North Carolina Product Liability Lawyer Blog

Depuy ASR Metal-on-Metal Hip: Timeline of Injury, Revisions, Lawsuits

Published on: June 29, 2017 | By Clay Hodges

I have written extensively about metal-on-metal (MoM) artificial hips. Specifically, I have covered the painful and sordid history of the Depuy ASR metal-on-metal (MoM) artificial hip. In this post I set out a timeline of important dates in the the journey of the Depuy ASR hip: from (quickly) finding its way into the market, then into thousands of patients, followed by thousands of revision surgeries, and ultimately to a massive multidistrict litigation (MDL) in federal court in Ohio involving thousands of injured people. Let’s take a look at the calendar of events of the Depuy ASR product failure.

1995

In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained how metal wear debris created from MoM hip joints was a serious problem because of poor design and manufacturing of the metal components. Dr. Isaac also stated that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were as “unpredictable as ever, working well for a period of time before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics most likely knew of the MoM risk factors in 1995, twenty-two years ago, and ten years before the company began selling the Depuy ASR artificial hip. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” I wrote more about what Depuy may have known about the serious risks of the ASR hip here.

Taxotere: Patients Allege Drug Maker Hid Permanent Hair Loss Side Effect

Published on: June 23, 2017 | By Clay Hodges

Cancer is rough. It is a disease that has caused massive suffering, and virtually every family will be affected by it at some point. Doctors and scientists have tried to treat or cure cancer in patients ever since humans have existed as a species. In fact the name of this disease originates from ancient doctors who treated cancer and observed how a tumor’s appearance reminded them of crabs (cancer is Latin for crab).

Despite these efforts at fighting cancer over thousands of years, there is no complete cure and many current treatments, such as chemotherapy, have severe side effects.

Because of chemotherapy’s significant side effects and a general inability to completely cure the patient, a cost benefit analysis has always been important for cancer patients. Many cancer patients have to ask themselves if going through several weeks or months of misery is worth adding months or years to their lives. It’s an awful choice to make.

Physiomesh Hernia Mesh Causes Painful Scar Tissue, Other Injuries

Published on: June 21, 2017 | By Clay Hodges

Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?

Invokana: Diabetes Drug Has Caused Alarming Side Effects, Lawsuits

Published on: June 7, 2017 | By Clay Hodges

Diabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.

Zofran: Fraud Claims Against GlaxoSmithKline Will Move Forward

Published on: June 2, 2017 | By Clay Hodges

Zofran is an anti-nausea drug. It works to prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that triggers nausea and vomiting. The drug was designed to help cancer patients dealing with the side effects of chemotherapy but it was also approved by the FDA for those suffering nausea due to radiation therapy, anesthesia and surgery. Nevertheless, GlaxoSmithKline (GSK) eventually pushed to market and sell Zofran to pregnant women. Women who are pregnant are often plagued by morning sickness, and some can suffer from extreme nausea. The problem is, the FDA never approved the use of Zofran for pregnant women; it’s an “unapproved” use of the drug. Unfortunately, “off-label drug use” is very common. I wrote about off-label drug use and its potential dangers here.

By 2013, 110,000 monthly prescriptions of Zofran were issued to pregnant women. If this were an approved use, we could rest easier, as an approved use means the drug has been thoroughly tested and evaluated, with the determination backed up by “strong scientific data.” For unapproved uses there is none of that. If a drug is approved for any use, a doctor can then use his best judgment to prescribe the drug for any other purpose.

Textured Breast Implants Linked to Anaplastic Large Cell Lymphoma (ALCL)

Published on: May 26, 2017 | By Clay Hodges

According to the American Society of Plastic Surgeons almost 280,000 breast augmentation procedures took place in the United States in 2015. Given the popularity of breast implants, a wide range of breast implant products have been released in the United States and the rest of the world. One such product is the textured breast implant.

Why Are Breast Implants Textured?

The purpose of adding texturing to the breast implant surface is to help the body keep the implant in place and avoid it from shifting. Another reason is to prevent a complication called capsular contracture, which occurs when the scar tissue that forms around the implant become painful and hard.

Your Health Insurance Company Expects to be Repaid for Your Product Liability Injuries

Published on: May 22, 2017 | By Clay Hodges

When a device or drug maker pays money to an injured person for a defective product, several costs must be repaid from these funds. There will likely be medical liens, expenses of litigation, attorney’s fees, and health insurance liens. You can get an overview of these cost repayments in a post I wrote last year. In today’s post I want to take a closer look at health insurance liens (and the related concept of health insurance “subrogation”), mainly because health insurance companies can take a big bite out of your product liability settlement funds. Best to understand this unpleasant news upfront.

How Do Health Insurance Liens Work?

If you have health insurance, much of the cost of your medical care will be paid by your health insurance plan. Let’s say you need revision surgery to remove defective hernia mesh. The total cost of the surgery is $36,000.00, but under contracted payment rates between the hospital and your health insurance company, the cost is reduced to $24,000.00. Under your agreement with your insurance company, it pays $20,000.00 for this surgery and you pay a total of $4,000.00 in “co-pays” (that is, the amount you must pay “out of pocket” under your health insurance plan). So far so good.

A week after the surgery, while you recover from the operation (and watch afternoon commercials asking if you have been injured by defective hernia mesh), you receive a letter from your health insurance provider asking specific questions about how you were injured. The health insurance company is trying to figure out if a third-party is ultimately responsible for your injuries and thus for the costs of your revision surgery. The insurance company may want to know if you are pursuing a product liability claim against the manufacturer of the hernia mesh. It is no secret that the health insurance company is looking to be reimbursed for the payments it made for your mesh revision surgery. The moment you file a lawsuit against the product manufacturer, your health insurance company will submit a “lien” identifying its claim to some of the settlement funds. And trust me, these companies will not let this claim go lightly; they will pursue reimbursement aggressively, and you will most likely have a contractual responsibility to pay the health insurance company from your settlement funds. In fact, if possible the insurance company will expect to be repaid 100% of the costs it paid for your health care caused by the negligence of others. Continue reading

Representing Yourself in a Product Liability Case: Where Do You Start?

Published on: May 16, 2017 | By Clay Hodges

Here’s a scenario: you had hip replacement surgery several years ago. In 2015 the hip began to hurt and cause other problems. You had revision surgery in 2016. While at home one afternoon recovering from the revision surgery, you see seventeen commercials from personal injury law firms asking if you recently had revision surgery following the failure of the [fill in the brand name] artificial hip. If so, lawyers are standing by to assist you with your case.

(At this point, if relevant to your situation please substitute “IVC filter” or “hernia mesh” or “artificial knee” or any number of risky prescription drugs in the scenario above for “artificial hip.”)

So your next thought may be: I should represent myself. This is known as being a pro se litigant. If that is your thought, your next question should be, “what steps should I take to make sure I get a full and fair settlement for my product liability case?” It’s a great question.

Preserving Explanted Medical Devices in Revision Surgery

Published on: May 3, 2017 | By Clay Hodges

If you have been the victim of a failed medical device like a metal-on-metal artificial hip, you may not ever think about preserving evidence. But it is essential to your product liability case. In this post I want to give you some tips about preserving medical device components that have been removed (“explanted”) from your body in a revision surgery. This information is important for all those undergoing revision surgery, but especially those of you who hope to pursue a product liability case without a lawyer.

Here is a quick illustration: You undergo hip replacement surgery in October 2009. In August 2010, you receive a letter from the manufacturer of the artificial hip stating that a recall has been issued on the medical device implanted in your body. Since the device is implanted in your body, you can’t easily turn it back in for a refund. So you monitor the situation. Ten months later, you begin to feel discomfort, and then outright pain. After a few more months you and your orthopedic surgeon decide to have the device removed in a revision surgery. In this operation, the surgeon will remove the defective parts of the artificial hip and replace them with new, non-defective parts. Those removed parts will sit on a surgical tray, and after the surgery they will end up . . . somewhere. They could be thrown out; they could be placed in a Ziploc bag and abandoned in a storage room; they could be handed over to the medical device manufacturer’s representative, who is often in the room during your surgery.

But they need to go to you.

Quite simply, before the revision surgery, the patient should take steps to ensure that he or she will be given the explanted medical device components. This usually involves careful conversations with the surgeon and the surgeon’s nurse or other staff. Unfortunately, most patients have no idea that need to take this step.

Depuy Knew About Metal-on-Metal Hip Risks Decades Ago: Documents

Published on: April 26, 2017 | By Clay Hodges

“What did they know and when did they know it?” When something goes wrong with a medical device, this eventually becomes the key question. Unfortunately for Depuy Orthopaedics (Depuy), a lot has gone wrong with its metal-on-metal (MoM) hip implants over the past ten years. And to make matters worse, recently released documents* show Depuy knew it would have problems with its MoM hip implants decades ago.

Depuy MoM Hip Implants: An Overview

Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.

One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and metallosis.

As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or MDL. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, which I wrote about here.

Basically, things have not been looking good for Depuy. And they just got worse.