Justia Drugs & Biotech Opinion Summaries

Plaintiff filed filed a qui tam action against a corporation and its subsidiary, both of whom manufacture and market medical devices, alleging that Defendants violated the False Claims Act in selling two particular medical devices to hospitals that seek reimbursement from the federal government through, for example, the Center for Medicare and Medicaid Services. Through two subsequent amendments, both with permission of the court, Plaintiff added several defendants and retooled his claims. Plaintiff then requested leave to amend fourth amended complaint. The district court applied the “good cause” standard from Fed. R. Civ. P. 16(b) to that request and struck the amended complaint. The First Circuit originally held that the district court should have evaluated Plaintiff’s fourth amended complaint under the standard set forth in Fed. R. Civ. P. 15(a). On remand, the district court concluded that Plaintiff’s desired amendment failed under that standard. The First Circuit affirmed, holding that Plaintiff’s request for leave to file his fourth amended complaint was properly denied as futile because none of the claims in Plaintiff’s fourth amended complaint was adequately pled. View "D'Agostino v. EV3, Inc." on Justia Law

Medgraph’s patents are directed to a method for improving and facilitating diagnosis and treatment of patients: data relating to “medically important variable[s],” such as blood sugar levels, measured from a patient’s body, are uploaded and transmitted to a central storage device, from which they can be accessed remotely by medical professionals. Medtronic manufactures and markets integrated diabetes management solutions, allowing patients to upload data relating to their diabetes, including blood glucose readings, to Medtronic’s server; patients can keep an online record and share the information remotely with a healthcare provider. Medgraph sued, alleging infringement. A year later, the Federal Circuit issued the first of its “Akamai” holdings, which culminated with a remand by the Supreme Court in 2014. The district court subsequently entered summary judgment of no infringement in favor of Medtronic, applying the law on direct infringement liability as it then stood, stating that “more than one person, i.e., the patient or doctor, neither of whom is an agent of or under contractual obligation to Medtronic, is required to perform all of the steps of the method claims.” The Federal Circuit then issued Akamai V, an en banc holding that attribution is proper “when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.” The Federal Circuit affirmed, finding the decision unaffected by Akamai V. View "Medgraph, Inc. v. Medtronic, Inc." on Justia Law

NuVasive’s patent generally relates to “[a] system and method for spinal fusion comprising a spinal fusion implant of non-bone construction releasably coupled to an insertion instrument dimensioned to introduce the spinal fusion implant into any of a variety of spinal target sites.” On inter partes review, the Patent Trial and Appeal Board found certain claims invalid as obvious. The Federal Circuit vacated. The Board did not adequately explain how a claim would have been obvious over prior art, 35 U.S.C. 103(a) and did not articulate a motivation to combine prior art references. View "In re: Nuvasive, Inc." on Justia Law

Plaintiff brought a qui tam action against Takeda Pharmaceutical Company and its affiliates (collectively, Takeda) and Eli Lilly and Company (Eli Lilly) (collectively, Defendants) under the False Claims Act (FCA) and the False Claims Acts of several different states, alleging that Defendants engaged in an illegal marketing campaign for Actos, a brand name drug approved by the FDA for improving blood sugar control in adults with Type 2 diabetes, and used illegal kickbacks to support that campaign. Plaintiff further alleged that through this campaign, Defendants knowingly caused third parties to submit false reimbursement claims to government entities for off-label uses of Actos. The district court dismissed Plaintiff’s claims, concluding that Plaintiff had failed to plead his claims with the particularity required by Fed. R. Civ. P. 9(b). The First Circuit affirmed, holding (1) the district court correctly dismissed Plaintiff’s complaint under Rule 9(b); and (2) the district court similarly did not err when it dismissed Plaintiff’s state claims with prejudice. View "Lawton v. Takeda Pharmaceutical Co." on Justia Law

AstraZeneca, a drug manufacturer that owns the patents covering Nexium, a prescription heartburn medication, sued Ranbaxy for patent infringement after Ranbaxy announced that it sought to market a generic version of Nexium. The two companies reached a settlement agreement under which Ranbaxy agreed to delay the launch of its generic until a certain date in return for various promises from AstraZeneca. Plaintiffs - pharmaceutical retail outlets and certified classes of direct purchasers and end payers - filed suit, arguing that the terms of the settlement agreements violated federal antitrust laws and state analogues. The jury found that although Plaintiffs had proved an antitrust violation, Plaintiffs had not shown that they suffered an antitrust injury that entitled them to damages. The First Circuit affirmed, holding (1) the district court did not commit reversible error in its evidentiary rulings, the formulation of the special verdict form and jury instructions, or its judgment as a matter of law on overarching conspiracy; and (2) the jury verdict rendered harmless any error that may have occurred during the summary judgment proceedings. View "In re Nexium Antitrust Litigation" on Justia Law

In the 1990s, Stryker purchased a Pfizer subsidiary that made orthopedic products, including the “Uni-knee” artificial joint. It was later discovered that those devices were sterilized using gamma rays, which caused polyethylene to degrade. If implanted past their five-year shelf-life, the knees could fail. Expired Uni-Knees were implanted in patients. Stryker, facing individual product-liability claims and potentially liable to Pfizer, sought defense and indemnification under a $15 million XL “commercial umbrella” policy, and a TIG “excess liability” policy that kicked in after the umbrella policy was fully “exhausted.” XL denied coverage, arguing that the Uni-Knee claims were “known or suspected” before the inception of the policy. Stryker filed lawsuits against the insurers, then unilaterally settled its individual product-liability claims for $7.6 million. Stryker was adjudicated liable to Pfizer for $17.7 million. About 10 years later, the Sixth Circuit held that XL was obliged to provide coverage. XL paid out the Pfizer judgment first, exhausting coverage limits. TIG declined to pay the remaining $7.6 million, arguing that Stryker failed to obtain “written consent” at the time the settlements were made. Stryker claimed that the policy was latently ambiguous because XL satisfied the Pfizer judgment first, Stryker was forced to present its settlements to TIG years after they were made. The district court granted Stryker summary judgment. The Sixth Circuit reversed, finding the contract unambiguous in requiring consent. View "Stryker Corp. v. National Union Fire Insurance Co." on Justia Law

The Alfred E. Mann Foundation owns two patents that cover implantable cochlear stimulators and formed Advanced Bionics to manufacture implants. The patents are directed to an ear implant with telemetry functionality for testing purposes, and generally describe a two-part system comprising an external wearable system with a wearable processor (WP) and headpiece, and an internal implantable cochlear stimulator (ICS). Sound is transmitted from the headpiece to the WP, which processes the transmissions before sending them to the ICS. The ICS processes the sound to stimulate the cochlea––the organ that converts sound to nerve impulses––via implanted electrodes, thereby allowing the user to hear. The system allows testers, usually physicians, to measure and adjust various parameters of the implant to assess whether the device is functioning properly. The Foundation sued Cochlear Corporation for infringement. The court found certain claims invalid for indefiniteness, entered judgment as a matter of law of no willful infringement, and granted a new trial on damages. The Federal Circuit affirmed in part, upholding the infringement determination with respect to some claims, but vacated and remanded with respect to willfulness in light of the Supreme Court’s 2016 decision, Halo Electronics, Inc. v. Pulse Electronics, Inc. View "Alfred E. Mann Foundation for Scientific Research v. Cochlear Corp." on Justia Law

NuVasive’s patent describes and claims implants for spinal fusion surgery. On inter partes review, the Patent Trial and Appeal Board cancelled all but one challenged claim under 35 U.S.C. 103, finding in one prior-art reference (Michelson), a spinal fusion implant that meets two of the claim requirements of the NuVasive patent—having a length both greater than 40 mm and at least 2.5 times its width. NuVasive argued that it did not receive adequate notice of or opportunity to address that reading of Michelson and its consequences for the overall obviousness analysis. The Federal Circuit vacated in part and remanded Medtronic’s petition put NuVasive on notice that Medtronic was relying on particular portions of Michelson to teach the NuVasive patent’s claimed long-and-narrow implants. Medtronic’s petition did not, however, notify NuVasive of the assertions about the pertinent portions of Michelson that later became critical; the Board’s ultimate reliance on that material, together with its refusal to allow NuVasive to respond fully once that material was called out, violated NuVasive’s rights under the Administrative Procedure Act. View "In re: NuVasive, Inc.." on Justia Law

Plaintiff filed a putative securities class action against defendants in connection with public statements made about Arena’s weight-loss drug, lorcaserin. When Arena filed its application with the FDA, the FDA’s advisory panel published a briefing document that disclosed, for the first time, that Arena had been in a “highly unusual” back-and-forth with the FDA regarding the results of cancer studies on rats (the “Rat Study”). Plaintiff filed suit after news of the Rat Study broke. The district court dismissed the First, Second, and Proposed Third Amended Complaints. The court agreed that once defendants touted the safety and likely approval of the drug based on animal studies, defendants were obligated to disclose the Rat Study's existence to the market. The court concluded that plaintiff has alleged scienter with sufficient particularity to survive a motion to dismiss. In this case, there is no question that plaintiff has alleged that defendants knew that the Rat Study existed, that defendants knew that the FDA’s request for bi-monthly reports and follow-up studies was highly unusual and out-of-process, and defendants went ahead and told investors about their confidence in lorcaserin’s approval based on preclinical animal studies. Therefore, the court concluded that plaintiff has properly pleaded scienter under Federal Rule of Civil Procedure 9(b) and the Private Securities Litigation Reform Act (PSLRA), 15 U.S.C. 78u-4. The court reversed and remanded. View "Schwartz v. Arena Pharmaceuticals, Inc." on Justia Law

Wagner, a licensed attorney proceeding pro se, took both brand‐name and generic hormone therapy drugs as prescribed by her gynecologist to treat her post‐menopausal endometrial hyperplasia. After taking the drugs, Wagner developed breast cancer. Wagner sued multiple pharmaceutical companies that designed, manufactured, promoted and distributed the drugs she took, asserting Wisconsin state law tort claims, all based upon allegations that the defendants sold dangerous products and failed to adequately warn of their risks. Defendants moved for Rule 12(c) judgment on the pleadings, arguing that federal law preempted Wagner’s claims. In response, Wagner asserted, for the first time, that the defendants delayed updating their generic brand labels to match the updated, stricter labels on the brand‐name drug. The district judge granted the motion, finding that the Food, Drug, and Cosmetics Act, 21 U.S.C. 301, preempted the state law claims. The Seventh Circuit affirmed: Wagner’s complaint lacked the requisite factual allegations to support a failure to update theory and federal law preempts her Wisconsin state‐law claims. View "Wagner v. Teva Pharmaceuticals USA, Inc." on Justia Law