According to the Food and Drug Administration (FDA), as many as 3 billion prescriptions for medications are written annually. While these drugs help in the fight against disease and illness, many carry serious risks. According to the FDA, adverse drug reactions lead to more than 4 million visits each year to emergency rooms, doctors’ offices and treatment centers.

At Becker Law Office, our injury attorneys know how devastating the side effects caused by unsafe medications can be. In some cases, these dangerous medications can cause serious illness or death.

If a prescription drug has harmed you or your loved one, you should explore your legal options. Our dedicated Kentucky dangerous drugs lawyers believe manufacturers should be held accountable when they release dangerous products into the marketplace without warning of the harmful side effects. Our attorneys can help you pursue monetary compensation for the losses you have suffered including the death of your loved one.

A legal professional can evaluate your case at no charge and explain your options for seeking compensation for the harm you have suffered. Contact us today at our offices in Lexington or Louisville, Kentucky.

The Dangers of Hazardous Drugs

According to the FDA, the 4 million adverse drug reactions that occur each year can have very serious consequences. These adverse drug reactions result in more than 117,000 hospitalizations every year. They cause hundreds of thousands of injuries and deaths. The fact is that as many as 40 percent of all adverse drug events and 60 percent of life-threatening or fatal events are preventable.

Adverse drug reactions occur for many reasons – from doctors prescribing the wrong medications to hospital staffers and nursing home staff administering the wrong doses. A number of injuries and fatalities each year occur even when drugs are administered correctly. Patients may use the drugs as intended by the manufacturer but suffer serious, sometimes deadly side effects.

Examples of Harmful Medications

Over the years, many different types of drugs have turned out to cause serious complications for patients. Some examples of drugs that have been the subject of lawsuits include:

  • Diet medications such as Fen-Phen and Redux®
  • Hormone replacement therapies including Premarin®, Prempro® and Premphase®
  • Birth control medications including Yaz, Yasmin and Ocella
  • Dialysis medications including GranuFlo and NaturaLyte.

Types of Injuries from Dangerous Medication

Before a medication is released to the public, manufacturers are responsible for testing the drug to ensure that it is safe and effective when used as directed. Manufacturers must provide information about clinical testing to the Food and Drug Administration, which decides whether to allow the drug to be sold.

Almost all drugs have side effects that should be understood through testing. If the benefits of the drug outweigh the potential side effects, the drug can be approved despite those dangers. But the drug manufacturer must warn patients of potential side effects. That information is contained in a fact sheet included with the medication or on a warning label. This allows patients to make an informed choice about the drug.

Unfortunately, the review process does not always keep harmful drugs off the market. Too often, dangerous drugs are released to the public before the side effects are fully understood. In some cases, internal documents eventually reveal that a manufacturer placed a dangerous drug onto the market and disregarded harmful side effects that were well understood.

Potential Side Effects:

  • Psychological problems
  • Birth defects
  • Stroke
  • Cardiac problems or heart attacks
  • Cardiovascular disease
  • Kidney failure
  • Liver failure
  • Uncontrollable bleeding
  • Death

Typically, the dangerous side effects may not show up for months or years after a drug’s use has become widespread. The FDA will begin receiving adverse reaction reports when problems develop, but manufacturers may be slow to recall dangerous drugs, meaning the help of a knowledgeable Kentucky lawyer could still be useful.

How Hazardous Medications Enter the Market

There are multiple ways that hazardous medications may enter the market for public use. These include:

  • Regulatory gaps—While the FDA has broad authority to regulate medications, there are limits to the FDA’s power and there are regulatory gaps. For example, pharmacies called compounding pharmacies were originally created to mix drugs for specific patients when no pre-existing drugs were available. These pharmacies were small and regulated by local authorities. However, compounding pharmacies began to serve a different function, essentially mass-producing drugs to cope with drug shortages and rising costs. The FDA didn’t have the authority to regulate these pharmacies and the compounding pharmacies worked in a regulatory gap. That ultimately led to a disastrous meningitis outbreak, resulting in 50 deaths and more than 700 people falling seriously ill.
  • Drug representatives failing to disclose side effects—A study of doctors in the United States, Canada and France published in the Journal of General Internal Medicine found that 59 percent of sales reps visiting doctors’ offices failed to disclose the side effects of the medications they were selling. Since doctors are more likely to prescribe drugs pushed by drug representatives, many drugs are prescribed by physicians without full information. Patients often are not aware of the risks of the medications they are taking.
  • Insufficient testing of long-term problems—When drug companies test a drug, they may not detect certain adverse side effects in small clinical trials, especially if the problems develop over a long period of time or in people in certain age groups. The adverse effects of a medication may only appear when the drugs are widely prescribed in the general population.
  • Off-label prescribing—When the FDA approves a medication, it is approved for a specific use(s). Often, however, a drug may be found to treat other medical conditions or diseases that the medication hasn’t been specifically approved to treat. Doctors may prescribe a drug to treat conditions other than those the FDA has approved it to treat. This is referred to as “off-label” use. In some instances, off-label use of drugs has led to patient injuries and deaths.

These are just a few examples of how unsafe drugs can make their way from drug manufacturers to patients. While you count on the FDA or your doctor to ensure that you take only safe medications, you or your loved one may still suffer an unintended adverse effect.

Drug Makers Can Be Held Responsible for Injuries

If you or a loved one was harmed by a dangerous medication, you should discuss your legal rights with a knowledgeable product liability attorney. Under the laws in Kentucky and Indiana, drug manufacturers are required to make and market products that are reasonably safe when used as directed and to warn of known side effect. They may be held legally liable if patients suffer injuries from taking the medication. There are a variety of different claims that you can make when hurt by a harmful drug. These include:

  • Strict liability—These rules say that drug manufacturers are always responsible for unexpected drug reactions that patients experience when taking medication as prescribed or directed. You do not have to prove the manufacturer was negligent to make a strict liability claim — you just have to show that the drug as released was dangerous.
  • Negligence—If a drug manufacturer was unreasonably careless in testing or producing their drug, you can argue that they are liable for injuries resulting from their negligence.
  • Failure to warn—When a drug manufacturer doesn’t warn about side effects or disclose important information about potential risks of a medication, the manufacturer may be liable for failing to provide adequate warning.

A successful lawsuit can compel the drug manufacturer liable for your injuries to pay damages. However, you must first prove that the drug caused you injury or harm. This is called proving causation. It can be very difficult to link a drug to an unexpected side effect. For example, if you have a heart attack from a dangerous drug, the manufacturer could argue there is no way to know whether the drug really was the cause. Unfortunately, when a drug is truly dangerous, many people are harmed. But as the cases come to light, the medication and its manufacturer get the kind of scrutiny the drug should have had before being sold to the public.

Evidence that supports a dangerous drug claim may come from independent research about the drug, FDA action, such as a recall, or, once initial lawsuits are filed, court-ordered release of the manufacturers’ documents about the drug and its testing.

Many allegedly dangerous medications become the subject of multiple lawsuits, each of which is backed by evidence of the harm done and the manufacturer’s liability. In fact, large drug manufacturers who face multiple suits will set aside millions of dollars to cover potential legal costs. When enough lawsuits have been filed against a manufacturer and its product, the courts will typically combine similar claims to make them easier to handle.

The Types of Lawsuits Available

  • Class Action lawsuits, which combine claims with similar allegations against a defendant. The court that creates a class action lawsuit will appoint one or more plaintiffs to represent the class and allow others to sign on as members of the class.
  • Multidistrict Litigation (MDL), which combines cases from a shared geographic region that have common legal issues for handling of pre-trial matters. The Judicial Panel on Multidistrict Litigation creates MDLs so the cases can be heard by a single court. The cases are still tried separately.

How a Kentucky Dangerous Drugs Attorney Might Help

There are pros and cons of either route, depending on the facts in your case. Our Kentucky dangerous drug lawyers at Becker Law Office can discuss with you the specifics of your drug injury and your legal options for pursuing compensation.

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