Can I File a Lawsuit?

To file a lawsuit over a defective drug or medical device, you have to have suffered an injury from it. This usually involves the product causing a serious medical complication or physical injury. It may mean you had to be hospitalized or have surgery because of the product. You may also have a case if the drug or device caused a family member’s death or disability.

How do I Prove My Case?

To win a drug or device lawsuit, you will have to prove three things: that you were injured, that the drug or device was defective in some way or lacked specific warnings and, finally, you have to prove the defect or lack of warnings led directly to your injury.

What Are Product Liability Lawsuits?

Product liability refers to the legal liability a manufacturer or seller faces if it produces or sells a faulty product. People harmed by those products can sue for the damages they cause.

There are three types of product liability claims when it comes to drugs or devices. A lawsuit may be possible if any one of these, or a combination, contributed to your injury:

  • Defectively Manufactured

    These are drugs or devices that were somehow tainted or faulty because of the manufacturing process. This may include contamination, components that don’t fit properly or errors in labeling.

  • Dangerous Side Effects or Complications

    These can include drugs that have been on the market for a long time before the side effect was discovered. The manufacturer sometimes may have known or should have known there was a risk of the side effect but never warned doctors or patients.

  • Improper Marketing

    This includes all the warnings, instructions and uses manufacturers provide on a
    particular drug or device. Sometimes, the warnings are insufficient or the product
    may be marketed for some use other than what the FDA has approved it.

Can I File a Lawsuit over a Drug’s Side Effects?

Many drugs have serious side effects, but they usually carry warnings on their labels or package inserts explaining what those are. If your doctor explained those dangers to you and you decide the benefits of the drug outweigh the risk, you may not be able to sue.

However, in many cases, drug makers may leave dangerous side effects off the label. In those cases, you are more likely to be able to file a successful lawsuit if that warning could have prevented your injury. Sometimes, drug makers will add warnings to their drug labels. But if you were using the drug before the warning was added, you may have a stronger argument if you suffer an injury related to the warning.

Who Would I Sue?

You may sue multiple companies involved in the delivery chain of the drug or device that caused your injury. This can include the company that developed the drug or device, the factory that manufactured it and the company that distributed it.

Can I Sue Even if the FDA Approved a Drug?

Even if their product gains approval from the U.S. Food and Drug Administration (FDA), drug manufacturers still face restrictions on how they can promote their products and what specific warnings they have to provide to patients who use them.

The U.S. Supreme Court ruled in 2009 that FDA approval is merely the minimum standard to bring a new drug to market. Under the ruling, companies are still responsible for deciding if additional warnings or other measures are needed to protect patients who use their products. If the company fails to provide those safeguards and you are injured, you may be able to sue.

Are there Time Limits?

There is a time limit to file lawsuit, and different states have different laws determining when the time limit begins and ends. For instance, it may begin when the injury actually happened, or it may start running when you first became aware of the injury, such as a diagnosis. A lawyer can help you understand if you have missed the deadline to file.

It is important to file a lawsuit as soon as possible. Waiting until the last few months or weeks can lead to unforeseen complications that may prevent your lawsuit from meeting the deadline.

The time limit to file is called the “statute of limitations” and it varies from state to state.

Time Limits for Filing Lawsuits

(Statute of Limitations by State)

Time Limit States
1 Year Kentucky, Louisiana, Tennessee
2 Years Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Minnesota, Nevada, New Jersey, North Dakota (for wrongful death), Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, West Virginia
3 Years Arkansas, District of Columbia, Maryland, Massachusetts, Michigan, Mississippi, Montana, New Hampshire, New Mexico, New York, North Carolina, Rhode Island, South Carolina, South Dakota, Vermont, Washington, Wisconsin
4 Years Florida, Nebraska, Utah, Wyoming
5 Years Missouri
6 Years Maine, North Dakota (6 years for personal injury, 2 years for wrongful death)

What if a Family Member Died?

As a spouse or immediate family member, you may be able to file a wrongful death lawsuit. Survivors may be able to seek compensation for lost wages of the family member you lost, loss of companionship and medical and funeral expenses. You have a time limit to file a wrongful death suit, so it is important to speak with an attorney as soon as possible.

What are Class Action Lawsuits and MDLs?

Drug and medical device lawsuits can be complicated, involving thousands of documents and requiring expert witnesses. Because the costs are so high, lawyers in these cases are likely to take on class action lawsuits or try to consolidate several plaintiffs’ cases into one proceeding such as a multidistrict litigation (MDL)

  • Class Action

    A class action is a single lawsuit filed by people who all have experienced similar injuries because of the same product. Several plaintiffs have to come together, usually through their attorney, who files a single lawsuit.

  • Multidistrict Litigation (MDL)

    An MDL combines several — sometimes thousands — of individual lawsuits that have been filed in different courts. Lawyers may file requests with the federal Judicial Panel on Multidistrict Litigation (JPML) to combine their clients’ various lawsuits into a single action in federal court. Some state courts may also consolidate lawsuits in a similar fashion, combining similar lawsuits filed in that particular state.

    Lawyers who specialize in defective drug and device cases have increasingly pursued MDLs in recent years due to the complexity of the cases involved. MDLs can dramatically reduce the time and expense involved in the legal process.

Do I need a Lawyer to Handle My Lawsuit?

Unless your injuries were minor, you will need an attorney. Lawsuits over defective drugs and medical devices involve complex issues requiring the review of thousands — even hundreds of thousands — of pages of documents. They also require expert witnesses and facts that involve detailed understanding of fields such as chemistry, biology, medicine, manufacturing or other issues. A lawyer specializing in drug and device lawsuits is better equipped to bring together the resources to argue your lawsuit.

Minor injuries may be handled in small claims courts. These courts usually do not require a lawyer and limit awards to $2,000 to $7,000 in most states, though some states have top limits of $15,000.

How Do I Find a Lawyer?

Finding a lawyer who specializes in drug and medical device lawsuits can be an advantage. The size of a law firm may also play a part. Pharmaceutical companies and device manufacturers frequently budget millions of dollars to fight lawsuits involving their products.

You can start your search for an attorney by asking friends or family members for recommendations. But remember that your case may not match up with the experience or specialty of the lawyers they recommend.

Advertisements may have raised your awareness of a particular attorney or law firm. These ads can sometimes give you a starting point, but it is again important to make sure that lawyer or firm has experience in your type of case.

Legal referral services can direct you to a lawyer to weigh your situation and recommend an attorney who would be well suited for your case. Local and state bar associations can also help with referrals.

How Much Does It Cost to Hire a Lawyer?

Virtually all lawyers who specialize in drug and medical device lawsuits offer free consultations. This allows attorneys to determine if you have a case and what your best legal options are.

Most lawyers who handle drug and device lawsuits work on a contingency basis. That means you pay them nothing unless you win your case. If you win or settle your lawsuit, the attorney is paid a percentage of your final verdict or settlement.

If yours is an individual lawsuit, the amount is usually 33 to 40 percent of the settlement or verdict. A lawyer’s rates depend on several factors including the complexity of the case, how long it may take and the money expected if there’s a judgement or settlement in your favor. Your attorney will negotiate the percentage before taking your case.

If your case is part of a class action lawsuit or MDL, your lawyer also works on a contingency basis. The attorney fees are a percentage of the overall settlement or judgement and are set by the court.

How Much Will I Have to Pay if I Lose?

In most cases, you won’t have to pay anything if you lose.
Generally, each side has to pay its own attorney’s fees whether they win or lose.

There are other costs that the losing party has to pay in some states. Usually, if you have a contingent fee agreement with your lawyer, you will not be responsible for those costs. You should ask your lawyer about the circumstances in your particular case.

What Should I Expect When I Meet with a Lawyer?

Be on time and bring any documents relevant to your case. Be prepared to ask questions and take notes, but let the attorney guide your conversation. He or she will want to know specifics that are important to the case. Explain your situation and be honest.

You should discuss fee structure and decide if he or she is someone you can get along with. Drug and medical device cases can take years, so it is important you hire an attorney you will be comfortable with for the long haul.

There are several outcomes for a consultation. The lawyer may decline to take your case, or you may decide you would prefer another attorney. The attorney may refer you to another firm better suited to your particular case. Or the lawyer may ask you to sign an agreement to represent you. You should always read over any contract.

What Questions Should I Ask an Attorney?

It is a good idea to write down any questions you have before your initial meeting. This way, you won’t forget to ask something. Typical questions to ask can include:

  • How long will the lawsuit take?
  • How do you calculate your fees?
  • How often will I receive updates in my case?
  • How much input will I have in decisions about the case?
  • Will I be able to speak to you anytime I want?
  • Will I be working with you personally or will I be assigned to another person at the firm?
  • How long have you practiced law?
  • How much trial experience do you have?
  • What experience do you have with these types of cases?
  • Can I see a list of your past settlements and verdicts?
  • How much time will you devote to my case?
  • Why should I choose you instead of another law firm?

What does a Lawyer Need from a Client?

Bring copies of any documents you have that pertain to your case. You will want to keep copies for your own records as well. Things the lawyer will need may include:

  • Doctor or hospital bills
  • Receipts for prescription or over-the-counter medication — this includes any drug that may have caused your injury, but also medicines you had to take as a result of the injury
  • Proof of lost wages — this may include pay stubs, bank records, business receipts or account books if you own your own business or other documents. Logs of missed work days, doctor visits and other relevant dates if possible.
  • Records of your medical treatment, hospital stays, doctor visits, pain levels and time missed from work
  • Any photos or video documenting your injury

How Will My Lawyer Work With Me?

Your lawyer will provide you with legal advice and should follow the basic decisions you make for your case. You can ask your lawyer to send you copies of all court documents that may be relevant to your case. Your attorney also must let you know about any settlement offers.

You will need to understand that your lawyer has other clients and cannot devote all of his or her time exclusively to your case. Provide your lawyer with any documents or other information your attorney requests from you. Be on time for all appointments and always return any phone call or email as quickly as possible. Listen carefully to anything your attorney discusses about your case and be sure to tell your lawyer if there is anything you don’t understand.

How Long Will a Lawsuit Take?

Lawsuits involving drugs and medical devices involve complicated issues and can take years to work their way through the courts. Negotiating a settlement can substantially reduce the time it takes to resolve your lawsuit, and some defendants are more willing than others to settle quickly. Even so, the settlement process can still be lengthy. You should ask your attorney about the specifics of your particular case and plan your finances accordingly.

What Do I Have to Prove to Win?

In most cases, to win a lawsuit over a defective drug or medical device, you will have to prove:

  • That you suffered an injury
  • That the drug or device was defective and/or lacked proper warnings or instructions
  • That the defect or the lack of warnings or instructions directly caused your injury
  • That you were following the directions provided and using the drug or device properly when the injury happened

In filing your lawsuit, you may claim things such as negligence, breach of warranty or strict liability. These are legal principles that provide grounds for a right to compensation for your injuries because of the defendant’s actions.

  • Negligence

    You have to prove the defendants failed to exercise a reasonable degree of care in designing, manufacturing and marketing the drug or device and that led directly to your injury.

  • Breach of Warranty

    You have to prove the defendant made and sold the drug or device with the promise that it would work in a certain way. You also have to show that the product did not perform as promised and that failure caused your injury.

  • Strict Liability

    You must prove the drug or device had a defect in its design, manufacturing or marketing that made it “unreasonably dangerous.” You then have to prove this particular defect was the cause of your injury.

What Is a Deposition?

Frequently, a lawsuit can be settled before a case moves through of the legal process. But if it isn’t settled early, you may have to give a deposition. Depositions are oral statements made under oath and can be one of the most important things you do in your lawsuit.

Your lawyer will accompany you and an attorney for the defendant will ask questions about your case. You will have to answer questions about your medical records and history, about your injuries and other issues involving your case.

The statements you give can be used at trial or to discover more information about your case that the defendant can examine before trial.

Do I Have to Testify in Court?

Most lawsuits are settled before ever reaching trial, but if your case goes to court, you will have to testify. Your testimony can be crucial to winning or losing your lawsuit.

Your lawyer will question you first, and then the defendants’ attorney will question you. This process can last for hours, or even days depending on the complexity of your case.

How Much Money Will I Get from a Drug or Device Lawsuit?

No one can guarantee your lawsuit will be successful. And if you reach a settlement or win a judgement, the amount of compensation can vary widely. Compensation is the money you may be paid in a settlement or from a jury verdict.

Several factors will determine how much compensation you may be able to receive. These include the total financial loss you’ve suffered — such as medical expenses and lost wages — along with how extensive your injuries are and how it has affected your day-to-day life and relationships.

The amount and quality of evidence and the degree of negligence or liability on the part of the defendant can also affect the amount of compensation you may be able to receive in a verdict or settlement.

What Kind of Compensation Can I Seek?

Compensation can include medical bills and wages you lost because of your injury. Depending on your circumstances, compensation may also cover pain and suffering, mental distress, loss of consortium or other injuries that occurred because of your injury. Jury verdicts may sometimes also include punitive damages.

Will It Pay for My Medical Bills?

If complications from a defective drug land you in the hospital, or you require surgery to replace a defective medical device, health care providers expect payment. Insurance companies may pay the initial cost, but they may be entitled to be paid back if you win your lawsuit or reach a settlement. If you have no insurance, you may have to work out a payment plan with the health care provider.

If you reach a settlement or win a verdict in a lawsuit against a drug or device manufacturer, your lawyer will arrange payment for these outstanding bills — referred to as medical liens.

In some cases, such as the DePuy ASR Hip settlement, the defendant may agree to pay these medical liens in addition to payments directly for your injuries.

Will It Pay for Wages I Lost Because of My Injury?

Injuries from defective drugs or medical devices can prevent you from working, costing you wages or profits. If the injury ended your ability to work prematurely, you can also seek loss of future earnings.

What Is Pain and Suffering and Loss of Consortium?

Pain and suffering is the actual physical pain and emotional distress caused by an injury. Medical device failures, for instance, can cause intense, debilitating physical pain if they fail inside the body. Emotional distress, sometimes called “mental anguish,” can take the form of depression, anxiety or other mental health conditions.

The spouse or family members of someone injured or killed by defective drug or medical device can claim loss of consortium. This refers to the loss of benefits in a family relationship. It varies from state to state but may cover only spousal relationships in some states while others extend it to the loss of love and affection between parents and their children.

What are Punitive Damages?

Medical bills, lost wages, pain and suffering and other claims are considered “compensatory damages” because they compensate a person for his or her actual loss. Punitive damages go beyond compensation to punish the wrongdoer.

Even if you have been harmed by a defective drug or medical device, you may not be able to receive punitive damages. These are only awarded if a judge or jury determines the defendant — a drug or device manufacturer — behaved in a truly outrageous manner. Courts calculate punitive damages based on the defendant’s misconduct compared to its wealth.

In some cases, punitive damages can be quite high. In April 2014, a Louisiana
jury levied $9 billion in punitive damages against the maker and distributor of diabetes drug Actos. A jury found Takeda Pharmaceuticals and Eli Lilly and Co. did not do enough to warn people of the risk of bladder cancer from taking the drug. A judge later reduced the punitive damages to $38.6 million.

When Will I Get My Money?

Depending on whether you agree to a settlement or win at trial, you must still wait weeks or years to be paid.

Judgement at Trial

If your lawsuit goes to trial and you win a verdict, the defendant will likely appeal. It may be a year or two before the case reaches the appellate court. This court can either decide in your favor, reverse the earlier decision — meaning you have lost your verdict — or send the case back to a lower court to do the whole trial over. Even if you win, and there is a third level of appeals, you may have to wait another year or two if the defendant decides to appeal again.

Settlement

If you reach a settlement, the attorneys on both sides will report to the court they’ve reached an agreement. You may be able to receive your payment in 30 to 60 days depending on the court. But the process involves several steps.

You will have to sign a release worked out between your lawyer and the defendants. You should read it carefully and ask your lawyer about anything you don’t understand.

Before your lawyer turns over any money to you, he or she is first required to use the settlement money to pay off any liens against the lawsuit. These may include medical liens and government liens.

Medical liens are legal rights your health care providers or others may have due to your medical bills or other expenses you owe them.

Government liens include any money owed to Medicare, Medicaid or for child support.

Will I have to Pay Taxes on Money I Receive in a Lawsuit?

You do not have to pay taxes on any compensation you receive for what the Internal Revenue Service (IRS) calls “observable bodily harm.” This includes any physical injury or sickness. It also includes emotional distress that resulted directly from the injury or illness. Compensation for your medical expenses as a result of the injury is also tax-free.

You will have to pay income taxes on any punitive damages you receive.

If your attorney is working on a contingency basis, the IRS considers his or her fees as part of your income since payment comes from the settlement. If your judgement or settlement was solely for a physical injury, this should be no problem. But if punitive damages are involved, you should speak to a tax accountant or other financial advisor about your options.

Should I Take a Settlement or Go to Trial?

This is a decision you will have to make for yourself, but you should carefully weigh your lawyer’s advice and expertise.

A settlement is where you and your lawyer negotiate a payment from the defendant you are suing. Costs skyrocket once a lawsuit actually goes to trial, so there is often an incentive for defendants to settle a case.
There is also no guarantee you will win if you go to trial. If you settle, you may not get as much as you were seeking, but you will be assured of walking away from your lawsuit with some relief. But if the defendant is not willing to agree to what is fair, your lawyer may advise you to take your case to trial.

Going to trial means not only the risk of losing, but the process can drag on for a long time. There’s the potential for appeals stretching your case out for years. There’s also the risk of losing on appeal or having to start over.

Most lawsuits — some estimates put it between 80 and 92 percent involving a personal injury — are settled out of court.

Author

Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.


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