Articles Tagged with MDL

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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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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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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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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:

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Diabetes Drug InvokanaDiabetes is a serious condition that affects the way the body metabolizes sugar. Over 29 million Americans currently suffer from the disease. Of the newly diagnosed cases of diabetes in adults, around 95% are for Type 2 diabetes. Type 2 diabetes occurs when the body produces enough insulin but cannot use insulin properly. Type 2 diabetes results in high blood sugar levels which can cause long-term health problems. So what does all this mean? From the perspective of pharmaceutical companies, it means there is a massive market for Type 2 diabetes drugs. Enter the latest diabetes “wonder drug,” Invokana.   Continue reading →

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Last Thursday a jury in Chicago found that AbbVie, Inc., the manufacturers of the testosterone product Androgel, must pay the plaintiff, Jeffrey Konrad, over $140,000,000.00 for injuries he suffered after using the company’s testosterone product. The jury found that AbbVie did not adequately test the testosterone roll-on gel product and misrepresented its safety to patients and doctors.

The Second Testosterone Bellwether Trial

Testosterone MDL in ChicagoMr. Konrad was in his late forties when he began using Androgel in 2010. He was prescribed testosterone to treat a decrease in his testosterone levels. Two months later he suffered a heart attack. He filed suit years later, alleging that AbbVie knew about the link between testosterone use and heart attacks but sold the product anyway, and without sufficient warnings. The jury did not find that Mr. Konrad proved the connection between his use of Androgel and his heart attack. Other factors, such as Mr. Konrad’s obesity, high blood pressure, and family history, could have caused his heart attack. Nevertheless, the jury found that AbbVie was liable for damages based on AbbVie’s negligence and misrepresentation.