Articles Posted in Multidistrict Litigation

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

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

Opioid-Addicted Infants Present Unique Claims

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Xarelto Plaintiffs seek new trialsRecently, three cases in the Xarelto multi-district litigation (MDL) ended in defense verdicts in favor of Xarelto’s manufacturers, Bayer, Janssen, and Johnson & Johnson. These lawsuits, specifically the Orr trial, the Boudreaux trial, and the Mingo trial, stem from the manufacturers’ failure to provide instructions regarding routine prothrombin time (PT) testing for patients with a high risk of bleeding while on Xarelto. In addition, the plaintiffs argued that defendants misled doctors about whether tests were available to assess effects and risks of the medicine.

Since the cases ended in verdicts for the drug manufacturer, the Plaintiffs are now appealing for new trials. The plaintiffs argue that the defense verdicts are a result of the district court wrongfully admitting evidence, denying admission of other evidence, and giving improper instructions to the jury.

In the legal brief, these arguments for new trials are broken down into four main points:

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Xarelto MDL Louisiana federal courtAfter more than three years of litigation, and with no settlement agreement in sight, Judge Eldon Fallon has issued a court ruling to move hundreds of cases along in the next several months. Just to recap, the federal court in Louisiana was chosen as the multi-district litigation (MDL) site for plaintiffs filing lawsuits for injuries suffered after taking the blood-thinning drug Xarelto. In 2017 Janssen, Bayer and Johnson & Johnson, manufacturers and sellers of Xarelto, won three “bellwether trials” in this MDL, which you can read about here. Nevertheless, studies and evidence show Xarelto can cause uncontrollable bleeding in patients, and there is no available antidote once the bleeding starts. But with the defense winning three cases last year, the drug companies have (so far) not been willing to agree to a global settlement of the remaining 21,000+ cases. In an effort to wind down the litigation and encourage settlement, Judge Fallon has chosen to move things along:

Case Management Order No. 6

On February 27, 2018, Judge Fallon issued Case Management Order No. 6 (CMO No. 6) in the Xarelto MDL. This Order sets out the procedure for the selection of 1,200 Xarelto cases over the next six months. These cases will enter rigorous individual discovery and will be prepared for trials in the plaintiffs’ home districts. Among other things, the plaintiffs chosen in these 1,200 cases will be responsible for completion of an extensive “Plaintiff Fact Sheet,” which is essentially a comprehensive questionnaire on all salient facts about the Plaintiff, the Plaintiff’s use of Xarelto, the injuries suffered, and other relevant information. The defendants will also have to submit a “Defendant Fact Sheet.”

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Plaintiff Sherri Booker Wins Jury Verdict Against C.R. Bard
Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces.

The plaintiff, Sherri Booker, was implanted with Bard G2 IVC filter to prevent blood clots from reaching the heart and lungs. The problem was, the G2 moved inside her inferior vena cava (it is not supposed to move), then it broke apart. In 2014, she had to undergo open heart surgery. The surgeon was not able to retrieve all the broken pieces.

The Jury’s Verdict

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

Smith & Nephew’s Birmingham Hip Resurfacing System

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

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Proton pump inhibitors may cause kidney disease
Millions of Americans have stomach issues, many of which are related to heart burn and acid reflux. Thankfully, there are several medicines available over-the-counter and by prescription that prevent and relieve these discomforts. Some drugs that help with these stomach issues are called proton pump inhibitors.

A proton pump inhibitor (PPI) is a medicine that reduces stomach acid. People take PPIs for heart burn, acid reflux, stomach ulcers, and other related conditions. While many PPIs are available by prescription only, some are becoming more readily accessible over-the-counter; you may have seen or heard of Prilosec, Prilosec OTC, Prevacid, or Nexium. These are all well-known PPIs.

PPIs work by preventing stomach acid from being produced – they stop heart burn, indigestion, and acid reflux before it begins. Many people take them first thing in the morning or take them before meals.

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Should I Fire My Lawyer?Occasionally I get calls from people who tell me they are unhappy with their product liability lawyer and want to fire that lawyer and hire someone else.

So should they? Let’s look at it.

Injury Litigation Can Be Highly Stressful

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As we saw in the previous post, the “Birmingham plaintiffs” submitted a 160-page Master Complaint in August 2017, alleging many Smith & Nephew misrepresentations that led to the introduction of an unreasonably dangerous product into the marketplace. In this post we continue our deep dive into the Smith & Nephew Birmingham Hip Master Complaint. (Part 2 in a series.)

“Apples to Oranges”

Smith & Nephew Birmingham Hip Like Other MoM Hips
In a stunning marketing document directed at surgeons titled “Apples to Oranges,” Smith & Nephew announced boldly that the Birmingham Hip Resurfacing system “is not your average ‘metal on metal.’ It’s BHR.” Depicted in the advertisement is an apple with the names of other artificial hip products: ASR, Durom, Cormet, Conserve. It is rather astonishing, suggesting that the BHR was better and safer than these other MoM hips. I guess the BHR is the orange.

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This is the story about the Smith & Nephew Birmingham Hip Resurfacing Device, the patients harmed by the metal-on-metal artificial hip, the lawsuits that followed, and the massive Master Complaint filed last August against Smith & Nephew.

But First, How Do We Get to a “Master Complaint”?

Smith & Nephew lawsuits moved to MDL
This is how product liability multidistrict litigation begins: a product (like an artificial hip) hits the market. The artificial hip is implanted in thousands of patients. A year passes, then a few more. Patients complain of aches, pains, inflammation, noises, maybe even neurological symptoms. Doctors notify the manufacturer and their patients of these bad outcomes. Post-market studies are done. Problems are discovered with the product (in the case of metal-on-metal artificial hips, those problems included metallosis, loosening, pseudotumors, and many other “bad outcomes”). Injured people file lawsuits in courts around the country. The Judicial Panel on Multidistrict Litigation (JPML) eventually realizes it needs to designate one court to handle pretrial issues with the hundreds of cases being filed, so a multidistrict litigation (MDL) site is chosen, and the lawsuits are transferred to that MDL court. From there, the plaintiffs consolidate their efforts, and eventually a Master Complaint is carefully drafted and filed.

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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.