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Physical therapist helps patient recover from artificial hip surgery
My friend Amy Dougherty is a physical therapist in North Carolina and operates Outer Banks Physical Therapy. She is a graduate of the University of North Carolina at Chapel Hill (where I also attended college and law school). She is an outstanding physical therapist and is beloved by her patients on the Outer Banks. Amy answers many of your questions about hip replacement surgery, metal-on-metal artificial hips, and the problems that have arisen from these hip products.

Clay: I want to focus on hip replacement surgery and I know you work with patients who are dealing with that kind of surgery every week. So let me start by asking what are a few reasons a person might need a hip replacement surgery?

Amy: You know, the most common reason is arthritic changes in the hip. So basically arthritis, that is the most common reason. Other reasons can include things like trauma. Some people have congenital mal-alignments where, it is basically called dysplasia where through the process of their development in utero and then following their bony surfaces of the femur, that is the long thigh bone and the acetabulum which is in the pelvis. They do not form correctly, so they might have ill-formed femoral heads. They might have ill-formed or ill-shaped acetabulum. So, the ball and the socket are not really designed well to weight bear. So, a lot of folks that, especially in a young population, that have early onset hip replacements. It is more likely the result of some type of congenital dysplasia. It could be a trauma. So, but arthritic changes is the number one reason and I have total hip replacement patients in my clinic every day. Very popular surgery, yes.

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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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Elmiron and Vision Loss
Elmiron (pentosan polysulfate sodium) is a prescription medication that was approved in 1996 for the treatment of interstitial cystitis. This condition is sometimes referred to as painful bladder syndrome and can consist of a range of symptoms. These can vary from the occasional mild discomfort to constant and significant pain in the bladder or lower abdomen of the body.

Currently, Elmiron is the only FDA-approved oral medication to treat interstitial cystitis. As a result, numerous individuals have taken the medication for an extended period. But over the past few years, several studies have been published that indicate that some people may suffer from vision problems from taking Elmiron. Some of the more notable studies came out in 2018 and 2019.

This blog post will examine the possibility of Elmiron causing vision loss in patients, its current status with the U.S. Food and Drug Administration (FDA), and what its makers, Janssen Pharmaceuticals, Inc. (Janssen) and Johnson & Johnson, potentially face in litigation.

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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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Zantac and cancer
Earlier this year I wrote a blog post that discussed the recent revelation that Zantac might cause cancer. Scientists found a link between N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance, and ranitidine, the key ingredient in Zantac.

A few things have changed since that blog post, such as the U.S. Food and Drug Administration (FDA) asking all manufacturers to immediately recall drugs containing ranitidine from the market.

Why Did the FDA Ask for a Recall?

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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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