Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, January 7, 2014

NPR: Johnson and Johnson $2 Billion Settlement for failed hip (metal toxicity)

Patients, Consumer Advocates Question Hip Implant Settlement


January 07, 2014 4:29 AM

Lawyers for thousands of patients who had to have their defective hip replacements removed have reached a settlement with the company that made the faulty device. Many patients, however, aren't satisfied, and consumer advocates say the case illustrates what's wrong with how the government regulates implantable medical devices.

Listen to the Story  5 min 54 sec

Morning Edition


The company that made a defective artificial hip has agreed to pay more than $2 billion to thousands of patients who had to have those implants replaced. But some patients are questioning whether the settlement is enough. Consumer advocates say the deal with Johnson & Johnson does nothing to prevent faulty medical implants from getting on the market in the future.

NPR's Rob Stein reports.

ROB STEIN, BYLINE: Mary Schrag is 69 and lives outside Seattle. Life has been a struggle since she got the defective metal joint implanted in her hip.

MARY SCHRAG: I'm still in a lot of pain in my back and my hips because I'm not really able to walk steadily. And I do feel very depressed because I - it's just trying to get through another day.

STEIN: And that's even after Schrag went through a complicated operation to have the implant replaced. She used to work, travel and hike. Now she has a hard time just standing up and can barely walk with a cane. She needs a wheelchair to go shopping.

SCHRAG: All I know is I'm just - I feel like I've been living in a hell for many, many years. My life just will never be the same.

STEIN: Schrag is one if about 8,000 patients who are candidates for compensation through the settlement with Johnson & Johnson, which owns the company that made the defective hip. Steven Skikos is a San Francisco attorney who helped negotiate the deal for the patients.

STEVEN SKIKOS: Those patients who had the implant taken out are eligible to participate in a settlement that amounts to two and a half billion dollars. And those patients are available to receive compensation, which is essentially around $250,000.

STEIN: The deal also pays patients' bills for getting their implants replaced and sets up a $475 million pool for those who suffered the worst complications. But the exact amount each patient gets could end up being higher or lower, depending on things like how long they had the bad hips, their age, their weight. Many patients would probably get about $160,000.

SKIKOS: There's no amount of money that, for a lot of these patients, will compensate for what they've been through. But the truth is, is that in terms of the negotiation of this particular agreement, there was no penny left on the table.

STEIN: Some patients are happy with the deal. Jeanette Trout is 66 and lives in Manchester, Pennsylvania. She's expecting about $165,000.

JEANETTE TROUT: I'm tickled to death with the money I'm getting. It's going to help me tremendously. I mean this - this is God-sent. This is God-sent.

STEIN: But some patients feel betrayed. Some are angry that lawyers are getting about $800 million. Others say the amount of money it looks like they'd get won't come close to making up for their suffering and any future medical bills they may have. Mary Schrag.

SCHRAG: I really do not think it's fair. I truly, truly don't. This has jeopardized my life and my health indefinitely.

STEIN: And patients aren't the only ones who aren't satisfied. Lisa McGiffert is with the Consumer's Union Safe Patient Project. She says the settlement does nothing for thousands of other people who also got the defective joints.

LISA MCGIFFERT: There are about 27,000 other people who got this particular brand of hip who are not included in this settlement.

STEIN: Not included because they haven't had their hips replaced yet or filed lawsuits, and there are thousands more who got similar devices. And, McGiffert says, the settlement does nothing to prevent another defective medical implant from destroying more lives in the future.

MCGIFFERT: I think the settlement is inadequate to address the fundamental flaws in this market.

STEIN: McGiffert says implants like artificial hips and knees can get approval without thorough safety studies if they are similar to other products already on the market.

MCGIFFERT: We think that all medical devices that are implanted in the body - that is, it takes surgery to put them in, it takes surgery to take them out - that those devices should have to go through rigorous testing that requires some clinical evidence that they are safe.

STEIN: And that every device should come with a warranty and be tracked closely to catch any problems more quickly. But the medical implant industry disputes all of this. David Nexon of the Advanced Medical Technology Association says the current system insures safety without stifling innovation.

DAVID NEXON: No process is perfect and sometimes things turn up that weren't detected when FDA reviewed it or when the manufacturer developed it. But by and large, patients can be very confident that the medical devices that are used in their procedures are very safe products.

STEIN: Johnson & Johnson would not make anyone available for an interview. In a statement, the company said the settlement was fair. Steven Skikos, the attorney who negotiated the deal, said the lawyers got patients the most they could.

SKIKOS: Every element of this was very hard fought, so I can say with confidence that the lawyers who put this together put together the best deal possible under these circumstances.

STEIN: Skikos says the lawyers will help any patients who need to have their hips replaced in the future get compensated. In the meantime, those who are eligible for this settlement have until April to decide whether to accept it or keep fighting for more. Rob Stein, NPR News.

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