Dangerous drugs and devices include, but are not limited to, those that cause injuries due to either or some combination of a: manufacturing defect, design defect, or a defect in their marketing (“failure to warn”).  If you have suffered an injury, that is – you have either taken a dangerous drug or used a dangerous medical device and experienced serious medical issues or physical harm, then you may be able to file a lawsuit to recover damages for medical expenses, pain and suffering and possibly more. Additionally, if you have lost a family member or loved one due to death or disability because of a dangerous drug or device, you may be able to file a lawsuit as well.

Legal actions that allege harm from dangerous drugs and medical devices are typically called “product liability lawsuits”.  Product liability lawsuits refer to the ability of the law to hold manufacturers or sellers liable for putting defective drugs and devices into the hands of patients and medical professionals.  In essence, this is where the law works to ensure that products meet the ordinary expectations of the consumer.  

Product liability lawsuits fall into three categories:

Manufacturing Defect
A product defect that occurs in the manufacturing process and which causes the product not to meet specifications set by the manufacturer itself.  Manufacturing defect claims usually involve a single product unit or device (as opposed to an entire product line).  Manufacturers are usually held to the standard of “strict liability” for these types of defects.

Design Defect
A design defect is a mistake in a product’s intended design that causes injuries to a consumer; and which could have been prevented by an alternate design.  Unlike manufacturing defects, design defects address multiple product units across an entire line or family of products.

Marketing Defect (“Failure-to-Warn”)
Marketing or “Failure-to-Warn” defects are the result of when a drug or device manufacturer fails to provide appropriate information about a product’s known hazards and how to avoid them.  If these hazards pose an undue risk of harm to consumers, the manufacturers can be held liable for that harm.

Most, if not all, medications have some sort of potential side effects.  Sometimes side effects are less severe: insomnia; dry mouth; or drowsiness, for example.  Other times, side effects can be serious and life-threatening.  Either way, you – the consumer is entitled to know, in advance what the potential risks of taking any medication or using any medical device are.  With that knowledge, consumers can make a judgment as to whether the risks of these side effects balance out the benefits they offer.  However, if a drug or device manufacturer is aware of a side effect or defect and chooses not to disclose that side effect while the consumer is using that drug or device, the manufacturer could potentially be held liable for not sharing that information with the consumer beforehand.

If you:

• Personally, have been injured by a dangerous drug or Medicaid device; or
• Are the legal guardian of someone injured by a dangerous drug or medical device; or
• You are the representative of the estate of someone who has died from a dangerous drug or medical device;

You potentially have the “standing” to bring a lawsuit for damages if that lawsuit alleges one of the three product liability claims discussed above.

Patients, consumers and other parties who have suffered harmful side effects or other injuries from dangerous drugs and devices, and can prove they are consumers of these products, may be able to sue the drug or device manufacturer under theories which allege either manufacturing defects, design defects or marketing defects. This is true for both non-generic prescription and over-the-counter dangerous drugs which have been approved by the FDA.

There are limits on the timeframe for when injured parties can file a lawsuit alleging product liability and they vary by state.  Known as “Statutes of Limitation” or “Statutes of Repose”, they require injured parties to file claims within a specified period of time either after they have been injured or the injury is discovered or when they should have known about or discovered their injury.  

The time limits for filing a lawsuit can be as narrow as two years in some states to as broad as four years or more in others.  It is important to know what the statute of limitations or repose is in your state before filing a lawsuit.  If an injured party does not file a lawsuit before the statute expires, the Court can throw out the case despite how meritorious the claims are within.

Click here for an up-to-date list of Statutes of Limitation and Repose by state.

Generally speaking, the legal system and courts of the United States do not bar non-attorneys from representing themselves in lawsuits. With that in mind, lawsuits concerning serious injuries and in particular, products liability lawsuits, involve complex procedural rules, briefings, motions, arguments, and rules concerning the collection and introduction of evidence. Additionally, it helps to have a skilled negotiator with you during encounters with opposing counsel for the manufacturer. And you can be assured – they will have a team of highly compensated professionals on their side. Therefore, it is generally always a good idea to hire an experienced legal professional to handle your case and advise you about your options.

The selection of a lawyer to represent your interests is a profoundly personal choice and one which should be guided principally by your level of comfort and trust in his or her abilities to effectively pursue your case and achieve a favorable outcome. With that in mind, you should, at a minimum, hire counsel with experience in product liability and who has experience litigating these types of cases before the court. Furthermore, most attorneys in the field of product liability law will always offer a free initial consultation to any potential client with whom they are meeting to discuss a case.

In the field of products liability, attorneys will almost exclusively handle cases on a “contingency” fee basis. This means that you will not be expected to pay an up-front retainer, hourly legal fees, or the expenses associated with litigation. The attorney’s fees and expenses are paid as a percentage of your recovery (typically 30-40% depending upon the state where the attorney is licensed and the amount recovered) either as a result of litigation or settlement between the parties. In some cases where your lawsuit is part of a larger “class action” or “multi-district litigation”, the Court will set the rate of contingent fees.

Generally speaking, if you lose your case and you have a contingency fee agreement with your lawyer, you will not be on the hook for any additional expenses or the other party’s attorneys fees. However, there are unique rules concerning these provisions in each state. Be sure to ask your attorney about them before signing an agreement for representation.

The level and types of damages that a consumer who has suffered harmful side effects can seek vary largely by the factual circumstances of each case. You will want to talk about these facts in great detail with your attorney. Bearing that in mind, sufferers may be entitled to: compensatory/economic damages; non-economic damages; and possibly punitive damages.  

These are more commonly framed as:

• Medical Costs
• Lost Wages
• Non-Medical Expenses
• Pain and Suffering

Punitive damages are those which are awarded by the Court for harm suffered as the result of intentional (i.e. more than negligent) conduct on the part of a drug or device manufacturer.  They are intended to “punish” the malfeasance of the manufacturer inasmuch as they compensate the victim.

At the core of every products liability and dangerous drug/device case, the party seeking compensation for harm must, at a minimum, prove:

• That they have suffered injury or harm;
• That the drug or device is defective by virtue of a:
  • Manufacturing Defect
  • Design Defect
  • Failure-to-Warn (Marketing Defect)
• That the defect caused the injury or harm suffered;
• That you were using the product as it was intended.

These are all questions that turn on the facts of your particular case and which must be discussed in detail with your attorney when evaluating the potential for a lawsuit.

For the most part, individual lawsuits for harm from dangerous drugs and devices tend to settle before they ever reach a courtroom.  However, if your case does go to trial, you will likely be expected to testify in order to advance your case. Again, there are a great many other facts and circumstances to consider before your case ever reaches the courtroom. You should take the opportunity at the outset to discuss the possibility of your being called to testify with your attorney against the backdrop of the specific facts involved in your case.

There is no hard and fast rule as to how quickly your case will be resolved, and no guarantee whatsoever that it will be resolved in your favor.  Whether your case is filed as an individual lawsuit, class action, or MDL, depending upon when it is filed and the factual circumstances of your case, it could take weeks or even years before a harmed party receives payment. 

Typically lawsuits conclude in either one of two ways:

• Judgment: The harmed party and the manufacturer present their cases in court, either before a judge or a jury and a verdict is reached.  If the verdict is in favor of the harmed party, then the judge or the jury will set a damage award.  The losing party may still yet appeal the case or the damage award, which could further prolong the time any amounts are paid to the harmed party.
• Settlement: The parties to a lawsuit may meet prior to heading into the courtroom and reach an agreement on an amount to be paid to the harmed party instead of going through the rigors of either a bench or jury trial.  The timeframe for payment of the settlement amount will depend upon the agreement of the parties, as well as the rules of the court where the lawsuit was filed.