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	<title>Closing Argument: a blog on truth, justice, the law (and the politics in between)</title>
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		<title>Closing Argument: a blog on truth, justice, the law (and the politics in between)</title>
		<link>http://rijustice.wordpress.com</link>
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		<title>Former Republican State Representative Steven J. Coaty Public Censured by Supreme Court</title>
		<link>http://rijustice.wordpress.com/2010/01/06/former-republican-state-representative-steven-j-coaty-public-censured-by-supreme-court/</link>
		<comments>http://rijustice.wordpress.com/2010/01/06/former-republican-state-representative-steven-j-coaty-public-censured-by-supreme-court/#comments</comments>
		<pubDate>Wed, 06 Jan 2010 16:15:25 +0000</pubDate>
		<dc:creator>Matt Jerzyk</dc:creator>
				<category><![CDATA[Ethics]]></category>
		<category><![CDATA[RI Courts]]></category>
		<category><![CDATA[disciplinary counsel]]></category>
		<category><![CDATA[Professional Responsibility]]></category>
		<category><![CDATA[ri disciplinary counsel]]></category>
		<category><![CDATA[RI Republicans]]></category>
		<category><![CDATA[RI Supreme Court]]></category>
		<category><![CDATA[steven coaty]]></category>
		<category><![CDATA[turner scott]]></category>

		<guid isPermaLink="false">http://rijustice.wordpress.com/?p=1029</guid>
		<description><![CDATA[This week, the Rhode Island Supreme Court, in the case of  In the Matter of Steven J. Coaty, publicly censured former Republican State Representative and lawyer Steven J. Coaty for committing a host of ethical violations while representing four clients who filed disciplinary complaints against him. The Court ordered attorney Turner Scott to to monitor [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=rijustice.wordpress.com&blog=6838216&post=1029&subd=rijustice&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p><img class="alignright" title="Steven J. Coaty Photo Courtesy of the Providence Journal" src="http://www.projo.com/photos/20090131/ri0131_coaty_01-31-09_KVD5JTR.jpg" alt="" width="64" height="81" />This week, the Rhode Island Supreme Court, in the case of  <a href="http://www.courts.state.ri.us/supreme/pdf-files/09-387.pdf"><em><strong>In the Matter of Steven J. Coaty</strong></em></a><em><strong>, </strong></em>publicly censured former Republican State Representative and lawyer Steven J. Coaty for committing a host of ethical violations while representing four clients who filed disciplinary complaints against him. The Court ordered attorney Turner Scott to to monitor Coaty&#8217;s practice of law.</p>
<p>Here is the relevant portion of <a href="http://www.courts.state.ri.us/supreme/pdf-files/09-387.pdf"><strong>the Court&#8217;s order</strong></a>:</p>
<blockquote><p>The respondent has committed a host of violations of the Rules of Professional Conduct in his representation of these four clients. He has exhibited a disturbing pattern of neglecting matters entrusted to his care, failing to maintain adequate communication with his clients, and failing to properly respond to disciplinary complaints. While the board did not find any intentional misappropriation of client funds, respondent’s billing practices and handling of client funds can, at best, be described charitably as sloppy and well below the standard of care expected of a fiduciary.</p>
<p>Accordingly, we enter the following order. The respondent, Steven J. Coaty is hereby publicly censured. Turner Scott, Esquire, a member of the bar of this state is hereby appointed to monitor the respondent’s practice of law. The respondent shall fully cooperate with Attorney Scott, and shall meet with him and review his cases at least once per month. The purpose of this monitoring is to ensure the following: (a) That the respondent shall properly adhere to all deadlines; (b) that the respondent shall provide diligent representation to his clients; (c) that the respondent shall maintain adequate communication with his clients; (d) that the respondent shall provide timely and accurate billings to his clients; and, (e) that the respondent’s use of his clients’ account conforms with the mandates of Rule 1.15 of the Rules of Professional Conduct. Attorney Scott shall submit monthly reports to disciplinary counsel regarding the results of his monitoring of the respondent’s practice. The respondent is ordered to participate in the Rhode Island Bar Association’s Fee Arbitration Program, provided that Bini, Towle, and Addison also agree to participate to resolve the issue of excessive fees. We direct disciplinary counsel to report to us about the respondent’s cooperation with and participation in the fee arbitration program.</p></blockquote>
<p>Coaty was the toast of the RI Republican community <a href="http://www.projo.com/ri/newport/content/EB_NPTELECT19_12-19-07_218AF5P_v14.2a742c6.html"><strong>when he upset Democratic candidate Bud Cicilline in the Newport special election in House District 75</strong></a> to replace the late Rep. Paul Crowley.  Less than 12 months later, <a href="http://www.elections.ri.gov/elections/results/2008/general_election/races/795.php"><strong>Coaty fell to Democratic newcomer Peter Martin</strong></a> by a final tally of 55% to 45%.</p>
<p>The Providence Journal also reported this story <a href="http://newsblog.projo.com/2010/01/former-state-rep-steven-j-coat.html"><strong>here</strong></a>.</p>
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		<media:content url="http://1.gravatar.com/avatar/5f85fdc9381bf1473cca18a8e26faea3?s=96&#38;d=wavatar&#38;r=G" medium="image">
			<media:title type="html">Matt Jerzyk</media:title>
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		<media:content url="http://www.projo.com/photos/20090131/ri0131_coaty_01-31-09_KVD5JTR.jpg" medium="image">
			<media:title type="html">Steven J. Coaty Photo Courtesy of the Providence Journal</media:title>
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	</item>
		<item>
		<title>Three Ways Google can Help your Practice</title>
		<link>http://rijustice.wordpress.com/2010/01/05/three-ways-google-can-help-your-practice/</link>
		<comments>http://rijustice.wordpress.com/2010/01/05/three-ways-google-can-help-your-practice/#comments</comments>
		<pubDate>Tue, 05 Jan 2010 20:01:23 +0000</pubDate>
		<dc:creator>Matt Jerzyk</dc:creator>
				<category><![CDATA[Technology]]></category>
		<category><![CDATA[advertising]]></category>
		<category><![CDATA[google]]></category>
		<category><![CDATA[google scholar]]></category>
		<category><![CDATA[google wave]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[ri lawyers weekly]]></category>

		<guid isPermaLink="false">http://rijustice.wordpress.com/?p=1027</guid>
		<description><![CDATA[RI Lawyer&#8217;s Weekly has a good story on the best ways to use Google tools to build your practice:
1) Google Wave
What it is: The hotly anticipated collaboration platform that allows users to share and edit documents, and upload pictures and videos remotely in a real-time format. For example, if you are looking to draft a [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=rijustice.wordpress.com&blog=6838216&post=1027&subd=rijustice&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p><a href="http://rilawyersweekly.com/blog/2009/12/30/three-ways-google-can-help-your-practice/"><strong>RI Lawyer&#8217;s Weekly</strong></a> has a good story on the best ways to use Google tools to build your practice:</p>
<blockquote><p>1) Google Wave</p>
<p>What it is: The hotly anticipated collaboration platform that allows users to share and edit documents, and upload pictures and videos remotely in a real-time format. For example, if you are looking to draft a complaint, you could upload it to a Wave (structured like a new Gmail message), allowing associates and clients to view or comment on it, rather than saving a new document each time. The Wave also allows real-time messaging.</p>
<p>(&#8230;)</p>
<p>2) Google Scholar</p>
<p>What it is: A free publication search tool featuring legal opinions. Users may search by case name, court, citation and topics.</p>
<p>(&#8230;)</p>
<p>3) Google Local Business</p>
<p>What it is: An add-on to the Google Maps feature that allows a small law firm or other business to upload a short blurb about its firm and coordinate contact information into a Google search. If a potential client wants a medical-malpractice attorney in Beverly, for example, he could search those terms and find information about your firm and other relevant ones.</p>
<p>(&#8230;)</p></blockquote>
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			<media:title type="html">Matt Jerzyk</media:title>
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		<title>Federal Prosecutor Gerard Sullivan Agrees to Plea Deal in Traffic Court</title>
		<link>http://rijustice.wordpress.com/2010/01/05/federal-prosecutor-gerard-sullivan-agrees-to-plea-deal/</link>
		<comments>http://rijustice.wordpress.com/2010/01/05/federal-prosecutor-gerard-sullivan-agrees-to-plea-deal/#comments</comments>
		<pubDate>Tue, 05 Jan 2010 18:08:08 +0000</pubDate>
		<dc:creator>Matt Jerzyk</dc:creator>
				<category><![CDATA[RI Courts]]></category>
		<category><![CDATA[RI Crime]]></category>
		<category><![CDATA[RI Politics]]></category>
		<category><![CDATA[dui]]></category>
		<category><![CDATA[Patrick Lynch]]></category>
		<category><![CDATA[Peter Neronha]]></category>
		<category><![CDATA[Providence Journal]]></category>
		<category><![CDATA[RI Superior Court]]></category>
		<category><![CDATA[ri traffic court]]></category>
		<category><![CDATA[US Attorney]]></category>

		<guid isPermaLink="false">http://rijustice.wordpress.com/?p=1022</guid>
		<description><![CDATA[The Providence Journal reports that federal prosecutor Gerard B. Sullivan agreed to a plea deal in which he admitted that he refused to submit to a chemical breath test when the Warwick police arrested him Thanksgiving morning under suspicion of driving under the influence of alcohol and the attorney general’s office agreed to drop two [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=rijustice.wordpress.com&blog=6838216&post=1022&subd=rijustice&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p><a href="http://www.projo.com/news/content/SULLIVAN_ADMITS_REFUSAL_01-05-10_8OH0G0E_v8.36f3741.html"><strong>The Providence Journal reports</strong></a> that federal prosecutor Gerard B. Sullivan agreed to a plea deal in which he admitted that he refused to submit to a chemical breath test when the Warwick police arrested him Thanksgiving morning under suspicion of driving under the influence of alcohol and the attorney general’s office agreed to drop two other motor-vehicle violations he was charged with the night he was arrested: not abiding by a laned roadway and not using a turn signal.</p>
<blockquote><p>As part of the plea agreement, Sullivan’s driver’s license will be suspended for seven months, from the time he surrendered it on Dec. 22. Magistrate Domenic A. DiSandro III had ordered Sullivan to turn over his license when he was in court Dec. 18.</p>
<p>Sullivan appeared at the Traffic Tribunal with his lawyer, Kevin J. Bristow, who told DiSandro that Sullivan is enrolled in an alcohol-treatment program. Because of that program, DiSandro did not order Sullivan to attend the safe-driving school that other motorists must enroll in when faced with a similar charge.</p>
<p>DiSandro also ordered Sullivan to perform 40 hours of public community service and to pay fines and fees totaling $1,135.</p>
<p>Sullivan was one of eight people charged by the Warwick police over Thanksgiving weekend with refusing to submit to a chemical breath test, a motor-vehicle violation. He was the only one of those eight who was not also charged with driving under the influence of alcohol or drugs, a criminal misdemeanor.</p>
<p>Sullivan was later charged with driving under the influence after The Journal and Warwick Police Chief Stephen M. McCartney reviewed the arrest reports for all eight drivers suspected of drunken driving Thanksgiving weekend. McCartney, who did not know Sullivan had been arrested until The Journal called him after the holiday weekend, has launched an internal review.</p></blockquote>
<p>While this civil matter has closed, <a href="http://newsblog.projo.com/2010/01/prosecutor-seeks-dismissal-of.html"><strong>the criminal case against Sullivan is still pending</strong></a>.</p>
<blockquote><p>Federal prosecutor Gerard B. Sullivan on Tuesday sought dismissal in District Court of a charge of driving while under the influence of alcohol.</p>
<p>Sullivan, an assistant U.S. attorney, a day earlier had <a href="http://newsblog.projo.com/2010/01/prosecutor-admits-to-facts-of.html">admitted in state traffic court that he failed to take a chemical breath test</a> when arrested on Thanksgiving by the Warwick police.</p>
<p>Sullivan sat in the front row during Tuesday&#8217;s District Court appearance as a city prosecutor and Sullivan&#8217;s lawyer, Kevin J. Bristow, approached the bench three times to discuss the case in subdued whispers.</p>
<p>Shortly after noon, the first public comment about the case came from Judge Frank J. Cenerini, who said the case has been continued until Monday at the request of both sides.</p></blockquote>
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			<media:title type="html">Matt Jerzyk</media:title>
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		<title>Closing the Justice Gap for Pro Se Litigants</title>
		<link>http://rijustice.wordpress.com/2010/01/03/closing-the-justice-gap-for-pro-se-litigants/</link>
		<comments>http://rijustice.wordpress.com/2010/01/03/closing-the-justice-gap-for-pro-se-litigants/#comments</comments>
		<pubDate>Sun, 03 Jan 2010 16:01:02 +0000</pubDate>
		<dc:creator>Matt Jerzyk</dc:creator>
				<category><![CDATA[National Civil Rights]]></category>
		<category><![CDATA[National Courts]]></category>
		<category><![CDATA[Civil Liberties]]></category>
		<category><![CDATA[Civil Rights]]></category>
		<category><![CDATA[pro se]]></category>
		<category><![CDATA[right to counsel]]></category>

		<guid isPermaLink="false">http://rijustice.wordpress.com/?p=1019</guid>
		<description><![CDATA[The New Hampshire Chief Justice, John T. Broderick Jr., and the California Chief Justice, Ronald M. George, offer a compelling Opinion piece in the New York Times in regards to the growing number of pro se litigants in the legal system:
As the economy has worsened, the ranks of the self-represented poor have expanded. In a [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=rijustice.wordpress.com&blog=6838216&post=1019&subd=rijustice&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>The New Hampshire Chief Justice, John T. Broderick Jr., and the California Chief Justice, Ronald M. George, offer <a href="http://www.nytimes.com/2010/01/02/opinion/02broderick.html?hp"><strong>a compelling Opinion piece in the New York Times</strong></a> in regards to the growing number of pro se litigants in the legal system:</p>
<blockquote><p>As the economy has worsened, the ranks of the self-represented poor have expanded. In a recent informal study conducted by the Self-Represented Litigation Network, about half the judges who responded reported a greater number of pro se litigants as a result of the economic crisis. Unrepresented litigants now also include many in the middle class and small-business owners who unexpectedly find themselves in distress and without sufficient resources to pay for the legal assistance they need.</p>
<p>As judges, we believe more needs to be done to meet this growing challenge: an inaccessible, overburdened justice system serves none of us well. California took a major step forward in October when it became the first state to recognize as a goal the right to counsel in certain civil cases. (The state also committed to a pilot project, financed by court fees, to provide lawyers for low-income citizens in cases where basic human needs are at stake.)</p>
<p>But this is only a beginning. It is essential that we promote other efforts to close the “justice gap.”</p>
<p>One such effort involves the “unbundling” of legal services. Forty-one states, including California and New Hampshire, have adopted a model rule drafted by the American Bar Association, or similar provisions, which allow lawyers to unbundle their services and take only part of a case, a cost-saving practice known as “limited-scope representation” that, with proper ethical safeguards, is responsive to new realities.</p></blockquote>
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			<media:title type="html">Matt Jerzyk</media:title>
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		<title>First Circuit Overturns Exclusion of Expert Witness</title>
		<link>http://rijustice.wordpress.com/2009/12/31/first-circuit-overturns-exclusion-of-expert-witness/</link>
		<comments>http://rijustice.wordpress.com/2009/12/31/first-circuit-overturns-exclusion-of-expert-witness/#comments</comments>
		<pubDate>Thu, 31 Dec 2009 17:26:10 +0000</pubDate>
		<dc:creator>Matt Jerzyk</dc:creator>
				<category><![CDATA[First Circuit]]></category>
		<category><![CDATA[1st Circuit]]></category>
		<category><![CDATA[expert disclosure]]></category>
		<category><![CDATA[expert opinion]]></category>
		<category><![CDATA[experts]]></category>
		<category><![CDATA[judge jeffrey howard]]></category>
		<category><![CDATA[Judge William Smith]]></category>
		<category><![CDATA[product liability]]></category>

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		<description><![CDATA[In the case of Robert Esposito v. Home Depot U.S.A, Inc. et. al., the First Circuit overturned the District Court&#8217;s discovery sanction of excluding the plaintiff&#8217;s expert witness.  Judge Jeffrey R. Howard wrote the opinion for the three judge panel:
Here, the district court was undoubtedly entitled to impose some type of sanction on Esposito. Esposito [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=rijustice.wordpress.com&blog=6838216&post=1015&subd=rijustice&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>In the case of <a href="http://www.ca1.uscourts.gov/cgi-bin/getopn.pl?OPINION=08-2115P.01A"><strong>Robert Esposito v. Home Depot U.S.A, Inc. et. al.</strong></a>, the First Circuit overturned the District Court&#8217;s discovery sanction of excluding the plaintiff&#8217;s expert witness.  <a href="http://www.ca1.uscourts.gov/cgi-bin/getopn.pl?OPINION=08-2115P.01A"><strong>Judge Jeffrey R. Howard wrote the opinion</strong></a> for the three judge panel:</p>
<blockquote><p>Here, the district court was undoubtedly entitled to impose some type of sanction on Esposito. Esposito failed to comply with a court-imposed deadline that he himself had suggested, and he could not offer a legitimate justification for his non-compliance. And despite Esposito&#8217;s argument that the appearance of his expert at the inspection of the saw constituted an &#8220;informal disclosure,&#8221; the rules require formal disclosure for a reason: without it, parties like the defendants in this case may be hindered in their ability to prepare effectively for trial. See Fed. R. Civ. P. 26 (a)(2)(B) (establishing that, &#8220;[u]nless otherwise stipulated or ordered by the court,&#8221; the formal disclosure of an expert &#8220;must be accompanied by a written report&#8221; that contains a host of information relevant to the expert&#8217;s testimony).</p>
<p>Nevertheless, whether the facts here justified the actual sanction imposed &#8212; the preclusion of the expert witness &#8212; is a closer question.  We start by stating the obvious.  The sanction here had serious consequences.  Esposito&#8217;s need for the expert was so great that the magistrate judge&#8217;s decision to preclude the expert, although technically not a dismissal of Esposito&#8217;s case, effectively amounted to one.  See Primus v. United States, 389 F.3d 231, 234 (1st Cir. 2004).  The district court acknowledged as much when it affirmed the magistrate judge&#8217;s imposition of the sanction, observing that &#8220;Both of the parties acknowledge that the decision to exclude the Plaintiff&#8217;s expert as a result of missing the discovery deadlines will, without much doubt, effectively dispose of the case.&#8221;</p>
<p>Because all parties acknowledged that the sanction carried the force of a dismissal, the justification for it must be comparatively more robust.  Young v. Gordon 330 F.3d 76, 81 (1st Cir. 2003) (&#8220;To be sure, dismissal ordinarily should be employed as a sanction only when a plaintiff&#8217;s misconduct is extreme.&#8221;); Tower Ventures, Inc. v. City of Westfield, 296 F.3d 43, 46 (1st Cir. 2002) (recognizing that dismissal should not be granted &#8220;casually&#8221;).  After considering the other relevant factors described above, we conclude that the circumstances here do not justify such strong medicine.</p></blockquote>
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			<media:title type="html">Matt Jerzyk</media:title>
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		<title>Justice for Eric Frimpong</title>
		<link>http://rijustice.wordpress.com/2009/12/30/justice-for-eric-frimpong/</link>
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		<pubDate>Wed, 30 Dec 2009 15:47:44 +0000</pubDate>
		<dc:creator>Matt Jerzyk</dc:creator>
				<category><![CDATA[National Civil Rights]]></category>
		<category><![CDATA[National Courts]]></category>
		<category><![CDATA[criminal justice]]></category>
		<category><![CDATA[Eric Frimpong]]></category>
		<category><![CDATA[sports]]></category>
		<category><![CDATA[Wrongful Convictions]]></category>

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		<description><![CDATA[Will the Appeals Court agree with Joel Engel?  I hope so.
After spending much of the last two years researching the 2007 trial of Eric Frimpong for rape, journalist and author Joel Engel believes that the former UCSB soccer player was wrongly convicted. This article is the result of the 6,000 hours of unpaid research he [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=rijustice.wordpress.com&blog=6838216&post=1011&subd=rijustice&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p><img class="alignright" src="http://ericfrimpong.files.wordpress.com/2008/01/youngjustice1.jpg?w=245&amp;h=365&#038;h=365" alt="Eric Frimpong" width="245" height="365" />Will the Appeals Court agree <a href="http://www.independent.com/news/2009/dec/30/exonerating-eric-frimpong/"><strong>with Joel Engel</strong></a>?  I hope so.</p>
<blockquote><p><em>After spending much of the last two years researching the 2007 trial of Eric Frimpong for rape, journalist and author Joel Engel believes that the former UCSB soccer player was wrongly convicted. This article is the result of the 6,000 hours of unpaid research he and his uncle did for Frimpong’s appellate team, and represents solely his opinions on the matter. Frimpong’s case is currently under appeal, and a decision is expected soon.</em></p>
<p>I used to think that even bad cops lied only about the worst bad guys. I believed most prosecutors tried only defendants they considered guilty beyond reasonable doubt. And I assumed that highly paid defense attorneys, aware that someone’s freedom was at stake, carefully prepared their cases before walking into court.</p>
<p>Then I met Eric Frimpong.</p></blockquote>
<div>
<div>
<p>Six years in state prison.  Remember that’s six more years than the Duke players got.  Of course, in this case, a black man is accused of raping a white woman with an all white jury.</p>
<p>I urge you to visit <a href="http://ericfrimpong.wordpress.com/"><strong>the Eric Frimpong Freedom Fund</strong></a> and read his story.  And donate.  And forward this site onto your friends. Justice denied is never stopped without the will of the people making it so.</p>
<p>Also, you can join me in <a href="http://blog.objectivo.com/eric-frimpong-soccer-t-shirt-caritable-design/"><strong>buying a t-shirt in support of Eric Frimpong</strong></a>.  Every single dollar from the sale will go to the Frimpong Freedom Fund.  <a href="http://blog.objectivo.com/eric-frimpong-soccer-t-shirt-caritable-design/"><strong>Click here</strong></a> to buy.</p>
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			<media:title type="html">Matt Jerzyk</media:title>
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		<title>Studies Question FDA Approvals of Cardiac Devices</title>
		<link>http://rijustice.wordpress.com/2009/12/30/studies-question-fda-approvals-of-cardiac-devices/</link>
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		<pubDate>Wed, 30 Dec 2009 14:37:28 +0000</pubDate>
		<dc:creator>Matt Jerzyk</dc:creator>
				<category><![CDATA[health care]]></category>
		<category><![CDATA[medical malpractice]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[medical negligence]]></category>
		<category><![CDATA[Product safety]]></category>
		<category><![CDATA[products liability]]></category>

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		<description><![CDATA[The New York Times reports that two studies have &#8220;found shortcomings in some clinical trials accepted by the FDA over the last decade in connection with the approval of high-risk cardiovascular devices,&#8221; such as &#8220;pacemakers, implanted defibrillators, and&#8230;coronary stents.&#8221;  For its part, the FDA said it &#8220;is developing guidelines that will set tougher scientific [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=rijustice.wordpress.com&blog=6838216&post=1009&subd=rijustice&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>The <strong><a href="http://mailview.custombriefings.com/mailview.aspx?m=2009123001aaj&amp;r=4309631-1b68&amp;l=001-bdd&amp;t=c" target="_blank"><span style="text-decoration:underline;">New York Times reports</span></a></strong> that two studies have &#8220;found shortcomings in some clinical trials accepted by the FDA over the last decade in connection with the approval of high-risk cardiovascular devices,&#8221; such as &#8220;pacemakers, implanted defibrillators, and&#8230;coronary stents.&#8221;  For its part, <a href="http://www.fda.gov/"><strong>the FDA</strong></a> said it &#8220;is developing guidelines that will set tougher scientific standards for data from tests on humans&#8221; that medical device makers submit.</p>
<p>The <strong><a href="http://mailview.custombriefings.com/mailview.aspx?m=2009123001aaj&amp;r=4309631-1b68&amp;l=002-0fe&amp;t=c" target="_blank"><span style="text-decoration:underline;">first study</span></a></strong>, published in the December issue of the Journal of the American Medical Association (JAMA), showed that many cardiovascular devices are not subjected to rigorous safety and effectiveness research before being approved for use and that &#8220;it&#8217;s common for such devices to receive&#8230;approval based on information from only a single study, which raises questions about the quality of data on which some cardiovascular device approvals are based.&#8221;</p>
<p>Meanwhile, a second study appearing in the American Journal of Therapeutics, co-authored by a medical reviewer from the FDA&#8217;s cardiovascular device division, found that studies submitted for approval of cardiovascular devices often lack important information, including details on the studies&#8217; participants.  The <strong><a href="http://mailview.custombriefings.com/mailview.aspx?m=2009123001aaj&amp;r=4309631-1b68&amp;l=005-742&amp;t=c" target="_blank"><span style="text-decoration:underline;">Associated Press reports</span></a></strong> that the second study &#8220;found about 40 percent of pivotal studies lacked precise targets for how safety would be measured,&#8221; and researchers &#8220;failed to fully account for what happened to all patients enrolled in the research.&#8221;</p>
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