Blocking A Second Punitive Damages Award In Product Cases

Punitive damages awards in product liability matters have reached new heights in recent years. Traditionally, product liability defendants have sought to contest liability in the first instance, and establish that the alleged conduct does not warrant punitive damages specifically

Two recent decisions highlight a perhaps lesser-known defense available in some jurisdictions that can limit or even preclude punitive damages where they have previously been awarded for the same product or conduct.

To read the full text of this article, originally published in Law360, by Duane Morris attorneys Anne Gruner and Ethan Feldman,  please visit the firm website.

California Appellate Court Permits Defense Expert Testimony Regarding Causation to Meet Lower Standard When Offered to Challenge Plaintiff’s Causation Evidence

Causation in personal injury actions, including product liability claims related to drugs and medical devices and toxic tort actions related to exposure to hazardous substances, must be proven within a reasonable degree of medical probability based upon competent expert testimony. That’s typically the plaintiff’s burden of proof. Do the defendants bear the same burden? In Kline v Zimmer, the California Court of Appeal recently held that, in challenging the plaintiff’s causation evidence, defense expert testimony should be held to a standard of “less than a reasonable medical probability.”

Kline involved the plaintiff’s claim that the Durom Cup hip implant, manufactured by defendant Zimmer, Inc. and utilized in his first hip replacement surgery, was defective and caused him to require an additional surgery, which resulted in further injury. Evidence presented by the plaintiff at trial included an expert who testified to a reasonable medical probability that the Durom Cup’s defects caused the plaintiff to need the additional surgery, which resulted in changes in his muscles and soft tissues causing him chronic pain.

To read the the full article by Duane Morris attorney Michael L. Fox, which originally appeared in the IADC Committee Newsletter, please visit the Duane Morris LLP website.

Oregon Cannabis Mislabeling Spurs Investigation and Recall

The Oregon Liquor and Cannabis Commission (OLCC) is conducting an ongoing investigation into Curaleaf regarding an alleged mislabeling of a nonpsychoactive cannabidiol (CBD) product, which actually contained psychoactive delta-9 tetrahydracannabinol (THC). Curaleaf operates 101 retail cannabis dispensaries in 16 states. The OLCC investigation revealed that the alleged mislabeling resulted from an employee’s confusing the CBD bottles with the THC bottles in preparing the Curaleaf cannabis products at issue. The incident caused consumers ingesting those products to have experienced a “high” they did not anticipate, and ultimately led to the recall of approximately 500 bottles of tincture from the Oregon market. At least three of those consumers went to the emergency room due to the high, one consumer was hospitalized and one consumer’s estate brought a claim for wrongful death.

To read the full text of this Duane Morris Alert, please visit the firm website.

Seth Goldberg is a Team Lead of Duane Morris’s Cannabis Industry Group, a cannabis business advisor, and a trial attorney with experience in products liability and consumer fraud claims. Ethan Feldman is an associate in the firm’s Trial department, with experience in products liability and consumer fraud.

3rd Party Litigation Funding Must Be Disclosed Under Recent New Jersey Local Rule

On June 21, 2021, the U.S. District Court for the District of New Jersey announced that it would amend Local Rule 7.1.1 to require disclosure of any third-party litigation funding received by any party. The rule requires that, within 30 days of filing an action or of transfer into the district, all parties file a statement identifying “any person or entity that is not a party and is providing funding for some or all of the attorneys’ fees and expenses” in exchange for either “a contingent financial interest based upon the results of the litigation” or “a non-monetary result” not in the nature of a monetary loan.

The statement must contain the identity of the funder, including the name, address, and (if the funder is a corporate entity) its place of incorporation. Parties must also disclose whether the funder’s approval is necessary for “litigation decisions or settlement discussions.” If the funder’s approval is necessary, the nature of the terms and conditions of approval must also be disclosed.

Continue reading “3rd Party Litigation Funding Must Be Disclosed Under Recent New Jersey Local Rule”

The Importance of 510(k) Evidence to Ensuring a Fair Trial

Since the onset of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) has received more attention than perhaps ever before. While Americans anxiously awaited for approval of a COVID-19 vaccine, the FDA and its regulatory scheme were ever-present topics on the news and in social media. The American population’s newfound familiarity with the FDA is especially pertinent in a medical device litigation context.  As litigators well know, jurors already enter a courtroom with preconceived notions of medical device companies, the FDA and the relationship between the two. So how will this newfound knowledge of the FDA influence juror opinions? Put another way, what would happen if a jury participating in a medical device trial failed to hear any reference to the FDA at all?  Potentially, the results would be catastrophic to device manufacturers.

To read the full text of this article co-authored by Duane Morris partner Sean Burke, please visit the AdvaMed website.

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”

FDA Issues Long-Awaited Action Plan for Artificial Intelligence/Machine Learning-Based Software As a Medical Device

On January 12, 2021, the FDA issued its long-awaited action plan concerning the regulation of artificial intelligence (AI) and machine learning (ML)-based Software As a Medical Device (SaMD).  The plan comes on the heels of an April 2019 FDA white paper, which provided an initial proposed regulatory framework for SaMD, as well as an open comment period in which the FDA solicited stakeholder feedback.  The action plan outlines five primary goals and commitments to advance the FDA’s interest in facilitating the innovation of SaMD while developing proper oversight, as follows. Continue reading “FDA Issues Long-Awaited Action Plan for Artificial Intelligence/Machine Learning-Based Software As a Medical Device”

3D Printing and its Implications for the Auto Industry

For as long as cars have existed, three fundamental truths appeared to be eternal. First, every car contains safety critical components, second these components are mostly metal and third, they are manufactured by one of two methods—stamping or cold forming. These eternal truths always led to an equally durable legal reality, that if the safety critical component fails the manufacturer will be liable to the injured party. It’s hard to think of a more trite and dependable set of principles. But these timeless precepts are about to become disrupted as the automotive industry continues to explore the innovation of 3D printing.

To read the full text of this article by Duane Morris partners Sean Burke and Alex Geisler, please visit the 3DPrint.com website.

Mitigating Litigation Risks with 3D Printing in Life Sciences

With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality.  Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]

Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.

To read the full text of this article by Duane Morris partner Sean Burke, please visit the 3DHeals website.

New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers

On June 4, 2020, the U.S. Food & Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological product and device constituent parts. In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections  in which CBER is the lead center.

To read the full text of this Duane Morris Alert, please visit the firm website.

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