Justia Drugs & Biotech Opinion Summaries

In 2012 Schmidt, a former shareholder in Genaera, a biotechnology company that dissolved in 2009 and liquidated its assets, brought suit on behalf of himself and other former shareholders against the liquidating trustee (Argyce); the Genaera Liquidating Trust; Argyce’s CEO and Genaera’s former CFO; former major Genaera shareholders Xmark and BVF; former Genara directors and officers (D&O defendants); and the purchasers of certain Genaera assets. The complaint alleged that the liquidating trustee and the D&O defendants breached their fiduciary duties by disposing of promising drug technologies in tainted insider deals for far less than their true value and that Xmark and BVF aided and abetted this behavior so that companies they controlled could acquire Genaera’s assets at fire sale prices. Schmidt did not dispute the applicability of the two-year statute of limitations and that he filed suit more than two years after the assets were sold, but argued that the limitations period should be tolled under Pennsylvania’s discovery rule because he could not have been aware of the insider nature of the sales or that the assets were sold for below actual value until he learned the details of the sales, and subsequent market events suggested to him that the assets were quite valuable. The district court dismissed. The Third Circuit reversed in part, stating that it was premature to determine whether Schmidt exercised reasonable diligence. View "Schmidt v. Skolas" on Justia Law

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

Appellant, by and through his attorney, John Irwin, filed a motion for rule on clerk and a motion to be relieved as counsel. Irwin, a full-time, state-salaried public defender, stated in his motion for rule on clerk that the clerk refused to file the untimely record because of Irwin’s failure to follow the Arkansas Rules of Appellate Procedure-Criminal. The Supreme Court granted the motion for rule on clerk, as Irwin candidly admitted fault for the failure to perfect the appeal, and granted the motion to be relieved as counsel, as Irwin was not eligible for compensation on appeal. View "Childers v. State" on Justia Law

A.S., who suffers from a congenital birth defect, and his mother, Miller, who ingested Paxil while pregnant, sued GSK in the Philadelphia County Court, alleging that all parties were citizens of Pennsylvania. GSK removed the case based upon diversity. On plaintiffs’ motion, the case was consolidated with other Paxil cases before a district court judge who had previously held that GSK was a citizen of Pennsylvania and who remanded A.S.’s case and the other consolidated cases to state court. The case returned to state court on January 4, 2012. On June 7, 2013, the Third Circuit issued its opinion in Johnson, which held that GSK was a citizen of Delaware. Less than 30 days after the Johnson decision, GSK filed a second notice of removal in A.S.’s case and in eight other cases with the same procedural posture. The district court denied the motion and certified its order for interlocutory review. The Third Circuit directed remand to state court, holding that the second removal request was untimely under 28 U.S.C. 1446(b) because there had been a final order. View "A.S. v. SmithKline Beecham Corp" on Justia Law

Plaintiffs, non-profit organizations representing the manufacturers and distributors of pharmaceutical products, filed suit challenging the Alameda County Safe Drug Disposal Ordinance, which requires that prescription drug manufacturers, who either sell, offer for sale, or distribute "Covered Drugs" in Alameda, operate and finance a "Product Stewardship Program." The court concluded that the Ordinance, both on its face and in effect, does not discriminate because it applies to all manufacturers that make their drugs available in Alameda County - without respect to the geographic location of the manufacturer; the Ordinance does not directly regulate interstate commerce where it does not control conduct beyond the boundaries of the county; under the balancing test in Pike v. Bruce Church, Inc., the court concluded that, without any evidence that the Ordinance will affect the interstate flow of goods, the Ordinance does not substantially burden interstate commerce; and therefore, the Ordinance does not violate the dormant Commerce Clause. Accordingly, the court affirmed the district court's grant of summary judgment to defendants. View "PRMA v. County of Alameda" on Justia Law

In 2008, ReGen Biologics, manufacturer of the Collagen Scaffold, obtained FDA approval to market the device. After allegations that improper political pressure tainted the clearance process, the FDA conducted an internal investigation and concluded that some procedural irregularities had occurred during the agency's review of the device. Asserting its inherent reconsideration authority, the agency reevaluated the scaffold and concluded that it had erred in allowing the device to be sold. The FDA issued an order rescinding its clearance decision. ReGen immediately pulled the scaffold from the market and subsequently filed for bankruptcy. ReGen and its successor in interest, Ivy, filed suit challenging the FDA's decision to rescind and the district court granted summary judgment for the agency. The court reversed, concluding that the FDA did not follow the proper statutory procedure for reclassifying a device. Rescinding its determination had the effect of putting the device into Class III, and thus required completion of the extensive pre-market approval process before the scaffold could be marketed again. Accordingly, the court vacated and remanded for further proceedings. View "Ivy Sports Medicine, LLC v. Sebelius, et al." on Justia Law

Ferring and Watson market competing prescription progesterone products. Progesterone plays a key role in helping women become pregnant and maintain pregnancies by preparing and maintaining the uterine lining to support the embryo during early pregnancy. Historically, women have received progesterone through intramuscular shots, which are not FDA-approved and which patients consider painful. Both companies manufacture a product that administers progesterone to women through vaginal inserts rather than shots. Ferring’s product, Endometrin, is delivered in capsule form. Watson’s product, Crinone, is a gel delivered via applicator. Ferring unsuccessfully sought a preliminary injunction under the Lanham Act, based on two presentations made by Watson in 2012 to healthcare professionals concerning Crinone. Watson’s consultant, Dr. Silverberg made statements concerning a “Black Box” warning on Endometrin’s package insert; a patient preference survey comparing the products; and Endometrin’s effectiveness in women over the age 35. Silverberg was alerted to the inaccuracy of his statement about a Black Box warning after the first webcast and certified to Ferring and to the court that he would not repeat the statement. The district court held that Ferring failed to demonstrate irreparable harm. The Third Circuit affirmed, citing Supreme Court holdings that a party bringing a claim under the Lanham Act is not entitled to a presumption of irreparable harm when seeking a preliminary injunction and must demonstrate that irreparable harm is likely. View "Ferring Pharm. Inc. v. Watson Pharm., Inc." on Justia Law

Tranexamic acid, the active ingredient in Ferring’s patented product, is used to treat heavy menstrual bleeding (menorrhagia) in women. Tranexamic acid has been widely used in an immediate release formulation for more than 30 years to treat menorrhagia in other countries. Ferring developed a tranexamic acid formulation with fewer gastrointestinal side effects than the immediate release version used abroad, but with the same benefits, by creating a formulation with a tranexamic acid release rate that matched the rate of absorption in the gastrointestinal tract. Ferring’s commercial product is known as Lysteda. In 2004, the FDA approved a fast-track designation for approval of Lysteda, and the Lysteda New Drug Application was approved in 2009 as the first tranexamic acid drug approved for use in the U.S. Apotex sought to market a generic version of Lysted that would avoid infringement of Ferring’s patent applications, but that would be bioequivalent to Lysteda, by altering the rate of absorption. Ferring then sued Apotex for infringement. The district court dismissed after Apotex amended its Abbreviated new Drug ApplicationView "Ferring B.V. v. Watson Labs, Inc., FL" on Justia Law

The Kennedy patents cover a popular treatment for rheumatoid arthritis: a combination therapy of a disease-modifying antirheumatic drug and an antibody. The 766 patent expired in October 2012; the 422 patent will expire in August 2018. In 2002, AbbVie1 obtained a license to the 766 patent. Thereafter, AbbVie obtained FDA approval to sell Humira, an anti-TNFα antibody, for use either alone or in combination with methotrexate to treat rheumatoid arthritis. AbbVie paid Kennedy more than $100 million in royalties for AbbVie’s U.S. sales of Humira. When the 442 patent issued in 2010, Kennedy demanded that AbbVie secure an additional license for that patent in order to continue sales of Humira. Kennedy conceded that the 766 patent encompasses the same inventive subject matter as the 442 patent, but contended that the 442 patent was nonetheless patentable because the 766 patent claims a “broad genus” of methods for treating rheumatoid arthritis, whereas the 442 patent claims a “narrower species” of those treatment methods with unexpected results. AbbVie obtained a declaratory judgment that claims of the 442 patent were invalid over the 766 patent for obviousness-type double patenting. The Federal Circuit affirmed.View "AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust" on Justia Law

Payne sued Novartis for failing to warn her doctor that two of the drugs it manufactures, Aredia and Zometa, could cause serious damage to a patient’s jaw bones. The drugs are given intravenously, most often to patients with cancerous conditions, and are effective in preventing pathological fractures and other bone pains. Payne took both in 1999-2001 and had to have part of her jaw removed in 2007 because of osteonecrosis, which results in the gums being eaten away until the bone is exposed The connection between the drugs and the condition began to come to light to the medical community in the early 2000’s. The district court entered summary judgment for Novartis. The Sixth Circuit reversed. Under Tennessee law, the question of whether Novartis’s failure to warn was a cause of Payne’s injuries is for a jury to determine. Payne’s testimony, combined with that of her doctor, could establish a sufficient causal link between Novartis’s failure to warn and Payne’s jaw death. A reasonable jury could conclude that Payne would not have taken Aredia or Zometa had her doctor warned her of the risk View "Payne v. Novartis Pharm. Corp." on Justia Law