Justia Civil Procedure Opinion SummariesArticles Posted in Drugs & Biotech
Dearinger v. Eli Lilly & Co.
The United States District Court for the Western District of Washington certified a question to the Washington Supreme Court, asking whether Washington law recognized an exception to the "learned intermediary doctrine" when a prescription drug manufacturer advertises its product directly to consumers. Under the learned intermediary doctrine, a prescription drug manufacturer satisfies its duty to warn patients of a drug’s risks when it adequately warns the prescribing physician. The Supreme Court answered the question in the negative: there was no direct-to-consumer advertising exception. "The policies underlying the learned intermediary doctrine remain intact even in the direct-to-consumer advertising context. Further, existing state law sufficiently regulates product warnings and prescription drug advertising. Accordingly, we hold regardless of whether a prescription drug manufacturer advertises its products directly to consumers, the manufacturer satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug’s risks and side effects." View "Dearinger v. Eli Lilly & Co." on Justia Law
California v. Johnson & Johnson
Johnson & Johnson, Ethicon, Inc., and Ethicon US, LLC (collectively, Ethicon) appealed after a trial court levied nearly $344 million in civil penalties against Ethicon for willfully circulating misleading medical device instructions and marketing communications that misstated, minimized, and/or omitted the health risks of Ethicon’s surgically-implantable transvaginal pelvic mesh products. The court found Ethicon committed 153,351 violations of the Unfair Competition Law (UCL), and 121,844 violations of the False Advertising Law (FAL). The court imposed a $1,250 civil penalty for each violation. The Court of Appeal concluded the trial court erred in just one respect: in addition to penalizing Ethicon for its medical device instructions and printed marketing communications, the court penalized Ethicon for its oral marketing communications, specifically, for deceptive statements Ethicon purportedly made during one-on-one conversations with doctors, at Ethicon-sponsored lunch events, and at health fair events. However, there was no evidence of what Ethicon’s employees and agents actually said in any of these oral marketing communications. Therefore, the Court of Appeal concluded substantial evidence did not support the trial court’s factual finding that Ethicon’s oral marketing communications were likely to deceive doctors. Judgment was amended to strike the nearly $42 million in civil penalties that were imposed for these communications. View "California v. Johnson & Johnson" on Justia Law
Paine v. Ride-Away, Inc.
Plaintiff Scott Paine appealed a superior court decision granting judgment on the pleadings for his employment discrimination claim against defendant, Ride-Away, Inc. Plaintiff suffered from Post-Traumatic Stress Disorder (PTSD) for many years, which substantially limited a major life activity. He was employed by defendant at its facility in Londonderry, New Hampshire as an automotive detailer in May 2018. In July 2018, his physician prescribed cannabis to help treat his PTSD, and plaintiff enrolled in New Hampshire’s therapeutic cannabis program. Plaintiff submitted a written request to defendant for an exception from its drug testing policy as a reasonable accommodation for his disability. Plaintiff explained that he was not requesting permission to use cannabis during work hours or to possess cannabis on defendant’s premises. Plaintiff was informed that he could no longer work for the company if he used cannabis. After plaintiff notified defendant that he was going to treat his PTSD with cannabis, his employment was terminated in September 2018. Plaintiff sued for employment discrimination, based on defendant’s failure to make reasonable accommodation for his disability. Defendant moved for judgment on the pleadings, asserting that, because marijuana use was both illegal and criminalized under federal law, the requested accommodation was facially unreasonable. After a hearing, the trial court granted defendant’s motion. The sole question before the New Hampshire Supreme Court was whether the court erred in ruling that the use of therapeutic cannabis prescribed in accordance with New Hampshire law could not, as a matter of law, be a reasonable accommodation for an employee’s disability under RSA chapter 354-A. The Supreme Court held the trial court erred in determining that the use of therapeutic cannabis prescribed in accordance with RSA chapter 126-X could not, as a matter of law, be a reasonable accommodation for an employee’s disability under RSA chapter 354-A. "[P]laintiff’s disability is PTSD, not the illegal use of or addiction to a controlled substance." Judgment was reversed and the matter remanded for further proceedings. View "Paine v. Ride-Away, Inc." on Justia Law
ACE American Insurance Company v. Rite Aid Corporation
Appellees, Rite Aid Corporation, Rite Aid Hdqtrs. Corp., and Rite Aid of Maryland, Inc. (collectively, “Rite Aid”), held a general liability insurance policy underwritten by defendany Chubb, Limited ("Chubb"). Rite Aid and others were defendants in multi-district litigation before the United States District Court for the Northern District of Ohio (the “MDL Opioid Lawsuits”). Plaintiffs in that suit filed over a thousand suits in the MDL Opioid Lawsuits against companies in the pharmaceutical supply chain for their roles in the national opioid crisis. Certain suits were bellwether suits - including the complaints of Summit and Cuyahoga Counties in Ohio (“the Counties”) which were at issue here. The question this case presented for the Delaware Supreme Court was whether insurance policies covering lawsuits “for” or “because of” personal injury required insurers to defend their insureds when the plaintiffs in the underlying suits expressly disavowed claims for personal injury and sought only their own economic damages. The Superior Court decided that Rite Aid’s insurance carriers were required to defend it against lawsuits filed by two Ohio counties to recover opioid-epidemic-related economic damages. As the court held, the lawsuits sought damages “for” or “because of” personal injury because there was arguably a causal connection between the counties’ economic damages and the injuries to their citizens from the opioid epidemic. The Supreme Court reversed, finding the plaintiffs, governmental entities, sought to recover only their own economic damages, specifically disclaiming recovery for personal injury or any specific treatment damages. Thus, the carriers did not have a duty to defend Rite Aid under the governing insurance policy. View "ACE American Insurance Company v. Rite Aid Corporation" on Justia Law
Ex parte Endo Health Solutions Inc. et al.
Several entities that owned or operated hospitals in Alabama ("plaintiffs") filed suit against manufacturers of prescription opioid medications, distributors of those medications, and retail pharmacies ("defendants"), alleging that defendants' marketing or selling of the medications resulted in an epidemic of opioid abuse in Alabama. Plaintiffs sought to recover unreimbursed medical expenses incurred in treating individuals with opioid-related medical conditions. Among other theories of liability, plaintiffs asserted that defendants had created a public nuisance in the form of the epidemic. The trial court entered a case-management order directing the parties to try each of plaintiffs' causes of action separately. The public-nuisance claim was to be tried first and is itself to be bifurcated into two separate trials. The first trial on the public-nuisance claim was to involve "liability," and the second trial was to involve "special damage." Defendants, asserting that the trial court had erred in bifurcating the public-nuisance claim, petitioned the Alabama Supreme Court for a writ of mandamus directing the trial court to vacate the relevant portion of the case-management order. The Supreme Court granted the writ: "conducting a trial on the issue of the defendants' 'liability' for a public nuisance and a second trial on 'special damage' neither avoids prejudice nor furthers convenience, expedition, or economy. We can only conclude that the trial court exceeded its discretion. We therefore grant the defendants' petition and issue a writ of mandamus." View "Ex parte Endo Health Solutions Inc. et al." on Justia Law
Neurelis, Inc. v. Aquestive Therapeutics, Inc.
Neurelis, Inc. (Neurelis) and Aquestive Therapeutics, Inc. (Aquestive) were pharmaceutical companies developing their own respective means to administer diazepam, a drug used to treat acute repetitive seizures (ARS). Neurelis was further along in the development process than Aquestive. According to Neurelis, Aquestive engaged in a “multi-year, anticompetitive campaign to derail the Food and Drug Administration” (FDA) from approving Neurelis’s new drug. Based on Aquestive’s alleged conduct, Neurelis sued Aquestive for defamation, malicious prosecution, and violation of the unfair competition law. In response, Aquestive brought a special motion to strike the complaint under the anti-SLAPP (Strategic Lawsuit Against Public Participation) statute. The superior court granted in part and denied in part Aquestive’s motion, finding that the defamation cause of action could not withstand the anti-SLAPP challenge. However, the court denied the motion as to Neurelis’s other two causes of action. Aquestive appealed, contending the court erred by failing to strike the malicious prosecution action as well as the claim for a violation of the UCL. Neurelis, in turn, cross-appealed, maintaining that the conduct giving rise to its defamation cause of action was not protected under the anti- SLAPP statute. The Court of Appeal agreed that at least some of the conduct giving rise to the defamation action was covered by the commercial speech exception and not subject to the anti-SLAPP statute. Accordingly, the Court held the superior court erred in granting the anti-SLAPP motion as to the defamation action. Some of this same conduct also gave rise to the UCL claim and was not subject to the anti-SLAPP statute too. However, the Court noted that Neurelis based part of two of its causes of action on Aquestive’s petitioning activity. That activity was protected conduct under the anti-SLAPP statute, and Neurelis did not show a likelihood to prevail on the merits. Thus, allegations relating to this petitioning conduct had to be struck. Finally, the Court found Neurelis did not show a probability of success on the merits regarding its malicious prosecution claim. As such, the Court held that claim should have been struck under the anti-SLAPP statute. View "Neurelis, Inc. v. Aquestive Therapeutics, Inc." on Justia Law
Celgene Corp. v. Mylan Pharmaceuticals Inc.
Celgene markets pomalidomide as a multiple-myeloma drug under the brand name Pomalyst. Many drug companies questioned the validity or applicability of Celgene's patents and sought to bring generic pomalidomide to market. The defendants submitted an abbreviated new drug application (ANDA) to the FDA. Celgene filed suit in New Jersey. Celgene is headquartered there, but no defendant is. MPI is based in West Virginia, Mylan Inc. in Pennsylvania, and Mylan N.V. in Pennsylvania and the Netherlands. The district court dismissed the case for improper venue (MPI; Mylan Inc.) and for failure to state a claim (as to Mylan N.V.).The Federal Circuit affirmed. Under the Hatch-Waxman Act, 21 U.S.C. 355(j)(5)(B)(iii), venue was improper in New Jersey for the domestic corporation defendants, MPI and Mylan Inc. Celgene did not show that those defendants committed acts of infringement in New Jersey and have a regular and established place of business there. The court rejected Celgene’s argument that receipt of the ANDA notice letter is an infringing act in New Jersey. Under section 271(e)(2), submitting an ANDA is the act of infringement; although the ANDA applicant must later send a notice letter that happens after the infringing submission. As to the foreign-corporation defendant, Mylan N.V., Celgene’s pleadings failed to state a claim upon which relief could be granted. View "Celgene Corp. v. Mylan Pharmaceuticals Inc." on Justia Law
St. Paul Fire & Marine Insurance Co. v. AmerisourceBergen Drug Corp.
The Supreme Court held in this case that the circuit court had the power to enter an order precluding a party to a West Virginia lawsuit from instituting or prosecuting collateral litigation in a sister state.This lawsuit was brought by a pharmaceutical distributor against the insurance companies that provided it with liability insurance. At issue on appeal was the West Virginia circuit court's "anti-suit injunction" prohibiting the insurance companies from pursuing parallel litigation against the distributor in California. The Supreme Court affirmed in part and reversed in part, holding (1) the circuit court clearly had the authority to enter an anti-suit injunction; but (2) an anti-suit injunction was not narrowly tailored to protect the court's authority while respecting the sister state court, necessitating remand. View "St. Paul Fire & Marine Insurance Co. v. AmerisourceBergen Drug Corp." on Justia Law
Optinose AS v. Currax Pharmaceuticals, LLC
OptiNose AS and OptiNose, Inc. (collectively, OptiNose) agreed to license its Exhalation Delivery Systems (“EDS”) technology to Currax Pharmaceuticals, LLC. The parties limited the License Agreement to a product which used a powder EDS device to deliver the migraine treatment drug sumatriptan into the nasal cavity. The product covered by the license, a powder EDS device and sumatriptan together, was trade-named ONZETRA(R) XSAIL(R). Currax had a limited right to sell the sumatriptan powder EDS device (the “Product”) in Canada, the United States, and Mexico. OptiNose retained the right to sell EDS devices: (1) with powders and liquids other than sumatriptan around the world; and (2) EDS devices with sumatriptan in every area other than those three countries. OptiNose also gave Currax the “first right” to “prosecute and maintain” certain patents related to the Product, listed in the License Agreement as the Product Patents. During Currax’s prosecution of the ’009 Patent Application, the U.S. Patent and Trademark Office (“USPTO”) rejected claims because they were not “patentably distinct” from the claims in another Product Patent. To overcome the patent office rejection, Currax needed to file a terminal disclaimer over the issued Product Patent. Currax needed a power of attorney from OptiNose to file a terminal disclaimer. OptiNose refused to provide it. Currax filed suit against OptiNose in the Court of Chancery, seeking an order of specific performance requiring OptiNose to grant it a power of attorney. OptiNose counterclaimed for a declaration that the License Agreement did not require it to provide a power of attorney. According to OptiNose, Currax’s right to prosecute Product Patents did not include a power of attorney, and, in any event, Currax could not file a terminal disclaimer without OptiNose’s advance approval, which it had not given. The Court of Chancery granted Currax’s motion for judgment on the pleadings, finding the License Agreement OptiNose to provide a power of attorney to prosecute the ’009 Application. On appeal, the parties focused primarily on OptiNose’s advance approval right, and whether a terminal disclaimer “relate[s] to or characterize[s] the Device component of the Patent or other OptiNose intellectual property.” The Delaware Supreme Court affirmed the Court of Chancery’s judgment that filing a terminal disclaimer in the ’009 Application prosecution was included in the rights OptiNose gave to Currax under the License Agreement. View "Optinose AS v. Currax Pharmaceuticals, LLC" on Justia Law
Association of American Physicians & Surgeons v. United States Food & Drug Administration
A drug manufacturer cannot distribute a drug in interstate commerce without obtaining the FDA’s approval for the uses listed on the drug’s official label, 21 U.S.C. 355(a). The Act does not prohibit doctors from prescribing FDA-approved drugs for “off-label” use but leaves the regulation of doctors to the states. Hydroxychloroquine is approved to treat malaria, lupus, and arthritis but not to treat COVID-19. In 2020, the FDA relied on then-available data and issued an Emergency Use Authorization, permitting hydroxychloroquine in the federal government’s strategic stockpile to be distributed to treat COVID-19 patients in limited circumstances.The Association, a nonprofit organization with physician members, sued, challenging restrictions barring use of hydroxychloroquine to treat COVID-19 except for hospitalized patients. The Association alleged that these restrictions violated the implied equal-protection guarantee in the Fifth Amendment; violated the First Amendment right to associate by limiting access to medication useful for meeting in groups; and violated the Administrative Procedure Act. The Association alleged an injury to itself: it was considering canceling a conference purportedly due to the restrictions. It also invoked associational standing on behalf of its physician members who could not prescribe hydroxychloroquine for COVID-19.The district court held that none of these injuries plausibly pleaded the Association’s standing to challenge the Authorization. The court dismissed the complaint for lack of subject matter jurisdiction. The Sixth Circuit affirmed. The Associaiton failed to plausibly plead that any member has been injured by the FDA’s actions. View "Association of American Physicians & Surgeons v. United States Food & Drug Administration" on Justia Law