Most of us pay our bills on time. If we break a neighbor’s rake, we promptly purchase a replacement. If our child dumps fruit punch on a friend’s carpet, we pay to have it cleaned. In fact, we don’t really think about these unwritten rules often; it’s just the right thing to do, so most of us do it instinctually: if we cause damage, we pay for the damage. But too often companies refuse to pay fair settlements to resolve product failure cases, even in the face of a mountain of evidence that (1) the product clearly failed and (2) the failure physically injured the person. For example, let’s say a sixty-eight year old retired schoolteacher learns her metal-on-metal artificial hip implant has failed; her doctor tells her that, in addition to the pain she feels in her hip and leg, she now suffers from dangerously high cobalt and chromium levels (a condition called “metallosis”). Thousands of other injured people have similar claims, but the manufacturer of the failed hip product simply won’t pay. Why not?

Well, I can’t know all the reasons, but let’s look at a few theories:

Companies Don’t Like to Pay Settlements

Companies do not like to pay claims, period. Companies are in the business of making money, not paying out money. Corporations are under enormous pressure to maximize value for their stakeholders, primarily those people who buy their stock. Paying out two billion dollars in settlements for a failed artificial hip is never good for the bottom line.

Companies Can Get Away with Not Paying

The playbook is no secret: when a company first receives complaints about a failing product, it almost always denies that the product is defective. When scholarly, peer-reviewed studies establish that the product is defective, the company invariably commissions its own studies on the product, and often those studies conclude that the product is safe or that the dangers have not been proven. When litigation begins, the company defends itself vigorously, because it is always the case that the company has much more money than any injured plaintiff and can use its superior financial position to grind down injured plaintiffs, even thousands of them.

Settlement Delays Are Profitable

Let’s say a defective product injures 12,000 people, and the company negotiated three billion dollars in a global settlement for the injured plaintiffs. And let’s say the company could pay today or, through artful delays, two years from now. Eight percent interest on three billion dollars for two years is four hundred and eighty million dollars ($480,000,000). That’s real money. If a corporation can delay settlement discussions for two or four or six years before finally paying out claims, the company comes out ahead.

Another positive result of delays is this: some injured people just give up. Some plaintiffs may walk away, or accept a reduced offer, or lose interest, or may even grow old and die. There is no question that justice delayed is justice denied for injured people. Corporations understand this.

One Example: Johnson & Johnson

Recently, Johnson & Johnson has taken a harder line against paying settlements. One Johnson & Johnson defense attorney said that J&J is inundated with lawsuits and that if the company paid every claim it could get a reputation as an “easy mark.” In 2018 alone, J&J spent two billion dollars on settlements and attorneys’ fees. According to reports, J&J is defending 100,000 lawsuits involving hip implants, surgical mesh, baby powder, prescription drugs, and other product cases. One school of thought holds that the massive number of pending lawsuits is actually a deterrent to settlement for J&J.

Medical device and drug companies like J&J can get burned with aggressive no-settlement policies. DePuy Orthopaedics, owned by J&J, lost several huge verdicts in the DePuy Pinnacle hip litigation. And last year a jury awarded damages of $4.7 billion to a group of women who used J&J’s baby powder and were later diagnosed with cancer. There is no question that J&J could have settled with these 22 women years ago for a fraction of that jury verdict. (Of course, J&J has appealed.)

Then there is the loss of goodwill in this scorched-earth litigation strategy. According to a report in Law360, in 2016 J&J was considered the sixth most reputable company in the United States. By 2018 it had dropped out of the top 100. Goodwill matters.

Finally, one important reason for companies like Johnson & Johnson to pay valid claims is this: it is the right thing to do. When corporations offer safe products that improve people’s lives, they should make a lot of money selling the products. But when one of their products turns out to be flawed and harmful, companies should want to do the right thing and pay all the valid claims, promptly.

Note: References to individuals in this article are fictional and hypothetical and do not represent any current or former clients, or any other person. Information about Johnson & Johnson was distilled from online news sources, including Law360, which own their content.

So the FDA gives the multi-billion dollar corporation 510(k) approval to sell the device. In the first year the company sells one billion dollars’ worth of the device. In the second year it sells $1.5 billion in new devices, but it also begins to receive an alarming number of “adverse event” reports. This means patients are reporting problems and injuries after receiving the device. The company undertakes an internal study but does not report its findings to the FDA. In the third year it sells even more devices, but by now hundreds of adverse reports are rolling in. The injuries finally get the attention of the FDA, and the company reluctantly hands over its data on the many serious injuries caused by the new device.

In the fourth year a woman with the implanted device is forced to undergo “revision surgery” to remove the device, and her recovery is lengthy and painful. She calls me and tells me her story. It is awful. She was once a competitive tennis player, but now she walks with a cane. She hasn’t played tennis in two years. She had to take time away from her job. Even with decent health insurance she has thousands of dollars in out-of-pocket medical bills related to the failure of the device.

I take her case. I file a lawsuit in the new “multidistrict litigation” organized to handle the hundreds of cases involving injuries from this new medical device. I move the case along, handle the discovery and make sure my client’s case complies with all Case Management Orders from the MDL judge. Eventually we secure a good settlement for my client.

Later, at a press conference, a spokesperson for the corporation breezily refers to lawyers as ambulance chasers.

So after that narrative of events, I am the ambulance chaser?

As John McEnroe might scream, “you cannot be serious!”

I understand in this age of constant spin, the primary defense to a bad act is to attack. We see it in business; we see it in politics. We see it so often on social media it seems social media was invented for the purpose. And it is very frustrating. But that’s why it is vitally important not to let agents of spin control how you understand any subject. If a corporation can manipulate you into considering whether I am an “ambulance chaser,” it does not have to defend itself for introducing a harmful medical device into the marketplace, seriously hurting thousands of people.

Fighting spin is necessary to appreciate the excellent work so many plaintiffs’ lawyers are doing for injured people across the country.

There is no doubt there are unscrupulous lawyers out there. Some are opportunistic. A few lawyers wade into a new area of law simply because it appears profitable. Some lawyers produce ridiculous and creepy television commercials. A few may even hand out business cards at hospitals like Danny DeVito did in The Rainmaker. I understand that. And I don’t like it. It hurts all lawyers when a few lawyers do incompetent work or play fast and loose with ethics rules.

But the large majority of plaintiffs’ lawyers are doing good work for their clients. And in a world where the 510(k) fast-track approval pathway exists, it is critically important that good plaintiffs’ lawyers keep holding companies accountable for selling flawed, defective medical devices. In fact, it is one of the only defenses a patient has against unscrupulous device manufacturers.

So if an “ambulance chaser” is considered this way, then count me as a proud ambulance chaser. Because taken in this context, ambulance chasers are consumer protection heroes.

At some point in your life, a medical device will likely become a necessary part of your medical care. You may need external items such as hearing aids, blood glucose meters, insulin pumps, or feeding tubes. You may also need the help of surgically implanted medical devices like artificial hips, heart pacemakers, breast implants, spine screws, rods, artificial discs, intrauterine devices, metal screws, pins, plates and rods, artificial knees, or coronary stents. No matter what type of medical device you need, you deserve safe devices of only the best quality that are responsive to technological updates. As a patient, you should have the right to make a fully informed decision about whether you want to use a newer or older version of a particular medical device. The FDA is now considering making changes to its (infamous) 510(k) medical device approval process.

FDA Pressures Medical Device Manufacturers to Utilize Newer Technologies

You only have to look at the evolution of cell phone technology to appreciate the abundance of technological changes that have occurred over the past decade. So, why should you be provided with the medical device equivalents of flip phones? That’s one of the key focuses of the proposed new changes to the 510(k) Approval Program the U.S. Food and Drug Administration (FDA) which would be incorporated in 2019. The 510(k) Approval Program, put in place originally in 1976, has provided an approval “short-cut” for medical devices which are based on medical devices currently on the market. I have written about the 510(k) process often on this site. The medical device currently on the market, upon which the new product is based, is known as a “predicate device.” Historically, there have been no restrictions concerning the age of the predicate device. This is about to change.

We don’t want our FDA approval programs to be so burdensome as to stunt meaningful growth and advancement in medical technologies. However, we must have safe medical devices on the market that are based on more recent predicates in order to encourage the incorporation of modern safety features. Currently, the FDA is considering whether to make information about devices and manufacturers using predicates older than a decade available to the public. The idea behind these notifications would be to place pressure on medical device manufacturers to utilize newer predicate devices. As some industry critics have noted, in many cases new medical devices are approved under 510(k) based on older “predicate devices” that have proven to be problematic and may no longer even be manufactured and marketed.

Would Publicizing Information on Older Predicate Devices Protect Consumers?

I don’t know. I have never been comfortable with the ease with which medical devices reach the market through the 510(k) process. While I welcome the effort to reform 510(k), these latest changes are just a modest start. The motivation behind the FDA’s efforts to bring the 510(k) Program up to speed with modern developments is well-intentioned. Public disclosure of those utilizing old predicates in order to expedite the release of medical devices allows patients and their doctors relying on the medical devices to make informed decisions about what medical devises they wish to incorporate into a treatment plan. But, will publication of this information, alone, put enough pressure on the medical device market to modernize medical devices? I doubt it. More aggressive methods, such as completely disallowing product approval short-cuts for devices based on predicates older than a decade, should be considered. In fact, in the interest of consumer safety, this country needs a robust debate on whether the 510(k) process should be eliminated altogether.

Still, because it shines a light on the flawed 510(k) process, the new proposed measure by the FDA is a small step in the right direction.

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.

I was reading an article about the latest study touting the benefits of exercise. It was stunning. The study involved analyzing the brains of two groups of mice: one group in a cage with an exercise wheel; the other in a cage without the wheel. Researchers watched the mice for four weeks. Predictably, the mice with the exercise wheel exercised; the mice without the wheel did not. After a month the scientists measured brain activity in both groups.

Turns out, running and other forms of exercise produce a protein in the brain called “brain-derived neurotropic factor” or BDNF (I feel smarter just writing that name). This stuff is very good for your brain. BDNF promotes the growth and vigor of neurons. BDNF has also been shown to strengthen the synapses that connect neurons, which allows the brain to function better. Low levels of BDNF has caused cognitive decline in people and animals. Exercise increases levels of BDNF in the brain.

Exercise Promotes BDNF and Ketones

In the study scientists discovered that in the brains of mice who exercised regularly, a molecule which blocked the growth of BDNF was less effective. As a result, much more BDNF was produced in the mice who exercised. Sadly but predictably, less BDNF was produced in the sedentary mice. Researchers also found that the exercising mice produced ketones which make their way to the brain and fight off the bad molecules and further promote the growth of BDNF. The guy who directed the study, NYU professor Moses Chao, said: “It’s incredible just how pervasive and complex the effects of exercise are on the brain.”

You can check out the new study here. It’s the latest in a long line of studies which prove time and again that exercise is vital to your health. Seriously, people have to exercise. Not exercising causes all kinds of physical and mental problems.

more Exercise Changed My Life

I started running nine years ago. I was several years into my law practice and had two young children. I was out of shape and stressed out. I began running. The first day I could run for only three or four minutes. But I kept at it. In three months I had lost twenty pounds. Six months later I ran a half marathon. I don’t need a study to know how exercise improved my life: my stress level dropped (I run often during trials); I slept better; I ate better; I felt better.

Medical Device Victims Deprived of Exercise

One often unacknowledged injury that is inflicted on victims of medical device failures is that it prevents people from maintaining a regular exercise regimen. Many of my clients who suffered an artificial hip device failure could barely walk, much less run three miles. Or swim, or bike, or play golf. One of my clients was a highly skilled tennis player. Her Depuy ASR artificial hip failed, and then the revision surgery failed. She can no longer play tennis, which deprives her of one of the great joys of her life, but also deprives her of vital exercise. This to me is significant injury.

Not Just Failed Artificial Hips and Knees

All kinds of medical device failures can make regular exercise difficult if not impossible. Women with failed transvaginal mesh often report severe pelvic or groin pain; in those cases exercise may not be possible, and certainly not a priority for the injured woman. Some of the symptoms of a failed IVC filter include chest pain, neck pain, lightheadedness, and shortness of breath. It is hard to run a 5K when you suffer from these physical ailments. In fact, your doctor may even forbid rigorous exercise if you have a broken or migrated IVC filter in your body.

My Simple Advice (That You Didn’t Ask For)

Exercise is essential to a healthy life. Study after study shows it helps the mind and body. I know it’s not easy, but if at all possible you have to find a way to exercise with a failed medical device implanted in your body. Although running may be out of the question, you can try to get in a pool and move around, even if you just tread water or merely move your arms. If walking does not hurt, walk. Ask your doctor or your physical therapist what exercises you can do if you have a failed artificial hip or other failed medical device.

And as for compensatory damages in a product liability case, the inability to exercise regularly should be a part of a settlement discussion. The courts should approach lost exercise the way they acknowledge loss of consortium. I see daily exercise the way financial planners speak of retirement savings: we all know that delaying regular savings can harm your ability to retire. With lost compounded interest and capital gains, every year you do not save will sharply reduce your ultimate retirement funds. Exercise should be viewed the same way: Each year you are prevented from exercising will do damage to your long-term health and well-being. Think of all the BDNF you failed to generate with one, two, or three years of a sedentary lifestyle.

So if at all possible, exercise.

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.