I will operate from the same office in Raleigh, North Carolina, though please note the change in my email address (chodges@clayhodgeslaw.com) and phone number (919.830.5602).

My new JUSTIA website (www.clayhodgeslaw.com) should launch in the next few weeks, so look out for it. Thank you!

Clay Hodges
Hodges Law, PLLC
1620 Hillsborough Street, Suite 200
Raleigh, NC 27605
919.830.5602 (office)
919.830.4198 (mobile)
chodges@clayhodgeslaw.com
www.clayhodgeslaw.com
www.northcarolinaproductliabilitylawyer.com

It appears as if Philips’ legal problems concerning their CPAP and BiPAP machines in the United States may be coming to an end. Late last year, there was a tentative settlement concerning the plaintiffs’ economic loss claims. Then just recently, a court not only approved the economic loss settlement proposal, but Philips just agreed to pay $1.1 billion to settle the personal injury and medical monitoring claims. Let’s take a closer look at this CPAP settlement and what plaintiffs and future claimants can expect.

Economic Loss Settlement

In October 2023, the U.S. District Court for the Western District of Pennsylvania (District Court) issued an order preliminarily approving a settlement concerning the economic loss claims. These are claims that relate to the financial losses connected to the purchase of the affected machines. In April 2024, the District Court granted final approval of that settlement.

The official website handling the settlement claims process has been set up. It has eligibility information, how to submit a claim and the amount of money eligible claimants can receive. Generally speaking, if you’re eligible for an economic loss settlement payment, you could receive up to three payments.

First, there’s the Device Payment Award. This amount depends on the specific device you used. Award amounts range from $55.63 (for the DreamStation CPAP) to $1,552.25 (for the Trilogy 100/200, Garbin Plus or Aeris LifeVent).

Second, there’s the Device Return Award. This is a flat $100 payment for each recalled device that’s returned to Philips by August 9, 2024.

Third, there’s the Device Replacement Award. This is to reimburse you if you used your own money to buy a CPAP, BiPAP or ventilator device to replace an affected Philips machine. You must have purchased this replacement device on or after June 14, 2021 and before September 7, 2023.

The amount of this award depends on the price of the machine you purchased minus any financial payments you received to help pay for that machine (from an insurance company or third-party payer). The Device Replacement Award amount could also be reduced based on how many valid claims there are.

Personal Injury and Medical Monitoring $1.1 Billion CPAP Settlement

This is the big CPAP settlement that everyone is now talking about. The above-discussed economic loss settlement did not address legal claims relating to personal injuries and medical monitoring.

Medical monitoring claims are for current claimants and/or plaintiffs who aren’t aware of any health problems right now (that are related to the litigation), but believe health issues could develop in the future. As a result, the defendant agrees to pay for future medical tests and doctor visits to find any medical problems so they can be detected and treated as soon as possible.

Philips announced the $1.1 billion settlement on April 29, 2024, with the vast majority of those funds intended to pay for personal injuries. A small fraction, roughly $25 million, will go towards medical monitoring. This settlement came thanks to mediation and applies to the legal claims in the United States.

Because of how recent this settlement is, many details are still unclear. For example, we don’t know how much each victim will receive, as that amount will depend on how many people file a settlement claim and the extent of their injuries.

Additionally, it’s not clear what method will be used to calculate how much money each claimant receives. There will be a point system or formula that determines the settlement award based on factors like the severity of the personal injuries, how long the Philips BiPAP or CPAP device was used and the age of the claimant. The strength of the scientific link between personal injury and the use of the affected device might also be considered.

There are currently tens of thousands of people who are likely eligible for compensation under this settlement. Using very simple math, this means the average payout per person could potentially range anywhere from $10,000 to $100,000, although this is merely rough estimate and should not be considered the official range of settlement payouts.

Finally, we don’t know exactly when the settlement awards will be paid. That being said, we shouldn’t expect any checks to start going out until at least 2025. As I’ve said many times, the administration of settlements of this size move slowly.

If you believe you might be eligible for either settlement, it’s a good idea to talk to an attorney. You may not know which situation may apply to you until you have an initial consultation. After that, you can best decide what to do. I’m available to answer any questions you might have. You can call me at (919) 830-5602.

Note: This post is not legal advice.

How Do I Prove I Have a Qualifying Injury?

You’ll need to provide medical documents indicating you were diagnosed and/or treated for a qualifying injury. These must be original or certified copies. If it’s impossible to provide either, you’ll need to sign a sworn statement explaining why you can’t provide an original or certified copy along with an uncertified copy.

How Do I Prove I Was Exposed to the Toxic Water at Camp Lejeune for More Than 30 Days?

You must offer employment or housing documents that show you lived and/or worked at Camp Lejeune for at least 30 days between August 1, 1953 and December 31, 1987. If your exposure was because you lived with a service member, you must provide documentation proving your relation to the service member and that the service member worked or lived at Camp Lejeune.

How Much Money Could I Get from an Elective Option?

Although the Elective Option is still very new, which means a lot of this is fluid, it depends on two main factors: how long you were exposed to the contaminated water (when working or living at Camp Lejeune) and what qualifying injury you suffered.

Individuals with Tier 1 qualifying injuries are potentially eligible for between $150,000 and $450,000. The exact amount will be divided as follows:

• Tier 1 qualifying injury plus 30 to 364 days of exposure: $150,000
• Tier 1 qualifying injury plus 1 to 5 years of exposure: $300,000
• Tier 1 qualifying injury plus more than 5 years of exposure: $450,000

Individuals with Tier 2 qualifying injuries are eligible for between $100,000 and $400,000. The exact amount will be divided as follows:

• Tier 2 qualifying injury plus 30 to 364 days of exposure: $100,000
• Tier 2 qualifying injury plus 1 to 5 years of exposure: $250,000
• Tier 2 qualifying injury plus more than 5 years of exposure: $400,000

In addition to the above, there is a $100,000 benefit added to the EO offer if a claimant died as a result of their Tier 1 or Tier 2 qualifying injuries.

If I Accept the EO Offer, Will it Affect My VA Benefits?

No, there will be no offset to VA benefits equal to the EO settlement offer received. Accepting an EO offer will not affect any treatment or medical support you’re currently receiving from the VA.

What Are the Benefits of Accepting an EO Offer?

The primary benefit of an EO is that it provides a guaranteed monetary payment much faster than through litigation. Litigation is naturally unpredictable, no matter how strong a case you have. You never know what sort of judge or jury you’ll get and what their perception of your case might be.

Even if you win your lawsuit at trial (or it settles before trial), you can expect it to take several years before you finally get a check, especially if there’s an appeal.

Another important advantage to an EO settlement offer is that it’s easier to prove your claim than in court. With a lawsuit, you’ll encounter legal defenses, such as how your injury was actually caused by your diet or exposure to a different toxin at a location other than Camp Lejeune. To overcome these arguments, you’ll need to submit extensive evidence, including expert witnesses.

While not necessarily applicable to everyone, settling a claim through the EO process could mean a lot less stress and worry. Whether it’s having money sooner to pay for much-needed expenses or not having to deal with the uncertainty of trial, being able to quickly move on from your Camp Lejeune claim can be invaluable.

What Are the Drawbacks to Accepting an EO Offer?

If you have severe and/or multiple injuries due to Camp Lejeune contaminated water exposure, the EO offer probably won’t provide you with fair compensation or compensation that significantly exceeds what you could potentially get with a lawsuit. This is because the EO offer doesn’t factor in the severity of your injury or if you have multiple Tier 1 or Tier 2 qualifying injuries.

Accepting an EO offer also means you can no longer pursue your lawsuit relating to Camp Lejeune toxic water exposure. In other words, you can’t “double-dip” and receive money from the EO and litigation.

There are also several unknowns about the EO offer which could lead to more potential disadvantages. For example, even though the EO offer won’t affect VA benefits, it might negatively affect other medical benefits, such as those from Medicaid, Medicare, Tricare or private health insurers.

There’s also the fact that it’s unknown how long it will take before most claimants can expect to receive their EO offer. While unlikely, it’s possible that the EO offer could be less than a lawsuit settlement offer, yet arrive at about the same time.

How Can I Check the Status of My Administrative Claim and/or EO Offer?

Unfortunately, the DOJ and the Navy have no way of providing individual claim status updates. If you have an attorney, you can contact them to see if they have additional information. If you don’t have an attorney and want to learn more about your options for filing an administration claim or going to court, feel free to call me at (919) 830-5602. There’s still time to do both, but the window for filing a lawsuit will close soon.

The Camp Lejeune toxic water litigation continues to chug along in the U.S. District Court for the Eastern District of North Carolina, with no major developments. This isn’t too surprising given how it’s still early in the overall litigation. However, there’s been a major development in the administrative claims process.

Specifically, the U.S. Department of Justice (DOJ) and the U.S. Department of the Navy have announced something called an “Elective Option.” On paper at least, this is designed to help speed up the time it takes for claimants to receive compensation, as well as ease the burden of proving claims.

This may seem like welcome news, because as of the time of this writing, there are almost 100,000 administrative claims filed with the Navy. But a claimant should be vigilant and make sure the compensation offer under this option is reasonable and fair.

Let’s take a look at how this Elective Option process will work.

Background: The Administrative Claims Process

Before filing a lawsuit in court, a potential Camp Lejeune contaminated water plaintiff must first file a Camp Lejeune Justice Act of 2022 (CLJA) administrative claim with the Navy. An individual can only file suit in federal court if the Navy denies the claim or doesn’t make a decision on the claim for six months after filing.

Until recently, there weren’t many updates or signs of progress from the Navy concerning these administrative claims. This meant that for most individuals, any sort of compensation was likely years away. Not only did they have to wait six months after filing an administrative claim before they could go to court, but once in court, they’d probably be stuck in litigation for years. This Elective Option may dramatically shorten the time it takes for eligible individuals to obtain compensation for their injuries.

How the Elective Option Works

To take advantage of the Elective Option (EO), a claimant doesn’t have to do anything in addition to filing an administrative claim with the Navy. The Navy will automatically review all claims for EO eligibility.

If the Navy determines a claim is eligible for the EO, the Navy will refer the case to the DOJ for final review. Assuming the DOJ approves the EO for the claim, the Navy will submit a settlement offer to the claimant.

The claimant then has 60 days to accept or decline the EO settlement offer. If they accept, the claimant can expect payment within 60 days. If the claimant denies the offer, they can choose to withdraw their administrative claim, keep their claim with the Navy for non-EO administrative claim processing or bring suit in federal court (after waiting the necessary six months or having the administrative claim formally denied).

If the Navy decides a claim isn’t eligible for an EO offer, the claim will remain with the Navy for non-EO claims processing. Right now, it’s unclear how these EO-ineligible claims will be processed or how long it will take to process them.

There are a lot more details about the EO process, but to best cover that information, the remainder of this blog post will consist of a Q&A format.

Do I need to Refile My Administrative Claim to Take Advantage of the EO?

No, as the Navy will review all administrative claims submitted to it, even those filed before the announcement of the EO.

Can Individuals Already in Federal Court Take Advantage of the EO?

No, although the DOJ will review cases currently in court to see if they’re eligible for a settlement offer that’s similar to what the plaintiff would have been eligible for if they could take advantage of the EO.

What are the Elective Option Eligibility Requirements?

The first major requirement is that you suffered an eligible injury. The EO recognizes two tiers of injuries, all of which have been identified by the Agency for Toxic Substance and Disease Registry (ATSDR) as being sufficiently linked to contaminants found in the Camp Lejeune water supply. Tier 1 qualifying injuries include:

• Bladder cancer
• Leukemia
• Non-Hodgkin lymphoma
• Liver cancer
• Kidney cancer

Tier 2 qualifying injuries include:

• Systemic sclerosis or systemic scleroderma
• Kidney disease or end stage renal disease
• Parkinson’s disease
• Multiple myeloma

Assuming a person has suffered an eligible injury, they must show that they were exposed to the Camp Lejeune water (or water from Marine Corps Air Station New River) for at least 30 days. For most people, this will involve showing that they lived or worked at Camp Lejeune for at least 30 days.

Claimants who allege their exposure occurred while their mothers were pregnant with them will need to demonstrate that their mothers lived or worked at Camp Lejeune for at least 30 days while pregnant.

After these two requirements have been met, a claimant must meet two more conditions. First, they must have been diagnosed or treated for their qualifying injury before August 10, 2022.

Second, the date of the first treatment or diagnosis for the qualifying injury must have occurred within a special time window. Specifically, this first treatment or diagnosis must have occurred at least two years, but no more than 35 years, after the most recent exposure to the contaminated water.

In Part 2, we will look at proving a qualifying injury, proving exposure to Camp Lejeune toxic water, and the potential settlement outlook for this Elective Option. Stay tuned.

Clients approach their defective product cases in different ways. Some call me with an injury caused by a medical device and say, essentially, “figure it out.” I have no problem with a client taking this position. Others keep detailed notes and meticulous records and send me a package of documents that can be several inches thick. I never require a client to do this initial “leg work,” but it can often jump start a case against the device manufacturer. If you are inclined to be more involved in the process, at least early on, I have noted some important tasks below you can accomplish to launch your hernia mesh case.

Let’s start with two assumptions: (1) you had hernia mesh implanted in your body in the past, and (2) you have suffered injury because of the hernia mesh. Where do you go from there?

Identify Your Product

It starts with this. The first and best place to go for this evidence is the product stickers page. These product stickers are found with the hospital’s medical records from the original implant surgery. It will look like a sheet of paper with a label or labels (“stickers”) attached to the page. These product stickers will identify (often in very small type) the manufacturer, the reference number, the catalog number, the lot number. It will likely mean very little to you when you see it, but trust me, it is an important document. I will say this: when a new client calls me with a mesh injury and promptly sends me the product stickers page, I know we are off to the races.

Caveat: the product stickers page is not always available. I’m not sure why, but occasionally a hospital will throw away the product stickers. It is an awful practice. In that case the hernia mesh must be identified through the implant surgery records (such as reference to the product in the operative note) and in a last resort through the billing records from the hospital. In some cases I have gotten the implant surgeon to sign an affidavit attesting to the specific product implanted. No matter how we get it done, we must identify the product implanted.

Gather Medical Records

This step is related to the step above, but involves more information and more documentation. You will need to contact all your medical care providers and ask for all medical records relating in any way to your hernia mesh surgery, as well post-surgery treatment. This would include implant and revision operative reports, discharge summaries, pathology reports, hospital notes, and other information gathered in the mesh implant surgery. These documents are the foundation of a strong hernia mesh lawsuit.

Identify Your Injury

Virtually all injury begins with the onset of pain or discomfort. But for a successful hernia mesh case, we will need to get specific. In most hernia mesh cases, there will have been a medically necessary revision surgery. The hernia mesh is implanted, it causes complications and pain, and it has to be removed. (That is, if it can be removed.) In normal medical procedures, revision surgeries should not be necessary; therefore, revision surgeries are inherently an injury to the patient. Beyond that, it will be important to identify the specific kind of injury the hernia mesh caused. Hernia mesh frequently causes adhesions, which are bands of scar tissue that bind organs or tissue together. Hernia mesh also causes inflammation, scarring, folding or curling, rejection, allergic reactions, and other serious complications. These injuries will likely be described in the medical records.

This step is important for a secondary reason: so we can identify whether the injury was caused by something other than the failure of the hernia mesh. In some cases after hernia mesh surgery, injury can occur because of surgical infection (that is, infection shortly after implant surgery), from other surgical complications, or even from an outside trauma (like a bad fall or a car crash).

Chart Your Hernia Mesh Timeline

You will need to confirm the dates of implantation, the identify the dates of onset of symptoms, the date of revision, and the dates of further revisions (if more revisions happened). Beyond that, you can use the product stickers to identify the hernia mesh implanted, and you will want to identify the hospital where you had the mesh implanted, the surgeon who performed the surgery, and the location and surgeon for any revision surgeries.

Maintain a Symptoms Journal

I always encourage this. It is simple enough: When you first begin to notice any sensations or pains which seem abnormal or unexpected, write down the date and a brief description of the pains on a piece of paper (or a notes app on your smart phone). The more detail the better—note the kind of pain you feel, the location, and any other descriptions. This journal may provide important information for your doctors but also for me as your attorney when I prepare a settlement package or a lawsuit. A pain/symptoms/well-being journal can provide valuable information to an attorney putting together the best case for you in the event you have a viable claim against a manufacturer for a failed hernia mesh product.

Contact a Good Product Liability Lawyer

Remember, you are not expected to do the work listed above. I have done this investigation often and I have gotten quite efficient at putting together strong cases. If you had hernia mesh revision surgery, you can contact me and ask me to sort it all out. So give me a call ((919) 830-5602) or use the contact form on this page to launch your hernia mesh case.

Note: A version of this article appeared on this site in July 2017.

In today’s blog post, we’re going to go dig a little deeper into Camp Lejeune claims arising from the Camp Lejeune Justice Act of 2022 (CLJA). I’ve written about this remarkable legislation on several occasions, from when it was just a bill to after it got signed into law by President Biden in August 2022.

If you read those blog posts, you’ll recall that before you can file a lawsuit to recover damages for your exposure to the contaminated water, you have to first file an administrative claim with the appropriate federal agency as required by 28 U.S.C. § 2675. Only if this administrative claim gets denied can you sue the federal government. Read on to learn more about this requirement and what it entails.

Where Do I File This Administrative Claim?

The government agency or department tasked with handling Camp Lejeune claims is U.S. Navy Judge Advocate General (JAG), specifically the Tort Claims Unit located in Norfolk, Virginia. This office is part of the U.S. Navy JAG’s Admiralty and Claims Division (also known as Code 15).

According to its website, the Admiralty and Claims Division handles more than 40,000 claims and pays out or recovers $60 to $70 million each year. These claims relate to various federal laws, such as the Military Claims Act and Federal Tort Claims Act. And now, they’ll be adding the CLJA to the list of laws that result in claims for them to handle.

How Do I File an Administrative Claim with the U.S. Navy JAG?

The exact process is undergoing modifications and tweaks as the Tort Claims Unit processes claims. But as of the time of this writing, the first step requires you to file a Camp Lejeune CLJA claims form.

Step two requires you to submit the form to the Tort Claims Unit and this can be completed in one of two ways. The first way allows you to email the form to CLclaims@us.navy.mil with the following subject line: “last name first name MM.DD.YYYY.” This date will be the date the claims form is being submitted. It’s strongly recommended that claims forms be submitted by email for faster processing.

The second option is to mail the claims form to:

Department of the Navy Office of the Judge Advocate General Tort Claims Unit Norfolk Attention – Camp Lejeune Claims 9620 Maryland Avenue, Suite 205 Norfolk, VA 23511-2949

If there are additional questions or need for extra guidance on completing the claims form, you can call the Tort Claims Unit at 757-341-4583. You can also refer to the Camp Lejeune Justice Act Claims Procedure form, which contains additional instructions on completing the claims form. One thing to keep in mind about the Camp Lejeune claims filing process is that you do not send any medical records or evidence along with the claims form. That information will be submitted at a later time.

The Tort Claims Unit is also trying to set up an electronic filing system to better handle the high volume of claims coming in, but that’s still in development right now.

What If I Already Filed a Claim Before the CLJA Became Law and My Claim Was Denied?

You’ll need to refile the claim for reconsideration before you file a lawsuit against the U.S. government.

Do I Need a Lawyer to File a Camp Lejeune Toxic Water Tort Claim with the Tort Claims Unit?

No, you do not. Camp Lejeune claims form is relatively straightforward, although I want to emphasize that this entire process can and probably should be handled by a competent attorney. Finding a good lawyer to assist you early in the process has distinct advantages. Check out my post about the pitfalls of injured plaintiffs representing themselves here. The Tort Claims Unit expects many claims forms to be filed by lawyers on behalf of their clients.

If you think you might have a claim for injuries sustained at Camp Lejeune due to toxic water contamination, it helps to speak with a lawyer. Most will offer free consultations to give you a clearer picture of what you need to do next, such as filing an administrative claim (and can also answer questions about that process).

If want to speak with a personal injury attorney, my law firm’s telephone number is (919) 830-5602. Whether you hire an attorney or handle your claim on your own, good luck. I hope you get a recovery that can help compensate you for your injuries and reflects the appreciation our country has for your service.

Health care is an industry that, for the most part, is pretty quick to make the most of new technology. One such area is medical records.

With the increased capabilities and reduced costs of computers, networks and electronic storage, electronic health records (EHR) are primed to take full advantage of what information technology has to offer the medical field. These advantages can include better cost efficiency and improved patient care.

That’s one reason why Congress passed the Health Information Technology for Economic and Clinical Health Act (HITECH Act). This law set out to promote the use and adoption of EHR and medical information technology.

One of the things the HITECH Act did was establish rules concerning access to patient EHR, including who can access them and how much it costs to obtain a copy of these records. But a court case just made it more expensive for attorneys acting on behalf of patients to obtain these records. This could have a notable impact on a plaintiff’s ability to recover for injuries caused by a negligent company or individual.

Access to Medical Records: An Overview

After the passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S. Department of Health and Human Services (HHS) created regulations that outlined a patient’s right to his or her medical information.

Specifically, 45 CFR § 164.524 set out how someone could review or obtain copies of his or her health care records. These regulations also set out how much a medical provider could charge individuals for obtaining copies of their records.

Basically, this regulation said that a medical provider could only charge patients a reasonable, cost-based fee (Patient Rate). This meant that the fee could only include actual production costs, such as labor, materials, and postage for producing and sending the documents to the patient.

When passed in 2009, the HITECH Act made a few changes. It not only streamlined a third party’s ability to get a copy of a patient’s EHR (with the patient’s permission, of course), but it further limited the fee that the medical provider could charge patients.

In 2013, HHS released new regulations relating to access to EHR. One of the things these regulations did was allow a patient to get a medical provider to send any of his or her medical records to a third party, even if it wasn’t an EHR.

Then a big change came in 2016, when the HHS release its Guidance titled “Individuals’ Right under HIPAA to Access their Health Information 45 C.F.R. § 164.524.” This provided additional information on how to calculate the Patient Rate, including the option for a flat rate of $6.50. But most importantly, the 2016 Guidance allowed third parties to pay the Patient Rate only as long as they were getting the documents at the request of the patient.

But a court case from January 2020 changed all this.

Ciox Health, LLC v. Alex Azar

Ciox Health, LLC (Ciox) is in the business of processing patient medical information on behalf of health care providers. Ciox’s pricing model relied on the understanding that the Patient Rate only applied to individuals who were asking for copies of their own medical records. But when patients asked that their records go to a law firm or insurance company, Ciox could charge a fee that far exceeded the Patient Rate.

But thanks to HHS’ 2016 Guidance, third parties only had to pay the Patient Rate, which was sometimes just $6.50. This was a problem for Ciox because it meant a significant loss in revenue.

So what did Ciox do? It did what almost any other business might do when the government makes a law or rule that cut into their profits – it sued.

Ciox won its case when the U.S. District Court for the District of Columbia concluded that HHS was not allowed to apply the Patient Rate to third parties and that patients could only ask for their EHR to be sent to a third party (as opposed to any medical records, regardless of format).

What the Ciox Case Means for Plaintiffs

This case means that injured plaintiffs will now have the added burden of not just requesting their medical information, but once receiving it, forwarding it to their attorney. Or if plaintiffs want the information sent directly to their attorneys, there will be a much higher fee, often in the hundreds of dollars.

Many attorneys will probably be the ones to advance this large hard-cost expense. But in the end, everyone will pay.

The plaintiff will be expected to pay litigation hard-costs from the proceeds of any settlement or trial verdict. If the case is lost, the attorney usually pays these litigation costs, which could make attorneys less likely to take on winnable but risky cases in the future. If it’s just one case, it’s not a big deal. But many injury law firms could have dozens or hundreds of cases where they have this new expense. Now we’re talking tens if not hundreds of thousands of dollars in hard cost expenses.

The defendant will also eventually pay, because these added costs for obtaining medical records will indirectly factor into any verdict or settlement.

Congress or HHS should make changes that make it more affordable for patients to get copies of their complete medical records to their lawyers, insurance companies or other third parties. Until then, plaintiffs and defendants can expect the litigation process to get even more expensive.

All you have to do is Google a phrase like “Roundup Settlement” and you will get plenty to read. Some articles suggest a massive settlement agreement may be announced any day, while another post may trumpet: “Parties Still Far Apart on Roundup Settlement.” Who is right? The truth is, aside from a very few people, like chief mediator Kenneth Feinberg, no one can say for sure. But this much is true: multi-billion-dollar settlements in massive product liability cases take a long time to complete.

What We Know

So this is what we know as of today: Bayer AG and Monsanto, the two corporate defendants, have been in negotiations with the plaintiffs’ executive teams for several months to attempt a settlement that is reasonable and fair. Multiple media outlets, including The New York Times, are reporting that both sides are discussing a settlement that could involve tens of thousands of plaintiffs and may reach $10 billion dollars. A few media reports indicate the sides are getting closer to a settlement. And if so, that is good news. Still, even though the Wall Street Journal has recently reported that “draft settlement terms” have been reached between defendants and several larger plaintiffs’ law firms, the article also stated that “[a] formal deal hasn’t been signed and could yet fall apart.” So be very cautious about optimistic reports of settlements. Often the final, smaller details are the hardest to hammer out.

And another word of caution: even if a settlement is announced later today, it will take several months before the infrastructure is in place to process the first settlement payouts. Each settlement requires rounds of careful review and paperwork, and this takes a lot of time. The best practice is to hire a lawyer you trust and wait for him or her to provide you with real updates on settlement.

Finally, there is this awful coronavirus. As I write this we are just beginning to see how destructive the pandemic will be to our national health, to employment, to markets, and to our ability to sustain normal business practices. This virus is going to delay everything, from the NBA season to the Roundup Settlement.

The Takeaway:

Be patient with the Roundup settlement news you read on the Internet. Although I am optimistic things are moving in a positive direction, product liability cases always take longer to resolve than anyone originally predicts. I realize each plaintiff has suffered a serious illness and deserves compensation now, but often the rush to report a rumor of settlement can inflict additional emotional damage if talks later break down. It’s always best to be patient and pace yourself. These things are marathons.

How is Roundup Harmful?

Glyphosate is the key active ingredient in Roundup, a weedkilling compound developed by Monsanto. Unfortunately, by 2008 glyphosate was identified as a risk factor for the development of non-Hodgkin lymphoma. In a May 2014 study, the International Agency for Research on Cancer determined that glyphosate increased the risk of developing non-Hodgkin lymphoma. By March of 2015, that organization stated that glyphosate should be considered a “probable carcinogen.” It works this way: exposure to glyphosate can occur through skin or eye contact or through inhalation. Studies suggest that once glyphosate enters the body, it acts as an antibiotic that kills bad bacteria but also good bacteria. This weakens the body’s immune system and can damage cellular DNA. Often, cellular damage occurs in the mouth and throat.

Non-Hodgkin lymphoma is a cancer that starts in the white blood cells and affects the body’s entire lymphatic system, the system responsible for protecting the body against disease and infections. This cancer can begin in any part of the body where lymphatic tissue is found, such as lymph nodes, the spleen, bone marrow, tonsils, and digestive tracts. Cancer that begins in the lymphatic system can spread quickly.

If you used Roundup often and later developed non-Hodgkin lymphoma, feel free to give me a call: (919) 830-5602. Either way, be patient and good luck.

Note: Bayer AG and Monsanto deny the connection between the use of Roundup and the increased risk of developing cancer. Photographs used in this post are for illustrative or editorial purposes only and are not intended for any commercial use.

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.

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

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

Companies Don’t Like to Pay Settlements

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

Companies Can Get Away with Not Paying

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

Settlement Delays Are Profitable

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

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

One Example: Johnson & Johnson

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

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

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

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

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

Last week news media outlets reported that Bayer AG and Monsanto had offered to settle United States Roundup cases for an amount up to $8,000,000,000. That’s eight billion dollars. If true, it would be welcome news, or at least a good start, as there are currently over 18,000 cases filed against the companies. These lawsuits allege that extended exposure to Roundup caused plaintiffs to develop non-Hodgkin lymphoma (NHL), a serious cancer that can spread to lymph nodes throughout the body. For plaintiffs afflicted with a serious illness like NHL, news that a global settlement has been achieved is always welcome, because these plaintiffs need compensation as soon as possible, and years of expensive litigation is not good for anyone (except maybe defense lawyers).

The news reports of settlement flashed across the Internet, as such things do, perhaps encouraged by recent statements made by Bayer’s CEO that the company would consider settling on reasonable terms if all United States cases could resolve. Further, Bayer and Monsanto recently lost a Roundup case where a California jury awarded a couple $2 billion dollars for the non-Hodgkin lymphoma they both contracted after using Roundup for years. You can read about that $2 billion Roundup verdict here.

Despite all that, on Friday Mediator Ken Feinberg issued a statement that “Bayer has not proposed paying $8 billion to settle all the U.S. Roundup cancer claims. Such a statement is pure fiction,” and that “[c]ompensation has not even been discussed in the global mediation discussions.” So there you have it. At this point I would recommend you listen to Mr. Feinberg’s statement, as he is a central figure in the Roundup settlement talks.

Still, it is also true that mediators must always control the flow of information. When dealing with two entrenched, adversarial sides, it is vitally important for the mediator to control the narrative. If one side believes (correctly or not) that it is getting the upper-hand in a complex negotiation, it can become emboldened. And an emboldened side can wreck what could have been a successful mediation. (I have seen it in mediations in my individual cases.) So, even if progress toward settlement is being made, I fully understand how Ken Feinberg would not want reports of this progress to be made public. After all, nothing is accomplished until both sides agree and sign the documents. And I believe that nothing has been signed as yet.

I would say it is also a positive sign for a Roundup settlement that Ken Feinberg is involved and has been named Special Master. Mr. Feinberg oversaw the compensation fund for victims of the September 11th attack and other large scale litigation involving thousands of injured plaintiffs. In fact, if you want to learn more about Ken Feinberg, you can check out The Neutral, a podcast by Michael Lewis where Ken Feinberg discusses his career resolving thousands of lawsuits and injury claims.

For now there is no Roundup settlement and the litigation marches on. The primary allegation in the lawsuits is that the key ingredient in Roundup herbicide, glyphosate, is not safe for human use. Monsanto has used glyphosate in Roundup herbicide since the early 1970s. In 2008, glyphosate was identified as a risk factor for developing non-Hodgkin lymphoma. Other studies followed which conclude that glyphosate should now be considered a “probable human carcinogen.”

A person can be exposed to glyphosate through personal use, such as using Roundup repeatedly on lawns or as part of a job (say, on a golf course or work as a landscaper). An individual can also be exposed to this carcinogen through proximity to Roundup use. For example, if an person lives near a farm where Roundup use is frequent, this exposure can potentially lead to non-Hodgkin lymphoma.

If you or someone you know has suffered from non-Hodgkin lymphoma and was exposed to Roundup, please call me today to discuss your potential case: (919) 830-5602. I can help. Either way, good luck to you.

Product Stickers: The Gold Standard

It all sort of starts with “product stickers.” These are the identifying stickers that are attached to the box containing the medical device, and they can be peeled off and affixed to a nurse’s hospital note or to another page in the hospital or surgeon’s record for the implant surgery. It goes something like this: the representative for the device maker shows up with the artificial hip components (or other medical device). The surgical nurse or the surgeon will double check that the components are the precise ones needed for the surgery, scan them into the system and note them in the record. The nurse will then peel off the product stickers and attach them to the hospital record and include them with all the other pages of documents explaining details of the surgery. The image at right is an approximation of what the stickers will look like: a bar code, the name of the manufacturer, the specific product name, the Lot and Reference numbers, and other identifying information.

Hospital Records: Typed Identification of Specific Components

For some reason, not all hospitals and surgery centers keep product stickers. Some simply throw them out with the boxes. It is not a good practice, but it happens. In those cases the person responsible for identifying the components usually types in the specific lot and reference numbers and other identifying information for each device component used in the surgery.

Operative Report

In any surgery the surgeon always writes up (usually dictates) an Operative Report where he or she describes what occurred during the surgery. In this report the doctor will explain the procedure and will reference the components used and implanted. In another section of this report, titled something like “Implants,” the doctor will list the specific components, with complete names and actual sizes.

Explants: Preserving and Keeping the Actual Device Removed From Your Body

The actual gun used in an armed robbery is better evidence than a description or a photo of the gun. The same holds for a product liability case involving a failed medical device. That’s why you should do all that you can to “preserve evidence” by making sure your surgeon understands you want to preserve and maintain any components removed from your body (“explants”). I wrote extensively about preserving explants here, and I invite you to read that article, but in a nutshell you need to send a letter to your physician asking her or him to preserve all evidence, especially explanted medical devices following the surgery. With written notice in advance, the doctor and the hospital usually understand the drill and will preserve the removed components, usually by sending the explanted components to the pathology department to hold the components for the patient or the patient’s attorney.

Surgeon’s Affidavit

As you can imagine, lawyers representing companies that sell defective medical devices will use every advantage to derail your case. If defense lawyers can cast doubt on what device is in your body, then you as the injured person cannot win your case. In some instances the product stickers were not maintained with the hospital records and the explanted components were not preserved. In that case, even with the typed identification of the products (see Hospital Records, above), you may need to obtain a signed and sworn affidavit from the surgeon testifying to the exact components implanted in your body. I have used this technique in the past and it has worked well.

Get Help From a Good Product Liability Lawyer

I’ve written about this subject on this site so often I’m not even going to link you to the other articles (they are easy to find). But I will say this: you need to work with an experienced product liability lawyer on any defective medical device case, and preferably before you undergo revision surgery (for several reasons, but mainly so the attorney can communicate with the surgeon and the hospital in advance about preserving all relevant evidence).

Identifying your medical device is very important. Being legitimately injured by a defective product is not enough. You have to show what product injured you. If you can’t, you don’t even know which medical device maker to sue. Put obviously: you cannot sue DePuy Orthopaedics for a defective Smith & Nephew artificial hip. So it is vital that you identify the exact components that injured you, in as many ways as possible. Good luck.

Stryker Orthopaedics has announced that it reached a national settlement in the multidistrict litigation focused on the Stryker LFIT V40 femoral head. The LFIT V40 femoral head is one component of Stryker’s artificial hip system. This settlement announcement is a bit surprising, as the MDL was created for the LFIT V40 femoral head in April 2017. As medical device multidistrict litigation goes, this is a very quick path from formation of the MDL to settlement. One reason for the speed is that this MDL is smaller than other artificial hip MDLs based on the number of injured plaintiffs. The LFIT V40 settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court.

In any event, for those people hurt by the LFIT V40 femoral head, this is good news. The terms of the settlement have not been released. I will certainly update this website when the settlement agreement is made available. As for now, all discovery and trial preparation have been stayed (or stopped). The first bellwether trial, scheduled for September 2019, will be removed from the trial calendar. The focus now will be on processing individual settlements for plaintiffs.

Remember that each plaintiff in this or any other medical device litigation is not required to accept the settlement. Although it is often reasonable for the plaintiff to accept the terms of settlement, no plaintiff will be compelled to accept any settlement. As with any litigation, it is important for individual plaintiffs and their attorneys to slow down, review all the terms of settlement, and make a careful decision on whether to participate in the settlement.

I have written about the LFIT V40 femoral head product failure several times in the past. Problems with the hip component began several years ago. On August 29, 2016, Stryker announced a recall for the LFIT V40 head. The recall focused solely on the femoral head, which is the “ball” part of the hip replacement. This femoral head fits inside the “cup” and is also attached to the “stem” (which is connected to the femur, or thigh bone).

The recall involved LFIT V40 heads manufactured before 2011 with the following catalog numbers and sizes:

LFIT V40 Femoral Head Is a Metal-on-Polyethylene (MoP) Artificial Hip

Unlike many other artificial hip product failures, the Stryker LFIT V40 not part of a metal-on-metal artificial hip system. The LFIT V40 system is built utilizing a metal acetabular cup, a polyethylene (plastic) liner, the LFIT V40 cobalt-chromium femoral head, and a titanium femoral stem. Unfortunately, soon after being sold and implanted, the Stryker LFIT V40 began to fail, at a high rate. Patients who received the Stryker LFIT V40 suffered similar symptoms as those who received metal-on-metal hips, including metallosis.

LFIT V40 Taper Lock Failure

The failure of the Stryker LFIT V40 involved the junction of the neck of the femoral stem and the femoral head or ball. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball. However, in many cases the LFIT V40 femoral head began to corrode, which means to disintegrate and lose metal. The corrosion occurred at the site of the connection to the neck (the taper lock). This corrosion in the head would progress slowly, but over time the corrosion would cause the taper lock to loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. One study found that the loosening would cause fretting and micro-motion at the taper lock site, and this friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like so many other patients who received metal-on-metal (MoM) artificial hips.

Keep in mind that the corrosion in the LFIT V40 can be slow. This means you may not know the Stryker hip is failing and releasing cobalt and chromium into the body for years. By then, the neck may have begun to corrode, and when that happens the femoral stem may need to be removed and replaced, which can be a very difficult surgery. The femoral stem is implanted down the center of the femur bone, and when it sets it is usually there permanently. Removing the femoral stem is difficult and painful.

Check back here for updates on the Stryker LFIT V40 femoral head settlement. And if you believe you have a failed artificial hip in your body, call me to discuss: (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 my pitch: People who had to undergo revision surgery because their DePuy ASR artificial hip failed should be compensated for their injuries, even if the revision surgery occurred beyond the ten-year anniversary date of the original implant surgery.

Let me admit the obvious: It’s a bit self-serving for me to argue this point. I am an attorney and I represent individuals injured by the failure of the DePuy ASR device. But I have read a lot about these cases, over many years, and the more I understand the science behind these metal-on-metal (MoM) hips (or the lack of science), I am more convinced that thousands of people have been unfairly injured, even if those injuries did not become obvious for several years. Even ten years.

The DePuy ASR Settlements

I have written extensively about the ASR Settlements. The first and second agreements offered compensation for individuals who had revision surgery up to nine years after the original implant surgery. The third settlement agreement (or second extension agreement if that makes more sense), for the first time, extended the offer of compensation to those individuals who underwent revision surgery after the nine year anniversary up to the ten year anniversary. So that was progress.

The deadline for the third settlement deadline has passed. It applied to people who had revision surgery prior to February 15, 2017 (essentially a year ago). Still, there are many people out there who had revision surgery after February 15, 2017. Other people are having problems but haven’t scheduled revision surgery. Some of these people had the ASR implanted eight years ago, but others may have had it implanted ten years ago, and even longer.

My Pitch:

Most of these people implanted with the ASR have no idea the product in their bodies fails at a much greater rate than other artificial hip systems. Many of these people are not aware that they have been injured. For example, many people do not immediately feel the effects of metallosis (the build up of metals in the blood and tissue). Others have neurological symptoms related to elevated metal levels but assume it is part of aging or caused by something else. A few victims know their DePuy ASR hip has failed but so dread further surgery that they put revision off and simply live with the unpleasant symptoms. These people are injured by the DePuy ASR device, much like people who had revision surgery five or six or eight years after implant surgery.

Beyond that, important information regarding the high failure rate of the ASR took years to be discovered. In hindsight it appears the makers of the ASR were in no hurry to release studies, information, and documentation detailing the high failure rates. I wrote about some of that extensive evidence here. The point is, if a person doesn’t know what has caused her injuries, how can she pursue a claim?

Necessary Evils

Settlements are necessary evils in litigation. With hundreds or thousands of injured plaintiffs in huge product cases, there is simply no other way to resolve so many lawsuits. And let’s face it: in many cases, both sides go away unhappy. The medical device makers don’t want to pay billions of dollars to settle cases, and the injured plaintiffs think the terms of settlement are not generous enough to compensate them for their specific injuries. And with any settlement, there will be deadlines that are completely arbitrary. These deadlines inevitably create bizarre and unfair results. For example, I suspect there are at least a handful of people who got revision surgery to remove the DePuy ASR hip on February 16, 2017. Those people did not qualify for the latest settlement agreement. By one day. And there will be plenty of people who received revision surgery at ten years and one day, or ten years and one month. It is simply bewildering that those people should not be permitted to participate in some kind of meaningful settlement.

I believe these people have viable claims. And DePuy Orthopaedics should recognize and pay these claims.

The bottom line is this: time is running out. If you have the DePuy ASR hip implanted, and you have had or need revision surgery, talk to a lawyer immediately about reviewing your possible claims. My firm number is (919) 830-5602. Good luck.

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.

The opioid epidemic in America is a national crisis. The U.S. Centers for Disease Control recently reported that more than 64,000 people died in 2016 from drug overdoses, with the great majority of those deaths caused by opioids. The numbers for 2017 only look worse.

Last month, I wrote about whether people affected by the opioid epidemic can sue the drug manufacturers and distributors, doctors, pharmacies, and other suppliers who contributed to the addiction that destroyed their lives. But what can victims recover in lawsuits involving dangerously addictive prescription drugs?

You know all too well what you have lost—your financial security, your health, or perhaps even a loved one’s life. Now, let’s review the legal terms we use to discuss these losses.

Defining Damages

Losses that a person seeks to recover in a lawsuit are known as damages. Damages are, in short, the financial reward that a successful litigant wins at the end of a case. Damages are generally divided into two broad categories: compensatory, or actual, damages and punitive damages.

Compensatory damages seek to restore what injured people or their survivors lost in terms of money. These damages are awarded to compensate someone for an injury. They are calculated by considering what a person lost because of someone else’s wrongdoing. Typical compensatory damages include lost income and medical expenses.

Not all compensatory damages are measurable, however. Economic damages—like hospital bills—have an exact, provable dollar amount. Noneconomic damages attempt to put a dollar value on pain and suffering or on the loss of a loved one’s companionship. They’re harder to measure and prove but often are worth more than economic damages.

Punitive damages, on the other hand, aren’t about paying back what a victim has lost—they’re about punishing the responsible party for doing something wrong and discouraging others from behaving in the same way. Punitive damages tend to be significantly greater than compensatory damages, but they aren’t available in every case.

As an example, remember the case against McDonald’s when a woman was scalded by excessively hot coffee? The jury in her case decided that she should receive $160,000 in compensatory damages, including her medical expenses, and another $2.7 million for punitive damages to prevent McDonald’s and others from serving dangerously hot beverages.

The McDonald’s case points out another critical reality about damages: just because a jury awards you damages doesn’t mean that the judge will (or can, in some cases) impose that full amount. The plaintiff in that case was ultimately awarded only $640,000 by the court and ended up settling for even less to avoid an appeal.

Damages in an Opioid Addiction Case

What do these definitions and terms mean for you? For an opioid addiction case, the actual damages suffered by addicts or their loved ones could include:

• lost income from missing work, losing a job, or losing the ability to work due to disability;
• medical costs, whether from a medical emergency (such as an overdose) or from long-term health problems caused by opioid abuse;
• drug treatment costs to overcome an addiction; and
• pain and suffering related to opiate addiction and the damage it does to relationships and lives.

Bear in mind that you will have to justify any damages you seek and explain how they are related to the addiction to opioids. This means both documenting any financial losses and connecting the responsible party’s actions—whether that’s the manufacturer who failed to properly warn about a drug’s addictive qualities or the doctor who prescribed you too many pills and enabled your addiction—to the damages you seek.

What Should You Do Now?

If you or a loved one has become addicted to opiates after receiving a prescription, there are a few things you should do today.

First, if you or your loved one is still actively addicted, get help. Nothing is likely to get better until the addiction is under control—and no amount of money will fix that.

Second, start to make notes about the losses you’ve suffered because of opiate addiction. Keep track of these and add to them as you think of additional types of damages or as more damages occur. It’s better to err on the side of including too much information or reaching too far than it is to leave something out and forget about it. While you’re making your list, consider what you would need to document those losses: collect paystubs, hospital bills, and treatment center receipts in one place.

Third, consider contacting a lawyer. This isn’t the type of case that people can handle on their own. Product liability and medical malpractice cases are complex and challenging, and your opponents have a host of lawyers to defend them.

There have been two major developments in testosterone replacement therapy litigation in the past week. Last Thursday Eli Lilly & Co., the maker of the testosterone product Axiron, announced to Judge Matthew Kennelly in Illinois that an agreement had been reached to settle claims by people injured by Axiron testosterone. In the second development, the same judge tossed a jury verdict awarding $150,000,000.00 in punitive damages to a man who suffered a heart attack while taking Androgel testosterone.

Let’s take a quick look at both litigation developments:

Axiron Testosterone Global Settlement

Two bellwether trials in the Axiron testosterone litigation had been scheduled for January and March 2018. In one case, a plaintiff alleged that Axiron had caused his heart attack. In the second case, the plaintiff alleged that the testosterone product had caused deep vein thrombosis (DVT). These two cases were going to be the first trials over injuries sustained by Axiron in the multidistrict litigation, or MDL. Nevertheless, on December 21, 2017 Eli Lilly announced to the judge that a framework for settling all Axiron lawsuits had been reached by the executive committees for the plaintiffs and defendants.

The terms of the proposed settlement were not announced. The judge gave both sides forty-five (45) days to finalize the terms of the settlement. The Axiron testosterone cases are part of more than 6,000 lawsuits brought against several testosterone makers, including Eli Lilly, AbbVie, and Auxilium.

On the strength of this settlement announcement, Judge Kennelly postponed the upcoming Axiron bellwether trials and all trial deadlines. In a way this is a shame, as several bellwether trial verdicts give all sides a clear picture of how juries view the harm done. Of course, there is serious risk on both sides in trying these cases. If a jury awards a huge amount of damages, the defendant company will eventually pay more in the larger settlement. If several juries find no link to the product and the injury, the plaintiffs suffer. We will not get to see what juries thought of the Axiron testosterone product at this point.

I will update you here as soon as the Axiron Master Settlement Agreement is released.

Androgel: $150,000,000 Jury Award Set Aside

I must admit I saw this coming. I essentially predicted it. I wrote about Mr. Mitchell’s large punitive damages award in August, which you can read here. You may recall that I pointed out then the serious problem with the jury’s verdict: that it awarded punitive damages without any award for compensatory damages. As I explained months ago, to support an award for punitive damages, there usually must be some award for actual damages. Think of this way: in order for a plaintiff to qualify for a punitive damages award, that plaintiff must show that he has been directly harmed by the product, even if the harm is minimal.

In this case, Mr. Mitchell suffered serious harm: a heart attack. However, the jury could not agree that the heart attack was caused by the Androgel testosterone. Nevertheless, the jury did believe that AbbVie, Inc., the maker of Androgel, should pay for its fraudulent misrepresentation. The jury agreed with Mitchell’s claim that AbbVie targeted middle-aged men with misleading marketing that Androgel could treat low testosterone and improve lives. The jury then awarded a huge punitive damages award, with no underlying compensatory damages award. The jury appeared to find that AbbVie should be punished for fraudulent marketing, even though it could not connect Androgel to Mitchell’s heart attack.

As I said then, this was a “glaring problem” with the jury’s verdict. And Judge Kennelly, last Friday, tossed out the award altogether. He wrote that it was illogical to assert “simultaneously” that Mr. Mitchell had been damaged and not damaged. The judge wrote that the verdict was “internally inconsistent.” He makes a point.

Plaintiff Jesse Mitchell will get a new day in court. Judge Kennelly ordered a new trial in the case, although a new trial date has not been set. But again, as I wrote above, there is risk for all sides in any trial, and Mr. Mitchell’s case is an excellent example of this risk.

If you took any testosterone product in the past and suffered injuries, give me a call ((919) 830-5602) to discuss your potential case.

I get calls from people all over the country worried that they may have missed a deadline for participation in the Depuy ASR Artificial Hip Settlement. I understand the alarm. It would be dreadful to have the ASR metal-on-metal hip implanted, suffer mysterious pains and then elevated metal levels in the blood, discover the artificial hip components failed, go through a painful revision surgery, and then find that the settlement deadlines have all passed. The reality is this: at the moment, all the deadlines have passed. But many viable ASR claims against Depuy and Johnson & Johnson are still out there, and they should be fairly compensated like all the injured people that have come before.

Third Settlement (Second Extension)

In the most recent extension of the ASR Master Settlement Agreement, the deadline to enroll in the settlement was July 19, 2017. This second extension of the Master Settlement applied to individuals who had the ASR hip removed in revision surgery between between January 31, 2015 and February 15, 2017. The reason for this specific set of dates is that the settlement committees for plaintiffs and defendants wanted to include victims who had revision surgery somewhat late in the game. Recall that the Depuy ASR hip was first sold in 2005, twelve years ago. It was sold aggressively for five years, until it was finally recalled on August 24, 2010. Thousands of people were implanted with the ASR hip in that five-year period. Most of them were forced to undergo revision surgery before August 31, 2013, the deadline for participation in the first settlement. But hundreds of people did not undergo revision surgery until after August 31, 2013. Therefore, a first and then a second extension of the original agreement was established.

At this point the settlement(s) applied to all individuals who received revision surgery from 2005 through February 15, 2017. That covers a lot of people. But not everyone. I have clients who have undergone revision surgery after February 15, 2017. I have others who have revision surgery scheduled for later this year. They have been injured in many of the same ways as those people who had revision surgery in 2007, and 2010, and 2015. And they absolutely deserve fair and complete compensation for their injuries.

Why Further Settlement Extensions Are Necessary

Let’s look at the calendar for a moment. The recall for the Depuy ASR was August 24, 2010. This means that many people received the ASR hip in 2009 and 2010, and possibly even beyond August 2010 (as one can’t assume that the implantation stopped on a dime precisely on the recall date). With MoM hips, the outward signs of failure may not be obvious for years. A person with rising metal levels in the body may not have noticeable symptoms. They may learn of their elevated levels of cobalt and chromium (the metals associated with ASR MoM hip failures) in a routine blood test as part of a physical. A person who received the ASR hip in July 2010 is just seven years removed from surgery. Many people who had revision surgery seven or eight or nine years after the implant surgery have already received compensation under the settlement. The person who received an ASR hip in 2009 or 2010 should not be punished simply because they received the ASR hip late in the period when the hip was marketed, sold, and implanted.

The Takeaway

My point is this: I am quite certain further extensions of the Master Settlement will happen. The Depuy ASR litigation has been massive, and thousands of people have been compensated already. It would be extremely unfair and unjust to deny recovery for those remaining people who were injured “late in the game.” I suspect a third extension may be announced in 2018.

When Will It End?

Plainly, the litigation and the extensions won’t continue forever. One arbitrary cut-off I have seen is ten years. That is to say, so far, Depuy has not shown willingness to compensate individuals who received revision surgery more than ten years after the original implant surgery. The logic behind this cut-off is that typical artificial hips historically last twelve to fifteen years, so revision surgery of more than ten years is within normal ranges in the life-cycle of an artificial hip. I don’t buy it. If the Depuy ASR hip fails, even ten and a half years after implantation, the patient should be compensated.

It may be that future extensions may stretch to include ASR failures beyond ten years. But I am not at all certain of this. The reality is this: if you have a failed ASR hip and your surgeon advises you to have it removed, don’t delay. Go ahead and schedule revision surgery. It is important mainly for your health but also, potentially, for your case against Depuy.

One date to keep in mind is August 24, 2020, which is the ten-year anniversary of the date Depuy recalled the ASR hip. I don’t see it as an absolute hard deadline to bring a viable claim against Depuy, but it will mark a key milestone in the multidistrict litigation.

Until then, more people with viable cases against Depuy for the failure of the ASR hip will come forward. If you are one of them, and would like more information, give me a call (919.830.5602).

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.