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Earlier this month the judge in the most recent Xarelto trial voided a $27.8 million jury verdict. I wrote about that case here and here and here. On January 9, 2018, Judge Michael Erdos in Philadelphia state court held that the jury’s verdict on plaintiff’s inadequate warning claim was not supported by the evidence. Let’s take a look:

Treating Doctor’s (Very Unhelpful) Testimony

Xarelto-259x300One key issue in the case was whether Defendants Bayer AG, Janssen Pharmaceuticals and Johnson & Johnson failed to provide adequate warnings on the Xarelto label regarding the increased risk of internal bleeding. In an important study, bleeding rates for patients taking Xarelto in the United States were much higher than the bleeding rates of patients in other countries. This information was not added to the Xarelto label until September 2015. Plaintiff Lynn Hartman was prescribed and took Xarelto in 2013 and 2014.

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Surgeon implanting artificial hipIt’s nice to see that I may be out in front of a national publication like The New York Times. For two and a half years I have been writing on the dangers of metal-on-metal artificial hips and the deeply-flawed 510(k) medical device approval process. On Saturday Jeanne Lenzer published a very informative piece in the Times on the potential dangers of hip replacement surgery: Can Your Hip Replacement Kill You? Ms. Lenzer examines the way too many medical devices reach the marketplace without proper clinical testing. It is a subject I have written about often. Most people don’t realize how easy the FDA has made it for companies to release new medical products, but it is important to be aware of this weak regulatory system before you allow any surgeon to implant a device in your body. Federal courts across the country are littered with multidistrict litigation involving dozens of failed medical devices. In my view the 510(k) process is the reason for much of this litigation and misery. With proper testing and analysis, many of these serious injuries from dangerous products could be avoided.

One chilling statistic in the NYT article: medical interventions–including artificial hip and other medical implant surgeries–are the third leading cause of death in the United States.

By the way, Jeanne Lenzer recently published a book that you should read: The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. I just bought a copy, have already begun reading it, and will discuss in a later post.

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Delaying Surgery Can Cost Money in Product Liability Case
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

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Damages in a Lawsuit Involving Opioids
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.

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Testosterone Litigation
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

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Invokana and Type 2 DiabetesInvokana is a drug prescribed to treat people with Type 2 diabetes. The medication lowers blood sugar levels by preventing the kidneys from reabsorbing blood glucose. I’ve written often about Invokana and the studies that have identified problems with the drug, which you can read about here. I thought it may be useful to give you a history of key dates in the life-cycle of the drug, from its market release through the latest developments in the multidistrict litigation, where currently 1,000 lawsuits have been filed.

May 31, 2012. On this date Janssen Pharmaceuticals, a drug company owned by Johnson & Johnson, submitted an application to the FDA for approval of Invokana.

March 29, 2013.  The FDA approves Invokana for sale. Janssen and J&J begin selling the drug.

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Opioids: Are Individual Lawsuits Imminent?
Have you been directly affected by the opioid epidemic in America? Millions of people have become addicted to these powerful drugs—and for many, that addiction started with a legally prescribed medication to treat legitimate pain. One report estimated that more than 59,000 people died from drug overdoses in 2016—and most of those were caused by opioids. The President has even declared opioid abuse a national public health emergency.

I’ve written before in this space about the opioid epidemic and the massive opioid litigation gearing up across America as well as the establishment of centralized multidistrict litigation. So far, these cases primarily involve state and local governments suing opioid manufacturers and distributors for their roles in the opioid crisis.

No doubt governments have suffered financial losses from the skyrocketing number of overdoses requiring emergency treatment. In North Carolina alone, the cost of opioid-related accidental overdose deaths was estimated at $1.3 billion in 2015.

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Xarelto Trial Verdict
Today, a jury in Philadelphia awarded approximately 28 million dollars to a woman who suffered serious gastrointestional bleeding after taking the blood-thinning drug Xarelto. It was a huge win for the plaintiff, Lynn Hartman. Ms. Hartman took Xarelto for over a year to treat atrial fibrillation. She suffered internal bleeding and was eventually hospitalized. She needed four blood transfusions. According to court documents, the internal bleeding eventually stopped, and Ms. Hartman was taken off the medication. After she stopped taking Xarelto and switched to another blood-thinner, she had no further internal bleeding.

Ms. Hartman sued Bayer Healthcare Pharmaceuticals, Janssen Pharmceuticals, and parent company Johnson & Johnson. Her primary claim was that the defendants failed to provide adequate warning of the bleeding risks associated with taking Xarelto.

One important witness for the plaintiff at trial was David Kessler, the former Commissioner of the Food and Drug Administration. Kessler testified that he believed the warning label on Xarelto was inadequate and lacked important information regarding the specific risks of internal bleeding.

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For many years my clients with failing artificial hips have asked me about the health effects of high cobalt and chromium levels in the body. These questions usually arise after clients get blood work done and the test reveals abnormally high metal levels. If you are reading this article, you probably already know that cobalt and chromium are two metals used in the construction of most metal-on-metal (MoM) artificial hip systems. In fact, cobalt and chromium are used to make artificial hips that are not metal-on-metal but instead use polyethylene liners, or ceramic heads, or other non-metal components. When metal components grind together, as they naturally do when a MoM artificial hip is implanted in a person, very small metal particles can be released into the tissue and the bloodstream. I wrote about the health effects of metallosis on the body over a year ago. You can check out that article here.

Cobalt poisoning from artificial hip implants
Dr. Steven Tower, an orthopedic surgeon in Alaska, recently gave a fascinating (and alarming) talk about the many neurological problems he has observed in hip patients with elevated cobalt levels in the body. For years the focus following hip replacement surgeries has been on the physical condition of the hip itself. Dr. Tower has concluded that this approach is wrong, or at least incomplete, and he has seen that often the first signs of trouble with hip replacement patients are neurological symptoms. He has even given it a name: Arthroplasty Cobalt Encephalopathy, or ACE.

What is Arthroplasty Cobalt Encephalopathy (ACE)?

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Calculating DePuy Pinnacle Jury AwardsIn the last three DePuy Pinnacle artificial hip bellwether trials, three juries awarded the following amounts of money: $502,000,000.00, $1,041,311,648.17, and $247,000,000.00. That’s a total of $1.79 billion dollars. The juries awarded plaintiffs compensatory damages (or actual damages) and punitive damages (to “punish” the defendant companies). Remember that these juries settled on these huge amounts of money based on their findings in three separate trials that DePuy and Johnson & Johnson were liable for design and manufacturing defects, that the defendants failed to warn plaintiffs about the risks of the defective artificial hip, and that defendants acted recklessly, intentionally, and even maliciously in marketing and selling the flawed DePuy Pinnacle hip. These last findings permitted the juries to award punitive damages.

In the bellwether trial in March 2016, a jury awarded more than $500,000,000.00 to five plaintiffs. On December 1, 2016 a jury awarded more than one billion dollars to six plaintiffs and four spouses. And finally, just two weeks ago, a jury awarded six plaintiffs (and four spouses) $247,000,000.00 in compensatory and punitive damages. Compared to the total awards, the amounts awarded to the spouses of the hip victims were modest, and appear to have totaled around $6,700,000.00.

Let’s do a little math: