Articles Posted in Multidistrict Litigation

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Patient's medical records and personal injury cases
Health care is an industry that, for the most part, is pretty quick to make the most of new technology. One such area is medical records.

With the increased capabilities and reduced costs of computers, networks and electronic storage, electronic health records (EHR) are primed to take full advantage of what information technology has to offer the medical field. These advantages can include better cost efficiency and improved patient care.

That’s one reason why Congress passed the Health Information Technology for Economic and Clinical Health Act (HITECH Act). This law set out to promote the use and adoption of EHR and medical information technology.

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Zantac and generic ranitidine
Generic drugs are a big deal in the United States. According to the U.S. Food and Drug Administration (FDA), 90% of prescription medications are filled with a generic drug. One of the reasons so many people take generic medications is the cost savings. From 2007 to 2016, generic medications saved $1.67 trillion. A generic version of Zantac has been sold since 1997.

But how is a generic drug different from a brand-name drug? Does this difference matter in the Zantac litigation? If so, where does innovator liability come in? I’ll address these questions in the following blog post. But first, a brief update into the Zantac litigation.

Current Status of Zantac Litigation

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iStock-518657244-300x286In Part 2 of this series we looked at the development of ranitidine (brand name Zantac), its rise as a hugely profitable heartburn drug, and the discovery that the carcinogen NDMA was found in rantidine, eventually leading to its recall and removal from the market. In this Part 3 I discuss how ranitidine can evolve into the cancer-causing chemical NDMA.

Nanitidine Can Form NDMA in the Stomach

When ranitidine enters the stomach, it can interact with “nitrites.” Nitrites are chemicals often found in spicy or salty foods. Food producers add nitrites to certain foods to prolong shelf life. All the way back in 1981, Dr. Silvio de Flora published a study showing that when ranitidine is introduced to nitrites it can lead to “toxic effects.” Dr. de Flora cautioned that if people take ranitidine, they should eat foods low in nitrites and avoid ranitidine near meal times.

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Zantac Master Complaint
In Part 1 I discussed the concept of the Master Complaint in product liability multi-district litigation, and we also set the table with the plaintiffs and the many defendant-companies involved in the Zantac litigation. Now let’s keep grinding through the Zantac Master Complaint. The story of Zantac, the presence of the carcinogen NDMA, and the links to cancer can be found in the Factual Allegations, beginning on page 39 of the Master Complaint. (Note that I use the brand-name Zantac and its actual name ranitidine mostly interchangeably in this post.)

These are the key elements of the story:

Inventing and Selling Ranitidine

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Zantac Master ComplaintIf you truly want to learn about a particular litigation involving a defective product (such as Zantac), the best place to start is the Master Complaint. This is the lengthy comprehensive document filed by the plaintiffs in a multi-district litigation involving a defective product. This does not mean the case is a class action. Most product liability cases are not class action lawsuits but are rather individual lawsuits gathered together in a “multi-district litigation or MDL.” These cases are transferred from across the country in one court, where one federal court judge will oversee the litigation until either (1) a global settlement is reached or (2) the cases are ready to be returned to the their home courts for trial.

The multi-district litigation involving the drug Zantac is located in the Southern District of Florida (MDL No. 2924). On June 22, 2020 the plaintiffs filed their Master Personal Injury Complaint. It is a long and detailed document, and it is worth your time to read if you have taken Zantac over an extended period, and certainly if you have taken Zantac and later developed cancer.

ZantacMany people, understandably, are not thrilled to read a 158-page legal document. So today and in the days to follow I am going to write up key bullet points from the Zantac Master Complaint. First, a few general guidelines: a complaint is the document a plaintiff files in a court to start a civil case. It can be a single page, alleging that the neighbor’s dog bit the plaintiff and caused injuries, or it can be hundreds of pages long, involving many defendants and many claims. The key thing to remember is that the complaint involves allegations, not proven facts. It may well be that every word of a complaint is true and that the plaintiffs provide compelling evidence for every allegation at trial. But at the start of a civil case the complaint should be understood as a series of allegations, which the defendants are allowed to deny and which they often deny. And that’s where the courts and juries come in: to figure out which side has proven its case.

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Smith & Nephew Birmingham hip litigation
COVID-19 has altered everyone’s schedule. Schools, colleges, and restaurants have closed. Even courts have shut down for non-urgent hearings and trials. In June, Judge Catherine Blake, overseeing the Smith & Nephew Birmingham hip litigation, issued an amended Case Management Order to extend discovery deadlines and bellwether trial dates for the multidistrict litigation.

Remember the Smith & Nephew Birmingham hip MDL is moving forward on two tracks: one set of cases involve the BHR components that were used in hip resurfacing procedures, and a second set of cases (“THA Track”) involve those individuals who received Birmingham hip components as part of a total hip arthroplasty (THA). Let’s breakdown the recent schedule changes for each track:

BHR (Resurfacing) Track:

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Soldier exposed to harmful levels of noise
Litigation involving 3M Dual-Ended Combat Arms Earplugs (“3M Earplugs”) is advancing. Recently deposition testimony from 3M and Aearo employees was made public, and some of the answers are troubling. It brings me no joy to play the role of Chicken Little, but when companies are tempted by massive profits, too often those companies will cut corners on consumer safety. In this case, those consumers were millions of soldiers serving their country from 2003 to 2015.

First, in a recent deposition a 3M marketing manager confirmed that 3M was selling the dual-ended earplugs to the military for $7.63, even though it cost the company just $.85 to manufacture, a 900% markup. In an email the 3M employee remarked “LOL,” apparently about the hefty price increase for the 3M Earplugs.

Second, as I wrote about a year ago, one of the central allegations in the soldiers’ claims against 3M is that the company did not adequately test the 3M Earplugs before selling millions of them to the military. Nevertheless, in deposition testimony 3M officials stated that they did not believe it was necessary for soldiers to know that the earplugs were tested under conditions that were different from the conditions the soldiers would experience in the field. In fact, a former vice-president at Aearo Technologies testified that he thought it was OK to conceal information from the government about potential defects in the earplugs. He also confirmed that it was acceptable to sell a product and conceal information that the product could have a negative effect on soldiers.

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Smith & Nephew Birmingham hip replacement
Judge Catherine Blake, who is overseeing the Smith & Nephew Birmingham hip multi-district litigation in Baltimore, Maryland, recently issued an order setting out the bellwether trial schedule for the Birmingham Hip Resurfacing (BHR) cases.

Just to recap: there are two tracks of cases in the Smith & Nephew Birmingham hip litigation: BHR and THA. BHR refers to cases involving injured people who received Smith & Nephew Birmingham hip components as part of a resurfacing procedure. The BHR resurfacing system is a metal-on-metal (MoM) artificial hip, but in resurfacing procedures the  hip “ball” bone is resurfaced with a metal covering and a metal acetabular shell is implanted into the hip socket, thus creating a MoM articulation. Smith & Nephew used cobalt and chromium to construct both of these resurfacing components. As with all metal-on-metal artificial hips, the Smith & Nephew BHR has been shown to wear down and leach metals into the blood and tissue of the patient, a condition called metallosis.

The second track of cases involves total hip arthroplasties (THA) using Smith & Nephew Birmingham components. These total hip replacements are constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the “ball-bone” with a metal covering the bone is removed and replaced with a metal ball component (a femoral head).

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Studies have linked Roundup to non-Hodgkins lymphoma
The makers of Roundup just lost another big case, this time involving a couple who used the weedkiller and were later diagnosed with non-Hodgkin lymphoma. This month, a jury in California awarded Alva and Alberta Pilliod more than two billion dollars. The jury found that Monsanto and Bayer acted negligently and failed to warn the plaintiffs of the dangers of using Roundup. The key active ingredient in Roundup, glyphosate, has been shown in studies to increase the risk of developing non-Hodgkin lymphoma (NHL). The jury then awarded Mr. Pilliod $18 million in “compensatory damages,” which is a money award for actual injuries suffered. The jury awarded Ms. Pilliod $37 million in compensatory damages, for a total of $55 million in compensatory damages. Finally, the jury awarded the Pilliods $1 billion each in punitive damages. The final jury award was $2,055,000,000. A truly astonishing number, and a major rebuke to the makers of Roundup.

The Pilliods testified that they used Roundup on their property for more than thirty years, from 1975 and 2011. They were diagnosed with NHL in 2011 and 2015.

Punitive damages play an important role in consumer protection. Punitives are awarded by a jury to punish or deter a bad-acting company, and similarly situated companies, from engaging in similarly awful conduct. Punitive damages are not common, and are usually awarded when a jury decides that the defendants had prior knowledge of a serious issue or problem and ignored this knowledge to the serious injury or detriment of other people.

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While mild hearing loss can be a side effect of aging, often people suffer hearing loss from working in loud environments. Military service can be a loud environment. There are environmental factors that can be avoided to protect your hearing. Your ability to hear is important and it can be debilitating to suffer hearing loss. 

Today, Product Liability Attorney Clay Hodges shares how noise-induced hearing loss (NIHL) can occur, and the litigation emerging from defective earplugs used in the military. To hear more about the impact of noise induced hearing loss and the cases involving Dual-Ended Combat Arms Earplugs, tune in to this episode of Failed Hips and Harmed Drugs. 

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