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	<title>The Law Offices of John David Hart &#187; NEWS</title>
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	<link>http://www.hartlaw.com</link>
	<description>Your Injury. Your Loss. Your Recovery. Our Priority.</description>
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		<title>Commercial Motor Vehicle Regulations and Requirements- Commercial Drivers License Program</title>
		<link>http://www.hartlaw.com/commercial-motor-vehicle-regulations-and-requirements-commercial-drivers-license-program/</link>
		<comments>http://www.hartlaw.com/commercial-motor-vehicle-regulations-and-requirements-commercial-drivers-license-program/#comments</comments>
		<pubDate>Wed, 13 Feb 2013 14:53:23 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[On the Stand]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1325</guid>
		<description><![CDATA[Driving commercial vehicles requires specialized skills and knowledge. Prior to 1986, there was no nationwide standard for obtaining or possessing a commercial drivers license (CDL). The Commercial Motor Vehicle safety Act of 1986 was signed into law on October 27, 1986 and was designed to help improve the highway safety by removing unsafe and unqualified [...]]]></description>
				<content:encoded><![CDATA[<p>Driving commercial vehicles requires specialized skills and knowledge. Prior to 1986, there was no nationwide standard for obtaining or possessing a commercial drivers license (CDL). The Commercial Motor Vehicle safety Act of 1986 was signed into law on October 27, 1986 and was designed to help improve the highway safety by removing unsafe and unqualified drivers. <span id="more-1325"></span>Prior to enactment, many states had required no additional training for commercial vehicle operators. Drivers were able to obtain CDLs in multiple jurisdictions in attempts to hide traffic violations in order to remain behind the wheel. The Act addressed these problems directly by establishing minimum standards for the issuance of CDLs.</p>
<p><b>CLASSES OF COMMERICAL DRIVERS LICENSE</b></p>
<p>The act does not require drivers to obtain a separate federal CDL, but instead defines the minimum standards for each state’s CDL program. These standards allow states to issue CDLs only after the driver passes knowledge and skills test related to the type of vehicle the driver expects to operate. There are 3 classes of CDL depending upon the type of CMV.</p>
<p>Class A &#8212; Any combination of vehicles with a gross combined vehicle weight of 26,001 or more pounds provided the gross vehicle weight rating of the vehicle(s) being towed is in excess of 10,000 pounds.</p>
<p>Class B &#8212; Any single vehicle with a vehicle weight rating of 26,001 or more pounds, or any such vehicle towing a vehicle not in excess of 10,000 pounds vehicle weight rating.</p>
<p>Class C &#8212; Any single vehicle, or combination of vehicles, that does not meet the definition of Class A or Class B, but is either designed to transport 16 or more passengers, including the driver, or is transporting hazardous material that is required to be placarded</p>
<p>A driver may qualify to operate specialized commercial motor vehicles (CMV) by obtaining endorsements on their CDL if they pass additional skills or knowledge test.</p>
<p>Endorsements:</p>
<ul>
<li>T &#8211; Double/Triple Trailers (Knowledge test only)</li>
<li>P &#8211; Passenger (Knowledge and Skills Tests)</li>
<li>N &#8211; Tank vehicle (Knowledge test only)</li>
<li>H &#8211; Hazardous materials (Knowledge test only)</li>
<li>X &#8211; Combination of tank vehicle and hazardous materials endorsements</li>
<li>S &#8211; School Bus (Knowledge and Skills Tests)</li>
</ul>
<p>States may have additional codes for additional grouping of endorsements, as long as such codes are fully explained on the license.</p>
<p>Similarly, states may further restrict a driver’s CDL by placing restrictions on the license.</p>
<p>Restrictions:</p>
<p>&#8220;L&#8221; On a full air brake vehicle, if a driver fails either the air brake component of the general knowledge test, or performs the skills test in a vehicle not equipped with air brakes, then the driver will have an &#8220;L&#8221; air brake restriction placed on their license.</p>
<p>&#8220;Z&#8221; If the driver takes the test in a vehicle with an air over hydraulic brake system, then they will have a &#8220;Z&#8221; no full air brake restriction placed on their license. In either case the driver is not authorized to operate a CMV equipped with air brakes.</p>
<p>&#8220;E&#8221; If the driver takes the Skills Test in a vehicle that has an automatic transmission, then an &#8220;E&#8221; no manual transmission restriction is placed on their license.</p>
<p>&#8220;O&#8221; If the driver takes the Skills Test in a Class A vehicle that has a pintle hook or other non-fifth wheel connection, they will have an &#8220;O&#8221; restriction placed on their license restricting them from driving any Class A vehicle with a fifth wheel connection.</p>
<p>&#8220;M&#8221; If a driver possesses a Class A CDL, but obtains his or her passenger or school bus endorsement in a Class B vehicle the State must place an &#8220;M&#8221; restriction indicating that the driver can only operate Class B and C passenger vehicle or school buses.</p>
<p>&#8220;N&#8221; If a driver possesses a Class B CDL, but obtains his or her passenger or school bus endorsement in a Class C vehicle; the State must place an &#8220;N&#8221; restriction indicating that the driver can only operate Class C passenger vehicle or school buses.</p>
<p>&nbsp;</p>
<p><b>OBTAINING A COMMERICAL DRIVERS LICENSE</b></p>
<p>When an individual applies for a CDL, the issuing state must check its own database, the Commercial Driver’s License Information System and the National Driver Register to ensure that the individual has not been disqualified from possessing a CDL and does not currently possess a license from more than one jurisdiction. If a driver possesses a license from another jurisdiction, they will be required to surrender that license before obtaining a new license. States are required to request additional documentation pertaining to the driver’s history including a driving record for the past 10 years and any necessary documentation for medical variances. Drivers applying for a hazardous materials endorsement will be required to provide proof of citizenship and/or immigration status.</p>
<p>States are required to administer, or use an authorized third party skills testing service to administer, a knowledge and skills test, which meets the minimum federal standard defined by the Act. States are authorized to waive the skills test for military service members who meet certain criteria.</p>
<p>If at any time, a State determines that the individual seeking a CDL has falsified information or documentation, the State will at a minimum suspend, cancel or revokes the individual’s CDL and disqualify them from operating a CMV for a minimum of 60 days.</p>
<p>Individuals operating CMV for military purposes are exempt from CDL requirements. There are also very limited circumstances in which the State can grant an individual an exemption to the CDL requirements provided certain requirements are satisfied.</p>
<p>POSSESSING A COMMERICAL DRIVERS LICENSE</p>
<p>As a condition of participation in the national CDL program, States are required to enact additional requirements on CDL holders and to impose minimum penalties for violations.  Violations of these regulations can result in suspension, cancelation, revocation or disqualification.</p>
<p>A CDL holder is required to notify his/her employ within 30 days of conviction for any traffic violation (excluding parking). If a CDL is suspended, canceled, revoked or disqualified, the holder must notify his/her employer by the end of the next business day.</p>
<p>Using a CMV or non CMV in the commission of a felony involving manufacturing, distributing, or dispensing a controlled substance will result in a disqualification for life, without the possibility of reinstatement.</p>
<p>Most States have established a blood alcohol concentration (BAC) level of .08% as the level at or above which a person operating a non-commercial motor vehicle is deemed to be driving under the influence of alcohol. However, the FMCSA has established 0.04% as the (BAC) level at or above which a CDL commercial motor vehicle operator is deemed to be driving under the influence of alcohol and subject to the disqualification sanctions in the Federal regulations.</p>
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		<title>Chemical Safety Board responds to East Texas storage tank explosion</title>
		<link>http://www.hartlaw.com/chemical-safety-board-responds-to-east-texas-storage-tank-explosion/</link>
		<comments>http://www.hartlaw.com/chemical-safety-board-responds-to-east-texas-storage-tank-explosion/#comments</comments>
		<pubDate>Thu, 07 Feb 2013 14:58:35 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[On the Stand]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1323</guid>
		<description><![CDATA[On January 29, 2013, the U.S. Chemical Safety and Hazard Investigation Board (CSB) issued a statement calling on the Railroad Commission of Texas (RCC) to enact more stringent safety regulations to ensure oil and gas production sites are properly secured. The statement came in response to a January 29, 2013 explosion at an East Texas [...]]]></description>
				<content:encoded><![CDATA[<p>On January 29, 2013, the U.S. Chemical Safety and Hazard Investigation Board (CSB) issued a statement calling on the Railroad Commission of Texas (RCC) to enact more stringent safety regulations to ensure oil and gas production sites are properly secured. The statement came in response to a January 29, 2013 explosion at an East Texas oil and gas production site, which critically injured two individuals.<span id="more-1323"></span> Investigators believe two individuals were seated on the storage tank when a cigarette sparked the explosion. In 2009, one person was killed and one seriously injured when an oil tank exploded in New London, Texas.</p>
<p>According to the CSB, oil and gas production sites in rural areas are often a gathering place or social hangout for children and young adults. From 1983 to 2010 there were 26 accidents involving explosion nears oil and gas storage tanks, resulting in 44 fatalities and 25 injuries to individuals under the age of 25. Alarmingly, the CSB reports that 27% of these accidents occurred in Texas and Oklahoma.</p>
<p>CSB Chairperson Rafael Moure-Eraso called on the RCC to take additional precautions to restrict the general public’s access to oil and gas production sites. Recommended safety measures include fencing, locked gates, barriers preventing access to ladders and stairways, and additional signs identifying the fire and explosion hazards. The CSB points out that California, which has implemented additional safety and security requirements at oil and gas production sites, did not have a single fatal tank explosion between 1983 and 2011.</p>
<p><a href="http://www.csb.gov/newsroom/detail.aspx?nid=449">Click Here</a> to view complete statement from CSB Chairperson Rafael Moure-Eraso</p>
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		<title>Truck crash fatalities increased for second year in 2011</title>
		<link>http://www.hartlaw.com/truck-crash-fatalities-increased-for-second-year-in-2011/</link>
		<comments>http://www.hartlaw.com/truck-crash-fatalities-increased-for-second-year-in-2011/#comments</comments>
		<pubDate>Tue, 29 Jan 2013 15:26:28 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[In The News]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1308</guid>
		<description><![CDATA[According to the National Highway Traffic Safety Administration (NHTSA) the number of traffic fatalities in 2011 fell 1.9% to 32,367. Based on data released by the NHTSA in December 2012, the number of traffic fatalities has been steadily declining in recent years. The 2011 number marks the lowest number of traffic fatalities since 1949 and [...]]]></description>
				<content:encoded><![CDATA[<p>According to the National Highway Traffic Safety Administration (NHTSA) the number of traffic fatalities in 2011 fell 1.9% to 32,367. Based on data released by the NHTSA in December 2012, the number of traffic fatalities has been steadily declining in recent years. The 2011 number marks the lowest number of traffic fatalities since 1949 and a 26% decline since 2005. The NHTSA reported that fatalities in crashes involving drunk driving declined 2.5% in 2011.<span id="more-1308"></span></p>
<p>Unfortunately, the data also indicates some increases in the number of fatalities.</p>
<p>The number of fatalities in vehicle accidents involving large trucks rose 1.9% to 3,757</p>
<p>The number of truck occupant fatalities increased 20% to 635</p>
<p>The number of motorcyclist fatalities increased 2.1% to 1612</p>
<p>The number of pedestrian fatalities increased 3.0% to 4432</p>
<p>The number of bicyclist fatalities increased 8.7% to 677</p>
<p>The number of fatalities in distraction-affected crashes increased 1.9% to 3,331</p>
<p>Preliminary information indicated a significant increase in the number of motor vehicle fatalities in January-September 2012. Complete data on 2012 motor vehicle fatalities is not expected to be released until late 2013.</p>
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		<title>July 1, 2013 Deadline Approaching for Hours of Service of Drivers Final Rule</title>
		<link>http://www.hartlaw.com/july-1-2013-deadline-approaching-for-hours-of-service-of-drivers-final-rule/</link>
		<comments>http://www.hartlaw.com/july-1-2013-deadline-approaching-for-hours-of-service-of-drivers-final-rule/#comments</comments>
		<pubDate>Tue, 22 Jan 2013 15:24:42 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[In The News]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1306</guid>
		<description><![CDATA[In December 2011, the U.S. Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) enacted a new rule that revised the hours of service (HOS) safety requirements for commercial truck drivers. The rule was aimed at preventing fatigue-related truck crashes and helping save lives.  The new HOS regulations became effective on February 27, 2012, but [...]]]></description>
				<content:encoded><![CDATA[<p>In December 2011, the U.S. Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) enacted a new rule that revised the hours of service (HOS) safety requirements for commercial truck drivers. The rule was aimed at preventing fatigue-related truck crashes and helping save lives.  The new HOS regulations became effective on February 27, 2012, but two provisions, limitations on minimum 34 hours restarts and rest breaks, were given a July 1, 2013 compliance date.  <span id="more-1306"></span></p>
<p>According to the FMCSA, a CMV is a vehicle that is used as part of a business and is involved in interstate commerce and weigh 10,001 pounds or more, is designated to transport 16 or more passengers not for compensation, is designated to drive 9 or more passengers for compensation or is involved in transporting hazardous materials in quantity requiring placards.</p>
<p>Under the <a href="http://www.fmcsa.dot.gov/rules-regulations/topics/hos/index.htm">Hours of Service of Drivers Final Rule</a> drivers face new restrictions. The new restrictions include:</p>
<p><strong>Limitations on minimum &#8220;34-hour restarts&#8221;</strong> &#8211; Must include two periods between 1 a.m.- 5 a.m. home terminal time and may only be used once per week.</p>
<p><strong>Rest breaks-</strong> May drive only if 8 hours or less have passed since end of driver&#8217;s last off-duty period of at least 30 minutes. [HM 397.5 mandatory "in attendance" time may be included in break if no other duties performed]</p>
<p><strong>Off duty time-</strong> Does not include any time resting in a <span style="text-decoration: underline;">parked</span> vehicle (also applies to passenger-carrying drivers). In a moving property-carrying CMV, does not include up to 2 hours in passenger seat immediately before or after 8 consecutive hours in sleeper-berth.</p>
<p><strong>Penalties-</strong> Driving (or allowing a driver to drive) 3 or more hours beyond the driving-time limit may be considered an egregious violation and subject to the maximum civil penalties. Also applies to passenger-carrying drivers.</p>
<p><strong>Oilfield exemption-</strong> &#8220;Waiting time&#8221; for certain drivers at oilfields must be shown on logbook or electronic equivalent as off duty and identified by annotations in &#8220;remarks&#8221; or a separate line added to &#8220;grid.&#8221;</p>
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		<title>FDA takes steps to tighten restrictions on metal-on-metal hip implants</title>
		<link>http://www.hartlaw.com/fda-takes-steps-to-tighten-restrictions-on-metal-on-metal-hip-implants/</link>
		<comments>http://www.hartlaw.com/fda-takes-steps-to-tighten-restrictions-on-metal-on-metal-hip-implants/#comments</comments>
		<pubDate>Thu, 17 Jan 2013 18:05:46 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[On the Stand]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1304</guid>
		<description><![CDATA[On January 17, 2013, the U.S. Food and Drug Administration (FDA) issued new safety information and recommendations to patients and health care professional regarding metal-on-metal hip implants.  The FDA recognized that in addition to the general risks associated with the implantation of any hip device, metal-on-metal hips expose patients to an additional set of unique [...]]]></description>
				<content:encoded><![CDATA[<p>On January 17, 2013, the U.S. Food and Drug Administration (FDA) issued new safety information and recommendations to patients and health care professional regarding metal-on-metal hip implants. <span id="more-1304"></span> The FDA recognized that in addition to the general risks associated with the implantation of any hip device, metal-on-metal hips expose patients to an additional set of unique risks including “adverse local tissue reaction (ALTR),” “adverse reaction to metal debris (ARMD)” and increased metal ion levels in the bloodstream. The new recommendations encourage doctors to take a much more proactive approach in monitoring patients for potential complications, and apply to both total metal hip replacement systems and metal hip resurfacing systems.</p>
<p>The FDA recommends that orthopedic surgeons select a metal-on-metal device over other alternative systems available only if the benefits outweigh the possible risks. Doctors are urged to consider a patient’s age, sex, weight, diagnosis and activity level when considering possible risks. After surgery, the FDA recommends that doctors conduct physical examinations and routine radiographs every 1-2 years.  Symptomatic patients or those with an increased risk for device complications should be monitored more closely.  When additional imaging is needed, doctors are encouraged to utilize specialized diagnostic imaging test such as a MRI with metal artifact reduction or CT scans to assess and diagnose soft tissue damage.  At this time, the FDA does not recommend routinely checking metal ion levels in the blood if the hip appears to be functioning properly and the patient does not report any complications. However, in patients experiencing complications, the FDA recommends that doctors consider monitoring serial metal ion levels. The FDA noted that it presently does not have enough scientific data to identify a specific metal ion level that produces adverse systemic effects.</p>
<p>On January 17, 2013, the FDA also issued a proposed rule requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications to the agency. The FDA commented that  metal-on-metal hip replacement systems were evaluated under the 510(k) approval program. These devices were approved by the FDA based on representations from the manufacturer that the device was substantially similar in terms of safety and efficiency to devices already on the market.</p>
<p>Under the new proposed rule, manufacturers of metal-on-metal hip devices would be required to submit clinical data proving that the device is safe and effective in order to continue selling the device or obtain approval for a new device.  If a company fails to provide the clinical data or the data fails to meet the FDA’s standards, the manufacturer would have to stop selling the hip device. According to agency officials, the rule will likely take a year to be finalized.</p>
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		<title>Pediatric bounce house injuries on the rise</title>
		<link>http://www.hartlaw.com/pediatric-bounce-house-injuries-on-the-rise/</link>
		<comments>http://www.hartlaw.com/pediatric-bounce-house-injuries-on-the-rise/#comments</comments>
		<pubDate>Tue, 11 Dec 2012 15:28:00 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[On the Stand]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1300</guid>
		<description><![CDATA[An article appearing in the November 26th issue of PEDIATRICS, the official journal of the American Academy of Pediatrics (AAP), examines the rapidly growing number of children’s bounce house related injuries. The study analyzed data on bounce house injuries treated in US emergency departments from 1990-2010. Data showed that more than 64,000 children were treated [...]]]></description>
				<content:encoded><![CDATA[<p>An article appearing in the November 26<sup>th</sup> issue of PEDIATRICS, the official journal of the American Academy of Pediatrics (AAP), examines the rapidly growing number of children’s bounce house related injuries. The study analyzed data on bounce house injuries treated in US emergency departments from 1990-2010. Data showed that more than 64,000 children were treated for bounce house related injuries in a 21-year timespan. Bounce houses, also know as moonwalks, jumping castles or inflatable bouncers have become an increasingly common source of entertainment in recent years.  <span id="more-1300"></span>However, the rapid rise in injuries has called into question the safety of the devices. The study, the first to use nationally representative date, found that from 1995-2010 the rates of injuries increased 15-fold. From 2008 &#8211; 2010, the number of bounce house injuries more than doubled. In 2010 alone, 31 children per day were treated for bounce house related injuries.</p>
<p>The most common injuries reported were fractures, strains and sprains, but other injuries included lacerations and concussions.  Many injuries reported were the result of falls in or around the bouncers, but other causes included collisions with other jumpers, entrapment and attempted stunts. Researchers expressed concern that more than 2,000 of the reported injuries resulted from stunts. Attempted stunts, especially flips, are very dangerous because they are often associated with neurologic injury.</p>
<p>Researchers determined that the data on bounce house related injuries is very similar to the data on trampoline related injuries and given the rapid growth of bounce house injuries, there is a need for additional guidance for safer bouncer usage. Earlier this year, the American Academy of Pediatric reaffirmed its recommendation that trampolines only be used as part of a structured training or therapy program with appropriate safety measures in place.  At this time, bounce houses have not been utilized as part of training or therapy. Given the recent increase in bounce house related injuries and similarities to trampoline injuries, researchers urge policy makers to formulate recommendations for safer bounce house usage and design.</p>
<p>For more information about the AAP, please visit <a href="http://www.aap.org">www.aap.org</a></p>
<p><a href="http://pediatrics.aappublications.org/content/early/2012/11/21/peds.2012-0473.abstract">Click here</a> to view the complete article.</p>
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		<title>Additional concerns emerge as fungal meningitis outbreak expands</title>
		<link>http://www.hartlaw.com/additional-concerns-emerge-as-fungal-meningitis-outbreak-expands/</link>
		<comments>http://www.hartlaw.com/additional-concerns-emerge-as-fungal-meningitis-outbreak-expands/#comments</comments>
		<pubDate>Tue, 16 Oct 2012 18:41:04 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[In The News]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1281</guid>
		<description><![CDATA[The fungal meningitis outbreak, linked to contaminated steroids produced and distributed by New England Compounding Center (NECC), has grown to 214 cases and 15 deaths. Health officials are working with medical professionals in 23 states to reach out to the more than 14,000 patients who may have been exposed to meningitis through contaminated injections. There [...]]]></description>
				<content:encoded><![CDATA[<p>The fungal meningitis outbreak, linked to contaminated steroids produced and distributed by New England Compounding Center (NECC), has grown to 214 cases and 15 deaths. Health officials are working with medical professionals in 23 states to reach out to the more than 14,000 patients who may have been exposed to meningitis through contaminated injections.<span id="more-1281"></span> There are currently 214 confirmed cases in 15 states including Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.</p>
<p>Last week, two companies also owned by the owners of NECC, Ameridose LLC and Alaunus Pharmaceutical LLC, suspended operations while state and federal officials inspect the facilities and regulators investigate the companies’ business relationship. Despite email communications from NECC employees referring to Ameridose as “our sister company,” company officials maintain that the companies are separate entities with “distinct operational management.”</p>
<p>On October 11<sup>th</sup>, the first lawsuit was filed over the deadly fungal meningitis outbreak in a Minnesota federal district court. Two more cases were filed this week in Tennessee and Michigan.</p>
<p>The company is facing intense scrutiny from officials in multiple states. Officials in Massachusetts are investigating claims that NECC provided prescription drugs to doctors and health care facilities without receiving the individual patients’ names and prescriptions. Officials in Michigan suspended NECC’s license and launched an inquiry into whether the company violated terms of its license by shipping large quantities of drugs for general use. The company is also being investigated in Indiana, Minnesota and Ohio and at least two other states have administration hearings scheduled regarding possible violations of state license regulations.</p>
<p>Across the country, members of Congress have vowed to introduce legislation that would provide the Food and Drug Administration (FDA) greater authority to license and regulate compounding pharmacies. Compounding pharmacies combine, mix, or alter ingredients to create customized medications in order to meet the specific needs of an individual patient. In response to the growing demand for cheaper prescription drugs, the number of compounding pharmacies has increased drastically over the last few years. According to the International Academy of Compounding Pharmacists, compounding is a $3 billion a year business with more than 7,500 compounding pharmacies in the U.S. Under the current regulatory structure, oversight of compounding pharmacies is shared between the FDA and state agencies. However, federal legislation gives the FDA very little authority over compounding pharmacies when compared to the agency’s more comprehensive regulatory oversight of large drug manufacturers. The medications, creams and solutions created by compounding pharmacies are not approved by the FDA for safety and effectiveness.</p>
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		<title>New warnings issued on hip resurfacing procedures</title>
		<link>http://www.hartlaw.com/new-warnings-issued-on-hip-resurfacing-procedures/</link>
		<comments>http://www.hartlaw.com/new-warnings-issued-on-hip-resurfacing-procedures/#comments</comments>
		<pubDate>Mon, 15 Oct 2012 13:27:10 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[In The News]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1277</guid>
		<description><![CDATA[A recent study appearing in the online version of The Lancet warns of increased early failure rates for hip resurfacing implants. The study, conducted on behalf of the National Joint Registry for England and Wales, compared data from more 30,000 hip resurfacing procedures from April 2003 to September 2011. Researchers analyzed the data to determine [...]]]></description>
				<content:encoded><![CDATA[<p>A recent study appearing in the online version of <em>The Lancet</em> warns of increased early failure rates for hip resurfacing implants. The study, conducted on behalf of the National Joint Registry for England and Wales, compared data from more 30,000 hip resurfacing procedures from April 2003 to September 2011.<span id="more-1277"></span></p>
<p>Researchers analyzed the data to determine how many resurfacing implants failed within the first seven years and if femoral head size impacted failure rates.  The data indicated that female patients who underwent resurfacing had an increased failure rate, up to five times higher than other bearing surfaces. Researchers also found that men of smaller stature had an elevated failure rate. Dr. Ashley W. Blom, Professor of Orthopaedic Surgery at The University of Bristol, headed the team of researchers and calls the failure rates “unacceptably high.” Blom explained, “Our findings show that resurfacings with smaller head sizes are prone to early failures, and in particular that resurfacing in women has much worse implant survival, irrespective of head size.” Dr. Blom recommended that resurfacing procedures are not undertaken in women.</p>
<p>Hip resurfacing, which is often used as an alternative to total hip replacement, allows for preservation of a patient’s thighbone. In a total hip replacement, a patient’s femoral head is removed and replaced, whereas in a hip resurfacing, the femoral head is covered with a <a href="http://en.wikipedia.org/wiki/Cobalt-chrome">cobalt-chrome</a> metal cap. Total hip replacements have a variety of bearing options including metal-on-metal, metal-on-ceramic or metal-on-polyethylene, but hip resurfacings always contain metal-on-metal bearings. In recent years, metal-on-metal hip devices have come under increased scrutiny after studies have indicated the devices release metal particles into the bloodstream and can cause increased metal ion levels in the blood, metal sensitivity, bone deterioration, swelling, pain, and nerve and tissue damage.</p>
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		<title>Plaintiffs seek consolidation of state court Stryker hip cases</title>
		<link>http://www.hartlaw.com/plaintiffs-seek-consolidation-of-state-court-stryker-hip-cases/</link>
		<comments>http://www.hartlaw.com/plaintiffs-seek-consolidation-of-state-court-stryker-hip-cases/#comments</comments>
		<pubDate>Wed, 10 Oct 2012 17:57:27 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[In The News]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1272</guid>
		<description><![CDATA[On September 19, 2012, attorneys representing plaintiffs who have been injured by the Stryker Rejuvenate and ABG II modular hip implant devices filed a petition requesting the State of New Jersey to designate the litigation as “multi-county” litigation. The petition, filed on behalf of 10 plaintiffs from New Jersey, Arizona, Florida and Minnesota, seeks to [...]]]></description>
				<content:encoded><![CDATA[<p>On September 19, 2012, attorneys representing plaintiffs who have been injured by the Stryker Rejuvenate and ABG II modular hip implant devices filed a petition requesting the State of New Jersey to designate the litigation as “multi-county” litigation. <span id="more-1272"></span>The petition, filed on behalf of 10 plaintiffs from New Jersey, Arizona, Florida and Minnesota, seeks to have a coordinated docket created in Bergen County Superior Court in Hackensack, New Jersey. Plaintiffs’ counsel cited the courts central location, proximity to defendant’s headquarters and Judge Brian Martinotti’s previous experience with metal-on-metal hip implant litigation. Judge Maritnotti is currently overseeing the state court cases involving the DePuy ASR metal-on-metal hip devices.</p>
<p>The Rejuvenate and ABG II, unlike other defective hip replacement systems, are not classified as metal-on-metal devices because they do not contain metal ball and socket components. They consist of interchangeable cobalt and chromium (CoCr) necks and titanium-coated stems. However, because of the cobalt and chromium neck and titanium stem articulation, patients may experience the same complications as patients with other metal-on-metal devices including, increased metal ion levels in the blood, metal sensitivity, bone deterioration, swelling, pain, pseudotumors and nerve and tissue damages. Patients experiencing any of these symptoms are urged to contact their orthopedic surgeon as soon as possible.  <a href="http://www.strykerhiprecallinfo.com">Click Here</a> for more information on the Stryker Rejuvenate and ABG II modular hip implant devices.</p>
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		<title>Fungal meningitis outbreak raises safety concerns over compounding pharmacies</title>
		<link>http://www.hartlaw.com/fungal-meningitis-outbreak-raises-safety-concerns-over-compounding-pharmacies/</link>
		<comments>http://www.hartlaw.com/fungal-meningitis-outbreak-raises-safety-concerns-over-compounding-pharmacies/#comments</comments>
		<pubDate>Mon, 08 Oct 2012 20:34:44 +0000</pubDate>
		<dc:creator>johnhart</dc:creator>
				<category><![CDATA[In The News]]></category>

		<guid isPermaLink="false">http://www.hartlaw.com/?p=1267</guid>
		<description><![CDATA[Health officials across the country are investigating an outbreak of fungal meningitis that has resulted in eight deaths. As of Monday, October 8th, there have been 105 reported cases in nine states. The outbreak has been linked to steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. The steroid, methylprednisolone acetate, is generally [...]]]></description>
				<content:encoded><![CDATA[<p style="text-align: left;" align="center">Health officials across the country are investigating an outbreak of fungal meningitis that has resulted in eight deaths. As of Monday, October 8th, there have been 105 reported cases in nine states.<span id="more-1267"></span> The outbreak has been linked to steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. The steroid, methylprednisolone acetate, is generally given as spinal epidural injections to alleviate lower back pain. The New England Compounding Center reported that 17,676 vials of the drug were shipped to 76 facilities in 23 states including California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia. Texas officials have confirmed that at least two Texas health care facilities received the tainted drug, including Texas Health Harris Methodist Hospital Southlake and Dallas Back Pain Management. At this time, there have been no confirmed cases of fungal meningitis in Texas. A spokesman for The Center for Disease Control and Prevention (CDC) reported that it is not possible to know how many cases there will be, but that an estimated 13,000 patients may have been exposed to the tainted spinal steroid injections.</p>
<p style="text-align: left;">Meningitis is an inflammation of the protective membranes covering the brain and spinal cord. There are different types of meningitis including bacterial, viral and fungal. The severity and treatment depend on the type of meningitis, so it is important for medical professionals to identify the specific cause of each case. Symptoms include headache, fever, nausea, stiffness of the neck, confusion, dizziness and sensitivity to bright lights. Fungal meningitis is not contagious and cannot be spread from one person to another.</p>
<p style="text-align: left;">On September 26<sup>th</sup>, NECC recalled three lots of the methylprednisolone acetate single dose vials linked to the outbreak. On October 4, 2012, out of an abundance of caution, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New England Compounding Center, located at 697 Waverly Street in Framingham, MA. On October 6, 2012, NECC expanded the recall to include all products compounded at and distributed from the NECC’s Framingham facility. The company has completely shut down operations and is working with health officials to determine the source of the contamination.</p>
<p style="text-align: left;">This outbreak raises concerns over the sterility and safety of compounding pharmacies and the products they produce and distribute. Compounding pharmacies combine, mix, or alter ingredients to create customized medications that meet the specific needs of individual patients. The medications, creams and solutions created by compounding pharmacies are not approved by the FDA and have not been tested by the FDA for safety and effectiveness. According to David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, the number of compounding pharmacies has grown from 5,000 in 2009 to more than 7,500 today. The current meningitis outbreak is not the first time the safety of compounded products has been questioned. In 2005, two patients were blinded and several others suffered permanent vision damage after using a compounded product that was contaminated with bacteria after cataract surgery. In 2006, three patients died from contaminated a compounded solution that was used to paralyze the heart during open-heart surgery. In 2007, three patients died after being given drugs that were incorrectly mixed resulting in a toxic dosage. In 2011, nine patients died after contracting bacterial infections from contaminated intravenous supplements mixed by a compounding pharmacy.</p>
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