Pre-emption Issue Weighed in Label Cases ....antidepressants

Pre-emption Issue Weighed in Label Cases ....antidepressants

Joined: April 1st, 2004, 4:56 pm

December 27th, 2007, 10:23 pm #1

<H1 class=headline>Pre-emption Issue Weighed in Label Cases</H1><!-- headline --><!-- img src="http://www.law.com/img/universal/spacers/blank.gif" height="10">
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<H3 class=subheadline>3rd Circuit hears arguments on antidepressant warnings</H3>
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<P class=byline>Shannon P. Duffy
<A class=source href="http://www.law.com/pa">The Legal Intelligencer</A>
December 14, 2007
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In two appeals that could have a huge impact on the litigation of drug product liability cases, the 3rd U.S. Circuit Court of Appeals heard arguments this week on the issue of whether plaintiffs should be pre-empted from suing over allegedly inadequate warnings on prescription drugs because the warning labels were approved by the Food & Drug Administration.

Lower court judges have reached <A class=linelink href="http://www.law.com/jsp/article.jsp?id=1178183076770" target=new>opposite conclusions</A>, with U.S. District Judge Michael M. Baylson in the Eastern District of Pennsylvania holding that such claims are pre-empted, and U.S. District Judge Jerome B. Simandle in the District of New Jersey holding that they are not.

Both cases stem from suicides in which the plaintiffs claim that manufacturers of antidepressant drugs failed to warn of the increased risk of suicide.

In Colacicco v. Apotex Inc., Baylson found that the plaintiffs' state law tort claims are pre-empted because Congress granted control to the FDA to regulate the prescription drug industry, including the authority to regulate "the specifics of drug labeling."

But in McNellis v. Pfizer Inc., Simandle concluded that a state tort claim was not pre-empted because the FDA's regulations "empower drug manufacturers to enhance the labeling warnings beyond the approved text when new risks emerge."

In nearly two hours of oral argument on Monday, the three-judge panel appeared inclined to rule in favor of the drug manufacturers on the grounds that the FDA has explicitly rejected the plaintiffs' proposed warnings for Paxil, Zoloft and Prozac -- antidepressant drugs known as "selective serotonin re-uptake inhibitors," or SSRIs.

Six lawyers presented arguments, including a Justice Department lawyer arguing for the FDA who urged the court to side with Baylson and hold that such claims are pre-empted.

Arguing for the plaintiff in the Colacicco case, attorney Derek T. Braslow of Pogust & Braslow in Conshohocken, Pa., told the court that Baylson should be reversed because the FDA's regulatory process does not conflict with a state law tort claim that accuses a manufacturer of failing to add to its warnings when it gets new information that shows an increased risk.

But Braslow was soon peppered with questions from all three judges -- 3rd Circuit Judges Dolores K. Sloviter and Thomas L. Ambro and visiting Judge Jane A. Restani of the U.S. Court of International Trade.

Restani asked if there were an "actual conflict" because the FDA has specifically rejected proposals to add suicide warnings to SSRIs.

Braslow insisted there was not because the manufacturers control the process of negotiating with the FDA on labels and never told the agency of the suicide risks it had discovered.

Under the FDA's own rules, Braslow said, a manufacturer is required to enhance its warnings whenever it discovers a risk that is not yet on the label.

In the case of Paxil, Braslow said, the FDA never told GlaxoSmithKline or the generic manufacturer, Apotex, that it was not required to strengthen the warnings.

Sloviter disagreed, saying "the FDA said more than that" by telling the manufacturers that it did not want the approved SSRI labels changed "because it will confuse people. ... People who might get help from the drugs won't take them if you put too many warnings on them."

"Why isn't that a conflict?" Sloviter asked.

But Braslow insisted that the information in the hands of the manufacturers was never passed on to the FDA and that the agency's decision about the warnings on the labels therefore did not conflict with a state law tort claim that accused the manufacturers of ignoring that risk.

Attorney Sol H. Weiss of Anapol Schwartz Weiss Cohan Feldman & Smalley, arguing for the plaintiff in the McNellis case, said that the FDA's decision is not entitled to deference because the agency conducts no clinical trials of its own and instead relies on the manufacturers to supply all of the evidence that supports its decisions.

Attorney Charles Becker, arguing for the Pennsylvania Association for Justice, formerly known as the Pennsylvania Trial Lawyers Association, said that the tort system is an "important and necessary adjunct to the regulatory process" and that, until recently, the FDA has always agreed with that premise and taken the position that drug products liability suits are not pre-empted.

Ambro asked Becker if the FDA should be accorded significant deference because of its "unique expertise."

But Becker said the FDA should not be allowed to dictate to the courts on an issue of constitutional law, and that the agency's current position should be rejected because it directly conflicts with the regulations -- which allow manufacturers to enhance warnings -- and because the FDA has been inconsistent on the issue of whether such suits are pre-empted.

GlaxoSmithKline's lawyer, Chilton D. Varner of King & Spalding, urged the court to uphold Baylson's ruling on the grounds that the FDA "has watched this issue ... over 16 years" and has specifically ruled that suicide warnings should not be added to SSRIs.

"When a federal agency -- the expert scientific federal agency to whom Congress has delegated authority to make certain that prescription drug labeling renders that drug safe and effective -- says you can't do it, and the plaintiff wants a state jury to say you can be liable because you didn't do it, that is just an irrevocable conflict," Varner argued.

When pressed by Ambro to articulate the specific conflict that should result in pre-emption, Varner said "a warning that has been declared adequate under federal law cannot be declared inadequate under state law."

Justice Department attorney Sharon Swingle told the judges that, in the case of SSRIs, the FDA's decisions about warning labels should be read as establishing both a "floor" and a "ceiling" and that the plaintiffs' claims were effectively demanding that the manufacturers violate that rule.

If the manufacturers had done what the plaintiffs asked, Swingle said, their drugs would have been deemed "mislabeled."

Swingle also said the Colacicco claim was flawed because the plaintiff in that case took a generic version of the drug and was demanding that a generic manufacturer alter the label that was taken from the brand-name drug -- something FDA regulations do not allow.

But Braslow argued that Swingle's description of the regulations was flawed and that both generic and brand-name manufacturers have an affirmative duty to enhance their warning labels when evidence exists of a risk that is not included on the FDA-approved version of the label.

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Joined: April 1st, 2004, 4:56 pm

December 27th, 2007, 10:24 pm #2


In Colacicco v. Apotex Inc., Baylson found that the plaintiffs' state law tort claims are pre-empted because Congress granted control to the FDA to regulate the prescription drug industry, including the authority to regulate "the specifics of drug labeling."
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Joined: April 1st, 2004, 4:56 pm

December 27th, 2007, 10:25 pm #3


But in McNellis v. Pfizer Inc., Simandle concluded that a state tort claim was not pre-empted because the FDA's regulations "empower drug manufacturers to enhance the labeling warnings beyond the approved text when new risks emerge."

In nearly two hours of oral argument on Monday, the three-judge panel appeared inclined to rule in favor of the drug manufacturers on the grounds that the FDA has explicitly rejected the plaintiffs' proposed warnings for Paxil, Zoloft and Prozac -- antidepressant drugs known as "selective serotonin re-uptake inhibitors," or SSRIs.

Six lawyers presented arguments, including a Justice Department lawyer arguing for the FDA who urged the court to side with Baylson and hold that such claims are pre-empted.
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Joined: January 1st, 1970, 12:00 am

December 28th, 2007, 1:39 pm #4

<A title="Permanent Link to White House Backs Preemption In Wyeth Case" href="http://www.pharmalot.com/2007/12/white-house-backs-preemption-in-wyeth-case/" rel=bookmark><FONT color=#3e7938>White House Backs Preemption In Wyeth Case</FONT></A>

<DIV class=entry><!-- sphereit start -->
<A title=supremecourt2.jpg href="http://www.pharmalot.com/wp-content/uploads/2007/12/supremecourt2.jpg"><IMG class="imageframe imgalignleft" height=150 alt=supremecourt2.jpg src="http://www.pharmalot.com/wp-content/uploads/2007/12/supremecourt2.jpg" width=113></A>Once again, the US Solicitor General has lined up in support of preemption, a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a controversial notion that is now making its way to the US Supreme Court.

In a related action, the Bush administration recently told the Supremes that FDA-approved medical devices are shielded from product-liability lawsuits in state courts. That position backs Medtronic in a case that has broad implications for devices makers. Unlike medical devices, however, there is no statute providing for preemption for drugs.

Nonetheless, drugmakers and the FDA argue that premption does, indeed, exist by maintaining that the agency’s actions are the final word on safety and effectiveness. The issue has become so contentious that the Supreme Court will, in fact, review a preemption case involving the Rezulin diabetes drug in February. For this reason, the Solicitor General’s brief in a case involving a Wyeth drug was widely anticipated.

And in its latest opinion sent to the Supreme Court (<A title=sg-wyeth-levine.pdf href="http://www.pharmalot.com/wp-content/uploads/2007/12/sg-wyeth-levine.pdf"><FONT color=#3e7938>here it is</FONT></A>), the Solicitor General disagrees with a ruling by a lower court - in this instance, the Vermont Supreme Court - that supported a patient’s right to sue Wyeth over the labeling for Phenergan, an injectable drug. Diana Levine, a professional musician, went to the hospital for treatment of a headache and, after being injected, was left with injuries that led to the amputation of her right arm.

<A id=more-11059></A>

Levine successfully argued that, even though the Phenergan labeling complied with FDA requirements, the adequacy of the warning still wasn’t established. Moreover, Levine’s attorneys contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine, by the way, was awarded more than $6 million.

The Solicitor General, however, sides with Wyeth. “If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval, based on information that was previously available to FDA, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted,” the Solicitor General writes.

Nonetheless, the Solicitor General recommends that the Supremes hold off on granting Wyeth’s request to hear the case until the <STRONG>Medtronic and Rezulin cases are decided</STRONG>.

Hat tip to <FONT color=#3e7938>Drug and Device Law</FONT>
</DIV></SPAN>
Last edited by peagee on December 28th, 2007, 1:59 pm, edited 1 time in total.
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December 28th, 2007, 1:47 pm #5


One of the comments beneath the pharmalot article which (if the poster is correct) explains a bit more:

http://www.pharmalot.com/2007/12/white- ... yeth-case/

"... As the DDL guys agree, the Wyeth case is “the big one” as far as FDA labeling preempting all failure-to-warn claims in the drug arena are concerned.

<DIV class=commenttext>
In case there’s any uncertainty, “state law,” in this context, mainly means the right to bring suit against a drug company for failure to warn.

So the preemption argument is premised on the notion that FDA labeling is sufficient to trump whatever else may turn out to be true - delay in reporting, spinning reporting, cat-and-mouse reporting, warning letters over “false and misleading” info dispensed (”cardio cards” etc.), suppressed internal studies, camoflaged reporting intimidating researchers, changing endpoints after the fact, etc.: All the kinds of behavior that now figure into a company’s potential liability - would be irrelevant.

Instead, a company would be fully shielded, with the possible exception of felony fraud, which the DOJ would have have to take upon itself to (a) discover (which usually happens through whistleblowers) and (b) prosecute (almost always settled beforehand). So, as far as a day in court for legitimate claims - Sayonara.

Below is the relevant section of the FDCA about which there is debate re: whether a company can take it upon itself to issue a warning prior to a formal FDA labeling change [my emphases].

Preemptors find a hundred ways to say it doesn’t say what it clearly says {”depends what ‘is’ is,” etc.). Anyone see any ambiguity?

21 USC 201.57 (e) Warnings. Under this section of the section heading, the labeling
shall describe serious adverse reactions and potential safety hazards, limitations in
use imposed by them, and steps that should be taken if they occur. The labeling shall
be revised to include a warning _as soon as there is reasonable evidence of an association
of a serious hazard with a drug_; a causal relationship need not have been proved.

21 USC 314.70 (c) Supplements for changes (in labeling) that may be made _before_ FDA approval “Special Supplement-Changes Being Effected.”. . . (2) changes labeling to accomplish any of the following:

(i) to add or strengthen a contraindication, warning, precaution, or adverse reaction;

(ii) to add or strengthen a statement about drug abuse, dependence, or over-dosage;
Or

(iii) to add or strengthen an instruction about dosage and administration that is
intended to increase the safe use of the product;

(iv) to delete false, misleading, or unsupported indications for use or claims for
effectiveness."
</DIV>
Last edited by peagee on December 28th, 2007, 1:48 pm, edited 1 time in total.
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Joined: January 1st, 1970, 12:00 am

December 28th, 2007, 2:05 pm #6


Same poster in a further comment:

"...If FDA preemption is upheld, <STRONG>there will be no civil liability for “failure-to-warn” in any court, state or feder</STRONG>al. I know - it’s hard to believe, given what we have taken for granted as the justice system.

There would probably be some version of a “fraud exception,” but - for reasons I won’t bore you with (unless you ask) - it would be de facto meaningless.

The most one could anticipate as far as compensation in a very large case (larger than anything we’ve ever seen) might be some version of the way the asbestos litigation was finally worked out. But that is entirely speculative on my part."
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December 28th, 2007, 2:49 pm #7

<A title="Permanent Link to White House Backs Preemption In Wyeth Case" href="http://www.pharmalot.com/2007/12/white-house-backs-preemption-in-wyeth-case/" rel=bookmark><FONT color=#3e7938>White House Backs Preemption In Wyeth Case</FONT></A>

<DIV class=entry><!-- sphereit start -->
<A title=supremecourt2.jpg href="http://www.pharmalot.com/wp-content/uploads/2007/12/supremecourt2.jpg"><IMG class="imageframe imgalignleft" height=150 alt=supremecourt2.jpg src="http://www.pharmalot.com/wp-content/uploads/2007/12/supremecourt2.jpg" width=113></A>Once again, the US Solicitor General has lined up in support of preemption, a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a controversial notion that is now making its way to the US Supreme Court.

In a related action, the Bush administration recently told the Supremes that FDA-approved medical devices are shielded from product-liability lawsuits in state courts. That position backs Medtronic in a case that has broad implications for devices makers. Unlike medical devices, however, there is no statute providing for preemption for drugs.

Nonetheless, drugmakers and the FDA argue that premption does, indeed, exist by maintaining that the agency’s actions are the final word on safety and effectiveness. The issue has become so contentious that the Supreme Court will, in fact, review a preemption case involving the Rezulin diabetes drug in February. For this reason, the Solicitor General’s brief in a case involving a Wyeth drug was widely anticipated.

And in its latest opinion sent to the Supreme Court (<A title=sg-wyeth-levine.pdf href="http://www.pharmalot.com/wp-content/uploads/2007/12/sg-wyeth-levine.pdf"><FONT color=#3e7938>here it is</FONT></A>), the Solicitor General disagrees with a ruling by a lower court - in this instance, the Vermont Supreme Court - that supported a patient’s right to sue Wyeth over the labeling for Phenergan, an injectable drug. Diana Levine, a professional musician, went to the hospital for treatment of a headache and, after being injected, was left with injuries that led to the amputation of her right arm.

<A id=more-11059></A>

Levine successfully argued that, even though the Phenergan labeling complied with FDA requirements, the adequacy of the warning still wasn’t established. Moreover, Levine’s attorneys contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine, by the way, was awarded more than $6 million.

The Solicitor General, however, sides with Wyeth. “If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval, based on information that was previously available to FDA, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted,” the Solicitor General writes.

Nonetheless, the Solicitor General recommends that the Supremes hold off on granting Wyeth’s request to hear the case until the <STRONG>Medtronic and Rezulin cases are decided</STRONG>.

Hat tip to <FONT color=#3e7938>Drug and Device Law</FONT>
</DIV></SPAN>
(Dated Dec 8th)

http://druganddevicelaw.blogspot.com/2007/12/supreme-courts-preemption-trilogy.html

<DIV class=post><A name=3963802557007912316></A>
<H3 class=post-title>"The Supreme Court's Preemption Trilogy </H3>
<DIV class=post-body>

<DIV style="CLEAR: both"></DIV>There's never been a more interesting time to be a drug and device defense lawyer; this field is hopping. The Supreme Court has granted <EM>certiorari</EM> in two preemption cases, and a third, even bigger, issue is in the pipeline. This is the Supreme Court's preemption trilogy, in chronological order:

<EM>Riegel v. Medtronic</EM>

On Tuesday, December 4, the Supreme Court heard argument in <EM>Riegel v. Medtronic</EM>. The case asks whether product liability claims against manufacturers of medical devices approved by the FDA through the rigorous "pre-market approval" process are barred by the doctrine of express preemption. There's a chance, although remote, that the Court will choose instead to resolve the case based on the doctrine of implied preemption. There's a chance, though again not likely, that the Court will discuss, or analogize to, drug preemption in this device preemption case. But we're most likely to learn only about PMA device preemption.

In terms of timing, no one will be surprised to see a decision in <EM>Riegel</EM> any time after February, and it's essentially a lock that the decision will come down before the Supreme Court recesses for the Summer at the end of June.

For coverage of <EM>Riegel</EM>, see our earliers posts (1) about the death of the plaintiff and the question whether the appeal would survive the associated procedural irregularity (<FONT color=#6699cc>here</FONT>, <FONT color=#6699cc>here</FONT>, and <FONT color=#6699cc>here</FONT>), (2) summarizing the arguments made in the defense briefs and linking to those briefs (<FONT color=#6699cc>here</FONT>), (3) analyzing the Solicitor General's <EM>amicus curiae</EM> brief (<FONT color=#6699cc>here</FONT>), (4) posting the transcript of the oral argument (<FONT color=#6699cc>here</FONT>), and (5) summarizing the oral argument and giving our best guess of where the votes lie based on the Justices questions during oral argument (<FONT color=#6699cc>here</FONT>).

But our coverage is hardly the only game in town.

Roger Parloff, at Fortune's Legal Pad, has <FONT color=#6699cc>posted</FONT> on both the <EM>Riegel</EM> case generally and the weird wrinkle involving the plaintiff's death. The SCOTUS Blog has a "wiki" about the case, inviting the world to add and revise the discussion (<FONT color=#6699cc>here</FONT>). The <FONT color=#6699cc>Mass Tort Litigation Blog</FONT> links to a Federalist Society webcast about the case, in which Richard Epstein speculates that the Court might rule nine to zero in favor of preemption. (If his crystal ball proves accurate, the drinks are on us!) And the Wall Street Journal Law Blog <FONT color=#6699cc>posted</FONT> about the case on the day of argument.

The popular press hasn't missed the party. On-line, we've seen <FONT color=#6699cc>CNBC</FONT>, <FONT color=#6699cc>Bloomberg</FONT>, and a host of others. And we've seen plenty of stories in the <FONT color=#6699cc>print media</FONT>, too.

<EM>Warner-Lambert v. Kent</EM>
<EM></EM>
Next up is <EM>Warner-Lambert v. Kent</EM>. A Michigan statute gives drug manufacturers immunity from product liability lawsuits unless the manufacturer defrauded the FDA. An earlier Supreme Court case, <EM>Buckman v. Plaintiffs' Legal Committee</EM>, held that federal law preempts private parties' claims for fraud on the FDA. Where does that leave the fraud-on-the-FDA exception in the Michigan statute?

There are three main possibilities: (1) federal law does not preempt the fraud-on-the-FDA exception, so the whole Michigan statutory scheme remains intact, (2) federal law preempts only the fraud-on-the-FDA exception, leaving the immunity in place, but eliminating the exception, or (3) the immunity and the exception are so intertwined that federal law preempts the whole schmear, so the whole statutory scheme is thrown out and parties litigate under the existing case law, unchanged by the statute.

Once again, we've been all over this puppy, posting about the grant of <EM>certiorari</EM> (<FONT color=#6699cc>here</FONT>), the implications of the case for states other than Michigan (<FONT color=#6699cc>here</FONT>), how the Supreme Court could use <EM>Kent</EM> to clarify its preemption doctrine more generally (<FONT color=#6699cc>here</FONT>), collecting other news about the case from around the web (<FONT color=#6699cc>here</FONT>), analyzing whether drug companies will be inclined to move their corporate headquarters if the Supreme Court rules in favor of industry (<FONT color=#6699cc>here</FONT>), and analyzing the Solicitor General's <EM>amicus</EM> brief (<FONT color=#6699cc>here</FONT>).

The Supreme Court has not yet set <EM>Warner-Lambert v. Kent</EM> for argument. We expect the case to be argued in relatively early 2008, and we expect a decision in the Spring, but surely no later than the end of June.

<EM><STRONG>Wyeth v. Levine</STRONG></EM>

Last, but not least, the 600-pound gorilla: <EM>Wyeth v. Levine</EM>. <EM>Riegel</EM> affects only PMA-approved medical devices -- about 50 medical devices each year. <EM>Kent</EM> affects only states with statutes granting some kind of immunity subject to a fraud-on-the-FDA exception. That's eight states, and the immunities vary -- from essentially complete immunity from all liability (in Michigan) to limited immunity from liability for failure-to-warn claims (in Texas) to immunity only from punitive damages claims (in New Jersey and elsewhere). That ain't chicken feed, but it ain't the main course, either.

<FONT size=4><STRONG>The main course is <EM>Wyeth v. Levine</EM>: Does federal law displace all product liability claims brought against all manufacturers of prescription drugs?
</STRONG></FONT>
The argument (with which we agree) is that the FDA -- the expert federal agency expressly assigned the task -- judges the safety and efficacy of all prescription drugs and controls the labeling on the drugs. The FDA considers the health of the country as a whole, permitting drugs to be sold where the drugs' benefits outweigh their risks, even though some people will, of course, suffer unfortunate side effects. So long as the drug labeling (which the FDA controls) tells physicians about the risks and benefits of the drug, society benefits if the drug is available with the approved labeling.

Uniform regulation by an expert agency makes sense; having the agency's decisions second-guessed by lay juries, sitting in courtrooms in the presence of injured plaintiffs, does not.

<STRONG><FONT size=4>That issue -- which affects essentially all claims against all drug companies in all 50 states -- is a showstopper.
</FONT></STRONG>
The Supreme Court has not yet decided whether to hear<EM> Wyeth v. Levine.</EM> <FONT color=#6699cc>In May</FONT>, the Court asked the Solicitor General to file an <EM>amicus curiae</EM> brief advising whether the government thinks the Court should accept the case. The SG has not yet filed that brief, but the smart money says we'll see it before the end of this month, which would give the Court time to hear argument in <EM>Levine</EM>, and decide it, this Term (before the end of June 2008). If the Supreme Court grants <EM>cert</EM> in <EM>Wyeth v. Levine</EM>, <EM>Riegel</EM> and <EM>Kent</EM> will look like small potatoes in comparison.

If the Supreme Court does not grant <EM>cert</EM> in<EM> Wyeth v. Levine</EM>, the federal appellate courts (and state supreme courts) will continue to wrestle with the broad drug preemption issue in many pending cases. (<EM>Ackermann v. Wyeth</EM>, argued in the Fifth Circuit last week, and <EM>Colacicco/McNellis, </EM>which will be argued in the Third Circuit on Monday, are just two examples.)

The legal and popular press have not yet focused on <EM>Wyeth v. Levine</EM> and similar cases -- but, when the Supreme Court agrees to decide that issue, <FONT color=#6699cc>katy bar the door</FONT>.

In the meantime, here's Wyeth's <FONT color=#6699cc><EM>cert</EM> petition</FONT> in <EM>Levine</EM> and Levine's <FONT color=#6699cc>brief in opposition</FONT>.
<DIV style="CLEAR: both; PADDING-BOTTOM: 0.25em"></DIV>

</DIV>
<P class=post-footer>posted by Beck/Herrmann at <A title="permanent link" href="http://druganddevicelaw.blogspot.com/2007/12/supreme-courts-preemption-trilogy.html"><FONT color=#666699>10:32 AM</FONT></A> <SPAN class=item-action><A title="Email Post" href="http://www.blogger.com/email-post.g?blogID=36762711&postID=3963802557007912316"><IMG class=icon-action alt="" src="http://www.blogger.com/img/icon18_email.gif"></A></SPAN><SPAN class="item-control blog-admin pid-80142081"><A title="Edit Post" style="BORDER-TOP-STYLE: none; BORDER-RIGHT-STYLE: none; BORDER-LEFT-STYLE: none; BORDER-BOTTOM-STYLE: none" href="http://www.blogger.com/post-edit.g?blogID=36762711&postID=3963802557007912316"><IMG class=icon-action alt="" src="http://www.blogger.com/img/icon18_edit_allbkg.gif"></A></SPAN>
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1 Comments:
  • <LI id=c3010535676399345288><A name=c3010535676399345288></A>
    <DIV class=comment-body>
    This post needs a warning label for drug executives who might read it and get overexcited.

    Not a chance that the Supreme Court will take a case arguing that, reading between the lines of the Food and Drug Act, Congress has prohibited mislabeling suits against drug manufacturers for seventy years, though somehow no one knew it before. Not even the Roberts Court. For one thing, even if they did rule that way, Congress would reinstate the right to sue in a heartbeat.

    Calm down.
    </DIV>
    <P class=comment-data>By <SPAN class="comment-icon blogger-comment-icon" style="LINE-HEIGHT: 16px"><IMG style="DISPLAY: inline" alt=Blogger src="http://www.blogger.com/img/b16-rounded.gif"></SPAN>&nbsp;<FONT color=#6699cc>cartographer</FONT>, at <A title="comment permalink" href="http://druganddevicelaw.blogspot.com/2007/12/supreme-courts-preemption-trilogy.html#c3010535676399345288"><FONT color=#6699cc>7:41 AM</FONT></A> "
    </LI>
</DIV>
Last edited by peagee on December 28th, 2007, 4:29 pm, edited 1 time in total.
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December 28th, 2007, 3:06 pm #8


<EM>"In the meantime, here's Wyeth's </EM><FONT color=#6699cc><EM>cert petition</EM></FONT><EM> in Levine and Levine's </EM><FONT color=#6699cc><EM>brief in opposition</EM></FONT><EM>. "</EM>

From Levine's brief in opposition (pdf file)
<FONT face=TimesNewRoman,Bold>
<P align=left>&nbsp;

<P align=left>"...QUESTION PRESENTED
</FONT><FONT face=TimesNewRoman>
<P align=left>The Vermont Supreme Court below affirmed an award

<P align=left>of compensatory damages to respondent Diana Levine. As the

<P align=left>case comes to this Court, petitioner <STRONG><EM><FONT size=4>Wyeth does not challenge</FONT></EM></STRONG>

<P align=left>that, as a matter of Vermont law, Ms. Levine’s arm was

<P align=left>amputated<STRONG> <FONT size=4><EM>because Wyeth failed to warn</EM></FONT> </STRONG>against using a method

<P align=left>of administering its anti-nausea drug Phenergan that causes

precisely the type of injury that Ms. Levine sustained..."
</FONT>
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Joined: January 1st, 1970, 12:00 am

December 28th, 2007, 3:32 pm #9

&nbsp;
<DD class=profile-data><STRONG>http://druganddevicelaw.blogspot.com/20 ... ilogy.html</STRONG>
<DD class=profile-data><STRONG></STRONG>
<DD class=profile-data><STRONG>"Name:</STRONG> Beck/Herrmann
<P class=profile-textblock><STRONG>JAMES M. BECK is a Counsel resident in the Philadelphia office of Dechert LLP</STRONG>. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He can be reached at james.beck@dechert.com. <STRONG>MARK HERRMANN is a partner resident in the Chicago office of Jones Day</STRONG>. He is the author of, among other things, The Curmudgeon's Guide to Practicing Law (2006), and Statewide Coordinated Proceedings: State Court Analogues to the Federal MDL Process (2d rev. ed. 2004) (with Geoff Ritts and Katherine Larson). He can be reached at [url=mailto:mherrmann@jonesday.com]mherrmann@jonesday.com[/url]."

<P class=profile-textblock>&nbsp;

<P class=profile-textblock>1.&nbsp; <STRONG>Who are Dechert LLP:</STRONG>

<P class=profile-textblock>http://www.dechert.com/library/TheDefen ... st2007.pdf

<P class=profile-textblock>See the last page.&nbsp; Rough summary of the actual words:

<P class=profile-textblock>Dechert has&nbsp;nearly a thousand&nbsp;lawyers in a number of offices in the US <STRONG>and Europe</STRONG>.. it is one of four trial counsel firms for Merck in litigation Vioxx.&nbsp; Dechert scored the first defense verdict for Merck in 2005.

<P class=profile-textblock>&nbsp;

<P class=profile-textblock><STRONG>2.&nbsp; Who are Jones Day?</STRONG>

http://www.jonesday.com/pharmaceuticals/

"...Jones Day’s pharmaceutical team advises participants in the pharmaceutical industry worldwide. The Firm’s clients include multinational pharmaceutical companies, domestic pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, and medical device companies."

"...Jones Day’s approach has enabled its clients to achieve outstanding results. Our recent work includes:
  • Serving as national coordinating counsel <STRONG>defending Wyeth in all product liability claims involving its prescription antidepressant medication, Effexor</STRONG>®.&nbsp;.."

    </LI>
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Last edited by peagee on December 28th, 2007, 4:30 pm, edited 1 time in total.
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Joined: April 1st, 2004, 4:56 pm

December 28th, 2007, 3:53 pm #10

One of the comments beneath the pharmalot article which (if the poster is correct) explains a bit more:

http://www.pharmalot.com/2007/12/white-house-backs-preemption-in-wyeth-case/

"... As the DDL guys agree, the Wyeth case is “the big one” as far as FDA labeling preempting all failure-to-warn claims in the drug arena are concerned.

<DIV class=commenttext>
In case there’s any uncertainty, “state law,” in this context, mainly means the right to bring suit against a drug company for failure to warn.

So the preemption argument is premised on the notion that FDA labeling is sufficient to trump whatever else may turn out to be true - delay in reporting, spinning reporting, cat-and-mouse reporting, warning letters over “false and misleading” info dispensed (”cardio cards” etc.), suppressed internal studies, camoflaged reporting intimidating researchers, changing endpoints after the fact, etc.: All the kinds of behavior that now figure into a company’s potential liability - would be irrelevant.

Instead, a company would be fully shielded, with the possible exception of felony fraud, which the DOJ would have have to take upon itself to (a) discover (which usually happens through whistleblowers) and (b) prosecute (almost always settled beforehand). So, as far as a day in court for legitimate claims - Sayonara.

Below is the relevant section of the FDCA about which there is debate re: whether a company can take it upon itself to issue a warning prior to a formal FDA labeling change [my emphases].

Preemptors find a hundred ways to say it doesn’t say what it clearly says {”depends what ‘is’ is,” etc.). Anyone see any ambiguity?

21 USC 201.57 (e) Warnings. Under this section of the section heading, the labeling
shall describe serious adverse reactions and potential safety hazards, limitations in
use imposed by them, and steps that should be taken if they occur. The labeling shall
be revised to include a warning _as soon as there is reasonable evidence of an association
of a serious hazard with a drug_; a causal relationship need not have been proved.

21 USC 314.70 (c) Supplements for changes (in labeling) that may be made _before_ FDA approval “Special Supplement-Changes Being Effected.”. . . (2) changes labeling to accomplish any of the following:

(i) to add or strengthen a contraindication, warning, precaution, or adverse reaction;

(ii) to add or strengthen a statement about drug abuse, dependence, or over-dosage;
Or

(iii) to add or strengthen an instruction about dosage and administration that is
intended to increase the safe use of the product;

(iv) to delete false, misleading, or unsupported indications for use or claims for
effectiveness."
</DIV>
FDAnews Drug Daily Bulletin

<DIV>&nbsp;</DIV>
<DIV class=divider></DIV>


<DIV class=body>
<STRONG>White House Backs Preemption in Wyeth Case (Pharmalot)</STRONG>
In his blog, Ed Silverman writes about the U.S. solicitor general upholding the concept of preemption, which states that FDA approval preempts state laws questioning the safety, efficacy or labeling of a drug. At issue is whether patients can sue a drugmaker over a product they believe caused them harm at the state level if the FDA has approved a drug. The U.S. Supreme Court has agreed to review a case involving drug preemption in February involving Rezulin, a diabetes drug made by Parke-Davis/Warner-Lambert.

As the Rezulin case looms, the White House has made it clear that it agrees with preemption. The solicitor general recently issued a letter disagreeing with a Vermont Supreme Court decision allowing a patient to sue Wyeth over the labeling of Phenergan, an allergy and motion sickness drug. The patient was injected with the drug and later suffered injuries that led to her right arm being amputated.&nbsp;

Silverman quotes the solicitor general who argued that if drugmakers were free to make changes to their labels after FDA approval, the agency’s “‘approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted.’”
</DIV>
Last edited by Ch_Isp_Morse on December 28th, 2007, 4:12 pm, edited 1 time in total.
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