Justia Drugs & Biotech Opinion SummariesArticles Posted in U.S. 6th Circuit Court of Appeals
Fulgenzi v. PLIVA, Inc.
Fulgenzi was prescribed the generic drug metoclopramide (FDA approved in 1980), sold originally under the brand name Reglan, a drug approved for short-term treatment of patients suffering from gastroesophageal reflux disease. In her suit, claiming failure to adequately warn of risks, she alleged that taking the drug caused her to develop tardive dyskinesia, an often-irreversible neurological disorder that causes involuntary movements, especially of the lower face. In 2009, the Supreme Court held that with respect to branded drug manufacturers, state failure-to-warn suits were not preempted by the federal Food Drug and Cosmetic Act , 21 U.S.C. 301. In 2011 the Court held that such suits could not go forward against generic drug manufacturers, as it is impossible to comply simultaneously with their state duty to adequately warn and their federal duty of sameness (federal law requires generic drug labels to be the same as their branded counterpart). The district court dismissed. The Sixth Circuit reversed, noting that after the branded-drug manufacturer of metoclopramide strengthened warnings on its label, the generic manufacturer failed to update its label as required by federal law, rendering compliance with both federal and state duties no longer impossible. View "Fulgenzi v. PLIVA, Inc." on Justia Law
Casias v. Wal-Mart Stores, Inc.
In 2008, Michigan passed the MMMA, Comp. Laws 333.26421, to protect medical marijuana. Any “qualifying patient” who possesses a registry identification card is not “subject to arrest, prosecution, or penalty of any manner, or denied any right or privilege, including but not limited to civil penalty or disciplinary action by a business.” Plaintiff was employed by Wal-Mart for five years before he was terminated after testing positive for marijuana, in violation of the company’s drug use policy. The test was administered on the day after Plaintiff injured his knee at work. Plaintiff was diagnosed with sinus cancer and an inoperable brain tumor at age 17; he experiences constant pain and side effects of medications. In 2008, Plaintiff’s oncologist recommended marijuana; Plaintiff obtained a registry card and maintains that he followed state laws, never used marijuana at work, nor did he work under the influence. Plaintiff sued in state court for wrongful discharge and MMMA violation; defendants removed to federal court based on diversity. The district court denied remand and dismissed. The court held that the store manager, a Michigan resident, was fraudulently joined and that the MMMA does not regulate private employment. The Sixth Circuit affirmed, noting that the manager had no potential liability. View "Casias v. Wal-Mart Stores, Inc." on Justia Law
Marsh v. Genetech Inc.
Genentech manufactured and sold the psoriasis medication Raptiva, approved by the FDA in 2003. Raptiva works by suppressing T-cells ; because T-cells help fight infections, suppression has the potential to cause potentially life-threatening side effects. Following reports of adverse health effects, including a rare brain infection, Genentech voluntarily removed Raptiva from the market in 2009. Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis and a collapsed lung. She sued in 2011, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. She claimed that, before and after FDA approval, Genentech knew of dangerous side effects that it concealed and did not include in the drug’s label. The district court dismissed, holding that Genentech was immune from suit because neither statutory exception to immunity for drug manufacturers applied. Marsh argued that immunity does not apply because failure to submit updated information rendered Raptiva noncompliant with FDA approval when it left Genentech’s control and that her claim was not preempted because it was premised on non-compliance rather than fraud or bribery. The Sixth Circuit affirmed. Allegations underlying Marsh’s argument that immunity does not apply are essentially the type of claim that is preempted. View "Marsh v. Genetech Inc." on Justia Law
Howmedica Osteonics, Corp. v. Nat’l Union Fire Ins. Co.
Stryker, a manufacturer of medical devices, sued its umbrella insurer XL, seeking coverage for claims stemming from the implantation of expired artificial knees. The dispute concerned the precise "defect" that triggers batch coverage under the Medical Products Endorsement. The district court held that XL was liable under the policy for the entirety of Stryker’s losses on both direct claims brought against Stryker, as well as claims brought against Pfizer that Stryker was obligated to reimburse under an asset purchase agreement. The court found that the items were defective if they were available in Stryker’s inventory for implantation by physicians beyond their shelf-life of five years. The Sixth Circuit affirmed XL’s liability for the full amount of Stryker’s losses and pre-judgment interest. XL’s payment to Pfizer applies to exhaust the policy with respect to the direct claims. The court reversed the holding that the aggregate limit of liability of the XL policy does not apply to the judgments on the direct claims and remanded for determination of what portion, if any, of the total liability for those judgments beyond $15 million represents consequential damages as defined under Michigan contract law. View "Howmedica Osteonics, Corp. v. Nat'l Union Fire Ins. Co." on Justia Law
Stryker Corp. v. Nat’l Union Fire Ins. Co.
TIG issued a $25 million excess policy to Stryker, a manufacturer of medical devices. Coverage attached above the underlying (XL) umbrella policy, with a limit of $15 million. Stryker sued XL, seeking defense and indemnification for claims related to replacement knees (first suit). Pfizer then sued Stryker, seeking indemnification with respect to claims based on Uni-Knees; the companies had an asset purchase agreement. The court ruled in favor of Pfizer. When XL denied coverage, Stryker sued both insurers. In 2008, the district court held that XL was liable for all of Stryker's liabilities with respect to both suits and also granted declaratory judgment against TIG. XL settled directly with Pfizer, and obtained a ruling that this satisfied its obligations. TIG moved to remove the declaratory judgment ruling, arguing that the ruling that XL was responsible with respect to both suits made it impossible to subject TIG to liability. The district court denied this motion. The Sixth Circuit affirmed that the case is not moot, noting that the claims may exhaust the XL policy; reversed a ruling that TIG is precluded from raising coverage defenses on remand, noting that TIG was not a party to the first suit; and remanded. View "Stryker Corp. v. Nat'l Union Fire Ins. Co." on Justia Law
Rodriguez v. Stryker Corp.
In 2004, plaintiff had arthroscopic surgery to treat pain and instability in his shoulder joint. The doctor implanted a pain-pump catheter and, over the next two days, a Stryker pain pump delivered a regular dose of a local anesthetic, bupivicaine, to the joint. Plaintiff’s condition improved after surgery but worsened over time, and in 2008 he learned he no longer had any cartilage remaining in his shoulder, a condition called chondrolysis. He sued, alleging strict liability, negligence and breach of warranty. The district court concluded that Stryker could not reasonably have known about the risk of chondrolysis in 2004 and thus had no duty to warn of the risk and held that Plaintiff failed as a matter of law to prove causation. The Sixth Circuit affirmed. Plaintiff did not present any evidence that Stryker knew or should have known that the use was dangerous or that a warning on Stryker's pain pump would have caused the doctor not to use the device in his joint space. View "Rodriguez v. Stryker Corp." on Justia Law
United States v. Cunningham
Defendants, two of three lawyers who represented several hundred Kentucky clients in a mass-tort action against the manufacturer of the defective diet drug "fen-phen," settled the case for $200 million, which entitled them under their retainer agreements to approximately $22 million each in attorney fees. By visiting clients and obtaining their signatures on "confidential settlements," for lesser amounts, the two actually disbursed slightly more than $45 million, less than 23 percent of the total settlement. The lawyers kept the remainder for themselves and associated counsel, transferring much of it from the escrow account to various other accounts, including out-of-state accounts. The scheme was discovered; the lawyers were disbarred and convicted of conspiracy to commit wire fraud, 18 U.S.C. 1343, 1349. One was sentenced to 240 months, the other to 300 months. They were ordered to pay more than $127 million in restitution. The Sixth Circuit affirmed, rejecting a variety of challenges to the sufficiency of the evidence and trial procedures. View "United States v. Cunningham" on Justia Law
Morris v. Wyeth, Inc.
Plaintiffs developed tardive dyskinesia as a result of use of generic metoclopramide, a drug prescribed for treatment of gastroesophageal reflux disease. They filed individual suits against manufacturers, alleging failure include adequate information on product labels concerning the risks of taking the drug long-term. They also named as parties manufacturers of the name-brand form of metoclopramide, alleging fraud and tortious misrepresentation. The district court dismissed plaintiffs' tort claims against the generic defendants on preemption grounds, finding conflict with federal regulation of generic drugs. The court also dismissed claims against name-brand defendants for failure to allege that they had ingested Reglan, a threshold requirement for a products-liability action under Kentucky law. The Sixth Circuit affirmed, stating that name-brand manufacturers have no duty to individuals who have never taken the drug they manufacture. View "Morris v. Wyeth, Inc." on Justia Law