SSRI Ed note: Father of boy who died by suicide after starting Paxil initially blames punk rock music, later realizes that the Paxil was the problem. Lawsuit fails.

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The Sacramento Bee

March 26, 1998

Author: Mary Lynne Vellinga Bee Capitol Bureau []

Barry Bratt is convinced that the depressing, death-obsessed lyrics of punk rock songs played a role in his 13-year-old son’s suicide.    The Cameron Park resident, whose son Ben hanged himself last year, came to the state Capitol on Wednesday to support legislation that would bar state pension funds from investing in recording companies whose music denigrates women or describes such acts as murder, drug use, gang activity and violence against a particular group. Investments in retail companies that sell such music also would be banned.

The bill, AB 2059 by Assemblyman Keith Olberg, R-Victorville, was debated at a special informational hearing of the Assembly Public Employees, Retirement and Social Security Committee. The panel will vote on the bill at a later date.

Backers of the bill said they’re convinced that lyrics advocating violence, crime or suicide prompt youngsters to act out. “Good kids are becoming involved in some very bad activities,” Olberg said.

Bratt allowed that music alone wasn’t responsible for his eighth-grade son’s suicide. He said the boy was on anti-depressants and was doing poorly in school.  But Bratt thinks lyrics by bands such as the Sex Pistols, the Dead Kennedys and Marilyn Manson had “a big influence” on Ben, who was a talented guitar player.

“His friends think so, too,” Bratt said. “After his death, they threw out all their records.”

Also at the hearing were former gang members and the parents of Elyse Pahler, 15, a high school freshman from the San Luis Obispo area who was murdered by three boys who belonged to a metal band called Hatred.  Authorities said the boys thought they could score points with Satan by sacrificing a virgin.

Tony Tiujaga, 33, of Carson, who once belonged to the Bloods street gang, said rap music encourages inner-city kids to carry guns and use them.

“Everybody’s talking about packing – you got to be packing in the ‘hood,” Tiujaga said. “They’ve got songs that are saying, point blank, “blow their heads off.'”

Olberg’s bill is opposed by the $128 billion California Public Employees’ Retirement System and by the recording industry, which says it would stifle free speech about society’s ills.

Karin Newman Krueger, a lobbyist for the Motion Picture Association of America, said the bill’s definition of “offensive” is so broad that “the state of California could not invest in any major entertainment company or conglomerate.”

Assemblyman Kevin Murray, D-Los Angeles, said the legislation unfairly targets rap music by African American and Latino artists. A packet of allegedly offensive lyrics passed out by Olberg’s office contained mostly excerpts of rap songs.

Music in the 1970s and ’80s by such white bands as Black Sabbath, Judas Priest, Ozzy Osborne and the Sex Pistols also tended toward the anarchist and violent, Murray said, “but now that some black guys are doing this, it’s a horrible thing.”

Murray and other opponents of the bill also disputed the connection between listening to music and committing violent acts. “People are not doing this stuff because they listen to violent music; they’re doing it because they live in a violent world,” Murray said.

Added Hilary Rosen, president and chief executive officer of the Recording Industry Association of America: “The American Academy of Pediatrics lists 14 signs to look for in a troubled child, and music choice is not among them.”

A December 1996 advisory from the pediatrics academy states that no connection has been found between behavior and sexually explicit or violent lyrics. Nonetheless, the group advocates content labeling of recordings. The music industry has for the past 13 years used stickers to flag recordings that have explicit lyrics.

Olberg’s bill is one of two being circulated this year that would force state pension funds to divest from a particular industry. A bill authored by Assemblyman Wally Knox, D-Los Angeles, would bar the state from investing in the tobacco industry. Both bills are opposed by PERS, which cites its constitutional duty to serve the “sole and exclusive” interest of members by earning them the highest possible return.

PERS spokeswoman Patricia Macht estimated that a ban on investing in recording companies and retailers that purvey music with “offensive” lyrics could force PERS to sell nearly $1 billion in holdings.

She said PERS doesn’t pick individual stocks to invest in; instead, it buys shares of all the nation’s top-performing companies. Eliminating certain stocks and bonds from consideration “contradicts our whole investment theory,” Macht said.

The state Constitution allows the Legislature to prohibit certain investments by state pension funds “if it is in the public interest to do so” and doesn’t jeopardize the fund’s responsibilities to provide sound investments.

Only once has the Legislature ordered state pension funds to divest from a certain category of investments. The state funds were barred from investing in South Africa from 1986 until the fall of apartheid, Macht said.

If Olberg’s bill becomes law, which a spokesman for Assembly Speaker Antonio Villaraigosa said is unlikely, it will face an “instant” court challenge, Rosen said. She noted that state employees in Texas have filed a lawsuit in federal court over a similar statute banning state investment in record companies that produce “offensive” music.

“They want their investment funds invested on the basis of yield and safety rather than public policy,” she said.

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King & Spalding Earns Victory in Products Liability Case for GlaxoSmithKline — (

February 3, 2008

GlaxoSmithKline 01/02/2008 17:25:00 Business Wire King & Spalding, a leading international law firm, has earned a significant victory for client GlaxoSmithKline (“GSK”) in a products liability case.
On January 30, a federal district judge granted summary judgment in O Neal v. SmithKline Beecham d/b/a GlaxoSmithKline and dismissed, with prejudice, all claims made by the plaintiff in a case involving the 1997 suicide of a 13 year-old.
This is the fourth major win in a series of victories over the past several months regarding suits filed against the drug manufacturer of the antidepressant drug Paxil.
Judge Frank C. Damrell, Jr., of the United States District Court for the Eastern District of California, dismissed the case on the grounds that under state law all of the claims required showing that GSK should have included a warning in Paxil’s labeling in 1997 that there was an increased risk of suicidality.
The plaintiffs claims created a direct conflict with the federal labeling requirements for Paxil established by the United States Food & Drug Administration, preempting the plaintiffs tort claims.
Importantly, the court recognized that at the relevant time, in this case 1997, there was no reasonable scientific evidence to support the plaintiffs proposed warning.
Agreeing with GSK, the court found that: A direct conflict of law exists in this case because GSK could not have been in compliance with federal law in February 1997 and have included the suicidality warning plaintiffs urge.
In other words, had GSK included the warning that plaintiffs insist upon, GSK would have risked misbranding Paxil in violation of the FDCA.
Therein lies the actual and direct conflict presented in this case–comply with federal law and be held liable under state law tort claims, or, to avoid state tort liability, add a warning without reasonable evidence and violate federal law.
Opinion at 19.
Accordingly, the court found “plaintiffs claims are preempted.” Further, the court affirmed that “the record indicates that the type of warning which plaintiffs claim SB/GSK should have included in its Paxil label had been considered and rejected by the FDA because such a warning was not supported by reasonable evidence at the time of ” the suicide.
at 23-24.
And, that: Absent reasonable evidence of a risk, GSK had no basis to petition FDA and simply did not have the option under federal law to include or secure a lawful warning for that risk in the drug s labeling.
Had it done so, GSK would have misbranded the drug in violation of the FDCA and subjected itself to a possible federal enforcement action against it or the withdrawal of its NDA by the FDA.
Stated otherwise, the obligation under state law on GSK that plaintiffs advance is flatly contrary to GSK s obligations under federal law.
As such, plaintiffs claims must be found preempted.
at 31.
The decision is significant and precedent setting because it is believed to be the first case in which a court has fully considered the legal issue of implied conflict preemption and rendered an opinion in a pediatric suicide case brought against an antidepressant manufacturer alleging a failure-to-warn of an increased risk of suicidality.
This ruling could potentially lead to the dismissal of similar cases on preemption grounds.
The King & Spalding team representing GlaxoSmithKline consisted of product liability partners Chilton Davis Varner, Andy Bayman, Todd Davis and Halli Cohn, and FDA/Healthcare partner Mark Brown, along with associates Nicole Taylor and Nathan Guest.
Varner, widely considered one of the nation s top product liability litigators, was appointed by the late Chief Justice Rehnquist to the Federal Civil Rules Advisory Committee in 2004, where she assisted in drafting new electronic discovery provisions.
Brown, a former Associate Chief Counsel with the FDA, is recognized as one of the nation s most experienced lawyers on a wide range of FDA issues in pharmaceutical and medical device litigation.

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Terri S. O’NEAL, individually and as successor-in-interest to the Estate of Benjamin L. Bratt; Barry M. Bratt, individually, Plaintiffs, v. SMITHKLINE BEECHAM CORPORATION d/b/a Glaxosmithkline, a Pennsylvania Corporation; and Does 1-50, Defendants — (Court Listener)



FRANK C. DAMRELL, JR., District Judge.

This matter is before the court on defendant SmithKline Beecham Corporation, d/b/a GlaxoSmithKline’s (“GSK”) motion for summary judgment on the ground plaintiffs Terri O’Neal and Barry Bratt’s (“plaintiffs”) state tort claims are preempted by federal law, i.e., the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., and its implementing regulations, because they require warnings that directly conflict with federal law governing the labeling and warnings for Paxil® (“Paxil”). Plaintiffs bring this action for the wrongful death of their son, Benjamin Bratt (“Benjamin”), who attempted suicide, on February 14, 1997, at the age of 13, while being treated with Paxil, an antidepressant medication manufactured and sold by GSK. Benjamin died on February 15, 1997 from injuries sustained from his suicide attempt.

The gravamen of plaintiffs’ claims is that GSK should have provided, at the time of Benjamin’s death, a warning that Paxil is associated with suicidality[1] in pediatric patients. GSK contends, however, that plaintiffs’ state tort claims directly conflict with the FDA’s-mandated labeling for Paxil in February 1997, and implementation of the warning urged by plaintiffs would have rendered Paxil’s prescribing information false and misleading under federal law, as no reasonable evidence existed, at the time, to support implementation of the warning. As such, because there is a direct and actual conflict between plaintiffs’ state law claims and federal law, GSK asserts plaintiffs’ claims are preempted and must be dismissed.

The court heard oral argument on the motion on January 18, 2008. By this order, the court now renders its decision, granting GSK’s motion in its entirety. For the reasons set forth below, the court finds Bathat federal law preempts plaintiffs’ instant action against GSK.