Litigation

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Former Acting Chief Counsel Of FDA, Jeffrey M. Senger, Joins Sidley Austin LLP
Posted on 10 Aug 2010 by LexisNexis Litigation Resource Community Staff

WASHINGTON, D.C. - Sidley Austin LLP has announced that Jeffrey M. Senger, former acting chief counsel and Deputy Chief Counsel of the Food and Drug Administration, has joined Sidley as a partner in the global food, drug and medical device regulatory... Read More

Glaxo Settles Bad Drug Claim For More Than $40 Million
Posted on 24 Jun 2011 by LexisNexis Litigation Resource Community Staff

PROVIDENCE, R.I. - (AP) The American subsidiary of a major British drug maker, GlaxoSmithKline LLC, has agreed to pay more than $40 million to 37 states and Washington, D.C., to settle complaints alleging manufacturing process issues at a now-shuttered... Read More

Amylin Sues Eli Lilly Over Diabetes Drug Development Deal
Posted on 17 May 2011 by LexisNexis Litigation Resource Community Staff

INDIANAPOLIS - (AP) Amylin Pharmaceuticals Inc. said Monday it filed a lawsuit against Eli Lilly and Co., accusing the larger drugmaker of breaking their commercialization deal for diabetes drugs by teaming with the German company Boehringer Ingelheim... Read More

D.C. Circuit Says FDA Can Regulate Stem Cell Drugs; Company Properly Enjoined
Posted on 4 Feb 2014 by Tom Moylan

WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals on Feb. 4 said the federal government can regulate a company that cultures stem cells for injection in the donor patient and said a lower court did not err in permanently... Read More

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory
Posted on 18 Aug 2015 by Ballard Spahr LLP

. . . A federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the... Read More

La. Supreme Court Reverses $330M Verdict For Risperdal Medicaid Law Violations
Posted on 29 Jan 2014 by Tom Moylan

NEW ORLEANS — (Mealey’s) In a 4-3 vote, the Louisiana Supreme Court on Jan. 28 reversed a verdict of more than $330.6 million against Janssen Pharmaceutical Inc. and parent company Johnson & Johnson, finding that the state attorney general... Read More

Pa. Supreme Court Says Drug Companies Can Be Sued For Marketing Dangerous Drugs
Posted on 23 Jan 2014 by Tom Moylan

PHILADELPHIA — (Mealey’s) Pennsylvania law allows drug companies to be sued if they fail to stop marketing drugs known to be unreasonably harmful, and the manufacturers are not immune from being sued for damages for lack of due care, the Pennsylvania... Read More

2nd Circuit Lifts Stay On 2-Pill Plan B Contraceptive, Expedites FDA's Appeal
Posted on 8 Jun 2013 by Tom Moylan

NEW YORK - (Mealey's) The Second Circuit U.S. Court of Appeals on June 5 said the federal government failed to meet the standard to obtain a stay of a lower court order that the Food and Drug Administration immediately make the older, two-pill Plan... Read More

FDA Removes More Than 500 Unapproved Cough, Cold And Allergy Drugs
Posted on 2 Mar 2011 by Tom Moylan

ROCKVILLE, Md. - (Mealey's) The Food and Drug Administration on March 2 announced that it is requiring drug manufacturers to take more than 500 prescription cough, cold and allergy drugs off the market because they are unapproved. The drugs... Read More

Supreme Court Justices Weigh Constitutionality Of Vermont Law Restricting Prescribing Data
Posted on 26 Apr 2011 by Tom Moylan

WASHINGTON, D.C. - (Mealey's) U.S. Supreme Court justices on April 26 questioned why Vermont needs to hide doctors' prescribing habits from drug sales representatives or if the state has a sound public policy reason for doing so ( William H. Sorrell... Read More

Preemption Summary Judgment Granted In Incretin-Mimetic Multidistrict Litigation
Posted on 11 Nov 2015 by Tom Moylan

SAN DIEGO — (Mealey’s) The California federal judge overseeing the incretin mimetic multidistrict litigation on Nov. 9 granted summary judgment to five makers or promoters of the diabetes drugs, finding clear evidence that the Food and Drug... Read More

2nd Circuit Upholds Fosamax Bellwether Defense Verdict
Posted on 31 Jan 2013 by Tom Moylan

NEW YORK - (Mealey's) A defense verdict for Merck, Sharp & Dohme in the fourth federal Fosamax jaw injury trial was upheld Jan. 30 by the Second Circuit U.S. Court of Appeals, which found that the trial court didn't err in excluding a plaintiff... Read More

Pennsylvania Jury Awards $10 Million To Girl In Children's Motrin Case
Posted on 20 May 2011 by Tom Moylan

PHILADELPHIA - (Mealey's) A Pennsylvania state court jury on May 20 awarded $10 million in compensatory damages to a 13-year-old girl who claims that she suffered extensive burns and was blinded in one eye by Children's Motrin when she was 3-1... Read More

U.S. High Court Won’t Decide ‘Clear Evidence’ In $63 Million Children’s Motrin Verdict
Posted on 19 Jan 2016 by Tom Moylan

WASHINGTON, D.C. — (Mealey's) The U.S. Supreme Court on Jan. 19 denied a petition by Johnson & Johnson and a subsidiary to decide if denial of a citizen petition constitutes “clear evidence” that the Food and Drug Administration... Read More