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Medical Malpractice – Off Label Use of Medical Devices and Drugs

 Posted on July 01, 2013 in Maryland Law

The Food and Drug Administration (FDA) regulates prescription drugs and medical devices to ensure that these products are safe and effective for their intended use. Frequently, medical professionals see clinical uses for medical devises that lie outside of the FDA-approved labeling. This is a practice known as “off label use.”

While off label use of a medical device may be legal, a prescription drug or medical device should not be used “off label” without a patient’s consent. In Maryland, and in most states, the medical malpractice doctrine of “informed consent” requires that doctors (in a non-emergency setting) present the patient with important information about the nature of their ailment, the nature of the proposed treatment, the probability of success of contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. This information allows the patient to decide which course of action to pursue.

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Your Business Has an Online Website—Does this Mean You Are an Internet Content Provider? – The Communications Decency Act and Your Online Website

 Posted on June 28, 2013 in Internet Law

Section 230 of the Communications Decency Act of 1996, 47 U.S.C.A. § 230, (CDA) provides online businesses a refuge from civil liability that could otherwise arise from content posted to a website, online blog or other social media platform by a third party. Specifically, § 230(c) of the CDA immunizes providers of interactive computer services against liability arising from content created by third parties, stating: “No provider … of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” 47 U.S.C. § 230(c).

Many businesses seek shelter under this provision of the CDA for legitimate business purposes, such as a commentary section for product or service reviews, but other businesses exploit this immunity, such as revenge porn sites like yougotposted.com.

It is essential, however, that all businesses that conduct business online or that operate an online website understand that the CDA’s immunity provision is not always a safe harbor. Why? Because the CDA’s grant of immunity applies only if the interactive computer service provider is not also an “information content provider,” (ICP) which is defined as someone who is “responsible, in whole or in part, for the creation or development of” the offending content. 47 U.S.C.A. § 230(f)(3), emphasis added.

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Your Employees and Social Media – Can You Read Their Online Activity? Worse, Could You Be Liable for It? Why Your Business Needs a Social Media Policy for Employees

 Posted on June 27, 2013 in Internet Law

Depending on the nature of your business, your employees may routinely handle or have access to information that is subject to privacy protection or financial/securities regulations under various federal and state laws. Improper handling or disclosure of statutorily-protected or otherwise private information could potentially result in (1) statutory and privacy violations and (2) civil liability exposure for your business generally and for your employees individually.

Even businesses that do not handle sensitive information must consider the impact of employees’ use of social media – posts can go viral within seconds. And once content is posted on the Internet, it is very challenging, if not impossible, to remove. For these reasons, it is essential that every employee be aware of and educated about these potential legal risks when posting content on social media sites-even when they do so on their own time.

Thoughtless or unthinking social media mistakes can create ethical dilemmas and embarrass both a business and its employees. And consider the potential legal claims that may arise from employee social media misuse:

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Medical Malpractice and Informed Consent Involving Off-Label Use Of Medical Devices and Drugs

 Posted on June 12, 2013 in Law in Maryland

The U.S. Food and Drug Administration regulates medical devices and prescription drugs to make sure that they are safe and effective for their intended use. Frequently, doctors see clinical uses for medical devices and drugs that lie outside of the FDA-approved labeling. This is a practice known as “off-label use.” The off-label use of a medical device is, in most cases, completely legal. The FDA understands that doctors have the right to make their own treatment decisions, including decisions about off-label uses, based on clinical experience and knowledge. However, the off-label use of medical devices can be a source of increased liability when such use falls short of patients’ expectations.

All doctors engaged in medical practice are liable for damages from negligent injury to patients due to medical malpractice. In such cases, the key question is whether the medical procedure or service at issue met the standard of care. The standard of care generally is defined as what a reasonable doctor would do under the same or similar circumstances.

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Negligence Involving Bed Rails

 Posted on June 11, 2013 in Hospital Malpractice

There are many hidden and unknown dangers in the very places we expect to heal; for example, hospital beds. Many of these hospital beds have rails, typically made of metal, that run along the side of the sleeping space. These bed rails operate to prevent someone from rolling off accidentally.

Several months ago the Consumer Product Safety Commission released a review of bedrail deaths and injuries of adults. Using data from hospitals, the report cited 155 deaths involving bed rails from January 2003 to September 2012. In that same period, almost 37,000 people were injured in bed rail accidents and treated at hospital emergency rooms. According to this report, the deaths and injuries most commonly occurred when the victim became stuck in the bed rails, mainly with his or her head or neck getting caught. These alarming numbers triggered the CPSC to move forward in addressing bed rail safety.

Last week, the CPSC “merged” two petitions related to bed rail safety. Combined, the two petitions offer the CPSC an array of options: it can decide to do nothing, ban the use of bed rails entirely, or choose any various steps in between. Safety advocates are insistent that no intermediary step will eliminate all harm, suggesting that a ban likely is the best and safest option. The prevalence of these beds and bed rails in residences, nursing homes, and hospitals suggests that it is likely this petition will gain deep collective interest among a number of organizations.

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Price-Fixers Beware! Recent Price-Fixing Decision By The Federal Trade Commission (McWane, Inc.)

 Posted on June 07, 2013 in Contracts

The processes of setting and communicating prices are two of the most fundamental roles of a business. Price affects a business’s sales, revenue, investment returns, and ultimately profit. As a result, the term “price fixing” has a strong negative connotation, and deservedly so. Restrictions on price competition represent actual threats to the economy, and they carry the possibility of harsh penalties. However, the term sometimes may be misused in reference to pro-competitive, legal conduct, which actually may be beneficial for businesses and consumers.

In a recent decision, an administrative law judge dismissed three illegal price-fixing charges brought against McWane, Inc. by the Federal Trade Commission, but upheld four charges alleging that it illegally excluded competitors from the market.

The privately-owned McWane, Inc. is the nation’s largest manufacturer of iron pipe and other products used in water distribution and wastewater treatment. In January 2012, the FTC Complaint accused McWane of orchestrating a complex scheme in which it worked with competitors Star Pipe Products Limited and Sigma Corporation to raise and stabilize prices. The FTC also alleged that a trade group was created to assist in this illegal scheme by serving as a clearinghouse through which the companies could exchange pricing information.

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Medical Malpractice Regarding Misdiagnosis of Strokes

 Posted on June 03, 2013 in Emergency Room Malpractice

Unfortunately, it is not uncommon for doctors and hospitals to misdiagnose a stroke in a younger person. Many people think that strokes only happen to older people. In reality, doctors around the world treat otherwise healthy people in their 30s, 40s and 50s who have had strokes, sometimes totally out-of-the-blue.

Misdiagnosis of stroke is a major medical malpractice problem that can have catastrophic consequences. In a landmark study in 2009, doctors found that young people who are having a stroke are misdiagnosed by emergency rooms 14 percent of the time. Such a misdiagnosis results in critical delay in treating stroke. As one of the authors of the study said, “early intervention is the most critical component of effective stroke care.

Doctors have known for decades that stroke symptoms include, but are not limited to: sudden numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; and/or sudden, severe headache with no known cause. When a patient has any of these symptoms, the must be carefully evaluated for a stroke.

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Maryland Businesses Cannot Enforce Waivers, Releases, and Indemnification Agreements Signed by Parents on Behalf of their Minor Children

 Posted on May 29, 2013 in Maryland Law

It is not uncommon for a business to require a parent to sign a waiver before their child may participate in any of the business’s activities. By signing such a release, a parent agrees that the business is not responsible for any injuries that the child sustains as a result of the child’s participation in an activity. These releases also often have language indemnifying the business from any claim brought on behalf of the child. Until now, the law in many states has allowed these businesses, although responsible for the injury, to rely on this waiver and avoid all liability. But in a recent case of first impression, the Maryland Court of Special Appeals ruled that such agreements are void and unenforceable on public policy grounds.

In Rosen v. BJ’s Wholesale Club, Inc., Russell and Beily Rosen were members of the Owings Mills BJ’s Wholesale store. As a perk of membership, the store provided a free, supervised children’s play area, subject to the parent signing a release, which contained both an exculpatory and indemnification clause. Russell Rosen signed that release in July 2005. Then, in October 2006, Beily Rosen dropped her five-year-old son, Ephraim, off at the play center and proceeded to shop in the BJ’s. Sadly, Ephraim fell in the play area and suffered life-threatening brain injuries. The Rosens sued BJ’s, arguing the Club was negligent because it failed to have adequate material protecting the play area floor. In turn, the Club argued that it could not be sued because the Rosens signed the waiver. The trial court sided with the Club and threw out the case.

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Malpractice litigation helps reduce medical error

 Posted on May 21, 2013 in Hospital Malpractice

The New York Times recently ran a fascinating op ed by Joanna Schwartz, a professor at UCLA. The subject was a study that Professor Schwartz did on the value of medical malpractice litigation in reducing medical errors. Professor Schwartz’s conclusion was that medical malpractice claims and lawsuits actually don’t result in doctors and other health professionals hiding problems and, in fact, such suits actually encourage improved practices.

In order to reach her conclusions, Professor Schwartz surveyed more than 400 people who are responsible for hospital risk management, claims management and quality improvement in hospitals in the U.S. She found that, although hospitals used to handle medical errors and lawsuits by taking an adversarial and secret approach, hospitals have begun changing that approach. Now, she reports, hospitals are more open with patients. In fact, she found that over 80 percent of hospitals that she surveyed now actually have a policy of apologizing to patients who are victims of errors. Most importantly, she found that most hospitals are willing to discuss and learn from errors with staff. This is a dramatic shift form the old days when health care providers kept from patients the fact of medical injury.

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Severe Nerve Injuries From Medical Malpractice

 Posted on May 15, 2013 in Surgery Malpractice

Severe and permanent nerve injuries due to medical malpractice unfortunately can occur. These cases can be challenging to win because there often is not clear evidence of exactly how the nerve injury occurred. Recently, I successfully concluded a case of a nerve injury that allegedly was caused by malpractice. That case involved a severed sciatic nerve which occurred during orthopedic surgery. The surgeon denied that he severed the nerve; however, the patient walked into the hospital on the morning of the surgery and woke up with the severed nerve.

Nerve injury cases also can be very challenging because the extent of nerve injuries can be hard to quantify objectively. In my experience, defense attorneys and insurance adjusters tend to be suspicious of plaintiffs who have nerve injuries because the pain caused by these injuries is subjective and, therefore, hard to objectively quantify.

As an experienced Baltimore, Maryland medical malpractice lawyer, I have handled a number of medical malpractice cases involving nerve injuries. They are extremely complicated and require expertise that most general personal injury attorneys do not have. To see some of the cases I have handled, click here.

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