Xarelto Federal Court Hearing – Judge Fallon “Need to devise an end game for this MDL”

Xarelto MDL 2592 – Judge Fallon “I need to devise an end game for this MDL”

Are Settlement Talks Coming to Xarelto Litigation?

By Mark A. York (January 30, 2018)

 

XARELTO: A BAYER CORP. AND JANSSEN PHARMACEUTICALS JOINT EFFORT

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) During the January 30, 2018 monthly status conference hearing in Xarelto products liability MDL No. 2592, US District Court Judge Eldon Fallon stated that this MDL is nearing its end, and “I need to devise an end game,” as he now seems to be pushing both sides toward a resolution. He also referred to selection of cases to remand where 400 cases each will be selected by plaintiff and defense counsel and 400 more by the court, for a total of 1200 cases being designated for remand back to the court of original jurisdiction for trial or settlement.

Judge Fallon also referred to resolving any lingering discovery issues that remain in certain cases to avoid mounting discovery costs in getting those case resolved, while trying to put a time frame on the proposed process of winding down the Xarelto MDL.

The sprawling nationwide litigation has produced over 21,000 lawsuits since the federal MDL was created in 2014 in New Orleans, and the number of new cases filed each month remains the same at about 400 per month. Even more cases have been filed in state courts in Philadelphia and Los Angeles, with there being about 1200 cases in the Philadelphia Court of Common Pleas docket in front of Judge Arnold New.

Michael Weinkowitz, lead plaintiff counsel in the recent Philadelphia trial verdict of $29 million, awarded to plaintiff Lynn Hartman, provided an update to the court, including a discussion on the January 9, 2018 ruling that overturned the Hartman verdict in a contentious post trial hearing, where Judge Michael Erdos granted a defense Motion for Judgement Notwithstanding the Verdict. The Philadelphia court post-trial issues of attorney misconduct were also interjected into Judge Fallon’s courtroom by defense counsel, which seemed to be totally unwarranted and out of place in the MDL hearing, when Bayer defense counsel felt the need to advise the federal court of “allegations of trial misconduct” that were heard at the January 9th hearing, even though the Hartman verdict was overturned based on proximate cause issues, not in any way related to plaintiff attorney misconduct,” as defense counsel seemed to offer to the court.

CASE DEMOGRAPHICS

Jacob Woody, of Brown Greer’s MDL Centrality program provided current data as to case numbers and plaintiff demographics including 21,465 cases currently filed into the Xarelto MDL, averaging 450 new filings each month. As well as:

  • Texas, Florida and California having the most plaintiffs with over 1,000 each
  • Hawaii having the fewest at just fourteen
  • Plaintiff age groups: age 60 – 69 = 20%, age 70 – 79 = 30% and age 80 – 89 = 30%
  • 48% of plaintiffs allege a gastrointestinal bleed as the primary medical issue
  • The number of new case filings per month has remained steady for the last 3 years

PHILADELPHIA XARELTO DOCKET

While Judge Fallon is seeking an apparent end to the federal Xarelto MDL in New Orleans, Judge Arnold New in the Philadelphia Court of Common Pleas, has set a rather aggressive trial schedule in the Xarelto docket there, including trial start dates of March 19th, April 16th and June 11, 2018 with additional trials being set at “one to two trials per month for perpetuity” quoting Judge Fallon on his interaction with the Philadelphia court. The appeal of Judge Erdos’ January 9th reversal of the Lynn Hartman $29 million verdict was filed today as well, on January 30 2018 in the Superior Court of Pennsylvania.

PROBLEMS WITH XARELTO

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescriptions, written to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots that can lead to heart attacks, strokes and pulmonary embolisms.

Plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiffs assert claims against Xarelto makers Bayer, Janssen and Johnson & Johnson of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud as well as violation of consumer protection laws where permitted by state statutes and loss of consortium when possible.

The GI bleed issue which is the most common allegation in the Xarelto complaints is by no means the only medical issue to arise in litigation over the block-buster blood thinner, with claims of both hemorrhagic and ischemic strokes, sudden uncontrolled internal bleeding, lack of an antidote to stop traumatic bleeding events related to trauma as well as thousands of deaths related to taking Xarelto after being prescribed the drug by doctors.

Bayer and Janssen have aggressively defended the safety of Xarelto and proclaim the previous three defense verdicts in the Xarelto bellwether trails that took place in 2017, show that Xarelto is a safe drug. Medical and scientific data do not seem to support that position, but the 21,000 remaining lawsuits waiting to be returned to federal court dockets across the country may well force the defendants to rethink their legal strategy due to the catastrophic costs associated with defending and preparing cases for that number of potential trials.

XARELTO CALIFORNIA JCCP DOCKET

In January, California Superior Court Judge Kenneth R. Freeman in Los Angeles appointed the plaintiffs’ liaison counsel in the state’s Judicial Council Coordinated Proceedings (JCCP) for all Xarelto cases in the state courts, JCCP Case No. 4862. The California Xarelto docket is moving forward as cases filed there continue to increase monthly, with almost 300 cases currently pending in the California state courts. A recent status conference was held in December, when the parties agreed to submit plaintiff and defendant fact sheets.

XARELTO MDL 2592 FUTURE

Even though Judge Fallon has determined that there will be no more bellwether trials in his court as a sitting MDL judge, there are individual Xarelto cases that will remain in the US District Court of Louisiana docket that he may be ruling on. He will also have to address the various housekeeping and legal issues that will arise in winding down such a large MDL docket where the cases are still active and viable and both sides don’t seem to be looking toward a quick settlement at this point.

The thousands of cases being placed in front of federal judges across the country could possibly force the parties to come to the settlement table sooner as opposed to later, with a push here and there from individual courts, as already overloaded federal courts are probably not readily agreeable and inviting of this large a number of cases that are returning to home venues.

At this point the ball rests with defense counsel and their primary clients Bayer Pharma AG and Janssen Pharmaceuticals et al, and the corporate decision makers who are also facing the recently started Opiate Prescription Drug MDL 2804, which may require defense legal talent to switch from the Xarelto docket to the Opioid crisis litigation. The Opiate Prescription MDL may easily dwarf the prior Tobacco Litigation, to which it’s being compared. Big Pharma has some key decisions to make when it comes to where and how they will assign future resources and capital in defending past decisions in the manufacture and marketing of their prescription pharmaceuticals.

 

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Punitive Damages Now Allowed in Philadelphia Risperdal Suits Per Superior Court Ruling

Janssen Facing Over 6,400 Cases in Philadelphia Court of Common Pleas

By Mark A. York (January 18, 2017)

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs in the Risperdal litigation, may now seek punitive damages under a recent ruling by the Pennsylvania Superior Court.  Previously, plaintiffs were prevented from seeking punitive damages because the laws of New Jersey, applied to the Risperdal cases filed in the Philadelphia Court of Common Pleas, see Risperdal Re: Janssen: Philadelphia Court of Common Pleas. Johnson & Johnson is headquartered in New Jersey, with the courts previously applying those laws which barred punitive damages.

More than 6,000 Risperdal lawsuits in the Philadelphia docket allege Risperdal caused young men and boys to develop a condition called gynecomastia, where female breasts develop in male patients, with J&J’s Janssen Pharmaceuticals failing to warn about the risk.

The three-judge Superior Court panel ruled on January 9, 2018, that plaintiffs in the Philadelphia cases may apply the law of their home state to seek punitive damages, which opens up an entirely new legal avenue for plaintiffs.

Johnson & Johnson stated they were “disappointed in the ruling” and will be considering all options moving forward, while plaintiff counsel commented “This is something we’ve been right about from the beginning and maybe now, once and for all, J&J will recognize they’re facing punitive damages.”

Now that there is a threat of punitive damages, J&J will have to determine long term case strategy, as the punitive awards against J&J in 2016 – 2017 in other mass torts amounted to over eight hundred million dollars, and plaintiffs’ attorneys hope J&J will consider settling the remaining cases.

Plaintiffs have filed more than 6,400 product liability cases resulting from the use of anti-psychotic drug Risperdal in the complex litigation docket of the Philadelphia Court of Common Pleas. Plaintiff lead counsel, Tom Kline of Kline & Specter in Philadelphia, says “stakes in these cases will be raised now that the prospect of punitive damages is in play.”

On Jan. 8, Superior Court Judges Jack A. Panella, Alice Beck Dubow and Kate Ford Elliott ruled that plaintiffs in the Philadelphia-based Risperdal litigation may apply the respective laws of their home states to attempt to obtain punitive damages from Janssen Pharmaceuticals, the developer of Risperdal and a subsidiary of Johnson & Johnson.

“This is a pivotal decision in the Risperdal litigation. The Court found that the trial evidence justified the verdict in plaintiff’s favor. In addition, the stakes in any mass tort are raised when punitive damages are recoverable. This thoughtful and thorough opinion will now provide guidance for the entire litigation moving forward,” Kline said.

J&J and Janssen official statement is “We are disappointed in the Court’s ruling and will consider our options going forward. Contrary to the impression plaintiffs’ attorneys have attempted to create over the course of this litigation, Risperdal (risperidone) is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions,” there was no comment released by Janssen defense counsel.

Currently, most of the 6,400 lawsuits based in the Philadelphia Risperdal docket have been filed by out-of-state plaintiffs, who assert Risperdal causes young males to contract gynecomastia, or the development of female breast tissue, and that Johnson & Johnson failed to adequately warn of these side effects from the drug.

The Superior Court’s new ruling applies across-the-board, as even plaintiffs who have previously received jury verdicts in Risperdal litigation, can now petition the court for new trials or request hearings to enhance verdict awards by adding punitive damages. One prior jury verdict was for more than $70 million and plaintiffs can now request additional punitive damages be awarded.

Before this ruling, seeking of punitive damages in Risperdal cases was prohibited according to New Jersey state law – because Johnson & Johnson is headquartered there.

The ruling on Risperdal punitive damages started when Johnson & Johnson appealed the Stange vs. Janssen Pharmaceuticals verdict; where Wisconsin plaintiff Timothy Stange asserted an inadequate warning of developing gynecomastia from taking Risperdal.

Mr. Stange used Risperdal for three years during his childhood, for treatment of Tourette’s syndrome, and at the close of the trial, a Philadelphia jury awarded him $500,000, and the recent Superior Court ruling has now upheld plaintiff arguments that an inadequate warning of the gynecomastia risks directly caused his injuries.

According to reports from the Philadelphia Court of Common Pleas, of the suits filed in the first 3 months of 2017, about 80 percent of cases in the Complex Litigation docket, came from out-of-state plaintiffs. With this recent ruling, it would seem logical that the number of Risperdal lawsuits filed in the Philadelphia court, may increase dramatically as the potential verdict award amounts have just risen to unknown numbers at this point.

One explanation for the surge in Risperdal filings can be directed toward defendants Johnson & Johnson, when they decided to cancel tolling agreements on thousands of cases. Knowing this strategy would increase the number of cases filed and the burden on the Court.

Tolling agreements pause the statute of limitations to file a lawsuit, and J&J actions seem to indicate that they wanted more lawsuits, not less, with J&J deciding to cancel the agreement after the $77 million verdict.

To date, eight Risperdal case have gone to trial in Philadelphia, with four juries ruling in favor of the plaintiffs, and J&J getting the other four cases dismissed.

The first case to trial, filed by Austin Pledger of Alabama was heard in 2012, with the jury siding with Pledger, finding J&J and Janssen failed to warn the drug could cause gynecomastia, and the jury awarded $2.5 million to Mr. Pledger.

After two more verdicts of $500,000 and $1.75 million were awarded to plaintiffs, in 2016 a Philadelphia jury handed a landmark verdict of $70 million to Andrew Yount of Tennessee, with. Judge Paula Patrick adding nearly $7 million in additional damages over intentional delays during the legal proceedings.

With the new rules regarding punitive damage,  including permitting retroactive claims by successful plaintiffs to now request punitives, Johnson & Johnson/Janssen Pharmaceuticals may need to rethink their long term case strategy, as having a punitive sword hanging over the 6,400 plus remaining cases, should cause defense counsel to re-evaluate their position sooner versus later.

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New York City sues Big Pharma over opioids – joining Chicago, Seattle, Milwaukee and other major cities

New York City Joins Chicago, Seattle, Milwaukee in Suing Opioid Industry Players

“PROFITS OVER PATIENTS BY BIG PHARMA CONTINUES”

 

MAJOR CITIES SUE BIG PHARMA OVER OPIOIDS

 

                                           

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) New York City has filed a lawsuit against pharmaceutical companies that make or distribute prescription opioids, on Tuesday the complaint was filed in New York state court, Superior Court of Manhattan, which is a break from other Opioid lawsuits filed by cities, who filed into federal court, see OPIOID-CRISIS: MDL-2804-OPIATE-PRESCRIPTION-LITIGATION. The primary claims state that the opiate drug companies fueled the deadly epidemic now afflicting the most populous U.S. city, joining Chicago, Seattle, Milwaukee and other major cities across the country in holding Big Pharma drug makers accountable for the opioid crisis.

New York Mayor Bill de Blasio stated the lawsuit seeks $500 million in  damages to help fight the crisis, which kills more people in the city annually than homicides and car accidents combined, which at last count was more than 1,100 from opioid-induced overdoses in 2016.

He also clarified “Big Pharma helped to fuel this epidemic by deceptively peddling these dangerous drugs and hooking millions of Americans in exchange for profit,” making his point clear as to where responsibility for the opioid crisis rests.

Named defendants include manufacturers Allergan Plc (AGN.N), Endo International Plc (ENDP.O), Johnson & Johnson (JNJ.N), Purdue Pharma LP and Teva Pharmaceutical Industries Ltd (TEVA.TA), and distributors AmerisourceBergen Corp (ABC.N), Cardinal Health Inc (CAH.N) and McKesson Corp (MCK.N), sourced from Reuters.

 

All were accused in the city’s complaint of creating a public nuisance, and the distributors were cited for negligence. The same allegations have been asserted in other complaints, including RICO claims by many plaintiffs who assert the companies conspired and created the opioid crisis by developing questionable opioid marketing plans, including offering financial incentives and making payments directly to doctors and others to write opiate prescriptions.

Allergan, Endo, J&J, Purdue, Teva, AmerisourceBergen and McKesson have all stated that they historically emphasized the importance of using opioids safely, in their business operations

BIG PHARMA OFF-LABEL DRUG ABUSES

Endo, J&J and Purdue denied the city’s allegations, with McKesson and Cardinal Health not immediately responding to requests for comment. All companies listed in the complaint have repeatedly been cited, fined and entered into consent decrees with the federal and state governments regarding questionable marketing practices related to prescription drugs. Often these fines have totaled hundreds of millions of dollars and never admit liability, simply agreeing to stop the cited activity, which as reflected in the hundreds of opioid based complaint recently filed, the agreement to cease and desist in “off label” or inappropriate drug marketing efforts has not been applied to the opiate prescription industry.

New York City, with over 4 million residents, has joined a long list of U.S. states and municipalities suing drug companies over opioid abuse, often referring to the drug makers “off label” use, where sales reps have continuously pushed an agenda of the opiates being “non-addictive” and part of proper healthcare.

OPIATES: A PUBLIC HEALTH EMERGENCY

The national opioid crisis incited President Trump to designate the it as a national public health emergency in November 2107, and the administration extended the emergency as of January 19, 2018. Although it should be noted that President Trump has not applied any federal funding to the now official “public health emergency” thereby leaving the state and local governments to push forward in the efforts to combat the opioid crisis on their own.

Opioids, including prescription painkillers and heroin, played a role in 42,249 U.S. deaths in 2016, up 28 percent from 2015 and 47 percent from 2014, according to the U.S. Centers for Disease Control and Prevention.

The complaint filed in state court in Manhattan, New York accused manufacturers of having for two decades misled consumers into believing that prescription opioids were safe to treat chronic non-cancer pain, with minimal risk of addiction.

The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

MILLIONS OF PILLS PRESCRIBED

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these state, with West Virginia numbers being 780 million painkillers in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a appoint where Big pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to simply assign a financial penalty for the alleged corporate opioid abuses.

The case docket information is: City of New York v Purdue Pharma LP et al, New York State Supreme Court, New York County, No. 450133/2018.

 

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FDA Delays “Off-Label” Intended Use Rule Change For Drugs

“Trump Lets Big Pharma Off The Hook”

By Mark. A. York (January 23, 2018)

Trump Removes FDA Rules

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Just as Big Pharma was looking at 2017 victories related to off-label marketing of drugs for unintended uses, drug makers were expecting some loosening of the regulatory shackles. Then the FDA rolled out a new rule on that subject, that wasn’t in Big Pharma’s bests interests, sending the drug industry into a lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials in their camp, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

As the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses.  The FDA will receive comments on this proposal through February 5, 2018.

Here is the official FDA publication of January 16, 2018:

The Federal Register:  https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

 

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$28 Million Xarelto Jury Verdict Reversed by Judge in Philadelphia Court

Defense gets fourth win in the four Xarelto bellwether trials

By Mark York (January 11, 2018)

 Xarelto Blood Thinner Developed by Bayer and Janssen

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The December 2017 Xarelto jury verdict of $27.8 million awarded to an Indiana couple, was overturned earlier this week, when the trial judge vacated the verdict. The plaintiffs had accused Bayer AG and Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary, of failing to warn of internal bleeding risks of their drug Xarelto.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, heard arguments on January 9, 2018 in a motion hearing to reverse the December verdict, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592, (see XARELTO MDL 2592 US District Court ED Louisiana briefcase) in front of Judge Eldon Fallon, US District Court of Louisiana.

Judge Erdos issued his ruling from the bench after the hearing on defense motions for a new trial or alternatively, for a judgement notwithstanding the verdict, and at the close of a full day of arguments stating, “a new trial is not necessary because plaintiff did not adequately demonstrate responsible cause,” and he then entered judgement for the defendants.

“J&J’s Janssen Pharmaceuticals Inc and Bayer, which jointly developed Xarelto, welcomed the decision and issued statements saying they will continue to defend against the allegations in all Xarelto litigation, with a total of more than 20,000 pending lawsuits now in both state and federal Xarelto dockets.

Bayer stated “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

The December 5, 2017 verdict came in a lawsuit filed by Lynn Hartman, who was prescribed Xarelto as treatment for an irregular heartbeat also known as atrial fibrillation, to prevent strokes. The testimony and opinions of Ms. Hartman’s treating physician and views on continued willingness to prescribe Xarelto, had a significant impact on the final ruling to overturn the verdict by Judge Erdos.

Hartman claimed she was prescribed the drug for a little more than a year, starting in February 2013, and was hospitalized with severe gastrointestinal bleeding in June 2014, at age 72, with the bleed attributed to taking Xarelto. The court record reflected that Ms. Hartman has since recovered from the hospitalization.

Lynn Hartman and her husband filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with the six week trial starting the first week of November 2017, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi.

The Hartman trial is just one of about 21,400 against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and the first selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court.

Plaintiff trial counsel Michael Weinkowitz, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia. The post trial legal arguments were related to the “learned intermediary doctrine and proximate cause” and was raised by defense in post trial motions and aggressively argued, which plaintiff counsel was unable to overcome in the full day hearing.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the Hartman trial. What impact the initial plaintiff’s trial win followed by the Judge Erdos reversal this week has on both Xarelto dockets remains to be seen.

 

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Eli Lilly Announces Settlement Of All Testosterone Cases in MDL 2545

Eli Lilly Settles All Testosterone Therapy Cases in MDL 2545 Ahead of Bellwether Trials

Did Lilly Make the Right Move at the Right Time?

By Mark A. York (January 2, 2018)

 

 

 

 

 

 

 

(Mass Tort Nexus Media) One month before the start its first bellwether trial in Testosterone MDL 2545, in an Illinois courtroom, related to drug side effects, Eli Lilly& Co., announced it has reached a global settlement in all cases filed against it in the Testosterone Replacement Therapy Products Liability Litigation MDL 2545, see Mass Tort Nexus  briefcase TESTOSTERONE PRESCRIPTION THERAPY LITIGATION MDL 2545.

The drug company was facing claims that they failed to warn that its testosterone replacement therapy drug Axiron, could cause potentially deadly heart attacks, strokes and blood clots.

The pharmaceutical company told U.S. District Judge Matthew Kennelly that it had entered into a memorandum of understanding to resolve all pending litigation. As a result, Judge Kennelly canceled two upcoming trial dates – in January and March – involving Axiron. The trials involved the case of Tracy Garner, who claimed that using Axiron caused him to suffer a heart attack, and the case of John DeBroka Jr., who said he developed deep vein thrombosis, a blood clot in the deep veins, after taking Axiron.

The terms of the settlement were not outlined in the court documents, however based on recent trial verdicts, Lilly may have made the correct move in settling all claims.

Eli Lilly faced a portion of the 6,000 cases in the testosterone side effects multidistrict litigation. Other testosterone manufactures named include AbbVie and Auxilium, both of which have already gone to trial. AbbVie faced about 4,200 cases and was hit with two back-to-back verdicts totalling $290 million.

The drug companies are accused of failing to warn of testosterone side effects as well as marketing the male prescription  hormone product for an alleged off-label use – for a made up condition called “Low T.” Testosterone treatments are intended only indicated for men with hypogonadism, a condition in which men have low testosterone levels due to defect, disease or injury.

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How Fentanyl Came to North America From China and Stayed

“A look at how Canada became addicted”

By Mark A. York (January 2, 2018)

Fentanyl is 100 times stronger than heroin

(MASS TORT NEXUS MEDIA)  Fentanyl: Manufactured in China, it easily crosses porous borders, triggering a heroin-like bliss in users – and, all too often, death. It’s as easy as ordering a book online: Sign up for an account, choose a method of payment, and receive the package in three to four business days.

But first, there are some choices to make. The fentanyl hydrochloride comes in a variety of quantities, ranging from a half-gram sample for $35 (U.S) to a kilogram for $21,000. It also comes in different strengths – purchasers are warned to “be careful” and do their research on the product, described as 99-per-cent pure. And of course, there are the related pharmaceutical products: the fentanyl patches, tablets and even lollipops.

Buyers are assured their package won’t get seized at the Canadian border. To avoid the risk of detection, says a supplier from China, he conceals the purchase alongside urine test strips. Not that there’s reason to worry: Canadian border guards cannot open packages weighing less than 30 grams without the consent of the recipient. (A Globe and Mail reporter corresponded with sellers and suppliers using a pseudonym and did not disclose himself as a journalist, in order to obtain accurate information from the seller.)

The supplier, who identified himself only as Alan, says he has two customers in Canada. He e-mails photos of fentanyl hidden inside silica-desiccant packets – the type normally used when shipping goods such as electronics – and a screen shot of a recent order from Canada, including a shipping address for a clothing store in British Columbia’s picturesque Okanagan Valley.

Fentanyl from China is sometimes hidden in silica desiccant packages.

 

 

 

 

 

 

 

 

 

 

 

 

Alan says he is based in the southern metropolis of Guangzhou, the trading crossroads for manufacturing in China – a country that is, in turn, at the centre of the vast underground world of synthetic-drug manufacturers. Enforcement is fragmented, and companies operate with impunity.

Fentanyl is an opioid, a class of painkillers that also includes oxycodone and morphine. Prescription-grade fentanyl is up to 100 times more toxic than morphine. Developed in 1959 by a Belgian chemist, it was quickly adopted as a pain reliever and anesthetic in medical settings. It came into widespread use in the mid-1990s with the introduction of the transdermal patch that releases the drug into the patient’s bloodstream over two or three days. When the drug is processed in a clandestine lab with no quality controls, it is difficult to get the dosage right, making it potentially much more dangerous.

Chemical companies in China custom-design variants of pharmaceutical-grade fentanyl by tweaking a molecule ever so slightly. A few hundred micrograms – the weight of a single grain of salt – are enough to trigger heroin-like bliss. But the line between euphoria and fatal overdose is frighteningly thin: An amount the size of two grains of salt can kill a healthy adult.

The supply chain for illicit fentanyl begins in China, but the problems Canada is experiencing start right here at home: No other country in the world consumes more prescription opioids on a per-capita basis, according to a recent United Nations report. The widespread use of prescription opioids is behind the rise of a new class of drug addicts, many of whom are turning to the black market to feed their habit. In British Columbia and Alberta, the two hardest-hit provinces, fatal overdoses linked to fentanyl soared from 42 in 2012 to 418 in 2015.

Among the investigation’s findings from interviews with nearly three dozen medical experts, public-health doctors, police and family members of overdose victims: Federal and provincial rejection of harm-reduction measures hindered the response to the fentanyl crisis in Alberta. Neither Ottawa nor the provinces are taking adequate steps to stop doctors from indiscriminately prescribing highly addictive opioids to treat chronic pain – in 2015 alone, doctors wrote enough prescriptions for one in every two Canadians. And addiction-treatment programs are few and far between – a legacy of the former Conservative government’s tough-on-crime policies.

The investigation also found that online suppliers are exploiting gaps at the border. Fentanyl and many chemically similar drugs are classified as controlled substances in Canada, making them illegal to import without a licence or permit. But, for online suppliers, the borders may as well not exist; they devise clever ways to conceal the drugs and skirt inspection rules. Suppliers often ship drugs in packages under the 30-gram threshold, ensuring border agents won’t open them. One supplier with whom a Globe reporter corresponded promised to ship fentanyl inside a gift-wrapped package. Another pledged, “No problem of police coming to you,” as the package would be labelled household detergent, complete with a certificate of analysis. Many suppliers will even offer guaranteed reshipment to customers in the event their package gets intercepted.

Because illicit fentanyl is so potent, once it arrives here, the white crystalline powder gets diluted with powdered sugar, baby powder or antihistamines before it can be sold on the street and consumed. It is also mixed into other drugs, and sold as heroin or OxyContin.

As Canada wakes up to a mounting public-health crisis, it is left playing catch-up with the United States, which is confronting its own epidemic of illicit and prescription drug abuse. Policymakers in Canada do not even have the basic tools to monitor this leading cause of accidental deaths – in contrast to the situation in the United States, there is no national system tracking fatal opioid overdoses.

The arrival of illicit fentanyl in Canada is a “game changer,” says Benedikt Fischer, a senior scientist at Toronto’s Centre for Addiction and Mental Health. When Canada’s opioid problem involved only the abuse of prescription drugs, he says, policymakers squandered an opportunity to address it. Now that many addicts are turning to a drug that is manufactured without government oversight – and in countries beyond our borders, to boot – it is nearly impossible to get a grip on the problem. “Even if we wanted to now suddenly take action, there’s nothing we can do,” he says. “We have no way of controlling thousands of illegal drug labs in China.”

Jason Berry (left) and Patrick Provencher were arrested for producing fentanyl tablets

 

 

 

 

 

 

 

 

The First Major Canadian Fentanyl Bust

It was the winter of 2012 when a Montreal police detective heard about a drug-dealing operation run by Patrick Provencher, at the time, unknown to police. But it would take another year for Det. Yves Rousseau to confirm the seemingly innocuous tip about the low-level drug dealer that would lead to the first big bust of a Canadian operation dedicated to producing and selling industrial quantities of bootleg fentanyl.

The case was uncharted territory for Canadian law enforcement – three investigators became ill after kicking in the door of the illicit lab and handling the toxic drug, including one who spent a night in hospital. The police drug lab, to which hundreds of kilograms of drug-making substances were hauled, was placed under quarantine. The fire department’s hazardous-material unit had to decontaminate the drugs before they could be examined.

“All of these products were in residential neighborhoods, next to people living their lives,” Det. Rousseau testified in court proceedings, after Mr. Provencher’s 2013 arrest, as he told an astonished judge about the turn of events. “This was very dangerous to public security.”

A year after police were tipped off about Mr. Provencher, a 40-year-old computer engineer trained at Montreal’s École Polytechnique, a second source confirmed the information.  Mr. Provencher had recruited Jason Berry, a 33-year-old who had just served time for producing and selling drugs, as his business partner. The two men had set up a lab in a garage in the hardscrabble Pointe-Saint-Charles neighborhood, rented several storage units, and were running the business out of the downtown gym where Mr. Provencher worked.

They received raw material from China, cut the drug with fillers, put the mixture through a pill-press machine to produce tablets, and then shipped them by courier all over North America, often in hollowed-out appliances. In fact, police arrested the two men on their way to a UPS store to ship a microwave oven containing 10,180 fentanyl tablets to New Jersey.

Police found nearly 200,000 pills in various storage units along with pill presses, pulverizers and dryers capable of churning out thousands of tablets an hour. The two men pleaded guilty, and were each sentenced to about eight years in prison in 2014, minus credit for time served.  “The quality of the pills was unbelievable and the quantity was unheard of,” Det. Rousseau said.

 

Purdue began sending adverse drug reaction reports to Health Canada in 2000, describing everything from patients who experienced hot and cold sweats and dizziness after taking Oxycontin to fatal overdoses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

An Opioid Addicted Nation

The raid of the Montreal lab in April, 2013, shows how fentanyl has revolutionized the illegal drug trade. Unlike the massive infrastructure and cartels required to manufacture and transport heroin or cocaine, just about anyone can buy and sell fentanyl. Because it is so powerful, a little goes a long way. A kilogram ordered over the Internet – an amount equal in weight to a medium-sized cantaloupe – sells on the street in Calgary for $20-million, making it a drug dealer’s dream.

The collective inaction of government leaders, doctors, police and border officials leaves Canada dealing with the fallout from a drug that wouldn’t even be on the streets were it not for a decision made two decades ago. Until the mid-1990s, opioids were primarily prescribed to cancer patients and others suffering debilitating pain. But in 1996, Health Canada approved OxyContin, a brand-name version of oxycodone, to relieve moderate-to-severe pain, heralding a sea change in the treatment of pain.

Purdue Pharmaceutical, the maker of OxyContin, launched sales campaigns promoting the benefits of the drug. Doctors started prescribing it for everything from backaches to fibromyalgia. OxyContin quickly became the top-selling long-acting opioid in Canada. But it also became a lightning rod in the early 2000s, as reports of addiction and overdoses exploded.

The Office of the Chief Coroner of Ontario raised concerns, noting in a 2004 report that deaths linked to oxycodone climbed steadily between 1999 and 2003, according to documents obtained by The Globe through an access-to-information request. The report says that although no attempt was made to determine whether the detected oxycodone was due to “the ingestion of OxyContin or any other oxycodone-containing formulation, it is noteworthy that the increase in the prevalence of oxycodone findings in death investigations coincides with the introduction of Oxycontin [sic] to the Canadian market.”

 

 

 

 

 

 

OxyContin was popular not only with people who became addicted after receiving prescriptions, but also with heroin users, because they could easily snort it like cocaine or inject it like heroin for a quick high.

In 2012, Purdue pulled OxyContin from the market and replaced it with OxyNEO, a tamper-resistant alternative that is difficult to crush, snort or inject. That same year, the provinces stopped paying for either opioid through their public drug plans. But by focusing specifically on those two drugs, medical experts say, policy makers missed the larger picture. Prescriptions for alternative painkillers, including hydromorphone and fentanyl, rose sharply: The crackdown pushed drug abusers and legitimate patients towards other, potentially addictive painkillers.

The removal of OxyContin left a void that organized crime exploited, says Sgt. Luc Chicoine, the RCMP’s National Drug Program Co-ordinator. Responding to an e-mail from The Globe, Purdue spokeswoman Aimee Sulliman said that the increase in fentanyl-related deaths across Canada is “tragic and a significant public-health concern,” but that it is unfair to blame OxyContin for the rise of the illicit drug. “This is a complex issue and the simplistic causality assertion of the question is misleading.”

Demand for a replacement for OxyContin also gave rise to another problem – a counterfeit version of the drug laced with illicit fentanyl smuggled into Canada and processed for street sale in labs. The labs would typically dye their pills green to mimic the 80-milligram OxyContin pills favored by opioid abusers, and sell them as “greenies” or “shady eighties.”

Fentanyl pills are made to look similar to OxyContin pills

 

 

 

 

 

 

 

 

 

 

 

In comparison to Europeans, North Americans rely heavily on pharmacological solutions to medical woes. In a culture whose citizens pop over-the-counter pills to treat every minor ailment, says Sgt. Darin Sheppard, of the RCMP’s Federal Serious and Organized Crime Synthetic Drug Operations, many drug users view the “greenies” as deceptively harmless.

“It’s just a pill to many people,” Sgt. Sheppard says. “Now, we’re starting to realize the true aspect of what harm can be realized as a result of this.”

Police across Canada have shut down 20 fentanyl labs since that first major bust in April, 2013, mostly operated by organized-crime groups, according to a Globe review. The biggest raids were in B.C., Alberta and Saskatchewan. Police have also made dozens of busts involving illicit fentanyl and the prescription-grade patches. This week, police charged a doctor and a pharmacist from the Toronto area with participating in a fentanyl trafficking ring.

The Canada Border Services Agency (CBSA), the first line of defence in preventing illicit goods from entering the country, is responsible for clearing international mail. In 2015, the agency made just under 11,000 illicit-drug seizures, half of which came through the postal system. And yet, even as the volume of all commercial goods cleared at the border increases, including international mail, the number of front-line officers continues to shrink.

As long as fentanyl continues to arrive in Canada undetected, municipal police cannot arrest themselves out of the problem, says Calgary Police Staff Sgt. Martin Schiavetta. He wants to know how serious the federal government is about fentanyl. “Are they aware of the scope of the problem?” he asks. “What strategies does the RCMP have to deal with these Chinese imports? Does CBSA have enough capacity to deal with all the packages?”

The problem is compounded by the fact that the illicit drug is highly profitable for traffickers. Hakique Virani, an Edmonton physician and former deputy medical officer at Health Canada, described the “whack-tastic” profits for traffickers during a conference last November for the Canadian Society of Addiction Medicine. The raw materials and equipment, including a kilogram of pure fentanyl powder and an industrial-grade pill press, cost under $100,000, he said in his presentation. A kilo of powder is enough to produce one million tablets, which sell for $20 each in Calgary. Police chiefs in Alberta asked the federal government last November to make it illegal to import and operate industrial pill presses, but have had no response.

Deadly Denial of Crisis

Many medical experts say that the former Conservative government did not devote enough resources to harm-reduction measures (such as the provision of overdose antidotes) to address the side effects of drug abuse; Ottawa fought a war on drugs instead, primarily by prosecuting low-level offenders.

Any mention of harm reduction was banished from Health Canada’s website in 2007, when the federal department changed the name of its National Drug Strategy to the National Anti-Drug Strategy.

The Conservatives quietly spread the word that not-for-profit groups would have difficulty getting federal funding if they continued to provide harm-reduction programs. Margaret Ormond, project director of Sunshine House, a harm-reduction centre in Winnipeg, says she was told that if she wanted to continue receiving funding from Ottawa, she should not “go on and on about harm reduction” in her application. Sunshine House stopped seeking federal funding six years ago.

Stephen Harper’s Conservatives also attempted to shut down Insite, North America’s only supervised-injection site, in Vancouver’s impoverished Downtown Eastside, which allows addicts to safely inject illegal drugs under a nurse’s supervision. The Conservatives eventually lost that battle at the Supreme Court of Canada, which in 2011 ordered the government to allow Insite to remain open. The government responded to the ruling by introducing legislation making it difficult, if not impossible, for other sites to open, even though Insite has demonstrated that it has reduced overdose deaths.

“Under the previous government, Health Canada did virtually nothing of consequence to address this epidemic,” says David Juurlink, head of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto. “In some ways, their actions have made it worse.”

Health Canada did not reply to The Globe’s request for comment on how opioids are managed. In a statement, the spokesman for Alberta’s health minister said that the province is actively looking for ways to improve physician education and prescription monitoring, but could not provide specifics on when any results are expected.

In an interview, federal Health Minister Jane Philpott says she is committed to addressing the problem and to making sure people struggling with opioid abuse have access to harm-reduction programs. “I have talked to families who have lost loved ones, whose lives could have been saved if they had either the opportunity to access a supervised-injection site or if the family had known about the availability of naloxone,” Ms. Philpott says, referring to an antidote that reverses the symptoms of an overdose in minutes. “Nothing is more heartbreaking than hearing the stories of these families.”

Rupa Patel, a family physician in Kingston – who, like a lot of her colleagues, has many patients asking for prescription opioids – sees an additional way the government could help mitigate the crisis: by introducing mandatory prescribing limits.

Unlike the United States, which released new guidelines last month advising doctors not to prescribe opioids for chronic pain in most situations, Canada has not revised its guidelines since 2010. Opioid prescriptions totalled 19.1 million in 2015, up from 18.7 million the year before, according to figures compiled for The Globe by IMS Brogan, which tracks pharmaceutical sales.

Dr. Patel sets her own limits with her patients, often refusing to prescribe painkillers, because the risks are substantial and the benefits uncertain. But saying no is difficult, she says, because patients are often in distress. “People expect a pill to fix their problems.”

Even if new guidelines were introduced, there are still not enough resources, nationally, to treat addiction. More beds are needed for those going through withdrawal as well as treatment programs for people addicted to painkillers, especially for aboriginals and those living in remote areas.

And as the pipeline for black-market drugs leads to an unprecedented surge in deaths, Canada has been slow to make naloxone more widely available. Last month, Health Canada changed the status of naloxone to a non-prescription drug. But before it can be sold without a prescription, each province and territory needs to approve the loosened restrictions – something that is not expected to happen until June or July in several regions.

Standoff is a community of 12,800 people that has endured a disproportionate number of Alberta’s fentanyl deaths

 

 

 

 

 

 

 

 

 

 

 

 

 

No province has been hit as hard as Alberta, where fentanyl was found in the blood and urine of 392 fatal-overdose victims over the past two years.

During those early days of the crisis, both federal and provincial health officials were slow to grasp the enormity of the problem, The Globe investigation found. The Alberta government did not issue a province-wide warning to doctors about illicit fentanyl until December, 2014. And it was not until a year later that Alberta’s health minister allowed all first responders across the province to treat overdose victims with naloxone.

The southwestern community of Stand Off, on the Blood Tribe reserve (also known as Kainai Nation), has endured a disproportionate number of Alberta’s deaths. Dr. Esther Tailfeathers, a family physician from Blood Tribe, responded to her first fentanyl overdose in July, 2014. She had just pulled her car into the parking lot of a shopping centre in Lethbridge when she saw a man in a white minivan slumped over the steering wheel. Only minutes earlier he had taken a pill. In the back seat, four children were crying for help as he lost consciousness.

The young man would survive that day. But within months, the reserve in a socially conservative corner of Alberta, where neighbouring communities enforce prohibition and cherish abstinence, would become ground zero for an emerging public-health crisis.

Within days of her first brush with fentanyl, Dr. Tailfeathers began seeing other overdose victims in her hometown of 12,800. At first, she treated one or two overdose cases a week. But that quickly escalated to two or three a shift. “We’ve never seen anything like this,” she says.

Patients soon began sharing stories about illicit pills circulating in the streets of their sprawling reserve near the Montana border. Drug dealers from Calgary and the small First Nations community of Maskwacis travelled there with backpacks full of fentanyl, selling each pill for $80. One girl collapsed at a party after snorting fentanyl, Dr. Tailfeathers says. “We put a tube in her nose, and while she and I were talking I pulled the tube out. There was a green pill stuck in the end.”

By August of 2014, reports of mounting deaths in Blood Tribe began arriving in the Edmonton office of Dr. James Talbot, the province’s chief medical officer at the time. Dr. Talbot quickly set up a working group and invited Dr. Michael Trew, then the province’s chief addictions and mental health officer, to join.

The first thing the two doctors tried to do was distribute naloxone kits to first responders. But they ran into roadblocks: While specialized paramedics were allowed to administer the drug, the majority of first responders in Alberta could not.

The Blood Tribe ended up reaching out to Dr. Virani, who was then still a deputy medical officer at Health Canada, for its first batch of naloxone kits. Dr. Virani remembers his employees going to discount stores to buy the plastic containers that would hold the first 90 doses of the antidote. “At the time that I sent naloxone to Blood Tribe, Health Canada made every effort not to talk publicly about it,” he says.

Meanwhile, crime rates began to soar in Blood Tribe. The community was already struggling with poverty, income inequality and substance abuse. Addicts were breaking into homes looking for valuables. People sold everything they owned to buy another pill, says Dr. Tailfeathers, with some nursing a habit that cost as much as $300 a day. She visited homes where there was no food, no heat and no blankets. The four walls of one house were covered with writings about suicide. “It’s like a natural disaster on the reserve,” she says.

Fence is tagged with “SSB” – South Side Bloods on a street in Standoff called Oxy-Alley 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In March of 2015, the local band council declared a state of emergency, making it the first community in the country to sound the alarm because of fentanyl. Despite that, Dr. Virani says that Health Canada told him to stop speaking publicly about First Nations health in Alberta. He resigned from the department last month. While he declined to comment about his departure, he accused the bureaucracy of being slow to respond to the fentanyl crisis and being out of step with the minister, Dr. Philpott. “I think she’s a public-health champion on this,” he says.

The naloxone program that Dr. Virani started in Blood Tribe, where the federal government has jurisdiction, helped reduce the number of people overdosing. But once the epicentre of the fentanyl crisis shifted to Calgary, it was up to the provincial government to take action.

In the final months of the former Conservative government’s time in power, the health minister mobilized the first resources to combat fentanyl. Shortly before the government was defeated last May, Alberta sent a notice to hospitals and clinics warning about the risks associated with illicit fentanyl and recommending naloxone to reverse the effects of an overdose. The end-of-government decision may explain what happened next. During the first chaotic week of New Democratic rule in Alberta, both Dr. Trew and Dr. Talbot were told by senior members of the civil service that they were being let go when their contracts expired. A new chief medical officer has yet to replace Dr. Talbot.

The strain was clear on Staff Sgt. Schiavetta’s face during an interview in February. He took over Calgary Police’s drug unit in early 2015, just as fentanyl use began to skyrocket in the city – 81 people in Calgary died from fentanyl overdoses last year, including residents of all genders, ages and socioeconomic groups. Complicating matters, his officers seized three pills last August that were later identified as W-18, an experimental drug 100 times more potent than fentanyl.

But fentanyl remains the drug that takes up most of Staff Sgt. Schiavetta’s time. “Calgary is flooded with fentanyl,” he says.

While Alberta has borne the brunt of the fallout from the arrival of bootleg fentanyl from China, no one saw it coming, Dr. Trew says. “It hit us between the eyes.”

The scourge of illicit fentanyl is now rapidly expanding east. Deaths linked to fentanyl more than doubled to 29 in Manitoba last year, according to a Globe tally of provincial coroners’ figures. In Ontario, fentanyl was the leading cause of opioid deaths for the first time in 2014 – the most recent figures available – and several communities (including Toronto, Kingston and the Niagara region) have been hit with a spike in fatal overdoses in recent weeks.

Drug vendors in China sent promotional pictures of their drug labs 

 

 

 

 

 

 

 

Back to the Source in China

Little is known about the companies in China that make fentanyl, including whether the substance is the product of backyard laboratories or professional chemists concocting it on the side. Or, more likely, both.

For most potential buyers, fentanyl manufacturers appear to exist in plain view, openly advertising the drugs they make. On the Chinese Internet – where no trace of them can be found – and on the ground, it’s a different story altogether.

A Globe reporter travelled to Wuhan to search for the addresses posted online by a series of drug sellers and laboratories. One address pointed to a massive apartment-construction project. Several others were for street numbers of buildings that have either been demolished or were never there.

One clue lies in photographs sent to Rodney Bridge, an Australian man who became an expert on Chinese drug manufacturing after his 16-year-old son died from taking a lab-made drug similar to LSD. His son jumped off a balcony, thinking he could fly.

Mr. Bridge travelled twice to China in search of the person who sold the $2 pill to his son. Vendors sent him pictures of their labs. One showed a cobbled-together arrangement resembling a high-school chemistry lab. Another showed a large industrial operation in a warehouse, complete with a forklift.

A photo of a fentanyl lab offered by a Chinese drug vendor 

 

 

 

 

 

 

 

 

 

 

 

Chinese officials have taken steps to crack down on the illicit drug business. Last October, the country banned 116 substances, including a half-dozen types of fentanyl. Hu Minglang, a director of China’s National Narcotics Control Commission, told The Globe the ban has been “very effective.”

But the ban appears only to have succeeded in placing chemicals slightly under the radar. Dharma Chemicals, a supplier named by the World Health Organization as a seller of acetylfentanyl, one of the 116 illegal chemicals, has struck the drug from its catalogue. But in response to e-mailed queries, a Dharma representative promised quick delivery of the drug, writing, “stock is available.”

China remains in some ways the ideal country to produce synthetic drugs, something no rules are likely to change. As the world’s biggest trading nation, China already sends huge volumes of goods to countries such as Canada, providing “numerous ways to disguise your drugs,” says John Coyne, a former Australian Federal Police intelligence agent who is now head of border security at the Australian Strategic Policy Institute.

It’s a problem the Mexican government has combatted for years. Mexican drug cartels have long imported chemical ingredients from China, which fuel the Latin American country’s manufacture of meth and finance its crime syndicates. “China was never willing to help. They didn’t see it as their problem,” says Jorge Guajardo, the Mexican ambassador to China from 2007 to 2013.

As long as Chinese officials do not crack down more aggressively on exporters, medical experts say, the responsibility for change falls squarely on those in power at the end of the supply chain. “It’s a national tragedy,” says Meldon Kahan, medical director of the Substance Use Service at Women’s College Hospital in Toronto, “and a health-care tragedy where most groups don’t come out looking very good.”

Coming next: How Fentanyl Made it Into the USA for Years

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