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.
Please share what you have learned!
Twitter: @JjrkCh

Wednesday, February 27, 2013

Joint Replacement Survey: Consumers Union

If you or a loved one have an implanted joint replacement, please go to the link above and fill in the survey.

Consumers Union is actively advocating for patients with implanted medical devices.  Today, CU Safe Patient Project, Senior Director, Lisa McGiffert participated by Brookings Institute webinar with FDA Jay Carney and NWHN Kate Ryan in a discussion on implementing UDI's.  Unique device identifiers are the first step in providing patients with accurate and timely information about the composition, origin and producer of their implant.  This information will be uniform and shared in the electronic health record, with the insurer and the FDA.  This will allow researchers to analyze which devices are safe and effective and provide the patient with a portal to determine which devices have been recalled.  The federal government is still working on implementation, so Consumers Union is providing this survey as a preliminary "registry" for patients until the national program is fully instituted.

Thank you!

Monday, February 25, 2013

Harmed patient not healed by $3.35M verdict.

By David Voreacos - Feb 25, 2013 11:44 AM CT  FiDA highlight
Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.
Jurors ordered J&J to pay $3.35 million to the nurse, Linda Gross, and her husband. Gross, 47, had 18 operations after the device was implanted.

J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor, the jury ruled. Jurors decided that the company failed to warn Gross’s implanting surgeon. The verdict in Atlantic City state court came in the first trial of claims Ethicon’s Gynecare Prolift injured women.
“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” Gross attorney Adam Slater said in an interview.
Slater argued to jurors that company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. Gross blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.
‘Doctors Knew’
J&J claims the Prolift is safe and effective and it warned of the risks.
“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments on Feb. 15.
Superior Court Judge Carol Higbee is considering whether to allow Gross’s attorneys to pursue punitive damages, which are intended to punish the company. If so, the same jury would hear evidence and decide whether to award such damages. New Jersey caps punitive damages at five times compensatory damages, which in this case would be $16.75 million. Jurors delivered their verdict on the fifth day of deliberations.
Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.
Difficult Removal
The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. J&J, based in New Brunswick, New Jersey, said in June that it would end sales worldwide because the products lacked commercial viability, not because of their safety and effectiveness.
Slater claimed that Gross’s chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies and was difficult for surgeons to remove.
Gross, of Watertown, South Dakota, testified on Jan. 31 that her life has changed dramatically for the worse since her mesh was implanted. She said she is in constant pain and can no longer sit comfortably, and she has prescriptions for 20 different medicines to help with her pelvic problems.
“Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.”
Little Risk
Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006 to shore up pelvic muscles, was “so gung-ho” about the Prolift that she thought she needn’t worry. She understood from talking to Benson and reading a company brochure that she faced little risk and that the mesh could be removed easily, she said. Had she known all the risks, she said, she wouldn’t have chosen the Prolift.
Gross said she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which have been “horrific.”
“I am fearful of dying because this pain is so bad,” she said.
On cross-examination, Jones sought to establish that before many of her surgeries, doctors warned that they may not help her pain. At one point, Gross shouted at Jones: “You’re trying to blame it on me, and it’s not right.”
Jurors saw the video deposition of Benson, who did three follow-up surgeries to remove portions of the mesh to help her with her pain. Other doctors also removed parts of her mesh.
During jury deliberations, the jury reheard testimony from both Gross and Benson. During the trial, which began Jan. 10, jurors also heard from 11 company witnesses and several experts on each side.
Johnson & Johnson shares fell 2 cents to $76.23 at 12:40 p.m. in New York Stock Exchange trading.
The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).
To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at
To contact the editor responsible for this story: Michael Hytha at

Accessing justice is a high barrier for patients who experience failed implanted medical devices. they are hurt and medically impoverished. The surgeons are not legally required to report "adverse events" to the FDA unless there is a fatality.  Registry of the devices (if there is any) is held in a proprietary silo and data of implants success/failure is obscured for patients making life-changing decisions.  The monumental failure of Johnson & Johnson both for DePuy MoM (metal on metal hips) and Ethicon surgical mesh were preventable if marketing had not led science.  Why is this not criminal?  It is defrauding the government because taxpayers absorb the expen$ive accountability that the industry does not. FiDA Failed Implant Device Allicance  Joleen Chambers

Wednesday, February 20, 2013

Women: Hip Implants 29% More Likely to Fail

By John Gever, Senior Editor, MedPage Today
Published: February 18, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Failure rates for hip implants were 29% higher for women than men in a large U.S. registry study after controlling for a variety of factors including device type, researchers said.
With a total of 35,140 patients undergoing primary total hip arthroplasty followed for a median of 3 years, the crude all-cause rate of failure (defined as subsequent revision surgery) was 2.3% for women (95% CI 2.1% to 2.5%) compared with 1.9% for men (95% CI 1.6% to 2.1%), according to Maria C.S. Inacio, MS, of the Southern California Permanente Research Group in San Diego, and colleagues.
After adjustments for age, body mass index, diabetes status, degree of presurgical symptom severity, implant fixation method, device category, and femoral head size, the authors calculated a hazard ratio (HR) for revision of 1.29 for women versus men (95% CI 1.11 to 1.51), they reported online in JAMA Internal Medicine.
The risk appeared most prominent for aseptic revision (HR 1.32, 95% CI 1.10 to 1.58) compared with septic failure (HR 1.17, 95% CI 0.81 to 1.68), the researchers found.
Larger femoral head sizes appeared especially problematic for women. For head sizes of 36 mm or more, the adjusted HR for failure in women versus men was 1.49 (95% CI 1.14 to 1.95), whereas differences in revision rates for smaller head sizes were not significant after adjustment.
Much of the increased risk for women also seemed concentrated in metal-on-metal implants, with a doubling in risk for women versus men (adjusted HR 1.97, 95% CI 1.29 to 3.00).
But that was primarily because of reduced risk of failure with metal-on-metal devices in men (adjusted HR 0.68 versus highly crosslinked polyethylene, 95% CI 0.45 to 1.02), whereas in women, the adjusted failure rates for metal-on-metal versus crosslinked polyethylene were similar, adjusted HR 1.07, 95% CI 0.72 to 1.60).
Clinical Implications?
In an accompanying commentary, Diana Zuckerman, PhD, of the National Research Center for Women and Families in Washington, D.C., suggested that the study's clinical implications were relatively trivial.
She noted that most patients considering hip replacement are already suffering pain and limited mobility and have few other options.
"Knowing that their chances of success are lower than men's is not helpful to women who are unable to perform many activities of daily living," Zuckerman argued.
Instead, she said, what is needed is "long-term comparative effectiveness research based on large sample sizes, indicating which total hip arthroplasty devices are less likely to fail in women and in men, with subgroup analyses based on age and other key patient traits, as well as key surgeon and hospital factors."
But Glenn Don Wera, MD, of UH Case Medical Center in Cleveland, told MedPage Today that the study provided valuable insights into the reasons for higher failure rates in women.
He noted that the higher rate of revision in women was already known from Medicare data. In the current study, however, "they were able to control for a number of clinical factors, including the kind of prosthesis the patient had, the experience level of the surgeon, and the different institutions and the different prostheses they were using."
That the increased risk in women was still evident despite adjusting for those factors indicates that something else, such as women's generally smaller stature, is responsible, Wera suggested.
Revision Rate: Beyond Infection
Data for the current study came from the Kaiser Permanente system's registry of total joint replacements from 2001 to 2010. Procedures were performed at 46 hospitals in California, Hawaii, Oregon, Washington, and Colorado by 319 different surgeons.
The registry is the largest of its type in the U.S., the authors said and includes data on surgeons' and hospitals' arthroplasty procedure volumes; the patients and the implants they received (cemented, uncemented, or hybrid); and implant bearing surface, such as metal on metal, metal or ceramic on highly crosslinked polyethylene, or ceramic on ceramic. The researchers put the DePuy metal-on-metal hip resurfacing monoblock device into its own category.
Only patients undergoing unilateral procedures were included in the analysis.
About 58% of the 35,140 procedures were performed in women (mean age 65.7 versus 63.8 for men). Just over 60% of both sexes had scores of 1 or 2 on the American Society of Anesthesiologists index, with nearly all of the remainder having scores of 3 or more.
The age difference between men and women was statistically significant. In addition, women in the cohort tended to be slightly more likely to be white or Asian and to have osteoarthritis, rheumatoid arthritis, or dysplasia. They were less likely to be diabetic or obese and to have osteonecrosis or post-traumatic arthritis.
Not surprisingly, women were much less likely to have implant femoral head sizes of 36 mm or more (32.8% versus 55.4% for men, P<0.001). About twice as many men as women had metal-on-metal bearings (19.4% versus 9.6%), whereas ceramic or metal on highly crosslinked polyethylene were more popular for female patients (P<0.001).
The DePuy resurfacing implant was used in 1.3% of women versus 2.6% of men (P<0.001).
Preferences for fixation types also differed between men and women, with hybrid methods more common in the women and cementless fixation more common in men.
Mean surgeon and hospital volumes did not differ between sexes.
The authors noted that with no significant increase in risk of septic failure for women, their results mean that "factors other than infection" are responsible for the higher overall revision rate.
Limitations to the analysis include its observational design, the relatively short follow-up period, lack of data on some potential confounding factors, and the use of revision surgery as the definition of implant failure. Also, the researchers used relatively broad categories of implant type, conceding that design variations within these categories could have influenced the results.
The study was funded by the FDA.
Study authors and Zuckerman declared no relationships with commercial entities. Several study authors were Kaiser Permanente employees.

Monday, February 18, 2013

NPR Diane Rehm Show: Failed Implants

New Questions About The Safety Of Hip Replacements 
The Diane Rehm Show WAMU 
Thursday, February 14, 2013 - 10:06 a.m

The Food and Drug Administration recently issued new warnings on the safety of some hip replacements. As part of our occasional series, "Mind and Body," Diane and her guests discuss what patients need to know about safety and cost of hip replacements.
Barry Meier staff reporter for "The NewYork Times" and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death."
Diana Zuckerman president of the National Research Center for Women and Families.
Dr. Henry Boucher orthopedic surgeon at Medstar Union Memorial Hospital in Baltimore, Md.
Sarah Brown CEO of The National Campaign to Prevent Teen and Unwanted Pregnancy and three-time hip replacement patient.
Kenneth Thorpe professor and chair of health policy and management at Emory University Rollins School of Public Health.

Patient/public access to implant data still missing!

Physicians face limited choice in medical device selection as hospitals push to slash supply-chain costs

 Modern Healthcare
By Jaimy Lee   FiDA highlight  
Posted: February 15, 2013 - 12:01 am ET

 Gagged by their supply contracts, some hospitals have devised a simple way to educate physicians about the cost of pricey implants: using color-coded stickers to indicate the level of a device's price.

Many of these hospitals are barred by confidentiality clauses with device manufacturers that limit, in some instances, whether hospitals in the same health system can share pricing data about the devices they purchase. Instead, they mark the devices with colored tags specifying high-, medium- or low-cost options.

The widespread use of confidentiality clauses—which limit price transparency and hospitals' ability to shop for devices based on price—and longstanding relationships between physicians and device companies are the two major factors driving costs higher on implantable devices such as artificial knees and hips or cardiovascular stents, which are among the most expensive items hospitals buy.

 They are frequently called physician preference items because orthopedic and cardiovascular surgeons traditionally make the final decisions as to which devices a hospital will use. Only over the past five years or so have some hospital administrators started to implement strategies to reduce the costs of these items.

However, mounting pressure on hospital margins, the increasing number of physicians employed by hospitals and the shift to new payment models that align the financial priorities of hospitals, physicians and a patient's cost of care indicate that the concept of a physician's preference may soon be a thing of the past.

“This will be an area where there is a lot of opportunity for cost containment because it's an area that has really run rampant in the past and has not been well controlled by many hospitals,” says Dr. Kevin Bozic, vice chairman of orthopedic surgery at the University of California at San Francisco. “There's not as much flexibility and fat in the system. They're going to have to be much more efficient and function with the same discipline as other businesses.”

At the same time, the costs of many implantable device procedures continue to rise. Orthopedic procedures accounted for most of the growth in Medicare implantable device procedures from 2004 to 2009, with spending on those procedures increasing 8.1% annually for five years, according to a Government Accountability Office report from January 2012.

There is little publicly available data showing the individual prices of implantable devices and whether those prices are rising. But the same report found examples of “substantial price variation,” with one hospital paying $4,500 for a specific primary total hip construct and another paying $8,000 for the same product.

“The cost of joint implant constructs used for knee and hip replacement vary widely and are major contributors to the variation in the cost of care for patients undergoing total joint replacement,” according to a separate study published last year in the Journal of Bone & Joint Surgery.

With hospital margins under pressure, many large health systems and integrated delivery networks have become increasingly aggressive about implementing cost-cutting initiatives that target medical devices. They usually focus on reducing prices and the number of manufacturers—which can lead to better volume discounts—as well as seeking better utilization practices.

Hospitals have introduced gain-sharing programs that allow physicians to share in cost savings. They're also creating device registries that track performance to help inform purchasing decisions and instituting bundled-payment models that may also reduce costs and improve quality.

However, there are no specific efforts under way to ban the use of confidentiality clauses.

Jeffrey Lerner, president and CEO of the ECRI Institute, an independent health technology assessment organization, says that increased awareness of the clauses, as well as the ongoing cost pressures and market changes, could lead to increased pricing transparency.

But there's more to reducing a health system's supply costs than just addressing price, says Brent Johnson, vice president of supply chain and imaging services and chief purchasing officer for Intermountain Healthcare, Salt Lake City. There is greater financial benefit when Intermountain better manages utilization and standardizes practices rather than solely focusing on price, he says.

“In this industry, we tend to tiptoe around physicians. That they are allowed preference is a huge conflict of interest most of the time,” Johnson says. “When the physician has a choice between keeping his loyalty and whatever benefit he gets from the vendor and keeping his salary whole, he'll abandon the preference in a minute.”

Many physicians develop preference for specific devices or manufacturers early in their careers. In a fee-for-service model, physicians have little incentive to choose less-expensive devices and more often than not their interests are closely aligned with those of the manufacturer rather than the hospital. This is changing.

“There have been more attempts to align the interests, financial or otherwise, of hospitals and physicians,” UCSF's Bozic says. “More physicians are employed by hospitals; more physicians are entering into joint ventures or co-management agreements with hospitals; and newer payment methodologies such as bundled payments are effectively putting both the hospital and the physicians at risk for the cost of care, (which) aligns their incentives around improving quality and reducing costs.”

The Affordable Care Act is at the center of many of these changes. Along with the introduction of new payment models, such as accountable care organizations and patient-centered medical homes, the inclusion of the Physician Payments Sunshine Act is expected to make the financial relationships between physicians and manufacturers more transparent.

Related content

Under the Sunshine Act, device companies are required to collect data about the payments, gifts and other “transfers of value” they give to physicians. That data will be posted online beginning in September 2014, which might give hospitals and physicians an incentive to reduce the appearance or prevalence of certain relationships.

“That level of disclosure may be operating to weaken the bond between the implanting surgeon and the company,” ECRI's Lerner says.

In fact, physicians are increasingly getting involved with supply chain-led initiatives to reduce costs. Dr. Richard Parker, chairman of orthopedic surgery at the Cleveland Clinic, has been working closely with the 11-hospital system's supply-chain staff since 2008. Parker, a sports medicine surgeon, was named chair of orthopedic surgery in 2009. “When I moved into that leadership role, I became much more acutely aware of costs,” he says.

With the move toward what Parker calls “value-based medicine,” physicians are becoming more engaged in supply decisions, especially in the cases where a change in device can affect patient care or when the price of a device makes up a large percentage of certain DRGs. He says there is little pushback from other physicians who may question some standardization efforts.

“We attract individuals who, quite frankly, value the brand of the organization more than their individual brand,” Parker says. “They realize that in order for this to continue we have to get our arms around these things.”

At Intermountain, the doctors who are members of physician preference committees for orthopedics, cardiovascular, neurology, trauma and surgical services items are “already more engaged, accepting of change and know this is where we're headed,” Johnson says.

The first time the supply-chain team tackled the costs of orthopedic devices was in 2007, when the 21-hospital system was spending about $32 million annually on that device category alone.

That same year, Johnson received approval from the system's administrators to share up to 30% of documented first-year savings on the costs of orthopedic devices with the system's orthopedic surgeons. By supporting Intermountain's strategy to implement standard pricing policies—physician support pressured suppliers to comply—the physicians could use the savings to purchase other equipment, supplies or training.

The approach worked, and Intermountain now re-evaluates the cost of physician preference device categories every two years. The average savings for every category assessment is about 20% each time, Johnson says.

However, he views many of the pending payment reforms as the potential forces in driving the concept of “preference” out of the industry. If a physician has to take a 20% deduction on the cost of a procedure or agree to use a limited number of suppliers, the physician will be more likely to support standardization, Johnson says.

“Healthcare reform isn't just about cost. We've got to manage utilization,” he says. “We need physicians and surgeons to not just be loyal to one supplier, we need them on board to help us manage utilization and standardization and value beyond just price.”

So while market and regulatory change may be coming, it may not be occurring as quickly as some hospitals would like. Physician preference items are usually among a hospital's most expensive supply costs. With few organizations willing to make further cuts to labor costs—an organization's highest expense—they are instead focusing on reducing their second-largest expense—supplies—with physician preference items being a key target.

“Nonlabor (cost) is now getting a lot of attention because we squeezed everything we can out of the labor side,” says Ed Hardin, vice president of supply chain management for Christus Health in Texas. “We can't afford to make those kinds of cuts, so we've got to get more efficient and more effective about how we run our supply chain.”

Physician preference items account for about 57% of total supply costs for Christus Health, Hardin says, a percentage that has increased 10% since 2008. “It's rising as a percentage of total supply expense, whereas commodity spend has gone down,” he says.

As the cost of physician preference items continues to make up a larger percentage of total supply costs, some hospital systems have looked outside of their networks in an effort to better address the costs of these devices.

Cleveland Clinic and Dignity Health, both large health systems, have formed separate joint ventures that specifically aim to address the costs of physician preference items.

San Francisco-based Dignity Health developed a for-profit company called SharedClarity with UnitedHealthcare and up to 10 additional and unnamed health systems.

“These organizations are combining data to help inform healthcare organizations about the best-performing medical devices through comparative effectiveness studies,” according to SharedClarity's website. “For the first time, these exclusive studies will enable doctors and administrators to make informed decisions based on clinical proof rather than manufacturer influence.”

When the Cleveland Clinic announced its joint venture with VHA this month, it stressed that it will focus on how it can reduce the costs of physician preference items for its hospitals. However, there are also plans to bring in VHA members, Cleveland Clinic affiliates and other organizations.

The Greater New York Hospital Association recently received approval from the U.S. Justice Department to establish a voluntary gain-sharing program for its member hospitals. UCSF's Bozic says the university is looking into the possibility of developing a similar program.

ECRI's Lerner says more hospital systems will form partnerships or other ventures to help them rein in the costs of these devices. “Change brings a lot of experimentation,” he says. “We have to see how it actually plays out.”

One of the largest concerns for executives who manage supply-chain purchasing at hospitals is how to obtain and use clinical data that allow them to choose between competing devices. The goal: improving patient outcomes and avoiding repeat operations known as revisions. As payers turn toward bundled payments, avoiding revisions can also lower costs. Kaiser Permanente and the Cleveland Clinic have each maintained system device registries that can better track how a device performs after implantation.

Government registries in Australia and the United Kingdom were the first to discover that metal-on-metal hip implants were failing at a faster rate than other hip devices. More than 93,000 metal-on-metal hip implants sold by Johnson & Johnson's DePuy Orthopaedics unit were later recalled, which led not only to revisions but also to thousands of lawsuits.

In addition, the number of recalls in recent years may have caused a splinter in the relationships between physicians and manufacturers.

“There have been disappointments for physicians,” Lerner says. “We've had high-profile recalls. You have this gigantic problem with metal-on-metal implants, which makes a huge impact. That's massive, and I think it undermines that complete trust bond between the surgeons and the companies.”

TAKEAWAY: Reducing the number of vendors and developing new ventures are among the ways hospitals are targeting supply-chain costs.

Thursday, February 14, 2013

U.S. lags in medical device implant safety.

January 14, 2013 12:57 pm by Amy Siegel | 0 Comments
It should come as no surprise that the movement toward more rigorous post-market surveillance of medical devices has gone global. While US med-tech titans like Medtronic and J&J have made headlines for selling bad defibrillator leads and faulty hip joints, America certainly doesn’t have the monopoly on device recalls; it was a French company that marketed substandard breast implants used in some half million women worldwide, landing the CEO in jail after a media-stirring manhunt.
Fueled by this highly visible run of device recalls, post-market data demands are increasing for the more risky (Class III and some Class II) new medical technologies in the U.S. as well as in Europe. While Europe may still provide a faster route to regulatory approval for such devices, post-market requirements are creeping in like an expensive final cheese course served by European regulators and health systems just when companies are feeling most broke and tired. So regulatory approvals may come, but actual, meaningful revenues? Not so fast.
To dig deeper on the changing med-tech launch conditions in Europe, S2N talked to Terry McCarthy, Co-Founder and Managing Director of FirstClinTech, a Holland-based company providing a range of services (business development, clinical support, logistics and technical service) aimed at ’easing’ medical device companies into the EU markets. FirstClinTech came to life filling a service void left by a failed ventricular assist device company, so Terry knows a thing or two about the market challenges for novel medical technologies in Europe.
On paper, European-wide efforts to strengthen and harmonize regulation of innovative medical devices are progressing at a leisurely pace, with a target adoption of yet-to-be-clarified regulations by 2019. ’Don’t let that timeline lull you into complacency, though,’ warns Terry, who is already seeing some Notified Bodies stepping up their post-market data requirements ahead of any new regulations being in force. This escalation in post-market requirements has real, quantifiable implications for emerging med-tech companies.
Delayed Commercial Revenues
Terry cites recent examples where Notified Bodies have made CE approval of implantable devices conditional upon satisfactory surveillance data captured for a defined period of time or number of implants. ’We often confront the unrealistic assumption that as soon as you have CE mark you can start selling and generate revenue,’ says Terry. While companies generally understand that significant revenue will be gated by reimbursement, which is in turn gated by efficacy data, heightened post-market regulatory requirements could translate into longer dwell times in ’limited launch’ (a.k.a. paltry revenue) mode than expected. For some product types, companies are often end up giving away lots of devices during this phase, further reducing early market revenues.
Increased Post-Market Expenses
The most obvious cost associated with post-market surveillance is study management; this expense can vary widely depending on the surveillance study size and device complexity. ’You want to do enough science to back up what you said in your dossier,’ advises Terry, ’and also see that the patients enrolled in the post-market study resemble those in the pre-market study.’ For example, a physician might be tempted to try a newly approved device in a ’train wreck’ patient for whom there are no other options, even if this is an off-label application with much lower efficacy prospects. ’Ensuring that appropriate patients are included in the post-market surveillance studies means that companies need to have people on the ground interacting with centers,’ says Terry.
Tougher Sales Channel Decisions
This need for tighter control in the early commercialization phase can also impact the decision of whether and when to go with direct sales representatives or sell through a distributor in Europe. ’A distributor will naturally want to sell as many devices as possible, whereas company management and the Notified Body all want the first tranche of patients to be done in a fairly controlled way,’ cautions Terry. Other post-market obligations, such as device traceability (another recall-inspired global initiative), must also be carefully considered in distributor relationships and contractual arrangements.
Despite heavier post-market burdens, regulatory consistency across Europe will likely benefit emerging med tech companies in the end. ’The current situation is confused,’ says Terry. ’Harmonization should improve transparency and establish a more level playing field for medical device companies.’ A major bridging of regulatory frameworks across the Atlantic, however, is likely a long way off. Terry and others agree that Europe will continue to take a more risk-based, safety-focused approach to device approvals for the foreseeable future. Getting insurance payment for new devices in Europe, or the US, is another matter entirely.
For more predictions and insights about the changing landscape for med tech in Europe, read this excellent article from FirstClinTech.

Wednesday, February 13, 2013

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

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 /]
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.

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

“Do Poor People Sue Doctors More Frequently? Confronting Unconscious Bias and the Role of Cultural Competency,” Clinical Orthopaedics and Related Research, May 2012 (
“On Average, Physicians Spend Nearly 11 Percent Of Their 40-Year Careers With An Open, Unresolved Malpractice Claim,” Health Affairs, January (
“Professional Liability Insurance Indemnity and Expense Payments, Claim Disposition, and Policy Limits, 2002-2011,” American Medical Association, December 2012, for AMA members only (