North Carolina Product Liability Lawyer Blog

Mirena IUD Has Caused Fluid Pressure in the Brain, Injuries, Lawsuits

Published on: February 9, 2017 | By Clay Hodges

Female contraception is common these days, with many medications, medical devices and methods available. One popular birth control method is the intrauterine device, or IUD.

There are many companies making different types of IUDs that work in different ways. Some use copper as the primary means of contraception while others use hormones. One of the most popular hormonal IUDs available goes by the brand name Mirena.

How Does the Mirena IUD Work?

Mirena is a hormonal IUD that is inserted into a woman’s uterus. Once inserted, the IUD continuously releases a small amount of the hormone levonorgesterel. The Mirena IUD is extremely effective and works primarily by preventing fertilization from occurring, rather than preventing implantation of the fertilized egg into the uterus.

Another advantage of the Mirena IUD is that it works for a long period of time (three to five years) without any intervention by the woman. And when the effective time period of Mirena passes or the woman decides she wants to try to get pregnant, the Mirena IUD can be removed and fertility restored. Because of these advantages, many women have chosen Mirena as their preferred form of birth control.

What’s Wrong with the Mirena IUD?

Despite its effectiveness as a contraceptive and its popularity, the Mirena IUD has caused some women to suffer from a variety of serious conditions, including the dangerous buildup of cerebrospinal fluid in the brain. This fluid buildup then causes an increase in intracranial pressure and can lead to severe headaches, ringing in the ears, nausea, blurred vision, neck pain, and blindness due to the swelling of the optic nerve.

Many women experience progressively worsening vision as the optic nerve swelling increases. Most of these symptoms are similar to those people suffering from a brain tumor. There are several names to describe this condition, including Pseudotumor Cerebri (PTC) and Intracranial Hypertension (IH).

Depending on the woman, the effects of PTC or IH can sometimes be reversed, but it often results in permanent damage to a woman’s vision. Even if the effects can be reversed, it usually takes years of maintaining normal intracranial pressure in the brain. As a result of these problems, many lawsuits against Bayer, the maker of Mirena, have recently emerged.

How Do I Know If I Have the Recalled Stryker LFIT V40 Femoral Head Implanted?

Published on: January 26, 2017 | By Clay Hodges

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

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

FDA Chief Urges Politicians to Respect Science in Drug Testing

Published on: January 24, 2017 | By Clay Hodges

Dr. Robert Califf is a cardiologist and the departing Commissioner of the Food and Drug Administration. He resigned his post last Friday, on Inauguration Day. Recently he gave a speech regarding his thoughts on the future of prescription drug testing, and he urged lawmakers to respect the value of science in approving and marketing prescription medications. According to Matthew Herper in Forbes magazine, Dr. Califf believes “the way forward requires putting science above politics and focusing on creating new ways to prove medicines help patients without causing undue side effects. Throwing out the standards that made the U.S. a global hotspot for medical innovation is not an option.”

Dr. Califf offered remarkable insight on the high failure rate of clinically-tested medications, as well as the urgent need for medications to do no harm:

“The most recent empirical data that we have at the FDA is that approximately 92% of drugs that go into human testing don’t make it to market because they have unacceptable toxicity, they actually don’t work for the intended purpose, or they can’t be manufactured at scale safely. Of the 92% of drugs that don’t make it to market, “100% had a lot of really smart people who thought they were going to work. If you were just going to start guessing about drugs you would do a lot of harm, because most of them would do more harm than good.”

Handling Your Product Liability Case Without a Lawyer: Good Idea?

Published on: January 20, 2017 | By Clay Hodges

Now and then I get calls from people who are representing themselves in product liability litigation. (An individual who represents himself in litigation is called a pro se litigant.) Usually these callers have worked their cases to a point and have questions. Sometimes the questions are rather modest: “I’ve been offered this amount of money to settle? Is that fair?” Other times the questions are ominous: “The judge now says I need an expert witness. What is an expert witness?” The first question is a mere judgment call. Is $150,000.00 enough to compensate you for the pain and suffering of a failed artificial hip? That is mostly for the injured person to decide (though lawyers have plenty of insight into the value of such a claim). The second question poses a serious threat to your case. If an expert witness is required to prove your case, and you don’t have an expert witness (or worse, you don’t even know what an expert witness is) your lawsuit will be lost. And quickly. (You can read about expert witnesses here.)

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

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

Physiomesh and C-Qur: Hernia Mesh Litigation Ramping Up

Published on: January 17, 2017 | By Clay Hodges

Even if you’ve never needed a surgical mesh implant, you’ve probably heard about a number of lawsuits due to problems patients are having with them. One type in particular has been the transvaginal mesh (TVM) implants in women. These TVM lawsuits are well underway, with tens of thousands of lawsuits currently pending. However, it appears another influx of lawsuits involving more surgical mesh implants are appearing on the horizon: surgical mesh used to treat hernias.

Treating Hernias with Surgical Mesh

First off, let’s briefly explain what a hernia is. A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it doesn’t belong. Depending on how bad the hernia is, surgery may be required to fix it.

Because hernias involve a hole in a muscle or other tissue, additional reinforcement is usually needed to close the opening and keep it from reopening. This is where surgical mesh comes in. The mesh often takes the form of a plug or sheet of biological or synthetic mesh and is surgically implanted over the hole.

Clinical studies have shown that using surgical mesh to treat hernias reduces the chances of the hernia returning. Each year hundreds of thousands of hernia surgeries are performed. Given their proven effectiveness, it’s no wonder that many of these surgeries use a surgical mesh. Unfortunately, a significant number of the meshes have serious flaws.

Risperdal: Two Recent (and Very Different) Case Results

Published on: January 13, 2017 | By Clay Hodges

Causation is usually simple: this happened because of that. The wheel fell off my bicycle, causing me to fall and break my arm. Legal causation is not so simple, and it can be very difficult to prove in a civil case. Legal causation or “proximate cause” involves an event (or thing) which is sufficiently related to an injury such that the cause of the event or thing is held legally liable for injuries sustained. It may not sound all that complicated, but millions of attorney hours are spent each year fighting over proximate cause. In fact, it’s one of the main reasons we have courthouses.

Of all the bad drug results you read about, you would think proving legal causation in a Risperdal case would be straightforward: a boy with autism or psychological issues is prescribed Risperdal; after a period of months or years on the drug, he begins to grow female breasts, a condition known as gynecomastia. Boys should not grow female breasts. It is extremely rare for an adolescent boy not taking Risperdal to grow female breasts. And studies have shown that Risperdal can cause gynecomastia. Ergo (sorry, I’ve been wanting to get that word in a post), if a boy is taking Risperdal, and fifteen months later grows female breasts, it should follow that the Risperdal caused the gynecomastia. And that the manufacturers of the drug should pay for the physical injury, the emotional trauma, and any other suffering.

But it doesn’t always work that way. Two recent court cases involving boys injured after taking Risperdal yielded two very different results, and the takeaway is the importance of medical experts who can testify to the connection of the injury (gynecomastia) to the cause (taking Risperdal).

Depuy Pinnacle Hip Trial: Judge Slashes Jury Award by $500 Million

Published on: January 5, 2017 | By Clay Hodges

Imagine going to sleep the night after making the decision to strip five hundred million dollars from six families. I imagine it would be unsettling. On Tuesday, Judge Ed Kinkeade, a federal judge in Texas overseeing the Depuy Pinnacle MDL, made the decision to cut $500,000,000.00 from a jury award presented to six families after a grueling ten-week trial last fall. You can read about the trial and the jury’s verdict here. In that post I wrote that the jury’s verdict was “staggering,” and it was. It may be more staggering that a judge, less than a month later, would wipe out half a billion dollars of the jury’s award.

“Single-Digit Multipliers”

On January 3, 2017, Judge Kinkeade issued his post-trial court order reducing the amount of punitive damages awarded to the six families, writing that “constitutional considerations limit the amount a plaintiff may recover in punitive damages.” The relevant portion of the Order states:

Smoking Can Harm Your Product Liability or Personal Injury Case

Published on: December 21, 2016 | By Clay Hodges

First, let me make the case for smoking:

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

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

21st Century Cures Act: Faster Approval of Devices and Drugs a Public Health Threat?

Published on: December 14, 2016 | By Clay Hodges

If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21^st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?

21^st Century Cures Act: The Good

The 21^st Century Cures Act has the potential to save lives. For instance, it will provide funding for cancer research, fight painkiller drug abuse, advance Alzheimer’s research and improve mental health treatments.

Product Liability Law: Litigation, Settlement, and Wellness

Published on: December 12, 2016 | By Clay Hodges

I will publish a new book this week: Product Liability Law: Litigation, Settlement, and Wellness.

The book offers concise chapters on issues you need to be aware of when you first discover that a medical device may have failed in your body, or when a prescription medication is beginning to cause dreadful side effects. Beyond that, I discuss issues that arise when you are involved in product liability litigation, as well as concerns about money: before a product liability lawsuit is filed, during product litigation, and after a product lawsuit is resolved.

If you would like a free copy of Product Liability Law, I ask that you subscribe to the website. It takes twenty seconds to sign up. You will receive a copy of Product Liability Law, and you will receive emails only when I post new articles to the site. Two emails a week, tops.