If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21^st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?

21^st Century Cures Act: The Good

The 21^st Century Cures Act has the potential to save lives. For instance, it will provide funding for cancer research, fight painkiller drug abuse, advance Alzheimer’s research and improve mental health treatments.

Specifically, the new law provides $4.8 billion in funding for the National Institutes of Health, $1.6 billion for brain disease research and $1 billion in grants to help states tackle opioid abuse.

Another touted benefit of this new law are provisions requiring the Food and Drug Administration (FDA) to speed up the approval process for medical treatments so patients can get them sooner.

21^st Century Cures Act: The Bad

The biggest potential problem with the 21^st Century Cures Act is that new medical treatments might receive FDA approval on an expedited schedule. While this sounds great in theory, patients should be extremely wary because drugs and medical devices available for treatment may not have been thoroughly tested for safety and effectiveness. To explain why this may be the case, let’s give a brief background of the FDA and how clinical trials work.

The FDA and Clinical Trials

Before the FDA, companies could sell products with almost any claim they wanted, without having to prove their product actually worked or was safe. Today, one of the FDA’s jobs is to ensure that medical treatments work as claimed and do so in a safe manner. In order to do this, clinical trials are necessary.

Clinical trials usually exist in three phases, with the first phase involving a small number of test subjects to figure out dosing and make sure there aren’t any really bad side effects.

Phase two includes more test subjects and the medical treatment is actually tested to see if it works. Assuming it works with manageable complications, the clinical trial advances to phase three.

Phase three includes an even larger number of test subjects, usually numbering in the thousands. At this stage, the medical treatment is further tested to make sure it works, especially in comparison to similar treatments already available on the market. Most importantly, phase three trials look for complications and side effects.

Occasionally a fourth phase will be run to examine a medical treatment’s long-term effects and see if the medical treatment can be used in high-risk patients, such as children.

Phases two and three are the most important because they ensure the effectiveness and safety of a medical treatment. Because of their importance, special testing procedures must be followed for a multitude of reasons, including looking out for the placebo effect.

The placebo effect refers to the phenomenon where a patient will believe a treatment they are receiving is making them better, even though they are receiving no real treatment at all. An example of the placebo effect is when someone takes a sugar pill, but still believes the pill is doing more than just giving them a dose of sugar.

Monitoring the placebo effect is very important for determining if a medical treatment works or not. When using a placebo, researchers can make sure test subjects who feel better are feeling better because the treatment actually works, not because they think it works.

The 21^st Century Cures Act is designed to bypass some of these special testing procedures and clinical trial phases. The legislation directs the F.D.A. to consider the “least burdensome” means of demonstrating their safety. For example, under the new rules, clinical trials don’t have to have as many test subjects. Additionally, when determining if a medical treatment works or has any side effects, the FDA can rely on “real world evidence” instead of strictly controlled clinical test results. In some instances, this “real world evidence” will basically amount to patient testimonials. This is not the scientific process necessary to make sure medical treatments work and are safe.

What Does This All Mean?

To put things simply, it means medical treatments will become available more quickly, but without proper testing. Some might think speeding up the approval process is a good thing, since all those clinical trials and studies aren’t really necessary. You would be wrong.

Ever heard of Essure? It is a contraceptive device for women that is now known to have serious complications, such as severe pelvic pain, device disintegration and puncturing of Fallopian tubes. And it turns out that it was approved by the FDA using a special fast-track review process. You can look through my site to find many flawed medical devices that were approved pursuant to the fast-track 510(k) process.

Perhaps the benefits of getting medical treatments to market faster will outweigh the reduced testing and oversight by the FDA. I hope so. But additional injuries are very possible, so patients need to be extra cautious with these new lower testing standards.

In November 2013, the first Settlement was reached between the Plaintiffs’ Committee and the Defense Team for Depuy and J&J. I have written about this Settlement and its terms here. So six years after the Original Surgery, and four years after the first onset of pain, and two years after Revision Surgery, Bill finally had the opportunity to accept the settlement offer or reject the offer and pursue a jury trial on his specific case. After much deliberation, Bill rejected the settlement offer.

Three years have now passed

. Bill’s case is not on a trial calendar. In fact, as far as I am aware no case has yet been tried of any person who rejected the settlement offers. To make matters worse, this summer Judge Katz, in charge of the MDL, passed away. A new judge had to be appointed to take his place overseeing the MDL.

Bill is at his wit’s end. He told me he merely wants his day in court. He is now nine years removed from the Original Surgery, seven years removed from the onset of symptoms, five years from Revision Surgery, and over four years from filing suit. And still no trial date in sight.

Bill is not alone. Hundreds of people in the MDL rejected the settlement. And those people are waiting too.

So how long does it take to resolve your artificial hip case?

more All Civil Litigation Takes Time

I wish I had better news, but it takes a long time. Any civil litigation takes time. There are “rocket dockets” scattered across the country that work really hard to dispose of cases in a matter of months or a year, but those courts are the exception. Even a basic breach of contract action in your state’s court can take two years or longer to resolve.

A product liability case is a particularly complex type of civil litigation. It is very difficult to prove that a product was defectively designed, or that a manufacturer failed to warn patients and their doctors of the risks involved in using a product. Often competing experts will spend many hours and many dollars fighting over these technical issues. This is one reason MDL courts were formed in the first place. Multidistrict litigation sites are designated precisely to resolve of hundreds or thousands of cases more efficiently, not less efficiently.

Multidistrict Litigation Often Takes Years to Resolve

That said, there is just no other way to say it: a case that finds its way to a multidistrict litigation court will probably take several years to resolve. So settle in. The biggest reason is this: there is simply a lot to do. Both sides need to engage in general, “shared” discovery, where the plaintiffs will depose the defense experts and fact witnesses, and the defendants will depose the plaintiffs’ expert and fact witnesses. Aside from that, often hundreds of thousands of pages of medical records, expert reports, scientific studies, and business records must be reviewed and analyzed. Dozens of pretrial motions are filed, and all must be ruled on by the MDL judge. It simply takes months and years to get through this work. Meanwhile, Bill, and thousands of people just like him, wait.

The waiting game is not limited to artificial hips, but includes all kinds of medical devices and harmful drugs. The Mentor ObTape Transvaginal Mesh MDL was formed eight years ago and is still going strong in Georgia. The Depuy Pinnacle Hip MDL was formed almost six years ago, and bellwether cases have been tried this year, with no settlement agreement in place. There are multiple IVC Filter MDLs, as well as MDLs for the drugs Risperdal, and testosterone, and Xarelto, and Viagra.

Every Case a Snowflake

Still, every single case that has ever been filed in any court is unique. The facts in each case are different. The parties involved are different, and the lineup of lawyers and judges and juries are different. Occasionally a person may find her case transferred to an MDL the week before a global settlement is reached. If she accepts the terms of the settlement, she may actually resolve her case in a few months. Other individuals may not qualify for a settlement based on the timing of their Revision Surgery, and they will be forced to resolve their cases one at a time without the benefit of a settlement structure. And other people, like Bill, will choose trial, which can take more years of waiting to calendar, to try, and to overcome the inevitable appeals.

Is all this waiting and effort worth it? I would say absolutely. If you were injured by a company’s negligence, you deserve to be compensated. Even if it takes years.

Note: The narrative above does not refer to any specific person or case.

Clients occasionally ask my advice on how best to handle the new money that has come into their lives. Frankly, this is a happy conversation. But it’s also extremely important to get the answer right. The worst thing clients can do is spend down the money quickly and have nothing left a few years down the road when they still need money.

more Find Good Advisors

The first thing you should do is select a competent tax accountant to help you maneuver through the tax consequences of newly acquired settlement funds. While funds paid as damages for personal injury are not taxable, money damages for lost wages and punitive damages are taxable. You need a smart tax accountant to help you create the best plan to protect your assets. One suggestion your accountant may give you is to make sure you contribute the full amount to your employer’s 401(k) retirement plan in the years following your receipt of personal injury funds. Contributions to an IRA may also be wise. This will allow you to protect more of your income from taxation. You may also need an estate planning lawyer to assist with distributing your assets at the time of your death. You will likely need a will (or to update an existing will), and you may also need to set up a basic trust for protection of the assets for your heirs.

Plan Plan Plan

You will also need to create a financial plan. You should ask yourself all the tough questions: Can I continue working? How long will my spouse continue working? What other sources of income do I have? Other than the injuries from the failed medical device or drug, what other health issues do I have? Does my spouse have health issues? My children? (Every single health “issue” costs money.) What is the state of my health insurance? Is my house paid for? Our cars? Am I on-track to retire at a reasonable age?

Financial advisors urge their clients to create a plan, especially when a substantial amount of “sudden” money arrives. Once you create your financial plan, revisit it after one year. And then every year after that.

Make Only Required Payments at First

Do not rush out and purchase a $60,000 Mercedes. That is really the worst thing you can do. I know that’s not a sexy answer, but it’s the truth. Instead, you should make all required or overdue payments first. If you have medical bills outstanding, you need to pay them. Your attorney must assist you in getting all medical “liens” paid, but you may have other incidental medical bills to pay. If he hasn’t done it for you already, ask your lawyer to help you negotiate lower payments to satisfy existing medical bills.

Further, pay off high interest credit card or other consumer debt. Debt is awful. And high interest debt is the absolute worst. High interest consumer debt can easily deplete settlement or trial funds in a matter of a few years. If you have debt at the time of recovering money in a personal injury case, pay it off in full. You can try to negotiate with your credit card company for a payoff that is less than the full amount, but regardless you have to rid yourself of ruinous consumer debt.

Set Up an Emergency Fund

To start with, everyone should have an emergency fund (if possible). An emergency fund is a savings account set aside for emergencies like home or car repairs, or living expenses if you lose your job. You should strive to build up savings to cover necessary living expenses like your rent or mortgage, car payment, utility bills, and groceries for six months. In fact, an ideal emergency fund will cover your living expenses for a year. You should keep this money somewhere accessible like a savings account or money market account, and you should not invest the emergency funds in pork bellies or oil wells or your nephew’s dog grooming business. Once you have the fund established, leave it alone. You should work hard to ignore it. After all, it’s there for emergencies only.

Invest Wisely

If you invest your personal injury settlement funds, invest wisely. Above all, diversify. This means don’t put all your money in one investment. I would recommend paying a financial advisor (as opposed to having the advisor actively “manage” your money) to give you sensible advice on investing. A combination of mutual funds, stocks, bonds, and cash on hand is often wisest. If you have the extra money, you may consider using a small portion of your settlement funds to purchase an annuity, which is an insurance product which entitles you to annual payments at a later time, and these payments can reoccur for ten or twenty years or the rest of your life. Annuities work well only in limited situations, and they can certainly be a mistake, so be careful with this option. Annuities are useful only when made part of a larger, comprehensive investment plan.

Have a Little Fun

Again, don’t buy that Mercedes. But once you have a plan for utilizing the money in the best way and for the longest time, then try to set aside a small amount to do something fun. You have been paid because a large corporation was negligent in a way that physically hurt you or a family member. You clearly have suffered needlessly. It’s vital that you put the money to its best and most long-term use, but you also need to pump the brakes and do something that brings you joy. A vacation is a great choice, because after years of surgeries and rehabilitation and litigation, you and your spouse may simply need to sit under a palm tree and relax.

The Takeaway: A Good Problem to Have

Figuring out what to do with money you receive from a settlement or trial verdict is a good problem to have. But you should nevertheless treat it as a problem to be solved. Wasting assets like this can become an injury similar to the original injury. Don’t let this happen. Be smart and careful with settlement funds, so the money can work for you for many years.

Note: I am a product liability lawyer, not an accountant, estate planning lawyer, or financial advisor. You will need to find these professionals to sort through all the questions you will have after you receive personal injury funds.

I don’t drink the Kool-Aid. I distrust simple answers, group-think, zealotry. I can’t stand when people make sweeping generalizations about the absolute evil of one side and the unconditional good of the other side. I don’t usually spend much time with plaintiffs’ attorneys who think every corporate decision is an act of violence and malfeasance. I am convinced there are two sides to every story (even if, often, one side of the story is weaker).

Medical Devices and Drugs Have Saved Many Lives

So it is with my law practice. I do not believe major companies are evil, that they are out to hurt people, that all the conspiracy theories are true. I am convinced the life-cycle of a medical device or drug begins with a beautiful idea: to develop a product that will save lives, that will make people more active, that will help people and not hurt them. In fact, virtually all medical devices or drugs are first developed by one or a few smart people attempting a solution to a pressing health problem.

And these medical devices and drugs have saved lives. And as a society we have to create an environment where doctors and scientists and corporations have the freedom and the opportunity to build new medical devices and new drugs to solve vexing health problems.

more But Corporate Greed is Real, and Dangerous

But something sinister occasionally happens on the road from inspired surgeon with a new idea to the release of 100,000 medical devices into the marketplace. Greed happens. Corporations rush products onto the market without proper testing (you can read about the flawed 510k medical device approval process here). Sales departments see huge profits on the horizon if only the product can get to the market right now. Marketing departments spend massive amounts on television commercials, Internet advertising, print ads, and access to doctors. Corporate leaders occasionally ignore clinical trials which show alarming evidence of harmful side effects and instead push the product to market with the knowledge that the product may hurt innocent people.

My Fight This is what I fight against. I fight for the people injured by the negligent or intentionally harmful acts of big corporations. I hate reading yet another white paper about a product that was released to the public even though the company had compelling evidence that the product had design flaws that could injure or kill patients. I hate this. And I will keep fighting corporations who do this to people.

My Challenge

So when corporations across the board do the right thing, when they properly test their devices and drugs, when they make decisions on new products based primarily on public health and not on immediate corporate profits, then there will be no work left for me to do. I will be out of business. I can then go back to teaching or maybe start a new career renting windsurfers at the beach. It would be an easy trade-off.

When corporations consistently put public safety and the public good over naked profiteering, I will stop representing individuals injured by flawed medical devices and drugs. I will stop practicing product liability law. I truly hope they put me out of business for good.

Job Security

Sadly though, I believe I have chosen a career path with job security. Each year, products flood the market that are inadequately tested and seriously flawed, and as the months pass hundreds of people come forward with horrific stories of permanent injuries, debilitating pain, lost jobs, and diminished lives. I hate these stories. When these people are no longer unfairly injured by failed products I will gladly “find myself a rock and roll band / That needs a helping hand.” Until then, I fight.

Call me if you need to talk about a possible product liability case: (919) 830-5602.