One year ago a multidistrict litigation site (MDL 2804) was chosen as the venue for cities, counties, and states to bring civil actions against the makers of opioids. As I wrote about then, the opioid crisis has created huge burdens on states and municipalities. State and local governments have shouldered much of the cost of caring for individuals addicted to opioids. The federal government estimated that, in 2015 alone, 12.5 million people misused prescription opioids, and 33,000 people died from opioid overdose. In 2013, opioid abuse resulted in over $78.5 billion in economic losses. Cities, counties, and states have picked up much of that staggering cost. These government entities in MDL 2804 are fighting back, and many have filed lawsuits against the makers of opioids to recoup the billions of dollars lost in this ongoing crisis.

And while MDL 2804 is critically important, and overdue, other groups of opioid victims do not necessarily “fit” within the concept of an MDL focused on government plaintiffs. Among other victims, huge numbers of infants have been born addicted to opioids. Starting life this way creates layers of physical, mental, and emotional challenges. These children are the ultimate “innocent victims,” and they deserve an MDL court dedicated to ensuring a fair and full opportunity to seek compensation for their injuries.

Opioid-Addicted Infants Present Unique Claims

Last week, a team of lawyers asked the federal judicial panel (JPML) to create a new MDL related to the opioid epidemic, in this instance focused on infants and children who are born addicted to opioids. In their motion before the JPML, the attorneys argued that infants and children present “unique claims” than the lawsuits filed by cities and states in MDL 2804. As such a separate MDL is appropriate.

One primary issue facing these newborns addicted to opioids is Neonatal Abstinence Syndrome (NAS), which is a group of conditions affecting an infant born to a mother who was a frequent user of opioids while pregnant. Opioids can pass through the placenta and severely injure the fetus in utero. Once the baby is born, he or she will suffer the effects of opioid withdrawal. Symptoms for newborns with NAS include body shakes, seizures, crying, poor feeding, breathing problems, fever, diarrhea. Needless to say it is a brutal way to start out in life. NAS can cause intellectual, physical, developmental problems for the child. The motion noted that “these innocent young victims risk losing the opportunity to achieve a productive adulthood.

These cases involving children would require extensive discovery in the following areas:

• studies showing the effects of opioids on pregnant mothers and children in utero;
• the effects of methadone use by mothers on their children in utero;
• studies examining which medications are safe for pregnant mothers who are addicted to opioids;
• discovery relevant to the plaintiffs’ product liability claims.

Heartbreaking Opioid Abuse Statistics

The motion set out heartbreaking statistics related to opioid addiction:

In West Virginia in 2017, 50.6 cases of Neonatal Abstinence Syndrome were identified in newborns for every 1,000 live births (5.06% of all children born in West Virginia).

One West Virginia county had 106.6 cases of NAS per 1,000 live births.

Between 2008 and 2012, 780 million hydrocodone or oxycodone pills were prescribed in West Virginia, a state of 1.8 million people. That’s 433 pills for every citizen in West Virginia over that five year period.

In the town of Williamson, West Virginia, population 2,900, 20.8 million opioid pills were shipped between 2006 and 2016. Or 7,172 pills per resident.

Plaintiffs Seek West Virginia MDL

As West Virginia is one of the hardest hits states for opioid addiction, the attorneys representing opioid-addicted newborns have asked the JPML to create the new MDL in the Southern District of West Virginia. If West Virginia is not selected, the plaintiffs’ team asked the JPML to place the MDL in the Southern District of Illinois.

A decision should come soon, and I will keep you posted.

As we get older, our bodies weaken, bones become sore, and joints break down. Hip and knee problems are common conditions of aging. In fact, in the past decade millions of Americans have had hip replacement surgeries. Unfortunately, some defective artificial hips have caused patients more suffering than their original hip ailments. For one recent example, many patients who received the Birmingham Hip Resurfacing System by Smith & Nephew have had to undergo revision surgeries to cure new and unanticipated problems relating to the medical device. Many of these people have filed lawsuits.

Smith & Nephew’s Birmingham Hip Resurfacing System

Smith & Nephew designs and markets medical devices. One of the medical devices Smith & Nephew manufactures is a joint replacement system. An example of a joint replacement system is a hip implant. The Birmingham Hip Resurfacing (BHR) System is an artificial hip replacement made of metal components. BHRs have been used since 1997. The FDA approved BHRs for use in the United States in 2006; this approval was conditioned on Smith & Nephew reporting and analyzing adverse events, negative side effects, and complaints regarding the BHR. Just like any other medical device or medicine, the BHR must not provide false information (or false hope) to patients about what the device can accomplish.

The BHR is not the only hip replacement of its kind. There are similar metal-on-metal hip devices such as the M2A-Magnum Hip by Biomet, the Durom Cup by Zimmer, and the Accolade TMZF Femoral Hip Stem by Stryker.

However, there have been several recalls of these metal-on-metal hip replacements. While many manufacturers have voluntarily recalled their metal-on-metal devices, the FDA has had to mandate other recalls.

These recalls are due to medical complications and problems caused by the unexpected wear of the metal device over time. More specifically, as the metal artificial hip bends and moves, there is friction between the metal pieces which causes metal debris to collect in the joint and move to the bloodstream. Metal debris in the body causes pain, swelling, immune reactions, and other serious medical complications. Also, as the artificial hip moves and deteriorates, the implant may begin to loosen and require yet another hip surgery (“revision surgery”).

These medical complications have led to thousands of lawsuits against manufacturers of metal-on-metal artificial hips. Companies such as DePuy, Stryker, Zimmer, and Smith & Nephew are being sued by patients who have received these artificial hips and have experienced problems.

In fact, more than 200 suits from 42 states have been filed against Smith & Nephew regarding the BHR device. These claims have been joined together in multidistrict litigation in federal court in Maryland. A Memorandum and Order was issued last week on March 26, 2018. In the Order, the Court recognized some but not all legal claims under which Smith & Nephew may be liable for the harm and injuries experienced by these patients.

Federal Preemption and Product Liability

Patients had claimed that Smith & Nephew should be liable for their medical complications for its failure to warn patients of problems with the BHR under legal theories of strict products liability and strict liability. However, these claims, based on state laws, are preempted by federal law, which means that the state law claims are “inferior” to applicable federal laws and regulations. If a federal law applies and controls a specific legal claim, it “preempts” or takes precedence over a state law claim that may otherwise apply. Plaintiffs are typically not allowed to sue under both state and federal laws when federal law applies and controls the issue. Since federal law specifically empowers the FDA to regulate medical devices such as the BHR, the FDA laws and regulations govern some but not all of these claims. This means that Smith & Nephew may still be liable for violation of federal laws and regulations.

Further, the injured plaintiffs claim that there are manufacturing defects in the BHR. But since “the plaintiffs fail to allege how the BHR device deviated from FDA design specification and do not provide other specific factual support for the inference they ask the court to draw,” this claim was also dismissed.

Some Injury Claims Survive S&N’s Motion to Dismiss

Even though some claims were dismissed, the injured patients in this case survived S&N’s motion to dismiss on other claims, which means plaintiffs get to continue with their lawsuits against Smith & Nephew. These claims include allegations that Smith & Nephew:

• Failed to warn and report problems with the BHR to the FDA;
• Was negligent in failing to provide true information, report adverse events, and train medical professionals about the BHR;
• Breached their express warranty by making false claims about the BHR; and
• Negligently misrepresented the BHR “by marketing the device as safer than rival metal-on-metal devices.”

So what’s next? The discovery phase comes next, where patients will provide their stories and medical histories, and Smith & Nephew will be forced to turn over research, documentation, and information about the BHR and its complications. After discovery, “bellwether trials” will be scheduled. These bellwether trials will be vital in determining if a set of juries believes that the BHR was a flawed and defective product and whether S&N should pay for all these injuries.

If you have any kind of metal-on-metal hip replacement, including the BHR by Smith & Nephew, you should call a lawyer to discuss your legal options. Of course, you are welcome to call me (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.

In litigation, there are several harsh and punishing deadlines. The worst one is the statute of limitations (“SOL”). The SOL is a statute in state or federal law that limits the time you are allowed to file a lawsuit. In North Carolina, for example, the SOL for bringing a personal injury claim against a person or company for negligence is three years. This means if a guy runs a red light and “T-bones” your car, causing you to break your leg, you have three years from the date of the car crash to file a lawsuit. This may seem like a reasonable amount of time; as the injured person you certainly have an obligation to pursue valid claims in a timely manner, but it can also lead to unintended and unfair results.

The SOL is just one unforgiving deadline that a person faces in the bumpy wagon ride of civil litigation. There are also discovery deadlines, deadlines to respond to motions, scheduling order deadlines, and others. One deadline may involve a settlement deadline. A settlement deadline is a date negotiated by both sides in a large-scale litigation requiring plaintiffs to take certain actions by a specific date or lose the right to participate in the settlement. In “mass tort” product liability cases, courts want to resolve hundreds or even thousands of cases as efficiently as possible. And settlement deadlines are a valuable tool in getting large numbers of plaintiffs to take quick action. Let’s look at one example:

The DePuy ASR Hip Settlement Deadlines

The parties in the DePuy ASR artificial hip litigation have negotiated three settlements so far, all with different deadlines. I wrote about those deadlines here. In a nutshell, each of the three settlements allowed plaintiffs to participate in settlement if conditions were met by a certain deadline. The most important date was the date the plaintiff had revision surgery to remove the (bad) artificial hip. In all three settlement agreements, an amount of money was offered based on the length of time the person had the hip implanted. If the plaintiff had the hip implanted for less than five years, that plaintiff was entitled to the full amount of the settlement (with some exceptions). After the five-year anniversary, the amounts paid for the injury went down. After the ten-year anniversary, the injured person was not entitled to compensation under the agreements. Why? That’s a good question. I don’t know exactly. But based on the most recent settlement, a person who had revision surgery nine years and eleven months after the original implant surgery was eligible for settlement but a person who had revision surgery thirty-five days later was not eligible. This is simply an unfair result, and it occurs any time there is some (arbitrary) settlement deadline imposed. The product-maker defendants will say: “Wait a minute. We have to draw the line somewhere, and in any case most non-defective artificial hips have a normal product life-span of around fifteen years. So we shouldn’t have to pay beyond ten years.”

I don’t accept this logic. If the product failed, there should be compensation, even if the revision surgery occurred beyond ten years.

So What if You Are Approaching the Anniversary of Your Implant Surgery?

I’ve gotten several calls from people who are nearing the ten-year anniversary from the original implant surgery. Some have pain; some have elevated cobalt and chromium metal levels; others have different symptoms. A few of them ask me: “Should I go ahead and get revision surgery to beat the settlement deadline?” It’s a good question.

My answer: get revision surgery if you need revision surgery. Medical decisions are always separate from legal considerations. Whether to get revision surgery is solely a decision to be made in careful discussion with your surgeon and your family.

That said, if you need revision or repair surgery, and if you make the decision to have revision surgery, and if you have some control over the scheduling of the surgery, and if a surgery anniversary is approaching, you may want to get revision surgery prior to the anniversary date of the original implant surgery. For example, if you had the DePuy ASR hip implanted on March 1, 2010, and you now need revision surgery, and your surgeon is available for revision surgery on February 20, 2018 and March 5, 2018, choose the earlier date. (This suggestion goes for any brand of failed artificial hip or other medical device.) If both dates work for you and your doctor, don’t potentially lose money simply by putting off the revision surgery by just a few weeks or months.

This is not legal or medical advice.