Justia Drugs & Biotech Opinion Summaries

Orexo’s 330 Patent, entitled “Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence,” claims a product having the brand name Zubsolv®, approved by the FDA for treatment of opioid dependence. Actavis filed an Abbreviated New Drug Application for a generic counterpart of Zubsolv, accompanied by a Paragraph IV certification, leading to Hatch-Waxman litigation under 21 U.S.C. 355(j) and 35 U.S.C. 271(e)(2)(A). The Federal Circuit reversed a finding of obviousness. The question is not whether the references separately taught components of the 330 Patent formulation, but whether the prior art suggested the selection and combination achieved by the 330 inventors. The district court erred in discounting the enhanced bioavailability in the 330 patent’s formulation as “a ‘difference in degree,’ not a difference in ‘kind.’” The clinical studies reported in the 330 Patent show 66% improved bioavailability. In the context of this invention, this is more than a trivial “degree.” View "Orexo AB v. Actavis Elizabeth, LLC" on Justia Law

Bayer AG, maker and marketer of One A Day brand vitamins, was sued in California Superior Court for alleged violations of California’s Consumer Legal Remedies Act, Unfair Competition Law and express warranty law. Plaintiff William Brady’s theory was that Bayer’s packaging of its “Vitacraves Adult Multivitamin” line of gummies was misleading. Brady argued that despite the One A Day brand name, these particular vitamins require a daily dosage of two gummies to get the recommended daily values. Thus buyers end up receiving only half the daily vitamin coverage they think they are getting. The initial complaint was filed as a class action in March 2016, followed by an amended complaint in April, followed by a demurrer in May. The trial court, relying on the unpublished Howard v. Bayer Corp., E. D. Ark. July 22, 2011 (2011 U. S. Dist. LEXIS 161583) involving the supposedly misleading packaging of Bayer’s One A Day gummies, sustained Bayer’s demurrer without leave to amend. The Court of Appeal concluded Bayer failed to appreciate the degree to which their trade name One a Day has inspired reliance in consumers, and held an action alleging they violated California’s Consumer Legal Remedies Act, Unfair Competition Law and express warranty law should have survived demurrer. View "Brady v. Bayer Corp." on Justia Law

Silver’s qui tam action, filed under the False Claims Act (FCA), 31 U.S.C. 3729–33, alleged that PharMerica, which owns and operates institutional pharmacies serving nursing homes, unlawfully discounted prices for nursing homes’ Medicare Part A patients (reimbursed by the federal government to the nursing home on a flat per-diem basis) in order to secure contracts to supply services to patients covered by Medicare Part D and Medicaid (reimbursed directly to the pharmacy by the government on a cost basis) in the same nursing homes--a practice called swapping. The district court dismissed, based on the FCA’s public disclosure bar. The Third Circuit reversed. The district court improperly determined that documents publicly describing the generalized risk of swapping in the nursing home industry served to bar his specific claim, which depended on non-public information that PharMerica was actually engaging in swapping in specific contracts. The district court also erred in concluding, on the basis of Silver’s testimony, that he relied upon certain publicly available information to reach his conclusion and that the information itself disclosed the fraud, without independently determining that the relevant public document did, in fact, effectuate such a disclosure. View "Silver v. Omnicare Inc" on Justia Law

The First Circuit held that federal law requires prior FDA approval for a manufacturer of prescription eye drops to change the medication’s bottle so as to alter the amount of medication dispensed into the eye, and therefore, state law claims challenging the manufacturers’ refusal to make this change are preempted.Plaintiff sued in federal court on their own behalf and on behalf of a putative class of prescription eye solution purchasers, asserting that Defendants deliberately designed their dispensers to emit unnecessarily large drops. Plaintiffs alleged that Defendants’ practice was “unfair” under Massachusetts state law and twenty-five other states and allied claims for unjust enrichment and for “money had and received.” The district court dismissed the complaint without ruling on the merits, finding that FDA regulations preempted Plaintiffs’ suit. The First Circuit affirmed, holding (1) changing a product bottle so as to dispense a different amount of prescription eye solution is a “major change” under 21 C.F.R. 314.70(b); and (2) therefore, Plaintiffs’ state law claims were preempted. View "Gustavsen v. Alcon Laboratories, Inc." on Justia Law

In 2010, a doctor prescribed Paxil, the brand‐name version of paroxetine, to treat Stewart’s depression and anxiety. His prescription was filled with generic paroxetine manufactured by another company (not a defendant). Days later, Stewart committed suicide at age 57. He had paroxetine in his system. GSK manufactured brand‐name Paxil and was responsible under federal law for the content of the drug’s label. Labels for paroxetine and similar antidepressant drugs then warned that they were associated with suicide in patients under the age of 24 but did not warn about any association between the drugs and an increased risk of suicide in older adults. It is virtually impossible to sue generic drug manufacturers for failure to warn because they are required to use the FDA-approved label used by the brand-name (original) manufacturer. Only the brand-name manufacturer can seek FDA approval to change the label. Stewart’s wife sued GSK, alleging that it negligently failed to include warnings that paroxetine was associated with suicide in patients older than 24. The jury awarded her $3 million. The Seventh Circuit reversed, holding that federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicides in adults. The FDA repeatedly told GSK not to add a paroxetine‐specific suicide risk warning. View "Dolin v. GlaxoSmithKline LLC" on Justia Law

In these consolidated appeals from orders dismissing two putative antitrust class actions, the First Circuit affirmed the judgment of the district court holding that purchasers of a brand-name prescription drug had not plausibly alleged that either exception to Noerr-Pennington immunity applied to the alleged conduct of the drug maker and, on that basis, dismissing the putative class actions for failure to state a claim.Plaintiffs filed these antitrust actions alleging that Defendant unlawfully delayed the entry of generic versions of the drug at issue into the United States market by a fraud on the United States Patent and Trademark Office. Defendant moved to dismiss the actions, arguing that there was no fraud and claiming that it was immune from antitrust liability based on the Noerr-Pennington doctrine. See United Mine Workers of America v. Pennington, 381 U.S. 657 (1965). The district court dismissed the putative class actions under Fed. R. Civ. P. 12(b)(6), concluding that Noerr-Pennington immunity applied to Defendant’s alleged conduct and that the two exceptions to the immunity did not apply here. The First Circuit affirmed, holding that there was no reason to disturb the district court’s ruling dismissing Plaintiffs’ antitrust suits for failure to state a claim. View "United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund v. Novartis Pharmaceuticals Corp." on Justia Law

Accutane was a prescription medication developed by defendants and approved by the FDA to treat recalcitrant nodular acne. Accutane’s alleged role as a cause of gastrointestinal disease ultimately resulted in a series of lawsuits against defendants. The case before the New Jersey Supreme Court here involved over two thousand plaintiffs who alleged they developed Crohn’s disease as a result of taking Accutane. In the years since many earlier Accutane cases were decided, epidemiological studies were published, all of which concluded that Accutane was not causally associated with the development of Crohn’s disease. Defendants filed a motion seeking a hearing on the association between Accutane and Crohn’s disease. The issue presented for the New Jersey Supreme Court’s consideration reduced to the admissibility of scientific evidence under the New Jersey Rules of Evidence. Plaintiffs claimed that a causal connection existed between Accutane and Crohn’s disease. The Supreme Court discerned little distinction between “Daubert’s” principles regarding expert testimony and New Jersey’s, and Daubert’s factors for assessing the reliability of expert testimony “will aid New Jersey trial courts in their role as the gatekeeper of scientific expert testimony in civil cases.” The Court reconciled the standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases. Here, the trial court properly excluded plaintiffs’ experts’ testimony. Moreover, the Court reaffirmed that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case. In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts. View "In re: Accutane Litigation" on Justia Law

This matter stemmed from a lawsuit filed by the State of Mississippi against the defendant pharmacies. The State alleged deceptive trade practices and fraudulent reporting of inflated “usual and customary” prices in the defendant’s reimbursement requests to the Mississippi Department of Medicaid. The State argued that Walgreens, CVS, and Fred’s pharmacies purposefully misrepresented these prices to obtain higher prescription drug reimbursements from the State. Finding that the circuit court was better equipped to preside over this action, the DeSoto County Chancery Court transferred the matter to the DeSoto County Circuit Court in response to the defendants’ request. Aggrieved, the State timely filed an interlocutory appeal disputing the chancellor’s decision to transfer the case. After a thorough review of the parties’ positions, the Mississippi Supreme Court found that though the chancery court properly could have retained the action, the chancellor correctly used his discretion to transfer the case, allowing the issues to proceed in front of a circuit-court jury. As a result, the Supreme Court affirmed the chancellor’s decision. View "Mississippi v. Walgreen Co." on Justia Law

Owens began using Testim, a topical gel containing 1% testosterone, in July 2011 when his doctor diagnosed him with hypogonadism. Owens used Testim sporadically. Although the medication guide directs users to apply a full tube of Testim to the shoulders and arms, Owens would apply part of a tube to his thighs and stomach. In July 2013, Owens was admitted to a hospital for pain in his leg. An ultrasound revealed blood clots. He was diagnosed with deep vein thrombosis (DVT). Owens was treated with blood thinners and released the following day. Owens sued, asserting strict liability, negligence, fraud, and negligent misrepresentation under Kentucky law. Each claim requires expert testimony to establish causation. Owens’s case was selected for a bellwether trial in multidistrict litigation. Owens planned to rely on testimony by Dr. Abbas that Testim had caused Owens’s DVT. That opinion assumed that Owens was applying the prescribed dose in the proper manner. When asked during his deposition about hypothetical cases that resembled Owens’s use of Testim, Abbas had no opinion. The district court excluded the testimony and granted Auxilium summary judgment. The Seventh Circuit affirmed. The court properly applied the Daubert framework when excluding Abbas’s testimony. It did not abuse its discretion by concluding that the testimony did not fit the facts of Owens’s case or by failing to consider an argument Owens never presented. Without expert testimony on causation, Owens’s claims necessarily fail. View "Owens v. Auxilium Pharmaceuticals, Inc." on Justia Law

The Jazz patents relate to a drug distribution system for tracking prescriptions of a “sensitive drug.” “A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive.” One such sensitive drug is Xyrem®. Jazz exclusively markets Xyrem®, which the FDA has approved to treat symptoms associated with narcolepsy. The active ingredient in Xyrem®, gamma-hydroxybutyrate (GHB), may also be illicitly used as a “date-rape drug.” Under the Controlled Substances Act any approved drug product containing GHB is classified as a Schedule III depressant, so the FDA approved Xyrem® under “restricted distribution regulations contained in [21 C.F.R. 314.500] (Subpart H) to assure safe use of the product.” On inter partes review, the Patent Board found certain claims invalid as obvious. The Federal Circuit affirmed, upholding a conclusion that implementing prior art, consisting of background materials and the meeting minutes, transcript, and slides on the FDA website, on multiple computers “would have been a predictable use of a known distributed data system according to its established function.” View "Jazz Pharmaceuticals, Inc.. v. Amneal Pharmaceuticals, LLC" on Justia Law