Serving Maryland, DC, & Virginia EnSe Habla Español (888) 607-8690
Start your free consultation

Dangerous Drug Lawyer

If you are sick or need medication to control an existing condition, your natural instinct is to trust your doctor and the medication they are prescribing you. Sometimes, however, that medication causes severe adverse reactions, sometimes leading to death. When that happens, you are certainly looking for answers. Our experienced dangerous drug attorneys here at Malloy Law Offices are skilled with litigating against insurance companies, healthcare facilities, and medical professionals to obtain justice for our clients. If you have suffered as the result of being prescribed a dangerous drug, call our office today at (888) 291-6445 for representation.

 

Why You Need a Dangerous Drug Lawyer

If you have suffered serious health consequences from a dangerous drug prescribed to you, whether recalled or still on the market, it is imperative that you engage the services of an experienced lawyer who has experience in these very complex cases. The pharmaceutical industry or “big pharma” has almost unlimited funds to fight back against even the most egregious cases. It is necessary that any victim is represented by an attorney that is ready to take on these corporate defense lawyers with confidence and skill. At Malloy Law Offices, LLC, our team of trial lawyers have the experience, knowledge, and resources to bring a case against a drug manufacturer and achieve success.

Why Choose a Dangerous Drug Attorney at Malloy Law Offices, LLC

At Malloy Law Offices, LLC our litigation team has extensive experience in bringing lawsuits against drug manufacturers, holding them accountable for the damage they have caused innocent people. Our firm offers personalized, individual service, and offers representation in English, Spanish, and Russian. You must have highly-professional counsel to address a case involving dangerous drugs, and at our firm, we provide the following:

  • All dangerous drug cases are taken on a contingency fee basis – no fees unless we win for you.
  • Our personal injury lawyers have 15 years of experience litigating tough cases and are well-versed in the processes involved in filing a dangerous drug lawsuit.
  • If a drug has caused you to suffer medical problems, complications, or led to the death of a family member, we believe you deserve the maximum in compensation, and we will fight for it.
  • You can expect personalized service, and to be consistently informed about the progress of your case.

How Drugs are Regulated

When a pharmaceutical company is developing a new drug, they must go through a rigorous testing and approval process set by the Food and Drug Administration (FDA). Manufacturers must also submit the results of their own safety testing. When they are first beginning the human testing process, an Investigational New Drug Application must be submitted to the FDA. This report contains all data from their animal testing, laboratory testing, toxicity data, information regarding manufacturing, study protocols, any data from previous human research, and investigator information.

The FDA then assembles a review team made up of a pharmacologist, project manager, medical officer, statistician, microbiologist, and chemist. Each team member will review their portion of the new drug, and within thirty days review the original IND submission. If they give their approval, the drug will move onto clinical trials.

If all research is positive, the pharmaceutical company can then file something called a New Drug Application (NDA), which is an application to market the drug. The NDA must include information regarding safety updates, labeling, information regarding drug abuse, patent information, data from an international study that had been conducted, compliance information from an institutional review board, and directions for use. If the NDA is complete, the FDA review team has six to ten months to make a decision on whether or not to approve the drug. If it is approved, all individual reports that have been made by the review team get assembled into one action package, which now serves as the record for FDA review.

Black Box Warning

A black box warning is the warning put on drug packaging that describes all serious and potentially fatal adverse effects the drug may cause. The FDA may order a pharmaceutical company to include these warnings on their packaging if the potential effects are serious enough. This warning also helps those who may consume the medication to determine whether the benefits outweigh the risks. Prescribers may also use this black box warning to determine whether that is the correct drug to prescribe a patient based on warnings, potential risks, and anything the patient consumes that may interact with the drug or serve as a catalyst for adverse side effects, including previous medical history and conditions a patient may be pre-inclined to having developed.

Difference between Market Withdrawal and Drug Recall

When a manufacturer decides to withdraw from the market, there may be several reasons. They may have discovered minor violations that do not require legal action from the FDA, or from a business perspective, lack of sales may be driving product revenue down. Instead of recalling the product, they will simply cease production or distribution, which gradually removes it from the market as supply dwindles.

A drug recall, on the other hand, is a much more serious matter that can either take place as the result of the manufacturing company FDA making the decision. Certain criteria have been met to necessitate partially or completely removing the drug from the market, including contamination, mislabeling, misbranding, and under-warning of adverse side effects, as well as others.

Recall Classifications

When a drug is recalled either by the FDA or the manufacturer themselves, there are three levels of classifications it can fall under. The most severe type is called a Class I recall. Class I recalls indicate that either having exposure to or using the drug will cause adverse reactions or potentially even death. Class II recalls are less severe, in that the adverse side effects of consuming the drug are usually temporary or reversible. Class III recalls are the least severe. Typically, adverse side effects are unlikely to occur with drug usage, but may potentially do so.

Recall Process

The recall process begins with identifying the problem with the drug. If the FDA decides after a review that a drug needs to be recalled, it can be one of two ways, mandatory or voluntary. If the manufacturer is recalling their own product, then they must submit all information to the FDA, including relevant drug information, a minimum of two drug samples (fully packaged), and a description of the problem, its discovery, and the reason why the problem occurred. The FDA will then conduct a Health Hazard Assessment to determine the level of recall classification. Once the recall has been completed, the drugs will either be repackaged with the appropriate label warnings and branding, or they will be destroyed in a controlled environment.

 

A Common Dangerous Drug

Some of the most commonly known dangerous drugs are ones that are prescribed by medical professionals every day. They are used to treat a number of different conditions, from type 2 diabetes to depression. Below is an abbreviated list of the drugs, their manufacturers, and any adverse effects or even recalls they have been part of.

  • Risperdal: Risperdal is an antipsychotic drug manufactured by Johnson and Johnson. It is used to treat conditions such as psychosis, bipolar disorder, and schizophrenia, but unfortunately has very serious side effects. Due to misbranding for unapproved uses, as well as downplaying risks and paying kickbacks to doctors and Omnicare, Johnson and Johnson agreed to pay over $2.2 billion to resolve criminal and civil investigations against the company in 2013. This is one of the largest penalties ever brought against a company for healthcare fraud.
  • Pradaxa: Pradaxa is an anticoagulant, or blood thinner, that is manufactured by Boehringer Ingelheim for conditions such as atrial fibrillation. Its competitors are Coumadin and warfarin, both anti-coagulants that require strict monitoring and diet modifications. Unlike either, Pradaxa allows for much more freedom in diet and does not require weekly blood tests. However, it is also the drug most commonly linked to complications and deaths through serious bleeding.
  • Invokana: Invokana is manufactured by Janssen Pharmaceuticals, a division of Johnson and Johnson, and has been used to treat type 2 diabetes. Unfortunately, it has also been shown to cause diabetic ketoacidosis in patients with type 1 diabetes as well as those who have type 2, which is a life-threatening condition that increases the acidity of the blood.
  • Lipitor: Lipitor is a medication commonly prescribed for monitoring cholesterol levels. Manufactured by Pfizer, its adverse effects include, shockingly enough, type 2 diabetes, liver damage, and memory loss. Lawsuits against Lipitor include failure to warn about dangers and label warnings lacking information regarding the risks for type 2 diabetes.
  • Xarelto: this is another anti-coagulant, manufactured by Johnson and Johnson and co-marketed by Bayer, also meant to replace warfarin and Coumadin. Like Pradaxa, there is less restriction when a patient uses Xarelto. Problems arose when patients taking it began experiencing internal bleeding. Unlike warfarin and Coumadin, Xarelto has no antidote. This means that if someone is experiencing internal bleeding and they are using Xarelto, there is a much higher chance that bleeding will be uncontrollable and they could die.
  • Talcum Powder: although talcum powder is not a traditional drug like the others listed above, it has gained heavy media attention through the ongoing lawsuits with one of its manufacturers, Johnson and Johnson, over alleged cases of ovarian cancer. Women who have used talcum powder consistently over years in their undergarments or around their genitals may be at a higher risk for developing ovarian cancer, as the talc particles may travel up into the ovaries. However, data is unclear as to whether talcum powder definitively causes ovarian cancer, though there is some suggestion of a possible increased risk.

Recent Drug Recalls: Blood Pressure Meds

Recently the FDA has recalled several medications, or the manufacturer has taken it off the market due to cancer-causing contaminants. The blood pressure medications recalled include:

  • Valsartan
  • Losartan
  • Irbesartan

These drugs are produced in different combinations and under different brand names. A widespread problem regarding drug contamination was at the root of the almost 75 blood pressure drugs recalled. The industrial contaminants in the medications have been linked to cancer, along with liver and blood cell damage. These recalls were so extensive that they became newsworthy but are just a few of the drugs recalled in recent years.

Why Drugs are Recalled

Medications are tested prior to being allowed on the market. Unfortunately, the testing may continue for a few years, but the long-term effects are not evaluated. Some drugs are recalled after being on the market, prescribed by doctors across America, and only later discovered to have serious or deadly side effects. Recalled drugs generally fall into one of several categories:

  • Faulty manufacturing processes
  • Contaminated medications
  • Faulty labeling
  • Failure to adequately warn

Legal Representation for Dangerous Drug Cases

At Malloy Law Offices, LLC, our goal is to seek justice for people who suffered health consequences, illnesses, or developed a life-threatening condition after being prescribed or administered a medication with serious side effects. Our team of litigators will evaluate your case to determine whether your situation warrants legal action being taken against the drug manufacturer, prescribing doctor, pharmacy, or other entity.

Who is Liable?

Drug manufacturers have the responsibility to ensure their products are safe for consumers. Testing for side effects must be performed prior to FDA approval. With seven in ten people taking at least one prescription drug, more than half taking two drugs, and twenty percent of people in America on five or more medications, a dangerous drug may impact thousands of people or more. While medications can be life-saving and help maintain health for those suffering from certain conditions, when a drug has unknown side effects that are discovered long after it has been released on the market, legal action is necessary to hold the manufacturer accountable. Drug manufacturers can be held liable for the harm they cause. If a physician prescribes a medication “off-label,” or beyond the scope of what it is currently approved to treat, leading to harm, the physician, clinic, or hospital may be named in a lawsuit to seek to recover damages.

Contact an Experienced Dangerous Drugs Attorney

If you or a loved one was prescribed a medication that then led to severe adverse effects, or even death, contact a highly skilled dangerous drugs lawyer  as soon as possible. They will go over all medical records and product information to determine whether the manufacturer misbranded, mislabeled, or under-reported risks, and fight to get you the compensation you deserve. Contact Malloy Law Offices today for your free consultation regarding your case.