E-Cig Makers Have 60 Days to Reduce Youth Sales

By Emily Cox
e-cig
flickr/Kingssummers

The FDA issued a historic ultimatum Wednesday to crack down on e-cigarette use among minors, sending out more than 1,300 warning letters and fines to retailers who sold to underage customers and giving five e-cig manufacturers 60 days to develop adequate plans to keep their products out of the hands of children.

The actions are in response to a nationwide undercover investigation of physical and online stores over this summer into what the FDA is calling an “epidemic” of minors using e-cig products. According to a statement the agency released Wednesday, products from Vuse, Blu, Juul, MarkTen XL, and Logic accounted for the vast majority of illegal sales. The five manufacturers account for 97 percent of the U.S. e-cig market.

Part of the measure’s focus is on e-liquids that have designs and flavors that are inherently appealing to children, like candy or cookies. The FDA indicated that it will monitor and take immediate action against companies that continue to sell nicotine and tobacco products that could be appealing to children. The FDA has looked to e-cigarettes as a way to help adults stop smoking. However, FDA Commissioner Scott Gottlieb said that the agency didn’t expect the widespread teen use.

“We didn’t foresee the extent of what’s now become one of our biggest challenges,” Gottlieb said in a statement. “We didn’t predict what I now believe is an epidemic of e-cigarette use among teenagers.”

The FDA indicates e-cigarettes are the most commonly used tobacco product among minors during the past several years. More than 2 million middle and high school students used e-cigarettes within the past year.

FDA Warns E-Cig Makers to Change Policies

In its letters to the five manufacturers, the FDA put the companies on notice that they had 60 days to submit plans to address youth access and use of their products. The regulatory body suggested that these plans may include: stopping sales to retailers that the FDA fined for selling to minors; eliminating online sales or providing evidence that these sales aren’t going to minors; revising marketing practices; developing or improving internal programs to monitor retailers; or removing flavored products from the market pending FDA authorization.

Should the companies fail to comply, the FDA said it will consider revisiting its current policy that allows the products to remain on store shelves without a marketing order.

This effort is part of measures the FDA announced in July 2017 to make cigarettes less addictive, while encouraging the development of products that deliver nicotine in less harmful ways.

“Smoking remains the number one preventable cause of death in America, killing nearly half a million people a year,” Gottlieb said. “If we aren’t successful in more sharply reducing the rate of addiction to tobacco, then we’ll continue to see this needless death and disease.”

Gottlieb went on to say that e-cigarettes represent an opportunity for smokers to move away from smoking traditional combustible cigarettes, attributing the harmful effects of cigarettes to burning them. However, he did warn that nicotine itself is harmful, especially to children whose brains are still developing, saying that the FDA still needs a stronger regulatory process for e-cigarettes.

E-Cig Company Response

CEO for JUUL Labs Kevin Burns said the company intends to work proactively with the FDA regarding its request and remains committed to preventing minors from accessing its products.

“Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes,” he said. “Appropriate flavors play an important role in helping adult smokers switch. By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission.”

Blu manufacturer Fontem Ventures released a statement, indicating the company supports the FDA’s initiative to keep e-cigs out of the hands of minors, adding that it also welcomes the opportunity to demonstrate its youth access prevention policies. These include an online verification process that monitors transactions for fraudulent activity and post-market surveillance.

A Logic spokesperson said the company received the FDA’s request and will continue working with the agency to prove it only markets its products to adults.

 

Fentanyl Crisis Is the Driving Force Behind Opioid Epidemic

By Emily Cox
fentanyl crisis
flickr/iPredator

Accounting for 60 percent of U.S opioid deaths this past year, the Fentanyl crisis is now the primary hallmark of the opioid epidemic that continues to scorch the nation.

Bloomberg reports that America’s opioid crisis has experienced a definitive shift. As the White House and Congress continue to twiddle their thumbs, the opioid death toll is unceasing in its ruthless ascent, reaching nearly 50,000 in 2017. This represents an increase of nearly 7,000 over the previous year, which is a record-breaker in and of itself. However, death’s primary harbinger is no longer regular prescription painkillers. It’s fentanyl, which is often illicitly mixed with street drugs like heroin.

Consequently, Bloomberg is calling for an equally drastic shift in the currently latent efforts to prevent opioid deaths. The focus on tighter prescription controls for oxycodone and hydrocodone are no longer adequate to limit the supply. The U.S. desperately needs a comprehensive and multi-targeted strategy to restrict illicit fentanyl importation, as well as a broader, better-funded push to reduce demand.

Since 2011, general prescription opioid fatal overdoses have remained relatively stable. However, overdose deaths from fentanyl have skyrocketed. According to the National Center on Health Statistics, the markedly more lethal drug played a role in 60 percent of opioid deaths in 2017, marking an 11 percent increase from five years ago.

Fentanyl Crisis Management Needs to Start with China

Fentanyl emerged on the market in 1960 as a cancer pain treatment. Due to its synthetic chemical composition, it quickly gained popularity on the black market. While “natural” opioids require producers to plant and protect acres of poppies, fentanyl can be cooked in a lab. Furthermore, its exceptional potency (mere granules of the stuff packs a deadly punch) allows distributors to mail it around the world in tiny, concealable packages. Chinese drug labs fulfill online orders from U.S. users or traffickers, as well as those in Mexico, who add the fentanyl to heroin and other drugs to amplify their effects or use it to create fake prescription opioid pills.

According to U.S. law enforcement, China is the source of almost all illicit fentanyl. Inadequately regulated and monitored chemical laboratories there sell fentanyl and its precursors to U.S. users and dealers, or Mexican drug suppliers who go on to market it in the U.S.

During the Obama administration, the U.S. had started soliciting the Chinese government’s assistance in cracking down on producers. This included persuading China to add many analogues of fentanyl to its list of controlled substances. A steady and purposeful diplomatic push, along with expert support, is necessary to fortify China’s capacity to inspect and regulate the country’s thousands of drug labs.

From China, the drug pipeline flows primarily through the mail to users and dealers. Recently, Congress provided Customs and Border Protection with more chemical detection equipment for package screening. However, the volume of mail prevents scanning everything that comes into the U.S. Currently, there is legislation pending that would require the U.S. Postal Service to obtain basic identifying information from senders, including name, address, and package content descriptions. Private parcel services already mandate this information.

Battling the Fentanyl Crisis at Home

But, even with these measures, a significant amount of the drug is likely to escape detection, necessitating strenuous efforts to crack down on the fentanyl crisis within the U.S. The Justice Department recently made progress by working with Dutch authorities to shut down two major dark web sites where users made deals in virtual currencies.

However, fentanyl is also available on the regular internet. So, FDA commissioner Scott Gottlieb is demanding that internet companies work harder to remove illegal listings. For its part, the FDA could limit supply by enforcing off-label prescribing restrictions for legal fentanyl to patients who don’t need such a powerful painkiller.

Significant measures on the demand side need to be taken as well. More than 2 million Americans have opioid or heroin disorders, and few can quit without assistance. Treatment needs to be accessible at every opportunity, especially when addicts enter prisons, hospitals, or emergency rooms. Methadone, buprenorphine, and other opioid medications, along with behavioral therapy, have proven effective in overcoming these addictions.

Thus far, the Trump administration has largely ignored the need for medication-assisted therapy. While Congress is considering bills that would expand its employment somewhat, like getting Medicaid and Medicare to provide more generous funding, lawmakers continue to refuse to prioritize these measures. Currently, only five percent of U.S. doctors have completed the required training to prescribe buprenorphine. Far more doctors, nurse practitioners, and healthcare providers need to have this authority.

Fentanyl along with other opioids are killing more than 130 people each day. The fentanyl crisis especially requires a thorough and well-coordinated national response. However, the White House and Congress continue to fall short, and more Americans pay the price every day.

Opioid Doctor Sentenced 20 Years for “Hospice-Level” Scripts

By Emily Cox
opioid doctor
flickr/ccPixs.com

A Florida opioid doctor will serve nearly 20 years in prison after a jury found him guilty of selling prescriptions for the painkiller oxycodone at “hospice-level” doses without ever verifying if patients actually needed it.

In June, a federal jury found John M. Gayden Jr., 64, guilty of seven counts of “distributing oxycodone outside the course of professional practice and for no legitimate medical reason.” On Monday, District Judge Carlos E. Mendoza sentenced Gayden to 19 years and seven months in prison.

Opioid Doctor Federal Charges

Prosecutors indicate that Gayden ran a pain management clinic between 2009 to 2011 and gave out medically dubious prescriptions for cash. Patients paid him $200 to $400 for an appointment. After little to no evaluation, these patients would walk out with prescriptions for what one expert dubbed “hospice-level oxycodone doses” for trivial health issues.

According to the Department of Justice (DOJ), patients would even come from other countries to line up at his clinic for their prescriptions. Many of these patients would go on to abuse or sell the pills. Furthermore, Gayden would work with patients for years without ever verifying any long-term medication necessities or consulting with them regarding their health.

The prosecutors’ sentencing memorandum requested the maximum guidelines penalty, citing the “egregious nature and scope of the defendant’s conduct, as well as his abuse of public trust.”

“The defendant was the center of a high-volume and prolific pill mill operation that was responsible for the dispensing of large volumes of opioids into the Brevard County community during the crest of the opioid crisis in Florida,” the DOJ wrote. “The defendant’s conduct had a widespread impact on his local community, as well as the lives of his patients, several of whom died of drug overdoses while under the defendant’s care or thereafter.”

The court sealed Gayden’s own sentencing memorandum.

Exxon Pushes Supreme Court to Stop Climate Probe

By Emily Cox
exxon climate change
Exxon refinery (flickr/airguy1988)

Exxon Mobil Corp. asked the U.S. Supreme Court on Monday to review the Massachusetts’ high court’s decision not to halt the state attorney general’s investigation into the company’s climate change statements, asserting that its tenuous connections to the state aren’t sufficient to give its attorney general jurisdiction.

In its petition for certiorari, Exxon said that state Attorney General Maura Healey’s probe and the Massachusetts Supreme Court’s ruling upholding it highlights an essential and unresolved question that has split lower courts over when a court can properly assert specific jurisdiction. Furthermore, the energy giant argues that the probe is a clear violation of its due process rights under the Constitution.

Exxon Mobil, citing the Supreme Court’s 2017 ruling in Bristol-Myers Squibb v. Superior Court of California, maintains that Healey and the Supreme Judicial Court are sanctioning a far too “liberal” approach to specific jurisdiction, which may only be employed when the lawsuit “arises out of or relates to the defendant’s contacts with the forum.”

Exxon Mobil argued in Massachusetts court that Healey couldn’t assert personal jurisdiction over the Texas company simply because there are company-licensed gas stations in the state. Healey informed the company that her investigation was on the merits of potential violations of the states consumer protection law “through the marketing and/or sale of energy and other fossil fuel derived products.” However, Exxon countered that its advertising agreements with franchisees are not adequate enough to warrant the current investigation.

“In its brief analysis, the Supreme Judicial Court focused principally on potential ‘deceptive advertising to consumers,'” Exxon wrote. “But counsel for [Healey] had been refreshingly candid on that score, acknowledging that there was ‘nothing in the record … that indicates a specific advertisement to consumers’ concerning climate change, and thus nothing in the advertisements at issue that was itself deceptive.”

Exxon Says Jurisdictional Grounds Unrelated to Climate Probe

The energy company further noted that although its franchise brand fee agreements allow it to approve advertising, it has never actually exercised this right in Massachusetts.

Exxon also criticized the Supreme Judicial Court for its adoption of a “but-for” standard for personal jurisdiction. This standard allows for a court to consider a defendant’s state contacts, whatever they may be, as a “first step in a train of events” that eventually results in some injury to a plaintiff, “such that, but for the defendant’s contacts, the plaintiff would not have been injured.”

Massachusetts is not the only state that takes this approach to establishing personal jurisdiction. The Ninth Circuit and the Washington Supreme Court have established jurisdiction along these same lines. However, the company noted that the First, Third, Sixth, Seventh, and Eleventh circuits, as well as the Oregon Supreme Court take a decidedly stronger vantage point, ruling that something more than “but-for” causation is necessary before a court can assert specific jurisdiction.

Exxon Mobil said that these inherent differences in interpretation stem from the fact that the Supreme Court has never directly addressed the question and cited the court’s decisions in 1984’s Helicopteros Nacionales de Columbia v. Hall and 1991’s Carnival Cruise Lines v. Shute.

“That question is what type of relationship is required between a plaintiff’s claims and a defendant’s forum contacts in order to satisfy the constitutional requirement that the claims arise out of or relate to the contacts,” the petition said. “The court should make clear that an unexercised contractual right regarding a third-party’s in-forum behavior does not constitute a contact for purposes of the specific-jurisdiction inquiry.”

Exxon Climate Change Probe Raises Due Process Issues

Exxon indicates that the Supreme Judicial Court’s decision also raises serious due process issues. Referencing Bristol-Myers, the company asserted that the high court “has emphasized the need to delineate appropriate exercises of specific jurisdiction from those that are ‘loose and spurious forms of general jurisdiction.'”

The company said that the Massachusetts’ court findings ignored the high court’s previous statements that indicate that to establish a “minimum” contact with a state, a plaintiff must show “that the defendant has purposefully directed his activities toward the forum, and … that the litigation arises out of or relates to those activities.”

“While this court has not articulated a definitive test for relatedness, it has sought to ‘ensure that a defendant will not be haled into a jurisdiction solely as a result of random, fortuitous, or attenuated contacts,'” Exxon wrote.

The company also said that any connection between a defendant’s conduct and the state needs to be “substantial.”

Tentative AbbVie Testosterone Deal Reached in MDL

By Emily Cox
testosterone deal
AbbVie tentatively reaches agreement to settle claims it created Low-T to boost sales (flickr/Beth Bryda)

AbbVie, the only company still facing claims of deliberately hiding the dangers of its hormone replacement therapy products, struck a tentative testosterone deal Monday to exit the sprawling multidistrict litigation (MDL).

Illinois District Judge Matthew Kennelly entered an order Monday, staying all cases currently pending against AbbVie and its subsidiaries Abbott Laboratories, Unimed Pharmaceuticals, and Solvay Pharmaceuticals after the companies agreed to confidential terms of a global settlement to resolve hundreds of plaintiffs’ claims over their dangerous products and malicious marketing practices.

Judge Kennelly’s order also requires the companies to provide the court with regular updates on their progress in drafting a final settlement agreement, relieving them of any MDL dates and deadlines to focus “their efforts” on finalizing the testosterone deal.

The tentative testosterone deal effectively ends the litigation in the MDL that the Judicial Panel on Multidistrict Litigation (JPML) centralized in the Northern District of Illinois in 2014. Since July 2017, the court has conducted several bellwether trials and still had nearly 6,000 pending cases as of August.

Lead plaintiffs’ counsel also filed a request Monday for the judge to increase their fee awards from the 10 percent attorneys’ fees and court costs the judge set for the litigation in 2014 to 19.5 percent in fees and costs According to the filing, while counsel projected the scope of their work to an extent at the start of the litigation, they did not expect the work to encompass four and a half years of litigation, six “full blown” bellwether trials, and preparation for an three additional rounds of bellwether trials.

Testosterone Deal MDL

All the MDL lawsuits allege that some of the nation’s most prolific drug companies actively hid harmful and life-threatening health risks associated with their testosterone replacement products, such as AbbVie’s AndroGel.

In the first bellwether trial against AbbVie, the jury cleared the big pharma giant of product liability claims. In fact, the jury did not even award any compensatory damages. However, they did levy a $150 million punitive damages verdict for AbbVie’s destructive advertising practices. AbbVie’s second time before a jury didn’t bode much better for the healthcare behemoth. The jury awarded compensatory damages of $140,000 for the plaintiff’s heart attack. But, then they hit AbbVie with $140 million in punitive damages. Punitive damages are designed to punish companies for immoral behavior. These verdicts speak volumes about the immorality at work behind the “Low-T” movement that these lawsuits claim that the testosterone manufacturers created to vastly expand market share and putting an entire population of men at substantial risk to satiate their collective greed.

Judge Kennelly ordered retrials in both of these instances, ruling that the juries’ punitive damages were inconsistent with their findings. In March, jurors slammed AbbVie with a $3 million verdict following the retrial of the original MDL trial.

Several companies were also facing MDL testosterone claims, including Eli Lilly & Co., Endo Pharmaceuticals Inc., and GlaxoSmithKline LLC. All these companies reached testosterone deals as AbbVie continued to proceed through the litigation. Auxillium was the only other company to face an MDL bellwether trial. The jury sided with the company over claims against its Testim product. However, Auxillium sill reached lawsuit settlements in February to exit the MDL.

Cigarettes and Asbestos Caused Fatal Cancer

By Emily Cox
kool cigarettes
flickr/Tim Vrtiska

During Friday’s opening statements, a Boston jury heard that RJ Reynolds and Phillip Morris cigarettes coupled with exposure to an auto parts company’s asbestos-laden brakes caused a man to develop fatal lung cancer.

Plaintiff Joanna Summerlin’s council kicked off the trial before Middlesex County Superior Court Judge Heidi Brieger by telling the jury that the plaintiff’s late husband, Louis Summerlin, became addicted to cigarettes during a time when tobacco companies knew, and actively concealed, that their products caused cancer. The combination of smoking and exposure to Hampden Automoive Corp.’s brakes multiplied both products’ cancer-causing effects.

During their opening statements, the tobacco companies’ attorneys countered that Summerlin, by his own admission, chose to smoke because he enjoyed it and that he could quit smoking when he had proper motivation.

Summerlin’s lawyer described how his client’s husband, who died in 2015 at age 73, began smoking cigarettes when he was a teenager, outlining how he didn’t initially take to cigarettes until he tried a menthol brand, saying the cigarettes’ additives gave a cooling, numbing sensation that “made it easier for teenagers like Mr. Summerlin to become initiated as smokers.”

The attorney went on the detail internal documents that show Brown & Williamson, the company responsible for Kool cigarettes that has since merged with Reynolds, clearly knew smoking caused lung cancer in the years Summerlin became addicted. Summerlin also smoked Philip Morris Marlboro Menthols.

According to the lawyer, Summerlin became deeply addicted to cigarettes, lighting one up each day “before his feet hit the floor,” adding that years before Summerlin filed his lawsuit, his primary care doctor noted that the man “cannot stop. He has tried all aids to stop smoking.”

Cigarettes and Asbestos Exposure Contributed to Cancer

Although Summerlin quit smoking in 2009, his lung cancer diagnosis “shattered” his life with his wife. The couple’s attorney indicated that the jury would see a videotaped deposition testimony from Summerlin, who originally filed the lawsuit in the months before his death.

The lawyer also emphasized Hampden’s role, telling the jury that Summerlin worked as an auto mechanic for 25 years, being continually exposed to asbestos-containing Hampden brake linings. He asserted that the company could and should have easily discovered the asbestos exposure risks when it was distributing its products. He went on to say that asbestos and cigarettes caused Summerlin’s lethal disease.

“The two interact, there’s a synergy. The more asbestos you’re exposed to, the greater your risk for developing lung cancer from smoking; the more smoking, the greater your risk for developing lung cancer from asbestos,” he said.

During his opening statement, a Phillip Morris’ lawyer told the jury that the plaintiff’s attorneys would not present any evidence, including Summerlin’s own testimony, that shows tobacco companies influenced his decision with their fraudulent information or any other information they disseminated.

According to the defendants’ attorney, Summerlin was a “smart and strong-willed person,” who enjoyed smoking and chose to do so for years after warning labels began appearing on cigarettes and even after he had decided to quit for a short time when he felt cigarettes were affecting his stamina.

The lawyer also pointed out that Summerlin didn’t smoke Philip Morris cigarettes until the 1980s when he tried a coworker’s Marlboro Menthol. At this point, cigarette packs had warning labels, including one saying smoking causes lung cancer.

Defendant attorneys focused on Summerlin’s “personal choice” to begin smoking, and to keep smoking, despite knowing the risks.

 

Biotech Executive Pleads Guilty to $12.7M Painkiller Fraud

By Emily Coxpainkiller fraud

One of three biotech executives facing federal painkiller fraud charges pled guilty Friday to helping a company fraudulently raise roughly $12.7 million by buying stock shares at artificially elevated prices to drive the value higher.

PixarBio Corp.’s Kenneth Stromsland, 46, entered a guilty plea to one count of securities fraud and one count of obstruction of an agency proceeding. Prosecutors indicate that PixarBio CEO Francis M. Reynolds used Stromsland to artificially create market interest in the company by buying stock at the highest price possible. Reynolds also falsely advertised the company’s Neurorelease painkiller system as an end to morphine and opioid addiction.

At Reynold’s direction, Stromsland made numerous purchases of PixarBio stock to defraud investors. He further conspired with Reynolds to lie to the Securities and Exchange Commission (SEC) when it launched its investigation into the Medford, Massachusetts, company in 2017.

“Do you dispute any of that?” District Judge Douglas P. Woodlock asked after the federal prosecutor had finished outlining the charges against Stromsland.

“No, I don’t,” Stromsland replied.

“Is that what happened?” the judge asked.

“Yes, it is,” Stromsland said.

Painkiller Fraud Scheme

Stromsland is the first to own to the painkiller fraud scheme. The SEC estimates that the plot cost at least 200 victims $12.7 million in PixarBio investments. A friend of Reynolds, M. Jay Herod, 51, who also purchased company stock, is also facing painkiller fraud chargers. Reynolds and Herold are each facing securities fraud and manipulative trading allegations. The pair pled not guilty at the initial federal court appearance in April. Stromsland was arrested in New York.

The SEC filed a parallel lawsuit against all three executives and PixarBio in Massachusetts federal court and asked the court to freeze their assets the same say the three were taken into custody.

Stromsland faces up to 20 years in prison on the securities fraud count, as well as another five years for obstruction. The court did not set his sentencing date during Friday’s hearing.

FBI special agent Jennifer Kennan’s affidavit indicates Reynolds made elaborate claims that NeuroRelease would end “thousands of years of morphine and opioid addiction.”

Kennan also said Reynolds emailed investors in December 2015 with claims that his own Reynolds School of Business had developed “the cure for paralysis in humans.”

However, prosecutors say that this was far from the truth. In fact, Keenan and the charging documents indicate that the device was not even ready for clinical trials. Furthermore, Reynolds was not the biotech expert he claimed to be. Contrary to his assertions to investors from 2015 to 2017, Reynolds was not a co-inventor of the spinal support implant, NeuroScaffold. He also claimed to be in the good graces of his former employers. However, InVivo Therapeautics forced him into resignation.

Prosecutors say that the trio began making deceptive trades in late 2016 to simulate market interest and drive stock prices.

NFL Painkiller Class Action Revived by 9th Circuit

By Emily Cox
NFL Painkillers
flickr/John Seb Barber

The Ninth Circuit reversed a class action dismissal Thursday from former players who allege the National Football League (NFL) encouraged painkiller abuse, including opioids, ruling that the lower court was wrong in its conclusion that the Labor Management Relations Act (LMRA) preempted NFL painkiller class action claims.

The panel’s opinion indicates that the LMRA does not bar the players’ negligence and other claims, because the court can evaluate their claims without cross-referencing their collective bargaining agreements. The court further found that the retired players are not only claiming that the league failed to intervene to prevent medication abuse by its teams, but that it coordinated illegal painkiller distribution for years. Furthermore, NFL doctors and trainers gave players medications without telling them what they were or potential side effects.

“The first question is whether the right at issue — the players’ right to receive medical care from the NFL that does not create an unreasonable risk of harm — arises from the CBAs,” the panel wrote. “It does not.”

NFL Painkiller Lawsuit and Collective Bargaining Agreements Assertions

The collective bargaining agreements do not require the league to provide medical care to players. And, according to the panel, that’s not even what the players are basing their claims on. The panel indicated that the players aren’t claiming the league violated the agreements at all. Instead, the players are maintaining that the NFL violated state and federal laws.

Whether the NFL breached it obligation to handle these drugs with reasonable case, the court said could be determined by analyzing its behavior in comparison to the requirements of the laws governing potentially dangerous drugs like the Controlled Substances Act.

“There is no need to look to, let alone interpret, the CBAs,” the panel wrote.

The court also rejected the league’s assertion that the players hadn’t adequately exhausted the collective bargaining agreements’ grievance procedures, because the players are not alleging that the NFL failed to comply with those terms. A California federal judge originally tossed the lawsuit in December 2014.

NFL Painkiller Class Action

Richard Dent and Jim McMahon originally filed the lawsuit in 2014. The 1985 Chicago Bears Super Bowl champions claim that teams use opioids, anti-inflammatories, and local anesthetics without incumbent prescriptions and negligible regard for players’ medical histories and potentially fatal interactions with other medications.

The players allege the NFL encouraged them to take painkillers to keep players on the field and revenues up. They also say that they received pills in small manila envelopes with no directions or labeling.

“I believe that this decision will have far-reaching impact, not just for the NFL and other professional sports leagues who have consistently tried to use the collective bargaining agreements to bar lawsuits brought against them, but for labor law generally,” counsel for the players told Law360 on Thursday. “We are also extremely happy for our clients who have waited many years to have their day in court.”

The Ninth Circuit is also currently considering a similar lawsuit. In this lawsuit, players assert that a lower court wrongly dismissed their claims as being time-barred, because they only recently learned of the league’s widespread scheme to administer pain medications recklessly.

 

Gadolinium Brain Depositions Linked to Hyperintensity Spots

By Emily Cox
gadolinium brain
flickr/Jon Olav Eikenes

Canadian researchers have found that gadolinium brain deposits from MRI contrast agents, such as Omniscan and Mangevist, can cause bright spots in non-enhanced MRI scans later, contributing to the growing body of evidence that the body may retain toxic metal from contrast dyes for dangerous periods of time.

The American Journal of Neuroradiology published the study in its August edition. Researchers indicate that gadolinium brain depositions from previous injections can cause hypersensitivity to appear on later scans even when these scans do not use gadolinium-based contrast agents (GBCA). The findings suggest a dose-dependent relationship, strongly indicating a causal link.

The new study comes as concerns continue to mount that gadolinium can build up in the brain and other organs, causing health problems later, which are now increasingly being referred to collectively as gadolinium deposition disease (GDD).

Researchers studied more than 200 subjects with secondary-progressive multiple sclerosis (MS) who were participating in a multicenter clinical trial. They analyzed data on 80 subjects who received nine linear GBCA injections over approximately a two-year period, as well as 115 who only received three such injections over the same timeframe.

Subjects in the high-exposure group demonstrated increased MRI signal intensity in all deep brain structure regions. The low-exposure group only presented with increased signal intensity in the dentate nucleus.

“Hyperintensity in deep brain structures from gadolinium deposition is related to the number of doses and the type of linear gadolinium-based contrast agent (nonionic greater than ionic) administration,” researchers wrote.

Other Health Concerns Beyond Gadolinium Brain Depositions

Concerns over the safety of MRI gadolinium contrast agents first emerged about ten years ago when they began to be associated with the development of nephrogenic systemic fibrosis (NSF). This is a rare and life-threatening condition that occurs among patients with compromised kidney function, causing their skin to harden and thicken, severely impairing mobility.

Sometimes called gadolinium associated systemic fibrosis, NSF is a painful disorder with no known cure. It often progresses to wheelchair confinement followed by death.

Consequently, in 2007, the FDA stepped in to limit gadolinium contrast doses in many kidney patients and contraindicated it for others, minimizing NSF risks. In September 2010, the FDA acted again to ban the use of Bayer’s Magnevist for patients with kidney problems due to the increased NSF risks.

The agency further required GBCA label changes to warn medical professionals to screen patients to identify those with acute kidney injury or chronic kidney disease before using gadolinium injections.

MRI contrast dye manufacturers are now facing a growing number of individuals without any kidney problems coming forward after developing severe and debilitating health problems linked to gadolinium brain and organ retention. Complications include bone and joint pain, cognitive difficulties, headaches, skin thickening, and other serious injuries.

FDA Further Intervention Regarding Gadolinium Brain Depositions

In September 2017, the FDA’s Medical Imaging Drugs Advisory Committee voted for new MRI contrast agent warnings pertaining to the risk of gadolinium brain depositions. However, the FDA concluded in May that brain gadolinium didn’t appear to pose any significant health threats.

In December 2017, the FDA released a drug safety communication for GBCAs, including Omniscan, OptiMark, Magnevist, Gadavist, and others, with new information about gadolinium retention risks and potential side effects.

The FDA cautioned that medical professionals should consider the fact that the body retains gadolinium when dealing with patients who would be at a higher risk for health problems. These include pregnant women, patients with kidney issues, children, and patients with inflammatory concerns. Regulators also recommend that healthcare professional minimize the repeated use of GBCAs when possible, especially when MRIs are occurring closely together.

 

 

 

Abilify MDL Requests Gambling Loss Claim Information

By Emily Cox
Abilify MDL
flickr/Lisa Brewster

As the four months that the court provided for parties to finalize the gambling loss multidistrict litigation (MDL) global settlement has drawn to a close, the District Judge presiding over the Abilify MDL is requiring plaintiffs to submit additional claim information.

Currently, there are more than 1,700 cases pending in the Abilify MDL against Bristol-Myers Squibb and Otsuka Pharmaceuticals over allegations that the drug’s inherently defective nature caused users to develop devastating gambling addictions or engage in other destructive compulsive behaviors shortly after starting treatment with the drug or changing doses.

Parties reached Abilify settlements for a small group of bellwether cases just before trials were to begin earlier this year. In May, District Judge M. Casey Rodgers issued an order, giving the parties until September 1 to finalize the global resolution framework of gambling loss claims. The parties notified the court that negotiations are progressing. However, they have not reported or finalized the details of the settlement program.

Abilify MDL Settlement Order

Judge Rodgers issued a new order August 31, indicating that additional information is necessary for all individual plaintiffs to facilitate an inventory evaluation of remaining cases currently pending in the Abilify MDL.

The court has given plaintiffs until October 31 to provide a Supplemental Plaintiff Profile Form. The form will provide answers to detailed questions about their Abilify use, gambling addiction diagnosis, other drug use, and further details about their case.

“The Supplemental PPF must be signed by each plaintiff under penalty of perjury,” Judge Rodgers wrote. “Failure to timely submit a completed Supplemental PPF will result in sanctions, up to and including dismissal of a case.”

The parties will meet with Judge Rodgers for the next Abilify MDL case management conference on September 13.

As settlement finalizations continue attempting to resolve Abilify gambling lawsuits over the medication causing users to suffer sudden compulsions to engage in destructive behaviors, the Abilify MDL is pressing forward with plans to select a second group of cases for early bellwether trials to help the parties evaluate the relative strengths and weaknesses of their positions and possibly help guide future settlements.

 

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