UNITED STATES DEPARTMENT OF JUSTICE CRACKS DOWN OF OPIOID INDUSTRY AS A WHOLE

US ATTORNEY CREATES NATIONAL TASK FORCE  TO CRACK DOWN ON OPIOID INDUSTRY

By Mark A. York (February 27, 2018)

MASS TORT NEXUS MEDIA

Attorney General Sessions Announces New Prescription Interdiction & Litigation Task Force

Official Press Release: Feb. 27, 2018

Attorney General Jeff Sessions today announced the creation of a new effort, the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force, to fight the prescription opioid crisis.  The PIL Task Force will aggressively deploy and coordinate all available criminal and civil law enforcement tools to reverse the tide of opioid overdoses in the United States, with a particular focus on opioid manufacturers and distributors.

“Over the past year, the Department has vigorously fought the prescription opioid crisis, and we are determined to continue making progress. Today, we are opening a new front in the war on the opioid crisis by bringing all of our anti-opioid efforts under one banner,” said Attorney General Sessions.  “We have no time to waste.  Every day, 180 Americans die from drug overdoses.  This epidemic actually lowered American life expectancy in 2015 and 2016 for the first time in decades, with drug overdose now the leading cause of death for Americans under age 50.  These are not acceptable trends and this new task force will make us more effective in reversing them and saving Americans from the scourge of opioid addiction.”

The PIL Task Force will include senior officials from the offices of the Attorney General, the Deputy Attorney General, and the Associate Attorney General, as well as senior officials from the Executive Office for U.S. Attorneys, the Civil Division, the Criminal Division, and the Drug Enforcement Administration.   The Task Force will coordinate the Department’s many efforts and tools to combat the opioid epidemic.

The PIL Task Force will combat the opioid crisis at every level of the distribution system.  At the manufacturer level, the PIL Task Force will use all available criminal and civil remedies available under federal law to hold opioid manufacturers accountable for unlawful practices.  The PIL Task Force will build on and strengthen existing Department of Justice initiatives to ensure that opioid manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules.

The Attorney General has also directed the PIL Task Force to examine existing state and local government lawsuits against opioid manufacturers to determine what assistance, if any, federal law can provide in those lawsuits.  The federal government has borne substantial costs from the opioid crisis, and it must be compensated by any party whose illegal activity contributed to those costs.

The Department will also use all criminal and civil tools at its disposal to hold distributors such as pharmacies, pain management clinics, drug testing facilities, and individual physicians accountable for unlawful actions.

The PIL Task Force will use criminal and civil actions to ensure that distributors and pharmacies are obeying Drug Enforcement Administration rules designed to prevent diversion and improper prescribing.  It will use the False Claims Act and other tools to crack down on pain-management clinics, drug testing facilities, and physicians that make opioid prescriptions.

The PIL Task Force will use the criminal and civil tools available under the Controlled Substances Act against doctors, pharmacies, and others that break the law.  The PIL Task Force will build upon and expand the efforts of the existing Opioid Fraud and Abuse Detection Unit.  Created in August 2017, the Unit uses sophisticated data analysis to identify and prosecute individuals who are contributing to the opioid epidemic, including pill-mill schemes and pharmacies that unlawfully divert or dispense prescription opioids for illegitimate purposes.

The PIL Task Force will also work closely with the Department of Health and Human Services to investigate and hold accountable any parties who engage in illegal activity surrounding prescription opioids.  The Attorney General has directed the PIL Task Force to establish immediately a working group to:  (1) improve coordination and data sharing across the federal government to better identify violations of law and patterns of fraud related to the opioid epidemic; (2) evaluate possible changes to the regulatory regime governing opioid distribution; and (3) recommend changes in laws.

This new Task Force will build on a number of new initiatives begun by Attorney General Sessions over the past year that will help us end the drug crisis, including the following:

  • In July, the Attorney General announced charges against more than 120 defendants, including doctors, for crimes related to prescribing or distributing opioids and other dangerous narcotics.
  • One week later, the Attorney General announced the seizure of AlphaBay, the largest criminal marketplace on the Internet.  This site hosted some 220,000 drug listings – including more than 100 vendors advertising fentanyl – and was responsible for countless synthetic opioid overdoses, including the tragic death of a 13-year old in Utah.
  • In August, the Attorney General created the Opioid Fraud and Abuse Detection Unit, a new data analytics program to help find evidence of overprescribing and opioid-related health care fraud.
  • The Attorney General then assigned 12 experienced Assistant United States Attorneys to opioid “hot-spots” to focus solely on investigating and prosecuting opioid-related health care fraud. By November they had begun issuing indictments.
  • In October, the Department announced the first-ever indictments of Chinese nationals and their North American-based traffickers and distributers for separate conspiracies to distribute fentanyl and other opioids in the United States.
  • Also in October, the DEA announced the establishment of six new enforcement teams focused on combatting the flow of heroin and illicit fentanyl into the U.S. These enforcement teams are based in communities facing some of the most significant challenges with heroin and fentanyl.
  • In 2017, the DEA held two of its National Prescription Drug Takeback Days, when people can dispose of unnecessary and potentially dangerous drugs with no questions asked. In total, DEA took a record 956 tons of drugs out of American communities.
  • In January 2018, the Department announced a new resource to target traffickers who sell drugs online called J-CODE: Joint Criminal Opioid Darknet Enforcement team.  The J-CODE team will coordinate efforts across the FBI’s offices all around the world – bringing together DEA, our Safe Streets Task Forces, drug trafficking task forces, Health Care Fraud Special Agents, and other assets – effectively doubling the FBI’s investment into fighting against online drug trafficking.
  • Also in January 2018, the DEA announced a 45-day surge of Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs.
  • On February 7, 2018, the DEA placed all fentanyl analogues not already regulated by the Controlled Substances Act into Schedule I – the category for substances with no currently accepted medical use – for at least two years.  This makes it harder for people to acquire illicit fentanyl and easier for law enforcement to investigate and prosecute drug traffickers.
  • The Department anticipates filing a statement of interest in the coming days in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors.

Read More

ZIMMER NEXGEN KNEE IMPANT MDL 2242 IS CLOSE TO SETTLEMENT AS PARTIES FINALIZE DETAILS

“Judge Pallmeyer Orders A Stay On MDL 2242”

By Mark A. York (February 27, 2018)

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The Zimmer NexGen Knee Implant MDL 2272 appears to be close to settling after both sides advised Judge Pallmeyer that they were actively pursuing a settlement, potentially ending the litigation which at one point involved nearly 1,800 individual lawsuits, of which most have been dismissed. The judge has previously pressed parties on all sides to negotiate an agreement to resolve the remaining cases.

The next status conference will be March 13, 2018 and the parties will update the court as to settlement negotiations. Zimmer has been on a winning streak after winning three of the prior bellwether trials, which may have contributed to the decision to move forward on settlement, see ZIMMER-BIOMET NexGen-Knee-MDL-2272 Briefcase.

According to the minimal information released by parties, they have reached a confidential settlement in principle that will potentially resolve all of the cases on the docket, with the court order of February 12, 2018 clarifying that settlement is imminent.

In the Feb. 12 order, Judge Rebecca Pallmeyer of the U.S. District Court for the Northern District of Illinois stayed all consolidated proceedings in the MDL, as well as any proceedings in individual cases in the MDL, including those selected for trial, pending the outcome and administration of the settlement.

The Zimmer NexGen MDL has been the primary litigation over allegations of failed knee implants and based on trial results and exclusion of experts, Zimmer Biomet and the defense team seem to have done very well in this litigation.

The FDA in 2007 cleared the NexGen Flex implant, designed to provide more flexibility than other knee replacement devices. Plaintiffs have not agreed in the thousands of product liability claims that were filed into the NexGen MDL, who’ve alleged that the device can’t withstand that extra flexion, despite the Warsaw, Ind.-based company’s marketing claims. The plaintiffs also allege that a design flaw makes the device more prone to premature loosening requiring revision procedures.

Since the Zimmer NexGen knee replacement system has been on the market, close to half a million people in the US alone have had Zimmer knee implants. However, the Zimmer knee replacement system, the NexGen CR-Flex Porous Femoral component, has been linked to a variety of problems, from loosening of the implant to failure of the replacement knee, requiring revision surgery, as the MDL plaintiffs have alleged.

 Zimmer Biomet denies that the devices are defective and said they have a successful track record; and in support of that stance, Judge Pallmeyer and 3 juries have agreed so far.

If approved, the settlement will end seven years of litigation, during which some 300 plaintiffs alleged the engineering changes that Zimmer made to allow a greater degree of flexibility in its NexGen components in fact caused greater stress on the knee implants. The NexGen high-flex components theoretically allow patients to bend their knees by 155 degrees, while standard NexGen components provide for up to 125 degrees of bending, according to the plaintiffs.

This case is: In Re: Zimmer NexGen Knee Implant Products Liability Litigation, case number MDL No. 2242 in the U.S. District Court for the Northern District of Illinois, Justice Rebecca Pallmeyer.

Read More

The Opioid Crisis: Is This A Doctor-Driven Epidemic? Looking At The Cause

“FINDING OUT HOW THE THE OPIOID EPIDEMIC CAME INTO BEING”

By Mark A. York (February 27, 2018)

WHEN WRITING PRESCRIPTION OPIOIDS BECAME MUCH EASIER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The speech of a medical specialty society president at a medical conference doesn’t usually get attention outside the conference center, sometimes a few trade publications might report something. On November 11, 1996, however, something different happened. Standing before a room of medical prescribers, James N. Campbell, MD, president of the American Pain Society (APS), announced a new initiative. “Vital signs are taken seriously,” he said. “If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly. It was the kickoff for the APS’s new campaign to convince doctors they should treat “pain as the 5th vital sign.”

And the initiative got instant traction, with the Veterans Health Administration and the Joint Commission on Accreditation of Healthcare Organizations (now the Joint Commission) adopting the slogan and calling on US physicians to manage patients’ pain. But just as quickly, some researchers say, the campaign got off track. Where leaders said, “Manage pain,” doctors and patients seemed to hear “Prescribe opioids.”

Today, governmental and professional groups are frantically trying to hit the rewind button. The American Medical Association has previously issued a “call to action” on opioid over-prescribing, as well as former President Barack Obama, who requested $1.1 billion to address opioid and heroin abuse. Then the Centers for Disease Control and Prevention (CDC) issued new guidelines calling for reduced use of opioids in chronic pain.

Among orthopedists, the calls for action carry particular urgency. By some measures, orthopedists are the third highest prescribers of opioid medications among medical specialties.[6] “In the United States, the current expectation of opioid use as the primary treatment for acute and chronic pain has created an opioid epidemic,” the American Academy of Orthopaedic Surgeons (AAOS) said in a statement .

A look at the statistics explains this tone of urgency. In the decade following Dr. Campbell’s speech, sales of prescription opioids in the United States quadrupled. And rates of overdose, death rates, and substance abuse treatment admissions spiraled in tandem.  In 2013, almost 2 million Americans 12 years of age or older either abused prescription opioids or were hooked on them. Also that year, more than 16,000 people in the United States died of an overdose related to opioid pain relievers. The drugs killed more people than heroin and cocaine combined, more than suicide, and more than car crashes.

The prevalence of pain remained undiminished during this period.

“There’s a fear that we’re going to get in trouble if we don’t control pain appropriately,” says Loree K. Kalliainen, MD, MA, who specializes in wrist and peripheral nerve surgery at the University of North Carolina in Chapel Hill. “But we’re creating people who are habituated to these medications, which is tragic, and we’re not using things that actually do work instead of or in addition” to opioids.

For example, whereas doctors were dramatically increasing their opioid prescriptions, they did not prescribe more nonopioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen.

 Why the Focus on Opioids for Pain Management?

Why did the emphasis on pain management in the 1990s result in a focus on opioid prescriptions? One reason may have been aggressive marketing efforts by opioid drug makers. For example, from 1996 to 2001, Purdue Pharma held more than 40 pain management conferences for healthcare providers to promote the use of its new OxyContin® extended-release formula of oxycodone. Sales surged from $45 million in 1996 to $1.1 billion a year in 2000—an increase of well over 2000%.

“We were told way back in the ’90s that these drugs were safe, that they wouldn’t hurt people, and that it was imperative to control pain,” Dr. Kalliainen recalls. Then, in 2007, Purdue admitted it had misled doctors into thinking OxyContin was less easily abused than other drugs in its class. It agreed to pay $600 million in fines and other fees to the Justice Department. Something else has changed in the culture as well, says Dr. Kalliainen. Patients seem to be in as much emotional pain as physical pain. “I’ve been in practice for 16 years now, and there’s been a huge increase in free-floating anxiety in patients,” she says.

US physicians often that find writing a prescription for an opioid is the most convenient way to respond to their patients’ demands, Dr. Kallianen says. As a resident in the 1990s, she remembers being told by the attending physician to write prescriptions for 60 or 70 opioid tablets for nearly every surgery patient. “You started a whole generation of physicians who are out there saying, ‘Write them for 60 [tablets] so they don’t call in.'”

One reason the practice has persisted is that surgeons often don’t know what effect their prescriptions are having, says Dr. Kalliainen. “We don’t see somebody dying of an overdose or becoming addicted. We don’t know if somebody is coming in and stealing their medications from their medicine cabinet and then having a problem. All the negative effects are away from our direct vision. So we’re not taking as much responsibility.” But research shows that once they have received opioid drugs, many patients can’t stop using them. One study found that 8.2% of patients who took opioids for the first time after total knee arthroplasty were still using them 6 months later, despite weak evidence that the drugs are effective for chronic pain management.

Among people already abusing drugs, some studies suggest that the opioids serve as a bridge between other substances and heroin.] Even when patients don’t abuse the opioids themselves, the drugs prescribed to them may end up in the hands of people who do. Surveys of people who abuse opioids show that as many as 23.8% obtained the drugs from clinicians, and 53% obtained them from friends or relatives, most of whom obtained them from clinicians.

“It’s not like these are stolen off the truck,” says Brent J. Morris, MD, a shoulder and elbow surgeon at the Shoulder Center of Kentucky in Lexington, who has published extensively on opioid prescribing patterns. “Certainly, physicians play a role in this.”

Strategies for Minimizing Treatment Addiction

So how can orthopedic surgeons avoid contributing to the epidemic?

In its October statement, the AAOS recommended nine strategies. In brief, it said orthopedic surgeons should:

  • Set strict policies about how opioids are used in their practices, perhaps limiting prescriptions to the amount they think a patient will actually use after surgery;
  • Identify patients at risk of abusing opioids, perhaps using an assessment tool, such as the Opioid Risk Tool (ORT) for narcotic abuse.
  • Rehearse empathetic conversations with patients who are in pain or requesting opioids;
  • Establish relationships with hospitals, employers, patient groups, state medical and pharmacy boards, law enforcement, pharmacy benefit manager, insurers, and others with whom they can collaborate on reducing opioid abuse;
  • Use state databases to check patients’ other opioid prescriptions and coordinate with other healthcare providers who can provide alternative pain management strategies;
  • Inform themselves and staff about opioid uses and misuses;
  • Add improved opioid practices to their practice’s quality metrics;
  • Recognize that patients with terminal conditions and other appropriate indications should have access to opioids; and
  • Spread the word that opioids are not the best way to manage pain in most circumstances.

Reducing opioid prescriptions may not only reduce abuse but also improve outcomes, says Dr. Morris. Patients who use opioids before surgery have worse outcomes than patients who don’t, he and his colleagues found in a study of total shoulder arthroplasty. And other researchers have found that patients who continue using opioids for 1 month or more after surgery have more psychological distress, less effective coping strategies, more symptoms, and more disability than patients who do not use opioids.

The information has changed what Dr. Morris says to his patients. “I still do shoulder surgery in patients who are on opioids before surgery, but now I counsel them. I say, ‘We now have data that says you will do very well, but you are not going to do as well as patients who are not using opioids.’ That sets the stage for postoperative liberation from the opioids after surgery. And we have an appropriate schedule for opioid tapering.”

Dr. Morris also relies on screening tools aimed at identifying high-risk patients. “When a patient has an ankle fracture or shoulder arthritis, we may not be aware of all the other things going on that that may be contributing to their response to pain, whether it’s pain catastrophizing, depression, anxiety, or things going on socially for them,” he says. Frequently, patients with chronic pain ask Dr. Morris for opioid medications. It’s hard to say no, he acknowledges. “Certainly, it makes for a challenging discussion if the patient is already on opioids for that arthritic problem,” he says. He responds to this situation by discussing it with the patient’s primary care doctor and the patient, quoting from the literature about the way outcomes can be affected, warning about the long-term risks of opioid use, and referring patients to pain management specialists.

Pain Management Is Still Educated Guesswork

But for postoperative pain management, Morris still writes plenty of prescriptions for opioids. And he acknowledges that all his research has not helped much in figuring out how much of the drugs to prescribe for postoperative pain management. That’s still a matter of educated guesswork, he says, because patients vary tremendously in their response to pain.

Many other orthopedists are struggling with the same question. After reviewing charts in her department at Regions Hospital in St Paul, Minnesota, Dr. Kalliainen found a huge range in the quantity of opioids prescribed for pain management after the same procedures.

Bothered by this, she calculated the average amount of opioids physicians in the department were prescribing for each procedure and listed them on a card. The other side of the card lists alternatives to opioids, such as nerve block, NSAIDs, ice, and elevation. She printed the card on pink paper, laminated it, and distributed it throughout the department. Then she once again surveyed charts. “About half the number of pills was being used, and peoples’ pain was better controlled,” she says.

And Dr. Kallianen has other evidence that patients can survive with fewer opioids. Currently on sabbatical in New Zealand, Kalliainen has noticed far less reliance on opioids in surgery departments there. “Patients are maybe a little bit sturdier,” she says. “They’re not asking for these medications. They understand that with surgery, there will be some discomfort.” New Zealand is not an outlier. The United States uses more opioids than any other country, including virtually all of the hydrocodone and 81% of the oxycodone in the world. One study comparing the United States with The Netherlands found that 85% of patients with hip fractures treated in the United States were prescribed opioids after discharge, compared with none of the Dutch patients.

The American Pain Society is now working to put the genie back in the bottle. In a press release last February, it announced new guidelines for pain management, calling on physicians to avoid relying on any one single class of medication to treat postoperative pain.

 Disclosure: This article contains excerpts from Medscape media releases and other sources – Mass Tort Nexus asserts no rights or ownership to media contents within this article.

Read More

It Was Raining Opiates: How drug companies submerged West Virginia in opioids for years

A small West Virginia town of 3,000 people got 21 million pills”

By Mark A. York (February 26, 2016 )

Why West Virginia has the highest rate of overdose deaths in the country

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Drug companies deluged tiny towns in West Virginia with a monsoon of addictive and deadly opioid pills over the last decade, according to ongoing investigations by various public and private entities. After Opioid Big Pharma has reaped billions in profits over the last 15 years at the expense of US citizens, often those in the most rural and distressed areas of the country, it now appears that the time has come for Big Pharma to be called to answer for its conduct.

For instance, drug companies collectively poured 20.8 million hydrocodone and oxycodone pills into the small city of Williamson, West Virginia, between 2006 and 2016, according to a set of letters the committee released Tuesday. Williamson’s population was just 3,191 in 2010, according to US Census data.  These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” committee Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a joint statement to the Charleston Gazette-Mail.

The nation is currently grappling with an epidemic of opioid addiction and overdose deaths. The Centers for Disease Control and Prevention estimate that, on average, 115 Americans die each day from opioid overdoses. West Virginia currently has the highest rate of drug overdose deaths in the country. Hardest hit have been the regions of West Virginia, Ohio and Kentucy where for some reason the opioid industry chose to focus on, the how and why will be address in the federal and state courts across the country, as the opioid crisis has caused the “Opiate Prescription Multidistrict Litigation MDL 2804” , to be created and heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.

OPIOID BIG PHARMA INDUSTRY CONSPIRACY

Beside drug distributors, drug manufacturers such as Purdue Pharma and others bare responsibility for the flood of opioids to hard hit areas of West Virginia, Ohio and Kentucky and they are very familiar with the “opiate litigation dance” often paying hundreds of millions in fines without accepting real responsibility or pleading guilty to criminal charges.  They often enter into consent decrees where they pay a huge fines and promise to monitor the bad conduct in the future. This is actually considered a “get out of jail free” card, a very expensive card but a free pass for Opioid Big Pharma, none the less.

Purdue isn’t new to court battles. In 2007, the infamous drug maker and three of its executives pled guilty in federal court and paid out $634.5 million in fines for purposefully misleading regulators, doctors, and patients about the addictiveness of their opioid painkiller. Around the same time, Purdue was also sued by several states, including Washington, over similar allegations. Purdue agreed to a $19.5 million multi-state settlement. And in 2015, Purdue settled a case with Kentucky, agreeing to pay $24 million.

As part of the state settlements, Purdue was supposed to set up monitoring programs to make sure that its opioid drug didn’t wind up in the wrong hands. It was supposed to watch out for shady pharmacies, unusually large orders, or suspiciously frequent orders. But on this front, Everett alleges that Purdue once again put profits over people.

In released letters that were addressed to two regional drug distributors, Ohio-based Miami-Luken and Illinois-based HD Smith, related to both companies having distributed eye-popping numbers of pills to small cities in the state. In the letter, the committee lays out distribution data it has collected and asks questions about the companies’ distribution practices, including why they increased distribution so sharply in some towns and why they didn’t flag suspicious orders.

But Miami-Luken and HD Smith are not the only distributors that have drawn the committee’s attention. The letters are just the latest in the committee’s ongoing probe into what’s referred to as pill dumping amid the opioid crisis. Last year, the committee sent similar letters to three other drug companies, asking about their drug distribution in the state, these included the largest opiate distributors in the country AmerisourceBergen, Cardinal health and McKesson Corp, with all three listed in the top 10 of Fortune 100’s corporate hierarchy.

Miami-Luken followed through by providing some data and requested files, according to the committee. But those new pieces of information “raise a number of additional questions,” according to the committee.

WV FLOODED WITH OPIOIDS

Combining data collected from the Drug Enforcement Administration and Miami-Luken, the House Energy and Commerce Committee dove into the situation in Williamson. Between 2006 and 2016, drug distributors collectively shipped 20.8 million hydrocodone and oxycodone pills to two pharmacies in the small city. Those pharmacies were located roughly four blocks apart from each other, the committee noted. Miami-Luken alone supplied 6.4 million of those pills to just one of the pharmacies between 2008 and 2015. And between 2008 and 2009, the company inexplicably increased the amount of pills it delivered by 350 percent. The committee pressed Miami-Luken to explain how a town of 3,191 people could require such massive supplies and why the increases didn’t raise alarms.

The letter also reveals that in Kermit, West Virginia, a town of just 406 people, the company delivered 6.3 million hydrocodone and oxycodone pills between 2005 and 2011. For just the year of 2008, the numbers work out to Miami-Luken providing 5,624 opioid painkiller pills for every man, woman, and child in the town, the committee notes.

Likewise, Miami-Luken also delivered 4.4 million hydrocodone and oxycodone pills to the 1,394-person town of Oceana, West Virginia, between 2008 and 2015. And in Beckley, West Virginia, the company didn’t hesitate to fulfill a string of orders for tens of thousands of opioid doses placed by one pharmacy in the span of five days.

WHERE WAS THE OFFICIAL OVERSIGHT

The House committee repeatedly asked if the company thought these orders were appropriate and what limits—if any—it would set on such small towns.  Miami-Luken would not respond to a request for comment. The committee had similar questions for HD Smith, who delivered 1.3 million hydrocodone and oxycodone pills to a pharmacy in Kermit—the 406-person town—in 2008.

“If these figures are accurate, HD Smith supplied this pharmacy with nearly five times the amount a rural pharmacy would be expected to receive,” the committee wrote. It noted that the owner of that Kermit pharmacy later spent time in federal prison for violations of the Controlled Substance Act. Still, the committee pressed the question of whether HD Smith thought its distribution practices were appropriate.

“We will continue to investigate these distributors’ shipments of large quantities of powerful opioids across West Virginia, including what seems to be a shocking lack of oversight over their distribution, all the while collecting record breaking profits and paying sale reps in the field enormous bonuses.  This is the pattern that all Opioid Big Pharma has followed across the United states for the last 20 years, pay field sales rep many thousands of dollars on bonuses, to push opiates on doctors, hospitals and anyone else who can move drugs into the healthcare treatment assembly line.

OPIOID INDUSTRY HAS INFLUENCE

To show the far reaching tentacles of Opioid Big Pharma,  West Virginia Attorney General Patrick Morrisey was a former lobbyist for a trade group that represented Miami-Luken and other drug companies. In 2016, Morrisey ended several state lawsuits with drug companies, including one with Miami-Luken. The lawsuits, filed by the state’s former attorney general, Darrell McGraw, alleged that the companies flooded the state with opioid painkillers.

How this conduct would be viewed outside West Virginia would normally not have become an issue if Morrisey’s halt to the litigation would have been the end of the legal story. But fast forward to December 2018 and the official opening of the “Opiate Prescription MDL 2408”, where hundreds of counties, cities, states, hospitals and others impacted by the opioid crisis across the country, are now able to file lawsuits against all “Opioid Big Pharma” players. The defendants include drug makers, distributors, major pharmacies and others, there may a second long hard look at Patrick Morrisey’ conduct and reasoning for stopping prior legal action against the prescription opioid industry.

 

Read More

This Week In Mass Torts Around The Country: Week of February 19, 2018

By MASS TORT NEXUS MEDIA

 

Opiate MDL 2804 Settlement Talks Start Before Discovery

See also OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION

>Federal Judge Dan Polster has ordered the start of formal settlement talks as the way to begin the Opiate Rx MDL 2804, he’s entered a settlement gag order and strongly suggesting the parties move ahead in this area or he will be forced “let both sides loose on each other and the government via wide open discovery” including access to the FDA and DEA files. The fate of multidistrict litigation over the opioid crisis now rests heavily with 18 plaintiff and defense counsel who’ve been tasked with negotiating a settlement in the historic case. The negotiators, chosen earlier this month, are from two camps: seven attorneys representing local governments that assert grievous financial harm from the opioid crisis, and 11 attorneys representing opioid manufacturers and distributors. Their assignment is daunting: broker a quick and meaningful deal that earmarks money for all parties who’ve been affected by the flood of opioids into the US marketplace over the last 15 years.

Johnson & Johnson Talc Use Will Kill Plaintiff Eventually Per Experts in NJ Talc Trial

See also Johnson & Johnson Talcum Powder Litigation Briefcase

>An occupational medicine expert told a New Jersey state court jury this week that a man alleging Johnson & Johnson’s baby powder contains asbestos faces a painful death from mesothelioma, and that the disease was caused by his daily use of J&J’s products.  According to plaintiff expert occupational health M.D. Jacqueline Moline, of the Feinstein Institute of Medical Research testified on behalf of plaintiff Stephen Lanzo, to support his claim that J&J’s products, including its baby powder, contained the asbestos that caused his mesothelioma.  Earlier this week, another plaintiff expert, William Longo, an electron microscopist told jurors Tuesday that he found asbestos in more than half of the 32 samples of Johnson & Johnson talcum powder products he had examined during a trial alleging that using J&J talc caused  him to develop mesothelioma, In the trials fourth week, Mr. Longo was called to the stand as a materials science and electron microscopy expert to support plaintiff Stephen Longo’s claim that J&J is responsible for his mesothelioma, an asbestos-related disease that is fatal.

 Xarelto Phila Court Bellwether Plaintiff Argues Trial Evidence Ignored

See Also XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase – Complex Litigation (PA State Court)

>Lynn Hartman, the woman who won a $28 million verdict in December 2017, in the first Philadelphia  bellwether trial over injuries linked to the blood thinner Xarelto has argued the Pennsylvania judge Michael Erdos, who threw out her damages award ignored evidence that additional warnings would not have changed her doctor’s decision to prescribe the medication. In a January 9th hearing Judge Erdos ruled for defense on their Motion to Vacate the Judgment on various grounds, and during the same hearing the judge also ruled on plaintiff trial counsel trial misconduct matters, which resulted in  various sanctions against certain members of Ms. Hartman’s trial team.

 Purdue Pharma Initiated Opioid Crisis With Massive Opiate Rx Marketing Push

See also Targeting Big Pharma and Their Opiate Marketing Campaigns

>Several New Jersey counties and unions have filed suits against OxyContin maker Purdue Pharma and other opioid manufacturers, distributors and retailers in New Jersey state courts, which is outside of the Federal MDL Opiate Prescription MDL 280, in the last 30 days, accusing Purdue of sparking the opioid epidemic with deceptive marketing practices that the others eventually adopted. The claims in NJ sate court appear to be a strategic move to provide local governmental entities with a home court advantage versus jumping into the every growing MDL 2804, where Judge Polster has already moved the parties into settlement talks. There are now many other counties and states that have decided to litigate opioid claims in their own state courts versus joining the masses in the federal MDL, how this plays out in the long run remains to be seen. Several county and state court suits originally placed in the Opiate MDL have already been remanded back to state courts by the federal court.

Pennsylvania Supreme Court Hears Risperdal SOL Dismissal Arguments

 See also  RISPERDAL – PHILADELPHIA COURT of COMMON PLEAS

 >A Johnson & Johnson unit on Tuesday urged the Pennsylvania Supreme Court to leave standing a recent decision jeopardizing thousands of pending lawsuits by rolling back the clock on when claims of abnormal breast growth allegedly linked to the antipsychotic drug Risperdal began to expire. The justices are weighing whether to hear an appeal of a November ruling from the state’s Superior Court finding that a two-year statute of limitations of Risperdal-related lawsuits, more than 6,600 of which are pending in Philadelphia County, should have started the Statute of Limitations clock, which if upholds the decisions, will cause the dismissal of many of the cases in the Phila court Risperdal docket. J&J has not fared well to date in the Risperdal cases, with verdicts against now reaching the hundreds of millions of dollars and a recent ruling that Punitive damages are now permitted for many cases. J&J’s Janssen R&D division is also facing thousands of suit in the Xarelto litigation also filed in the Phila Court of Common Pleas docket.

Pennsylvania Appeals Court Won’t Overturn Plaintiff Risperdal Verdict

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

>A Pennsylvania appeals court on Tuesday rejected efforts by a Johnson & Johnson unit to challenge expert testimony relied on by jurors in finding that the antipsychotic drug Risperdal had caused a Maryland boy to grow female breast tissue. A three-judge Superior Court panel shot down arguments from Janssen Pharmaceuticals Inc. that Dr. Francesco DeLuca had improperly relied on an 8-year-old photograph to conclude that Nicholas Murray had been suffering from gynecomastia, or the abnormal growth of female breast tissue in males, at the time the drug was prescribed. However the Superior Court panel did rule that  the Murray v. Janssen Pharmaceuticals, case would go back to the trial court for further determination as to the jury award cap based on Maryland law, wher the plaintiff resides,  and taking into account the recent Superior Court ruling that permits punitive damages in the Risperdal litigation. The Murray trial which was the third case to go to trial in the Risperdal mass tort docket in the Philadelphia Court of Common Pleas. The plaintiff was initially awarded a $1.75 million verdict, which was later reduced by the trial court to $680,000, pursuant to the Maryland statute capping damages.  The unanimous panel rejected defendant Janssen Pharmaceutical’s attempt to overturn the verdict and affirmed the trial judge’s decision to limit the jury award based on a Maryland law that caps noneconomic damages.  However, citing its decision in a case last month that opened the doors for Risperdal plaintiffs to seek recovery of punitive damages, Judge John Bender remanded the case to the trial court to determine whether plaintiff Nicholas Murray, a Maryland resident, should be allowed to seek punitive damages in the case.

State of Kentucky Files Opioid Suit in State Court

See State of Kentucky and Counties vs. Opioid Makers and Distributors

 >Drug distributor Cardinal Health has exacerbated the opioid epidemic by filling suspicious drug orders and neglecting to alert the authorities about them, Kentucky’s attorney general claimed in a suit filed Monday in state court. Andy Beshear, lead plaintiff counsel claims Cardinal shipped massive opioid orders throughout Kentucky for years, that were unusually large, frequent and deviated from a past pattern, shunning its own data and “common sense” in favor of profits and market share. Beshear had previously sued McKesson Corp., who along with Cardinal and AmerisourceBergen, distributes 85 percent of the country’s prescription opiates, and are alleged to have engaged in an organized and boardroom acknowledged policy of not reporting massive opiate order increases or failing to accurately track the millions of opiate pills that made their way into so many small towns in the region of Kentucky, West Virginia and Ohio. How the drug distribution monitors at these companies couldn’t recognize that often 2 million plus opioid tablets were being shipped to towns that had populations of less than 2,000 remains as the big question, that nobody at these Fortune 50 companies will admit to or acknowledge was an issue.  The lack of oversight and re[porting took place during the last 15 years of record breaking profits where billions of dollars in revenue were collected year in and year out by drug distribution companies.

Settlement Agreement Reached In Zimmer NexGen Knee MDL 2272

 See also ZIMMER NexGen Knee MDL 2272 Briefcase (USDC ND Illinois)

>Federal Judge Rebecca Pallmeyer enterd CMO No. 13 on February 12, 2018 placing a stay on proceeding in MDL 2272, pending the outcome of the finalization of the settlement discussion and a full resolution of the Zimmer NexGen Knee litigation. Lead counsel in the Zimmer NexGen litigation on Feb. 6 told Judge Pallmeyer, that they have reached an agreement in principle that will potentially resolve all MDL cases and similar cases filed in state court as of Jan. 15, 2018.  If approved, the settlement will end seven years of litigation, during which some 300 plaintiffs alleged the engineering changes that Zimmer made to allow a greater degree of flexibility in its NexGen components in fact caused greater stress on the knee implants. The NexGen high-flex components theoretically allow patients to bend their knees by 155 degrees, while standard NexGen components provide for up to 125 degrees of bending, according to the plaintiffs.

The Zimmer NexGen knee replacement system has been on the market, almost half a million people in the US alone have had Zimmer knee implants. However, the Zimmer knee replacement, namely the NexGen CR-Flex Porous Femoral component, has been linked to a variety of problems, from loosening of the implant to failure of the replacement knee, requiring revision surgery, as the plaintiffs in the MDL also allege.

The case is MDL 2272  Re: Zimmer NexGen Knee Implant Products Liability Litigation, (MDL Docket No. 2272, U.S. District Court for the Northern District of Illinois)

 

 

Read More

“PELVIC MESH” – WHAT’S CHANGED SINCE JANUARY 2016? HAS THE FDA LOOKED CLOSER AT THE THOUSANDS OF FILED ADVERSE EVENTS? MESH IS NOW A CLASS III HIGH RISK MEDICAL DEVICE

Who’s Telling Who About The High Risk Of Synthetic Surgical Mesh?

By Mark A. York (February 21, 2018)

Do you want polypropylene “fishing line” in your body? That’s what surgical mesh is made of.

 

 

 

 

 

 

 

 

(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.

50,000+ MESH LAWSUITS FILED

Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.  For more information see Mesh Litigation Briefcase -50,000 Cases Pending and More Each Day along with TVM mesh cases there are now two more “hernia mesh” multidistrict litigation cases , designated as “Ethicon Physiomesh MDL 2782 (Ethicon Physiomesh MDL 2782 Briefcase Re: Hernia-Mesh-Litigation) and the Atrium Medical C-Qur Hernia Mesh MDL 2753 (ATRIUM MDL 2753 Re: C-QUR-HERNIA-PATCH Briefcase) these case apply to synthetic hernia mesh complication with adverse systems and long term medical complications, being the same as those alleged in the massive TVM litigation, which are pending in federal court across the country.

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.

Read More

Orange County and Santa Clara County Suits Against “Opiate Big Pharma” In California State Court Can Proceed

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.

Read More

Minnesota State Court Judge Rules Against Bair Hugger Plaintiffs

“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.

The federal rules say the judge need only exclude testimony that is so fundamentally unsupported that it cannot offer assistance to the jury, see MDL Order Denying 3M Motion to Exclude Plaintff Experts.

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.

Read More

Gary, Indiana joins litigation against opioid manufacturers 

“Profits Before Patients”

By Mark A. York (February 12, 2018)

Gary City Hall

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Economically hard hit Gary, Indiana is the latest local government to join the hundreds of other cities, counties and states across the country, along with private entities such as hospitals and unions in suing opioid manufacturers and distributors for their roles in the opioid addiction crisis.  Gary joins other Indiana communities including Indianapolis, Hammond, Fort Wayne and more than 10 Indiana counties in filing lawsuits against Bi Pharma drug makers such as Purdue, Endo, Abbott, Watson-Actavis and others, asserting that the marketing campaigns and a boardroom supported corporate philosophy of “profits before patients” would result in records profits from opioid drugs, which it clearly has for more than 10 years.  Many major cities have also filed lawsuits against the same opiod drugmakers and distributors, New York City sue Big Pharma over opioids – joining Chicago, Seattle, Milwaukee and other major cities.

Along with record profits came record overdose deaths, catastrophic increases in emergency response budgets for local communities, major metropolitan areas and most every region of the USA that has been impacted by the opioid crisis.

OPIATE Rx LAWSUITS EXPLODE

In light of escalating costs to combat the city’s opioid epidemic, the city of Gary on Jan. 29 filed a complaint in Lake Superior Court seeking to recover damages for use of public resources to fight the problem. Gary has decided to file the lawsuit in Indiana state court versus joining the fast growing Opiate Prescription Multi-District Litigation known as MDL 2804, (see MDL 2804 OPIATE PRESCRIPTION LITIGATION BRIEFCASE), which according to experts will dwarf the Tobacco Litigation of 1990’s and its $200 billion settlement with governments from 46 states. According to Mass Tort Nexus consultant and opioid expert John Ray, “In a comparative sense, the Opioid Litigation will make the financial and social impact of the Tobacco Litigation appear insignificant, due to the sheer size of the opioid addiction crisis and related treatment, healthcare and social-economic impact that’s occurred over the last decade, which will have to continue for years to come.”

Gary Mayor Karen Freeman-Wilson stated “I have seen addiction as a deputy prosecutor, defense attorney, drug court judge and Indiana Attorney General. We understand the scourge of addiction created by illegal drugs. To think that legal drugs have been manufactured and distributed in a way that increases and risks the harm to citizens of Gary and other communities is unconscionable,” with Gary being a community severely impacted by the residual affect of years of pharmaceutical opioids flooding the market.

LOCAL BUDGETS OVERWHELMED

The complaint which names more than 25 defendants — alleges that manufacturers, distributors and other entities intentionally mislead the public about the dangers of opioids, including marketing campaigns that minimized addiction and overdose risks to the medical and healthcare industry. The claims outline the history of how defendants downplayed the risks associated with OxyContin, Fentanyl and Percocet while aggressively marketing them, often paying huge commission to field sales reps who increased opioid prescriptions written in an assigned area, which was often low income and rural areas across the country.

“This negligent behavior has led to a significant increase in the City’s budgets for law enforcement, emergency care, first responder overtime, Narcan training and prevention and treatment programs. There will be no cost to City taxpayers with this filing,” The increase in the city’s budget to combat the opioid related issues has stressed an already tight budget, as well as the economic and social impact of the addiction and deaths associated with opiate abuses.

Hospitals in the state of Indiana have seen a 60-percent increase in non-fatal drug overdoses from 2011 to 2015, with deadly overdoses rising by an average of 3.5 percent each year, according to a report from the Indiana State Department of Health.

Indiana and other states, including Ohio, West Virginia and Kentucky have also seen a dramatic increase in children placed in foster care because of parents’ addiction, as well as related healthcare and addiction treatment costs.

FORCING OPIOID BIG PHARMA TO TABLE

Filing lawsuits against the Big Pharma opioid drug industry seems to be the only recourse available to cities such as Gary and the hundreds of other economically depresses local governments across the country, to force the opioid prescription drug industry to finally face the crisis that they’ve designed, marketed and placed into the US commerce stream.

Read More

DePuy Pinnacle Plaintiffs Request Cases Be Remanded For Trial in Hip Implant MDL 2244

Plaintiffs Request Remaining Pinnacle MDL 2244 Cases Be Remanded For Trial 

Mark A. York (February 9, 2018)

A DePuy Pinnacle Hip Implant Component

 

 

 

 

 

 

 

 

(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.

Read More