Weekly Mass Torts Bulletin 2023-December-25

A federal panel of judges is set to hear oral arguments next month to decide whether lawsuits related to Suboxone tooth decay, currently spread across the federal court system, should be consolidated before a single judge for coordinated pretrial proceedings.

Both the manufacturer of the opioid addiction drug and plaintiffs' lawyers support this move. Suboxone (buprenorphine and naloxone) gained FDA approval in 2002 for treating recovering opioid addicts by alleviating withdrawal symptoms during therapy. Originally available as a tablet, the drug makers later introduced Suboxone film, dissolved beneath the tongue.

However, users have reported severe dental injuries, including tooth decay and loss, leading former users to file lawsuits against the drug maker for allegedly failing to disclose these risks to users and the medical community.

In early 2022, Suboxone tooth decay warnings were added to the medication following the FDA's identification of over 300 reported cases of dental problems. Plaintiffs argue that adequate warnings could have prevented permanent dental damage, emphasizing that they should have been informed about the risks and advised on preventive measures against enamel erosion and tooth loss.

To address the common issues raised in complaints filed nationwide, several plaintiffs jointly submitted a motion to the U.S. Judicial Panel on Multidistrict Litigation (JPML) on November 14. They called for the centralization of all Suboxone lawsuits in the U.S. District Court for the Northern District of Ohio. The manufacturer subsequently supported this request in a filing on December 6, highlighting the need for consolidated pretrial proceedings due to the expanding litigation.

The oral arguments before the federal panel of judges aim to determine whether consolidating these cases will streamline discovery and pretrial procedures, ensuring efficiency and coherence in handling the Suboxone tooth decay lawsuits. The outcome of these proceedings may significantly impact the future trajectory of the litigation and the resolution of claims against the drug manufacturer.

A comprehensive review of opioid use for cancer-related pain has revealed significant gaps in evidence regarding the actual benefits of these medications.

Contrary to the prevailing belief that opioids are the most potent pain relievers, the University of Sydney-led review suggests a nuanced approach to cancer pain management, emphasizing the absence of a one-size-fits-all solution.

Opioid pain relievers are widely prescribed for cancer pain management, with international guidelines, including those from the World Health Organization, endorsing their use for background cancer pain (constant pain) and breakthrough cancer pain (temporary flare-ups in addition to background pain).

However, the study found a notable scarcity of trials comparing commonly used opioid medications, such as morphine, oxycodone, and methadone, with a placebo. Surprisingly, there was insufficient evidence to establish that morphine was superior or safer than other opioids for background cancer pain, contradicting its widespread perception as the "gold standard treatment" for cancer care.

The review also suggested that non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and diclofenac, may be equally effective as certain opioids for background cancer pain.

The lead researcher from the University of Sydney School of Public Health emphasized the ethical and logistical challenges associated with conducting trials comparing opioid medicines to placebos for cancer pain. Despite these challenges, such trials are deemed crucial for informing clinical decision-making.

Co-author Professor from the University of Warwick highlighted the potential for a better overall life experience for individuals with background cancer pain if there is less emphasis on using opioids to reduce pain levels.

The study's findings may guide doctors and patients in choosing between different opioid treatments for cancer pain and encourage consideration of alternatives, especially for those unable to tolerate or choosing not to take opioid medicines.

The analysis incorporated data from over 150 published clinical trials. Few trials compared opioid medicines to placebos, but evidence suggested that tapentadol might be more effective than a placebo for background pain caused by cancer. Opioids considered weaker (e.g., codeine), NSAIDs like aspirin, piroxicam, ketorolac, diclofenac, and the antidepressant imipramine were found to be comparable to potent opioids for background cancer pain with fewer side effects.

For breakthrough cancer pain, fentanyl, administered through various methods, was identified as potentially more effective than a placebo, albeit with more side effects. The study also called for research to investigate potential negative interactions between opioid medicines and anti-cancer treatments or the immune system to ensure that pain management does not compromise cancer treatment effectiveness. Additional research on non-drug interventions for cancer pain management was deemed necessary.

Three major national drugstore chains, CVS, Walmart, and Walgreens, are set to pay over $56 million in the final round of legal settlements with the state of Rhode Island over allegations of flooding communities with addictive opioid painkillers.

The settlement amounts, expected to be received by Rhode Island starting in early 2024 and continuing through 2037, were announced by the state attorney general. Walgreens will pay approximately $23.1 million, CVS $21.5 million, and Walmart $11.9 million.

Rhode Island's per capita opioid sales from 2006 to 2014 were reported to be significantly higher than the national average, leading to the state's legal action against the pharmacies. The state's attorney general stated that these national pharmacies prioritized profits over the well-being of Rhode Islanders and Americans.

CVS, Walgreens, and Walmart were identified as dominant buyers of opioids in Rhode Island from 2006 to 2019, with CVS being the largest buyer from 2016 to 2014, holding a 46% market share and purchasing over 148 million dosage units during that period.

Data provided by the state attorney general's office indicated that certain CVS and Walgreens branches dispensed alarming quantities of prescription opioids relative to the size of their communities. For instance, an East Providence CVS purchased over 800,000 dosage units in 2014 in a community of under 48,000 people. A CVS location in North Smithfield in 2012 purchased enough dosage units to supply 80 units to every resident of the town.

In addition to the financial settlement, the state attorney general's office highlighted that the funds will be distributed, with 80% going to the state and 20% directly to Rhode Island's cities and towns, in accordance with an agreement governing opioid settlement funds.

Rhode Island has already received over $250 million in settlement cash from opioid manufacturers, distributors, and sellers, including more than $40 million designated for cities and towns. The settlement funds, intended for opioid treatment, prevention, and recovery efforts, will be directed to Rhode Island's Statewide Opioid Abatement Fund, managed by the state Executive Office of Health and Human Services with guidance from the state Opioid Settlement Advisory Committee.

The attorney general's office emphasized that while no amount of money can fully undo the harm caused by the opioid crisis, the settlements provide crucial resources for treatment, prevention, and recovery efforts. The state is already utilizing settlement funds to expand in-patient treatment capacity for individuals with opioid use disorder, demonstrating the practical impact of the allocated resources.

Individuals who purchased, leased, or rented specific Philips Respironics sleep apnea machines now have the opportunity to file claims for restitution.

Philips, the Dutch medical equipment manufacturer, recently agreed to a compensation settlement of at least $479 million for users affected by 20 different breathing devices and ventilators sold in the United States from 2008 to 2021.

The issue arose two-and-a-half years ago when these devices were initially recalled, with the Food and Drug Administration (FDA) subsequently receiving 105,000 complaints, including 385 reported deaths, linked to leaking foam in the continuous positive airway pressure (CPAP) machines. Although Philips attempted to address the problem by fixing more than 5 million recalled machines, the repaired ones were also subject to a recall, as announced by the FDA a year ago.

Numerous sleep apnea patients filed lawsuits against Philips, leading to the consolidation of these cases into a class action. In September, a proposed settlement was reached, with Philips agreeing to pay $479 million to compensate affected users. Attorneys for the plaintiffs emphasized that the settlement provides substantial financial compensation for the millions of Americans who purchased defective Philips devices, encouraging affected users to file claims as part of the settlement.

Eligible users can file claims for financial losses related to the purchase, lease, or rent of the recalled devices. The compensation options include a Device Payment Award for each recalled device, a Device Return Award of $100 for each recalled device returned by August 9, 2024, and a Device Replacement Award for money spent on purchasing a comparable machine between June 14, 2021, and September 7, 2023, to replace a recalled device.

To determine eligibility and receive payment instructions, the settlement administrator has established an interactive website. Users can check their recalled device's serial number to determine the entitled device payment award. Those returning recalled Philips machines by the August deadline are entitled to both the return and payment awards without submitting a claim form, using prepaid shipping labels provided at no cost. Users who independently purchased a replacement CPAP or ventilator to substitute a recalled device must complete a device replacement claim form.

The deadline for submitting claims is August 9, 2024. The settlement, administered by the U.S. District Court for the Western District of Pennsylvania, does not affect or release any claims for personal injuries or medical monitoring relief.

According to 2022 data from the American Medical Association, approximately 30 million people suffer from sleep apnea, a condition where airways become blocked during rest, disrupting breathing.

As of October 6, Philips is actively working to ensure patients receive remediated devices amid ongoing testing and research. The company stated that based on current results, the use of its sleep therapy devices is not expected to cause appreciable harm to patients' health. Philips has not yet responded to requests for further comment.

Amidst a surge in lawsuits regarding dental injuries associated with Suboxone, manufacturers of the opioid dependency drug are expressing alignment with plaintiffs in advocating for the establishment of a multidistrict litigation (MDL) in federal courts.

The proposed MDL aims to consolidate all claims before a single judge for streamlined discovery and pretrial proceedings. Initially approved by the U.S. Food and Drug Administration (FDA) in 2002 for aiding recovering opioid addicts in managing withdrawal symptoms during therapy, Suboxone (buprenorphine and naloxone) was initially marketed as a tablet.

However, a Suboxone film was later introduced, meant to be placed beneath the tongue until dissolved. Disturbingly, users have reported severe dental injuries from the film, including tooth decay and loss. Consequently, an increasing number of former users are pursuing legal action against the drug manufacturer, alleging inadequate disclosure of risks to both users and the medical community.

The addition of Suboxone tooth loss warnings to the medication in early 2022 came after the FDA identified over 300 cases of dental problems reported to the agency. Plaintiffs argue that proper warnings and instructions to mitigate enamel erosion and tooth loss could have prevented permanent dental damage.

With numerous lawsuits across U.S. District Courts sharing common factual and legal aspects, plaintiffs moved on November 14 to centralize all Suboxone dental injury cases in the U.S. District Court for the Northern District of Ohio. Notably, both Indivior and Reckitt-Benckiser, the drug makers, submitted responses on December 6 endorsing the establishment of a Suboxone MDL. They not only acknowledge the necessity for centralization but also concur with plaintiffs that the Northern District of Ohio is the most suitable venue.

In their responses, the drug manufacturers state, "Defendants agree that there are issues of fact common to the cases identified in the Schedule of Actions accompanying Plaintiffs’ Brief. Defendants also agree that transfer of these and any subsequently filed ‘tag-along’ cases involving similar factual allegations or claims to the United States District Court for the Northern District of Ohio, for consolidated pretrial proceedings is appropriate."

In complex pharmaceutical litigation involving numerous claims stemming from the use of the same medication or medical product, centralizing the litigation through an MDL is a customary approach. This consolidation aims to streamline the legal process, prevent conflicting pretrial rulings, and enhance the efficiency of proceedings for all involved parties.

A recent study suggests a potential connection between exposure to the potent opioid painkiller fentanyl during pregnancy and the occurrence of physical deformities, such as cleft palates, clubbed feet, and other birth defects in newborns.

The report outlines findings by a team of pediatric researchers who examined the medical history of infants exposed to nonprescription fentanyl in utero. Fentanyl, a synthetic opioid prescribed for severe and chronic pain, is significantly more potent than morphine, and its use has surged in recent years. The U.S. Centers for Disease Control and Prevention (CDC) has identified fentanyl as the most perilous drug in the country.

The study focused on six infants exposed to nonprescription fentanyl during pregnancy, all exhibiting similar physical traits and health issues. These infants faced challenges with feeding and shared birth defects, including distinct facial features, smaller heads, shortened stature, and deformities in fingers, hands, feet, and genitals. Three of the infants experienced abnormal brain development and disruptions in cholesterol metabolism, resolving within months after birth.

Four additional cases contributed by clinicians showcased similar physical characteristics and abnormal cholesterol metabolism but with less distinctive facial features. While initially resembling Smith-Lemli-Opitz syndrome, genetic testing ruled out this condition and other potential factors, prompting researchers to explore the possibility of a new syndrome associated with prenatal fentanyl exposure.

The pediatricians concluded that the additional cases supported the causal relationship between prenatal fentanyl exposure and the observed syndrome. Given the ongoing fentanyl epidemic, they anticipate a significant public health impact related to this novel syndrome.

Researchers emphasize the need for further evaluation to understand potential growth, behavioral, and intellectual effects of prenatal fentanyl exposure on developing babies and throughout their lifetimes. While fentanyl is legally prescribed, its association with more overdose deaths than any other drug in the U.S., along with its abuse potential and inclusion in other substances, raises concerns about accidental overdose.

Numerous studies have linked opioid use during pregnancy, including fentanyl, to adverse birth outcomes, such as debilitating birth defects and neonatal abstinence syndrome. The escalating opioid epidemic has led to a substantial increase in infants born with opioid withdrawal symptoms, raising serious long-term health concerns for these children.

In July, research indicated that babies born to opioid-addicted mothers faced a higher risk of mortality within their first year, even if opioid abuse was reduced or eliminated early in pregnancy.