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.

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”

Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL

On April 3, 2020, the United States District Court for the Southern District of Florida issued an order in the pending Zantac multidistrict litigation (”MDL”) requiring disclosure of funding arrangements and funding documentation between plaintiffs’ counsel and third-party litigation financiers. This order represents some increased traction in favor of arguments seeking to require disclosure of third-party funding arrangements in MDLs.

The Zantac MDL, In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, was originally formed by the Judicial Panel for Multidistrict Litigation on February 6, 2020. The plaintiffs sued various defendants, including manufacturer Sanofi and its distributors, alleging that the active ingredient in the heartburn medication Zantac breaks down to form a carcinogen that caused personal injuries. Included in the MDL are also six putative classes of consumers who sought refunds and economic damages based on their purchase of Zantac. Due to a number of actions already pending in the Southern District of Florida, the Panel transferred the remaining actions to that court to be assigned to the Honorable Robin L. Rosenberg.

Continue reading “Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL”

Contaminated Cosmetics: Recalls, Lawsuits And Legislation

In recent months, reports of asbestos-contaminated cosmetics[1] have illustrated the enduring challenges of manufacturing and marketing cosmetics as safe for consumers, particularly teens, children and expectant mothers. This is especially true where still-developing science, emotion and rapidly disseminated information (and misinformation) all play critical roles in shaping public perception, even influencing jury outcomes.

This article explores the potential legal challenges for supply chain participants arising from contaminated cosmetics, as well as significant proposals to change the way the U.S. Food and Drug Administration regulates cosmetic safety.

To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website.

Supreme Court Rules That Judges, Not Juries, Must Decide Preemption of Failure-to-Warn Claims

On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”

View the full Alert on the Duane Morris LLP website.

Emerging Product Liability Concerns for Medical 3D Printing

Additive manufacturing, commonly known as 3-dimensional (3D) printing, has been billed as the new industrial revolution. It is a lofty prediction; but we are seeing this prognostication materialize. Everyday consumer products ranging from children’s toys to running shoes are being 3D printed, sometimes right in consumer stores or at home. More and more manufacturers have begun or are exploring additive manufacturing options for their products. 3D-printed products even won an Oscar, when Ruth Carter won Best Costume Design for her work in the movie Black Panther, where portions of Carter’s costumes were 3D printed. From everyday consumer products, to its appearance on the red carpet, 3D printing has arrived.

Recognizing the potential advantages, endless possibilities, and unique manufacturing capabilities offered by 3D printing, more and more medical device manufacturers are entering this new field of technology. However, industry standards and regulations lag behind the pace of innovation. The unique aspects and potential availability of additive manufacturing raise novel products liability issues that may impact traditional product liability litigation doctrines. This article examines the current status of additive manufacturing as well as potential issues and uncertainties it raises for the future of product-liability litigation.

To read the full text of this article by Duane Morris partner Sean K. Burke, please visit the MD&DI Qmed website.

The Hidden Preemption Defense: What You Should Know

The most recent talc verdicts have demonstrated some traction in defeating claims based on certain go-to defense strategies, including personal jurisdiction dismissals, the use of expert testimony and Daubert motions discrediting scientific causation, and even requests to jurors to use their “common sense” in evaluating scientific evidence. However, there is another tool that defense attorneys should consider in talc cases: federal preemption.

Part of the mass appeal of talc cases lies in the prevalence of talc-based products in the marketplace, due to the numerous uses for talc in a variety of consumer products across cosmetics, over-the-counter (OTC) drugs, and even foods. As talc litigation expands into products that may be regulated as OTC drugs, defense counsel should consider the options that they might have in invoking federal preemption as a defense strategy. While the defense remains untested, there is a sound basis for its application. This article will discuss the federal U.S. Food and Drug Administration (FDA) regulatory scheme that is applicable to talc-based products and when federal preemption may support an argument for defeating conflicting state law claims against talc-containing OTC drugs.

To read the full text of this article by Duane Morris attorneys Anne A. Gruner and
Nicholas M. Centrella, Jr., please visit the Duane Morris website.

Risks Of Promoting Products As “Safe” For Pregnant Women

Conducting an online search for “things to avoid while pregnant” will bring back over 100 million hits, advising pregnant women to avoid, among other things, alcohol, caffeine, turkey sandwiches, certain hair dyes and “looking up ‘things to avoid while pregnant.’”

But increasingly, moms-to-be have been given reason to potentially avoid items as unexpected and as varied as shampoo, lipstick, nail polish, moisturizers, fragrances, deodorants and styling products, because of chemicals commonly found in these products that have been linked to potential gestational or developmental harm in unborn children.

Lacking conclusory information about the potential effects of these ingredients, industry participants are left to navigate the risks of promoting and/or labeling their products as safe for pregnant women. Meanwhile, consumers — primarily women, who control an estimated 85 percent of household purchases, and wield in excess of $5 trillion in purchasing power annually — are increasingly concerned about their ability to make informed decisions affecting their reproductive health, as well as the lives of their children. Consequently, these concerns are driving major changes in personal care spending, and creating new risks and opportunities for industry participants.

To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the Duane Morris website.

Should Juries Try To Predict FDA Drug Labeling Decisions?

On June 28, 2018, the Supreme Court of the United States accepted for review Merck Sharp & Dohme Corp. v. Albrecht, an appeal from the Third Circuit Court of Appeals’ decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation.[1] At the marrow of the high court’s review lie the thorny questions of whether a state law failure-to-warn claim is preempted where the U.S. Food and Drug Administration has rejected a drug manufacturer’s proposed label warning about the health risks at issue, and, in making this determination, whether a jury, as opposed to the trial court, may be asked to look beyond the FDA’s rejection and decide if the FDA would have approved a differently worded warning had it been proposed by the manufacturer.

While the issue is a relatively narrow one, the Supreme Court’s analysis promises to shape the way courts around the country decide whether and how the decisions of regulatory agencies should be interpreted ― and here, predicted ― by juries.

How Did We Get Here?

The Fosamax litigation began in 2011, when the Judicial Panel on Multidistrict Litigation consolidated several thousand lawsuits in the United States District Court for the District of New Jersey. The common question raised by the plaintiffs was whether their use of Fosamax, a drug developed and manufactured by Merck for the treatment and prevention of osteoporosis, led to femur fractures and similar bone injuries, and further, whether Merck had properly warned of these potential risks.

To read the full text of this article by Duane Morris attorneys Alan Klein and Matthew Decker, please visit the Duane Morris website.

Policing Bad Claims In Consolidated Litigation: Part 2

With the proliferation of consolidated litigation in recent years, various courts have lamented the lack of scrutiny often given to individual cases prior to filing in a class action or multidistrict litigation. Given the structure of these mass proceedings, individual claims frequently do not get meaningfully assessed. Against this backdrop, recent federal court decisions demonstrate courts’ increased willingness to police meritless claims by assessing whether counsel’s pre-suit investigation was adequate.

The first part of this article examined the obligation to conduct a pre-suit investigation under Rule 11 of the Federal Rules of Civil Procedure, and reviewed what different courts have said in recent years about meritless claims in mass litigation.

This part will discuss the importance of conducting plaintiff interviews, gathering basic information, avoiding language copied from dissimilar complaints and other issues.

Given the recent pronouncements of courts on the lack of scrutiny applied to individual cases in consolidated litigation, plaintiffs counsel should pay strict attention to Rule 11’s requirements prior to filing suit, particularly in a consolidated litigation, and defense counsel should be aware of the circumstances under which plaintiffs counsel’s efforts fall short of Rule 11’s requirements such that sanctions may be warranted. While the analysis is a factual determination that varies to some extent by jurisdiction, an examination of recent cases provides general guidance.

To read the full text of this article by Duane Morris attorneys Danielle N. Bagwell and Anne A. Gruner, please visit the Duane Morris website.