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	<title>CPhTLink.com &#187; law suit</title>
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		<title>Ruling could spur tougher drug warnings</title>
		<link>http://cphtlink.com/2009/03/06/ruling-could-spur-tougher-drug-warnings/</link>
		<comments>http://cphtlink.com/2009/03/06/ruling-could-spur-tougher-drug-warnings/#comments</comments>
		<pubDate>Fri, 06 Mar 2009 14:09:34 +0000</pubDate>
		<dc:creator>Fred</dc:creator>
				<category><![CDATA[Drugs]]></category>
		<category><![CDATA[drug warnings]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[law suit]]></category>

		<guid isPermaLink="false">http://cphtlink.com/?p=1136</guid>
		<description><![CDATA[(Todd Wallack &#8211; The Boston Globe) Bay State pharmaceutical companies could decide to strengthen safety warnings on their products after Wednesday&#8217;s Supreme Court ruling made it easier for patients to sue drug makers for injuries. But overall, the ruling drew surprisingly little reaction from biotechnology companies and industry groups.
In a closely watched case, the court [...]]]></description>
			<content:encoded><![CDATA[<p>(Todd Wallack &#8211; <a href="http://www.boston.com/bostonglobe">The Boston Globe</a>) Bay State pharmaceutical companies could decide to strengthen safety warnings on their products after Wednesday&#8217;s Supreme Court ruling made it easier for patients to sue drug makers for injuries. But overall, the ruling drew surprisingly little reaction from biotechnology companies and industry groups.<span id="more-1136"></span></p>
<p>In a closely watched case, the court ruled 6-3 that patients can file lawsuits against drug companies in state courts for inadequate or flawed safety warnings, even though the Food and Drug Administration is responsible for reviewing and approving drug labels.</p>
<p>The case involved a Vermont musician who lost her right forearm after she suffered complications from a drug made by Wyeth. A jury awarded her $6.7 million.</p>
<p>Wyeth unsuccessfully argued she had no right to sue because the FDA had approved the label.</p>
<p>It&#8217;s unclear whether the ruling will hurt the Boston area&#8217;s biotechnology industry, which is considered key to the state&#8217;s economic growth.</p>
<p>David Ferrera, a partner with the Boston law firm Nutter McClennen &amp; Fish, said the ruling would almost certainly spur drug companies to include lengthier safety warnings on their drug labels &#8211; citing even the rarest of potential side effects &#8211; to shield themselves from liability.</p>
<p>The FDA would still have to approve such changes.</p>
<p>If that happens, industry advocates warn, it could further complicate drug labels, making them harder for doctors to understand and potentially scaring off patients who could benefit from such therapies.</p>
<p>But some consumer advocates have long complained that drug companies and the FDA haven&#8217;t done enough to warn patients about potential side effects.</p>
<p>Overall, Ferrera predicted, the ruling probably would have little impact because the justices simply upheld a lower court&#8217;s judgment.</p>
<p>In addition, Ferrera said, such suits had already been permitted in many states for decades, even though the drug industry has hoped the court would put an end to such litigation.</p>
<p>Diane Bieri, chief counsel for Pharmaceutical Research and Manufacturers of America, the industry&#8217;s main trade group, said companies might decide to update their drug labels more frequently to limit exposure to lawsuits. But Bieri said she wasn&#8217;t sure whether drug makers would make any other changes, such as issuing more safety warnings.</p>
<p>&#8220;I think it&#8217;s too soon to tell how companies will respond to the ruling,&#8221; Bieri said. &#8220;Like PhRMA, they are still reviewing the ruling.&#8221;</p>
<p>For now, Bieri said, the ruling is likely to introduce some uncertainty as companies try to figure out exactly what it means.</p>
<p>Boston-area companies had a muted reaction.</p>
<p>Genzyme Corp. and Biogen Idec Inc., the state&#8217;s largest biotechs, and both based in Cambridge, declined to comment. EMD Serono Inc. in Rockland, another major player, did not return a call seeking comment.</p>
<p>And two key trade groups, the Massachusetts Biotechnology Council and the national Biotechnology Industry Organization, declined to comment.</p>
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