I get this question fairly often, and it’s a good one. It usually goes something like this: a person had a total hip replacement several years ago. A few years pass. Then out of the blue the individual receives a letter from the artificial hip manufacturer or from the implanting surgeon explaining that a recall has been issued for the artificial hip components implanted. (And these are the lucky patients; many people who receive an artificial hip that was later recalled never get notification from their doctor, the manufacturer, or anyone. They don’t discover they have a defective artificial hip until the pain, metallosis, or other injury develops.) If I were in this position, and I received a recalled artificial hip, I would want to know: Should I have the recalled hip removed? And should I have the hip removed immediately?

As with most things in life, the answer is not simple.

I have been a product liability lawyer for many years now, and in that time I have spoken with hundreds of people suffering from defective products. I have heard dozens of variations on a similar narrative. While this is neither medical nor legal advice, here are my suggestions:

Don’t panic. Panic never helps, whether you are confronting a decision on revision hip surgery or trying to escape from a bear. (I know, this is easy for me to say.) You do not need to rush out and schedule emergency surgery as soon as get the recall letter. But you should start taking deliberate steps to find answers to your questions and to protect your health, which means first:

Take stock of your physical condition. How do you feel? How does the hip function? Do you feel any pain? Any other symptoms? Can you still exercise, or have you slowly given up many of the physical activities you used to enjoy? What has your doctor said to you in your recent office visits related to the condition of the hip replacement?

Schedule an appointment with your orthopedic surgeon. You need to meet with your orthopedic surgeon and ask him all the questions you have about the recall and the implanted artificial hip: why was it recalled? what is the defect? how has the defect harmed people? what symptoms can the defect cause? And of course: should I get the revision surgery?

Get metals levels checked. As part of this visit with your surgeon, you will want to have him or her order lab work to check your cobalt and chromium levels. Even artificial hips that are not metal-on-metal (MoM) can leach metals into the blood and tissue. It is important to get blood work done to see if you have elevated metal levels.

Do your research. Read as much as you can about the recalled artificial hip, starting with the FDA website but also working your way to reputable news sources. Find out what is defective about the artificial hip and what problems it is causing when the hip fails.

Self-assess. What is your level of anxiety? Are you the kind of person who will suffer with the idea of a recalled product in your body, even in the absence of serious symptoms? Or do you trust your surgeon to give you good advice on revision surgery? If your hip feels good and you have no anxiety, you may be able to hold off on revision surgery. As part of this step, it would also be helpful to discuss revision surgery with your spouse, your family, and even with trusted friends.

Get revision surgery if you need revision surgery. Once you go through the steps above, you and your surgeon should have a long discussion about the pros and cons of revision surgery. No surgery is low-risk, so you need to make this decision deliberately and carefully. If you have pain, and if you have elevated metal levels, your surgeon will most likely advise revision surgery. On the other hand, if your hip is functioning well, and you have no discernible metal levels, and you otherwise feel fine, you and your surgeon may decide to take a wait-and-see approach. In this case, however, you need to maintain vigilance: schedule periodic metal blood tests, arrange frequent follow-ups with your surgeon, and keep a symptoms journal if they arise.

If necessary, seek out a second opinion. It is vital that you trust your surgeon. If you feel you are not getting your surgeon’s full attention or consideration, find another orthopedic surgeon. Ask around for trusted surgeons in your area. Go through the process with the new surgeon. Occasionally some surgeons have reasons for dismissing the importance of recalled medical devices like artificial hips, so they may downplay the importance of removing the recalled artificial hip. (I’ve known at least one surgeon who said high metal levels were not a health risk.) Above all, you should always rely on doctors you trust to make decisions on surgery.

This is not legal or medical advice.

What We Have Here is a Failure to Communicate

Often, the problem starts with the lawyer’s failure to communicate. People will tell me that they never hear from their attorney, and then suddenly, after many months or even years have passed, the lawyer will call and quickly explain the terms of a settlement offer then hurry off the phone. This is a mistake. The lawyer should take as long as necessary to fully explain why the settlement number is what it is. In fact, it is important for the lawyer to keep the client updated on developments throughout the litigation. For example, if another plaintiff in the larger litigation loses an important bellwether case, the lawyer should call and report the loss and what it may mean for the litigation and how it might impact settlement (obviously, it’s not good for all plaintiffs if a bellwether case is lost). If the client understands generally how the multi-district litigation is progressing, the client will be more prepared when a settlement offer finally arrives.

Suffering is Very Real and Very Personal

I have represented many people who have truly suffered when a medical device like an artificial hip has failed. The suffering is real. Some people endure tremendous pain and can’t get a good night’s sleep. Others must give up tennis; some can no longer garden or walk; still others have to quit their jobs. Let’s face it: money—even a lot of money—will not compensate the person for these hardships. It is difficult to walk with pain for years, then hear that the manufacturer who sold the defective product is offering X to settle all claims the person has now and in the future. For most people, X (no matter what it is) is never enough.

Settlement Offers Always Reflect the Strength of the Plaintiff’s Case

This is an obvious point but it must be emphasized: some cases are better than others. In the metal-on-metal (MoM) artificial hip litigation (several manufacturers were involved) it became clear that it was a big mistake to rush these MoM artificial hips to the market under the 510(k) pathway (which I have written about often). It would have been much safer if the companies slowed down, performed pre-market testing and analysis of the metal hip, and then made a prudent and careful decision about whether to move forward. Several companies didn’t choose that path, many thousands of people were injured as a result, and plaintiffs won a lot of bellwether trials. Eventually, the manufacturers of these metal-on-metal hip products paid billions of dollars to settle thousands of valid claims.

By contrast, in the Xarelto litigation, plaintiffs lost six bellwether cases. This does not mean the product is safe or even non-defective, but it does mean that the plaintiffs’ litigation teams struggled to marshal the facts sufficient to convince juries of the defects and defendants’ failure to warn of the risks. (A few plaintiffs in other Xarelto trials won their cases.) These bellwether trial losses undoubtedly affected the size and scope of the larger settlement that followed.

Every Product Case is Different

The individual confined to a wheelchair has a different claim and different damages from the person who had revision surgery but is now walking and pain-free. If one person is rendered disabled at a young age, he or she should have a strong lost earnings claim. If the second individual was injured after his retirement, he would not be in position to recover lost earnings. In defective product cases, some people have extraordinary injuries and others have more modest injuries. Both cases are important, but the settlement outcomes will be different.

Above all, before you sign anything, talk to your lawyer, ask all the questions you have, read the settlement documents carefully, and make an informed decision.

Note: This article was written in general terms and does not represent any details from any current or former client or any caller to this law office.

I’ve been writing on this product liability website for three years. I have now published over 200 articles, and two ebooks, and a page with definitions, and another page providing links to other useful websites, and yet another page where I answer “frequently asked questions” about medical devices and prescription medications, and a bunch of other information. I know many of you have benefited from this information because you have called and told me you have benefited. (I really like getting these calls.) I intend to keep writing articles as often as I can while maintaining a full-time product liability practice.

But today I am excited to announce the launch of my podcast:

Failed Hips and Harmful Drugs: The Product Liability Podcast

In this podcast I will answer your product liability questions, except in a new audio format. This way you can discover a few things about medical device and drug litigation while you walk, or drive to work, or garden. The podcast will focus on the BIG QUESTIONS I often get from people calling my office. Down the road I will interview key individuals who may be able to provide deeper insight into the problems of failed medical devices and harmful prescription drugs. And I encourage you to reach out to me with pressing product liability questions. Who knows? My answers may become my next podcast episode.

To listen to the first two podcasts, simply click the link above, or click “Podcast” on the menu bar at the top of this site. I will also make these podcast episodes available on iTunes, Stitcher, Radio Public, Tunein Radio, and anywhere else I can find to post them.

As always, if you want to talk about a specific issue you may be having with a failing medical device or a problem drug, you can email me or call me at any time: 919.830.5602.

So What’s the Difference?

Medical malpractice is the legal term for a doctor who has been negligent. This means that the doctor failed to perform the surgery with an expected degree of care and competence. In a phrase, the doctor simply screwed up the surgery. For a plaintiff to win a medical malpractice claim, he or she must show that the doctor failed to perform his duties with a normal “standard of care” typical of similarly situated doctors. This means that surgeons in small towns will be judged against similar doctors in similar towns, while doctors from major research hospitals in big cities will be judged against their similarly situated peers, and of course will be held to a higher standard. The bottom line is this: medical malpractice is the failure to provide competent medical care, causing the patient unexpected injury.

Please understand that medical malpractice is not limited to surgeons: hospitals, nurses, and other medical care providers can be liable for malpractice. For example, a nursing staff may fail to do the proper count of “sharps” in a surgery and leave a surgical needle inside the patient’s body. That’s a bad thing, potentially very harmful, and certainly malpractice.

Product liability is an area of tort law where a person is injured by a defective product. Virtually any kind of product can harm us: a car, a heating pad, an artificial hip. On this site I focus on two kinds of product failures: medical devices and prescription drugs, two products which can cause serious injury when they turn out to be defective.

A defective product is one that has a substantial flaw or imperfection. The defective characteristic could be a design flaw, or a manufacturing defect, or even a missing or inadequate warning (for example, “do not take this mix this medication with alcohol”). A defective product becomes a product liability case when the defect causes injury to the consumer. To use an example from this site, when a metal-on-metal (MoM) artificial hip causes metal shavings to leach into the body, and the blood metal levels become dangerously high, the product is defective and has caused injury, and the patient should have the right to bring a lawsuit against the manufacturer.

In many cases it is not always simple to sort out whether the injury was caused by the defective product or by negligent surgical technique.

And here’s another problem: in many of these cases, when the case is grinding forward, the separate defendants will point fingers at each other. The surgeon will insist he performed the surgery correctly, but that the defective product (a defect of which he was unaware) was the cause of the injury. The product manufacturer will state that the product is fine, but the surgeon was a hack and did not understand the correct implantation technique. (In fact, Smith & Nephew may be suggesting this defense in the Birmingham Hip Resurfacing (BHR) litigation, which you can read about here and here.) Still, a good lawyer can figure it out.

Can’t It Be Both?

Yes. You can certainly be the victim of a defective product and negligent medical care. But it’s often like threading a needle. To win such a case, you will need to prove that your injuries were caused by the failure of a defective product and by negligent surgical technique. So sticking with the MoM artificial hip example, let’s say you were injured following hip replacement surgery. In the months that followed your cobalt and chromium metal levels shot up, but you also developed a painful infection near the surgical site. An investigation revealed the hospital was flagged for inadequate sterilization practices, leading to an outbreak of dangerous infection. In that case, the plaintiff-patient can rightly bring claims both for the defective product and for medical malpractice.

Unfortunately, it is rarely simple to identify two separate injuries from two separately identifiable acts of negligence in a single surgery. In most cases, it is one or the other: the surgeon implanted a faulty device, or the surgeon implanted a non-defective medical device, but put it in upside down.

Either way, you need a good lawyer to help you find the answers.

This is the question I get most often from people who have hired a lawyer but are not happy with the legal representation. Above almost everything else, good communication is the key to a healthy attorney-client relationship. I try not to be the kind of lawyer who doesn’t return phone calls. I don’t want any of my clients talking to another lawyer about me. And I understand: every client deserves to be updated regularly on his or her case.

Let’s look at some reasons why your lawyer may not be returning your calls:

• Your lawyer is doing lawyer things.

Every professional is busy. I won’t tell you that lawyers are busier than doctors or stonemasons or accountants, but most lawyers are busy too. And sometimes very busy. When I am on a court deadline, it feels as if I go down in a hole. Everything else is blocked out. For example, when I am writing a legal brief for a client to support a motion for summary judgment, I have to do what Cal Newport calls “deep work.” The legal brief may be a thirty or forty-page legal analysis applying relevant law to the facts of my client’s case. It is complex. It is not easy. For me to do it right, I have to shut out everything else. On these days, I simply cannot pull another file and call another client with an update on her case. I just can’t get to it that day.

The good news is that when it comes time for me to prepare a complaint or a motion or a legal brief for the client whose call I could not return, I will do “deep work” for that client and shut out everything else. This is how the practice of law is supposed to work. So often when a lawyer does not return your call for a few days it may simply mean your lawyer is busy getting some important work done in your case or in another client’s case.

• There is nothing going on with your case.

The work of civil litigation comes in waves. There are weeks when I spend day after day preparing legal documents or engaged in depositions for one individual case, and then weeks can go by with no activity at all. I usually call a client during a week of intense activity (“Just wanted you to know we filed your lawsuit in the multi-district litigation yesterday. Everything went smoothly.”), but I may not call a client for some time if there has been no meaningful activity. Still, I understand that this practice may be a mistake, especially for some clients who need more frequent attorney contact. I try to perceive which clients need regular check-ins, even if there is nothing to report, and which clients can absorb a few weeks with no communication.

I always tell clients: you call me whenever you need to talk to me, but if I don’t call you it’s because we are between deadlines and there is nothing going on at the moment with your case. But I am always watching over your case, even in periods of inactivity.

• You call twice a day.

Not really. OK, rarely, but it happens. Most clients understand there are times when big events are occurring and communication is essential (“we reached a settlement!” or “you won your appeal!”), and times when nothing is going on and no communication is acceptable. As I have written in this blog many times, product liability litigation is a slow moving train, particularly with mass torts such as artificial hips or prescription drugs. These cases take years to resolve. And for much of that time, no meaningful activity is occurring in your case.

I would likely lose my law license if I called every one of my clients every day. Even though I make a point not to represent too many clients at any one time, I have enough active cases that if I called each client every day I would simply not be able to complete the legal work required to move each case forward. There simply would not be enough time each day.

If you need weekly or daily check-ins about your case, let your attorney know up front (“I expect to hear from you twice each week . . . “). If the attorney cannot meet that standard he or she should let you know up front. And maybe you can work out a call schedule that works for both of you: “Unless I am in court, I will call you each Thursday with an update.”

• You hired an attorney from a national marketing firm.

These guys get to you before the rest of us. You see them in afternoon television commercials, in online ads, in your local newspaper. (It is hard for me to compete with them.) When you call that 800 number you get an intake phone person who is often not a member of the firm but a separate paid contractor. The intake person will write up your story, confirm it is a promising “lead,” and if viable will send it to a more thorough review person at the marketing “firm.” Once the medical records “check out,” the marketing firm may refer the case to one of many participating law firms across the country who will take on the case and pay a referral fee to the marketing firm who took your original call. That will likely be the last time you hear from the “firm” who caught your eye in a late-night advertisement.

I don’t mean to disparage this crowd of marketing firms, but I caution you to be careful in choosing your law firm. The advertising group may not be your best fit.

• Your lawyer doesn’t want to talk to you. Or maybe doesn’t even know who you are.

This is the worst reason. Let’s say a firm pays referral fees to obtain dozens or even hundreds of product failure cases. This firm is employing many paralegals and attorneys to move cases forward as quickly as possible. Returning a client’s phone call is not an efficient use of their time. Often, if you get a return call at all it is a paralegal assigned to the case, and often this paralegal cannot answer many of the legal questions you may have. Try not to become just another number in a law firm’s “inventory.” Slow down and choose a law firm and your lawyer carefully.

And if it gets really bad, you may be forced to fire your attorney and hire another one. This is a delicate subject, and I would say be careful and deliberate when hiring or firing a law firm.

If you want to talk to an actual product liability lawyer, give me a call any time: (919) 830-5602.

Occasionally I get calls from people who tell me they are unhappy with their product liability lawyer and want to fire that lawyer and hire someone else.

So should they? Let’s look at it.

Injury Litigation Can Be Highly Stressful

First, it’s important to recognize that litigation is stressful to the parties involved. Litigation involving injuries from a failed product can be very stressful. The defendants are large and well-funded corporations, and they will aggressively defend themselves against claims that their product harmed you. So you will have a fight on your hands. And fights are never fun.

Second, product liability litigation, particularly medical device and prescription drug multi-district litigation, takes a long time to resolve. You have to absorb this unfortunate reality of product liability cases. I had one case that lasted over seven years before we were able to resolve it. Although that is an extreme case, you can expect your device or drug case to take years to resolve. This slow walk to “justice” can cause a natural strain on the attorney-client relationship.

Choose the Right Lawyer the First Time Around

The attorney-client relationship begins with an often serious injury, and continues through years of contentious litigation. It can be a pressure cooker. This is why it is so vitally important to choose the right lawyer for you the first time. You should never hire a lawyer quickly or impulsively (not me, not anyone). I have written about choosing the right attorney in the past, and you can read more about that here and here, but the key thing is to slow down. Read as much as you can about the attorney and the firm you are considering. Ask questions. Do not sign with a lawyer after seeing one television commercial. Even a really good commercial.

“I Hired a Lawyer, and It’s Just Not Working”

OK, we’ve gotten this far. You hired a lawyer and you really don’t feel comfortable. Perhaps you left three voicemail messages over four months and you still haven’t received a return call. You have no idea what is going on with your case. Maybe you spoke with the lawyer for ten minutes on the day you signed the retainer agreement, and you haven’t heard from him or her since. If you feel deeply unhappy with the representation, you should first call your attorney and explain that you are dissatisfied and that you are considering hiring a new lawyer to represent you. This may motivate the lawyer and the firm to discuss all your issues in an open and honest way, and maybe you can rehabilitate the relationship and move forward. If not, read your retainer agreement carefully; this document is a contract for services between you and your lawyer, and it defines the terms of the representation and the rights of the client and the lawyer. Understand what happens in the event that you terminate the relationship. After that, send your attorney a letter stating that you want to get out of the engagement, the reasons you want to move on, then ask that the attorney release you (in writing) without any further obligations on your part. Often the lawyer will accept this no-strings-attached termination. If not, you will have to go through some negotiation to establish the terms by which you can move on. It may be that the fired attorney will expect to be paid a portion of fees in the event of a resolution of the case, but some attorneys will simply allow you to move on. You will need to work this out before you hire the new attorney.

I will say this: if you are close to settlement (especially if you have accepted terms of a settlement) it is a bad move at that point to attempt to fire your attorney. If you are truly dissatisfied, you need to make the change as early in the litigation as possible.

Final Thoughts

This subject is delicate, and I don’t want to come off as sanctimonious. Sometimes a lawyer truly does not handle a client or a case competently, and sometimes a client can expect too much from a lawyer. Do your research on the lawyer and then set reasonable expectations through the litigation. If you are a client, be patient and give your lawyer the benefit of the doubt, at least for a period of time. If some time passes after you leave a message, it could mean that the attorney is in trial (and trials can takes weeks or months). But if your attorney is almost never available, rarely calls you back, and takes other actions that you deeply dislike, you may need to make a change. You deserve to have confidence in your lawyer throughout the litigation.

And if you are an attorney, call your client. Check in periodically. Keep your client updated on developments, even if the report turns out to be: “nothing happened this month with your case.” If you do, the likelihood is that your client will never have any interest in reading this article.

Note: This post is not legal advice.

Diabetes is a serious condition that affects the way the body metabolizes sugar. Over 29 million Americans currently suffer from the disease. Of the newly diagnosed cases of diabetes in adults, around 95% are for Type 2 diabetes. Type 2 diabetes occurs when the body produces enough insulin but cannot use insulin properly. Type 2 diabetes results in high blood sugar levels which can cause long-term health problems. So what does all this mean? From the perspective of pharmaceutical companies, it means there is a massive market for Type 2 diabetes drugs. Enter the latest diabetes “wonder drug,” Invokana. more Invokana

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a diabetes medication sold by Janssen Pharmaceuticals and Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by preventing the kidneys from reabsorbing blood glucose. The blood glucose is removed with the body’s urine. Unfortunately, many patients who took Invokana suffered side effects they did not anticipate because Janssen allegedly did not warn users adequately of these side effects. Injuries claimed as a result of Invokana include diabetic ketoacidosis, stroke, renal failure and other kidney injuries, urinary tract infections, and leg and foot amputations.

After its approval and release in the United States, canagliflozin was the subject of several safety announcements and warning label updates. In May 2017 there was another FDA Drug Safety Communication which confirmed an increased risk of leg and food amputations for those patients taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk.

So what should you do if you suffered an injury while taking Invokana? Here are six helpful steps:

1. Don’t Stop Taking Invokana Until You Speak with Your Doctor.

The FDA currently recommends that patients taking Invokana to contact their doctor if they’re experiencing problems with the medication. The FDA has also recommended that patients should not stop taking Invokana until they meet with their doctor first.

I would go a step further and recommend that even if you have no injuries or symptoms, you should ask your doctor if Invokana poses an unnecessary risk to your health. There may be safer medication options for you.

2. See Your Doctor Immediately.

This is the most important thing to do if you are suffering injuries or side effects while taking Invokana. Your health issues must come first. Ask your doctor if Invokana is simply too risky to continue taking. If your doctor insists that you should continue taking Invokana, ask your doctor why (and write down the answers). Also ask your doctor if there are safer alternative medications. Gather as much information as you can. If your doctor does not give the issue the attention you think it deserves, seek a second opinion.

3. Keep a “Symptoms Journal.”

It is simple enough: when you first begin to notice symptoms which seem abnormal or unexpected or troubling, jot down these sensations on a piece of paper or a notes “app” on your smart phone. The more detail the better. This journal may well provide critically important information for your doctors but also for your attorney as he or she prepares a settlement package or a lawsuit. A person who has been injured by a harmful drug can recover money “damages” in a category known as pain and suffering. A symptoms/pain/well-being journal can provide extremely valuable information to an attorney putting together the best case for you in the event you have a viable claim against a pharmaceutical company for a potentially dangerous drug like Invokana.

4. Keep Careful Record of Medical Bills, Out-of-Pocket Expenses, and Time Missed from Work.

Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your medical care related to injuries suffered from Invokana, including inpatient treatment, surgeries, recovery, rehabilitation, other medications, etc. In some cases, drug companies will pay the out-of-pocket expenses of a victim of a failed prescription medication. Finally, keep detailed records of all time missed from your employment, including sick days you were forced to spend, and days out of work for which you lost compensation.

5. Find an Attorney You Trust.

This step is very important and not easy. Do your research on the attorney and take your time with this important decision. If the first lawyer you call is not a good fit, you can easily move on to the next lawyer. Of course, you can always call me (919.830.5602).

6. File a Lawsuit Against the Makers of Invokana.

The primary legal argument of the plaintiffs is that Janssen did not adequately warn them or their doctors of the risks associated with taking Invokana. Had these injured people been warned about these risks, they could have chosen an alternative method of treating their Type 2 diabetes.

The Invokana federal lawsuits have been placed into a multi-district litigation, or MDL. The purpose of this consolidation is to allow for a more efficient pretrial litigation process and perhaps facilitate a potential settlement. The cases are currently in the “discovery phase,” which will take several months to complete. The pretrial work must run its course and that can take a while. The discovery process occurs when both sides share information that may be used at trial. In large cases involving corporate defendants like Janssen and J&J, the discovery process can be the most time consuming and expensive part of the lawsuit.

In the Invokana MDL, the judge intends to have three bellwether trial cases chosen by January 2018, with the first bellwether trial beginning in September 2018.

Note: I am not a doctor. As a product liability lawyer, I can’t diagnose your health issues and cannot connect any injury you may have suffered to Invokana or to any other drug. Please see your doctor immediately if you suffer any negative health issue (related to Invokana or another drug).

If you are injured by a defective or faulty medical device or medication, you may be able to recover damages from the responsible manufacturer. Depending on the facts of your case, these damages can compensate you for things such as medical bills, pain and suffering and lost wages. In cases where the manufacturer acted in particular nasty ways, such as burying a product study which showed an increased risk of injury, punitive damages may even be possible.

For plaintiffs who are able to obtain a damage award from the responsible medical device or pharmaceutical company, they understand they will not be able to keep every penny received. For example, some of it will go to their attorney (if they have one) and some of it may be subject to taxes. But sometimes, an unexpected “bill” comes from their health insurance company.

Why Do I Have to Pay My Health Insurance Company?

This is sometimes an unpleasant surprise, and you might be wondering if there is some sort of mistake; it usually isn’t. Even though your health insurance may have paid for much of your medical care resulting from the defective medical device or medication, you could still be on the hook for paying those bills indirectly. To effectively explain how this is so, let’s take a step back and see how insurance works.

How Insurance Works

Individuals sign up for health insurance to avoid the risk of a serious medical problem creating healthcare related financial burdens the individual can’t afford. Insurance companies agree to take on this risk so they can make a profit from it. An insurance company’s profit can be understood with the following simple mathematical equation:

Insurance premiums – covered losses = profit

The insurance companies decide how much of a profit they want, use actuaries and fancy computer programs to predict their covered losses, then set their premiums accordingly. This is an oversimplification as to how insurance companies make a profit, but it gives you a general idea.

However, insurance companies can lower the premiums, yet still maintain their profit, by reducing what they pay for covered losses. One way they do this is with subrogation.

What is Subrogation?

The term subrogation means to stand in the place of another. In the context of insurance, it usually refers to the insurance company standing in the place of the insured. When might this happen? When the insured has a legal claim against a third party, such as a medical device or pharmaceutical company.

Most insurance policies have special language that gives insurance companies this subrogation right. You may already be familiar with the concept of subrogation when dealing with your car insurance company. For instance, if you were injured in a car accident due to the fault of another and your car insurance company pays you for your covered loss, the car insurance company also has the right to go after the responsible party to recover what it paid you. Basically, subrogation gives car insurance companies the right to reimbursement.

Many health insurance policies give health insurance companies this same right. So if you get hurt, requiring the use of your health insurance benefits, your health insurance company may be able to recover from the responsible party what it paid to you. When a health insurance company exercises this right, they will place a healthcare lien on your settlement or judgment amount. It may not seem fair, but whether you know it or not, you actually agreed to this arrangement.

But I Never Agreed to Subrogation!

Actually, you probably did, but just didn’t know it. When you signed up for your health insurance and paid your premiums, you agreed to the terms of your insurance policy, which is a contract. Theoretically, you could have renegotiated a few of the terms in your insurance policy, including taking out the part that gives your health insurance company the right of subrogation.

But reality doesn’t allow for an individual consumer looking for health insurance to have this type of negotiating leverage. So if you really didn’t like the subrogation provision in your health insurance policy, your only option was to find another insurance policy that didn’t have it (which would have been unlikely).

Is There Any Good News?

The good news is that if your attorney negotiates a settlement with the medical device or pharmaceutical company, your attorney will make sure that any settlement amount will include money to pay any healthcare liens you may have. This is particularly true in multidistrict litigation (MDL) settlements. In some MDL global settlements, the wrongdoing manufacturer will agree to compensate the plaintiff for his or her injuries, and will also agree to cover the subrogation demands of the person’s health insurance coverage. This important benefit, for example, was part of the Depuy ASR Settlements.

Also, depending on which state laws apply to your health insurance policy, a health insurance company’s subrogation rights may be restricted. For example, some states have laws that limit the amount the insurance company can recover from you. This area of law is extremely complex, however, and beyond the scope of this post. But be aware that health insurance companies are powerful entities, and they work constantly to protect their rights to subrogation and ever higher profits. So at the end of the day, be prepared to pay health insurance liens from your personal injury recovery.

So should you hire an out of state attorney? This is a question many people must answer, including those injured by a failed medical device or a prescription drug. I have had several clients who were initially skeptical about hiring an attorney who practiced 500 or 2,000 miles away. And I get it.

For many types of cases, choosing an attorney in your hometown or in your state is best. Do you need to set up a will with powers of attorney? Ask around and call the good lawyer who lives down the street or across town. Going through a divorce? Have a traffic ticket? Did someone breach a contract? Find someone in your city who comes highly recommended.

But what about product liability? Specifically, what about medical device or prescription drug cases? You need to find the right person to represent you, even if that person practices law in another state or across the country. Let’s look at some pros and cons of hiring an out of state product liability lawyer:

CONS How Do You Know If the Lawyer is Competent?

It’s a good question. In some cases you simply can’t know, or at least you can’t know until it’s too late. Often, if you become aware of a law firm from another state, you stumbled on the firm as a result of aggressive advertising. This does not necessarily mean the firm is not competent, but marketing does not make a firm competent. Many of these firms spend thousands (even millions) on mass marketing and TV commercials and Internet advertising. This is why you found them first. Their primary focus is to “sign you up.” So tread carefully.

You Do Not Get to Meet Face-to-Face

It is usually better to sit down with your attorney. If you hire an attorney who practices 1,500 miles away, this meeting may not be possible. And even if you meet once, you will be prevented by distance from meeting face to face on a regular basis. Something has been lost in our modern age when we rely almost exclusively on our smart phones and our computers to interact. That said, we live in 2017, not 1967. This communication trend will only intensify. And as I suggest below, it may not be the obstacle it seems to be.

The Out of State Lawyer May Not Understand Your Specific State Laws

The out of state lawyer may not understand specific laws that govern cases in your state. For example, for product liability cases, many states have consumer protection statutes that may create a unique cause of action for your injury in your state. How can you be sure a lawyer across the country will know about these state consumer protection laws? The answer: you have to ask your attorney how he or she plans to handle your specific case, including all relevant state law claims.

PROS You Need a Specialist

For medical device and drug cases, you need to find someone who specializes. It could be a disaster for you to choose the kindly man who years ago set up your limited liability company to represent you in a nationwide multidistrict litigation (MDL) involving a failed medical device or drug. The likelihood is that lawyer (whose office may be around the corner from your house) has no idea how to handle a product liability case or even knows what an MDL is. Most of these local lawyers will admit they do not handle these kinds of cases and may refer you to someone else. But some may try to take it forward. And that would be a mistake. You do not want your divorce lawyer to handle your hernia mesh or Xarelto lawsuit, just like you don’t want your podiatrist to operate on your shoulder.

So it is far better to choose a lawyer from another state who has handled fifteen or fifty artificial hip cases than to go with the local person you know, even if that person is very nice and did a great job handling your last real estate closing.

Pro Hace Vice Admission and Online Legal Research

Lawyers are allowed to represent clients in other states through pro hac vice admission. Pro hac vice means “for this turn” or “for this occasion.” It allows me to represent a client in another state for a specific purpose and for a specific case if I complete all the written requirements for this limited admission. It is straightforward and simple.

Beyond that, online legal research services like Westlaw and Lexis allow lawyers to access the complete laws of any state. I can read Oregon appellate court opinions on an Oregon consumer protection statute in seconds. I have virtually the same access to Oregon’s state laws as any Oregon lawyer has (as that Oregon lawyer is most likely using online research services just like I am). In the modern age, information everywhere is at our fingertips.

Proximity is Overrated

It is comforting to imagine that the lawyer who has helped your family in legal matters over the years can also effectively represent you in your medical device case against a multinational corporation. But these cases can be complex, and they can take years to resolve; you do not want to risk your valuable case on the local lawyer who must learn the case as he goes along. Beyond that, we do live in an age with extraordinary ways to communicate: phone, fax, email, text, PDF, FedEx, Skype, Drop Box. I have had phone calls with prospective clients 2,000 miles away, and five minutes after the call ends the client sends me hundreds of pages of medical records in scanned attachments to an email. The truth is, it is easier to handle most cases electronically. In fact virtually every court in the country now has electronic case filing. I regularly file lawsuits in federal courts in California or Ohio or Texas while sitting in my office in Raleigh, North Carolina.

So What Should You Do?

It depends. You may be quite lucky and live down the street from a very good lawyer who focuses his or her law practice on medical device and drug cases. If not, you should not limit your search to your home state. Do your homework on any lawyer, whether in state or out of state. You should read online law firm reviews and online testimonials. You can even ask the prospective lawyer for references from former clients and give those people a call. If the firm has a website or a blog, review the site carefully. Get a sense if the lawyer knows the subject area. Try to discern if the firm website is geared simply to marketing and search engine optimization (SEO) or if the site provides useful information. When you get the retainer agreement from the out of state lawyer, review it carefully and ask any questions about any provision that concerns you. But do not exclude very good lawyers simply because they may not live in your state. Your best option may well be to hire an out of state attorney for your product liability case.

When a device or drug maker pays money to an injured person for a defective product, several costs must be repaid from these funds. There will likely be medical liens, expenses of litigation, attorney’s fees, and health insurance liens. You can get an overview of these cost repayments in a post I wrote last year. In today’s post I want to take a closer look at health insurance liens (and the related concept of health insurance “subrogation”), mainly because health insurance companies can take a big bite out of your product liability settlement funds. Best to understand this unpleasant news upfront.

How Do Health Insurance Liens Work?

If you have health insurance, much of the cost of your medical care will be paid by your health insurance plan. Let’s say you need revision surgery to remove defective hernia mesh. The total cost of the surgery is $36,000.00, but under contracted payment rates between the hospital and your health insurance company, the cost is reduced to $24,000.00. Under your agreement with your insurance company, it pays $20,000.00 for this surgery and you pay a total of $4,000.00 in “co-pays” (that is, the amount you must pay “out of pocket” under your health insurance plan). So far so good.

A week after the surgery, while you recover from the operation (and watch afternoon commercials asking if you have been injured by defective hernia mesh), you receive a letter from your health insurance provider asking specific questions about how you were injured. The health insurance company is trying to figure out if a third-party is ultimately responsible for your injuries and thus for the costs of your revision surgery. The insurance company may want to know if you are pursuing a product liability claim against the manufacturer of the hernia mesh. It is no secret that the health insurance company is looking to be reimbursed for the payments it made for your mesh revision surgery. The moment you file a lawsuit against the product manufacturer, your health insurance company will submit a “lien” identifying its claim to some of the settlement funds. And trust me, these companies will not let this claim go lightly; they will pursue reimbursement aggressively, and you will most likely have a contractual responsibility to pay the health insurance company from your settlement funds. In fact, if possible the insurance company will expect to be repaid 100% of the costs it paid for your health care caused by the negligence of others.more

Health insurance subrogation is the closely-related concept whereby your health insurance carrier pays for your health care and then directly pursues reimbursement of those payments against the negligent third party or the third party’s insurance provider. Subrogation is the substitution of one person or entity for another with respect to an insurance claim or debt, and the entity substituted will obtain all the rights associated with the insurance claim or debt. What this means is that if your health insurance company pays money for your medical care, and it turns out your injuries were caused by a negligent third-party (such as a distracted driver or the manufacturer of hernia mesh) then the health insurance provider can step forward and demand to be repaid for the costs it incurred in your treatment. Essentially, it can pursue a lawsuit against the negligent third-party on its own, without you.

But Isn’t My Health Insurance Company Supposed to Pay for My Health Care?

In a word, yes. And these companies will pay for your health care related to injuries you sustain from a failed medical device, a problem prescription, or a car crash. At least, they will pay what they are required to pay based on the health insurance contract (and not a penny more). However, if a third party is at fault, they will want to be repaid from the third party for payments made.

This repayment can sting because it will naturally lower your overall net award from your product liability settlement. It also stings because you have paid health insurance premiums for years to provide medical care when you are injured, and the moment you receive compensation for an injury caused by someone else, your health insurance company will expect to be repaid for the medical care it paid on your behalf.

Let me put it another way, in any given year you may not receive any health care, but you paid monthly health insurance premiums every month. The insurance company does not give you that money back, and there is no mechanism for you to recover these premiums in a year when you did not need health care. What can I say? The health insurance industry has a more robust lobby in Washington D.C. than do individuals injured by defective products.

How Much Can the Health Insurance Company Take of my Product Settlement?

This can be the shocking part: in some cases the health insurance lien can be larger than the third-party is willing to pay in settlement. This means that you as the injured person may receive nothing from pursuing an injury claim against a negligent person or company. Quick example: you are hurt by the failure of a metal-on-metal artificial hip, but in the revision surgery you suffer a mild heart attack. Your health care related to your recovery from the heart attack eventually costs the health insurance company $225,000.00, but the hip manufacturer will only offer $300,000.00 to settle your case. In that situation, after other costs are paid there would be no money left over for your pain and suffering.

Some good news is that many states recognize the “Made Whole Doctrine.” This doctrine is a defense to a health insurance provider’s lien or subrogation rights. It goes like this: the insured (or injured person) must be “made whole” before an insurance company may step in and assert its rights to be repaid. But a word of caution: often the subrogation rights of insurance companies is stronger than the defense of the made whole doctrine.

If the “Made Whole Doctrine” does not protect you in your state, the other modest good news is that health insurance companies will occasionally work with a competent lawyer to lower the overall health insurance lien. For example, in the above example the health insurance company may agree to take two-thirds of the total cost for the health care “to get the deal done.” In that case, there would be money left over for you.

Finally, in many multidistrict litigation settlement agreements, the parties negotiate an arrangement for the product manufacturer to pay the health insurance liens and other liens as part of the overall settlement package. This can be one of the more attractive features of a multidistrict litigation settlement.

If you have more questions, call me: (919) 830-5602.

Note: this is not legal advice.

Here’s a scenario: you had hip replacement surgery several years ago. In 2015 the hip began to hurt and cause other problems. You had revision surgery in 2016. While at home one afternoon recovering from the revision surgery, you see seventeen commercials from personal injury law firms asking if you recently had revision surgery following the failure of the [fill in the brand name] artificial hip. If so, lawyers are standing by to assist you with your case.

(At this point, if relevant to your situation please substitute “IVC filter” or “hernia mesh” or “artificial knee” or any number of risky prescription drugs in the scenario above for “artificial hip.”)

So your next thought may be: I should represent myself. This is known as being a pro se litigant. If that is your thought, your next question should be, “what steps should I take to make sure I get a full and fair settlement for my product liability case?” It’s a great question.

The First Thing You Do

In a word: hoard. Collect, gather, organize. Seriously, it is time to start building your case file. You will need to collect everything related to your product liability failure and to your injuries. What is relevant? Well, virtually everything could be relevant to your product failure injury claim, so gather and keep track of and organize everything. When in doubt, identify it and file it away.

Some of the documentation and evidence you will need:

• Medical records. This is rather obvious, but don’t assume just because you obtained the operative notes from your surgeon in the revision surgery that you have all you need. You don’t. You will also want to gather your complete medical history from the surgeon, your primary doctor, your physical therapist, any other medical care providers, even chiropractors and pharmacists. You need to gather your complete medical file. The defense will ask for everything, because one thing they will be searching for is a defense to your claim (e.g., were you rollerblading with your grandchildren the week before your revision surgery, taking a horrific spill?)
• Journal of symptoms/pain. It may sound like overkill, but keeping detailed notes on the onset of pain, the severity of pain, the levels of pain through the day, and other information may well win your case or increase your settlement offer. For example, what if you and your husband were competitive square dancers, and traveled the United States to dance and compete? Then your artificial hip failed, you needed revision surgery, and complications from the revision surgery forced you to retire from square dancing? That scenario sets up a very plausible argument for additional compensation, and it also sets up a loss of consortium claim for your spouse, as he just lost his dance partner.
• Explanted components. I wrote about retrieving the failed medical device from your revision surgery here, so you can read about that process by clicking the link, but it is vitally important that you send a letter to your hospital administrator and to your surgeon prior to the revision surgery so all medical staff are on alert to retain and preserve the explanted components. These components will certainly be needed as evidence as your case advances. And do not let the manufacturer’s sales representative, who may be in the room during your revision surgery, take away the explanted components “for further study.”
• Medical bills. Keep every one of them. From the surgeon, the hospital, receipts from the pharmacist, everything related to your hip surgeries.
• Expense journal. Keep careful track of all expenses: out-of-pocket expenses, co-pays, costs for prescriptions, mileage to and from the university hospital in the next town.
• Tax information. Did you miss two months of work in 2016 following your revision surgery? Did your 2016 W-2 show that you made $6,000.00 less than you made in 2014 and 2015? Make copies of your tax information going back to the time of your original implant surgery, and keep copies for every year through the year of your revision to the present day.
• Health insurance information. Gather all documentation related to any payments or services provided by your health insurance company. Most likely, the health insurer will expect to be reimbursed for payments it made on your behalf relating to a failed medical device or harmful prescription drug. You will eventually have to deal with that health care lien.

Not all of this information will be useful to your case. But in the early stages, you will not know what is useful and what is not (especially if you are working without a lawyer). So if you have any doubt about “relevance,” keep the document or the receipt or the letter. And keep all of the information carefully organized. If you have a receipt, paperclip an explanation (“second prescription for Percocet following my revision surgery”).

A Word of Caution

Let me be clear: I do not recommend representing yourself in a product liability case. There are simply too many things that you can overlook or that can go wrong. The best evidence that you should not represent yourself may be this: the medical device or drug manufacturer really wants you to represent yourself. Unrepresented parties often receive much smaller settlement amounts than do injured people who are represented by competent lawyers. It’s not that product liability lawyers are smarter than other people; it’s simply that a person who does this work day-in-day-out, month-after-month, for years will be more experienced in maneuvering through the dozens of steps it takes to prepare a good product liability case for (1) the best settlement or (2) trial.

But if you take on your product liability case yourself, you should start by building your case file, one document or record at a time. Good luck.

Note: This post is not legal advice. And I don’t have TV commercials.

I imagine it can seem overwhelming. Let’s say you had artificial hip surgery in 2011. By 2016 you begin to feel some unusual, new pain. So you Google artificial hip implants and you discover an ocean of words on the many failed artificial hip components that have been sold and implanted (and then failed) over the past decade. Then you run across an article on an urgent recall of the Stryker LFIT Anatomic CoCr V40 Femoral Head (let’s call it the V40 Head). You have a vague recollection that you were implanted with a Stryker artificial hip back in 2011, but you certainly don’t know if the V40 Head was implanted. So the question for a person like you would be: How do I know if I have the Stryker LFIT Head implanted in my body?

It’s a great question. In fact, you should not be expected to know what precise artificial hip components have been implanted in your body. I had cataract surgery last year, and I don’t have any idea what exact artificial lenses were implanted in my eyes. I hope I don’t ever have to figure out what product they actually are. But back to you. Here is a simple procedure you should follow if you need to find out if a medical device like the V40 Head is currently implanted in your body:

more Do You Feel Pain?

The first question you should ask if: Do I have pain? If you have great results from your hip replacement surgery, you may not need to confirm what specific parts are in your body. Although I think information is always a good thing, if your results are good, you may just take a wait-and-see attitude. After all, the artificial hip is not going anywhere.

If you have pain in the hip area, or in your legs or back, then you need to begin keeping a pain journal. I have written about this simple information-gathering tool, and it is an important action to take. It will likely help your doctor diagnose the problem, and it may help your attorney with your product liability case down the road.

Did You Receive a Recall Letter?

For many recalled medical devices, the manufacturer often sends a letter directly to the patient identifying the recalled medical device, or the company sends a letter to the patient’s surgeon asking the surgeon to notify all his or her patients who received a recalled product. From what I understand, Stryker did not send any such letter to patients or doctors. So in the case of the V40 Head, a recall letter will not help you figure out if you have the V40 Head in your body, because one was not mailed.

Stryker did issue an Urgent Medical Device Product Field Action Notification for the LFIT Anatomic CoCr V40 Femoral Heads, which you can read here: Stryker LFIT Urgent Notification. This Urgent Notice was delivered on August 29, 2016 to surgeons and hospitals who may have received the V40 Heads in the last fifteen years. But Stryker did not send the letter directly to the patient who had the V40 Head implanted. Without direct notification from Stryker to you, the patient, it therefore falls to your surgeon to let you know about the recall. And your surgeon may or may not voluntarily tell you about the recall.

Ask Your Doctor

If you are feeling pain as described above (and maybe even if you are not), you need to visit your surgeon. Schedule an appointment and let your surgeon explain to you what is going on. At that doctor’s visit, you should ask if your artificial hip components are subject to any recalls or other product failure issues. If you have the V40 Head implanted, your surgeon absolutely should let you know at that point that you have the V40 Head implanted. He or she should then tell you what you should do next, at least from a surgical or medical treatment standpoint.

Ask for the Product Stickers Page

Now you are getting somewhere. Whether you meet with your surgeon to discuss the new and different hip pain, you have the right to all your medical records. Call the surgeon’s office and ask the person in charge of medical records to send you copies of the “product stickers” page. This is a simple page that has all the hip component labels affixed to the sheet of paper. When you had the original implant surgery, the surgical nurse should have carefully removed all stickers from each hip component and stuck the label to the product stickers page. It may have a heading at the top that states “nurses’ notes” or “hospital notes” or “operative note,” but any product stickers page is unmistakable, because the product stickers or labels has all the key identifying information: name of the component, lot number, reference number, manufacturer’s name and logo. When you have the product stickers page in hand, you are on your way to establishing whether you have the Stryker LFIT V40 Head implanted.

While you are asking for the product stickers, feel free to ask for all medical records relating to your original implant surgery. These documents can prove very helpful in the early going to a product liability lawyer.

Call a Lawyer to Discuss

A good product liability lawyer will be able to help you identify whether you have the V40 Head implanted, especially if you have obtained the product stickers page. But even if you haven’t recovered that page from your surgeon’s office, a lawyer can figure it out for you.

Recap on the Stryker LFIT V40 Femoral Head Failure

Stryker has admitted that a higher than expected number of its V40 Heads are malfunctioning due to a failure in the taper lock. The taper lock is the part of the hip prosthesis that connects the femoral head to the stem. When the taper lock fails, various symptoms can result, such as:

– Loss of movement – Joint instability – Legs of differing lengths – Severe pain – Annoyance – Inflammation – Joint dislocation

These symptoms can be caused by any of the following:

– Metallosis – Fractured hip stem trunnion – Disassociation of femoral head from hip stem – Excessive wear debris – Insufficient soft tissue tension – Loss of implant: bone fixation strength

These are just some of the possible symptoms and hazards associated with a failing V40 Head. Two of the more serious issues are metallosis and disassociation of the femoral head from the stem.

The exact cause of taper lock failures in the V40 femoral heads has not yet been provided by Stryker. But regardless of how the V40 femoral head is defective, if you are suffering any of the above symptoms, there’s a good chance you may have a V40 femoral head hip replacement component that needs to be fixed or “revised.”

I get the impulse to “do it yourself.” Prior to attending law school, I sued my landlord in small claims court for the return of my security deposit (I won). I also tried to replace the steering box in my 1974 Ford Bronco (that didn’t turn out so well).

These phone calls from pro se litigants are often interesting. Plainly some people have developed a distrust of lawyers. For others, the thought of paying legal fees for a good attorney seems unpleasant and undesirable, even overwhelming. Some may be trying to litigate their claim “on the cheap.” But the real question is: does it work? Can a person represent himself or herself successfully in a product liability injury case?

more Do You Really Need a Lawyer?

Here’s the quick answer: No. Technically a person does not need a lawyer to bring any civil action. You can always represent yourself (as an individual) in a lawsuit.

The pro se litigant has a long road. If you’ve read my blog at all, you know how complicated it is to identify a viable product liability case, to gather (and pay for) the relevant medical records, to draft the complaint, to make all the proper case filings, to meet all deadlines from the multidistrict litigation’s case management orders, and to position your case for trial or to negotiate for the highest possible settlement. It’s a slog.

Can a pro se litigant handle it? It’s possible. But you should expect to spend hundreds of hours researching the claim, reading court orders, double and triple-checking deadlines and court filings. One misstep and the case can be dismissed. I would say that the life of a pro se litigant is stressful and difficult at best, and the defense lawyers representing the companies will know immediately that they are dealing with a pro se plaintiff and will reduce settlement offers accordingly. It’s just the way of the (defense) world.

It’s impossible to say whether the defendants will make an offer to a pro se plaintiff that is less than net amount an injured person represented by a competent attorney could expect, but in many cases that is exactly what happens. The pro se plaintiff often gets much less in settlement.

So if you choose to represent yourself, be careful, and be ready to do a boatload of research and work on your case.

By the way, here’s another answer: you do not need a bad lawyer. You should always take the time to research the lawyers and the law firms you are considering. I wrote about this subject some time ago, which you can read here. But my answer is that you do not want to hire a bad lawyer.

So the real question then becomes:

Will a Competent Lawyer Improve My Case Result?

I am sure some law professor at some point has done a study of the results obtained by pro se litigants: the wins and the losses and the weak settlements and the strong settlements. I have not done such a study. But I have practiced law for many years, and I am quite certain a good lawyer who is knowledgeable about the subject matter will get good results for his or her client, and often considerably better results than the client would get on her own.

Did I Miss Something?

Beyond that, the lawyer is responsible for all the headaches and all the responsibilities of the litigation, from start to finish. If there is a deadline, the lawyer must know it and must comply with all filings by the deadlines. Your lawyer will let you know if you need to make a litigation decision, and will inform you of the scheduled date for your deposition, and will let you know of upcoming hearings. You will be freed from the stress and anxiety and chaos of litigating your own case. You will not wake up in the middle of the night and ask: did I miss something today? The psychic benefits of hiring a competent lawyer can be substantial. Instead of poring over discovery, you can do things like focus on your surgery rehabilitation, or read a book, or take a nap.

But Lawyers Are Expensive!

Lawyers are not cheap (and if they are they are probably not worth hiring). But lawyers are expensive the way surgeons and hospitals are expensive, the way a comfortable, reliable car can be expensive.

In a product liability injury case, the minefields are everywhere. After all, you are suing huge corporations who make billions of dollars each year, often on the product that harmed you. These corporations have truckloads of money to spend on armies of dark-suited lawyers, all working feverishly to make your case go away.

So at the end of the day, I’d say it is a dangerous game to represent yourself in any litigation, but especially in complex product liability litigation. Hire a good lawyer, and if your case has value your lawyer will find the value.

As always, good luck.

Note: this article is not legal advice.

First, let me make the case for smoking:

You enjoy it. It tastes good (I guess). It makes you alert (I hear); but also, oddly, it can calm you as well (from what I’ve read). You also look cool doing it (I confess; this last part is often true). And it’s legal. But perhaps the strongest argument I hear from smokers is this: no one is going to tell me I can’t smoke. This is a free country after all.

That’s about it, really. That’s all I’ve got. And I’m not here to nag you. By all means, smoke if you must. But let me present a different perspective: setting aside the many health problems smoking causes, it can also destroy or damage your product liability or personal injury case.

Smoking Can Make Proving Causation More Difficult

In many cases, the fact that you are a smoker may make it more difficult for you to prove your case. I recently investigated a potential case against a medical professional for injury to a patient. I had a medical expert review the case and give me his opinion. He said, “it looks like it could be an injury caused by negligence, but the patient was a heavy smoker, so she likely failed to heal properly after the injury because of all the smoking.” Translation: this person may have been injured through the negligence of the medical professional, but it would be very difficult to separate the actual injury from the failure to heal, and the heavy smoking probably contributed to the client’s failure to heal. So there it was. I may be able to prove that the medical professional injured my client, but even an average defense lawyer could make the case that it was the smoking that caused much of the the pain and suffering and slow recovery after the injury.

And that’s the thing: smoking injures people. It also prevents healing. Putting all that together, smoking can make it difficult or impossible to prove injury in a product liability or personal injury case.

Even if you prove your case, and you can show injury caused by the negligence and not caused by the smoking, you can lose thousands of dollars in settlement or through a jury verdict simply by being a smoker. In many product liability master settlement agreements, the fact that you smoked can reduce your total settlement award.

The Loss of Money Is Quantifiable

By quantifiable I mean you can actually calculate (often to the penny) the money you will lose just by being a smoker. In the Depuy ASR hip settlement agreement, the Part A base award for qualifying plaintiffs was reduced by 5% if the individual used tobacco products at the time of the revision surgery. The base award in the ASR settlement scheme was $250,000.00, which means the smoker lost $12,500.00 right out of the gate, simply by being a smoker.

But that’s not all: the ASR settlement also provided an opportunity for extra payments classified as “extraordinary injury.” If the plaintiff could show some extra injury, such as a second revision surgery (“re-revision”), or a condition such as foot drop or pulmonary embolism, that person qualified for additional compensation. Nevertheless, out of the gate these amounts were reduced if the plaintiff was a smoker:

“There will be an up to 10% reduction of the QUSC’s [plaintiff’s] applicable PART B Award if the QUSC (or Product User) was a current smoker of cigarettes or other tobacco products at the time of ASR Revision Surgery or Covered Post-ASR Re-Revision Surgery as reflected in the contemporaneous medical records (with the exact percentage to be determined by the SOC).”

For example, a re-revision surgery typically qualified for $150,000.00 in extra compensation under the Part B portion of the settlement agreement. But if the injured person were a smoker, she would lose 10% of that amount, or $15,000.00. Just like that, the Depuy ASR plaintiff in this example lost $27,500.00 simply because she was a smoker, and that’s presuming she did not qualify for other compensation under the settlement, which would have resulted in further reductions of the total settlement amount.

Other settlements reached in other product liability multidistrict litigation also include reductions in pay-outs if the plaintiff smoked. The thinking in all these reductions is simple: smoking causes all kinds of health problems, so it is logical to presume that the injuries relating to the failed product or prescription drug was at least made worse by smoking. It may not seem fair; it may not even be true, but it happens often.

The Takeaway

From what I hear, it is very difficult to quit smoking. And there are many better reasons to quit smoking than to preserve or strengthen your product liability or personal injury case. I just want you to be aware that smoking can make it more difficult to prove an injury case, and it can reduce your settlement offer in cases ranging from defective artificial hips to harmful medications to medical malpractice. If you can quit now, for all kinds of great reasons, quit.

Let’s say you are a woman in your forties, and the mother of three children. After the birth of your third child you began to suffer from pelvic organ prolapse. This condition occurs when an organ like the bladder drops from its normal position and presses against the walls of the vagina. You go to your gynecologist, who recommends implantation of transvaginal mesh (TVM), the net-like plastic product that was marketed and sold as a solution to the problem of pelvic organ prolapse. You have the surgery. Soon you begin to suffer new and different pain and new health problems. You undergo three revision surgeries to remove all the pieces of the mesh. But after the revision surgeries you still suffer from pain and incontinence. You call an attorney, who files a lawsuit against the manufacturer of the TVM product. A few months into the litigation, your attorney explains that you now need an expert witness.

Your attorney is absolutely correct: you will need an expert witness in virtually all product liability cases. And a good one. And fast. If you do not have a qualified expert witness who can make the connection between your injuries and the failed product, then in the eyes of the court you do not have a case.

Your Most Important Witness

Expert witnesses are critical members of the team that is built to win your product liability case. In fact, other than your choice of attorney, the selection of the expert witness will be the most important decision you will make to help you win your case.

Expert witnesses are common in all kinds of litigation. In a simple car crash case, a treating doctor is almost always called to testify about the nature of the plaintiff’s injuries after the crash. In some car crash cases, a second expert witness will be called to explain why a car’s brakes failed, or why the car’s airbag did not deploy. Usually this testimony ends by showing causation, “and if the brakes did not fail, the driver would not have crashed into that oak tree and broken his arm.”

In a product liability case, the expert must be able to show causation, to make the connection between the failure of the product and the injuries the person suffered. If the injured person cannot show this causation through the testimony of a qualified expert witness, she cannot win her case. In the example at the top of this post, the expert will have to be able to testify that the new pains and the new health problems were medically caused by the failure of the mesh and the need for multiple revision surgeries.

But I’m getting ahead of myself.

more Finding a Qualified Expert Witness

Before an expert witness can testify as an expert, he or she must be qualified by the trial judge. You may have heard the name of this case before, but in most states the admissibility of expert testimony is governed by a Supreme Court case from the 1990s, Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The Daubert standard requires a trial judge to scrutinize all potential expert witnesses before the expert is permitted to testify as an expert. If the expert is qualified by “knowledge, skill, experience, training, and education,” the expert will be allowed to testify if:

(1) the information provided by the expert will help the trier of fact to understand the evidence or determine a fact in issue;

(2) the testimony is based on sufficient facts or data;

(3) the testimony is the product of reliable principles and methods; and

(4) the expert has reliably applied the principles and methods to the facts of the case.

The qualification of an expert is one of the biggest battles that a plaintiff will face in litigation. The plaintiff’s lawyer will argue aggressively for the qualifications of the expert and the relevance of the expert’s testimony. The defense will argue just as aggressively that the plaintiff’s expert is unqualified, and that even if the expert is qualified, the testimony will not be helpful for the jury to understand the case. The trial judge will ultimately have to make the determination whether to permit the expert to testify. It is one of the key decisions the judge will make in a product liability case.

I can’t stress this enough: your expert witness is a vital part of your case. If the expert does not have proper education or credentials, or if the expert fails to provide convincing analysis of the connection between the failed product and the injuries, then the judge will reject the expert and the plaintiff will lose her case.

This situation happened recently in the Zimmer NexGen knee case. On the eve of the second “bellwether” trial, Judge Pallmeyer rejected the plaintiff’s expert and granted summary judgment for the defendants. Among other things, the judge concluded that plaintiff’s proposed expert has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17) After years of litigation, the plaintiff was out of court.

Your Expert Must be a Good Communicator

Choosing the right expert is very difficult. First, you must find a person with the right kind of expertise for the particular case. This expertise must be of a kind that will survive a motion to exclude the testimony by the defendants (such as a Daubert challenge). If your expert survives that scrutiny, he or she will still need to be able to communicate effectively with a jury. And those jurors will likely have almost no understanding of transvaginal mesh or pelvic organ prolapse (although they will know a lot about it by the end of the trial). Your expert must be able to communicate complicated medical or scientific terms in a simple way so that jurors will understand the concepts. This is no easy task. Your lawyer must talk to several potential experts before hiring one to testify on your behalf. My favorite experts are natural teachers. They can take very complicated subjects and explain them so that my teenage son can easily understand them. When that happens, you often win over the jury.

Experts don’t work for free. Every expert will charge the plaintiff for the time it takes to review the case file, analyze the information, write an expert report, and testify. Beyond that, the expert will have to be paid for travel expenses, hotels, and other costs. But if you find the right expert, the expense will easily pay off. Good luck.

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.

The Free Consultation Has Very Limited Value

Let’s start with the hourly-rate case. If the legal representation will ultimately be subject to an hourly fee payment arrangement, this “free consultation” will not likely save you much or any money. First, some lawyers allow thirty minutes “free” and then announce, “if we go further I’ll need to charge you my hourly rate.” But even if the attorney sits patiently and listens carefully to you explain your case for forty-five minutes or an hour, it is unlikely the attorney will be able to give you sound legal advice at that point. Quite simply, a legal dispute is complex (otherwise you could have handled it yourself). Even a basic breach of contract action will usually have two conflicting stories, and behind those stories will sit documents: agreements, letters, invoices, emails, texts, witness statements, all of which must be reviewed carefully and analyzed. So a one-hour consultation usually gives the attorney a surface understanding of your issues. Imagine if a doctor offered a “free consultation,” and after a twenty-minute visit announced, “I understand completely. We must perform surgery and remove one part of your lung.” It doesn’t work that way. Instead, the doctor listens to your story (and charges an office visit fee), then orders the appropriate tests (more fees), and finally makes a decision on proper treatment (again, more fees).

more The Contingency Fee Agreement

In a personal injury case, the attorney will most likely charge legal fees pursuant to a contingency arrangement, which means he or she will collect a percentage of the fee after the case is settled or tried to a jury (and won). So this first visit or consultation would not be charged pursuant to an hourly fee anyway, nor would the second or third or thirtieth. It’s all part of the labor involved in representing a client and earning a 33.33% or 40% contingency fee.

So when a contingency-fee attorney promises the first consultation free, recognize that it is not actually free, nor would he charge you per hour anyway. The “Free Consultation” in personal injury matters is simply a marketing tactic. I have listened to hundreds of prospective personal injury clients explain their issues to me over the years, and in those cases I do not “charge” for this first visit. Given that it is an injury case, I will charge a “contingency fee” rather than an hourly rate, so I recognize that it is all part of the work I will do on behalf of my new client. In that way, I am not providing a free consultation. If the injury case is successful, the client will get paid and I will get paid at the end of the case. If not, unfortunately, no one gets paid.

You Get What You Pay For

Here’s the thing: you don’t want a free consultation. You should recognize the value you receive and the power you have when you pay for services. It will be the best way to ensure that you receive careful, quality representation from an attentive and responsive lawyer. (And this applies to all professions: doctors, accountants, money managers, barbers, painters—everyone.)

There is much truth in the adage that you get what you pay for. When I was in my twenties, and broke, I went to a hotel ballroom that promised a trip to the Bahamas if only I would listen to a simple, four-hour presentation on time-share purchases. I went. It was horrible. Highly trained and highly caffeinated salespeople talked and talked and talked at me about purchasing a time share. I endured this torture for hours, and then received a small document explaining how I was now entitled to receive a four-day stay in the Bahamas. Reading the details, it became clear that I could only use the offer during certain very limited periods in the year, and that I couldn’t arrive (or depart) on certain days of the week. Beyond that, I wasn’t even sure the hotel they promised me had vacancies on the days of the week I was allowed to show up. It quickly became clear my free Bahamas trip was useless. I never made it to the Bahamas (at least with my free voucher). And I will never get back that afternoon listening to “Keith” tell me about the unbelievable time-share deal (available for a short time only!).

Don’t Select an Attorney Based on Website Promises

As always, the best course of action for selecting the right attorney for your case is to do your research. Look for an attorney with demonstrated knowledge in your specific case area. Take a long look at the information provided on the attorney’s website. Does the attorney have knowledge about your specific legal issue? Does the attorney provide recent, timely, up-to-date information on the legal issues you are facing? Make sure the attorney has litigation experience in the relevant area of law. Has the lawyer handled cases such as the one you have? Finally, if possible meet with the attorney you wish to hire. After doing your research, call and explain your case to the firm’s paralegal and arrange a time to meet in person with the attorney. If after the meeting you aren’t convinced that you have found the right lawyer, or the fit simply doesn’t “feel” right, go back and start the process over.

I write more about choosing the right medical device lawyer here.

This is the safe and correct call. If you are diagnosed with melanoma, you need to focus on getting back to health. I suggest you stop taking the drug and schedule an immediate appointment with your dermatologist. In fact, I would say that even without a diagnosis of any skin cancer, you should ask your doctor (or a second doctor) if you should stop taking Viagra (or Cialis or Levitra). If a doctor you trust reviews your patient history and encourages you to remain on Viagra, fine.

2. Get Healthy

See your dermatologist or personal physician immediately. This is the most important thing to do if you are diagnosed with melanoma. Melanoma is the most serious of the skin cancers, and can certainly cause death is untreated or if treatment is delayed. Your health comes first. So move briskly to have the cancer removed. And of course stay out of the sun until you speak at length with your doctor.

3. Read the Studies

The starting point should be the post I wrote recently about the latest study identifying a possible connection between the use of Viagra (and Cialis and Levitra) and the onset of melanoma. This study is peer-reviewed and appears scientifically reliable. From my site you can click through to the study itself, or here. Read it carefully. Discuss the study’s findings with your dermatologist. In fact, discuss the findings with as many medical professionals as you have access to.

After reviewing the recent Sildenafil Study, do some additional research on the Internet. Many websites are well-researched, well-meaning, and helpful. But not all of them. I can’t stress this enough: The Internet is a freaky place. I once saw a funny cartoon depicting a doctor handing a prescription to a patient with the caption, “take two of these before you Google your symptoms.” Indeed, within a matter of minutes on the Internet you can be reading about the worst possible outcomes from taking a medication. Also, most people understand this but there is no requirement for truth on the Internet. People can write anything. (Of course, this rule applies to this website and to me too.) If something sounds unbelievable on a website, it is likely false. So again, be cautious and skeptical when conducting research on the Internet. The goal is to find reliable, helpful information, not the most sensational or terrifying.

4. Keep a Melanoma Journal

If you’ve read my posts in the past, you know I’m a big advocate of keeping detailed notes on your physical condition after any injury, whether that involves pain from a faulty artificial hip or strange symptoms after taking testosterone. In this case, write down when you first discovered the melanoma on your skin, what pain you may be experiencing (if any), what your doctor tells you about your treatment, what medical care you’ve received, etc. If the information is related in any way to your skin cancer, write it down. This journal will assist you in getting back to health, and it may also assist your attorney with a possible court case down the road. A melanoma journal (for lack of a better name) can provide extremely valuable information to an attorney putting together the best case for you in the event you have a viable claim against a pharmaceutical company for a harmful drug like Viagra.

5. Maintain Records of Medical Bills, Expenses

Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your medical care related to the melanoma, including surgeries, chemotherapy and radiation treatments, recovery, rehabilitation, medications, etc. In some cases, pharmaceutical companies will pay the out-of-pocket expenses of a victim of a failed drug like Viagra. In addition, keep detailed records of all time missed from your employment, including sick days which you were forced to use, and days out of work for which you lost compensation.

6. Call an Attorney You Trust

Let me say this: the scientific study linking melanoma to the use of erectile dysfunction drugs like Viagra, Cialis, and Levitra is in the early stages. Studies so far show an increased risk of developing melanoma among men who use these drugs, but we still need to look more closely at the connection. That said, a multi-district litigation site has already been established for the dozens of lawsuits filed against Pfizer, the manufacturer of Viagra, and I suspect we will shortly see MDLs against the makers of Cialis and Levitra, as those drugs work in the body in similar ways to Viagra. For more information on choosing the right product liability lawyer, you can check out my posts here and here and here. You can also simply call me for more information: (919) 830-5602.

Note: I am no doctor. As a product liability attorney, of course I can’t diagnose your health issues and cannot connect any injury you may have suffered to Viagra or to any other drug. Please see your doctor immediately if you suffer any negative health issue (related to the use of Viagra or not). That said, the general recommendations in this post are common-sense and reasonable, and consistent with the research I have done on this class of drugs.

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.

Over the years I have worked with many people who had hip replacement surgery. Many of these clients discovered high metal levels in their bodies from metal-on-metal (MoM) hip components. Often the person would let me know that she had her metal levels checked and that the blood work came back with abnormally high readings of cobalt, chromium, or other metals. Still, the treating physician would occasionally dismiss the blood work results. At least one doctor told a patient, “no one knows the effects of higher metal levels on the body. We haven’t studied the impact of metallosis sufficiently. It is nothing to be worried about at this point.”

Sadly, this isn’t true. And it’s not the best medical advice. There have been several studies over the years that looked at metallosis in the body derived from metal-on-metal hip components. The first incident of metallosis from MoM hip implants was reported in 1971. Since then, doctors have been reporting the higher incidence of metallosis in patients who received MoM artificial hip implants. Several scholarly studies have been conducted, including a recent one whose results were published this month examining the impact of metallosis on the cells of patients.

What Is Metallosis?

Metallosis is a serious medical condition involving the deposit and build-up of metal debris in the soft tissues of the body. Metallosis has been shown to occur when metal components in medical implants rub or scrape against each other. Imagine the metal cup and the metal ball in an artificial hip grinding against each other day after day, for months and years. Very tiny metal shavings can be scraped away and released into the human body. Over time, these tiny shavings can build up alarming metal levels in the blood. It is common in hip replacements but also occurs in other joint replacements.

The Latest Study on Metallosis

In the August 2016 edition of Biomaterials, an international research team looked at the physical impact of metallosis on the body. They studied metal-on-metal hip components made of cobalt and chromium and/or molybdenum alloys (CoCrMo). The study confirmed that use of these hip components can lead to the “release of wear products such as metallic particles and dissociated metal species, raising concerns regarding their safety” for orthopedic surgeons and patients. The study showed that release of these metal particles in the body are capable of producing problems on a cellular level, and can cause “aseptic osteolysis” and other health problems. Osteolysis is the destruction or disappearance of bone tissue.

The study also examined the impact of metallosis on “mesenchymal stromal cells.” These are multi-functional cells that can develop into several different cell types which produce bone, cartilage, muscle or fat. According to the study, metallosis interferes with this cell development and can cause serious problems and “impair osteogenic differentiation of MSCs.” That’s a mouthful, but it’s not good.

Importantly, the study concluded by saying that the continued use of cobalt, chromium, and molybdenum alloys for joint replacement implants “needs critical reconsideration.”

Dr. James Pritchett is an orthopedic surgeon who writes a lot about the onset of metallosis following hip implants. He states that symptoms of metallosis include pain, instability, and increasing noise from the hip. In addition, metallosis may cause some or all of these symptoms: pseudo-tumors, nerve and thyroid problems, brain impairment, heart problems, depression and anxiety, visual impairment, rashes, infection, and implant loosening.

The Takeaway

The takeaway is that more and more studies are showing that high metal levels in the blood are a bad thing. The recent study in Biomaterials journal points to harmful changes that metal levels can cause to the cells of human tissue, and that use of metal-on-metal components for artificial hips and other joints must be “reconsidered.” I hear that to mean: “discontinued immediately.” In any event, do not accept your physician’s offhand comment that your higher metal levels (even if only slightly higher than normal) are of no concern. Get a second opinion. Metallosis is not a healthy condition. Good luck.

Note: This post does not reference any individual person or client. The information is general and is derived from many circumstances over several years.

For further information, check out the Biomaterials website. Biomaterials is an international journal covering the science and clinical application of biomaterials. But be warned: these are people with high levels of very specific knowledge. Pack a medical dictionary.