Articles Posted in Drugs & Biotech

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In 2001, BioEnterics obtained FDA approval for the Lap-Band, “designed to induce weight loss in severely obese patients by limiting food consumption" by creation of a small gastric pouch. The FDA indicated that the Lap-Band’s labeling must “specify the requirements that apply to the training of practitioners who may use the device” and required annual progress reports on a postapproval study. BioEnterics's brochure states that surgeons planning laparoscopic placement must have specific experience, participate in a training program authorized by BioEnterics, be observed by “qualified personnel” during their first placements, have the equipment and experience necessary to complete the procedure via laparotomy if required, and report on their personal experiences using the device. In 2003, plaintiff underwent a surgical procedure to implant a Lap-Band, which eventually eroded into her stomach and her liver; Lap-Band tubing became entangled with her small intestine. During surgery to remove the Lap-Band she suffered a massive hemorrhaging from her liver, causing her to experience profound hypotension and systemic shock, resulting in brain damage. More than nine years later, plaintiff filed suit. The court of appeal affirmed dismissal of her claim that the company failed to adequately train physicians in the use of the Lap-Band, as preempted by federal law. View "Glennen v. Allergan, Inc." on Justia Law

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The People filed a complaint charging defendants with causing, aiding, and abetting the illegal delivery of marijuana. The trial court granted an injunction barring defendants from further developing or marketing their marijuana delivery app. At issue on appeal is whether Proposition D, L.A. Mun. Code, 45.19.6, which City voters enacted in 2013 to regulate medical marijuana businesses, generally prohibits the delivery of marijuana by vehicles. The court concluded that the City established a likelihood of proving defendants’ app caused, aided, or abetted the violation of Proposition D because, outside of the narrow exception for designated primary caregivers, it prohibits the vehicular delivery of medical marijuana to qualified participants, identification card holders, or primary caregivers in the City. Further, defendants’ opposition to the City’s unfair competition allegations necessarily fails because the City has demonstrated a likelihood of success on its claim that defendants facilitated a violation of Proposition D. In this case, defendants made no showing at all concerning the balance of hardships, much less that the balance tipped sharply in their favor. Accordingly, the court affirmed the trial court's judgment. View "People v. Nestdrop, LLC" on Justia Law

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Plaintiffs, including Jack and Nancy Cooper, filed suit against Takeda, manufacturers of the prescription drug Actos, which is used to treat type 2 diabetes mellitus. The Coopers appealed the trial court's grant of Takeda's motion for judgment notwithstanding the verdict and Takeda's alternative motion for new trial on the grounds that without the testimony of plaintiffs’ expert, Dr. Smith, the evidence was insufficient to support the verdict, and that the trial court should not have instructed the jury regarding concurrent causation. The court concluded that the trial court erred in striking the expert’s testimony. The court concluded that, by requiring that the expert rule out all other possible causes for Jack Cooper’s bladder cancer, even where there was no substantial evidence that other such causes might be relevant, the trial court exceeded the proper boundaries of its gatekeeping function in determining the admissibility of the complex scientific testimony. The court also concluded that the evidence supported giving a jury instruction on multiple causation. Accordingly, The court reversed the judgment notwithstanding the verdict and the order granting a new trial, as well as the subsequent judgment entered in favor of Takeda, and remanded the matter to the trial court with directions to enter a new judgment based on the jury’s verdict. View "Cooper v. Takeda Pharmaceuticals" on Justia Law

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Laura Nunez's attorneys served Lunada with a notice under the Consumer Legal Remedies Act (CLRA), Civil Code section 1750 et seq., alleging that her dietary supplement, Amberen, was being marketed falsely and misleadingly as a natural remedy for Menopausal symptom relief. Lunada subsequently filed a declaratory relief action against Nunez and her attorneys. Nunez and her attorneys moved to strike the complaint under the anti-SLAPP statute, Code of Civil Procedure section 425.16. The trial court granted the motion and Lunada appealed. The court held that the declaratory relief action seeking a declaration that Lunada had not violated the CLRA is subject to the anti-SLAPP statute because it arose out of protected activity under the statute. Consequently, the trial court properly granted the special motions to strike because Lunada's declaratory relief action had no probability of success. The court, under the reasoning of Filarsky v. Superior Court, held that a potential defendant in a CLRA damages action after receiving the statutory notice may not maintain a declaratory relief action to establish that there was no violation of the CLRA. Accordingly, the court affirmed the order striking the complaint and the award of attorney fees to Nunez and her attorneys.View "Lunada Biomedical v. Nunez" on Justia Law

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Bristol-Myers Squibb (BMS) was sued in a coordinated proceeding before the San Francisco Superior Court for alleged defects in Plavix, a drug BMS manufactures and sells throughout the country. BMS moved below to quash service of the summons regarding the complaints concerning plaintiffs who are not California residents, for lack of personal jurisdiction. The trial court denied BMS’s motion, finding that California had general jurisdiction over BMS, and did not address the issue of specific jurisdiction. Following the U.S. Supreme Court’s ruling in Daimler AG v. Bauman (2014) which limited the application of general jurisdiction under the Fourteenth Amendment, the California Supreme Court remanded to the court of appeals, which affirmed denial of the motion to quash. California does not have general jurisdiction over BMS in this case, but, applying the International Shoe Co. v. Washington test of “fair play and substantial justice,” the court reasoned that BMS has engaged in substantial, continuous economic activity in California, including the sale of more than a billion dollars of Plavix to Californians. That activity is substantially connected to claims by non-residents, which are based on the same alleged wrongs as those alleged by California-resident plaintiffs. BMS has not established that it would be unreasonable to assert jurisdiction over it. View "Bristol-Myers Squibb Co. v. Superior Court" on Justia Law

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Hardin suffered complete blindness and permanent, severe and painful scarring after she took Lamotrigine, the generic form of the medication Lamictal. Hardin sued the prescribing physician, the manufacturer, the store where she bought the prescription (Safeway), WKH, which produced the drug information pamphlet (monograph), and PDX, a software provider that distributes drug information to pharmacy customers. Unlike physician package inserts and patient medication guides, which are FDA-mandated, WKH monographs are not regulated or reviewed by the FDA, but are produced as part of a self-regulating action plan required under 110 Stat. 1593. The WKH monograph was the only information received by Hardin when she first filled her prescription for Lamictal. The abbreviated warning used by Safeway and provided to Hardin omitted the “Black Box” warning: “BEFORE USING THIS MEDICINE” that stated: “SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE. Hardin says that had she been provided this warning, she would not have taken the medication. WKH moved to strike Hardin’s claims against it under Code of Civil Procedure section 425.16, the “anti-SLAPP” (Strategic Lawsuit Against Public Participation ) statute.. The trial court ruled that WKH’s production of drug monographs was protected speech concerning a public issue or an issue of public interest and that Hardin had no probability of prevailing because she could not establish that WKH owed her any duty. The court denied PDX’s motion to strike, finding that the activity underlying PDX’s alleged liability was the reprogramming of its software to permit Safeway to give customers an abbreviated, five-section monograph that omitted warnings instead of the full eight-section version that included those warnings. The court of appeal affirmed. View "Hardin v. PDX, Inc." on Justia Law