How Will Bayer Address Over 11,000 Lawsuits Linked To Roundup Cancer Risk?
By Mark A. York (February 28, 2019)
(MASS TORT NEXUS MEDIA) The troubles keep mounting for German pharmaceutical giant Bayer since it acquired Monsanto last June for $62.5 billion, as they now face thousands of lawsuits in state and federal courts.
In a just started bellwether trial in the Monsanto Roundup MDL 2741 federal litigation, plaintiff Edwin Hardeman, 70, the second plaintiff to go to trial against Monsanto, is claiming agribusiness giant Monsanto’s weed killer causes cancer. He claims his decades-long use of the weedkiller on his 56-acre Sonoma County property is linked to his diagnosis of non-Hodgkin’s lymphoma in 2015
Last August, a California state court jury concluded that Roundup presented a “substantial danger” to terminally ill 46-year-old Dewayne “Lee” Johnson, and awarded him $289 million in damages. Lee Johnson became sick with non-Hodgkin’s lymphoma after using the spray for more than two years as a groundskeeper.
Hardeman’s trial is before a different judge and may be more significant. U.S. Judge Vince Chhabria is overseeing thousands of Roundup lawsuits and has deemed Hardeman’s case and two others “bellwether trials” in ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California). Six others trials are scheduled to begin this year as well.
Glyphosate, the active ingredient in Roundup, has been under scrutiny for years including when in 2015, the International Agency for Research on Cancer (IARC), which is part of the World Health Organization, identified the ingredient as a “probable carcinogen.” Monsanto has adamantly denied those claims.
The lawsuits pose a threat to Monsanto and its corporate parent, German chemical giant Bayer, which last year merged in the $60 billion deal with Monsanto. While Monsanto doesn’t break out sales of glyphosate, the product delivered $4.8 billion in revenue in 2015. In its last earnings report before Bayer acquisition, Monsanto said profits in its agricultural productivity division soared 30 percent due to “improved pricing” on glyphosate.
The Lee Johnson verdict award was seen as a positive step in the ever-growing litigation against Monsanto-Bayer, however that $289 million verdict was in California state court, and not the more restrictive US District Court in San Francisco where Judge Chhabria has bifurcated the trial, as well as prohibited admission of documents and research data that reflects badly on Monsanto.
The jury awarded Mr. Johnson, a school groundskeeper more than $289 million in damages after he claimed Monsanto’s best-selling weedkiller Roundup gave him cancer, and now the controversial ingredient – glyphosate — has been detected in popular kids’ breakfast cereals, including Cheerios, Lucky Charms and Quaker Old Fashioned Oats, according to an activist group.
Edwin Hardeman, 70, is the second plaintiff to go to trial claiming agribusiness giant Monsanto’s weed killer causes cancer. He claims decades-long use of the weedkiller on his 56-acre Sonoma County property is linked to his diagnosis of non-Hodgkin’s lymphoma in 2015. Hardeman’s trial is before a different judge and may be more significant for the overall litigation, due to this being a bellwether trial, the results may set the stage for how the other cases are addressed in dockets across the country.
The outcome of bellwether cases help attorneys on both sides decide whether to continue fighting in court including at ongoing bellwether trials or look toward settlement. A jury verdict in favor of Hardeman and the other test plaintiffs would give their attorneys a strong bargaining position in any settlement talks for the remaining cases before Chhabria.
Lab tests conducted by the Environmental Working Group (EWG), a nonprofit advocacy group that specializes in toxic chemicals and corporate accountability, indicated almost three-fourths of the 45 food products tested detected high levels of glyphosate, which has been identified as a “probable carcinogen” by the World Health Organization in 2015.
Popular children items, including General Mills’ Cheerios Toasted Whole Grain Oat Cereal, Lucky Charm’s, Kellogg’s Cracklin’ Oat Bran and Quaker’s Old Fashioned Oats, all had levels exceeding EWG’s safety guidelines.
But makers of the foods EWG tested said they and their suppliers operate within U.S. government safety guidelines and dismissed the group’s findings as irrelevant.
Since the state court verdict won by Lee Johnson showed that juries can hold Monsanto liable, the Roundup litigation has made national headlines, and Bayer has been flooded with thousands of other lawsuits.
A Bayer spokesperson has stated that it would like “to emphasize once again that we disagree with the verdict in the Johnson case. We have therefore filed an appeal, and we will continue to defend ourselves vigorously in all the other proceedings as well.”
Bayer added that glyphosate, which is the controversial active ingredient in Roundup, “is a safe product” and “that has been proven by numerous scientific studies and the independent assessments of regulatory authorities throughout the world over a period of more than 40 years.”
However, glyphosate has been under scrutiny for years, including in 2015, the International Agency for Research on Cancer (IARC), which is part of the World Health Organization, identified the ingredient as a “probable carcinogen.”
Bayer stock has fallen more than 27 percent since the first courtroom defeat in August, and the boardroom must be concerend about additional plaintiff verdicts in the future and how this will affect their stock proces. How Bayer begins to view the Monsanto merger and the tag-along liabilities of thousands of Roundup lawsuits may force Bayer to begin settlement discussions in earnest. The German parent entity Bayer AG, has started aggressively divesting assets including their animal products division, cutting consumer marketing group costs, closing several US manufacturing locations to the tune of more than $3 billion. Where Bayer decides to put the recently acquired cash remains to be seen, since they are also facing more than 20,000 lawsuits in the Xarelto MDL 2592 litigation.
The Xarelto lawsuits are pending in federal and state courts across the country where the blockbuster blood-thinner drug Xarelto is alleged to have injured and/or killed thousands while Bayer withheld and manipulated drug dangers and clinical study results.
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(MASS TORT NEXUS MEDIA) Uloric made by Takeda Pharmaceuticals gained FDA approval subsequent to New Drug Application (NDA: 021856) in February 2009 and is now facing review by the FDA and others as to the risks associated with the drug.
Following an in-depth review of results from a safety clinical trial, the FDA has found that there is an increased risk of heart-related death and death from all causes with Uloric. Besides adding the Boxed Warning, the FDA is limiting the approved use of Uloric only to patients who have failed or do not tolerate another gout medicine Allopurinol.
Excerpt: [2-21-2019] The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.
As a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.
The FDA-mandated study, published in The New England Journal of Medicine in 2018, revealed that the “treatment with Uloric resulted in overall rates of major cardiovascular events that were similar to those associated with Allopurinol treatment among patients with gout who had coexisting cardiovascular disease. However, cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group”.
Takeda Pharmaceuticals is now under additional scrutiny as well as facing litigation if they withheld, altered or failed to properly disclose risk that that they were aware of, dating as far back to the initial clinical trials in 2009. Takeda is already facing legal problems over Uloric, with multiple Qui Tam lawsuits filed by a former safety consultant for the company. These suits that the company withheld information about dangerous side effects related to Uloric, including kidney problems, liver damage, bone marrow failure, drug interactions and more.
Gout, a type of arthritis that occurs when uric acid crystals build up in the joints. Gout has been found to be more common in men than in women Gout is believed affects about 8.3 million people, or 4% of the U.S. population.
Uloric was the first new drug approved to treat Gout in 40 years. Unfortunately, this new treatment which promised relief for those who suffer from Gout, appears to have numerous significant and potentially life threatening side effects that Takeda never warned the public about.
Initial clinical trials testing febuxostat prior to FDA approval linked the medication to possible increased risks of serious adverse cardiovascular outcomes, including heart attack, stroke and death. The FDA rejected the medication twice over these safety concerns before approving it in 2009 on the condition that the manufacturer conduct the now-completed large, post-market randomized clinical trial to further evaluate the cardiovascular risks.
Excerpt:[ 11-15-2017 ] The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.
Febuxostat is FDA-approved to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Febuxostat works by lowering uric acid levels in the blood.
Takeda started post-marketing trials in 2009 and there are glaring issues with the trial results if Takeda had followed normal protocols.
Notably, 57% of the 6,198 enrolled patients left the trial prematurely, often when they encountered gout flares or thought they weren’t being taken good care of, explained lead investigator William White, MD, of UConn Health in Farmingdale, Connecticut, at the meeting. He noted that withdrawal occurred at the same rate in the febuxostat and allopurinol groups.
The CARES population not uncommonly had difficult problems like alcoholism and obesity and would commonly drop out when they felt like it, White said. “They’re ornery. They’re in pain all the time from the disease.” Such a large drop-out rate would have biased results to the null, which makes the observed cardiovascular mortality risk even more striking, according to panelist Bruce Psaty, MD, of the University of Washington in Seattle.
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Course attendees will receive the benefit of a step by step analysis of the emergingUloric Litigation, using these primary metrics:
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By DAVID ARMSTRONG — PROPUBLICA, FEBRUARY 21, 2019
and MOLLY FERGUSON FOR STAT
(This is a partial reprint by MASS TORT NEXUS of a collaboration between STAT and ProPublica contained in the full article link above).
“Purdue’s Sackler embraced plan to conceal OxyContin’s strength from doctors, unsealed Richard Sackler deposition shows”
(MASS TORT NEXUS MEDIA) In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.
The Sackler family has always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin, and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.
That is now changing, as the State of Massachusetts has filed a lawsuit against Purdue Pharma and the Sackler family as well as various Purdue executives over the prescription painkiller OxyContin. Oxycontin is now recognized as the opioid fuse that ignited America’s opioid crisis, and in a positive move forward, the leading executives and members of the multibillionaire Sackler family, now known to be feuding over the opioid crisis have been named in civil litigation.
In the Kentucky vs. Purdue Pharma litigation (Pike County Kentucky Circuit Court) , where in the recently unsealed court documents is the only known deposition testimony of a Sackler family member, with this being the August 28, 2016 deposition of Pudue Pharma family member Richard Sackler, a link to the full deposition transcript is contained within this article, as well as the full ProPublic/StatNews article link, statnews.com/2019/02/21/purdue-pharma-richard-sackler-oxycontin-sealed-deposition/Feb 21-2019.
Who is Richard Sackler, and why was he deposed?
The son of a Purdue co-founder, Sackler began working at the company in 1971 and has been at various times its president and co-chairman of the board. The Sackler family controls Purdue and has received billions of dollars from OxyContin sales.
That state court litigation has been the subject of an ongoing legal battle in the Kentucky courts where Purdue is fighting to keep the original court records from that settlement sealed, due to the only deposition testimony of one of the Sackler brothers is known to be located. The Purdue court records were unsealed by Pike County Judge Stephen Combs in May 2016, and Purdue immediately appealed with oral arguments taking place June 26, 2017 in front of a three judge panel of the Kentucky Court of Appeals, which had failed to rule on the argumanets as recently as January 2019
In May 1997, the year after Purdue Pharma launched OxyContin, its head of sales and marketing sought input on a key decision from Dr. Richard Sackler, a member of the billionaire family that founded and controls the company. Michael Friedman told Sackler that he didn’t want to correct the false impression among doctors that OxyContin was weaker than morphine, because the myth was boosting prescriptions — and sales.
“It would be extremely dangerous at this early stage in the life of the product,” Friedman wrote to Sackler, “to make physicians think the drug is stronger or equal to morphine. … We are well aware of the view held by many physicians that oxycodone [the active ingredient in OxyContin] is weaker than morphine. I do not plan to do anything about that.”
“I agree with you,” Sackler responded. “Is there a general agreement, or are there some holdouts?”
Ten years later, Purdue pleaded guilty in federal court to understating the risk of addiction to OxyContin, including failing to alert doctors that it was a stronger painkiller than morphine, and agreed to pay $600 million in fines and penalties. But Sackler’s support of the decision to conceal OxyContin’s strength from doctors — in email exchanges both with Friedman and another company executive — was not made public.
The email threads were divulged in a sealed court document that ProPublica has obtained: an Aug. 28, 2015, deposition of Richard Sackler. Taken as part of a lawsuit by the state of Kentucky against Purdue, the deposition is believed to be the only time a member of the Sackler family has been questioned under oath about the illegal marketing of OxyContin and what family members knew about it. Purdue has fought a three-year legal battle to keep the deposition and hundreds of other documents secret, in a case brought by STAT; the matter is currently before the Kentucky Supreme Court.
Meanwhile, interest in the deposition’s contents has intensified, as hundreds of cities, counties, states and tribes have sued Purdue and other opioid manufacturers and distributors. A House committee requested the documentfrom Purdue last summer as part of an investigation of drug company marketing practices.
In a statement, Purdue stood behind Sackler’s testimony in the deposition. Sackler, it said, “supports that the company accurately disclosed the potency of OxyContin to healthcare providers.” He “takes great care to explain” that the drug’s label “made clear that OxyContin is twice as potent as morphine,” Purdue said.
Still, Purdue acknowledged, it had made a “determination to avoid emphasizing OxyContin as a powerful cancer pain drug,” out of “a concern that non-cancer patients would be reluctant to take a cancer drug.”
The company, which said it was also speaking on behalf of Sackler, deplored what it called the “intentional leak of the deposition” to ProPublica, calling it “a clear violation of the court’s order” and “regrettable.”
Much of the questioning of Sackler in the 337-page deposition focused on Purdue’s marketing of OxyContin, especially in the first five years after the drug’s 1996 launch. Aggressive marketing of OxyContin is blamed by some analysts for fostering a national crisis that has resulted in 200,000 overdose deaths related to prescription opioids since 1999.
Taken together with a Massachusetts complaint made public last month against Purdue and eight Sacklers, including Richard, the deposition underscores the pivotal role of the Sackler family in developing the business strategy for OxyContin and directing the hiring of an expanded sales force to implement a plan to sell the drug at ever-higher doses. Documents show that Richard Sacklerwas especially involved in the company’s efforts to market the drug, and that he pushed staff to pursue OxyContin’s deregulation in Germany. The son of a Purdue co-founder, he began working at Purdue in 1971 and has been at various times the company’s president and co-chairman of its board.
In a 1996 email introduced during the deposition, Sackler expressed delight at the early success of OxyContin. “Clearly this strategy has outperformed our expectations, market research and fondest dreams,” he wrote. Three years later, he wrote to a Purdue executive, “You won’t believe how committed I am to make OxyContin a huge success. It is almost that I dedicated my life to it. After the initial launch phase, I will have to catch up with my private life again.”
During his deposition, Sackler defended the company’s marketing strategies — including some Purdue had previously acknowledged were improper — and offered benign interpretations of emails that appeared to show Purdue executives or sales representatives minimizing the risks of OxyContin and its euphoric effects. He denied that there was any effort to deceive doctors about the potency of OxyContin and argued that lawyers for Kentucky were misconstruing words such as “stronger” and “weaker” used in email threads.T
The term “stronger” in Friedman’s email, Sackler said, “meant more threatening, more frightening. There is no way that this intended or had the effect of causing physicians to overlook the fact that it was twice as potent.”
Emails introduced in the deposition show Sackler’s hidden role in key aspects of the 2007 federal case in which Purdue pleaded guilty. A 19-page statement of factsthat Purdue admitted to as part of the plea deal, and which prosecutors said contained the “main violations of law revealed by the government’s criminal investigation,” referred to Friedman’s May 1997 email to Sackler about letting the doctors’ misimpression stand. It did not identify either man by name, attributing the statements to “certain Purdue supervisors and employees.”
Friedman, who by then had risen to chief executive officer, was one of three Purdue executives who pleaded guilty to a misdemeanor of “misbranding” OxyContin. No members of the Sackler family were charged or named as part of the plea agreement. The Massachusetts lawsuit alleges that the Sackler-controlled Purdue board voted that the three executives, but no family members, should plead guilty as individuals. After the case concluded, the Sacklers were concerned about maintaining the allegiance of Friedman and another of the executives, according to the Massachusetts lawsuit. To protect the family, Purdue paid the two executives at least $8 million, that lawsuit alleges.
“The Sacklers spent millions to keep the loyalty of people who knew the truth,” the complaint filed by the Massachusetts attorney general alleges.
The Kentucky deposition’s contents will likely fuel the growing protests against the Sacklers, including pressure to strip the family’s name from cultural and educational institutions to which it has donated. The family has been active in philanthropy for decades, giving away hundreds of millions of dollars. But the source of its wealth received little attention until recent years, in part due to a lack of public information about what the family knew about Purdue’s improper marketing of OxyContin and false claims about the drug’s addictive nature.
Although Purdue has been sued hundreds of times over OxyContin’s marketing, the company has settled many of these cases, and almost never gone to trial. As a condition of settlement, Purdue has often required a confidentiality agreement, shielding millions of records from public view.
That is what happened in Kentucky. In December 2015, the state settled its lawsuit against Purdue, alleging that the company created a “public nuisance” by improperly marketing OxyContin, for $24 million. The settlement required the state attorney general to “completely destroy” documents in its possession from Purdue. But that condition did not apply to records sealed in the circuit court where the case was filed.
In March 2016, STAT filed a motion to make those documents public, including Sackler’s deposition. The Kentucky Court of Appeals last year upheld a lower court ruling ordering the deposition and other sealed documents be made public. Purdue asked the state Supreme Court to review the decision, and both sides recently filed briefs. Protesters outside Kentucky’s Capitol last week waved placards urging the court to release the deposition.
Sackler family members have long constituted the majority of Purdue’s board, and company profits flow to trusts that benefit the extended family. During his deposition, which took place over 11 hours in a law office in Louisville, Ky., Richard Sackler said “I don’t know” more than 100 times, including when he was asked how much his family had made from OxyContin sales. He acknowledged it was more than $1 billion, but when asked if they had made more than $5 billion, he said, “I don’t know.” Asked if it was more than $10 billion, he replied, “I don’t think so.”
By 2006, OxyContin’s “profit contribution” to Purdue was $4.7 billion, according to a document read at the deposition. From 2007 to 2018, the Sackler family received more than $4 billion in payouts from Purdue, according to the Massachusetts lawsuit.
During the deposition, Sackler was confronted with his email exchanges with company executives about Purdue’s decision not to correct the misperception among many doctors that OxyContin was weaker than morphine. The company viewed this as good news because the softer image of the drug was helping drive sales in the lucrative market for treating conditions like back pain and arthritis, records produced at the deposition show.
Designed to gradually release medicine into the bloodstream, OxyContin allows patients to take fewer pills than they would with other, quicker-acting pain medicines, and its effect lasts longer. But to accomplish these goals, more narcotic is packed into an OxyContin pill than competing products. Abusers quickly figured out how to crush the pills and extract the large amount of narcotic. They would typically snort it or dissolve it into liquid form to inject.
The pending Massachusetts lawsuit against Purdue accuses Sackler and other company executives of determining that “doctors had the crucial misconception that OxyContin was weaker than morphine, which led them to prescribe OxyContin much more often.” It also says that Sackler “directed Purdue staff not to tell doctors the truth,” for fear of reducing sales. But it doesn’t reveal the contents of the email exchange with Friedman, the link between that conversation and the 2007 plea agreement, and the back-and-forth in the deposition.
A few days after the email exchange with Friedman in 1997, Sackler had an email conversation with another company official, Michael Cullen, according to the deposition. “Since oxycodone is perceived as being a weaker opioid than morphine, it has resulted in OxyContin being used much earlier for non-cancer pain,” Cullen wrote to Sackler. “Physicians are positioning this product where Percocet, hydrocodone and Tylenol with codeine have been traditionally used.” Cullen then added, “It is important that we be careful not to change the perception of physicians toward oxycodone when developing promotional pieces, symposia, review articles, studies, et cetera.”
“I think that you have this issue well in hand,” Sackler responded, while Friedman and Cullen could not be reached for comment.
Asked at his deposition about the exchanges with Friedman and Cullen, Sackler didn’t dispute the authenticity of the emails. He said the company was concerned that OxyContin would be stigmatized like morphine, which he said was viewed only as an “end of life” drug that was frightening to people.
“Within this time it appears that people had fallen into a habit of signifying less frightening, less threatening, more patient acceptable as under the rubric of weaker or more frightening, more — less acceptable and less desirable under the rubric or word ‘stronger,’” Sackler said at his deposition. “But we knew that the word ‘weaker’ did not mean less potent. We knew that the word ‘stronger’ did not mean more potent.” He called the use of those words “very unfortunate.” He said Purdue didn’t want OxyContin “to be polluted by all of the bad associations that patients and healthcare givers had with morphine.”
In his deposition, Sackler also defended sales representatives who, according to the statement of facts in the 2007 plea agreement, falsely told doctors during the 1996-2001 period that OxyContin did not cause euphoria or that it was less likely to do so than other opioids. This euphoric effect experienced by some patients is part of what can make OxyContin addictive. Yet, asked about a 1998 note written by a Purdue salesman, who indicated that he “talked of less euphoria” when promoting OxyContin to a doctor, Sackler argued it wasn’t necessarily improper.
“This was 1998, long before there was an Agreed Statement of Facts,” he said.
The lawyer for the state asked Sackler: “What difference does that make? If it’s improper in 2007, wouldn’t it be improper in 1998?”
“Not necessarily,” Sackler replied.
Shown another sales memo, in which a Purdue representative reported telling a doctor that “there may be less euphoria” with OxyContin, Sackler responded, “We really don’t know what was said.” After further questioning, Sackler said the claim that there may be less euphoria “could be true, and I don’t see the harm.”
The same issue came up regarding a note written by a Purdue sales representative about one doctor: “Got to convince him to counsel patients that they won’t get buzzed as they will with short-acting” opioid painkillers. Sackler defended these comments as well. “Well, what it says here is that they won’t get a buzz. And I don’t think that telling a patient ‘I don’t think you’ll get a buzz’ is harmful,” he said.
Sackler added that the comments from the representative to the doctor “actually could be helpful, because many patients won’t get a buzz, and if he would like to know if they do, he might have had a good medical reason for wanting to know that.”
Sackler said he didn’t believe any of the company sales people working in Kentucky engaged in the improper conduct described in the federal plea deal. “I don’t have any facts to inform me otherwise,” he said.
Purdue said that Sackler’s statements in his deposition “fully acknowledge the wrongful actions taken by some of Purdue’s employees prior to 2002,” as laid out in the 2007 plea agreement. Both the company and Sackler “fully agree” with the facts laid out in that case, Purdue said.
The deposition also reveals that Sackler pushed company officials to find out if German officials could be persuaded to loosen restrictions on the selling of OxyContin. In most countries, narcotic pain relievers are regulated as “controlled” substances because of the potential for abuse. Sackler and other Purdue executives discussed the possibility of persuading German officials to classify OxyContin as an uncontrolled drug, which would likely allow doctors to prescribe the drug more readily — for instance, without seeing a patient. Fewer rules were expected to translate into more sales, according to company documents disclosed at the deposition.
One Purdue official warned Sackler and others that it was a bad idea. Robert Kaiko, who developed OxyContin for Purdue, wrote to Sackler, “If OxyContin is uncontrolled in Germany, it is highly likely that it will eventually be abused there and then controlled.”
Nevertheless, Sackler asked a Purdue executive in Germany for projections of sales with and without controls. He also wondered whether, if one country in the European Union relaxed controls on the drug, others might do the same. When finally informed that German officials had decided the drug would be controlled like other narcotics, Sackler asked in an email if the company could appeal. Told that wasn’t possible, he wrote back to an executive in Germany, “When we are next together we should talk about how this idea was raised and why it failed to be realized. I thought that it was a good idea if it could be done.”
Asked at the deposition about that comment, Sackler responded, “That’s what I said, but I didn’t mean it. I just wanted to be encouraging.” He said he really “was not in favor of” loosening OxyContin regulation and was simply being “polite” and “solicitous” of his own employee.
Near the end of the deposition — after showing Sackler dozens of emails, memos and other records regarding the marketing of OxyContin — a lawyer for Kentucky posed a fundamental question.
“Sitting here today, after all you’ve come to learn as a witness, do you believe Purdue’s conduct in marketing and promoting OxyContin in Kentucky caused any of the prescription drug addiction problems now plaguing the Commonwealth?” he asked.
Sackler replied, “I don’t believe so.”
THIS IS A PARTIAL REPOSTING OF A STATNEWS and PROPUBLICA ARTICLE COLLABORATION (February 21, 2019)
McKesson Corp. Failed In Opioid Diversion Reporting: “By Failing To Report In-House Diversion”
(MASS TORT NEXUS MEDIA) In a very clear and direct statement, the FDA has issued a formal warning letter to McKesson Corp. where “failure to monitor and report” diversion of prescription opiates including when the diversion took place within McKesson’s in-house control. Examples of opiate deliveries to Rite-Aid pharmacies containing naproxen instead of opiates were delivered in broken-seal containers. Even after Rite-Aid reported the diversions on more than one occasion, there was a failure by McKesson to report the diversion to authorities as required by law, as well as failing to conduct a proper internal investigation.
A December 2018 congressional report on prescription pill dumping squarely placed the blame on U.S. prescription drug distributors and the Drug Enforcement Administration for not doing enough to help mitigate the nation’s opioid addiction and overdose crisis.
The report released by the House Energy and Commerce Committee followed an 18-month investigation and focused on the three largest U.S. wholesale drug companies, McKesson Corp., Cardinal Health and AmerisourceBergen, and regional distributors outlines a pattern of total avoidance at the highest levels where opioid prescription reporting was required by law.
The report cited examples of massive pill shipments to West Virginia, which has a population of 1.8 million and has by far the nation’s highest death rate from prescription drugs. McKesson shipped an average of 9,650 hydrocodone pills per day in 2007 to a now-closed pharmacy in Kermit, which has a population of about 400. The shipments were 36 times above a monthly dosage shipment threshold the company had established that year. Why there was no reporting on the catastrophic numbers remains a matter to be resolved in litigation, because McKesson offers no realistic explanation for their bad conduct in failure to report as required by law.
The report cited prior federal records that showed drug wholesalers shipped 780 million hydrocodone and oxycodone pills to West Virginia from 2007 to 2012, a period when 1,728 people fatally overdosed on the painkillers. 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 their efforts, the how and why of their focus is being addressed in the federal and state courts across the country, with the primary cases being filed in the “Opiate Prescription Multidistrict Litigation MDL 2804” , being heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.
It would now seem that McKesson will have to defend their failed diversion reporting conduct not only in the thousands of lawsuits they are facing, but in the renewed scrutiny that comes along with being outed as on eof the primary causes of the existing opioid crisis in America.
THE FULL FDA WARNING LETTER TO MCKESSON CORPORATION DATED FEBRUARY 7, 2019 IS BELOW
Via SIGNATURE CONFIRMED DELIVERY
February 7, 2019
John H. Hammergren
Chief Executive Officer
One Post Street
San Francisco, California 94104
Dear Mr. Hammergren:
From June 25 to July 3, 2018, U.S. Food and Drug Administration (FDA) investigators conducted an inspection at your corporate headquarters located at One Post Street, San Francisco, California. FDA investigators also inspected your distribution center facility at 9700 SW Commerce Circle, Wilsonville, Oregon, from June 26 to 29, 2018.
This warning letter summarizes significant violations of the verification requirements found in section 582(c)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(c)(4)). These verification requirements are intended to help preserve the security of the supply chain for prescription drug products, thereby protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.
FDA issued a Form FDA 483 to McKesson Corporation at its San Francisco corporate headquarters on July 3, 2018. FDA reviewed your firm’s responses, dated July 25, 2018, September 25, 2018, and November 4, 2018.
During FDA’s inspection, FDA investigators observed that your firm failed to have systems in place to enable compliance with the verification requirements of section 582(c)(4) of the FD&C Act. Specific violations include, but may not be limited to, the following:
Your firm failed to respond to illegitimate product notifications as required, which includes identifying all illegitimate product subject to such notifications in your possession or control and quarantining such product (section 582(c)(4)(B)(iii)).
2. Your firm failed to quarantine and investigate suspect product (section 582(c)(4)(A)(i)).
3. Your firm failed to keep, for not less than 6 years, records of the investigation of suspect product and the disposition of illegitimate product (sections 582(c)(4)(A)(iii) and 582(c)(4)(B)(v)).
Failure to comply with any of the requirements under section 582 of the FD&C Act is a prohibited act under section 301(t) of the FD&C Act (21 U.S.C. 331(t)).
Example 1: In September and October 2016, McKesson was notified by your pharmacy trading partner, Rite Aid, that three separate Rite Aid pharmacies received illegitimate product, which they reported had been distributed by McKesson. Initially, McKesson was notified by Rite Aid on September 1, 2016, that their pharmacy located in Milford, Michigan, received a bottle labeled as containing 100 tablets of oxycodone hydrochloride (NDC 0406-8530) manufactured by Mallinckrodt. The seal of the bottle was broken, and the bottle contained no oxycodone hydrochloride. The bottle contained only 15 tablets, which were later determined to be naproxen. Rite Aid reported to McKesson that it had received this product through a transaction with McKesson. Mallinckrodt submitted an illegitimate product notification (via Form 3911) to FDA about this oxycodone hydrochloride, noting that “the tablets that were in the bottle were foreign tablets.”
Rite Aid’s pharmacy located in Waterford, Michigan, also received illegitimate product, which they reported had been distributed by McKesson. The pharmacy received one bottle, also labeled as containing 100 tablets of oxycodone hydrochloride, which had a broken seal and did not contain oxycodone hydrochloride. The bottle’s contents were also replaced with 15 tablets of naproxen. Rite Aid reported to McKesson that it had received this product through a transaction with McKesson. On September 15, 2016, Rite Aid alerted McKesson by email about this discovery of product with missing tablets. Mallinckrodt submitted an illegitimate product notification to FDA (via Form 3911) about the oxycodone hydrochloride, noting that the Rite Aid pharmacy in Waterford “reported that upon opening a bottle of Mallinckrodt Oxycodone 30mg the seal was broken and 100 tablets of Oxycodone 30mg were missing. Fifteen tablets of generic Aleve ([n]aproxen sodium 220mg tablets) manufactured by Amneal Pharmaceuticals were inside the bottle.”
On October 6, 2016, Rite Aid’s pharmacy located in Warren, Michigan, also received illegitimate product, which they reported had been distributed by McKesson. The pharmacy had ordered five bottles of oxycodone hydrochloride. In three of the bottles they received, all the oxycodone hydrochloride had been removed. These three bottles contained various combinations of naproxen and ciprofloxacin hydrochloride. Mallinckrodt submitted an illegitimate product notification (via Form 3911) to FDA about these products, noting that “three bottles were missing all 100 tablets of [o]xycodone [h]ydrochloride 30mg tabs and contained foreign tablets.”
Your firm’s investigation of these three incidents of illegitimate product determined that, because of the lack of evidence of tampering with these packages and the proximity of these three Rite Aid pharmacies, it was likely that the oxycodone hydrochloride was replaced with other product while the packages were in the possession or control of McKesson.
These instances illustrate your firm’s failure to have systems in place to enable compliance with the requirements of section 582(c)(4) of the FD&C Act. After receiving illegitimate product notifications from Rite Aid, your firm was required to respond by identifying all illegitimate product subject to such notification that was in its possession or control, including any product that was subsequently received (section 582(c)(4)(B)(iii)). McKesson was then required to quarantine such product within its possession or control from product intended for distribution until such product was dispositioned (section 582(c)(4)(B)(i)(I)), dispose of any illegitimate product within its possession or control (section 582(c)(4)(B)(i)(II)), take reasonable and appropriate steps to assist trading partners to dispose of illegitimate product not in the possession of McKesson (section 582(c)(4)(B)(i)(III)), and notify within 24 hours FDA and all immediate trading partners that may have received such illegitimate product (section 582(c)(4)(B)(ii)). Your firm was also required to keep, for not less than 6 years, records of the disposition of illegitimate product (sections 582(c)(4)(B)(v)).
Although your firm conducted an investigation related to these bottles of oxycodone hydrochloride, your firm was unable to demonstrate that you met key obligations under section 582(c)(4). For example, you did not demonstrate that you identified all illegitimate product subject to the notification, such as by searching for product with the same lot number or NDC, or that you quarantined any such product. Similarly, your firm failed to demonstrate that you notified your immediate trading partners who may have received product with the same lot number or NDC. This is particularly troubling because your firm’s investigation noted that the oxycodone hydrochloride was likely replaced with different product at a McKesson distribution center. Also troubling is that during the FDA inspection of your firm’s San Francisco headquarters, a McKesson representative stated that incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act (DSCSA) verification events within the firm. In fact, DSCSA explicitly defines illegitimate product to include “a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.” Finally, your firm provided no records to demonstrate the disposition of these illegitimate products.
FDA has reviewed your firm’s responses to the Form FDA 483 and subsequent correspondence.
Your firm’s response to the Form FDA 483 states that while you investigated “incidents related to potential diversion and theft issues … the incidents were not necessarily related to suspect or illegitimate products.” This response parallels your representative’s statement to FDA investigators at your San Francisco headquarters that incidents involving stolen or diverted controlled substances are not treated as DSCSA verification events within the firm. These statements demonstrate a lack of understanding of the definitions of suspect and illegitimate products, and of your firm’s responsibilities when notified of an illegitimate product by a trading partner. All prescription drug products in finished dosage form for administration to a patient– including those containing controlled substances – are subject to DSCSA verification requirements in section 582(c)(4). Moreover, the statute defines illegitimate product to include “a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.” Under the law, your firm must treat incidents involving suspect and illegitimate products as subject to DSCSA requirements, including products that are controlled substances.
Your firm’s response to the Form FDA 483 cannot be evaluated because it lacks sufficient supporting documentation. Your response states that McKesson plans to make procedural updates to its standard operating procedures, without describing what these updates are or providing new standard operating procedure documents for review. FDA does not have enough information to conclude that future investigations of suspect or illegitimate product by McKesson will be conducted in a manner compliant with DSCSA. Your firm’s response dated November 4, 2018, contains similar information as your previous response; namely regarding updates you have made to various policy documents. Again, however, your firm provided no supporting documentation for review.
Although your November 4, 2018, response to FDA states that you intend to form a “Product Safety Committee that will be responsible for coordination of all actions related to suspect or illegitimate product,” your firm provided no information about the composition of this committee or the procedures under which the committee will function. As a result, your response does not demonstrate how the proposed change will improve McKesson’s compliance with DSCSA verification requirements.
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facilities. You are responsible for investigating and determining the causes of the violations identified above, and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law.
Failure to promptly correct these violations may result in legal action without further notice, including injunction. Unresolved violations in this warning letter may also prevent other federal agencies from awarding contracts.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to (1) correct the violations identified in this warning letter, and (2) identify and conduct appropriate investigations and follow-up related to other reports of suspect or illegitimate product that you have identified or received. Please include an explanation of each step being taken to prevent the recurrence of violations and include copies of related documentation. In addition, provide the steps your firm has taken to prevent incidents of theft and diversion. If you disagree with the characterization of the violations of the FD&C Act in this warning letter, include your reasoning and any supporting infom,ation for our consideration. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.
Please send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Rd.
Irvine, California 92612-2506
Indiana Jury Awards Tonya Brand $3 million In Damages
By Mark A. York (February 6, 2019)
(MASS TORT NEXUS MEDIA) A federal jury awarded plaintiff Tonya Brand $3 million in the most recent Cook MDL 2570 IVC Filter bellwether trial on February 1, 2019 in Indianapolis. See Tonya Brand v. Cook IVC Filter Jury Verdict Form Feb 1, 2019 , where the jury determined that the design of the Cook Celect IVC Filter was defective and returned a verdict of $3 million dollars.
The jury declined to award punitive damages against Cook Medical, Inc. with Ms. Brand’s trial counsel, Misty Farris offering “we are happy with the jury verdict and are encouraged that the Celect IVC Filter was recognized as being defectively designed, as far as punitive damages not being awarded—we respect the jury decision to not award punitives and look forward to the next trial.” See Tonya Brand v Cook Punitive Jury Instructions Feb 5, 2019.
Ms. Farris further added, “We believe this was the right verdict and perhaps the defense may consider this when determining whether or not to begin settlement discussions,” as there are no other bellwether trials scheduled in the Cook MDL 2570 following the Tonya Brand trial. Will this verdict move Cook Medical and its legal team toward the start of settlement negotiations?
The Brand trial is just one of the more than 5,000 cases filed against Cook Medical, Inc. and its affiliates, where plaintiffs are alleging its blood clot filters were defectively designed. Ms. Brand’s attorneys offered to the jury that she pulled a part of her Cook IVC filter out of her thigh in 2011 after it broke up and deteriorated, while pieces of the device remain lodged in in other areas of her body and are unable to be removed. For additional information on the Cook IVC Filter MDL 2750 docket see Cook-Medical IVC-Filter-MDL-2570-Docket Briefcase, by Mass Tort Nexus.
In addition to Misty Farris, of Dallas-based Fears Nachawati, the trial team consisted of Ben Martin of the Law Offices of Ben C. Martin; Denman Heard, of the Heard Law Firm; Laura Baughman, with Baron & Budd and Joseph Williams of Indiana-based Riley Williams & Piatt, with a sincere congratulations to the entire team on their trial victory!
The Brand jury verdict came in the third bellwether trial in the Cook IVC MDL 2750, after two previous cases selected for trial resulted in wins for Cook.
Cook promoted its Celect IVC filter which was implanted into Ms. Brand as retrievable, but the filters often tilt and pierce the inferior vena cava, or pieces break off and may travel to the duodenum and aorta as well as other parts of the body, resulting in metal fragments pressing against the spine and other critical areas and organs, making it impossible to remove without major surgery. Many times the filter migration requires multiple attempts at surgical removals which fail due to the location of where the metal IVC filter fragments have migrated to.
What is an IVC Filter?
An inferior vena cava (IVC) filter is a small device surgically inserted into the inferior vena cava, the largest vein in the body. These devices, resembling a cage with spindly legs, are designed to trap blood clots from traveling to the lungs and causing a pulmonary embolism. A pulmonary embolism is a potentially fatal blockage of an artery that carries blood from the heart to the lungs. The idea is that the clots will dissolve naturally once trapped in the filter. Some filters are permanent, but otherwise the U.S. Food and Drug Administration (FDA) recommends removing the filter between the 29th and 54th day after the filter is implanted, unless the threat of pulmonary embolism hasn’t subsided. The FDA concluded this specific time span based on a mathematical model they developed using available medical data. When the agency discovered this, they did issue a safety notice in 2010 and again in 2014 outlining the risks of leaving the devices in for too long.
Plaintiff claims include that Cook knew its Celect IVC filter had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway. There are independent studies that found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate.
Over 9000 IVC Filter Claims Filed
Since 1979 when IVC filters were first introduced, hundreds of thousands of IVC filters have been implanted in patients. In August 2010, the FDA issued a safety communication stating IVC filters “are not always removed,” and known long term IVC filter risks include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation. There are now over 9,000 IVC filter lawsuits pending against Cook Medical, Johnson & Johnson, C.R. Bard, Cordis Corporation, B. Braun, Rex Medical, and other manufacturers in state and federal courts.
What are the risks of an inferior vena cava filter placement?
Damage to the blood vessel at the insertion site
Blockage of blood flow through the vena cava, which can cause leg swelling
A filter that travels to the heart or lungs, causing injury or death
A filter that pierces through the inferior vena cava, causing pain or damage to other organs
Problem with placement of the filter
Continued risk of a blood clot that travels to the lungs
Clinical Research Shows IVC Filter Dangers Were Known
Blood clot filters are implanted in an estimated 250,000 people in the U.S. each year, most without incident. In the last decade, millions of filters have been implanted in Americans and Cook Medical, Inc. is justone of 11 manufacturers that make these devices and are involved in litigation pending in both federal and state court dockets across the country.
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