Here's $200k! (Only requirement: live with pain of a faulty hip the rest of your life.)

Biomet reaches $56 million settlement over faultyhip replacements

Mon Feb 3, 2014 11:30pm EST

(Reuters) - U.S. medical device maker Biomet Inc will pay at least $56 million to settle a multi-district lawsuit relating to defective metal hip replacements, a court filing showed, ending a protracted legal tussle.

The litigation involves Biomet's metal-on-metal hip replacement device known as M2a Magnum. Hundreds of plaintiffs claimed in various courts across the country that the hip device led to injuries.

The lawsuits were combined and jointly heard at the federal court of Indiana, the state where Biomet is headquartered. The multi-district litigation began in 2012.

As part of the settlement, Biomet will deposit $50 million into an escrow account and another $6 million into an attorney fee fund, the filing showed.

The agreement with the plaintiffs shall extend to all pending cases, and any future lawsuit filed in a federal court on or before April 15, 2014.

Plaintiffs who have received a Biomet M2a 38 or M2a Magnum hip replacement system as part of an initial hip replacement that was rectified more than 180 days after it was implanted shall receive a base award of $200,000.

Biomet, however, maintains that the injuries, losses and damages were not due to its hip implants.

"Plaintiffs and Biomet are mindful of the uncertainties engendered by litigation and are desirous of settling and compromising their differences by entering into this settlement agreement," Judge Robert Miller wrote in his order.

Biomet said in a statement late on Monday that it is pleased to reach a settlement and resolve the lawsuits.

The case is Biomet M2A Magnum Hip Implant Products Liability Litigation (MDL 2391), Case No. 12-02391, U.S. District Court, Northern District of Indiana.

(Reporting by Sakthi Prasad in Bangalore; Editing by Supriya Kurane)

http://www.reuters.com/article/2014/02/04/us-biomet-settlement-idUSBREA1305Y20140204

My testimony to scrap 510(k) FDA approvals of implanted medical devices 6/13/13

Are you the compliant, uninformed low income patient the AMA and lawyers are targeting?

How doctors can spot patients likely to sue

Knowing what types of patients are more lawsuit prone can help reduce physicians’ liability risks.

By ALICIA GALLEGOS, amednews staff. Posted Feb. 4, 2013.  (FiDA editing and highlight-this is a compilation of quotes only-please read full story on link above)

Lower-income people are less likely to sue their doctor than wealthier patients.  probably because of lack of access to legal resources, according to  a May 2012 study in Clinical Orthopaedics and Related Research

“There are individuals in society where it doesn’t matter what happens to them; they’re going to look the other way,” said Gerald B. Hickson, MD, director of the Center for Patient and Professional Advocacy at Vanderbilt University School of Medicine in Nashville, Tenn. 

People who have higher social statuses, live in urban areas and have higher education also are more likely to file claims, Sacopulos said. Another contributing factor is whether the patient personally knows a doctor or attorney, adds Mark Horgan, senior vice president for claims at CRICO, a professional medical liability insurer in Massachusetts.

 If people beg for a procedure or demand treatments, that should raise a red flag, said Dr. Scherger, co-contributor of a 2011 video presentation called “The Legal Risk Patient” posted on the website of QuantiaMD, an online physician learning collaborative.  Medical liability defense attorney Michael J. Sacopulos  She complained about nearly every doctor she had seen previously.

“Now more than ever before, patients are well-informed, 

 Potential indications of a suit include receiving a subpoena or a request for medical records, or experiencing an unexpected or unfortunate outcome in which a patient is upset.

65% of medical liability lawsuits are dropped, dismissed or withdrawn. 

[Illustration by Gilbert Ford / www.gilbertford.com]

just under a quarter resulted in settlements. Of the 8% that went to trial, 90% of those claims ended in a doctor’s favor, the AMA analysis showed.

In 2011, the average expense payment was $49,756, an increase of 5% from 2010. Expense payments include bills paid to attorneys, expert witnesses and other defense costs. A January study in Health Affairs found that the average physician spends nearly 11% of his or her career with an unresolved medical liability claim.

“I don’t think the majority of lawsuits are filed because the patient is litigious, but 

“The trouble is if a lawsuit is ever filed, the doctor has that on their record, even if the case is dismissed.”

said Sacopulos, chief executive officer for the Medical Risk Institute in Terre Haute, Ind. The institute counsels health professionals on understanding and reducing litigation risks.

“You don’t really know what the circumstances were, and that patient may have had every reason to sue, but if it’s happened more than once, that would concern me,” he said. “Before I would refuse a patient, I would talk to my risk manager or insurance company.”

“I’m not saying, I want medical professionals to maintain a code of silence, but 

The ethics of parting ways

If a patient continues to be dissatisfied with a physician, it may be time to end the relationship,

American Medical Association ethical policy states that a physician is under both ethical and legal obligations to provide services as long as a patient needs them. A termination generally should be communicated verbally to the patient and with a letter outlining the reasons for the dissolution, the policy says.

ADDITIONAL INFORMATION: 

How to address legally risky patients

Doctors should use caution when treating patients they believe may sue. Being open and communicative with such patients can reduce liability risks and help build stronger relationships.

Document. Carefully document patient conversations, treatments and clinical evaluations.

Use secure communication. Encourage secure online communication with the patient so documentation is recorded on both sides and stories cannot be changed later.

Build trust. Focus on getting to know the patient and developing trust with him or her.

Be transparent. Be open with the patient and clearly explain all medical treatments and diagnoses.

Encourage inquires. Invite the patient to ask questions, and answer all concerns honestly.

Say you’re sorry. Apologize to the patient and take responsibility for any mishaps when appropriate.

Source: “The Legal Risk Patient,” QuantiaMD, 2011

WEBLINK

“Do Poor People Sue Doctors More Frequently? Confronting Unconscious Bias and the Role of Cultural Competency,” Clinical Orthopaedics and Related Research, May 2012 (www.ncbi.nlm.nih.gov/pubmed/22367624/)

“On Average, Physicians Spend Nearly 11 Percent Of Their 40-Year Careers With An Open, Unresolved Malpractice Claim,” Health Affairs, January (content.healthaffairs.org/content/32/1/111)

“Professional Liability Insurance Indemnity and Expense Payments, Claim Disposition, and Policy Limits, 2002-2011,” American Medical Association, December 2012, for AMA members only (www.ama-assn.org/resources/doc/health-policy/x-ama/prp2012-03piaa.pdf)

Health Leaders Media encourages patient harm dialogue

New Facebook Page Gathers Stories of Medical Harm

Cheryl Clark, for HealthLeaders Media , May 24, 2012  (FiDA Blog Bold)

As if Facebook didn't grab enough headlines on Wall Street this week, the social media forum is also making healthcare news that should prompt any leader to pay close attention.

ProPublica, the two-time Pulitzer Prize–winning newsroom that collaborates with other media outlets for investigative journalism, a few days ago launched its Facebook "Patient Harm Community."

People can sign up and post a healthcare horror story in graphic detail. Journalists are joining to find patients in their communities who have details to share. There's a special "Files" page entitled "What to do if you've been harmed," which instructs patients on where and how to lodge complaints about doctors, nurses, and hospitals. Even some healthcare providers are weighing in.

ProPublica's Marshall Allen, who uncovered systemic poor quality in Nevada hospitals for a 2010 series in the Las Vegas Sun called Do No Harm, and himself a Pulitzer finalist, explains what prompted the Facebook venture.

For starters, he says, the one million people—a staggering number—who suffer injuries, infections, and errors in healthcare facilities across the country each year had very few places to turn for advice, until now.

"Over the years, I've talked to scores of patients who have been harmed while undergoing medical care, and the one thing that always struck me is the fact they feel so alone," he says.

"When they suffer this type of harm, they complain to doctors and hospital officials and regulators, but they often don't feel that they're being listened to. 

"I wanted to find a way to give these folks an opportunity to talk to one another, offer advice, encouragement, and comfort, and get questions answered. A lot of them are at different stages of the process of working through the things that happened to them."

Healthcare professionals especially should pay attention to what's said on this site, he says, because it might illuminate what a patient with a bad episode of care really goes through. They should join in the conversation.

"I think for hospital leaders this would be a great place for them to put an ear to the ground, to hear what patients are really saying, and factor that in when they make decisions," Allen says. "We created this for doctors, nurses, hospitals, and healthcare officials just as much as it was created for patients."

"Doctors, nurses, and hospital officials also are very interested in reducing the number of patients who suffer infections, injuries, and errors while undergoing medical care," he adds.

Leah Binder, CEO of the Leapfrog Group, which plans to publish patient safety scores for 2,600 hospitals on its website in a few weeks, says ProPublica's patient safety community "is a great idea ... so people who suffer this kind of harm don't think they're the only ones."

"All too often I will hear from someone, 'I had the most unusual experience; I got an infection in a hospital' or 'someone gave the wrong medication.' But that's not unusual; that's usual," Binder says. "Most people who have been in a hospital have suffered some kind of harm and it's time to put a stop to that. People deserve to know that some hospitals are safer than others."

She notes that the Office of Inspector General at the U.S. Department of Health and Human Services counted up the number of deaths to Medicare beneficiaries caused by medical mistakes for one month. The extrapolated one-year total was 180,000. That makes for a lot of bereaved and frustrated family members.

By my count, membership in the fledgling Patient Harm Community is growing by about 100 a day as word gets out.

In recent days, for example, postings included these issues:

• A nurse in Phoenix claimed she was fired by her hospital, and now faces nursing board charges, for informing a patient about risks of upcoming surgery and the benefits of hospice.
• An infection prevention nurse in California, formerly a hospital inspector with the state Department of Public Health, told of undergoing a spinal disc procedure with a flawed protein material she was never informed about by her surgeon, resulting in multiple subsequent surgeries.
• A warning from an employee at the federal Agency for Healthcare Research and Quality for patients to not take antibiotics and proton pump inhibitors (like Prilosec or Prevacid) at the same time because of links to clostridium difficile infections.

Allen says ProPublica's social media experts looked around the country to find a similar online forum but without success.

This isn't like Yelp or Angie's List, where unhappy patients can anonymously pile on about a rude receptionist. "These are peoples' real identities, as far as we can tell, so if they say something to the group, their name is behind it. There's a little bit more accountability," Allen says.

It occurs to me that hospitals and doctors might be nervous about the page, fearing a free-for-all of complaints from emotional patients and family members who exaggerate claims or confuse the natural course of illness and disease with preventable misdiagnoses, infections, and medication mishaps. I see both sides, and appreciate the very human ways that can happen when people are in distress.

So I asked the American Hospital Association to take a look, noting that ProPublica wants providers to join the conversation.

Nancy Foster, AHA vice president of quality and patient safety, gives a tepid response: 

"When patients have concerns about their care, we encourage them to talk with staff at the hospital. Patients and their family members will find that their care givers are deeply concerned about making care right for them and that care givers also want to improve the care experience for future patients.
"Further, it is often helpful for patients to share their stories in forums like this one. However, as providers, we are both legally and ethically bound to honor our patients' privacy and not discuss their care in open public forums."

The American Medical Association did not respond to a request for comment.

Robert Wachter, MD, a patient safety expert at the University of California in San Francisco and chief of the Division of Hospital Medicine at UCSF Medical Center, thinks the site could be useful for healthcare officials. "One learns about medical mistakes through a variety of lenses, and this is another one," he says. "I suspect there'll be some interesting, useful information, a fair amount of ranting, and lots of people with painful stories they simply want to share with others. It'll be interesting to see how it plays out and whether it gets any traction."

ProPublica's team members monitor discussions and comment, posting relevant news or reference articles. As the site gets going, Allen says, "We want to do keynote question-and-answer sections with healthcare leaders and patient advocates, and whatever the topics are that audiences are most interested in, we'll try to provide useful resources."

I wondered how Allen's team will handle comments specific to named hospital facilities or physicians. "Let's say someone posts 'St. Augustine Hospital in Kansas City, MO killed my father when it gave him an overdose of morphine?'" I asked.

He replies that ProPublica will try to seek comment, "and to the extent we become aware of something we know is not true, we will take it down."

Allen acknowledges that the Facebook effort "is kind of an experiment, to be honest. We don't know how it's going to go or what direction it's going to take. We're trying not to control it too much, but let the members participate and engage one another and direct the direction that things take."

I know people at ProPublica personally, and the excellent reputation it has garnered in the last four years. If anyone can do this in a responsible way, surely this organization can, and highlight at a human level the harm that negligence and nonchalance can cause.

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Cheryl Clark is a senior editor and California correspondent for HealthLeaders Media Online. She can be reached at cclark@healthleadersmedia.com. Follow Cheryl Clark on Twitter.

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