Generic drugs are non-brand versions of popular medications or drugs. Generic drugs are typically over-the-counter versions of prescription medications such as Concerta. Generic drugs may be essentially the same as their brand-name counterparts. They may contain the same type of active ingredients as the original drug. Many people buy generic drugs as a cost-effective way of obtaining medicine since generic drugs are often cheaper.
On the other hand, there is always a slight risk whenever using generic drugs. There is always the danger that the manufacturer didn’t correct the combination of ingredients or used inferior ingredients. Also, cheap generic drugs or drugs originating from unreliable sources can sometimes be improperly labeled.
What Are Some Common Generic Drug Injuries?
Therefore, these risks associate generic drugs with various kinds of injuries. Some common types of generic drug injuries may include:
- Improper dosages due to incorrect labels or instructions
- Allergic reactions to inferior or alternative ingredients
- Overall misdiagnosis- using the wrong drug for certain conditions can happen, especially if the advice of a physician is missing
- Long-term side effects that may be unaccounted for with the original product
- Illness resulting from defective medicines
- Injuries resulting from misrepresentation of a product
Thus, many generic drug injuries result from product confusion, mislabeling, or incorrect comparisons with the brand-name product. Even if two products use the same ingredients, they can have different effects due to how they are prepared or produced. Symptoms may include stomach or digestive disturbance, headache, nausea, or vomiting, depending on the product.
What Are Some Legal Remedies for Generic Drug Injuries?
Some legal remedies for generic drug injuries may include:
- A damages award for making up for financial losses (i.e., additional medical expenses, hospital bills, etc.)
- A product refund or replacement
These may depend on the type of injuries involved and state and local laws. Other remedies may involve a recall of the generic drug or a suitable product replacement.
Can Manufacturers Be Held Liable for Injuries Sustained from Generic Drugs?
The laws regarding recovery for pharmaceutical injuries are more complicated than those for injuries caused by name-brand medications. Federal laws require that manufacturers of generic drugs identify their products with labels that meet the same standards as brand-name drugs.
The Supreme Court has held that this law prevents a person who was injured by a generic drug from recovering damages according to a state design-defect law. In other words, generic drug manufacturers must follow federal laws with regard to labeling their products.
The litigation issues involving manufacturer liability are incredibly complex. The question about holding the manufacturer starts with determining which manufacturer is to blame. Determining whether the generic manufacturer of the drug or the manufacturer of the original brand name drug is liable is tricky. Factors that go into this consideration are:
- Who controls the labels on the drugs?
- How is the product marketed?
- Who controls the marketing?
- What side effects were disclosed?
Some believe that preventing generic drug manufacturers from changing warning labels is unfair because it protects them from potential lawsuits.
Plaintiffs argue that name brand manufactures should be liable for injuries caused by generic drugs because it is foreseeable that a generic drug manufacturer will use the labeling of the name-brand manufacturer, as required by the federal regulatory framework applicable to prescription drug labels.
How Are Generic Drugs Regulated?
Most countries require generic drug manufacturers to prove that their formulas are equivalent to their brand-name counterparts. The generic drugs do not have to be exactly the same as their brand-name counterparts. Chemical differences may exist. Different salts or esters may be used, for instance. Different inactive ingredients mean that the generic drug may look different than the original brand. However, the therapeutic effect of the drug must be the same.
Before a company can market a generic drug, it must file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration. This filing seeks to demonstrate therapeutic equivalence to a previously approved drug by proving that the manufacturer can safely and consistently manufacture the drug. The absorption of brand-name drugs and generic drugs by a person’s body is compared by the FDA.
When an application is approved, the FDA adds the generic drug to its Approved Products with Therapeutic Equivalence Evaluations list. This list is then reviewed to show the equivalence between the brand-name drug and the generic.
In order to start selling a drug, a generic company has to file its ANDA before its patent expires. This may put the generic company at risk of being sued for patent infringement. When faced with patent litigation from the original drug innovator or patent holder, generic companies often counter-sue by challenging the validity of the patent.
Like any litigation between private companies, the innovator and the generic companies often settle the litigation. Some of these settlement agreements have been struck down by courts, however, if the generic company essentially accepts a payment to drop the litigation and delay the introduction of the generic product into the market.
What is Innovator Liability?
The majority of courts have rejected the idea that name-brand manufacturers could be liable for a drug that they did not make. However, the plaintiff’s lawyers have made theories and arguments in trying to hold generic and original manufacturers liable for generic drug injuries. One theory is called innovator liability.
This theory contends that as the original innovator, the original manufacturer should be liable for damages if the warning labels on generic drugs were defective. Litigation is taking place throughout the country at the state and federal levels on this issue. The Massachusetts Supreme Court and the California Supreme Court have recently recognized innovator liability. The courts held that a name-brand manufacturer owes the ordinary duty of care to users of generic drugs regardless of who made the drug.
Are Generic Drugs Riskier Than Brand Name Equivalents?
Research suggests that generic drug labels are often different from those found on their brand-name counterparts. A study by Indiana University found that 68% of drugs showed different safety information on their labels, although some differences were minor. Alarmingly, nearly one-tenth of the prescription drugs with labeling differences between the generic and brand name versions had at least 10 side effects that didn’t match up.
Some of the generic labels contained information that was:
- Incomplete or omitted
- Pertaining to the wrong drug
Omitting information on prescription drug labels can be dangerous. Physicians often use information on drug labels when prescribing a drug or deciding what dosage a patient can safely take. Incomplete safety information can lead to overlooked side effects and have fatal consequences.
Safety labels also may not reflect that generic drugs taken on their own have side effects or risks.
Should I Hire an Attorney?
A lawsuit involving generic drugs can be difficult to handle on one’s own. It’s in your own best interests to hire a qualified class action attorney if you need assistance in filing a lawsuit. Your attorney can provide you with the legal advice and understanding needed to succeed with your claim. Generic drug products are subject to strict laws that often require a legal professional for interpretation.
Use LegalMatch’s services to locate an experienced personal injury lawyer in your area today. Consultations are always free, and our service is 100% confidential.