Top court to hear arguments over generic drugmaker liability

* Generic drugmaker seeks to overturn $21 million jury award

* Woman suffered severe skin reaction after taking generic drug

* Drug company says suit barred by federal law By Terry Baynes

March 18 (Reuters) - The U.S. Supreme Court will hear arguments on Tuesday in a case that could decide whether generic drugmakers can be held liable for alleged flaws in the designs of their medications, even though federal law requires generic manufacturers to copy the brand drugmaker's design.

The case, closely watched by pharmaceutical companies, regulators and lawyers, could determine the extent to which individuals can hold generic drug manufacturers liable for injuries allegedly caused by their copycat products.

Mutual Pharmaceutical Co has asked the high court to overturn a $21 million jury award to Karen Bartlett, a New Hampshire woman who took Mutual's generic non-steroidal anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it for shoulder pain.

Mutual, based in Philadelphia, is a unit of URL Pharma, owned by Sun Pharmaceutical Industries , and manufactures dozens of generic drugs ranging from antibiotic doxycycline to the antifungal nystatin.

The trial judge upheld the jury's award, and a federal appeals court agreed, describing Bartlett's experience as "disastrous."

Doctors diagnosed a rare hypersensitivity reaction associated with the drug that developed three weeks after Bartlett started taking it. Her skin began to peel off, leaving her with burn-like lesions over two-thirds of her body. She spent close to two months in a hospital burn unit, some of that time in a medically induced coma, and has since undergone 13 eye surgeries.

The reaction, a severe form of Stevens-Johnson Syndrome, left Bartlett with permanent near-blindness, scarred lungs and a constricted esophagus that makes it difficult to swallow. She sued Mutual in 2008 for alleged design defects under New Hampshire law.

After a 14-day trial, a jury awarded Bartlett $21 million for her injuries.

Asking the Supreme Court to overturn the award, Mutual argues that federal law bars such claims because its drug had already been approved by the U.S. Food and Drug Administration and federal law requires generic drugs to have the same design as their brand-name equivalents.

The company cites a 2011 Supreme Court ruling, PLIVA v. Mensing, which dramatically constrained consumers' ability to sue generic manufacturers over alleged injuries. In that case, the court found that generic drugmakers could not be sued for failing to warn about certain health risks because federal law requires brand-name and generic drugs to carry the same label. That ruling has wiped out the bulk of personal injury cases against generic manufacturers.

PHARMACIST'S CHOICE

Bartlett's case skirted the Mensing ruling by claiming that the generic drug was inherently dangerous, based on the number of incident reports of the skin reaction submitted to the FDA. From that data, Bartlett concluded that sulindac's design was unreasonably dangerous and defective.

Mutual argues that the logic of Mensing should also apply to design defect claims because, as with their labels, generic drug companies have no control over their product's design, which has to mimic the brand-name counterpart.

But in May a unanimous three-judge panel of the 1st Circuit Court of Appeals in Boston refused to extend the ruling to design defect claims. The court ruled that Mutual could simply have decided to stop making sulindac, based on the brand name Clinoril, and take it off the shelves.

If the Supreme Court finds that the product defect claims under state law are barred by federal law, it would become virtually impossible to hold a generic drugmaker accountable for injuries caused by their products.

About 80 percent of all U.S. prescriptions are filled with generics, according to healthcare information provider IMS Health. When a doctor prescribes a brand-name drug, state laws allow pharmacists to automatically substitute the cheaper generic version in filling the prescription. Bartlett's doctor prescribed the brand-name Clinoril, and her pharmacist filled it with the generic sulindac.

Most people are unaware they're taking a generic instead of the brand-name drug, said Richard Schulte, a lawyer who represents plaintiffs in personal injury suits against generic drug companies.

"When they pick up their script, they have no idea they have no legal claim and they're not protected," Schulte said.

"HORRIFIC"

Bartlett's lawyer, Keith Jensen, said that even though the FDA is responsible for approving all drugs, the agency is too ill-equipped and underfunded to ensure that drugs are safe and effective. Lawsuits like Bartlett's are crucial for exposing safety problems with drugs, he said.

When Bartlett took the drug, sulindac's label included a warning that it was associated with the rare but potentially fatal skin reaction. In 2005, Mutual strengthened its warning after the FDA recommended that all manufacturers of non-steroidal anti-inflammatories, or NSAIDs, include a description of the early symptoms of the skin reaction in the label. That year the FDA also asked Pfizer to withdraw its drug Bextra after reports of the reaction, but it allowed other NSAIDs to remain on the market.

Mutual's lawyer, Jay Lefkowitz, declined to comment on the case. URL Pharma and Sun Pharmaceutical Industries did not immediately respond to requests for comment.

"There is no question that the results were horrific," Mutual said in its brief, noting that Bartlett can no longer eat normally, have sexual relations, read, drive or work.

But the company said Congress created a regulatory framework that allows generic drugs to piggyback on the brand-name drugs in order to keep generic prices down. To gain FDA approval, generic drugmakers have to show only that their product matches the brand drug, without having to conduct expensive clinical studies.

"It is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more drugs more quickly and cheaply to the public," the company said in its brief, quoting the Mensing decision.

In the Mensing case, the Supreme Court was divided 5-4, with Justice Clarence Thomas delivering the majority opinion. The case came down along predictable lines, with swing justice Anthony Kennedy joining the court's conservative camp to form a majority. A majority could again find that Bartlett's suit conflicts with federal law, said lawyers for pharmaceutical companies.

The Solicitor General, which filed an amicus brief and will argue on behalf of the FDA on Tuesday, says the agency conducts a rigorous scientific evaluation to determine whether a drug's benefits outweigh its risks. Juries should not be able to second-guess those decisions, the FDA maintains, and generic pharmaceutical companies agree.

"If jurors with no technical expertise can decide healthcare matters like what is medically safe for patients, the result will be an unpredictable flow of needed medicines, which is a major problem for patients," said the industry trade group, the Generic Pharmaceutical Association.

Bartlett said she is planning to attend Tuesday's oral arguments.

"I think generic drugs should be held accountable for the harm they do to people, just like brand-name drugs should be," she said.

The case is Mutual Pharmaceutical Company v. Bartlett, U.S. Supreme Court, No. 12-142.

(Reporting By Terry Baynes in New York; Editing by Eileen Daspin and Douglas Royalty)

((terry.baynes@thomsonreuters.com)(+1 646 223 8022)(Reuters Messaging: terry.baynes.reuters.com@thomsonreuters.net))

Keywords: USA COURT/GENERICS

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The 6 Best Arguments For Gay And Lesbian Equality In Obama’s DOMA Brief

On Friday, President Obama’s Solicitor General, Donald Verrilli, filed a brief in United States v. Windsor, a case urging the Supreme Court to outlaw Section 3 of a 1996 federal law that prohibits the federal government from recognizing same-sex marriages.

The Defense of Marriage Act or DOMA, the Obama administration contends, “denies to tens of thousands of same-sex couples who are legally married under state law an array of important federal benefits that are available to legally married opposite-sex couples,” does not substantially further “any important governmental interest” and is thus unconstitutional, violating “the fundamental constitutional guarantee of equal protection.” Here are the six most pro-equality arguments in the administration’s brief:

1. Section 3 “denies to legally married same-sex couples many substantial benefits afforded to legally married opposite-sex couples under federal employment, immigration, public health and welfare, tax, and other laws.” For instance, a same-sex spouse of an “active-duty military servicemember is excluded from certain housing, healthinsurance, and disability benefits that would be afforded to an opposite-sex spouse…. A non-citizen same-sex spouse of a United States citizen cannot qualify as the citizen spouse’s immediate relative for purposes of obtaining lawful permanent residence. ”

2. Gay and lesbian people have been subject to a significant history of discrimination in this country. Until Lawrence v. Texas, 539 U.S. 558 (2003), criminal laws in many states prohibited their private sexual conduct. In addition, gay and lesbian people have long suffered discrimination in employment, immigration, criminal violence, child custody, police enforcement, voter referenda, and other contexts. “That history ranges from colonial laws ordering the death of “any man [that] shall lie with mankind, as he lieth with womankind,”… to state laws that, until very recently, “demean[ed] the[] existence” of gay and lesbian people.”

3. Sexual orientation is such a “distinguishing characteristic,” and that is true even though so many gay and lesbian people have been forced for so long to hide their identities in order to avoid discrimination. As this Court has recognized, sexual orientation is a core aspect of human identity, and its expression is an “integral part of human freedom.”

4. The “broad consensus in the scientific community is that, for the vast majority of people (gay and straight alike), sexual orientation is not a voluntary choice.There is likewise a medical consensus that efforts to change an individual’s sexual orientation are generally futile and potentially dangerous to an individual’s well-being. Accordingly, sexual orientation readily constitutes an “obvious, immutable, or distinguishing characteristic” for purposes of equal-protection law.”

5. “No sound basis exists for concluding that same-sex couples who have committed to marriage are anything other than fully capable of responsible parenting and child-rearing. To the contrary, many leading medical, psychological, and social-welfare organizations have issued policy statements opposing restrictions on gay and lesbian parenting based on their conclusions, supported by numerous scientific studies, that children raised by gay and lesbian parents are as well adjusted as children raised by heterosexual parents.”

6. If anything, “the denial of federal benefits otherwise accorded to married individuals undermines the efforts of same-sex couples to raise their children, hindering rather than advancing any interest in promoting child welfare.”

The brief also cites California’s Proposition 8 “as an example of the ongoing problem of bias against homosexuals.” Obama is reportedly considering asking the Court to overturn California’s ban against same-sex marriage before it hears oral arguments in that case on Tuesday, March 26. The Windsor case will be heard on Wednesday, March 27.

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NOM Relies On Hackneyed Arguments In Anti-Equality Newspaper Ad

Click to see it full-size.

The National Organization for Marriage published a full-page newspaper ad this week attacking same-sex marriage in Rhode Island. Like decades of anti-gay propaganda before it, the ad relies on two familiar tropes. First, marriage equality will somehow curb “religious freedom” because people will not have free reign to discriminate against same-sex couples. Secondly, children will learn that gay people exist.

Neither of these arguments is particular convincing, but NOM believes they are calling out “The Big Lie” of marriage equality, because “people of faith will pay the price.” The new coalition to support marriage equality in Rhode Island has published a thorough fact-check of the ad. Here’s a sample:

Claim: Small businesses that oppose marriage equality will face lawsuits.Fact: A Seattle Times investigation “failed to turn up any evidence that same-sex marriage had produced a rash of suits involving businesspeople.”  The Times “also checked with human rights commissions in four of the six states where marriage is legal; the commissions said there was not an increase in discrimination findings or suits involving same sex marriage.”

Indeed, NOM’s scare tactics increasingly fall on deaf ears. Though as Jeremy Hooper suggests, the ad does provide some nice publicity for the children’s book King & King.

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Washington Post Promoting Misleading Filibuster Arguments

Today Ezra Klein at the Washington Post put out a piece promoting Common Cause’s lawsuit to have the Senate filibuster declared unconstitutional.  Klein repeats myth after myth about the filibuster.  This piece should commence an interesting national debate finally putting the argument to bed that the filibuster is somehow unconstitutional.  Abolition of the filibuster will lead to a Senate with less time for debate and limited transparency for the American people.

It is interesting to note that these short sighted leftists may be laying the table for an easy repeal of ObamaCare, Dodd-Frank and extending the Bush tax cuts.  Clearly, Republicans control of the Senate is within reach (see RCP analysis of Senate polls).  There is also a 50-50 chance that Republicans win the presidency.  Liberals are trying to get rid of the one tool they would have to stop Republicans from dismantling the Obama legacy of higher taxes and more regulation.

I have to imagine that some Republicans will want to take liberals up on the offer of ridding the Senate of the filibuster in January of 2013. 

First of all, many of the voices on the left are hypocrites.  Many of the same groups calling for filibuster reform, were defending the filibuster in 2005.  When it served the purpose of obstructing President Bush’s agenda in 2005, they were 100% for the filibuster (see here).

It is ironic that Common Cause is fighting for filibuster reform.  In 2005 they were singing a different tune.

Jonathan H. Adler at The Volokh Conspiracy writes in a post titled, Common Cause’s Filibuster Flip:

In 2005, Common Cause vigorously defended the filibuster when some Republicans proposed invoking the “nuclear option” to end the filibuster of judicial nominees.  From a 2005 press release: Common Cause strongly opposes any effort by Senate leaders to outlaw filibusters of judicial nominees to silence a vigorous debate about the qualifications of these nominees, short-circuiting the Senate’s historic role in the nomination approval process. “The filibuster shouldn’t be jettisoned simply because it’s inconvenient to the majority party’s goals,” said Common Cause President Chellie Pingree. “That’s abuse of power.” (Hat tip: Don Surber)

Now it seems that Common Cause supports the “abuse of power.”   I did a Google search to find the text of a Common Cause press release titled “Filibuster shouldn’t be tossed aside to convenience Senate majority” and it has been taken off the web site.

Also, it is a convenient myth for Klein and opponents of the filibuster to argue that “the filibuster was a mistake.” History does not prove this assertion to be true.

John Quincy Adams wrote in his memoir that the early Senate rejected a rules change that would have limited debate, because in 1806 Vice President Aaron Burr argued that a rules change was not necessary to end debate on a question.  According to the late Senator Robert C. Byrd’s in The Senate, 1789–1989, “Henry Clay, in 1841, proposed the introduction of the ‘previous question’ but abandoned the idea in the face of opposition.”  Byrd also noted that “when Senator Stephen Douglas proposed permitting the use of the ‘previous question’ in 1850, the idea encountered substantial opposition and was dropped.” According to Byrd, “An effort to reinstitute the ‘previous question,’ on March 19, 1873, failed by a vote of 25–30.” Byrd cited the following: “Between 1884 and 1890, fifteen different resolutions were offered to amend the rules regarding limitations of debate, all of which failed of adoption.” This is evidence that the filibuster was not an accident of history, yet it was an accepted practice that was validated by Senate votes.

James Madison wrote in Notes of Debates in the Federal Convention of 1787 that one of the purposes of the Senate was to protect the people against the temporary feelings Members of Congress may posses.

In order to judge of the form to be given to [the Senate], it will be proper to take a view of the ends to be served by it. These were first to protect the people against their rulers: secondly to protect the people against the transient impressions into which they themselves might be led.

Finally, the Constitution specifically delegates rule making authority to the House and Senate in Article I, Section 5, “each house may determine the rule of its proceedings.”  The filibuster is constitutional and the federal courts have no jurisdiction to litigate this political question.

To argue that supermajority votes are unconstitutional, is to ignore the many supermajority rules  as part of the statutory budget process, explicit rules of the Senate and tradition.  Today, the Senate will hold a series of votes on legislation to extend the life of the Export-Import Bank, and amendments to the legislation, with a 60 supermajority required to pass as agreed to by both parties.  This practice is commonplace in today’s Senate.

The Senate and House frequently have votes on matters that are subject to supermajority votes.  In the House, a suspension of the rule vote is a supermajority vote.  In the Senate there are 60 vote points of order, suspension of the rules and a supermajority to shut off debate are a weekly occurrence.

The big question is whether this full court press by the left is merely setting up a liberal talking point that Republicans are obstructionists or if this is a serious effort to set the table for changing the filibuster rule.

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Toobin on Obamacare Supreme Court Arguments: ‘This Was a Train Wreck for the Obama Administration’

I’ll leave further commentary to our excellent lawyers, but here’s the video:

The CNN legal correspondent’s comments included the following:

This was a train wreck for the Obama administration. This law looks like it’s going to be struck down…All of the predictions including mine that the justices would not have a problem with this law were wrong.

…The only conservative justice who looked like he might uphold the law was Chief Justice Roberts who asked hard questions of both sides, all four liberal justices tried as hard as they could to make the arguments in favor of the law, but they were — they did not meet with their success with their colleagues.

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