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Drug & Device News
FDA Certification Does Not Shield Generic Drug Maker from Suit
Generic drug manufacturers are not insulated from lawsuits by a Food and Drug Administration (FDA) approval process that certifies such drugs as the “bioequivalent” of their brand-name predecessors, a federal judge in Philadelphia has ruled. In the 29-page decision rendered in In re Budeprion XL Marketing & Sales Litigation, U.S. District Judge Berle Schiller refused to dismiss a suit brought by consumers who were previously taking Wellbutrin, a brand-name antidepressant drug, and claim they experienced side effects upon switching to generic buproprion. The suit alleges that two manufacturers ' Teva Pharmaceuticals and Impax Laboratories ' became aware of the potential problem but failed to warn the public about differences between the name-brand and generic versions of the product that affected the release rate of the active ingredient. Schiller applied the U.S. Supreme Court's recent decision in Wyeth v. Levine, and concluded that generic drug manufacturers, like manufacturers of the previously approved name-brand drugs their products mimic, also have a continuing duty to issue warnings about any new hazards that arise after approval.
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Bit Parts
Summary Judgment Denied Defendant in Declaratory Action by Producer of To Kill a Mockingbird Broadway Play Seeking Amateur Theatrical Rights
Risks of “Baseball Arbitration” in Resolving Real Estate Disputes
“Baseball arbitration” refers to the process used in Major League Baseball in which if an eligible player's representative and the club ownership cannot reach a compensation agreement through negotiation, each party enters a final submission and during a formal hearing each side — player and management — presents its case and then the designated panel of arbitrators chooses one of the salary bids with no other result being allowed. This method has become increasingly popular even beyond the sport of baseball.
Disconnect Between In-House and Outside Counsel
'Disconnect Between In-House and Outside Counsel is a continuation of the discussion of client expectations and the disconnect that often occurs. And although the outside attorneys should be pursuing how inside-counsel actually think, inside counsel should make an effort to impart this information without waiting to be asked.