Justia Drugs & Biotech Opinion Summaries

Solis alleged that his former employers violated the federal False Claims Act (FCA) by promoting dangerous off-label uses of a cardiovascular drug, Integrilin, and by paying physicians kickbacks to prescribe Integrilin and an antibiotic drug, Avelox. The district court found that Solis’s FCA claims were foreclosed by the public disclosure bar, which deprives federal courts of subject matter jurisdiction over FCA suits when the alleged fraud has already been publicly disclosed unless the relator is deemed an original source. The Ninth Circuit affirmed in part, holding that Solis’s Integrilin claims were substantially similar to those in prior public disclosures, and were close enough in kind and degree to have put the government on notice to investigate the alleged fraud before Solis filed his complaint. The court vacated the dismissal of Solis’s Integrilin claims and remanded for a determination of whether Solis qualified for the “original source” exception, 31 U.S.C. 3730(e)(4). Concerning Solis’s Avelox claims, the court held that the district court clearly erred in finding that the Avelox claims were publicly disclosed based on court complaints that never mentioned Avelox but affirmed the dismissal of Solis’s Avelox claims on the alternative ground of failure to plead with particularity as required by Fed.R.Civ.P. 9(b). View "Solis v. Millenium Pharmaceuticals, Inc." on Justia Law

Smith & Nephew’s patent relates to an endoscope and method to remove uterine tissue; it claims priority to an earlier-filed PCT application by the same inventor with a nearly identical specification. On inter partes review, the Patent Trial and Appeal Board found that S&N’s earlier-filed PCT application has sufficient written description to make it a priority document instead of an invalidating obviousness reference. The Federal Circuit affirmed. Substantial evidence supported the finding that the PCT application reasonably conveys to a person of ordinary skill that the inventor had possession of the “first channel having a light guide permanently affixed therein.” The court also upheld the Board’s definition of a person of ordinary skill in the art as a “degreed engineer having at least 5 years of experience designing and developing devices used in minimally invasive surgery (endoscopes, resectoscopes, shavers, tissue removal devices, etc.).” View "Hologic, Inc. v. Smith & Nephew, Inc." on Justia Law

Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

Shuker underwent a hip replacement surgery that resulted in unexpected complications and brought tort claims against Smith & Nephew, the manufacturer of his hip replacement system. The Medical Device Amendments of 1976, added comprehensive medical device approval processes to the Federal Food, Drug, and Cosmetic Act, prescribing tiers of federal requirements for certain devices corresponding to the device’s inherent risk level. In exchange for compliance with the strictest federal mandates, Congress afforded manufacturers express preemption from state laws imposing different or additional “safety or effectiveness” requirements for those devices, 21 U.S.C. 360k(a)(2). Shuker’s medical device was comprised of multiple components, some of which are from “Class III” medical devices subject to federal requirements and some of which are from medical devices that carry a different class designation and are not subject to those requirements. The Third Circuit affirmed a determination that Shuker’s negligence, strict liability, and breach of implied warranty claims are expressly preempted. The court reversed the dismissal of other claims. Shuker adequately pleaded non-preempted claims based on Smith & Nephew’s alleged off-label promotion in violation of federal law and loss of consortium, and jurisdictional discovery is warranted with respect to personal jurisdiction over one of the defendants. View "Shuker v. Smith & Nephew PLC" on Justia Law

The Ninth Circuit affirmed the district court's judgment for EpiCept in an action brought by doctors, alleging claims for breach of contract, breach of the implied covenant of good faith and fair dealing, and fraud. The doctors' claims relate to two patents for a non-FDA approved drug (NP-2) and EpiCept's failure to develop those patents into FDA-approved drugs. The doctors' arguments mainly center on the jury's determination that the doctors materially breached their contract with EpiCept by failing to disclose that Dr. Flores treated burn patients with NP-2. The panel held that the district court did not abuse its discretion in formulating the jury instructions, or in determining that the jury's verdict was not against the clear weight of the evidence; neither the jury instructions given in this case nor the evidence presented at trial warrant the do-over the doctors demanded; the district court's response to the jury's question also did not merit a new trial because the jury's question was essentially factual and the district court's answer appropriately directed the jury to consider its original instructions and the evidence presented at trial; and because the panel affirmed the jury's finding that the doctors materially breached the contract, the district court's exclusion of the doctor's damages expert was necessarily harmless. View "Crowley v. EpiCept Corp." on Justia Law

The Ninth Circuit affirmed the district court's judgment for EpiCept in an action brought by doctors, alleging claims for breach of contract, breach of the implied covenant of good faith and fair dealing, and fraud. The doctors' claims relate to two patents for a non-FDA approved drug (NP-2) and EpiCept's failure to develop those patents into FDA-approved drugs. The doctors' arguments mainly center on the jury's determination that the doctors materially breached their contract with EpiCept by failing to disclose that Dr. Flores treated burn patients with NP-2. The panel held that the district court did not abuse its discretion in formulating the jury instructions, or in determining that the jury's verdict was not against the clear weight of the evidence; neither the jury instructions given in this case nor the evidence presented at trial warrant the do-over the doctors demanded; the district court's response to the jury's question also did not merit a new trial because the jury's question was essentially factual and the district court's answer appropriately directed the jury to consider its original instructions and the evidence presented at trial; and because the panel affirmed the jury's finding that the doctors materially breached the contract, the district court's exclusion of the doctor's damages expert was necessarily harmless. View "Crowley v. EpiCept Corp." on Justia Law

Merck’s 353 patent claims mometasone furoate monohydrate, the active ingredient in Merck’s Nasonex® nasal product. Amneal submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration (FDA) seeking approval to market a generic mometasone furoate nasal spray. In Merck’s infringement suit, the district court found that Merck failed to prove that Amneal’s ANDA product will infringe. The Federal Circuit affirmed, upholding the district court’s refusal to require Amneal to produce additional samples of its ANDA product for testing before trial. The court rejected a claim that the noninfringement finding must be reversed because it was not based on Amneal’s final commercial product. The district court did not clearly err in finding that a Raman spectroscopy three-peak analysis was required to confirm the infringing form of mometasone furoate in Amneal’s product. Raman spectroscopy is a vibrational spectroscopy technique. A laser is used to generate a Raman spectrum, which indicates the vibrational modes of molecules and can be used to differentiate crystalline forms. View "Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC" on Justia Law

The Eleventh Circuit denied the petition for review of the DEA's denial of Jones Pharmacy and SND Healthcare's application for certificates of registration to dispense controlled substances under the Controlled Substances Act (CSA), 21 U.S.C. 801 et seq. The court held that substantial evidence supported the DEA's determination that Jones Pharmacy's owner did not credibly accept full responsibility; the DEA's refusal to consider Jones Pharmacy's remedial measures did not render its decision arbitrary or capricious in this case; and the chosen sanction was not arbitrary or capricious. View "Jones Total Health Care Pharmacy, LLC v. DEA" on Justia Law

Testosterone replacement drugs have been FDA-approved prescription drugs for more than 60 years. In recent years, manufacturers have found a new market: older men. Numerous lawsuits were filed against manufacturers alleging that the drugs increase health risks. Cases alleging that the manufacturers failed to warn doctors and patients adequately about the risks, citing state product-liability laws, were consolidated for pretrial proceedings. The district court granted a motion to dismiss brought by Depo-T’s manufacturer, finding the failure-to-warn claims preempted by federal law. The court stated that DepoT’s manufacturers could not change their drug labels to add warnings because FDA regulations prohibit them from “making a unilateral labeling change.” The Seventh Circuit affirmed. In Wyeth v. Levine, the Supreme Court held that claims against a manufacturer of a brand-name prescription drug for failure to warn adequately of the drug’s dangers were not preempted by federal law.; in PLIVA v. Mensing, the Court held that such failure-to-warn claims against manufacturers of generic drugs are preempted. The Court cited the different regulatory requirements and processes for approving and labeling prescription drugs. Depo-T “does not fit neatly into the colloquial dichotomy between brand-name and generic drugs” so the Seventh Circuit focused on whether the FDA approved public sale of its drugs through the “new drug application” or through the “abbreviated new drug application” (ANDA) and stated that the FDA-approved label defines an ANDA holder’s duty of sameness and the lines of federal preemption. View "Guilbeau v. Pfizer Inc." on Justia Law