and Medication Errors

A medical malpractice lawyer will frequently investigate cases involving severe personal injury or wrongful death resulting from a medication error.  Medication errors include mislabeled prescriptions, wrong prescriptions, wrong dose, overdose, misfilled prescriptions, and wrong medication.  In addition, serious injury can occur from side effects of medications.  Almost every drug carries side effects that can result in serious harm.  Drug manufacturers prepare a package insert that includes key information about the drug, including side effects, uses, dosage limits, contraindications and drug interactions.  Some package inserts include a black box warning which is meant to alert pharmacists and doctors about life threatening risks of a particular medication.

Lawyers who sue drug manufacturers over dangerous drugs recognize that black box warnings are not intended for patients, but are meant to drive profits higher for the pharmaceutical industry.  Prescription bottles do not carry black box warnings or symbols alerting patients to hazards associated with the medication.  Likewise, pills are not color coded in any way to alert patients about their dangers.  Instead, the black box warning is included on the package insert so that pharmaceutical companies can claim that they have warned about dangers associated with the medication and wash their hands of any accountability for harm caused by the medication.  Pharmaceutical companies point the finger at physicians who, as learned intermediaries, fail to warn the patient or prescribe different medicines that will not result in serious harm or a medication-related fatality.  

Generally, drug makers do not like to include black box warnings on the package inserts because they discourage physicians from prescribing that medication.  However, litigation costs associated with dangerous drugs can drive manufacturers to post black box warnings.  You will often read that a particular drug manufacturer’s stock price will rise when they resolve litigation arising out of a dangerous drug.  Investors seek stability in their investments.  When a major class action lawsuit is settled, and a black box warning issued, no further lawsuits will arise out of that dangerous medication because a warning has been issued.  At no time is the patient’s safety taken into consideration.  It is all about profits.

Since the black box warnings shift the burden to physicians to warn their patients about dangers associated with a medication, a medical malpractice lawyer will focus on the doctor’s negligence or a pharmacist’s negligence when a patient is seriously injured by, or dies as a result of, a particular medication.  Pharmacy liability can arise from failure to warn patients about dangerous prescription interactions or dangerous doses.  

The battle over black box warnings can be seen on the website for groups like Parents United for Pharmaceutical Safety and Accountability.  This group exists because even children are targeted by pharmaceutical companies seeking to maximize their profits through the sale of unsafe drugs.  

If you have questions about a pharmacy error or other medication error, contact an experienced medical negligence lawyer in Cleveland, OH.   

Thanks to Mishkind & Kulwicki Law Co. for their insight into medical malpractice claims and warning labels.

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