Parallel or Preempted? The Massachusetts Supreme Judicial Court Highlights the Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices

The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices.  The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.

Background

As background, the Food and Drug Administration (“FDA”) must approve or clear medical devices before they can be marketed or sold to the public.  The approval process employed depends upon the category of the medical device.  Under the Medical Device Amendments of 1976 (the “MDA”) to the Federal Food, Drug, and Cosmetic Act (the “FDCA”), devices are separated into three categories depending on the potential risks they present: Class I, Class II, and Class III.  Class I devices “are those that present no unreasonable risk of illness or injury and therefore require only general manufacturing controls; Class II devices are those possessing a greater potential dangerousness and thus warranting more stringent controls; Class III devices ‘presen[t] a potential unreasonable risk of illness or injury’ and therefore incur the FDA’s strictest regulation.”  Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343-44 (2001) (citation omitted); see also 21 U.S.C. § 360c.  Class III devices include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators, among other devices.  Riegel v. Medronic, 552 U.S. 312, 316 (2008). Continue reading “Parallel or Preempted? The Massachusetts Supreme Judicial Court Highlights the Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices”

Liability Protections Under Consideration for Businesses Set to Reopen During the COVID-19 Pandemic

With the Senate set to return from recess on Monday, liability protections related to the COVID-19 pandemic are anticipated to be a hot button issue. While state and local governments are seeking financial aid from the federal government to assist in their battle against the COVID-19 pandemic, relief packages may also include protection from future legal actions against businesses.

As stay-at-home restrictions are beginning to be lifted, and businesses are starting to reopen, there are concerns that employees and customers will file suit against businesses, claiming that they were infected with COVID-19 as a result of the businesses’ failure to take appropriate measures to protect them once reopening occurs. This fear is likely in response to lawsuits that have already arisen against businesses related to COVID-19. For instance, earlier this month, a Celebrity Cruises crewmember, who contracted COVID-19 while working on a Celebrity ship, filed a proposed class action alleging that the cruise company failed to take adequate measures to protect the employees on its ships.[1] The crewmember filed the proposed class action in a Florida federal court, claiming that the cruise company failed to follow safety precautions after receiving notice that COVID-19 was or was likely present on the ships, such as permitting crewmembers to continue to eat in a buffet setting, and mandating crewmembers’ participation in shipboard drills.[2] Continue reading “Liability Protections Under Consideration for Businesses Set to Reopen During the COVID-19 Pandemic”