As we prepare to welcome both a new year and a new decade, we look back on the developments in drug and device law this year and potential implications for 2020. Below is a brief recap and assessment of the top five developments from 2019.
A “Negotiation Class” Is Approved in the Opioid Litigation
Developments in opioid litigation have received extensive coverage this year, a product of more than 2,000 lawsuits filed in the ongoing opioid multidistrict litigation (MDL). From the announcement of manufacturer Purdue Pharma’s bankruptcy filing to attempts to disqualify MDL Judge Dan Aaron Polster three weeks before the start of the bellwether trials, coverage of the litigation has filled the news.
Plaintiffs in these suits primarily are local governments that allege that opioid manufacturers and distributors have created a public health crisis by pushing opiates into the hands of millions of patients, contributing to otherwise preventable opiate addictions. Perhaps the most significant legal development to come from the opioid litigation in 2019 is the concept of a “negotiation class.”
In June, the plaintiffs moved to certify a novel “negotiation class” to permit group negotiation within the MDL. In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, 2019 WL 4307851, at *2 (N.D. Ohio Sept. 11, 2019). They proposed organizing a class of every U.S. city and county to negotiate with drug manufacturers, distributors, and pharmacies. With over 30,000 local governments across the country, the plaintiffs argued that a negotiation class would allow for coordinated settlement discussions and the exhaustion of substantially less judicial and party resources.
The plaintiffs’ arguments for adoption of the class echoed many of Judge Polster’s previously expressed concerns—namely, expeditious termination of the MDL in the interest of localities across the United States that remain plagued by addiction. In opposition, defense counsel for drug distributors argued that the idea wasted time and unnecessarily complicated the litigation. Various state attorneys general also weighed in on the proposed class, arguing that its adoption infringed on their authority.
Judge Polster approved the negotiation class, opining that the process was a “powerful, creative, and helpful one.” Id. at *1–2. He detailed the certification process, which would proceed in five stages. Id. at *3–4. First, the class must develop a plan to allocate any lump sum achieved and a plan for voting on the reasonableness of the potential lump sum. Any settlement would require supermajority support from 75 percent of voting governments based on a variety of metrics. Second, the plaintiffs must move to certify the negotiation class. Third, if the motion is approved, the class members would be given notice of certification and have an opportunity to opt out. Fourth, the class would begin negotiations over the lump-sum settlement with a defendant or defendants. No defendant is required to negotiate with the class, a point that Judge Polster stressed several times in his opinion. Finally, if a settlement is reached, the parties must move for judicial approval.
The negotiation class is a development in civil procedure that may alter the path to settlement in complex MDLs in the years to come.
The Federal Trade Commission Expresses Concerns over Plaintiffs’ Legal Ads
Plaintiffs’ attorneys have increasingly used advertisements for personal injury lawsuits. Many of these ads imply that a drug or device is defective or dangerous, often including words like “fatal” and “deadly.” These ads leave many consumers worried that a product that they (or their loved ones) are using is likely to cause catastrophic consequences, and some stop taking their prescribed medication. There is some concern that premature termination of a prescribed medical treatment, based on attorney advertising and without consulting a doctor, can increase the risk of adverse events. Lars Osterberg & Terrence Blaschke, “Adherence to Medication,” 353 New Eng. J. Med. 487 (2005) (discussing the rates of medication adherence among individual patients and some general adverse consequences); Fred Kleinsinger, “The Unmet Challenge of Medication Nonadherence,” 22 Permanente J. 18 (2018).
In September, the Federal Trade Commission (FTC) addressed these concerns when it issued a press release announcing actions taken in the form of letters to seven legal practitioners and lead generators (individuals and companies that generate “leads” or potential new clients). Press Release, U.S. Fed. Trade Comm’n, FTC Flags Potentially Unlawful TV Ads for Prescription Drug Lawsuits (Sept. 24, 2019). The FTC highlighted concerns that some television advertisements soliciting clients for lawsuits against drug manufacturers may be deceptive or unfair. Although the FTC declined to announce the recipients or the specific contents of official letters, the FTC did confirm that the letters “state that some lawsuit ads may misrepresent the risks associated with certain pharmaceuticals and could leave consumers with the false impression that their physician-prescribed medication has been recalled.” The press release also indicated that the use of “sensational warnings or alerts” may mislead consumers into thinking the ad is actually a government-sanctioned medical alert or public service announcement. Id.
The FTC is not the first to express concern over legal advertising. In 2016, the American Medical Association recommended that such ads contain warnings to consult with a physician before discontinuing medication. Am. Med. Ass’n, Attorney Ads on Drug Side Effects H-105.985 (2019). U.S. House Representative Bob Goodlatte (R-VA) generated media support in 2017 when he sent letters to state and national attorney bar associations asking them to better regulate such ads. Sara Randazzo & Jonathan D. Rockoff, “Have You or Your Loved Ones Been Hurt by This Ad? Congressman Wants to Know,” Wall St. J., Apr. 14, 2017. And these concerns are nothing new to defense attorneys specializing in drug and device work, who defend clients in lawsuits in which the plaintiffs allege a product defect based solely on what they have seen on TV, not based on their medical history or treatment.
In the press release, the FTC noted that its letters warned practitioners that the agency “will take follow-up action as warranted.” It is unclear what such follow-up enforcement will look like, but the FTC’s public denunciation of “sensational” advertising was a welcome development in 2019.
Vaping Issues Dominate the Headlines
As the year unfolded, e-cigarette manufacturers faced a crescendo of concern from government agencies and the public. Critics condemned these companies for contributing to a national youth vaping crisis and have employed a variety of strategies to combat what former Food and Drug Administration (FDA) commissioner Scott Gottlieb identified as an “epidemic” in 2018. U.S. Food & Drug Admin., Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use (Sept. 11, 2018). Strategies include lawsuits from parents of youth vape users, bans by concerned states and cities, and a criminal probe.
In April, a Florida couple filed a proposed class action against JUUL and Altria Group. Complaint & Demand for Jury Trial, Nessmith v. JUUL Labs, Inc., No. 8:19-cv-00884 (M.D. Fla. filed Apr. 15, 2019). The suit, brought on behalf of the Florida couple’s minor child, alleged that the defendants intentionally targeted teenagers by offering fruity flavors and marketing heavily on social media. Several states have filed similar suits, arguing that the e-cigarette companies inappropriately market their products to minors.
In August, Illinois public health officials announced that an adult patient with a history of vaping had died after being hospitalized for a severe respiratory illness, speculated to be the first recorded death associated with vaping. As of October 8, 2019, the Centers for Disease Control and Prevention (CDC) reported 1,299 confirmed and probable lung injury cases across the United States associated with the use of e-cigarette or vaping products. Press Release, Ctrs. for Disease Control & Prevention, CDC, states update number of cases of lung injury associated with use of e-cigarette, or vaping, products (Oct. 10, 2019). The CDC also reported 26 confirmed deaths as of that time. In response to these reports, the FDA launched a criminal probe into the vaping-related deaths and illnesses.
In addition, seven states, New York City, and San Francisco imposed some sort of ban on e-cigarettes and related products. Michigan became the first state to do so with an emergency ban on the online and retail sale of vaping products in any flavor except tobacco. Soon after, New York, Rhode Island, Washington, Oregon, and Montana instituted similar bans. At the end of September, Massachusetts announced a four-month ban of all marijuana and tobacco vaping products, followed in November by an enacted law that taxes all vaping products. Several of these bans are temporary, applying for only 100–120 days. The White House similarly announced plans to ban flavored e-cigarettes.
Legal challenges to these bans have had mixed results: Federal judges in Michigan and Massachusetts and a state judge in Rhode Island upheld the bans, while state judges in New York and Oregon temporarily blocked the bans from taking effect. States upholding the bans generally did so based on emergency grounds. In contrast, states rejecting the bans have done so for many reasons, such as finding that the ban proponents had not established a direct connection between vapes and lung injuries. VIP Vapors of Orem, LLC v. Miner, No. 190908334 (Utah Dist. Ct. Oct. 28, 2019) (granting vaping companies’ motion for a temporary restraining order on the state’s ban). Or finding that the vaping companies would be harmed if the emergency rules went into effect. Slis v. State, 2019 WL 5214944 (Mich. Ct. Cl. Oct. 15, 2019) (granting vaping companies’ motion for a temporary restraining order on the state’s ban).
In July, U.S. District Court Judge Paul Grimm (Maryland) issued a decision ordering the FDA to impose a 10-month deadline for e-cigarette companies to submit applications for FDA approval. Am. Acad. of Pediatrics v. FDA, 399 F. Supp. 3d 479, 487 (D. Md. 2019). Judge Grimm’s reasoning was clear: An earlier deadline was essential to address the issue of e-cigarettes’ known youth appeal and the “clear public health emergency.” The plaintiffs in that case asked the court to vacate the FDA’s 2017 guidance allowing e-cigarette manufactures to continue marketing and distributing the products while they sought FDA approval. This policy, the plaintiffs argued, violated the Tobacco Control Act’s requirements of premarket review before distribution to consumers. The ruling rocketed the manufacturers’ deadlines from 2022 to May 2020 and limited the FDA to a one-year review period.
The year 2019 marks a clear rise in vaping litigation, with more legal developments expected in 2020.
MDL Reform Receives Increased Attention
The use of multidistrict litigation has continued to grow. In early 2019, MDL proceedings made up more than 50 percent of the federal docket. Mass tort litigation relating to product liability represents the largest subset of these MDLs—in 2018, the Judicial Panel on Multidistrict Litigation reported products liability cases represented 32.9 percent of pending MDLs. U.S. Judicial Panel on Multidistrict Litigation, Calendar Year Statistics—January through December 2018 (2018).
With increasing frequency and success, defense counsel have employed early screening techniques in MDLs, such as asking courts to require notices of diagnosis, plaintiff fact sheets (PFSs), medical authorizations, and Lone Pine orders early in the MDL proceedings. Peter Meyer & Eldin Hasic, “The MDL Factor: A Survey of Case Law Recognizing MDL,” Mass Torts Litig., Sept. 23, 2019. These measures require plaintiffs to provide information supporting their claim up front to avoid dismissal of their case.
Growing calls for MDL reform reflect a shared concern over whether the civil rules and procedures adequately address the increasingly heavy MDL load. In October, 45 general counsel signed a letter supporting review of MDL procedures. Dan Clark, “45 General Counsel Sign Letter Supporting Review of MDL Procedures,” Law.com, Oct. 8, 2019. The concerns expressed in the letter are echoed by legal practitioners—particularly litigators who face scores of frivolous filings.
One proposed area of reform with increased attention in 2019 is interlocutory review during MDL proceedings. Currently, a defense win on preliminary issues is immediately reviewable as a final order during MDL proceedings. The reverse, however, is not true: If defendants lose their pretrial motions, the order is not reviewable until after a verdict is reached in one of the cases in the proceedings. Various legislative and rule-based proposals have been offered. In April 2019, the Advisory Committee on Civil Rules considered whether to draft an amendment to the Federal Rules of Civil Procedure that would authorize swift appellate review of specific rulings. See Advisory Comm. on Civil Rules, Agenda for the April 2–3, 2019, Meeting, at 212–14 (MDL Subcommittee Report). The committee met again at the end of October, and “most of the subcommittee’s attention has focused on PFSs and interlocutory appellate review.” See Advisory Comm. on Civil Rules, Agenda for the October 29, 2019, Meeting, at 35 (MDL Subcommittee Report).
Although no definitive rules have been adopted so far, MDL reform is an area to watch in 2020.
Daubert Gatekeeping at Work
A well-known quote from Judge Richard Posner in 1996 remains instructive in 2019: “[T]he courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996). Drug and device manufacturers are all too familiar with expert witnesses offering opinions that masquerade as “supported by science.”
Such was the case in 3M’s Bair Hugger MDL, in which several plaintiffs’ experts offered opinions on general and specific causation. In December 2017, U.S. District Court Judge Joan Ericksen denied 3M’s Daubert challenges after an extensive three-day hearing. Eighteen months later, in July 2019, Judge Ericksen not only reconsidered her 2017 order but also excluded all of the plaintiffs’ experts and granted summary judgment. In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., MDL No. 15-2666, 2019 WL 4394812, at *1 (D. Minn. July 31, 2019). The intervening bellwether trial exposed the weaknesses in the plaintiffs’ causation case, with opinions based on unproven and untested modeling, failure to account for important operating room conditions, and development for use in litigation. Id. at *5. The ruling, which ended more than 5,000 cases, is now on appeal to the Eighth Circuit.
The Bair Hugger case illustrates the importance of sticking with science-based arguments, even after losing a Daubert motion.
Cheers to a new year and a new decade—may it bring interesting and positive legal developments to the world of drug and device law!
Hannah Anderson and Isabelle Chammas are associates and Christine Kain is a partner in the Minneapolis, Minnesota, office of Faegre Baker Daniels. Patrick Reilly is a partner in the firm’s Indianapolis, Indiana, office.
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