Despite the addictions, injuries, and deaths, and despite reports of awful business practices by the makers of these prescription painkillers, defense lawyers have developed certain legal defenses to help these drug companies avoid liability. Let’s look at a few:

The FDA Approved the Drug, So It’s the Government’s Fault

This is a tough one. Essentially, the drug companies proclaim: the FDA approved the opioid product for manufacture and sale, so we can’t be liable for claims such as defective design. If opioids were a problem, they argue, the FDA should not have approved the drug for sale in the first place.

I have struggled with this defense for years. For one, the FDA is one government agency, and it is tasked with overseeing the review and approval of all new drugs, as well as monitoring practices among drug companies after approval. Plus, and although it shouldn’t be, the FDA inevitably becomes political, and depending on the administration, the policing efforts can range from effective to cozy with drug companies. In political climates with relaxed enforcement, problem drugs can reach the market.

The solution: the FDA must remain independent, and protected from political influence, and serious and competent people must run the operation. If that can happen, this defense would hold more weight.

The Learned Intermediary Doctrine, So It’s the Doctor’s Fault

A drug maker has a duty to warn patients about the risks of its drug. If the drug label is inadequate, leaving out vital information, the person injured by the drug can bring a claim for failure to warn. However, if the label lists all the risks (even if a key risk is buried deep in the package insert) the drug company can often rely on a defense known as the learned intermediary doctrine. This means a manufacturer is not liable for a high-risk prescription drug if the risk was placed on the label and technically made available to the patient’s doctor (the “learned intermediary”). In these cases, the duty to warn shifts away from the drug company and to the physician, who is supposed to give the patient a full explanation of the benefits and risks of the medication he prescribes.

The problem is this: in many cases general practitioners don’t know all the risks of a certain drug. And really, how could they? Doctors must stay current on all kinds of illnesses and conditions, and they can’t be expected to know granular detail of every drug on the market.

I’ve never liked this defense. Of course, I represent individuals injured by defective medical devices and drugs, so I guess it is predictable that I wouldn’t like it, as it can cause me and my clients certain difficulties. But aside from my potential professional bias, the learned intermediary doctrine is a flawed defense, mainly because it occasionally allows drug companies to escape truly negligent and harmful behavior.

The Patient Misused Opioids, So It’s the Victim’s Fault

This defense can be very effective, and in many ways it is galling. A drug company puts a highly addictive drug on the market, pushes the drug in marketing campaigns and in aggressive one-on-one meetings with doctors to push prescriptions, and then, when the patient becomes addicted and misuses the product, the drug company points to the bad behavior as an affirmative defense. And it often works. The alleged misuse can take many forms: taking the drug after recovery from the underlying injury is complete, or, after addiction has set in, attempting to procure opioids from different doctors or for made-up health reasons. Now granted, many people can and have abused these drugs. I get it. But it is a complicated matter when you are dealing with an addictive prescription medication like opioids.

The Statute of Limitations Has Run, So It’s the Calendar’s Fault

I have written about the statutes of limitations many times on this site. As a plaintiff’s lawyer, the statute of limitations haunts my dreams like The Lone Biker of the Apocalypse in Raising Arizona. The statute of limitations is a law limiting the time you may bring a lawsuit for personal injury. In each state you have a certain number of years from the injury, or the date of discovery of the injury, to file a complaint in court. In opioid cases, plaintiffs argue that the court should use the “discovery rule,” which states that the limitations period cannot begin to run until the plaintiff knows or should have known about the specific injury. As you can imagine, however, vicious fights occur in court about the start date for many statutes of limitation.

Now you be the lawyer: what arguments can you make to overcome these defenses? What weaknesses do you see in these defenses? Feel free to email me your thoughts. Or call me to discuss further.

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.

Let me get right to it: Judge Clay Land has a point. On September 7, 2016, Judge Land issued a blistering Order in the Mentor Corporation ObTape Transobturator Sling Mesh multi-district litigation. In a nutshell, he wrote that he was fed up with frivolous claims. Judge Land stated that he will consider money sanctions against plaintiffs’ lawyers who file and pursue lawsuits in the MDL that they know have no merit or which suffer from some fatal flaw. A fatal flaw could be the passing of the statute of limitations, or the failure to find an expert who can testify that the transvaginal mesh product caused the specific injuries to the plaintiff. In those cases, Judge Land writes, the plaintiffs’ lawyers ought to know better, and should not bring the claim in the first place, or should at the very least dismiss the action when the lawyer discovers a flaw in the case which is fatal to gaining a recovery.

The worst transgression identified by Judge Land is when the product manufacturer seeks “summary judgment” in a particular case and the plaintiff’s attorney simply throws in the towel on the case and does not even bother to show up for the court hearing. In those cases, even though the plaintiff is inevitably going to lose the case, the judge and the law clerks and court personnel and defense attorneys still have to show up and do the work of handling and deciding the motion.

more Attorneys Should Never Abandon a Case

This is not right. Plaintiffs’ attorneys should never abandon a case. If the case is fatally flawed and everyone knows it, the attorney must inform the client and has an obligation to dismiss the lawsuit. I understand Judge Land’s frustration for these clearly weak or abandoned cases. There are many reasons this behavior is bad for the legal system: it takes up time and money unnecessarily; it puts the client in a bad position with the court; and it also makes product liability lawyers look bad.

The Order

Judge Land, who oversees the Mentor Corp. Mesh MDL in federal court in Georgia, has been handling several motions for summary judgment over the past year. He has dismissed many actions based on the passing of the statute of limitations and for other reasons. He seems quite tired of it. He wrote that lawyers for plaintiffs in the MDL “are on notice that in future orders granting summary judgment in which no good faith basis existed for maintaining the action through the summary judgment stage, the Court intends to include an addendum in the order requiring counsel to show cause why sanctions should not be imposed. Thus, it would behoove counsel to take a close look at your cases and decide whether you truly have a good faith basis for proceeding; and if you do not, dismiss the case.” You can read the full order here.

Let’s unpack this. Judge Land is unambiguously issuing a strong warning to plaintiffs’ lawyers who do not closely scrutinize their cases and who fail to ensure that a fatal flaw does not exist in their cases. Quick example: let’s say there is a absolute deadline for identifying a medical expert who will testify that the transvaginal mesh injured the client. And let’s say that the lawyer let that deadline pass without finding a suitable expert. The lawyer must take immediate action: either he must file a motion requesting an extension of time to identify the expert, or he must dismiss the case without prejudice, or he must dismiss the case outright. Doing nothing is bad.

But Wait a Minute!

Now, a “good faith basis” for continuing a case is often in the eye of the beholder. And there are times when the passing of the statute of limitations is not at all clear. And sometimes it is the product manufacturer itself who makes the limitations period difficult to calculate.

A statute of limitations is a law which limits the period of time when you can bring a lawsuit for money damages for an injury. In each state you have a certain number of years from the date of injury, or the date of discovery of the injury, to file a lawsuit and recover money for your injuries. If you miss this deadline, you lose your right to bring the lawsuit forever.

But when does the clock begin to run? Let’s say you are a woman who received a transvaginal mesh implant. After a few months you began feeling new pains and other unpleasant symptoms. But the manufacturer kept insisting to everyone–the media, doctors, patients–that the TVM product was safe and effective. You visit your doctor and she says, “the manufacturer is saying the mesh is safe, so your pains must be coming from some other problem.” In that case (and it is very common) how can this injured woman know she has a valid claim against the manufacturer? The fights over statutes of limitation are often fierce, as I write about here. And they should be. If the defense wins the argument, the defendant has to pay no money for what might be a real injury to a real person. The plaintiff has ever right to fight back against this SOL defense. And should.

And I guess that is Judge Land’s point: if you are the lawyer for the plaintiff and you are facing a summary judgment motion, show up, make your case, fight for your client. Don’t abandon the client, and don’t leave a case behind you know to be fatally flawed. I agree.

But I also believe that judges need to be mindful of the unfair fight injured people face. No person injured by transvaginal mesh, or a failed artificial hip or knee, or an untested drug, can compete with the power and resources of a major corporation. I would like all plaintiffs’ lawyers to handle their cases competently, but I also would like to see judges give an injured person the benefit of the doubt in the face of this uphill struggle. After all, nowhere in Judge Land’s order does he say that these plaintiffs who lose summary judgment were not injured by the negligence of the manufacturer. Rather, the person was simply unable to pursue her claims based on a legal or technical defense.

In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, No. 4:08-MD-2004 (M.D. Ga.)

Many people still have the Depuy ASR hip components implanted in their bodies. I get calls from them. Some have elevated metal levels in their blood; others are telling me about pain in the hip area, popping sounds, and other problems. They are preparing to schedule revision surgery, and they want to know if they may qualify for compensation based on the settlements that have been reached with Depuy, Inc. and Johnson & Johnson, the parent company.

These are good questions. I want to make sure you are aware of a nine-year window for undergoing revision surgery.

Two Settlement Agreements So Far

As I have explained in this blog, there have been two Depuy ASR settlement agreements, mostly identical in material terms. The major difference is that the first settlement agreement covered those who had undergone revision surgery prior to August 31, 2013. The second settlement covered those people who had revision surgery between August 31, 2013 and January 31, 2015.

more No Settlement Agreement (Yet) for Recent Revision Surgeries

There has been no “third” settlement agreement. This means that there is currently no procedure in place to settle claims with individuals who received revision surgery after January 31, 2015. I suspect that a third settlement agreement (looking much like the first two) will eventually be established and announced. But as of today there is no agreement by which a person revised after January 31, 2015 can pursue settlement compensation with Depuy and J&J.

Length of Time Between Implant and Revision

The 2013 Settlement Agreement did not explicitly set out a cut-off date for settlement eligibility based on the length of time between implant surgery and revision surgery. In that agreement, to be an “Eligible United States Claimant,” you had to be a U.S. Patient, had implantation of the Depuy ASR, and underwent revision surgery.

The 2015 Settlement Agreement added a fourth condition: The time between implantation and revision surgery must be less than nine years. Which is to say, if nine years or more have passed between implantation surgery and revision surgery, you would not be eligible to participate in the settlements.

Nine-Year Cut Off

So that seems to be a bright line drawn in the sand: If you lived with the Depuy ASR hip in your body for nine years or longer, Depuy and J&J do not seem willing to recognize a compensable injury. (Note: This does not mean you cannot attempt to seek compensation outside the settlement scheme if you had revision beyond the nine-year cut-off. In fact you should. But it does signal that Depuy is not willing to recognize damages in cases where the individual lived with the Depuy ASR hip for nine years or longer.)

Example: if the Depuy ASR hip was implanted in your body on May 12, 2008, you would arguably have until May 11, 2017 to undergo revision surgery to be considered “eligible” for participation in any settlement.

Remember that the official recall of the Depuy ASR artificial hip was August 24, 2010. For the sake of simplicity, let’s presume that no Depuy ASR hips were implanted after the recall date (and this can’t be true, but go with it). In that case, the outermost limit for eligible claims under the settlement agreement would be August 23, 2019. Keep these timelines in mind.

Always Beware the Statute of Limitation

Even though you may still be able to schedule revision surgery less than nine years from implantation, the statute of limitation could still end your case. I wrote about statutes of limitation here. I will say to be very cautious about delaying legal action if you believe you have a claim. A case involving revision surgery more than eight years after implantation may well have a statute of limitation issue lurking. And if it does, it could stop an otherwise valid claim in its tracks.

I would chalk up this court decision as a victory for any injured person dealing with the C.R. Bard IVC filter. I would also chalk up the decision as yet another example of the complexities of handling statutes of limitations in defective product cases.

As always, let’s take a step back. I have written about C.R. Bard’s potentially dangerous IVC filters, which you can read about here and here. In 2015 a multidistrict litigation (MDL) site was selected for lawsuits arising from injuries relating to Bard’s G2 Series and Recovery IVC filters. The primary complaints have been that the Bard IVC filters moved out of position and/or broke apart. Lawsuits mounted, and the MDL was formed.

Lurking in virtually every personal injury case is a statute of limitations defense. I wrote about statutes of limitations here. To recap, a statute of limitations is a law which limits the time when an injured person may bring a lawsuit for money damages. You miss the deadline, you lose your right to bring a lawsuit forever.

But as I have discussed before, determining when the clock starts running on your injury case is far from easy.

Bard Lawyers Sought Rigid Framework For Statute of Limitations Analysis

In the Bard IVC filter MDL, C.R. Bard lawyers filed a motion seeking a bright-line test to identify the running of the statutes of limitation. The defense lawyers asked Judge David Campbell to adopt a strict procedure for this analysis similar to the procedure used in the Mirena IUD MDL. (Yes, there is an MDL for women injured by Mirena IUDs made by Bayer Pharmaceuticals.) The Mirena procedure was determined in the case titled Truitt v. Bayer.

more Truitt v. Bayer

In the Truitt v. Bayer case, the judge accepted the defendants’ proposal that the statute of limitations should begin to run in Mirena IUD cases based on the date the injured woman “learned that the Mirena [IUD] had perforated her uterus.” This event, according to the judge in Truitt, gave an injured woman adequate notice that she was injured and that she should begin to figure out if she had a defective product claim against the manufacturer.

The Truitt judge then set up a procedure for figuring out which plaintiffs’ cases should be dismissed based on the passing of the statute of limitations. Both defendants and plaintiffs would submit three-page letters arguing why each case should or should not be dismissed under the Truitt framework. Utilizing this procedure, thirty-one (31) cases were dismissed in the Mirena IUD MDL.

Admittedly, the Truitt decision had the advantage of simplicity. The medical records in most cases should show the date (or close to it) when an injured woman was told by her doctor that her uterus was perforated (that is, when her IUD poked a hole in her uterus). The thinking was that a woman would be told by her doctor: “Hey look. Something bad has happened. The IUD we placed inside you just punctured the wall of your uterus and we must perform surgery to remove the device.” (Or words to that effect.) The judge then also presumed that virtually every woman at that point would be savvy enough to begin an investigation into whether this punctured uterus was the result of a defective medical product.

I have no doubt the defense lawyers in the Mirena IUD cases were pleased with the Truitt decision.

There are problems with the Truitt decision. First, it presumes that a doctor clearly communicated to the patient that her uterine wall was punctured by her IUD and that she needed surgery. Second, it presumes that all women injured through the negligence of a medical device manufacturer like Bayer would know they had a claim against Bayer the moment their doctors mentioned that the IUD had punctured their uterine wall. These are big presumptions. Doctors are not always easy to understand. And it can takes months or years to figure out that you were the victim of negligence. Some people never figure it out. In my view, Truitt allowed several valid cases against Bayer to be dismissed unfairly. Sadly, I have had many calls from injured people who waited too long to call me about their (otherwise valid) case against defective product manufacturers.

Quick Example

Let’s say the defense lawyer brought a Truitt motion in a case in a state with a statute of limitations of three years. If the defense team could show (in a three-page letter) that the injured woman was told about her injury more than three years before she filed suit, the court would dismiss her lawsuit with prejudice. Even if the underlying claim was valid, and Bayer was negligent in manufacturing and selling the Mirena IUD, the injured woman would receive no compensation for her injuries.

Now Back to the Bard IVC Filter MDL

The defense lawyers in the Bard IVC filter cases wanted a Truitt type procedure for pinpointing the running of the clock on claims against Bard. Thankfully, Judge Campbell gave many solid reasons for rejecting this procedure in the Bard IVC filter MDL. The Order was entered on April 20, 2016 and is worth reading. Essentially, Judge Campbell concluded that figuring out when the clock starts to run on a defective product claim is very complex, and should not be reduced to three-page letters to the court. He then gave many examples of how a Truitt procedure could pose all kinds of problems and could yield inconsistent and unfair results.

Ultimately, Judge Campbell denied the motion and effectively rejected a Truitt analysis for considering statute of limitations defenses. This is a good thing for people injured by the Bard IVC filters. Nevertheless, the statute of limitations in each state remains a serious threat to your product liability claim. It is crucial that you find a competent attorney the moment you suspect you may be the victim of a defective product.

My firm is currently taking IVC filter cases in all states. (919) 830-5602.

Note: If you received any type of IVC filter, you should download the free app titled “IVC Filter Compendium” (http://www.ivcfilterapp.com). In this app physicians have compiled information on the different types of IVC filters, the complications that may arise, images of the different IVC filters, recommendations for removal of the filters, and other information.

The statute of limitations can be the strongest defense a product manufacturer will bring to defend itself and avoid paying money in a product liability lawsuit. It can be deadly to your medical device or drug case. The problem is, determining the proper deadline to bring your lawsuit is rarely simple. It is critical that you find someone who can figure out when the clock started ticking on your product liability case.

Definition

Let’s start with a simple definition: a statute of limitations is a state law which limits the time period when you may bring a lawsuit for money damages for a personal injury. In each state you have a certain number of years from the injury, or the date of discovery of the injury, to file a lawsuit and recover money for your injuries.

If you miss this deadline, you lose your right to bring the lawsuit, forever. These statutes must be taken very seriously.

Rationale

The rationale makes sense: citizens and companies do not need to be vulnerable to being sued indefinitely for an act of negligence. If you were in my grocery store twelve years ago, slipped on a banana peel, broke your arm, got medical treatment, recovered, then waited over a decade and finally sued me and my grocery store for negligence, it could be a serious hardship on me and deeply unfair. I need reasonable assurance that I won’t be exposed to lawsuits forever. So states across the country have written statutes that limit the amount of time an injured person can bring a lawsuit. Essentially, state legislatures are telling injured persons: we respect your right to sue for money damages when you are the victim of some kind of negligence, but don’t sleep on your rights. If you are hurt because of someone else, get on with it and file a lawsuit. And if you wait too long, you lose your right to recover damages.

(I don’t really own a grocery store.)

Determining When Your “Lawsuit Clock” Starts Ticking moreIn some cases determining the start of the running of the statute of limitations is quite easy. For example, in a car crash case where injuries are obvious (like a broken arm), the clock starts at the time of the crash. In North Carolina, the statute of limitations in negligence actions is three years from the date of injury. If your car crash occurred on April 27, 2016, you must file a lawsuit within three years, no later than April 26, 2019. That one is easy. But as you will see below, often the determination of the “relevant period” for the statute of limitations can be difficult to sort out. And this much is clear: if there is any chance the statute of limitations has run or has passed, the defense lawyers will argue loudly that the case is void and should be dismissed.

The Discovery Rule

Many states, including North Carolina, use the Discovery Rule to start the clock running on the statute of limitations. In many injury cases, the injured person does not know she is injured. For example, a young woman may not realize for months or years that a physician negligently left a surgical needle inside her body during a surgical procedure. It may take some time for symptoms and pain to develop. The discovery rule states that the clock does not begin to run on your injury until the person’s injury becomes “apparent or ought reasonably to have become apparent” to the injured person.

The Discovery Rule is helpful to injured persons but can be difficult to sort out. As you can imagine, the date the clock starts ticking (or should have started) can be a hotly debated issue, particularly if the defense wins the debate and thus avoids liability altogether. Example: Suppose a man undergoes total hip replacement, has pain for months afterward, but the surgeon keeps telling him, “the pain is normal; it is part of the recovery process.” Then the artificial hip manufacturer sends a letter to the man informing him that his artificial hip components have been recalled. Still, his doctor keeps telling him the artificial hip is fine and that he should not consider revision surgery. When does the man’s statute of limitations begin to run? The date of the hip recall letter? Or later, when the artificial hip moves out of place and causes him to have to undergo emergency revision surgery?

The answer is unsatisfying: it is what the judge presiding over your case says it is.

The Statute of Limitations in Each State

Figuring out the proper statute of limitations period for any particular case can be complicated. What follows is a basic guideline for bringing claims for product liability causing physical injury. Still, you always need a good lawyer to review your case history then double and triple check the timelines and the statutes in your state.

In North Carolina, a medical device or drug failure is essentially a personal injury/negligence action, and the statute of limitations in those cases is three years. N.C. Gen. Stat. § 1-52.

Warning! If you are searching the Internet for the statute of limitations in product liability cases, make sure you distinguish between product liability cases causing physical injury (which in North Carolina is three years), and general product liability cases (such as when a washing machine malfunctions), which is six years.

In South Carolina, a product liability/personal injury claim must be brought within three years of the injury. South Carolina uses the discovery rule, so the injured person has three years from the date when he or she knew or should have known that injury had occurred.

In Virginia, a product liability/personal injury claim must be brought within two years of the injury or the reasonable discovery of the injury.

In Georgia, a product liability/personal injury claim must be brought within two years of the injury or the reasonable discovery of the injury.

If you have a question about the statute of limitations in your state, please give me a call and we can figure it out together: (919) 830-5602.