Justia Drugs & Biotech Opinion Summaries

This appeal arose from 532 product-liability claims filed against Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal places of business in New Jersey. Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs alleged Accutane caused them to contract inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to advise them of the known risks of the medication. At issue for the New Jersey Supreme Court was : (1) what law governed whether Roche’s label warnings were adequate (the law of each of the 45 jurisdictions in which plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated); and (2) the adequacy of the label warnings for the period after April 2002. The Court found that because Roche’s warnings received the approval of the FDA, they enjoyed a “rebuttable presumption” of adequacy under New Jersey’s Products Liability Act (PLA). The Court reversed all cases in which the Appellate Division reinstated plaintiffs’ actions against Roche. "New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes. New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact. Plaintiffs have not overcome the PLA’s presumption of adequacy for medication warnings approved by the FDA. As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD." As a result, the 532 failure-to-warn cases brought by plaintiffs against Roche were dismissed. View "Accutane Litigation" on Justia Law

Esperion has never generated any revenue, relying solely upon investor funding. Esperion’s sole focus is the development of ETC-1002, a first-in-class oral medication for lowering LDL “bad cholesterol,” a significant risk factor in cardiovascular disease. Esperion hopes to market ETC-1002 as an alternative treatment for statin-intolerant patients and as an add-on for patients are unable to reach their recommended levels using statins alone. In 2015, Esperion had completed several clinical studies and reported that ETC-1002 was well-tolerated and demonstrated significant average LDL-cholesterol reductions. After a meeting with FDA officials regarding Phase 3 of the approval process, Esperion published a press release, stating that “[b]ased upon feedback from the FDA, approval of ETC-1002 in [specific] patient populations will not require the completion of a cardiovascular outcomes trial,” with cautionary language, suggesting that “Esperion may need to change the design of its Phase 3 program once final minutes from the FDA meeting are received.” Market reaction was mostly positive. Following its receipt of the final FDA minutes, Esperion published another press release, indicating that the “FDA has encouraged the Company to initiate a cardiovascular outcomes trial promptly.” Esperion’s stock dropped 48% the next day. Plaintiffs, the purchasers of Esperion common stock between the two press releases, brought a class action under sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5. The Sixth Circuit reversed the district court holding that Plaintiffs failed to adequately plead a strong inference that Esperion’s CEO willfully or recklessly made misleading statements. Plaintiffs adequately alleged scienter. View "Dougherty v. Esperion Therapeutics, Inc." on Justia Law

Acorda’s patents claim the administration of a medication containing the active ingredient 4- aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. Acorda holds an FDA-approved New Drug Application and markets, under the name “Ampyra®,” 10 milligram 4-AP sustained-release tablets for twice-daily oral administration and holds an exclusive license to the earlier, broader “Elan patent,” which is listed in the FDA Orange Book for Ampyra with the Acorda patents, and claims methods of treating patients having certain conditions, including multiple sclerosis, by administering a drug containing a sustained-release formulation of any of certain agents, including 4-AP. Defendants sought FDA approval to market generic versions of Ampyra. In Acorda's infringement suit, the district court held that the asserted claims in the Acorda patents are invalid for obviousness but upheld the Elan patent and enjoined infringement of that patent until it expired in July 2018. The Federal Circuit affirmed that the asserted Acorda patent claims are invalid, discounting the weight of Acorda’s evidence of commercial success, failure of others, and long-felt but unmet need. The court noted the Elan patent issued in 1996 and was licensed exclusively to Acorda in 1997 for spinal cord injury and in 1998 for multiple sclerosis treatment, which blocked others from domestic marketing without risk of infringement and deterred other entities from investing in research whose reward depended on marketing a drug like Ampyra. View "Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc." on Justia Law

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