Pharmaceutical/Medical Device

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Dictionary series: Tort

Since prescription opioids were first introduced for pain treatment in the 1990s, the number of drug overdose deaths has quadrupled, and more than a half million Americans have died from an overdose involving an opioid.[1] The CDC has labeled this an epidemic, and most agree that it is a public health crisis. But courts are divided over whether this crisis is legally a public nuisance. As appellate courts issue decisions and trials across the country reach verdicts, the contours of tort law are being reshaped and defined — specifically the applicability of public nuisance in product liability and mass torts cases.…
Continue Reading Trending in Tort Law Part II: Courts Address the Growing Use of Public Nuisance in Mass Torts

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After a very difficult 2020, rapid vaccine development has sparked optimism among the public and in the business community. But as we wrote last week, there’s a long road ahead while infections remain high. Today we look at considerations for a new transition period – vaccines becoming more widely available, but before the country achieves herd immunity.…
Continue Reading How Companies Can Approach Wider Availability of COVID-19 Vaccines in the Coming Months

Dictionary series: Tort

Manufacturers are used to defending strict product liability actions when plaintiffs claim that their products are defective. But in the opioid litigation, plaintiffs have filed something else: more than 2,500 public nuisance cases so far.…
Continue Reading Trending in Tort Law: Transforming Product Liability Claims into Public Nuisance Actions

Opioid painkillers crisis and drug abuse concept

Generic pharmaceutical drugs are versions of brand-name counterparts with one major difference:  they typically cost a lot less. By FDA regulation, the two have the same active ingredients, dosage forms and strengths, and routes of administration.[1] And while federal law generally regulates pharmaceutical approval, states can regulate pharmaceutical distribution. Why is this significant? All states permit pharmacies to substitute generic drugs for the brand name equivalent, and some states require substitution in certain circumstances.[2] But a generic pharmaceutical company cannot change the brand company’s product label, so a person’s ability to sue a drug manufacturer is limited to the brand company who created the label.[3]…
Continue Reading Generically Speaking: Liability is Limited in Failure to Warn Claims

Molecular Structure

Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).

Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually.…
Continue Reading New Legislation Gives More Time for Medical Device Reporting

verdict

A Chicago jury awarded a single plaintiff $150 million in punitive damages, finding that AbbVie, Inc. fraudulently misrepresented the safety risks of its drug used to treat low testosterone, AndroGel. But the jury also decided in AbbVie’s favor on the plaintiff’s strict liability and negligence claims—meaning that they determined that AndroGel did not cause the plaintiff’s alleged injury. As a result, the jury awarded no compensatory damages.…
Continue Reading Who Won? The Verdict in the AndroGel Trial

EKG monitor

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring.…
Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

EKG monitor

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring.…
Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

Male hacker with mask stealing information

Millions of Americans rely on implantable medical devices to stay alive. These battery-operated devices communicate through wireless transmissions — and can be hacked like any other wireless device. For example, a wireless pacemaker regulates a person’s heartbeat and records the heart’s activity, and then transmits this information to doctors who can reprogram the pacemaker. The interconnectivity between medical devices and clinical systems leaves wireless medical devices vulnerable to security breaches.…
Continue Reading Hacking Health Care: When Cybersecurity Can Mean Life or Death

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Two partners from Schiff Hardin LLP’s Product Liability & Mass Torts Practice Group spoke about the future of mass tort litigation in the United States at the Lloyd’s Old Library in London on October 20, 2015.  Paul A. Scrudato and Edward Casmere discussed the state of mass tort litigation and its future with a group of London-based insurance professionals in the historic Old Library at Lloyds on Lime Street in London.  The topics included nanotechnology, pharmaceuticals and medical devices, e-cigarettes, wearable technology, and fracking.
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Continue Reading Schiff Hardin Partners Present on the Future of Mass Tort Litigation at Lloyd’s Old Library in London