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CASE UPDATE: Litigation Continues with Discovery Phase
February 2019 – We are back in litigation and are currently in the discovery phase. We recently started receiving corporate documents and are reviewing and analyzing them. Once we have completed our review we will be gathering testimony from corporate witnesses.
Incretin is a natural hormone that is produced by the body. It tells the body to release insulin, which lowers blood sugar after eating. Incretin mimetics are a class of Type-2 diabetes medications that act like, or mimic, the incretins in the body that lower blood sugar after eating.
There are two categories of incretin mimetics. One works by mimicking a hormone called GLP-1 to stimulate natural insulin production. The other is known as a DDP-4 inhibitor and it works by inhibiting glucagon release thereby stimulating insulin secretion.
In 2007, the FDA warned that incretin mimetics may cause pancreatic diseases. The warning was based on reports that an increased number of users of incretin mimetics were diagnosed with acute pancreatitis and pancreatic cancer. From 2006 to 2009 alone, 88 cases of acute pancreatitis were linked to Januvia. Half of these patients indicated that pancreatic inflammation diminished after they stopped taking Januvia.
Januvia and Janumet are manufactured by Merck, Byetta is manufactured by Amylin Pharmaceuticals, Inc. and was at one point co-promoted by Eli Lilly, & Co., and Victoza by Novo Nordisk. Onglyza and Kombiglyze XR are both manufactured by AstraZeneca and Bristol Myers Squibb.
In the United States, more than 3 million diabetics took the top five selling incretins in 2013, according to estimates from the Institute for Safe Medication Practices.
The drugs are top sellers for the manufacturers, causing concern that the companies do not care about the well-being of the individuals taking the drugs, but, care instead of the profits the drugs bring in.
Studies of the effects of incretin mimetics are crucial to understanding how these drugs may be affecting consumers in adverse ways. Consumers rely on this information to make educated decisions when choosing medications.
Researchers who were not wholeheartedly convinced by the supposed safety of incretin mimetics decided to look to the FDA adverse reporting system to see how these drugs affected humans. In individuals who took incretin mimetics, the researchers found an increase in the number of reports of pancreatitis and pancreatic cancer.
Yet, it was not just researchers who noted the link. In September 2008, drug manufacturer Eli Lilly noticed a connection between Byetta and pancreatitis. However, they maintained that the warning on the drug of contracting acute pancreatitis was sufficient and adequately communicated. Furthermore, in 2009, the FDA asked Merck and other companies that manufactured these drugs to do further safety studies using rats which resulted in the death of three rats. Frighteningly enough, the pharmaceutical companies continue to state that these drugs cause no damaging effects.
In an independent analysis of health insurance published in February 2013, researchers found that people taking GLP-1 incretin mimetics were at twice the risk of hospital admission for acute pancreatitis as compared with people taking other anti-diabetic drugs.
In 2013, an independent body released the results of its research indicating that the entire class of incretin mimetics may carry up to 20 times the risk of developing pancreatic cancer for patients taking these drugs.
The Institute for Safe Medication Practices “ISMP” analyzed data from the FDA Adverse Event Reports between July 1, 2011, and June 30, 2012, from 1,723 patients taking these drugs. The ISMP concluded that the increased risk of developing pancreatic cancer for patients taking these drugs could be as much as 20% higher than those who were taking other medications to control their type-2 diabetes.
Tom Moore, a senior scientist for drug safety and policy at the ISMP said, “I think the whole class is in question.” Moore further stated that additional analysis is required, but “if the results are confirmed in a broader patient population, it raises questions about the entire class of drugs.”
Although this data has some inherent limitations because it is based on adverse event reporting, it is a significant signal that more study and investigation should be undertaken, especially considering the other reports from different investigators found similar alarming connections between the drugs and pancreatic cancer.
The results of these studies are very unfavorable to the drug manufacturers who continue to maintain that their product is safe. Unsurprisingly, this research has shown that these manufacturers continue to put profit above safety when they conduct inadequate testing and put unsafe drugs on the market.
In an effort to dismiss allegations that their product was unsafe, Merck offered to fund a professor at the University of California, Los Angeles to conduct a study about the effect of sitagliptin (Januvia) on rats that have diabetes similar to that in humans. What should not have been a shock to Merck, the results of this study demonstrated that their product caused an increase in pancreatic damage.
During the 12-week study, the researchers gave the rats sitagliptin, metformin, or a combination of both drugs. When examining the rats after the 12 weeks, the researchers found that every rat given sitagliptin had an enlarged pancreas. Furthermore, one rat showed acute pancreatitis and 3 out of 16 had acinar to ductal metaplasia, a pathological change thought to be a potential precursor of pancreatic cancer. Immediately after these results were published, Merck held a closed-door meeting to discuss the adverse findings. In this meeting, a professor of digestive diseases said that the results of the study could suggest an increased risk of pancreatic cancer. Had Merck and other pharmaceutical companies adequately tested these drugs before rushing them to the market, they likely would have found these results before the drug caused pancreatic damage to thousands of users.
Plaintiffs and their families throughout the United States have alleged that they now suffer or have died from pancreatic cancer as a result of taking these types of drugs.
In August 2013, a panel of federal judges entered an order consolidating all current and future Byetta, Januvia, Janumet, and Victoza cases into one courtroom in the Southern District of California under the title In re:Incretin Mimetics-Based Therapies Products Liability Litigation due to the increasing number of lawsuits against manufacturers.
Given the complexity of this litigation and anticipated resource demands that accompany “mass tort” (multiple plaintiffs injured in a similar fashion by a defective product) cases, the consolidation is intended to allow the litigation to move forward in an efficient, organized and timely manner. The consolidation of these mass tort cases is called multidistrict litigation, or an MDL.
These actions involved a common question of fact making multidistrict litigation an efficient option for the courts to promote the just and efficient conduct of this litigation. Despite the fact that the courts are generally hesitant to create an MDL for multiple defendants, the panel of judges proceeded with centralization with the support of the defendants – Merck, Amylin, Eli Lily, AstraZeneca, Bristol Myers Squibb, and Novo Nordisk.
As the case proceeded, the defendants argued that the plaintiffs in the MDL had no claim to a “failure to warn” incretin lawsuit, citing the FDA’s approval of the drugs’ labels. In ruling on the summary judgment motion, the trial judge agreed with the defendants and dismissed 749 pending cases.
In September 2016, the plaintiffs’ attorneys filed an appeal to the summary judgment decision with the 9th Circuit U.S. Court of Appeals.
In December 2017, the appellate court returned a decision, determining that the district court had misapplied a Supreme Court case, Buckman Co. v Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), in two ways: (1) the district court relied on Buckman to impermissibly circumscribe discovery, and (2) the district court relied on Buckman to deem the plaintiffs’ newly discovered evidence “irrelevant” to the court’s preemption analysis at the summary judgment stage. Either of these errors, independently, would have warranted a reversal on the dismissal decision.
The court’s opinion further holds that the court abused its discretion in partially excluding plaintiffs’ expert, Dr. Fleming.
Now, the 749 previously dismissed cases, along with new cases that have joined MDL 2452 since the original dismissal, will continue on towards trial in the Southern District of California.
The individuals involved in MDL 2452 claim that the “defendants willfully, wantonly, and with malice withheld the knowledge of an increased risk of pancreatic cancer in users of the Drugs to prevent any chances of their products’ registration being delayed or rejected by [the] FDA.”
The Complaint further alleges that (1) the defendants manufactured defective drugs which caused “unreasonable and dangerous side effects,” (2) the defendants failed to conduct adequate research and test the incretin mimetic drugs before making them available on the market, (3) the defendants failed to warn healthcare professionals and consumers of these potential side effects, even concealing the risks of pancreatitis and pancreatic cancer from the public (4) the manufacturers failed to include specific wordage, such as “pancreatic cancer”, on the drugs’ labels, and (5) the plaintiffs allege that the current warnings for the drugs are still inadequate.
MDL 2452 proceedings resumed after the 9th Circuit issues its mandate — the formal order transferring cases back to the district court. Generally, the mandate is issued 21 days after the release of the opinion, but the release can be pushed back if the defendant’s petition for rehearing within the 14-day filing window. If a rehearing is denied, the mandate will issue sometime around 7 days after the court denies rehearing.
The defendants also had 90 days to file a petition for certiorari at the Supreme Court level. If the defendant’s petition for rehearing, then the deadline for a cert petition is pushed back to 90 days after the denial of rehearing.
As pharmaceutical drug liability cases continue to grow, many are left questioning the FDA’s approval method of these dangerous drugs. FDA approval is based on surrogate measures, such as tests that lower blood sugar levels but not on proof that they prevent heart attacks. Drugs can be approved so long as they are deemed safe in early studies based on the limited surrogate measures.
FDA’s Adverse Events Reporting System collects case reports from the public and medical community. Nevertheless, the majority of cases are unaccounted because the reporting system is voluntary for users and health professionals. Although drug companies are required to file reports, patients and doctors rarely report incidents to drug manufacturers. The system is deeply flawed as there are more reports that staff can review, thus it may be years after a drug was approved before the public is warned of any side effects.
According to an analysis of case reports from 2004 to March 2014, there were 964 deaths and 4425 hospitalizations amongst users of Januvia. The analysis also reported 880 deaths and 7115 hospitalizations amongst users of Byetta.
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are continuing to investigate the connection between this class of drugs and pancreatic cancer.
More concerning news surrounding popular Type-2 diabetes medications and their link to pancreatic cancer has come to light. Independent academic and scientific researchers have called on the FDA to take a serious look at their data concerning certain incretin mimetics and their potential to cause this serious and oftentimes fatal form of cancer.
At the urging of these researchers, the FDA is currently reviewing a recent body of research that suggests pre-cancerous cellular changes in the body may be triggered by incretin mimetic medications. These changes may produce an inflammation of the pancreas, which has been shown to cause pancreatic cancer.
In addition, reports of pancreatitis associated with the use of these drugs continue to flood through the doors of the FDA.
As of 2019, both classes of incretin mimetics are still being marketed to millions of people with Type-2 diabetes. But, there is a reason for the manufacturer’s insistence the drugs are safe for consumers. Merck’s global sales increased from $2.39 billion in 2010 to $3.7 billion in 2017. Additionally, the manufacturer has since released newer Type-2 diabetes medications, likely to be profit driving drugs, too.
More and more research continues to emerge linking these Type-2 diabetes medications with pancreatic cancer, pancreatitis, and thyroid cancer. However, the profits of incretin mimetic drugs are substantial. Manufacturers are not going to give up these products without a fight.
If you or a loved one have suffered side effects such as pancreatitis or pancreatic cancer that is believed to be caused by Byetta, Victoza, Byuderon, Onglyza, Kombiglyze XR, Januvia, NEsina, Tradjenta, or Janumet, contact TorHoerman Law to review your legal options in an incretin mimetics lawsuit.
February 2018 – We will be incredibly busy over the next several months and as we continue working, we will keep you updated. It is still going to be a battle against the manufacturers, but we are up for the challenge and hope you are too.
December 11, 2017 - The 9th Circuit U.S. Court of Appeals decided on Wednesday to reverse the dismissal of all incretin cases involved in incretin mimetics lawsuit MDL 2452, which had been previously dismissed by the Southern District of California trial court in November of 2015.
MDL 2452 is filed against drug manufacturers Merck, Amylin, Eli Lilly, and Novo Nordisk on behalf of individuals injured by Januvia, Byetta, Victoza, Onglyza, and similar drugs – commonly referred to as incretin mimetic drugs, which are used to treat type-2 diabetes. In the incretin lawsuit, the plaintiffs allege that incretin mimetics caused them to develop pancreatic cancer.
May 17, 2017 - On November 25, United States District Court Judge Anthony J. Battaglia issued an order calling for "Science Day" hearings, a special type of hearing typical in complex pharmaceutical drug litigation proceedings. These hearings, which will take place on February 5 and 6, 2018, include all Byetta, Janumet, Victoza and Januvia lawsuits. In these special hearings, both parties will have the opportunity to explain the medical and scientific facts behind the complex allegations involving the effects on the pancreas of incretin mimetic Type 2 diabetes drugs. The parties will discuss the nature of diabetes, the role of incretin-based therapies, pancreatic cancer morbidity, and data on the effects of incretin therapy.
This meeting will take place as a non-adversarial hearing where both parties will present "off-record" testimony from non-expert witnesses. These witnesses will present their information without cross-examinations or sworn statements.
Though the first trials might not take place for a few years, Judge Battaglia has ordered the parties to submit a Joint Motion outlining the bellwether trial process. The outcomes of these trials could signal which direction these cases will proceed – whether they will continue to be tried, or whether the parties will attempt to settle.
2016 - A study released in 2016 examined the FDA's adverse event reporting database and found that pancreatic cancer developed much more frequently in Januvia users.
April 24, 2014 - A published piece in the BMJ journal, questioned whether patients and doctors had been given full risk information about incretin mimetics and the increased risk of pancreatic damage. This commentary analyzed thousands of pages of regulatory documents obtained under Freedom of Information rules and located unpublished data indicating that "unwanted proliferative or inflammatory pancreatic effects" are associated with the use of incretin mimetics.
June 2013 - A two-day conference hosted by the National Institute of Diabetes and Digestive and Kidney Diseases in June 2013 put the drugs under the microscope once again. Pancreatic cancer specialists gathered to consider whether these drugs could be the cause of the increasing diagnosis of pancreatic cancer.
October 23, 2013 - Litigation over the class of multi-billion dollar diabetes drugs incretin mimetics and their relationship to pancreatic cancer moved forward as consolidated cases in front Judge Anthony J. Battaglia in the Southern District of California.
At the initial status conference on October 24, 2013, with a courtroom full of defense and plaintiff lawyers, Judge Battaglia announced leadership for the MDL. Tor Hoerman was appointed as co-lead counsel and Jacob Plattenberger was appointed for the first time as a member of the Plaintiff's Steering Committee. Tor and Jake are honored by and appreciative of the support provided by Plaintiffs' lawyers involved in the case. They are also honored by the appointment and humbled by the incredible task that lay ahead.
These leadership roles will put TorHoerman Law in the position to make strategic decisions that will impact all plaintiffs and more importantly, defendants, in this litigation. As leaders of this litigation, Tor and Jake take very seriously their roles and look forward to achieving justice for those suffering from pancreatic cancer and the families of those that have died from this horrible disease.
July 10, 2013 - A federal district court judge in San Diego rejected Amylin Pharmaceuticals' bid to avoid having to defend Byetta-induced pancreatic cancer cases in California state court.
Dawn Smith, who is a citizen of California, developed pancreatic cancer after ingesting Amylin's diabetes drug Byetta. She sued Amylin, its marketing partner McKesson Corporation, and others in a state court in San Diego. Both Ms. Smith and McKesson Corporation are California citizens and federal courts generally have no authority to hear state law cases between citizens of the same state. Despite this well-settled rule, Amylin asked the court to move the case from California state court to federal court and argued that although it maintains its headquarters in California, it is not technically a California "citizen" because last August it changed its form from a "corporation" to a "limited liability company."
This restructuring, however, did not authorize federal jurisdiction over the case because Amylin's marketing partner and distributor McKesson Corporation is, like Ms. Smith, a citizen of California. To get around this hurdle, Amylin offered a host of arguments to the effect that Ms. Smith could not possibly win against McKesson in state court and so the federal judge should act as though Ms. Smith didn't even sue McKesson.
In its argument before the court, Amylin primarily relied on two recent U.S. Supreme Court opinions, PLIVA v. Mensing and Mutual v. Bartlett, which protect manufacturers of generic drugs from certain state law failure to warn claims. In this case, the district court refused to extend Mensing and Bartlett to distributors of brand name drugs and therefore rejected the argument.
Next, Amylin argued that even if federal law did not bar Ms. Smith's claims, she could not prevail under California state law. The court rejected this argument and explained that it is a well-settled general rule under California law that in a product liability action, every supplier in the stream of commerce or chain or distribution, from manufacturer to retailer, is potentially liable. The court also explained the learned intermediary doctrine, which bars liability against manufacturers and distributors who prove adequate warnings were given to physicians, did not protect McKesson here because Ms. Smith alleged that no one provided proper warnings to her physicians.
For these reasons, the court returned the case to state court where it was originally filed.
March 31, 2013 - The FDA reacted to the numerous studies published and issued an FDA Drug Safety Communication notifying healthcare professionals that it was evaluating the findings of researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes in patients with Type 2 diabetes treated with incretin mimetics. As of early 2018, the FDA has not reached any conclusions on whether incretin mimetics can cause pancreatic cancer in users.
February 27, 2013 - The results of the first case-controlled epidemiological study looking at the incretin mimetic drugs and their effects upon the pancreas were published by Singh et. al. out of the Johns Hopkins School of Medicine and School of Public Health. The results of this study "support findings from the previously mechanistic studies and spontaneous reports submitted to the U.S. Food and Drug Association that such an association may be causal."
April 2012 - Public Citizen, a non-profit consumer advocacy organization based in Washington DC, sent a petition to the FDA to withdraw Victoza. Dr. Sidney Wolfe, director of Public Citizen, noted that his concern extends to the other drugs in the incretin mimetics class, but that the petition to withdraw Victoza was based on information pulled from the FDA’s adverse-event reporting database.
2011 - A safety alert was issued in regard to a study that suggested individuals were unaware of the life-threatening severe risks, including cancer risk, associated with taking incretin mimetics for Type 2 diabetes.
June 2011 - Merck & Co., the manufacturer of Januvia and Janumet, faced heat from the FDA for failing to comply with FDA requirements. The final report that the FDA required by June 2011 was not submitted. Merck failed to provide any suitable explanation of that failure to meet FDA deadlines, according to the FDA. As a result, the FDA decided to label Januvia and Janumet as “misbranded” medications.
2010 - The FDA approved Victoza as a Type 2 diabetes medication.
2009 - In response to mounting complaints of acute pancreatitis associated with the use of Januvia and Janumet, the FDA required Merck to investigate the risk of acute pancreatitis in a rodent population treated with these drugs. Additionally, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Byetta, which requires investigating pancreatitis. The REMS was required because the FDA had received reports of severe cases of pancreatitis.
2009 - The FDA notified healthcare professionals that Januvia could cause pancreatitis after receiving 88 complaints in a three-year period. The FDA also made the public aware that incidents of hemorrhagic or necrotizing pancreatitis in six people who had taken Byetta had been reported in 2008.
October 2006 - The FDA approved Januvia.
2005 - The U.S. Food and Drug Administration approved Byetta for consumer use.
Cohen, Deborah. "Two Drugs for Type 2 Diabetes Seem to Raise Risk of Acute Pancreatitis, Study Shows." The BMJ, British Medical Journal Publishing Group, 27 Feb. 2013, www.bmj.com/content/346/bmj.f1304.
McCullough, Marie. "Cancer Questions over Popular Diabetes Drugs Raise Furor." Https://Www.philly.com, The Philadelphia Inquirer, Daily News and Philly.com, 19 Feb. 2016, www.philly.com/philly/health/cancer/20160221_Cancer_questions_over_popular_diabetes_drugs_raise_furor.html
Nauck, Michael A. "A Critical Analysis of the Clinical Use of Incretin-Based Therapies." Diabetes Care, American Diabetes Association, 6 May 2013, care.diabetesjournals.org/content/early/2013/05/06/dc12-2504.abstract
Pagliarulo, Ned. "FDA Shoots down Merck's Bid to Expand Januvia Label." BioPharma Dive, Industry Dive, 7 Apr. 2017, www.biopharmadive.com/news/merck-januvia-crl-fda-cardiovascular-outcomes-tecos/440034/
Tseng, Chin-Hsiao. "Sitagliptin and Pancreatic Cancer Risk in Patients with Type 2 Diabetes." European Journal of Clinical Investigation, U.S. National Library of Medicine, Jan. 2016, www.ncbi.nlm.nih.gov/pubmed/26584246
Incretin mimetics are a class of Type 2 diabetes medications that have come under fire for causing pancreatitis and pancreatic cancer in users. Lawsuits have been filed that allege incretin mimetics manufacturers failed to provide adequate warning of the risks involved and knowingly promoted the dangerous drugs to the public.
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