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.”
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.
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.
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.
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.
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.
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, where claims are often resolved on a global level, with payout determined by the number of filings, individual claims frequently do not get meaningfully assessed.
This process has an obvious inherent risk of including meritless individual cases. 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 requirement that counsel conduct a meaningful pre-suit investigation is derived from Rule 11 of the Federal Rules of Civil Procedure. Rule 11 states that by filing a pleading, counsel represents that, to the best of their knowledge “formed after an inquiry reasonable under the circumstances,” the legal theories are warranted by existing law or nonfrivolous argument, and the factual contentions have evidentiary support or will have evidentiary support after a reasonable opportunity for further investigation.
On Jan. 30, the U.S. Government Accountability Office issued a report on the threat of counterfeit products to consumers. Among other things, the report highlighted the prevalence of counterfeit cosmetics on popular e-commerce websites such as Amazon.com Inc. and eBay Inc., noting that 13 out of 13 samples purchased from third-party sellers with exceptional approval ratings were fake.
In the age of e-commerce, counterfeit cosmetics present a growing challenge — not only do they pose significant health risks to consumers, but they raise serious legal concerns for brand manufacturers, distributors and retailers.
A Growing Problem
It is no secret that personal care is big business. According to a report commissioned by the Personal Care Products Council and prepared by PricewaterhouseCoopers, the U.S. personal care industry — which encompasses color cosmetics, perfumes, moisturizers, shampoos, hair color and deodorants — was alone responsible for $236.9 billion in gross domestic product in 2013.
As of January 2018, individual spending on personal care products was forecast to grow at an annual compounded rate of four percent between 2018 and 2022. Yet, as cosmetics sales have steadily increased, so too have sales of counterfeit cosmetics.
It is not often that the testimony or circumstances surrounding sales representatives take center stage in a products liability trial involving prescription drugs and medical devices. However, two recent cases involving allegations of improper witness contact by pharmaceutical and medical device sales representatives have brought this issue to the forefront.
They provide a glimpse of the consequences that can arise from such allegations, including putting counsel in the crosshairs of a government inquiry and, perhaps equally damaging, diverting precious trial resources. Examination of these cases provides an overview of why these witnesses may be targeted in witness tampering claims, the extremely serious regard with which courts have considered accusations of witness tampering and how, moving forward, accusations of such impropriety — whether well-founded or not — may become a more likely scenario that can have significant unwanted consequences.
The Recent Case Examples
Recent trials involving DePuy Orthopaedics Inc.’s Pinnacle hip and Janssen Pharmaceuticals Inc.’s Xarelto blood thinner products illustrate how counsel can attempt to capitalize on sales representatives’ unique role as an intermediary between defendant manufacturers and physicians — who may also be witnesses — by testing the propriety of communications with those sales representatives, who might be parties to the litigation themselves and defended jointly by the manufacturer’s defense counsel. Both cases involve accusations that defense counsel inappropriately used sales representative communications to influence the testimony of a physician witness.
The DePuy Example
In a recent trial involving the DePuy Pinnacle hip product pending in the United States District Court for the Northern District of Texas (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, Case No. 3:15-cv-03489-K), the plaintiffs’ counsel made accusations of witness intimidation and tampering arising out of communications between a company sales representative and a physician witness.
In a recent decision in a DePuy ASR hip system case (DellaCamera et ux. v. DePuy Orthopaedics Inc. et al., No. CJC-10-004649, Proceeding No. 4649 (Calif. Super. Ct., San Francisco Cty. Nov. 1, 2017), a California Superior Court held that it has specific personal jurisdiction over nonresident defendants DePuy Orthopaedics Inc. (DePuy), Johnson & Johnson and Johnson & Johnson Services Inc. (Johnson & Johnson) for nonresident Connecticut-based plaintiffs’ claims on the basis that DePuy and Johnson & Johnson entered into consulting contracts with two California-resident surgeons on the design of the metal-on-metal hip implant device at issue.
This ruling bears noting in the wake of recent landmark personal jurisdiction decisions, including Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 582 U.S. ___, 137 S. Ct. 1773 (2017), BNSF Ry. Co. v. Tyrell, 581 U.S. ___, 137 S. Ct. 1549 (2017), and of course Daimler v. Bauman, 134 S. Ct. 746 (2014), which have armed defendants with tools to limit plaintiff forum shopping by obtaining favorable dismissals for lack of both specific and general personal jurisdiction.
In DePuy, the court latched onto the fact that the nonresident defendants intentionally contracted with in-state consultants who participated in the design of the hip implant product at issue, and that design was part and parcel of plaintiffs’ product liability causes of action. DePuy is not necessarily a novel approach to questions of specific jurisdiction, but it is a relative outlier in the context of the overall trend of cases restricting the ability of plaintiffs to “forum shop” and litigate outside of jurisdictions where defendants are not located and plaintiffs were not actually injured.
Thus, DePuy may foreshadow a new area of focus in which plaintiffs seek to subject defendants to suit in jurisdictions where consulting agreements and other targeted activities are directed, and which are alleged to give rise to plaintiffs’ causes of action.