Category: Defective Drugs

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.

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.

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.

 

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.

 

Invokana Heart Attack Risks Highlighted in New Lawsuit

By Emily Cox
Invokana heart attack risks
flickr/Ian McKellar

A new lawsuit indicates that Johnson & Johnson and its Janssen Pharmaceuticals unit concealed significant Invokana heart attack risks.

Mitchell Greenbaum filed the complaint August 28 in the Northern District of Ohio. He indicates that he suffered a heart attack six months after starting treatment with Invokana for diabetes.

According to his complaint, Greenbaum began taking Invokana in early 2016. In August 2016, he was stopped at a traffic light and suffered a myocardial infarction, or heart attack. Consequently, Greenbaum suffered hypoxia, necessitating resuscitation and causing permanent injuries that have led to a loss of consortium with his wife, Maria Greenbaum, among other serious consequences.

Greenbaum alleges that the drug manufacturers actively withheld Invokana heart attack risks from the public and medical community to protect its bottom line and profited immensely from this intentional concealment at the peril of diabetes patients. The complaint notes that when Invokana first received FDA approval in 2013, federal regulators ordered a study that showed that there were significant heart attack risks. However, J&J and Janssen never added new warnings to the drug’s label.

“Janssen Defendants had a duty to the public and the Plaintiff to manufacture, formulate, design and create a drug which would not adversely increase the risk of cardiac arrest in users, especially given the fact that some users foreseeably may have a prior history of hypertension,” the lawsuit states. “Janssen Defendants failed to recognize the risk of increased clotting and cardiac arrest, or intentionally chose not to recognize said risk, which constitutes both negligence and intentional misconduct.”

Health Concerns Beyond Invokana Heart Attack Risks

Invokana (canagliflozin) is a new-generation type 2 diabetes drug. It hit the market in March 2013 as the first member of a new class of diabetes medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors. These drugs work in a unique way to eliminate excess glucose through urination by altering normal kidney functions. However, thousands of patients have come forward due to a number of life-threatening side effects from the drugs.

In December 2015, the FDA required J&J to add new diabetic ketoacidosis warnings to Invokana, indicating the medication increases the risk of this serious condition that usually requires emergency treatment to avoid life-threatening injuries. Before this update, the Invokana warnings didn’t alert patients about the importance of getting immediate medical attention if they experience abdominal pain, fatigue, nausea, respiratory problems, or vomiting.

In May 2017, the FDA mandated Invokana warning labels regarding the risk of leg and foot amputation. Manufacturers of other similar diabetes drugs maintain that this risk is unique to Invokana alone.

This past month, the FDA released a statement that SGLT2 drugs carried elevated risks for Fournier’s gangrene, a rare flesh-eating genital infection. The condition has resulted in at least one death so far among those taking these medications.

 

Insys Prosecutors Push Back Against Expert Witness Disqualification

By Emily Cox
Insys Prosecutors
flickr/Bryan Furnace

The founder of Insys and several former top executives at the opioid company are accusing a doctor of double-crossing them by agreeing to testify for the federal government in an upcoming racketeering trial after meeting with the pharmaceutical company’s attorneys on multiple occasions. Consequently, the company is moving for the court to disqualify the expert from testifying; however, the federal government fought back Tuesday, saying that the doctor should still be able to take the stand for Insys prosecutors.

The government retained Dr. Christopher Gilligan as one of numerous pain management experts to possibly testify against Insys’ founder, billionaire John Kapoor, and his predecessor as CEO, Michael Babich, who Insys prosecutors allege created a fraudulent speaker program to conceal illegal kickbacks for doctors to prescribe the powerful Schedule II narcotic Subsys and illicitly boost sales. According to Insys executives, Gilligan met with their attorneys several times before the government retained his assistance. The executives further assert that Gilligan learned confidential information about their case and defense strategy during these meetings.

However, Insys prosecutors pushed back Tuesday, telling District Judge Allison D. Burroughs that the court should allow Gilligan to testify, arguing that the information he learned from defense lawyers wasn’t significant enough to substantiate an agreement of confidentiality.

“The lack of any confidentiality agreement is a telling factor, which weighs heavily against the defendants’ claims,” the government stated in its opposition. “The defendants do not assert that they advised, or even requested, that Dr. Gilligan keep his interactions with counsel confidential.”

“Despite that omission, defense counsel claim that they ‘repeatedly’ held ‘privileged calls and meetings’ with the witness during which they shared confidential information,” prosecutors continued. “That experienced counsel failed to contemplate the need to simply request confidentially from a possible expert strongly suggests confidentiality was simply unnecessary.”

Insys Prosecutors Opposition to Expert Disqualification

Gilligan, who the government has retained in other cases, told Insys prosecutors about his meetings with defense counsel when the government first reached out to him in July. According to Gilligan, defense lawyers asked him about off-label marketing and if he had prescribed Subsys. Prosecutors argue that these lines of discourse do nothing to tip the defense’s hand. Furthermore, if they do, then the defendants should have exercised more caution.

“This court should not reward the defendants’ failure to protect whatever confidential information they believed they needed to protect, particularly from a doctor whom the government has previously called upon,” the opposition stated. “Such a ruling would be contrary to the interests of justice.”

Insys prosecutors conceded that confidentiality isn’t exclusive to having an agreement. However, they added that it is ““also true that this court can reject any assertion that it is objectively reasonable to believe that a confidential relationship existed where experienced counsel, from respected law firms, failed even to mention confidentiality in five different meetings with the witness.”

Insys Executives Motion to Disqualify

The defendants’ motion to disqualify indicates that Gilligan met with their lawyers repeatedly, discussing confidential case strategy with them. Gilligan informed them that he had not spoken about the case with the government, saying he would be open to acting as a defense witness. In May, Gilligan notified them that his employer would not allow him to serve as a witness in the case and even offered to help find a replacement.

After discovering that the government had named Gilligan as a potential expert, the executives tried to figure out what happened. They said they informed the government about their past involvement with Gilligan and asked for assurance that the government would drop him as an expert witness. According to the defendants, the government told them that it would not communicate with the doctor until the court settled the matter. However, the government wrote in a Friday letter that an assistant US attorney had spoken with the doctor five days before its expert witnesses’ disclosure deadline and that Gilligan had told the government lawyer he had previously met with the defendants’ attorneys.

The Insys prosecutors included a footnote in Tuesday’s filing, saying that they would have no further contact with Gilligan until the court decided on the motion. If the court opts to remove Gilligan as a witness, prosecutors requested 60 days to locate a replacement.

Insys Racketeering Indictment

The Insys indictment claims that at least nine doctors and one nurse took bribes to distribute the fentanyl-based spray. The company organized parties or intimate meetings to disperse these payments, cloaking them as speaking events to people who did not need it to treat breakthrough cancer pain, which is the only FDA-approved use for Subsys. Company executive Michael J. Gurry and Babich reportedly directed the Insys call centers to fraudulently tell insurance companies that patients needed the spray to get them to cover the prescription cost.

Federal prosecutors say Kapoor and Baich hired four sales executives to network with prescribers and launch the plan into action. Alec Burlakoff, Sunrise Lee, Joseph A. Rowan, and Richard M. Simon are the other defendants in the case.

The executives claim the conspiracy is actually a series of perfectly legal marketing strategies that “safe harbors” laws specifically protect. They also argue the indictment fails to sufficiently show that the executives targeted doctors they knew would break the law.

Taxotere MCL Conference Set for October 4

By Emily Cox
taxotere mcl
flickr/Haukeland universitetssjukehus

The newly established Taxotere multicounty litigation (MCL) in New Jersey is hitting the ground running, setting its initial Taxotere MCL conference to get the litigation underway.

Middlesex County Superior Court issued the order August 24, scheduling the litigation’s first Case Management Conference (CMC) for October 4 at 10am.

The Court is mandating that parties submit a brief statement seven days before the conference, outlining the following information:

  • All company and financial affiliations with the parties and counsel associates participating in the litigation, so the court can easily identify any recusal or disqualification issues early.
  • All relevant actions pending in federal and state courts, as well as their current status.
  • Discovery status
  • Settlement negotiations status, including settlement demands, mediation, and settlement prospects.

New Jersey Superior Court consolidated all the lawsuits pending in the state’s court systems August 15, transferring 353 cases to Middlesex County for pretrial proceedings. The plaintiffs in the Taxotere MCL allege that the cancer drug’s manufacturer actively concealed considerable risks, including permanent hair loss, while grossly overstating the potent drug’s efficacy. Similar New Jersey cases in the future will be filed directly into the Taxotere MCL to maximize judicial efficiency.

Taxotere MCL Background

Taxotere (docetaxel) initially received FDA approval in 1996 to treat aggressive, metastatic breast cancer when other treatment options have failed. However, despite its limited indications, Taxotere is the most commonly prescribed breast cancer drug in the US, often as a first-line treatment even though it is considerably more toxic than equally effective and safer treatments, such as Taxol. An ongoing Qui Tam lawsuit alleges that Sanofi provided exorbitant illegal kickbacks to encourage doctors to prescribe the medication as a first-line treatment, skyrocketing Taxotere to the forefront of the cancer treatment market, while Sanofi raked in the profits – much of which was obtained by defrauding the Medicare and Medicaid.

With about 300,000 breast cancer cases diagnosed each year, Taxotere is the most prescribed drug in its class despite the fact that studies show that less-toxic Taxol is more effective. In 2009, Sanofi made more than $3 billion from Taxotere before losing patent protection.

Taxotere and Permanent Hair Loss

Not only is Taxol more effective and less toxic than Taxotere. It also doesn’t have the same permanent side effects as Taxotere. Studies have linked Taxotere with about a 10 percent occurrence of permanent hair loss. Sanofi knew about this side effect and hid it from its most profitable market – American women.

Sanofi knew about Taxotere’s alopecia risk since at least 2005. This is when the company updated Canadian warning labels to specifically include this risk. Sanofi would go on to update European warning labels in 2012. Somehow, the U.S. must just have gotten lost in the shuffle, because warning labels would not include this warning until the end of 2015. This was more than a decade after Sanofi became aware of a GEICAM study showing that 10 percent of Taxotere patients suffered permanent hair loss. Even the company’s own studies indicated more than a nine percent rate for permanent alopecia occurrence.

Outside of the Taxotere MCL, Sanofi is facing thousands of additional Taxotere lawsuits throughout the county, including nearly 10,000 federal cases that are currently pending in a multidistrict litigation (MDL) that is underway in the Eastern District of Louisiana.

 

Invokana Linked to Flesh-Eating Genital Infections

By Emily Cox
genital infections
flickr/Steve Depolo

The FDA has issued yet another warning regarding horrific side effects from Invokana, Jardiance, Farxiga, and other similar diabetes drugs. This time, the agency indicates the drugs are linked to serious genital infections.

Federal regulators released the latest Invokana drug safety communication Wednesday in a long series of similarly significant warnings regarding sodium-glucose cotransporter-2 (SGLT2) inhibitors. This time around, the FDA says that the drugs have now been linked to cases of rare but serious flesh-eating genital infections.

SGLT2 Genital Infections

Necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, is commonly classified as a “flesh-eating” infection. Federal regulators indicate that the rare infection can be life threatening. Diabetes alone can increase the risk of these infections. It is still rare among diabetes patients but cases involving SGLT2 inhibitors are currently on the rise. The FDA anticipates that the number of genital infections linked to the medications will likely increase significantly as awareness regarding the connection continues to spread.

“In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor,” the warning notes. “This number includes only reports submitted to FDA and found in the medical literature, so there may be additional cases about which we are unaware.”

Most drug experts agree that the FDA only receives notice of approximately 10 percent or less of drug adverse event incidents.

Even within this limited scope, federal regulators note that their findings indicate that there are twice as many cases of genital infections with SGLT2 inhibitors as those linked to all other diabetes drugs combined over the past three decades. The SGLT2 genital infections also only occurred in a mere five-year span. Furthermore, five of the SGLT2 inhibitor cases involved women. All previous cases associated with other diabetes drugs only involved men.

Consequently, the FDA is mandating new warning labels for all drugs in the class. This includes Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Steglujan. Steglatro is the only drug that appears to be free of flesh-eating genital infection associations. However, the agency is requiring it to carry the label regardless.

Regulators indicate that the infections developed within several months of starting treatment with one of these drugs. All 12 patients underwent hospitalization and surgery. According to their findings, at least one patient died. Others have suffered numerous disfiguring surgeries and other irreparable complications.

SGLT2 Health Concerns Beyond Genital Infections

Flesh-eating genital infections are just the latest in a string of significant health risks from SGLT2 inhibitors like Invokana that the FDA has uncovered since manufacturers first introduced them to the market. Previous warnings include kidney failure, diabetic ketoacidosis, and amputations. However, manufacturers continue to maintain that amputation risks are unique to Invokana specifically. The drugs’ warning labels failed to address any of these substantial risks when they first received FDA approval.

Invokana (canagliflozin) was the first SGLT2 inhibitor to hit the market. The FDA approved the drug in March 2013. Thanks to Johnson & Johnson’s typically aggressive marketing approach, the medication soon became a blockbuster treatment and has remained at the front of the pack ever since. SGLT2 inhibitors work in a unique way by eliminating excess glucose from the body through urination by impacting some normal kidney functions.

In December 2015, the FDA required all SGLT2 inhibitors to carry warnings about diabetic ketoacidosis, indicating that the medications significantly increase the risk for this serious condition that generally requires emergency treatment to avoid life-threatening injuries. Prior to the FDA’s intervention, warnings failed to alert patients of the importance of seeking immediate medical help if they experienced abdominal pain, nausea, fatigue, vomiting, or respiratory problems.

In June 2016, the FDA mandated additional warning labels about the connection between kidney risks and SGLT2 inhibitors, telling patients that the medications can increase the risk of acute kidney injury, kidney failure, and other severe health issues.

In May 2017, the FDA intervened once again to require amputation risks for Invokana, indicating the drug carries an increased incidence of leg, foot, and toe amputations. Regulators are only requiring Invokana to carry these warning labels for now.

Currently, Johnson & Johnson and its Janssen Pharmaceutical subsidiary are facing several thousand Invokana lawsuits, alleging that the healthcare behemoths deliberately withheld significant risk factors when they introduced the drug to maximize its marketability. Manufacturers of other diabetes drugs in the same class, including Xigduo and Farxiga, are also facing similar lawsuits. But, most of the lawsuits pending in the nation’s court systems are against J&J and Janssen thanks to the companies’ reckless, but supremely effective, marketing tactics.

The FDA indicates that prescribers wrote 1.7 million prescriptions for SGLT2 inhibitors in 2017. The agency is urging anyone who has suffered side effects after taking one of these medications to file a report with the FDA MedWatch adverse event reporting system.

 

 

 

 

 

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