Justia Drugs & Biotech Opinion Summaries

In these consolidated appeals arising out of two “off-label” prescription drug marketing cases aggregated for pretrial proceedings in the district court by order of a multidistrict litigation panel, the First Circuit reversed the dismissal of claims brought by two of the four plaintiffs, vacated the denial of Plaintiffs’ motion to compel the production of additional documents, and otherwise affirmed the district court's rulings.In their complaint, Plaintiffs claimed that Defendants, Forest Pharmaceuticals, Inc. and Forest Laboratories, Inc., engaged in an off-label marketing scheme aimed at fraudulently inducing doctors to write pediatric prescriptions of their antidepressant drugs when the FDA had not approved the use of these medications for minors. After discovery, the district court entered summary judgment for Defendant on Plaintiffs’ Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. 1962(c)-(d), claims and dismissed Plaintiffs’ state-based allegations as deriving from their noncognizable RICO claims. The First Circuit (1) reversed the district court’s entry of summary judgment on certain plaintiffs’ RICO and state-law claims and on another plaintiff’s RICO and unjust-enrichment claims on the basis that the evidence was insufficient on these claims; (2) vacated the denial of Plaintiffs’ motion to compel; (3) affirmed the denial of class certification; and (4) otherwise affirmed. View "Painters & Allied Trades District Council 82 Health Care Fund v. Forest Pharmaceuticals, Inc." on Justia Law

Dr. Barry’s patents, entitled “System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions,” claim methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at once. Dr. Barry sued Medtronic, alleging that Medtronic induced surgeons to infringe the patents. The jury found infringement of method claims 4 and 5 of the 358 patent and system claims 2, 3, and 4 of the 121 patent, rejected Medtronic’s several invalidity defenses, and awarded damages. In post-trial rulings on the jury issues, the district court upheld the verdict, rejecting challenges as to induced infringement and associated damages for domestic conduct, invalidity of the asserted 358 patent claims under the public-use and on-sale bars, and invalidity of all asserted claims due to another’s prior invention. The district court then rejected Medtronic’s inequitable-conduct challenge and enhanced damages by 20 percent while denying attorney’s fees to Dr. Barry, The Federal Circuit affirmed, rejecting several arguments by Medtronics, principally concerning the public-use and on-sale statutory bars, but also concerning prior invention, inequitable conduct, and induced infringement and associated damages. View "Barry v. Medtronic, Inc." on Justia Law

Bard manufactures a surgical patch, consisting of two pieces of mesh that surround a flexible plastic ring. During a hernia repair, the patch is folded to fit through a small incision, then the plastic ring springs back into its original shape and flattens the mesh against the abdominal wall. Bard recalled several versions of the patch in 2005-2006 following reports that the plastic ring was defective. Sometimes the ring broke, exposing a sharp edge that could perforate the patient’s intestines. Other times the ring caused the patch to bend and warp, exposing the patch’s adhesive to a patient’s viscera. Before the recall, Bowersock underwent hernia repair surgery, involving a Bard patch. Roughly one year later, she died of complications arising from an abdominal-wall abscess. Her estate sued. Unlike defective patches in other injured patients, Bowersock’s patch did not adhere to her bowel or perforate her organs. Plaintiff's expert tried to present a new theory of causation: the patch had “buckled,” forming a stiff edge that rubbed against and imperceptibly perforated her internal organs. The court excluded that testimony, finding the “buckling” theory not sufficiently reliable. The Seventh Circuit affirmed summary judgment for the defense. The novel theory of causation was not peer-reviewed, professionally presented, consistent with Bowersock’s medical records or autopsy, or substantiated by other cases. View "Robinson v. Davol, Inc." on Justia Law

Helsinn makes a treatment for chemotherapy-induced nausea using the chemical palonosetron. While developing that product, Helsinn granted another company the right to market a 0.25 mg dose of palonosetron in the United States; that company was required to keep proprietary information confidential. Nearly two years later, in 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Helsinn filed four patent applications that claimed priority to the 2003 date. Helsinn’s fourth application, filed in 2013 (the 219 patent), is covered by the Leahy-Smith America Invents Act (AIA). In 2011, Teva sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued for infringement. Teva countered that the 219 patent was invalid under the “on sale” provision of the AIA, which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention,” 35 U.S.C. 102(a)(1), arguing the 0.25 mg dose was “on sale” more than one year before Helsinn filed the 2003 application.The Federal Circuit held, and the Supreme Court unanimously agreed, that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements. A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under section 102(a). The patent statute in force immediately before the AIA included an on-sale bar. Supreme Court and Federal Circuit precedent interpreting that provision indicated that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. The Court applied the presumption that when Congress reenacted the “on sale” language in the AIA, it adopted earlier judicial constructions. View "Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

The Ninth Circuit affirmed the district court's grant of summary judgment for defendants, makers of vitamin E supplements, in an action alleging that the labels on the supplements violated California laws against false advertising. The panel held that section 343-1(a)(5) of the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempts state law requirements for claims about dietary supplements that differ from the FDCA's requirements. In this case, the panel held that section 343-1(a)(5) preempted most of plaintiff's claims.The panel held that because the FDCA and California law have the same labeling requirement with respect to failing to disclose an increased risk of death, section 343-1(a)(5) did not preempt this part of plaintiff's action. The panel held that the record lacked evidence that vitamin E supplements were actually harmful, as opposed to simply useless at reducing all-cause mortality (which they did not claim to reduce). Therefore, there was no genuine issue of material fact as to whether defendants' immune-health structure/function claim was misleading. View "Dachauer v. NBTY, Inc." on Justia Law

Plaintiff filed suit against pharmaceutical companies, alleging that they were liable for substantial gambling and other financial losses that resulted from obsessive compulsive behavior, a side effect of taking a dopamine agonist called Mirapex for his Parkinson's disease. The Eighth Circuit affirmed the district court's grant of summary judgment dismissing all claims as barred by the applicable California statute of limitations. The court rejected plaintiff's contention that the statute should be tolled because he was insane when the cause of action accrued; rejected plaintiff's contention that each ingestion of the drug gave rise to a separate and distinct claim under the continuing violations doctrine; and held that the district court did not abuse its discretion in denying a motion to stay defendants' motion for summary judgment. View "Mancini v. Boehringer Ingelheim Pharmaceuticals" on Justia Law

Hi-Tech filed suit alleging that the label of a protein-powder supplement distributed by HBS misled customers about the quantity and quality of protein in each serving, violating both the Georgia Uniform Deceptive Trade Practices Act and the federal Lanham Act. The district court dismissed the complaint.The Eleventh Circuit affirmed the district court's dismissal of the state law claim because it was preempted by the Food, Drug, and Cosmetics Act (FDCA). However, the court reversed the district court's dismissal of the Lanham Act claim, and rejected HBS's arguments that the FDCA barred the claim under the Lanham Act. In this case, Hi-Tech's Lanham Act claim would only require a court to determine whether the protein-content representations on the HexaPro label were misleading to consumers in the context of the label's failure to specify the sources of the nitrogen measured by the federal test. Therefore, this inquiry would not require a court to interpret or apply the FDCA to determine whether or not the marketing of the supplement was deceptive. View "Hi-Tech Pharmaceuticals, Inc. v. HBS International Corp." on Justia Law

In late 2015, Mississippi filed a complaint against fifteen pharmaceutical manufacturers and their affiliates (“Defendants”). In this interlocutory appeal, the issue this case presented for the Mississippi Supreme Court's review centered on whether the location of a foreign corporation’s registered agent was relevant when determining the appropriate venue for an action. The Supreme Court found that the adoption of the Registered Agents Act (“RAA”) made the location of a corporation’s registered agent irrelevant for purposes of venue. View "Purdue Pharma L.P. v. Mississippi" on Justia Law

The First Circuit reversed the district court’s certification of a class of all purchasers of Asacol, including purchasers who had not suffered any injury attributable to Defendants’ allegedly anticompetitive behavior, holding that the district court’s approach to certifying a class was at odds with both Supreme Court precedent and the law of this circuit.Drug manufacturer Warner Chilcott Limited’s coordinated withdrawal and entry of two drugs, Asacol and the similar drug called Delzicol, precluded generic manufacturers from introducing a generic version of Asacol, which would have provided a lower-cost alternative to Warner’s drugs, Delzicol and Asacol HD. Plaintiffs filed a class action alleging violations of the consumer protection and antitrust laws of twenty-five states and the District of Columbia. The district court certified a class of all Asacol purchasers who subsequently purchased Delzicol or Asacol HD in one of those twenty-six jurisdictions, finding that while ten percent of the class had not suffered any injury, those uninjured class members could be removed in a proceeding conducted by a claims administrator. The First Circuit reversed, holding that where injury-in-fact is a required element of an antitrust action, a class cannot be certified based on an expectation that the defendant will have no opportunity to press at trial genuine challenges to allegations of injury-in-fact. View "Teamsters Union 25 Health Services & Insurance Plan v. Warner Chilcott Limited" on Justia Law

The Ninth Circuit reversed the dismissal of an action alleging California consumer claims against MusclePharm Corporation, a manufacturer of nutritional supplements. The complaint alleged that MusclePharm made false or misleading statements about the protein in one of its products.The Ninth Circuit held that the Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations concerned only the calculation and disclosure of protein amount; the FDCA preempted a state-law misbranding theory premised on the supplement's use of nitrogen-spiking agents to inflate the measurement of protein for the nutrition panel; but the FDCA did not preempt a state-law misbranding theory premised on the label's allegedly false or misleading implication that the supplement's protein came entirely from two specifically named, genuine protein sources. In this case, plaintiff's claims were not preempted to the extent they arose under this theory. View "Durnford v. MusclePharm Corp." on Justia Law