Trusted Defective Drug Lawyer Serving Victims in Connecticut
Today, in the healthcare industry, dozens of new prescription drugs enter the market every year. While most of these medications are safe, some cause harmful side effects, contain formula errors, or have a manufacturing defect that makes them outright dangerous for consumption.
In 2015, drug approvals hit a 66-year high. In fact, there was a total of 51 new drugs approved in 2015 and 45 drugs were approved by the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) alongside six recombinant therapies that were approved by the Centers for Biologics Evaluation and Research (CBER).
Out of the 51 drugs approved in 2015, there were 39 companies; therefore, some manufacturers were quickly producing and releasing medications. Novartis had five approvals alone in 2015.
By 2015, Johnson & Johnson had released nine new medications in a five-year span, while GlaxoSmithKline (GSK) released nine too.
With so many medications, it is hard to keep track of which ones there are, let alone keep up with any recalls or issues that might be known with these medicines. That is why patients rely on their physicians to tell them the risks of a prescription, but also rely on manufacturers to release safe drugs and use quality control measures to ensure a simple mistake does not lead to a severe complication.
Understanding Defective Drug Lawsuits in Bridgeport
There are numerous medication error lawsuit types, but today we are focusing on defective drugs and the differences between formulation errors and manufacturing errors.
In a nutshell, a formulation error means that the drug was defective from creation. A manufacturing error indicates that the formula is fine, but there was an error during the manufacturing which led to a defective drug. We will delve deeper into these types of defective drug claims and how the defective drug lawsuit process works. It is important to have some of this knowledge so that you understand what your rights and options are if a defective medication injures you.
Formulation Errors (Design Defects) in Medications
A poor drug design can include a drug with harmful side effects, poor formulas, or interactions. Medications that are defective by design are manufactured as specified, but the harm the drug does outweighs the benefit it provides to patients taking it.
Before submitting a drug for approval by the FDA, a manufacturer must ensure their drug is safe for consumption. To do this, they will use clinical tests. Clinical tests go through several phases and have numerous patients enroll voluntarily to determine the actual effects of a medication.
A drug maker must also ensure that any adverse reactions noted in these trials is placed on their warning label so that physicians, pharmacists, and patients are aware of those risks.
Pharmaceutical Companies Have an Obligation to Ensure They Produce Safe Medications
A pharmaceutical manufacturer must ensure that their medications are safe and effective when used as directed by the patient. They must advise a patient of any potential side effects, including those rarely reported. Also, they must inform on any health risks or conditions that may increase these side effects. When they knowingly fail to test or notify patients of potential risks, they are liable for the harm caused.
How Do Dangerous or Defective Medications Get Released?
Because a formulation error means the drug was defective by design, you may wonder how these medications are released in the first place. It is difficult to understand how some drugs slip through the cracks, but defective drugs are released every year. Sometimes, the side effects or real harm of these medications are not realized until years after they have been released.
Some factors play a role in determining how defective medications reach the market:
- FDA only requires that a manufacturer demonstrate how their benefits outweigh the risks of taking a medication. That means that the manufacturer only needs to tell consumers about the side effects but then explain to them why the medication’s benefits make these side effects unimportant for their overall health. If you have ever seen a drug commercial, then you have seen a long, captivating ad about the benefits – with an announcer quickly spewing the risks at the end.
- The FDA allows drug companies to monitor and conduct their own testing. The FDA does not test new drugs in the formulation. Instead, they leave the testing to the company. With a company’s profits obviously at the forefront of their operation, they could skew test results to get their drugs to the market faster. Some studies are simply too short to properly test the long-term effects of a medication.
- Drug companies downplay the information or fail to report it to the FDA. Even if the tests reveal that there is a harmful side effect, the FDA puts full trust in the manufacturer. Therefore, a manufacturer could downplay the actual harm of their medication in order to get it released.
- Drug companies may advertise for off-label usage. Other times, the FDA has approved the medication, but the manufacturer will then market the medication for off-label use. In this case, the medication is used by a physician for reasons other than it was originally approved for by the FDA.
Examples of Defective Drugs
Some medications that were recently discovered to be defective in the design include:
- Mirena – An IUD contraceptive that now has been linked to damage to the organs and abdominal tissues.
- Lipitor – A popular anti-cholesterol medication that was found to cause diabetes in women.
- Actos – A diabetes medication that now may cause bladder cancer.
- AndroGel – A testosterone replacement supplement that has been found to cause heart attack and cardiovascular disease in men taking the medication.
- Xarelto – A blood-thinning medication that is used to prevent strokes, but now can lead to catastrophic, uncontrollable bleeding.
These medications were released after thorough tests, but the manufacturers failed to disclose these side effects and risks of their medicines to the FDA.
Drug Manufacturing Defects
In a manufacturing defect, the medication itself is designed without defects. When manufactured correctly, this medicine does not have harmful side effects or long-term adverse results. Instead, something goes wrong during manufacturing, such as a label being mistaken for another drug, the wrong dose of medicines added to the drug, and so forth.
Defects in manufacturing are not intentional. Instead, the product departs from the manufacturer’s original design even though care was exercised in preparation and marketing of the product.
Regardless of how “cautious” the manufacturer might be, they are still responsible for ensuring all medications produced in their facility are safe and free of defects. Therefore, a manufacturing defect still means that the company is liable for injuries caused.
Types of Manufacturing Defects that Occur with Medications
Defects in manufacturing can happen in numerous ways, including:
- Mislabeling Medications – Most pharmaceutical manufacturers create multiple medications (including prescription and over-the-counter drugs) in the same facility. Therefore, there is a high risk of labeling errors. One medication may be labeled as another and shipped to a drugstore or pharmacy.
- Contamination – A medication may become contaminated during manufacturing. For example, a drug that is meant to be gluten-free could be contaminated with gluten products. Other times, medicines may be contaminated with other medicines, which leaves trace amounts of these medicines in the batch that should not be there. Trace amounts can still be deadly too – especially if those medicines together create a harmful interaction.
- Foreign Objects – Another type of manufacturing defect can include a foreign object, such as plastic or glass shards that find their way into capsules.
- Too Much Potency or Too Little – A medication’s effectiveness is based on the formulation and the potency of the final product. A manufacturing defect might include a batch of medicine that is too potent, which can lead to toxicity or adverse side effects. For example, a diabetes medication that helps regulate blood sugar is too potent, which in turn causes the patient to have extremely low blood sugar and a diabetic episode. On the other hand, a medication may have too little strength, which makes the drug ineffective.
FDA Responsibility for a Defective Drug
When medications are found to be dangerous, the FDA is required to investigate that medicine and decide if the drug’s benefits truly outweigh the risks. If the risks are found to be greater than the benefits, the medication is recalled and removed from the market. Other times, the FDA may require that the manufacturer places more warnings on their label to accurately notify potential patients and physicians of those risks.
The FDA uses recalls removing products from the market, and some recalls are voluntary, while other times they are requested by the FDA. When a drug is hazardous, the recall is ordered and overseen by the FDA.
FDA Approval Does Not Mean a Medication is Safe
Never assume that a medication is safe because it has FDA approval. Approval from the FDA is only needed to market a product commercially; but even after approval, a medication can be found to be defective in design or manufacturing.
Manufacturer Liability for Defective Drugs and Defective Manufacturing
A dangerous drug will usually be found within 12 months of its release, which means that most drugs are already on the market and used heavily before their defects are found. Some drugs are still marketed by pharmaceutical companies even though there is evidence that they are dangerous.
Manufacturers are held to the strict liability standards, which means they are liable for injuries and deaths caused by their defective medications.
Holding Drug Manufacturers Accountable
If you or a loved one was severely injured because of a defective design or defective manufacturing from a prescription medication, you could hold the manufacturer, pharmacy, and possibly the physician liable. To explore your options for compensation and see if you have a case, you need to speak with an attorney that has experience in defective medication lawsuits.