Tag

Pfizer Inc Archives - Carey Danis & Lowe

Carey Danis & Lowe Evaluating Zoloft Cases and Offers an Update on Zoloft Lawsuits in Zoloft MDL No. 2342

By | Pharmaceutical litigation, Uncategorized, Zoloft

Published January 14, 2013 by PR Web

St. Louis, Missouri (PRWEB) January 14, 2013

Zoloft MDL Updates: Zoloft MDL No. 2342 Progresses with Order to Submit Initial Discovery Zoloft Birth Defect CasesZoloft lawsuits have been consolidated into a Multi-District Litigation in the U.S. District Court for the Eastern District of Pennsylvania. Judge Cynthia M. Rufe is presiding over the Zoloft MDL.

As to recent developments in the Zoloft MDL, on January 2, 2013, Judge Rufe sent forth Pretrial Order No. 16. Fundamentally, the Pretrial Order outlines how to deliver responses in the MDL. The court document imparts detailed information as to “the procedure for filing responses to all civil actions that are or become consolidated in MDL No. 2342”.*

The Pretrial Order goes on to supply information on how the defendants, Pfizer Inc., Greenstone LLC, and Pfizer International LLC, shall go about filing a Master Short-Form Answer. In essence, the Master-Short Form Answer and Affirmative Defense is the defendants’ response to the claims of the plaintiffs.

According to the Pretrial Order, the Defendants will only have the opportunity to file one Master Short-Form Answer, and in doing so can address any and all charges made against them in each of the cases consolidated in the Zoloft MDL. As the document will stand as their initial response to allegations, Pfizer and Greenstone can deny the plaintiffs’ allegations, and in so doing, they can lay out a defense.

If relying upon information supplied in a recent report, there are quite a number of Zoloft cases in the MDL, and therefore each of these cases will necessitate address in the defense’s response. A Florida attorney who sits on the Plaintiffs’ Steering Committee (PSC), Bryan F. Aylstock, recently submitted a report late last year regarding the status of the Zoloft MDL. The legal journal, The Madison-St. Clair Record, stated that according to information contained in Alystock’s report, there are over 250 cases that have been consolidated into the Zoloft MDL.*

Plaintiffs in the Zoloft MDL have filed lawsuits against Pfizer, the manufacturer of Zoloft, claiming that the antidepressant drug, classified as a selective serotonin re-uptake inhibitor (SSRI), causes birth defects in newborn children when taken by women during pregnancy.

In a separate Zoloft lawsuit being heard in the Wayne County Circuit Court in West Virginia, nineteen plaintiffs, who are the children of mothers who claimed to have taken Zoloft during pregnancy, filed their lawsuit alleging that exposure to Zoloft in the womb resulted in the development of their birth defects.

According to the legal journal, The West Virginia Record, the plaintiffs identified these Zoloft linked birth defects as heart defects, such as atrial septal defects and holes in the heart, persistent pulmonary hypertension of the newborn (PPHN), skull and facial deformations, and a number of other congenital birth defects related to Zoloft exposure in utero.*

Lawyers at Carey Danis & Lowe are currently evaluating Zoloft cases, and they are offering legal consultations to those individuals who claim to have been harmed by the use of Zoloft during pregnancy. For more information about filing a Zoloft lawsuit, and specifically one related to Zoloft and birth defects, contact a lawyer at Carey Danis & Lowe by calling 800-721-2519.

Abbott to Pay $1.6B to Settle Depakote Claims

By | Depakote, Pharmaceutical litigation, Uncategorized

The following article was originally published on May 8, 2012 by Chicago Tribune.

Abbott Laboratories said Monday it will pay $1.6 billion to settle federal and state claims that it illegally marketed the anti-seizure medication Depakote for uses not approved by the Food and Drug Administration.

As part of the settlement agreement, North Chicago-based Abbott said it would pay $800 million to resolve civil cases brought by federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters.

The company will to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary period in which it must report any probable violations of the law to the probation office, according to the U.S. Department of Justice.

Illinois Attorney General Lisa Madigan said the state will receive $20 million as part of the deal.

The settlement was expected by investors. Last year, Abbott earmarked $1.5 billion to cover projected costs of the settlement, and set aside another $100 million in April for the same purpose.

Shares of Abbott finished Monday up 10 cents, at $62.51.

Abbott, Chicagoland’s largest company as measured by market capitalization, plans to spin off its legacy drug business into a separate, publicly traded firm called AbbVie this year. It said in a release that certain compliance measures and certification requirements will transfer to the new company.

“We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement,” Abbott General Counsel Laura Schumacher said in a statement.

“The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements,” Schumacher said.

Depakote, an anti-seizure and mood-stabilizing drug, was first approved by the FDA in 1983 to treat certain seizures in adults and children older than 10. Since then, the drug has been approved to treat other types of seizures, manic episodes of bipolar disorder and for the prevention of migraine headaches.

The Justice Department said in a release that the company illegally marketed Depakote for uses including for treatment of schizophrenia, agitated dementia and autism.

Though doctors can prescribe drugs “off-label,” as the practice is known, companies are prohibited from marketing them to treat conditions that are not approved by the FDA.

Abbott said it had been under investigation for four years in connection with the sale and promotion of Depakote stretching back to 1998.

The investigations led by the federal government and states’ attorneys general were based partly on whistle-blower lawsuits filed in federal courts in Illinois, Virginia and the District of Columbia that accused Abbott of illegally promoting Depakote. Those suits also alleged that the company gave doctors and pharmacists illegal kickbacks to talk about off-label uses of the drug to boost sales.

The first suit, filed in 2007 by former Abbott saleswoman Meredith McCoyd, accused the drug maker of encouraging her and other salespeople to promote the drug in nursing homes and public mental health centers, where most patients were covered by federal health care programs, including Medicaid.

The Justice Department intervened in those suits to determine whether the company’s marketing of the drug violated civil and criminal laws.

In a release, the Justice Department said Abbott admitted that from 1998 to 2006, it “maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use.”

From 2001 to 2006, it said, the company marketed the drug for use in combination with anti-psychotic drugs to treat schizophrenia, though its own clinical trials showed Depakote provided no benefit.

“Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, Deputy Attorney General. “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

The Abbott settlement is one of a string of recent enforcement actions pursued by the FDA, which has ramped up its investigation of off-label drug marketing, ensnaring several other large drugmakers within the last several years.

In November, GlaxoSmithKline PLC said it would pay the U.S. government $3 billion to settle civil and criminal charges for illegal marketing of diabetes drug Avandia and others.

In 2009, Pfizer Inc. paid $2.3 billion for similar allegations about its painkiller Bextra, and Eli Lilly & Co. settled for $1.4 billion the same year for Zyprexa, used to treat schizophrenia.

St. Louis-based Carey Danis & Lowe Announces Suit Against the Maker of Zoloft Sent Back to St. Louis Circuit Court

By | Pharmaceutical litigation, Uncategorized, Zoloft

Posted April 11, 2012

Pfizer’s attempt to litigate lawsuit in federal court rebuffed

ST. LOUIS–(BUSINESS WIRE)–St. Louis–based law firm Carey Danis & Lowe announces a lawsuit against Pfizer Inc. (NYSE: PFE), maker of the antidepressant drug Zoloft, that was originally filed in St. Louis Circuit Court then removed to federal court by the drugmaker, has been ordered back to the state court.

The lawsuit, Shainyah Lancaster, et al. v. Pfizer, Inc., cause no. 1222-CC00766, was filed on Feb. 2 in St. Louis Circuit Court on behalf of 21 children born with defects after their mothers were prescribed Zoloft while pregnant. The suit was brought on behalf of the plaintiffs by the law firms of Carey Danis & Lowe; Matthews & Associates; Freese & Goss; and Clark, Burnett, Love & Lee.

On March 8, Pfizer removed the case to the U.S. District Court for the Eastern District of Missouri alleging that diversity of citizenship existed between the plaintiffs and the defendant. The lawyers representing the plaintiffs opposed the effort to remove the case to federal court. (S.L., et al. v. Pfizer, Inc., Case 4:12-cv-00420).

On April 4, U.S. District Judge Carol E. Jackson sided with the plaintiffs and ruled that the federal court did not have jurisdiction over the lawsuit because complete diversity of citizenship did not exist, granted the plaintiffs’ motion to remand and sent the case back to St. Louis Circuit Court for further proceedings.

Zoloft (generic name sertraline) belongs to a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs. The suit notes that SSRIs have been found to cause severe birth defects in the children of women who were prescribed the drug while pregnant and alleges that Pfizer knew or should have known that children born to mothers who had taken SSRIs during pregnancy had a greater risk of congenital birth defects and that despite knowing that physicians were prescribing Zoloft to women of childbearing age, Pfizer failed to adequately warn the medical community and the public of the danger.

The lawsuit asserts state law claims against Pfizer of negligence; negligence of pharmacovigilance, which requires Pfizer to monitor safety data for its drugs; strict liability; negligent design; failure to warn; and fraud. The suit seeks actual and punitive damages.

Founded in 1995, Carey Danis & Lowe has offices in Missouri and Illinois. The firm handles personal injury, pharmaceutical liability, product liability, medical malpractice, class action and commercial cases throughout the United States.