Who’s Telling Who About The High Risk Of Synthetic Surgical Mesh?
By Mark A. York (February 21, 2018)
(MASS TORT NEXUS MEDIA) FDA labels pelvic mesh as a “High Risk Medical Device” yet minimal review, investigation or action has been undertaken regarding the thousands of annual adverse events that are recognized in the medical industry as caused by “plastic or synthetic mesh” which is comparative to high quality polypropylene fishing line, which in both mesh and fishing line is available in various strengths. Is this something that’s either disclosed by your doctor and would it have an affect on your surgical decision?
WHO DISCLOSES RISK?
In January 2016, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning. Are healthcare professionals and surgical mesh manufacturers making sure this is a known factor in pre-surgical decisions? If notice to the public of the high risk designation of surgical mesh devices follows historical medical device manufacturers standards, that answer is an emphatic “NO”- medical device makers and their sales and marketing staff do not advertise or declare FDA and other regulatory defined risks to the public unless forced to, which includes patients undergoing surgeries. You physician may disclose whatever minimal product warning or risk statements that they’ve been provided by the medical product manufacturer.
DOES THIS HELP PATIENTS?
Mesh surgical implants used to repair pelvic organ prolapse in women, a condition that frequently develops after childbirth, will face tougher federal scrutiny following thousands of injuries reported with these devices.
The Food and Drug Administration said Monday that pelvic mesh will now be considered a class III, or high-risk, medical device, and manufacturers will be required to submit premarket approval applications demonstrating the safety and effectiveness of their products.
The change follows years of reports of pain, bleeding and infection among women who had the devices implanted to correct pelvic organ prolapse (POP). The condition occurs when the bladder or other reproductive organs slip out of place, causing pain, constipation and urinary issues. The new FDA requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.
Plastic mesh is often used to strengthen the pelvic wall and support internal organs in cases of prolapse. The mesh is often inserted through the vagina, using a small surgical incision. The Washington Post recently reported that as many as half of women may experience pelvic floor symptoms in their lifetime, and 200,000 undergo such operations each year.
Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.
WHAT IS MESH?
Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).
Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.
Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat pelvic floor disorders with surgical mesh:
Transvaginal mesh to treat POP
Transabdominal mesh to treat POP
Mesh sling to treat SUI
MESH REPAIR VERSUS SUTURES
The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were introduced for pelvic repair in the 1990s and promoted as a way to speed patients’ recovery time. But the FDA said in 2011 that about ten percent of women experienced complications from mesh, sometimes requiring multiple surgeries to reposition or remove it.
In a second rule, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning.
FDA recommends that women be aware of the risks associated with surgical mesh. On an advice page on the FDA website, the agency writes: “Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options.”
Non-surgical options include pelvic floor exercises known as Kegels. There are also non-invasive devices such as the PeriCoach, a smartphone-connected pelvic floor muscle training device for incontinence.
WHY WAS THERE AN FDA DELAY?
The FDA first proposed the 2016 changes in 2014 draft orders, why would a regulatory safety agency wait two years to announce the high risk designation of a product being used over 200 thousand times a year in the USA? This reflects the back office control and influence of the medical manufacturing industry as a whole and how they use influence to defer and often stop disclosure of adverse risk s related to the medical products they sell to consumers. Profits before patient in the general rule in most device manufacturer boardrooms..
Like 90 percent of medical devices sold in the U.S., pelvic mesh was originally cleared under a streamlined FDA review process for devices deemed similar to older products. This has resulted in billions of dollars in profits for major medical manufacturers and the medical field as a whole, while thousands and thousands of patients have been afflicted with life changing post-surgical complications and until the FDA or other parties make the high risks known, many thousands more patients will have plastic products surgically implanted into their bodies, without knowing the true risks.
Ruling Rejects Opioid Manufacturers’ Arguments To Dismiss Deceptive Marketing Litigation
By Mark A. York (February 19, 2018)
(MASS TORT NEXUS MEDIA) On February 13, 2018, the Orange County Superior Court rejected efforts by opioid manufacturers to dismiss a lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney on behalf of the People of the State of California. The lawsuit, filed in May 2014, alleges that the defendants—including opioid manufacturers Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., Endo Health Solutions, Inc., and Actavis PLC—engaged in a deceptive marketing scheme that trivialized the risks of opioids, resulted in rampant over-prescribing, and led to a nationwide epidemic of opioid abuse and addiction.
“The court’s ruling puts an end to years of delay tactics by the defendants,” said Santa Clara County Counsel James R. Williams. “Now we will finally be able to move forward with the litigation and obtain key documents demonstrating the manufacturers’ misconduct. This is a critical step in addressing the opioid crisis that plagues California and the nation, and we will fight to hold opioid manufacturers accountable for their actions.”
STATE COURTS AHEAD OF FEDERAL OPIATE LITIGATION
In addition to the California counties suing in state court there are more than 200 counties from across the country as well as 30 major cities that have filed suits against opioid manufacturers in Opiate Prescription Multidistrict Litigation MDL 2804, pending in the US District Court of Northern Ohio in front of Judge Dan Polster, see Prescription Opiates MDL 2804 Briefcase. In addition to governmental entities, Judge Polster has also permitted unions and hospitals to join in the consolidated opioid litigation against Purdue Pharma, et al. The age of “Profits Before Patients” by Big Pharma may finally have started to come to an end, but it will not occur with very aggressive legal tactics and maneuvering by the opioid makers defense teams.
INSURERS ARE FIGHTING BACK
Earlier this year Travelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.
OPIOID RX DRUG MAKERS CHANGING TACTICS
The ruling comes the same week that Purdue Pharma, maker of the opioid OxyContin, announced that it will cut its salesforce in half and stop promoting opioids to doctors. The lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney was among the first lawsuits brought by government officials to hold opioid manufacturers responsible for their role in the opioids crisis. Manufacturers like Purdue now face pressure from hundreds of additional lawsuits nationwide.
The lawsuit was filed on May 21, 2014, against major opioid manufacturers. (People of the State of California v. Purdue Pharma, et al., Orange County Superior Court, Case No. 30-2014-00725287-CU-BT-CXC.) In 2015, defendants moved to stay the lawsuit, and the case was stayed until October 2016, when the court partially lifted the stay to consider defendants’ arguments that the case should be dismissed. The court has now lifted the stay entirely, and its ruling allows the lawsuit to go forward.
UP TO $500 BILLION SETTLEMENT
The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.
“State Court Claims in Bair Hugger Warming System Dismissed”
By Mark A. York (February 16, 2018)
(MASS TORT NEXUS MEDIA) Defense won a major legal victory in a Ramsey County, MN court this week in the state court litigation where orthopedic surgery patients alleged the 3M company’s Bair Hugger forced-air warming systems caused their deep joint surgical infections.
Ramsey County District Judge William H. Leary’s ruling on January 9, 2018 dismissed all of the lawsuits filed by Minnesota residents against 3M Company, maker of the Bair Hugger system. The opinion stated that the plaintiffs had presented no evidence showing that their theory of the case, that the Bair Hugger system may increase the risk of surgical infection, by offering any supporting evidence that’s accepted in the scientific community.
“There is no generally accepted scientific evidence — and plaintiffs offer none — that the risk of infection associated with FAWs [forced-air warming systems] is greater than that associated with patients who are not warmed during surgery,” Leary wrote Monday, granting 3M’s motion for summary judgment. There was also no generally accepted evidence that other companies’ warming devices had lower rates of infection than 3M’s, the judge wrote.
Defense counsel is pleased with the ruling, but counsel for plaintiffs said the cases are not resolved yet, stating “Plaintiffs are surprised and disappointed with the Ramsey County Order, and will appeal,” according to plaintiffs’ attorney Genevieve Zimmerman.
FEDERAL MDL NOT AFFECTED
U.S. District Judge Joan Ericksen ruled in December that plaintiffs can present their expert witness to jurors to support their claims, just as 3M can present their own experts to rebut the allegations. Leary’s ruling on the state-court cases doesn’t directly impact the much larger federal litigation, known as MDL 2666,3M BAIR HUGGER MDL 2666 Briefcase, where more than 4,000 lawsuits filed by patients from across the country have made the same allegations as the Ramsey County plaintiffs, using many of the same expert witnesses and published studies that Judge Leary ruled were not science based.
The first “bellwether” trial in MDL 2666, in Gareis vs. 3M, is slated to begin in April 2018, Mr. Gareis is a South Carolina resident who claims the Bair Hugger device caused an infection during a 2010 hip replacement surgery.
The Food and Drug Administration says that using systems like the Bair Hugger to keep patients’ bodies warm before and during surgery can result in less bleeding, faster recovery times and a lower risk of infection. 3M said its Bair Hugger system, which was originally designed by Minnesota’s Dr. Scott Augustine, has been safely used in more than 200 million surgeries over three decades.
Dr. Augustine himself now says that the forced-air system he invented has flaws that increase the risk for infection. Leary’s ruling noted that Augustine formed a new company that sells a competing patient-warming device.
In an e-mail, Augustine said he was “very sad” for the Minnesotans who contracted infections but then had their cases dismissed by Leary’s ruling. “Judge Leary’s opinion ignored the excellent science supporting the plaintiffs’ claims,” stated the device inventor.
The design flaw in the Bair Hugger, according to the MDL and state court plaintiffs, is that the device creates warm air currents that rise from the floor of the operating room with enough lift to pick up germ-containing particles and deposit them in a surgical wound. The plaintiffs have also asserted that device itself including the air-blower may harbor and breed the bacteria, which is then speared throughout the operating room.
Plaintiffs have not yet offered direct evidence that shows that a germ-laden particle traveling from the floor of an operating room and into a surgical wound via air currents created by the Bair Hugger is a viable method of contamination or transfer of infectious particles. However, they do have computer modeling showing that it is possible, a significant group of experts who say it’s likely to happen, and published studies that they say support their allegations. 3M attempted to have the experts barred in the federal MDL 2666, who assert the Bair Hugger device cause post- surgical infections in court filings during the fall of 2017, and which Judge Joan Ericksen ruled against in a December 13, 2017 Order, stating “the issue of believing the experts is up to the jury” and denied defense attempts to exclude plaintiff experts.
3M asserts the science behind the safety of its air warming system is sound and is supported by numerous experts and studies. In the motion for summary judgment in Ramsey County, company lawyers said plaintiffs presented no evidence of any doctor reporting a Bair Hugger system causing a surgical infection.
2 JUDGES HEAR SAME EVIDENCE – 2 DIFFERENT RULINGS
The state and federal judges were sitting side by side in court during a three-day hearing last October about expert testimony, yet they reached different conclusions about whether to allow the plaintiffs’ experts to testify. However, the judges were applying different legal standards in their analyses.
In Minnesota state courts, the bar for experts is higher , litigants are required to show that evidence supporting expert testimony is generally accepted within the relevant scientific community if the expert is presenting a “novel” theory, such as the Bair Hugger increasing infection risks.
3M was contacted to provide comments on the state court ruling and how it affects their strategy in both state and federal court, but did not respond.
Plaintiffs Request Remaining Pinnacle MDL 2244 Cases Be Remanded For Trial
Mark A. York (February 9, 2018)
(MASS TORT NEXUS MEDIA) Plaintiffs have asked U.S. District Court Judge Ed Kinkeade, Northern District of Texas, who’s hearing thousands of hip implant lawsuits in the DePuy Orthopaedics’ Pinnacle Hip MDL 2244, to remand their cases to the original court of filing for individual trial dates.
According to the February 5th motion filed with the U.S. District Court, plaintiffs request the Court begin an “orderly and efficient staggered remand process,” where both plaintiffs and defense would select 10 cases each for remand to federal courts in California, New York and Texas, for a total of 60 cases being set for trial starting in 2019.
There were further requests that the Court begin not only the remand process, but start phased MDL discovery as well in peripherally related cases alleging RICO, qui tam and other non-personal injuries as part of the metal-on-poly hip revision lawsuits currently pending in the multidistrict litigation.
DePuy Pinnacle Implants and Metallosis
DePuy Orthopaedics, a subsidiary of Johnson & Johnson, have been named in more than 9,500 hip replacement lawsuits involving the metal-on-metal Pinnacle hip system, which utilizes the Ultamet liner, pending in the multidistrict litigation (see DEPUY MDL 2244 Pinnacle Hip Implant Briefcase) currently underway in the Northern District of Texas.
Plaintiffs allege that the metal-on-metal design within the Ultamet liner configuration can cause dangerous amounts of toxic metal debris to be released into the joint surround the hip, and into the blood stream resulting in metallosis, causing adverse local tissue reactions, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the DePuy hip implant components.
DePuy/J&J Loses Bellwether Trials
So far, the Pinnacle hip MDL 2244 litigation has convened four bellwether trials related to the metal-on-metal implants with the trial in October 2014, ending with a verdict for DePuy and Johnson & Johnson, which to date, is the only defense win in this litigation.
In the second trial, plaintiffs were awarded a verdict of $500 million in March 2016, however, Judge Kinkeade ultimately reduced the award to $151 million, based on Texas statutes that limit punitive damages. The third bellwether trial ending in December 2016, resulted in a massive billion dollar verdict, when six Pinnacle recipients who were residents of California were awarded more than $1 billion, with 90 percent of the verdict being punitive in nature, meant to send a clear message to the defendants. California does not have a limit on punitive damages, but the judge reduced the award to $543 million, based on the US Supreme Court ruling limiting excessive punitive damages. The most recent trial resulted in the plaintiff being awarded $247 million in November 2017.
J&J Wants To Avoid More Massive Verdicts
J&J are simply using every legal tool available to them, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to its various medical device and pharmaceutical product lines.
DePuy Metal-on-Metal Hip Implant Issues
In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials. Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.
In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure. Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.
In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the Pinnacle hip system. The New York Times stated that the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.
Artificial hips are designed to last for 15 years in the best of situations, often that is not the case with many implants failing after just 10 years, and in the case of design defects such as those alleged in Pinnacle devices and many other hip implants, onset of metallosis and other adverse conditions resulting, as well as the ever present implant mechanical breakdown, which cause life altering health problems for patients.
FDA Issues Pinnacle Warning
The U.S. Food & Drug Administration issued a warning in January 2013, stating that patients receiving metal-on-metal hip replacements were more likely to experience premature device failure compared to those who received other types of implants.
In November 2013, DePuy Orthopaedics announced a $2.5 billion settlement in the DePuy ASR Hip Impant MDL2197 ( MDL 2197 DePuy Orthopaedics, Inc. ASR Hip Implant Briefcase), related to the ASR line of metal-on-metal hip implant components. DePuy ended sales of the all-metal Pinnacle hip system that same year, purportedly due to “low clinician use”. However, the company has so far declined to settle the Pinnacle hip litigation.
J&J Facing Many Legal Hurdles
Johnson & Johnson has been hit with numerous large jury verdicts across all areas of the J&J pharmaceutical and medical device operations, with plaintiff trial verdicts Risperdal, Ethicon TVM, Talcum Powder, Xarelto and other products, where recent combined trial verdicts have easily exceeded an additional $200 million. J&J and it’s subsidiaries are now facing more than 100 thousand lawsuits over it’s drug and medical device product lines, in both federal and state courts across the country. To complicate matters further for J&J, the recently started Opiate Prescription MDL 2804 (MDL 2804 Re: NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 Briefcase) names Johnson & Johnson as a defendant in suits filed by more than 400 cities, counties and states across the country.
They Have Opioid MDL Issues Too
Perhaps J&J should look at settling some of the cases they’ve defended so aggressively over the last 5 years, such as the Pinnacle MDL 2244 to prepare for the Opioid Crisis litigation, which is now looking to displace Tobacco Litigation as far as size and scope as well as the massive multi-billion dollar settlements and years of ongoing litigation that came from lawsuits filed initially by governmental entities.
Xarelto MDL 2592: Are Settlement Talks Coming to Xarelto Litigation?
> 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.
> Insys Therapeutics Sued by New York Attorney General for “Opioid Marketing Abuses” Even After MDL Judge Schedules Settlement Conference Inviting State AG’s
How will Opiate MDL 2805 Judge Polster view NY AG’s suit after he requested states attend his January 31, 2018 full day opioid “settlement” meeting in Cleveland? More than 200 attorneys for city and county governments as well as unions and others met all day in closed door meetings. The day included presentations by non-legal “opioid experts” including Dr. Anna Lembke from Stanford, Dr. Aaron Kesselheim from Harvard Medical School who offered views on the who, how and why the opioid drug makers were able to create the opioid crisis, including how Congress hindered attempts at controlling Big Pharma as well as Joseph Rannazzi, former DEA Head of Diversion Control who spoke to restrictions on DEA enforcement against opioid abuses by drug manufacturers and distributors.
>New York State Attorney General Eric T. Schneiderman on Thursday became the latest attorney general to sue Insys Therapeutics Inc. for allegedly misrepresenting that a spray version of the opioid fentanyl is safe for non-cancer patients and appropriate for mild pain.
Schneiderman alleged in state court that Insys’ marketing of the drug Subsys for unapproved uses caused physicians to overprescribe the treatment, exacerbating the opioid epidemic currently affecting New York and many other states. The MDL judge has stated he wants all parties to come to the settlement table with an open mind, however behind the scenes parties are expressing different views on a quick settlement, since more and more of the suits filed against “Opioid Big Pharma” are RICO claims and some parties want to punish the drug makers for creating the opioid crisis.
Pennsylvania Appeals Court Affirms Doctor Conviction For Opioid Prescriptions
>A Pennsylvania appeals court panel on Jan. 26 affirmed a doctor’s sentence for illegally prescribing opioid medications and submitting fraudulent bills to insurance companies after finding that the jury was properly instructed about the state’s standards for properly prescribing the drugs (Commonwealth of Pennsylvania v. Lawrence P. Wean, Nos. 1165 EDA 2016, 1167 EDA 2016, Pa. Super., 2018 Pa. Super.
Insys Therapeutics Sales Manager Wants Term “Opioid Crisis” Barred From Trial
>A former Insys Therapeutics Inc employee going to trial for paying kickbacks to doctors to prescribe fentanyl, has requested the court bar U.S. prosecutors from referring to the “opioid crisis” at his trial. Defendant, Jeffrey Pearlman, a former Insys district sales manager , filed a motion asking a Connecticut federal judge to bar references at his trial to the crisis and evidence the dangers opioids pose. His lawyers cited the “rampant media attention” devoted to opioids, stating “jurors would likely have strong biases against someone like Pearlman whose company sold and marketed opioids:, even though Pearlman and Insys engaged in rampant illegal sales and marketing of Subsys, the Insys Theraputics, Inc. fast acting fentanyl based opioid drug. . Pearlamn is jusyt one of more than 15 people at Insys to be indicted, including billionaire founder, John Kapoor, and the entire Board of Directors, for marketing off-label prescriptions of Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).
Rhode Island Doctor Pleads Guilty to Taking Kickbacks from Insys Therapeutics, Inc
>A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).
510(k) Defense Allowed In Bard IVC Bellwether Trial
>An Arizona federal judge overseeing the C.R. Bard Inc. inferior vena cava (IVC) filter multidistrict litigation on Jan. 29 denied a plaintiff motion to preclude evidence about the devices’ 510(k) clearance in an upcoming bellwether trial, but said he will put the evidence in context and will not allow it to be used as evidence that the devices are approved by the Food and Drug Administration (In Re: Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-2641, Sherr-Una Booker v. C.R. Bard, Inc., et al., No. 16-474, D. Ariz.)
>California State Court Cordis IVC Plaintiffs Argue “No Mass Action” To US Supreme Court
WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup)
>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:
ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).
>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration
TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re: Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J.)
Hip Implant Litigation
UTAH FEDERAL JUDGE ASK STATE SUPREME COURT “Does Unavoidably Unsafe Apply To Medical Devices”
A Utah federal judge on Jan. 23 asked the Utah Supreme Court whether the state recognizes the unavoidably unsafe product doctrine for medical devices, such as hip implants, as well as drugs (Dale Burningham, et al. v. Wright Medical Group, Inc., No. 17-92, D. Utah)
Most Wright Profemur Hip Claims Dismissed in Iowa Federal Court Ruling
>An Iowa federal judge on Jan. 26 dismissed most claims in a metal-on-metal hip implant lawsuit and found no personal jurisdiction of Wright Medical Group Inc. (Rebecca Dumler, et al. v. Wright Medical Technology, Inc., et al., No. 17-2033, N.D. Iowa, Eastern Div).
Actos Cases Dismissed in California Court: 2014 Global Settlement Applies
>A California federal judge on Jan. 25 dismissed for lack of jurisdiction an Actos class action because the four plaintiffs previously settled their individual claims against the diabetes drug maker Takeda Pharmaceuticals America Inc. (Gary Bernor, et al. v. Takeda Pharmaceuticals America Inc., et al., No. 12-04856, C.D. Calif)
Non-Missouri Plaintiffs Dismissed From Essure Litigation “No Personal Jurisdiction”
NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re: Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir)
>Seventh Circuit Appeals Court: “Premeption Applies to Thousands of Depo-T Cases”
CHICAGO — The Seventh Circuit U.S. Court of Appeals on Jan. 19 said a regulatory quirk in how the testosterone drug Depo-T is classified means that thousands of product liability claims involving the drug are preempted (Rodney Guilbeau, et al. v. Pfizer Inc., et al., No. 17-2056, 7th Cir., 2018 U).
>Defense Wins 4th AndroGel MDL Bellwether Trial
An Illinois federal jury on Jan. 26 returned a defense verdict for AbbVie Inc. in the fourth AndroGel multidistrict litigation bellwether trial (Robert Nolte v. AbbVie, Inc., et al., No. 14-8135, N.D. Ill.)
>Fosamax Plaintiffs Request Supreme Court To Deny Merck Preemption Argument
Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct.)
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)
(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.
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.
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.
New York City Joins Chicago, Seattle, Milwaukee in Suing Opioid Industry Players
“PROFITS OVER PATIENTS BY BIG PHARMA CONTINUES”
(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.
Defense gets fourth win in the four Xarelto bellwether trials
By Mark York (January 11, 2018)
(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.
(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.
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.”
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.
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.”
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.
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.
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.
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.
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