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METAL ON METAL HIP IMPLANT PATIENTS NEED TO KNOW THIS!

A Dallas, Texas jury last week unanimously found that a subsidiary of Johnson & Johnson, the baby powder people, sold defectively designed metal on metal hip implants that significantly harmed five people. The jury awarded more than $400 million in punitive and compensatory damages against Johnson & Johnson and its subsidiary after a ten-week trial. I watched almost every day of that trial, and I came away with a good understanding of how bad these particular medical products are and how much harm they can cause. I also know that far too many people are unaware of the silent harm that these products can cause. This is because the manufacturers, the government, and far too many doctors don’t publicize when bad products, like metal on metal hip implants, are unleashed on the public.

Today’s blog is my humble effort to send a message to the hundreds of thousands of Americans who received one or more “metal on metal” hip implants in the past ten years or so. This message is intended primarily for those folks who do not have a lawyer, or who have not been back to their hip implant surgeon for a year or so. You should be getting this important from your doctor, but I know that many doctors simply don’t keep their patients updated when the products they put in them are recalled from the market. This information also should come from the manufacturers of the implants, but many of them claim that “privacy rules” prevent direct communication with patients. Some of this information actually comes from the Federal government, but it is not well-publicized, is hard to find, and even harder to understand.

I know from experience that many patients with metal on metal implants simply do not understand the risk they took and the problems they might encounter in the future. I also know that the government, the companies, and probably even your doctors are not reaching out to you to provide this message. So I’ll do it for them.

 

  • Bad Products.

My last blog explained that any metal on metal hip implants placed in your body a few years ago have probably already been removed from the U.S. market or will be very soon. Check out: “Metal Hip Implant Makers Stop Selling Products Rather than Prove they are Safe” (March 8, 2016). The Food and Drug Administration has given the metal hip implant companies a May 18, 2016 deadline to either prove their implants are safe or stop selling them altogether. This nationwide phenomenon should be grabbing headlines everywhere, but few people even seem to realize it is happening.

 

  • A Silent Injury.

It is important to understand that you might be having serious medical problems related to your metal on metal hip implants without even knowing it. You cannot assume you are doing fine just because you are not hurting or experiencing significant difficulties with your hip implant. Your implant could be shedding metal debris in your body and causing significant, permanent injuries without you even knowing it.

 

Message # 1Do some investigation.

The first thing you need to do if you are concerned is determine if you actually have a metal on metal (“MoM”) hip implant. You probably already did that if you are still reading this, but make sure you clearly understand what product you received. Today’s blog is directed only to people who have or had MoM hip implants. The FDA cleared dozens of hip implants containing metal parts during the past fifteen years, but this blog and most public announcements about hip implants only apply to hip implants where there is a metal part rubbing directly against another metal part.

 

Message # 2A medical checkup.

I am not a doctor and cannot make a medical recommendation, but the FDA recommends that you make an appointment with your orthopaedic surgeon promptly for further evaluation if it’s been over a year since your last visit or if you develop any symptoms that your device is not functioning properly. Aside from a physical exam of the hip, the orthopaedic surgeon may consider several tests to evaluate these symptoms including:

Using a needle to remove fluid from around the joint (joint aspiration).

Soft tissue imaging.

Blood tests, including checking levels of metal ions in the blood.

The FDA also recommends that patients who received MoM hip implants should pay close attention to changes in their general health including new or worsening symptoms outside their hip. If they are referred to a doctor to evaluate new conditions, they should let their physician know they have a MoM hip implant. There have been some case reports and articles in the medical literature that suggest patients with a MoM hip implant may have certain symptoms or illnesses elsewhere in the body (systemic reactions). These include:

  • General hypersensitivity reaction (skin rash).
  • Cardiomyopathy.
  • Neurological changes including sensory changes (auditory, or visual impairments).
  • Psychological status change (including depression or cognitive impairment).
  • Renal function impairment.
  • Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold).

Even if you are not experiencing any of the above problems, the FDA is recommending that patients with MoM hip implants continue to follow-up with their orthopaedic surgeon every 1 to 2 years to monitor for early signs of change in hip status.[1]

This means the FDA thinks it is a good idea to see your doctor about your hip implants if you haven’t done that for over a year. That is exactly what I recommend to every person I talk with if they haven’t seen their orthopedic doctor for over a year. You may as well accept the fact that metal implants shed metal particles as the metal surfaces rub against each other during normal activities of daily living. The metal particles, though much smaller than microscopic in size, can migrate throughout your body. Your body has been fighting your metal implants since you received them, deploying valuable biologic defense resources with every step you take. You don’t get clear warning signs when your body is losing the battle. Your blood can be measured for excessive metal with a simple and inexpensive metal ion test, but those are not completely reliable or determinative of a growing medical problem. A positive result does not mean there’s impending disaster and a negative result does not mean all is well, but these tests are better than nothing.  The test results can establish a baseline to compare against past or future tests and they can help your doctor assess your condition even if the tests do not give all the answers.

All doctors who implanted metal on metal implants know of the importance of obtaining these tests periodically on their metal on metal hip patients. It would be a good idea to ask your doctor if you should be concerned at this time. I would be very concerned if your doctor is not concerned for you. Give it a try and see what he or she says.

 

Message # 3Know Your Rights.

One of the wonderful things about living in America is that companies can sometimes be held financially accountable to the people they hurt. There is cause for concern if you received MoM hip implants, and many people in this position have legal rights that may entitle them to monetary compensation. There have been thousands of lawsuits filed nationwide and you might even have a right to participate in a financial settlement that already exists or is about to occur. There are deadlines and statutes of limitations that apply to any legal rights you might have. You should take the time to know your rights before it is too late. It all depends on knowing your product and when you received it, so go back to “Message # 1” above if you are still not sure. You have to know your medical product if you want to know your legal options.

 

Message # 4A Legal Check Up.

The MoM hip implant world is going through major medical and legal changes right now.  There are several reasons for the legal changes, including a huge jury verdict last week and numerous fast-approaching legal deadlines. Changes are occurring in the medical world as many thousands of people with MoM hip implants are requiring revision surgery every year in this country, and because patients are starting to ask their doctors additional questions about these bad products.

You should consider yourself one of the lucky ones if you already have a knowledgeable lawyer who is interested in your case and is responsive to your questions and concerns. But I know there are many folks who do not have a lawyer or who are unsure if they need one. Now is a good time to decide if you need a lawyer for your potential hip implant lawsuit or claim. Lawyers who rejected your case previously might be interested again in light of the recent developments discussed above. Some law firms who stopped taking new cases months or years ago have already reversed course and are once again eagerly accepting new cases. If you currently have or have ever had MoM implants in your body there are statutes of limitations that are running, so you cannot delay any longer if you think you will ever pursue a legal case or claim.

There is no time like the present to check out your legal options. Lawyers nationwide are showing a renewed interest in these cases. I would be happy to talk with you about your case if you have any questions, but I probably will not take your case unless it involves a Smith & Nephew hip device. Just complete the online Hip Implant Questionnaire or Contact Form at www.kippetroff.com, and I will promptly contact you and try to help.

 

[1] http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm

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METAL HIP IMPLANT MAKERS STOP SELLING PRODUCTS RATHER THAN PROVE THEY ARE SAFE

  1. A Failed Regulatory System.

I am a relative newcomer to metal on metal hip implant cases, but I am in my fourth decade of working on litigation involving bad medical devices, starting with breast implants and HIV-tainted blood products in the early nineties and continuing with vaginal mesh and metal hip medical devices more recently. I have seen many things change during the 30+ years I have been suing drug and device companies. The FDA has changed. The litigation environment and parts of the court system have even changed. Most of these changes, though not perfect, resulted in a net improvement for patient safety and regulation of drugs and devices. But not all change represents an improvement.

  1. The Metal on Metal Hip Implant Experience.

Metal hip implants have been in the news recently for many reasons, including ongoing trials over allegedly bad implants nationwide. Recent trials have resulted in mixed results for the implant patients, but that will change in coming months as the issues and company conduct become clearer through experience. I predict a steady flow of increasingly large verdicts against hip implant makers in coming months. I will discuss the trials and company defense strategies in more detail in future writings, but I’ll briefly describe here the circumstances that resulted in an American tragedy for hundreds of thousands of people with bad hips who ended up getting bad hip implants.

The FDA quietly issued a “Final Order” last month that finally gave all the manufacturers of artificial hips one last chance to apply for “premarket approval” of their metal on metal hip implants. The Final Order was issued on February 18, 2016, after more than three years of consideration and public comment, and it gave the companies ninety days to submit a plan for proving their metal hip implants are safe and effective. Companies choosing not to stand up for their products in front of the FDA by mid-May of this year have to remove their unproven implants from the market.  It looks like the majority of metal on metal hip implant makers will quietly remove most of their products from the market rather than try to prove they are safe.

Hundreds of thousands of American patients have suffered serious problems from these bad products without the companies ever having to prove or even address the safety or effectiveness of the new devices. This happened because of a regulatory loophole that permits “grandfathering” of new devices simply by showing the FDA that the new devices were substantially similar to the old ones. Every company that wanted to enter the U.S. metal on metal hip business could do so quite easily, and they all did just that.

The companies will probably continue to argue that they did the best they could. They will argue that medical progress and innovation requires some element of experimentation. They will claim there was a void in technology twenty years ago that made orthopedic surgeons literally beg for a new alternative device which resulted in this failed metal on metal experiment. The companies will also argue that their implants really were not that bad.

I will discuss this regulatory loophole in future blogs, but the main point here is that our system of medical device regulation has once again put the cart before the horse – ten years of bad hip implants sold to the American public since the mid-2000s and our regulators are just now catching up with them.

  1. What happens to the patients?

I have spent the last nine weeks in a Dallas courtroom watching almost every day of a trial involving five unfortunate patients-turned-Plaintiffs suing DePuy/Johnson & Johnson over bad implants they received from 2004 to 2010. The FDA “Final Order” requiring “premarket approval” came out in the middle of this trial. The companies involved will probably quietly remove their bad products rather than try to prove they are safe and effective, but the patients who received these implants can’t remove them so easily. They are stuck with them. Even removing the implants and replacing them with non-metal parts isn’t a sure cure, because many millions of metal debris particles are already in their systems.

Dozens of medical articles about bad metal implants have been published over the past decade and the journals are full of new articles in every issue. Companies are now finally funding studies about hip implant safety. These new studies are mainly aimed at defending hip implant products that are no longer on the market. Tens of thousands of people will have to undergo revision surgeries in the next decade to remove these bad products and clean up the toxic metal mess left behind. Many of these patients are much worse off now than when they received these products. I’ll be there watching and taking names and notes, and I’ll tell you all about it right here.