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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Litigation
Law.com |

Viagra Skin Cancer MDL Assigned to San Francisco Federal Judge

Lawsuits filed against Pfizer Inc. claiming that Viagra caused men to get skin cancer have been transferred to a judge in San Francisco by a federal judicial panel.


Thursday’s order by the U.S. Judicial Panel on Multidistrict Litigation coordinated the cases, now totaling more than 100, for pretrial purposes to U.S. District Judge Richard Seeborg. The suits, most of which were filed this week in the Northern District of California, have been brought by men diagnosed with melanoma or by the estates of those who died from the deadly form of cancer.


They cite studies finding that the enzyme used in Viagra, which the U.S. Food and Drug Administration approved in 1998 for the treatment of erectile dysfunction, causes a cell mutation that could develop into melanoma. In particular, a 2014 study in the Journal of the American Medical Association Internal Medicine found that men who took sildenafil, the active ingredient in Viagra, had an increased risk of developing melanoma by up to 84 percent.

Litigation
National Law Journal |

Tyson Foods Wage Case ‘Straight Out of Sinclair’s Era’

In Upton Sinclair's watershed 1906 novel "The Jungle" about cruelty and oppression in Chicago's stockyards, the protagonist Jurgis Rudkus gradually has an epiphany that the life he brought his family to is not all it seems.


"And so on Christmas Eve Jurgis worked till nearly one o'clock in the morning, and on Christmas Day he was on the killing bed at seven o'clock," wrote Sinclair. "All this was bad, and yet it was not the worst. For after all the hard work a man did, he was paid for only part of it."


Astoundingly, just last month, the U.S. Supreme Court issued an opinion on facts straight out of Sinclair's era. Bouaphakeo v. Tyson Foods upheld a verdict in favor of pork slaughterhouse workers suing to recover overtime wages.

Litigation
ABA Journal |

Judge Allows RICO Claim to Proceed Against Lawyer Accused of Creating ‘Litigation Chaos’ in Child Custody Case

A federal judge in Atlanta is warning litigants in a suit over a lawyer’s litigation tactics that they could face sanctions if they file court documents “for the purpose of harassment, intimidation or grandstanding.”


U.S. District Judge Timothy Batten issued that warning in a March 31 order allowing RICO claims against a lawyer in a child custody case who is accused of creating “litigation chaos” as part of a civil racketeering enterprise.The Daily Report (sub. req.) covered the decision.


The suit filed by John Murphy and his current wife claims Atlanta lawyer Millard Farmer used “conflictineering” to extort payments and force concessions by Murphy. Conflictineering, the Daily Report explains, is a tactic invented by Farmer that uses litigation or other events to expose what he believes to be immorality, creating social and political consequences for adversaries.


Murphy’s suit alleges that, during the child-custody litigation, Farmer:

  • Filed more than 20 motions to disqualify judges. (Farmer told the Daily Report his motions were intended to remove just one judge, and to change the way cases are assigned to judges.)
  • Filed a “frivolous and vexatious” third-party complaint against Murphy’s current wife that included “abusive, impertinent material.”
  • Sought to disqualify a guardian ad litem appointed for the children.
  • Pressured a psychiatrist he had once represented for free to support the ex-wife. When she testified about her concerns, he revealed personal information about her in court briefs.
  • Intimidated a landlord who had rented to the ex-wife and raised concerns about her conduct.
  • Filed frivolous litigation against the court reporter for the judge in the child custody litigation, then offered to dismiss the case if she would persuade the judge to recuse himself.
  • Participated in a town hall meeting that was “replete with false accusations against” Murphy and his current wife.

Litigation
The Legal Intelligencer |
serggn-istock-thinkstock

Fact-Specific Dismissal of Paxil Bellwether Not Expected to Have a Broad Effect

The first of several Paxil birth-defect cases expected to hit trial may have ended abruptly, but court watchers do not expect the litigation to be coming to an end so soon.


On Monday, Philadelphia Court of Common Pleas Judge Kenneth Powell Jr. dismissed the case Rader v. Smithkline Beecham, after finding that the plaintiff did not present enough evidence to send the case to the jury. The decision came after about five years of pretrial venue issues and two weeks of trial.


The ruling specifically hinged on the judge's determination that the plaintiffs did not present sufficient evidence to show the prescribing physician would have made a different prescribing decision based on additional information the plaintiffs have argued should have been included on the drug's label.


According to court watchers, because the ruling hinged on a very fact-specific issue, it is unlikely the dismissal will have a broad effect on the eight related Paxil birth-defect cases that remain in the Philadelphia Court of Common Pleas.

Litigation
The Pop Tort |
creative-commons

Satirical ‘Leaked’ Memo from U.S. Chamber Calls Out Efforts to ‘Block the Courthouse Door’

Someone just leaked this confidential memo to ThePopTort. We had to reprint it! (Hope we don't get sued.)


To: U.S. Chamber of Commerce Board of Directors


From: Chairman, U.S. Chamber Litigation Center


Re: It's a comeback!


Our goal all along has been to change the law so that corporate lawbreakers can precisely budget their potential liability as a cost of doing business. We want it to be cost-effective for all of you - our members - to simply pay victims and their families for deaths or injuries rather than fix the "problem". This Circuit Court decision gets us further along than we ever thought possible.


So let’s just relish in our ridiculous good luck for a moment. And until we can properly stack the Supreme Court again, maybe we should hope that SCOTUS looks the other way. At least for now.

Litigation
Legal Reader |
serggn-istock-thinkstock

Paxil Birth Defect Bellwether Dismissed on Directed Verdict Motion

In a blow to one family in particular, a GSK Paxil birth defect suit was dismissed today. The case, involving 12-year-old Braden Rader and his mother, Elisabeth Balzer, did not survive a mid-trial motion for nonsuit (dismissal based on failure to present evidence sufficient to support a case).


Braden, whose mother took Paxil during her pregnancy, suffers from a rare heart defect known as tetralogy of fallot (actually a combination of four different heart defects). He has undergone two open-heart surgeries, one as an infant and one in 2015, and will likely endure more throughout the course of his life, according to an expert witness for the plaintiffs


However, Judge Kenneth Powell of the Philadelphia County Court of Common Pleas based his decision to dismiss the case on a different expert witness, the doctor who originally prescribed the Paxil that allegedly caused Braden’s condition. Judge Powell found that Dr. Robert Kiehn’s testimony did not include an important detail: that he would have refrained from prescribing Paxil to the pregnant Mrs. Balzer had he been given more adequate warnings of the possible risks.

Litigation
ABA Journal |
Robert-Redelowski-Hermera-ThinkStock

GM Ignition Jury Finds Car Unreasonably Dangerous, But No Causation

Both sides proclaimed victory Wednesday after the first jury verdict in a General Motors ignition-switch case.


That’s because the jury, while finding a 2007 Saturn Sky unreasonably dangerous because of an ignition-switch defect, also found that the defect did not cause the plaintiff driver to lose control on an icy New Orleans bridge in 2014. Hence, it awarded no damages, reports the Detroit News.


“The jurors studied the merits of the case and saw the truth: this was a very minor accident that had absolutely nothing to do with the car’s ignition switch,” said GM said in a written statement. “The evidence was overwhelming that this accident—like more than 30 others that occurred in the same area that night—was caused by the driver losing control on an icy bridge during a state-wide winter weather emergency.”