Recent Blog Posts

Are You Owed Commissions? Michigan's Sales Representative Commissions Act Packs Quite a Punch!

Kevin Stoops, Michigan Employment Lawyer — Tue, 03 Apr 2012 14:17:00 GMT

Michigan's workforce includes a substantial number of employees and independent contractors who earn part or all of their compensation by way of commission. This is particularly true in the automotive industry where such commissions are calculated as a percentage of sales, units sold, or profits.

On most occasions, these types of commission structures are spelled out in a written policy or contract, but sometimes the employer or business fails or even refuses to pay earned commissions to the employee/independent contractor. Michigan law prohibits this and provides for a legal action to enforce payment.

The specific law that governs these situations is the Michigan Sales Representative Commissions Act ("MSRCA"), enacted in 1992 to protect those who have been shortchanged with legal firepower to recover their unpaid commissions. MSRCA covers all individuals (including people, corporations, partnerships, or other legal entities) who sell a good for another – the "principal" – and by doing so, earn a commission. By way of definition, a "principal" is a person or business entity that either 1) manufactures, produces, imports, sells, or distributes a product in Michigan; or 2) contracts with a sales representative to solicit orders for or sell a product in Michigan.

Although the law can be a tough read, MSRCA's main rule is actually pretty simple:

All commissions that are due at the time of termination of a contract between a sales representative and principal shall be paid within 45 days after the date of termination. Commissions that become due after the termination date shall be paid within 45 days after the date on which the commission became due.

The Act provides that the employer or business that fails to pay the required commission is liable not only for the unpaid commission amount, but also must pay liquidated damages equal to two times the amount of the unpaid commissions due or $100,000.00, whichever is less. For example, if the unpaid commission equals $50,000, then the employer or business must pay the employee/independent contractor an additional $50,000 in liquidated damages. Because the liquidated damage amount can never exceed $100,000, however, if the unpaid commission equals $150,000 then the defendant employer/business is liable to the plaintiff for a maximum additional amount of $100,000 in liquidated damages. That can be a huge payoff!

Furthermore, the law gives employees/independent contractors an advantage by not requiring them to prove that the employer or business acted in bad faith. In one case involving a MSCRA claim, the Michigan Supreme Court determined that an employee/independent contractor need only show that the principal failed to pay the commission, and that the only defense the principal could lawfully raise would be its "inadvertence or oversight" in not paying the amount owed.

If you're an employee or independent contractor and believe you are owed commissions, MSRCA's give you a legal club to swing against the employer or business that failed to make good on its commission obligations. Although no one ever really wants to go to court, you may have no choice but to file a legal action to get the money that you are due. We would be happy to evaluate your case and help you determine your rights under the law.

The DePuy Artificial Hip Debacle: Part III - Time for Some Changes in FDA Rules

Michigan Medical Device Lawyer — Fri, 16 Mar 2012 17:37:00 GMT

The ongoing irony in this matter is that, technically, DePuy's actions and behavior relative to FDA and other regulatory protocols was legal. Questionable rules and unaddressed loopholes essentially made the FDA complicit.

When DePuy sought to launch the resurfacing ASR design overseas pending clinical trials in the US, one could argue that the FDA had some responsibility to notify regulators in those other countries that the product was not approved for sale here. Certainly, such a message from the FDA would have carried some weight and may have prompted foreign health care agencies to take some action before opening the door to their own markets. Granted, Britain's Medicines and Healthcare Products Regulatory Agency and others make their own rules and may not have paid any heed to the information from the FDA, but at least the knowledge would have been shared.

Perhaps the most dangerous provision in FDA guidelines is that which allows designs derived from or similar to previously approved devices to receive virtually rubber-stamp authorization. This was the root problem in the current multitude of vaginal mesh implant cases (discussed in an earlier Sommers Schwartz blog post), and apparently contributed to injuries in US patients caused by DePuy's second ASR device. Both ASR versions employed a solid metal cup component to replace a patient's hip socket, a component which experts say flawed in its initial design. Had there been a threshold requirement for clinical testing, additional research, heightened review, etc., the FDA – the government agency entrusted to protect the public from such harm – could have prevented those injuries. Instead, it allowed DePuy to sidestep the patient interests in favor of its bottom line.

Lastly, the FDA's policy of keeping its approval process confidential is suspect. An agency spokesman told the Times that the FDA has a policy of not releasing such notices as the August 2009 nonapproval letter because they might contain confidential business information. While this is understandable, not all of the letter's contents deserved such privilege; other facts could and should have been disclosed to keep the public, the medical community, and Johnson & Johnson's investors informed. As the Times learned, "It is not known precisely what the agency's letter stated nor is it clear how, or if, the agency's concerns about the resurfacing version of the hip implant applied to the model used in this country in standard replacement surgeries." That's precisely the problem!

More and more, the burden is on the consumer – the patient – to look after his or her own care. Before undergoing any implant procedure, research the device's background, clinical trials, and effectiveness. Ask your doctor precisely why he or she is recommending a particular device over another. Make sure that you have all the facts you need to make an informed decision to proceed with the surgery.

And if you or someone you care about has been the unfortunately victim of a defective medical implant, please contact us to speak with a trained Michigan medical device attorney. We'll be happy to discuss your situation and help you take appropriate action if warranted.

The DePuy Artificial Hip Debacle: Part II: What Was Johnson & Johnson Thinking?

Michigan Medical Device Lawyer — Fri, 16 Mar 2012 17:30:00 GMT

Setting aside the arguments regarding the merits of the 5,000 pending product liability claims against the company (which includes patients crippled by tiny particles of metallic debris shed by the ASR implants), DePuy's actions in the regulatory process demonstrate two things above all else – greed and a complete lack of transparency.

First, DePuy kept its foreign consumers completely in the dark about the resurfacing version of its ASR device. How would physicians and patients in other countries have responded had they been advised that the device was not yet being sold in Johnson & Johnson' largest market pending US government approval? Additionally, even though Britain's Medicines and Healthcare Products Regulatory Agency and other countries' watchdogs don't require notification of FDA rejections for products sold in their markets, DePuy purposely chose not to disclose information regarding its receipt or the contents of the August 2009 nonapproval letter.

Second, DePuy kept details about the clinical trials and regulatory action from the medical community. The trials authorized by the company (results of which were submitted to the FDA to support its application for approval) were staffed by doctors chosen by DePuy, meaning that even a handpicked team of surgeons couldn't produce sufficient evidence to warrant a nod from the agency. And when the FDA issued the nonapproval letter, neither DePuy nor Johnson & Johnson revealed it to the public, doctors at large, or even those it selected to run the trials. The New York Times interviewed Dr. Antoni Nargol, an orthopedic surgeon in England who worked on the study that DePuy submitted to the FDA. Dr. Nargol indicated that the company never informed him that of the FDA's nonapproval. Furthermore, DePuy appears to have faulted Nargol and others for the poor results:

Throughout the episode, DePuy blamed orthopedic surgeons for the model's failures, saying that doctors were not positioning a component properly. But the clinical findings rejected by the FDA came from ASR studies run by surgeons hand-picked by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.

Lastly, DePuy and Johnson & Johnson circumvented the investment community and, worse, its own shareholders. As the Times wrote, "a review of publicly available information indicates that the company did not discuss the agency's nonapproval letter in financial reports or in presentations to analysts while the device remained on the market," which, according to a lawyer specializing in FDA regulation, may have been required if it had "a material impact on a company's finances." Considering that Johnson & Johnson incurred a special $3 billion charge that was largely associated with the legal and medical costs related to the recall of the two ASR products, as well as the "reputational impact" the company has suffered, there may be additional exposure and liability to the company's stockholders and financiers.

Although technically not illegal, DePuy's decisions regarding the sale of the two ADR devices constituted an "end run." The company could have opted to share its plans – and setbacks – publicly, build trust, and protect patients against undue harm. Instead, it sought to cash in here and in other countries while trying to outwit regulators and keeping its various constituents in the dark.

Up next… Part III: Time for Some Changes in FDA Rules

If you or someone close to you was implanted with the either of the DePuy ASR devices and suffers from ongoing pain or injury, please contact a Michigan medical device attorney familiar with this situation right away to discuss your legal options.

The DePuy Artificial Hip Debacle: Part I - The Facts

Michigan Medical Device Lawyer — Fri, 16 Mar 2012 17:24:00 GMT

When U.S. Food & Drug Administration regulations wouldn't let Johnson & Johnson's DePuy orthopedic division immediately market an innovative hip replacement device in the United States, DePuy opted to sell it overseas while conducting clinical trials as required by the FDA. At the same time, it launched a similar device in the US by finding a loophole in FDA approval protocols. The entire scheme was legal, but there was only one problem – the two products proved to be defective. Now both DePuy and the FDA have some serious explaining to do.

Here's the background, according to a recent article in the New York Times…

Unlike standard hip replacement surgeries performed prior to 2003, a new procedure known as a resurfacing allowed surgeons to remove less bone. As an adjunct to this new technique, DePuy developed an articular surface replacement device, marketed under the name "ASR." Before it could market the product domestically, however, the FDA required the company to conduct clinical trials to support the efficacy the effectiveness of both the procedure and the device. Notwithstanding, DePuy launched the product in foreign markets beginning in 2003; as of 2009, the device had been used in more than 60,000 resurfacing procedures in Europe and elsewhere.

By 2005, DePuy had commenced the clinical trials required by the FDA prior to approval for sale in the US; it was later discovered that the surgeons who participated in the study were selected by DePuy, and even included doctors who helped design the device.

During that period, DePuy obtained FDA approval to sell a second version of the ASR in the US based on an earlier metal cup design used in traditional joint replacement surgery. Under agency rules, because the design was similar to implants already on the market, DePuy received approval without the need for clinical testing. Over the next four years, the company sold approximately 30,000 units.

In August 2009, the FDA sent DePuy a confidential 13-page "nonapproval" letter regarding the ASR devise that the company was marketing overseas. The agency advised that the studies and clinical data did not adequately prove the implant's safety and effectiveness, and therefore could not be approved for sale in the US. DePuy could continue to pursue approval, but would need additional clinical data take would take at least another year to generate.

At roughly the same time, both ASR models came under fire in light of alleged failures. Doctors both here and abroad as well as doctors in this country were raising concerns about the performance of each design.

In November 2009, DePuy announced that it would discontinue sales of the ASR devices, citing declining sales as the reason, and also announced that it had withdrawn its application for FDA approval to market domestically the model it had been selling overseas. In August 2010, it formally recalled the devices among claims that they were failing at high rates.

What is one to make of all this? Corporate greed? Governmental bureaucracy? Read our next posts to find out more.

Up next… Part II: What Was Johnson & Johnson Thinking?

If you or someone close to you was implanted with the either of the DePuy ASR devices and suffers from ongoing pain or injury, please contact a Michigan medical device lawyer right away to discuss your legal options.

Have You Blown the Whistle on Your Employer? Michigan Law Protects You!

Daniel Swanson, Michigan Employment Lawyer — Tue, 06 Mar 2012 15:04:00 GMT

We've heard the term "whistleblower" a lot in recent years – with good reason. Companies don't always play by the rules, prompting conscientious employees to report illegal activities to the authorities. Many times, however, employers discriminate against or fire employees in response. That, too, is illegal, according to the protections offered by Michigan's Whistleblowers Protection Act ("WPA").

Here's how it works…

If you believe that you've been the subject of the retaliation described above, you need to show that:

1. You were engaged in "protected activity" as defined by the WPA,
2. You were discharged from your job, threatened, or discriminated against, and
3. A causal connection exists between the protected activity and the discharge.

The WPA defines a "protected activity" as:

1. Reporting a violation of a law, regulation, or rule to a public body,
2. Being about to report such a violation to a public body, or
3. Being requested to participate in an investigation by a public body.

A "public body" includes a state, county, or local government entity (i.e., police department, county prosecutor, Michigan Department of Licensing and Regulatory Affairs) or a federal law enforcement authority (F.B.I., federal prosecutor, Environmental Protection Agency, etc.).

There are different kinds of whistleblowers, depending on the situation. Some examples…

In one case, a nursing home employee who reported incidents of suspected patient abuse to state investigators was terminated by her employer one week later, and subsequently filed a lawsuit claiming that she was terminated in retaliation for her reports to the authorities. The jury that heard the case agreed, and rendered a verdict in favor of the employee. This situation illustrates a "Type 1" whistleblower – an employee who, on her own initiative, took it upon herself to communicate the employer's wrongful conduct to a public body.

In another case, a police commander who chaired a board of review investigating a highly publicized death was subpoenaed to give a deposition in another lawsuit brought by a former employee claiming wrongful termination. In his deposition, the commander testified that department rules concerning the board of review were violated and that the board was not allowed to perform its duties. Although he didn't necessarily testify about a specific violation of law committed by the city, he directly contradicted several witnesses and substantiated many of the former employee's claims. When the commander was later fired, he brought his own civil suit. A jury then found that he was terminated in retaliation for providing his deposition testimony and awarded him a $1.08 million verdict on his WPA claim. This is an example of a "Type 2" whistleblower – an employee who participates in a previously initiated investigation or hearing at the request of a public body.

The time to bring a lawsuit under the WPA is very short – the law requires that an employee file his or her claim within 90 days of the alleged violation. If the employee's claim is successful, remedies include job reinstatement, back pay, front pay, attorney fees, and costs.

If you've been fired or discriminated against by an employer and believe that one of the underlying reasons was your involvement in a protected activity, you may well have a claim for damages based on a violation of the Michigan Whistleblower Protection Act. We would be happy to evaluate your case and help you determine your rights under the law.

Michigan's "Public Policy" Doctrine Prohibits Employers from Firing Employees Who Refuse to Break the Law

Daniel Swanson, Michigan Employment Lawyer — Tue, 21 Feb 2012 00:44:00 GMT

In Michigan, the general rule is that employers are free to terminate employees "at will." This means that unless you have some form of individual contract or agreement indicating otherwise or you are a union member and subject to a collective bargaining agreement, you can be fired at any time with or without a good reason or cause.

Common exceptions to the at will rule include civil rights discrimination claims. Under federal and state law employers are prohibiting against discriminating against employees in connection with their employment based on age, race, sex, religion, disability etc.

Another less well known exception to the at-will rule prohibits employers from terminating an employee for refusing to help his or her employer break the law. This is known as the "public policy" doctrine.

To give you an idea of what public policy doctrine means, here are some examples:

In Morrison v. B Braun Medical, Lynn Morrison worked as a medical sales representative. Her employer fired her after she refused to unlawfully promote a drug to her customers for uses not approved by the Food & Drug Administration. Additionally, she refused to violate anti-kickback laws by providing special consideration to a hospital customer. Despite the fact that Ms. Morrison consistently met or exceeded her sales goals over the nine years she worked there, the company terminated her employment. She consequently filed a wrongful termination suit, claiming that her firing violated Michigan's public policy doctrine. After a trial in federal court, the jury returned a verdict of $880,000, which the appellate court later affirmed in December 2011.

In an earlier case, Silberstein v. Pro-Golf of America, Inc., Ronald Silberstein served as CFO for the company, but claimed to have been fired for refusing to "cook the books" by making accounting entries that would have violated various securities and franchise laws. A jury rendered a verdict of $700,000 in economic damages and $150,000 in emotional damages in Mr. Silberstein's favor, which was later upheld on appeal in 2008.

So how do you know if a termination is in violation of public policy? Here's the test:

An employer who fires an employee violates public policy if the employee was discharged:

(1) in violation of an explicit legislative statement prohibiting the discharge, discipline, or other adverse treatment of employees who act in accordance with a statutory right or duty,

(2) for failure or refusal to violate a law in the course of employment, or

(3) for the exercise of a right conferred by a well-established legislative enactment.

Note that employees do not have to demonstrate that their employers directed them to violate a law in order to have a legitimate public policy claim; they need only show that one of the motives or reasons for the firing was a failure or refusal to violate a law.

As the Morrison and Silberstein cases demonstrate, juries have entered substantial verdicts in these types of wrongful discharge cases.

If you've been fired and believe that one of the underlying reasons was your refusal to break a law, you may well have cause to pursue damages against your former employer based on a violation of public policy claim.

Unsafe Medical Devices on the Market?

Michigan Medical Device Lawyer — Mon, 06 Feb 2012 19:35:00 GMT

Congress Seeks to Close a Loophole in Approvals for Suspect Medical Devices

If the Food and Drug Administration (FDA) pulls a medical device from the market, shouldn't the agency then scrutinize subsequent versions to ensure that the defect doesn't continue? Lawmakers think so, and have introduced bills to close the gap, as reported in the newest issue of Bloomberg Businessweek.

Under current federal law, the FDA must release a device for sale without human testing if it is "substantially equivalent" to a prior device, a measure meant to streamline approval. But the positive legislative intent hasn't always had a positive outcome.

Consider the case of vaginal mesh implants developed to treat feminine incontinence. Johnson & Johnson, C.R. Bard, and Boston Scientific manufactured and sold the devices after getting the nod from the FDA under the current law, resulting in nearly 300,000 implants each year. When complaints arose about pain and internal injuries, it was discovered that the implants were derived from a mesh product developed by Boston Scientific that was recalled in 1999.

House Democrats, led by Rep. Edward Markey (D-Mass.) want to fix the problem, and have introduced a bill that would give the FDA the power to disallow a medical device if a prior product – a "predicate" – was removed or was in the process of being pulled from the market. Also, if enacted, the law would require device manufacturers to explain the differences between their proposed products and recalled predicates, and would further mandate that the FDA review approved devices to determine whether there are any recalls in their "device lineage."

Said Markey in a statement, "If an automobile is recalled for a major safety problem, we wouldn't allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies."

Have you been the recipient of a medical implant that caused you additional pain or injury? Changes in the law, like those described above, impact you. Please contact us to tell us more about your situation – we may be able to help.

Think You Have a Disability Discrimination Claim Against Your Employer?

Jesse Young, Michigan Employment Lawyer — Wed, 01 Feb 2012 15:48:00 GMT

Think You Have a Disability Discrimination Claim Against Your Employer? Recent Changes in the Law May Make It Easier to Prove Your Case.

For more than two decades, the Americans with Disabilities Act ("ADA") prohibited employers from discriminating against current and prospective employees with disabilities. What many don't know, however, is that a series of recent changes have broadened certain definitions to ease some of the burden on those filing discrimination disability claims. The effect has been a 30% increase in the number of such cases filed with the Equal Employment Opportunity Commission ("EEOC") with more disabled workers having their day in court.

What Hasn't Changed

Under the ADA, an individual seeking protection under the law must prove that:

1. He or she is a qualified individual with a disability,
2. who can perform, with or without reasonable accommodation, the essential functions of the specific employment position,
3. without creating undue hardship for the employer,
4. or a direct threat to oneself or others.

Additionally, the definition of disability remains unchanged and includes:

1. A physical or mental impairment that substantially limits one or more of the major life activities of an individual;
2. a record of such an impairment; and
3. being regarded as having such an impairment.

A "major life activity" is defined to include caring for one-self, performing manual tasks, walking, seeing, hearing, speaking, breathing and learning. In addition, other major life activities may include standing, lifting, sleeping, bending eating, reading, concentrating, thinking, communicating and the operation of any major bodily function.

It should be noted that the ADA specifically prohibits discrimination against a disabled employee in ways which include the following: failure to hire or promote, demotion, denial of a pay increase, bonus or other benefit or termination. In addition, the ADA, also prohibits an employer from retaliating against the individual for seeking accommodation of his or her impairment or filing a discrimination complaint.

If a disabled person is capable of performing the job, the employer is required to discuss with the individual possible accommodations based upon the nature of the disability and the essential functions of the position.

Additionally, a successful claim of discrimination, or the failure to provide reasonable accommodation, may warrant damages including back wages and benefits, compensation for mental and emotional distress, and reimbursement of attorney fees and costs.

What Has Changed

Prior to 2008, a disturbing trend among disability discrimination cases took hold – courts and administrative agencies focused more attention on the existence of the employee's disability rather than the employer's alleged discrimination. As a result, a significant number of claims were dismissed without ever examining the propriety or impropriety of the employer's conduct.

Beginning with the enactment of the Americans with Disabilities Act Amendments Act ("ADAAA") in 2008 the focus has shifted away from the disability in favor of greater emphasis on the purported discrimination. New interpretive regulations from the EEOC implemented in May 2011 provide a set of rules by to evaluate whether the individual's impairment substantially limits major life activities, such as:

· The assessment of an individual's impairment, previously required by the ADA, be interpreted against a standard of functional limitation lower than previous standards
· The analysis must compare the individual's impairment to the abilities of most people of the general population, while not necessarily calling for scientific or medical evidence
· Mitigating measures or ameliorative devices (except ordinary glasses or contact lenses) will not be considered in the determination of the impairment

Some legal experts believe that these and the other interpretive rules will effectively eliminate employers' ability to defend these claims by challenging whether the impairment qualifies as a disability.

If you or someone you know has been the victim of discrimination based on a disability, the law has perhaps never been more favorable to you than it is now. We can help assess the facts of your claim against the ADA, ADAAA, and other laws – feel free to contact us to discuss your situation.

How Doctors Can Avoid Being Sued for Medical Malpractice

Michigan Medical Malpractice Lawyer — Tue, 31 Jan 2012 16:56:00 GMT

According to USA Today, there are ways a physician can reduce the chance of a medical malpractice lawsuit:

Apology Laws

Wouldn't it be great if states encouraged a doctor to say, "I'm sorry" if a mistake was made? To date, federal efforts at a national act have failed and no jurisdiction has put a law on its books either, although 36 states have passed legislation that protects apologies from being admitted as evidence against doctors in the courtroom. If there's any doubt that such a measure would work, you need only look to the University of Michigan Health System – they've had an apology program in place for more than ten years, and the number of medical malpractice suits against the them has dropped 36%.

Better Physician-to-Patient Communication

Regardless of the presence or absence of an apology law, many believe that doctors can prevent lawsuits simply by being better communicators. A 1999 report from the Institute of Medicate indicated that, at the time, 90% of the 100,000 deaths that occur each year were attributable to "systemwide procedural failures" at medical facilities. The doctor, as the quarterback for a patient's healthcare team, is the most qualified and most effective spokesperson to explain that not all adverse outcomes are due to physician or hospital errors.

Transparency

We all know that patients are routinely asked to give their informed consent to medical treatment and procedures. And while this helps the patient to understand the potential risks, many argue that it doesn't fully educate the patient about underlying processes and systems. The USA Today article cites "the seemingly simple task of dispensing a drug at a hospital. It's actually a complex process that requires five interdependent steps: ordering, transcribing, dispensing, delivering and administering. A poorly designed system can lead to an error in any of those steps, with a potentially deadly outcome." Giving patients glimpses into the complexity and rationale behind their treatment makes them more educated consumers and perhaps more realistic in their expectations.

Demonstrate Humanity & Humility

Patients need to understand that doctors are people, too. A study published last year in the Journal of theAmerican College of Surgeons found that physicians sued for medical malpractice were more susceptible to burnout, depression, and even suicide, along with a greater propensity to make mistakes when caring for patients. Consequently, the argument is being made that fewer lawsuits might leader to better medical care, something doctors can do with clearer communication.

Interestingly, a TEDxToronto presentation given by Dr. Brian Goldman last fall offers another perspective, not commonly considered in the medical malpractice arena. For a physician to admit a mistake to a colleague has traditionally been taboo, leading to what Dr. Goldman calls "unhealthy shame." Doctors who are discouraged from admitting errors and seeking support and dialogue with others often drive themselves to "redouble their efforts to be perfect" making the fall from a subsequent mistake that much more devastating. All the public bravado, combined with quiet self-doubt, has to have some impact upon patient care.

Apology or not, if you or a loved one have been injured or damaged by what you suspect is hospital or doctor negligence, call our team of medical malpractice specialists.

Hip or Knee Replacement Failure? Contact Us

Michigan Medical Malpractice Lawyer — Mon, 23 Jan 2012 22:45:00 GMT

A newly published study from Australia (and reported in the New York Times) advises that recent artificial hip and knee technology didn't perform any better than prior versions. The new technology – referred to as metal-on-metal in hip designs because both the ball and cup are comprised of metal – are expected to fail prematurely rather than lasting the 15 years that artificial joints are supposed to last. The problem could affect tens of thousands of patients in the U.S., where the newer design is widely used.

Some additional findings:

· No artificial hip or knee introduced between 2003 and 2007 was any more durable than older ones; in fact, 30% performed worse
· Surgeons used the new designs with little test data
· The expense of replacing the new all-metal hips in Australian patients could cost that country's companies, insurers and taxpayers billions of dollars

It's important to note that the study was generated from data collected by Australia's orthopedic registry. As the NYT article describes,

"In a registry, information about a patient is entered into a database when he or she receives an implant. Then, when that patient undergoes surgery again to replace that device, more data is added. By looking at large numbers of patients followed in a registry, researchers can tell whether certain device models are failing prematurely at significantly higher rates."

The U.S. doesn't have a registry, but the FDA is funding efforts to determine whether overseas databases as well as those maintained by U.S. hospitals can be employed to monitor device performance. This is a significant move given that 700,00 Americans received knee and hip replacements each year, a figure that will most certainly rise as our population grows older.

The U.S. Senate is now reviewing proposed legislation that would compel implant manufacturers to track the performance of their products once the FDA greenlights them. The bipartisan bill, however, faces strong opposition as the industry and its supporters in Congress argue that additional regulations slow research and development of new products.

Says Dr. Stephen E. Graves, the director of the Australian National Joint Replacement Registry and a co-author of the study, "The purpose of regulation is not to impede innovation but to ensure safety and effectiveness of medical devices. This protects patients, but it also protects companies."

If you have had hip or knee replacement surgery and your implant has failed to relieve your pain or has caused more pain and disability, you should investigate the problem by contacting the defective medical device experts at Sommers, Schwartz. Call either Rob Sickels, Jason Thompson or Matt Turner.

FDA Tells Vaginal Mesh Implant Makers to Study the Risks

Michigan Medical Malpractice Lawyer — Thu, 19 Jan 2012 13:15:00 GMT

Has your vaginal mesh device failed you? Call us

On January 4th, 2012 the FDA issued an order requiring manufacturers of implantable surgical mesh – used to treat urinary incontinence in women – to research the risks associated with their products. The agency’s action appears to have been prompted from years of complaints of infections, pain, complications, and other injuries. Details of the FDA’s order were reported in the New York Times and elsewhere.

Female urinary incontinence is usually the result of a weakening of the muscles around the bladder and other support organs. Pelvic organ prolapse, one condition of this type, can be treated by surgically implanting a vaginal mesh device. Although the FDA issued a warning in 2008 regarding complications related to the device, it indicated that the occurrence was rare. Over the next two years, however, reports of those complications increased by 500%, and the agency issued an update in July 2011.

It is important to note that surgical mesh, like all-metal artificial hips, are part of a class of implants that manufacturers are not required to study in patients before or even after the products are put on the market. That means that none of the 185,000 or so women in whom vaginal mesh was implanted in 2010 had the benefit of clinical studies or research prior to their procedures.

In 2010, about 185,000 women underwent procedures in which mesh was implanted vaginally to treat urinary incontinence, and roughly 15% of them experienced related problems, according to research published in the journal Obstetrics & Gynecology. The study also advised that the mesh had no greater benefit than using the patient’s own ligaments to reinforce the vaginal wall, the traditional procedure for treating the condition.

The FDA anticipates that manufacturers, including Boston Scientific, CR Bard, Ethicon, and WL Gore & Associates, will track patients for a three-year period to gauge both the quantity and severity of any complications.

We at Sommers Schwartz are currently evaluating cases of vaginal mesh failures. If your vaginal mesh has failed you, give us a call and learn what we can do for you.

33% of Hospital Patients Injured, 15,000 Die Monthly During Admission - But Who's Listening?

Medical Error Attorney — Tue, 17 Jan 2012 01:35:00 GMT

Two recent studies raise critical questions about the frequency of serious hospital mistakes and the measures used to track them.

Researchers affiliated with the Institute of Healthcare Improvement developed a new method to track "adverse events" – what you and I call injuries caused by medical error. Using their Golden Trigger Tool, the team scanned medical records for certain triggers for such problems, and then investigated each case to see if, in fact, an adverse event arose. As reported in an L.A. Times article, the showed that injuries due to medical errors occurred in 33.2% of admissions, 10 times more than previously detected using other methods.

Meanwhile, Medicare Inspector General Daniel Levinson released a report today indicating that hundreds of serious hospital errors go unrecorded because the inspectors who uncover the problems fail to report them to federal accrediting agencies. According to the USA Today article discussing the report:

15,000 Medicare patients die each month in part because of the treatment they receive in a hospital. Tuesday's report focuses on the worst errors — or "immediate jeopardy complaints." They include surgical fires, patient suicides, sexual assault, surgeries performed on the wrong patients and medical instruments left inside a patient after a surgery.

The law dictates that in most cases patients must given informed consent before undergoing medical treatment, but studies like this beg the question – how can you give informed consent if you aren't given all the information?

Doctors and Patients Don't Agree on the Future of Health Care

Michigan Lawyer — Thu, 12 Jan 2012 01:20:00 GMT

A recent study commissioned by Optum Institute for Sustainable Health USA Today Article highlights the differing views physicians and patients have about health care. What's at the heart of the gap? Value.

"I think there's pretty wide agreement that, overall, the nation is not getting a good value for the $2.6 trillion that will be spent in health care this year," Simon Stevens, co-chair of Optum Institute, told USA Today. Stevens suggested that because patients don't know enough about health care, they can't assess the value of the service they receive, but they do know there's plenty of room to cut costs.

Here are some key takeaways from the study:

· Doctors believe patients receive appropriate preventive care about 50% of the time, whereas patients feel that happens only 33% of the time.

· About 60% of doctors believe the quality of care varies wildly even within their local areas.

· 50% of hospital executives think their health care systems are on target to become more cost-efficient and accountable; only 26% of patients agree.

· Patients believe that nearly 30% of health care costs could be cut without affecting quality; doctors believe that figure is around 14%.

Perhaps the most promising solution is broader acceptance and implementation of electronic health records, which would give patients access to the pricing that goes along with the care they receive. The problem is that doctors just can't – or won't – make the change.

Only 46% of the doctors surveyed indicated that they have electronic records, and although 90% believe they will make the transition within the next three years, there are some significant hurdles such as getting physicians who don't type to use the systems and selecting from the more than 1,000 electronic health record systems on the market – which aren't cheap, even with aid and incentives from the federal government.

The bottom line is that doctors may not have a choice. Physician compensation will be tied to performance, which necessitates electronic record keeping among other measures. The survey suggested that nearly 50% of doctors are "not at all prepared for this shift."

What can you do about this? Ask questions. Does your doctor have an electronic records system? Do you have access to it, including rate and fee information? Ask about the necessity of ordered tests and procedures, and find out if there are alternatives or if they can be conducted elsewhere at lower costs. Get referrals and make informed choices regarding doctors, hospitals, and providers. Take charge of your own health care and make sure you have the right physicians working for you!

Study of Breast Biopsies Finds Surgery Used Too Extensively

Michigan Medical Malpractice Lawyer — Sat, 07 Jan 2012 16:55:00 GMT

An article published in The New York Times, "Study of Breast Biopsies Finds Surgery Used Too Extensively," by Denise Grady, discussed a study that found that too many women with abnormal mammograms or other breast problems are undergoing surgical biopsies when they should be having needle biopsies, which are safer, less invasive and cheaper, according to the article.

The article is based on a study in Florida that found 30 percent of the breast biopsies from 2003 to 2008 were surgical, when according to medical guidelines, the rate should be 10 percent or less.

Researchers say the figures in the rest of the country are likely to be similar to Florida's, which would translate to more than 300,000 women a year having unnecessary surgery, at a cost of hundreds of millions of dollars.

The author of the Florida study, Dr. Stephen R. Grobmyer, and his colleagues, said they kept seeing patients referred from other hospitals who had undergone surgical biopsies (also called open biopsies) when a needle should have been used.

A surgical biopsy requires an inch long incision, stitches and sometimes sedation or general anesthesia. It leaves a scar. A needle biopsy requires only numbing with a local anesthetic, uses a tiny incision and no stitches and carries less risk of infection and scarring.

Many of these women do not even have cancer: about 80 percent of breast biopsies are benign. For women who do have cancer, a surgical biopsy means two operations instead of one, and may make the cancer surgery more difficult than it would have been if a needle biopsy had been done.

Some researchers suggest the problem was that not all doctors keep up with medical advances and guidelines. Others suggest surgeons keep doing open biopsies because needle biopsies are usually performed by radiologists. The surgeon would have to refer the patient to a radiologist, and lose the biopsy fee.

"I see it all the time," said the surgeon, Dr. Elisa R. Port, the chief of breast surgery at Mount Sinai Medical Center in Manhattan. "People are causing harm and should be held accountable."

Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, California, and a clinical professor of surgery at the University of Southern California, said it was "outrageous" that 30 percent of breast biopsies were done by surgery.

Doctors interviewed in the article urged not only educating surgeons, but the patients. Any woman who is told that she needs a surgical biopsy should ask why, and consider a second opinion.

Dr. Silverstein suggested, "Maybe we have to get patients to say, 'This guy took a big chunk out of me and I didn't even have cancer, and now I'm deformed. "

Grady, Denise. "Surgical Breast Biopsies Study of Breast Biopsies Finds Surgery Used Too Extensively." The New York Times 18 Feb 2011.

Absent State Regulations, Some Doctors Use Their Offices to Moonlight as Cosmetic Surgeons, Risking Patients' Safety

Michigan Medical Malpractice Lawyer — Thu, 05 Jan 2012 02:20:00 GMT

Did you know that only 21 states require medical offices where doctors perform surgery to be accredited or licensed? Offices that are accredited or licensed are required to have certain life-saving emergency equipment and drugs; comply with strict recordkeeping, anesthesia, and cleanliness protocols; and be subject to inspection.

Because cosmetic surgery has become more popular and profitable, and because of the decrease in insurance payouts, doctors in other specialties are being tempted to branch out into new, potentially risky procedures in which they have not be formally trained. And while insurance companies and hospitals generally prohibit doctors from practicing outside of their specialties, office surgery facilities are unregulated in more than half of states including Michigan, Illinois, Massachusetts, Maryland, and the District of Columbia.

As reported in a recent USA Today exposé, what's being called "practice drift" can have serious, sometimes fatal consequences:

· Three patients of a former Arizona ER doctor died after undergoing cosmetic surgery at his office. The doctor was convicted of two counts of second-degree murder and one count of manslaughter and sentenced to 25 years in prison in September.

· A North Carolina ear, nose, and throat surgeon had his license suspended indefinitely based on patient complaints regarding substandard cosmetic surgery procedures, and another North Carolina doctor – a general practitioner – also had his license suspended due to concerns over his cosmetic surgery practice and the fact that he operated on family members and prescribed drugs to himself.

Cases such as these have prompted North Carolina and other jurisdictions to adopt position statements calling for doctors who expand their practices to be held to the same standards as more extensively trained physicians and to ensure that they have enough education and training.
"With cosmetic surgery, procedures are almost always done in the office, often without necessary and appropriate arrangements for emergencies," says North Carolina medical board spokeswoman Jean Fisher-Brinkley. "Doctors who drift typically do not have hospital privileges to do the procedures they are doing in the office (so) if complications do arise, the doctor often cannot even accompany the patient to the hospital."

If a state doesn't have formal guidance or a law covering office-based surgery and the doctors who practice it, "more people are going to get injured," says Sidney Wolfe, a medical doctor and director of Public Citizen's Health Research Group.

So what steps should you take if you're considering cosmetic surgery? First, find out where your doctor is licensed and if he or she is board certified in plastic surgery. Determine whether your doctor has been the subject of any disciplinary actions, which can be done by ordering a full physician profile and disciplinary history report. Search the American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF) and Accreditation Association for Ambulatory Health Care databases (AAAHC) databases for the office in which your proposed surgery will be performed.

It's up to you take control of your health!