Many Americans are seriously injured and die every year from adverse reactions and side effects associated with prescription medications. Drug manufacturers are legally responsible for marketing medications that are safe to use. The Food and Drug Administration (FDA) is the federal agency responsible for assessing the safety and effectiveness of prescription drugs before they are sold to the public.
However, even FDA approved drugs may still cause harmful side effects that are not identified during the approval process. Harmful effects can also result from errors in the administration of medications, or, if a person is taking more than one medication at a time, from the interaction of drugs in the body.
If a person is injured because of a prescription medication, the person may need to file a prescription drug lawsuit. This can help them get compensation from healthcare providers or the pharmaceutical manufacturer of the drug.
Drugs That May Be Considered Unsafe
A high alert drug or medication (HAM) is a medication that carries an increased risk of causing significant harm if it is used in a way other than exactly as prescribed. These high-alert medications are dangerous because small changes in the dose given or in levels of the drug in a person’s blood can lead to critical events. Moreover the adverse events caused by error in the administration of HAMs are persistent, life threatening, or even permanent, and can lead to disability, hospitalization, or death.
These drugs are different from over-the-counter-drugs such as ibuprofen or aspirin. While these medications can be misused, a small variance in the amount taken would not be possibly life-threatening.
HAMs are different. Small differences in the amount given can be critical and might even lead to death. The Institute for Safe Medication Practices has three categories of high-risk medications according to the settings in which they are used. The categories are as follows:
- Medications that are high alert medications in community/ambulatory care settings;
- Medications that are high alert medications in acute care settings;
- Medications that are high alert medications in long-term care settings.
Some examples of HAMs are the following:
- Anticoagulants: anticoagulants are blood thinners, such as warfarin and heparin; they are used to treat blood clots, so they are used for such conditions as venous thrombosis or pulmonary embolism; too much of an anticoagulant can be life-threatening, so it is important to take only as much as is prescribed and to take it on a strictly regular dosing schedule, neither missing a dose or taking more than a dose at one time;
- Insulin: insulin is a prescribed treatment for diabetes; it must be taken as prescribed; there are numerous risks to taking insulin;
- Opiates and narcotics: for example, OxyContin, hydrocodone and methadone are opioids which carry a high risk of addiction and when taken in excess, can result in death by overdose;
- Injectable potassium chloride or phosphate concentrate: these medications are for treatment of electrolyte imbalance but require monitoring and careful supervision for administration;
- Potassium and other electrolytes: These medications are used to regulate electrolytes but can be dangerous if not used correctly and with supervision.
All of these medications are potentially life-saving treatments when prescribed correctly and administered strictly as directed by a physician’s prescription. However, if used incorrectly and not as directed, their effects might be life-threatening. A list of all HAMs is freely available on the Internet
Various kinds of monitoring may be involved in regular use of these medications. Often, in hospitals and in long-term care settings, there are specific protocols for administering these medications in order to avoid mistakes. If a person or their relative is taking a medication on the HAM list, they might wish to review the treatment with their doctor so they have the peace of mind of knowing that required protocols are followed during administration of the medication.
It is important to keep in mind that it is not only drugs on the HAMs list that can injure a person. All medications have the potential for undesirable side-effects, even if used properly. Also, interactions between different drugs can lead to serious health consequences.
What Should I Do If I Feel That the Listed Drugs Have Bad Effects on My Health?
If a person feels that the HAM-listed drugs, or any others that the person may be taking, are having an adverse effect on the person’s health, the person should discuss the issue with the doctor who prescribes the medication. If a person does not get answers that seem satisfactory from their doctor, they should consult another physician also.
If a person believes that they have already experienced adverse effects on their health from taking HAMs, or any other prescription medication, they could consult with an unsafe drugs lawyer, who would be a lawyer who specializes in medical malpractice or product liability lawsuits.
A malpractice or products liability lawyer will analyze the facts of a person’s case in order to determine whether any adverse effects on a person’s health are the result of an error on the part of the doctor or other health care provider in prescribing the medication. Or, the lawyer may determine that the medication itself is defective in some manner and the fault lies with the pharmaceutical company that made the medication.
A person can also report adverse drug reactions to the MedWatch program of the FDA. The MedWatch program exists for the purpose of receiving reports of serious reactions, product quality problems, therapeutic failure, and product use errors with medical products for people. The types of products that can be reported include drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If a doctor prescribed the medication that a person wishes to report, the person can ask their doctor to assist with the report. However, if a person does not wish to involve their doctor for whatever reason, the person can fill out the form themselves. Or, a person might wish to consult an attorney about making a report to the MedWatch program. The FDA acknowledges receipt of these reports. .
It is important to keep in mind that reporting adverse experiences with medications to the MedWatch program may be helpful for the purpose of improving regulation of medications by the FDA. However, it is not a way to get damages for any injury that the medication may have caused to a person. That requires a lawsuit.
Should I Join a Class Action Lawsuit or Sue the Manufacturer on My Own?
There are pluses and minuses to both class actions and suing a pharmaceutical manufacturer on one’s own. A person who files the complaint in a civil lawsuit is called the “plaintiff” and the person or entity who is sued is the “defendant. Some of the positives to consider when trying to choose between the two options are as follows:
- Plaintiffs are stronger as members of a large class of claimants:
- Plaintiffs are in a stronger negotiating position and are more likely to be able to settle before trial, which reduces the costs and avoids the uncertainty of a trial;
- When a plaintiff joins with others it reduces the cost of the lawsuit to each of them; cases involving medical malpractice or pharmaceuticals can be expensive because they might involve many experts;
- As with most personal injury claims, plaintiffs only pay the attorney fees if they win money, in which case it comes from their award;
- Class action plaintiffs have a longer period of time in which to file a lawsuit;
- If your claim is for a relatively small amount, it is probably not worth the cost and aggravation to prosecute a lawsuit; also most attorneys are not interested in small-value cases. A plaintiff is better off aggregating their claim with those of others;
- There may be a huge disparity between what the various claimants recover if each proceeds on an individual basis;
- Less strain on the court system;
- Although not necessarily a concern of an individual plaintiff, having only one case is more efficient for courtrooms and fewer judges.
Among the negatives of class action lawsuits are the following:
- Compensation for an individual plaintiff in a class action is usually limited to economic damages and rebates;
- If a person wants to recover a substantial amount of money damages for their pain and suffering or other non-economic damages, a class action may not be the best option;
- The individual plaintiff has no say in the decisions made during the legal process;
- If a person wants more control and personal involvement, an individual action may be a better choice;
- If a person joins a class action, the person gives up their right to make an individual claim;
- If the class action does not succeed or if a person believes that their award in the end is unsatisfactory, they will not be able to pursue an individual action later on.
Will I Need a Lawyer for Help with an Unsafe Drugs Lawsuit?
If you or a family member has been injured by a prescription medication, including one that is not on the HAMs list, you should consult with an experienced personal injury lawyer. All drugs come with side-effects and some of them can be life-threatening. Also one drug can interact with another.
A person who has been injured by taking prescription medications may have a claim against the doctor who prescribed the drug, other healthcare workers who were involved in administering the drug or the pharmaceutical company that made the drug. An experienced personal injury lawyer can review the facts and advise you whether a lawsuit is the right approach in your situation. They could be able to locate class action lawsuits that you might join. You are most likely to achieve the best outcome if you consult an experienced personal injury lawyer.