Xarelto MDL: Settlement

An In Depth Look At The Xarelto Case

Johnson & Johnson and Bayer, who were recently sued as part of several mass tort litigations on both state and federal levels, have agreed to pay $775 million to settle approximately 25,000 lawsuits involving the blood thinner Xarelto, which is jointly sold by both companies. They decided to split the settlement evenly between them.

Warafin, Xarelto, And Andexxa

Intended as a replacement for Warafin, which had been on the market for about 60 years, Xarelto thins the blood in order to prevent arterial fibrillation, a rhythmic heart disorder, and to prevent the types of blood clots that cause pulmonary embolisms, strokes, and heart attacks. It was approved by the U.S. Food and Drug Administration (FDA) in 2011.

The lawsuits allege that the medication triggered substantial bleeding that led to death and grave injury. The episodes were resistant to standard treatments, and patients had to endure years without an antidote. Last year, however, the FDA approved Andexxa, which successfully stops bleeding induced by Xarelto. The medication is sold by Pfizer and Bristol-Myers Squibb.

Interestingly, patients taking Warafin, the original drug, had to be closely monitored, including undergoing frequent blood tests, to confirm that the drug was working at all. Too little of the drug could result in a stroke, too much could result in the kind of stomach bleeding exhibited in the Xarelto cases.

Statements And AccusationsBoth state and federal cases blame the companies for failing to warn about potentially fatal bleeding that can occur when the drug is ingested. Interestingly, neither company admitted liability, with each noting in separate statements that they had won in six previous lawsuits that actually went to trial.

Hartman Etal vs. Janssen Pharmaceuticals, Inc Etal

Plymouth, Indiana resident Lynn Hartman, 75, was prescribed Xarelto by her doctor and took the drug from March 2013 to June 2014. Throughout that time Hartman claims she experienced gastrointestinal bleeding, at which point she stopped taking the drug. Hartman drew from the Xarelto amended master complaint to bring the following claims: design defect, manufacturing defect, negligent misrepresentation, breach of express warranty, failure to warn, breach of implied warranty, and both fraud and violation of consumer protection laws in Indiana and Pennsylvania.

A Flawed Clinical Trial?

Lawyers for the plaintiffs in previous lawsuits questioned whether the initial clinical trial that resulted in the drug’s approval was inherently flawed due to a defective blood-testing monitor that was used throughout the study. Essentially, the lawyers claimed the machine skewed the results. However, the FDA eventually stepped in and concluded that the defects had no bearing on the trial’s outcome.

The device in question is the INRatio, which is sold by Alere. The INRatio was originally used to test whether patients were administered correct doses of Warafin. During the trial, the plaintiff’s attorneys compared the overall number of bleeding occurrences experienced by patients taking Xarelto to those who used to take Warafin. One of the key questions regulators are examining is whether the defective INRatio may have given doctors inaccurate information, which caused them to prescribe too much Warafin.

The Defendants Settle Despite Winning Streak In State And Federal Courts

Johnson & Johnson and Bayer’s decision to settle seems all the more perplexing in light of a specific 2018 case that saw the plaintiff, Lynn Hartman, awarded $28 million, only to have the ruling subsequently reversed by Judge Michael Erdos. This decision was quickly followed by another victory for the defendants.

Lawyers for the plaintiffs in the second case accused Johnson & Johnson and Bayer of spreading “inaccurate or misleading statements regarding the present status of the Xarelto litigation in an attempt to undermine the soundness of plaintiffs’ failure-to-warn claims”.

The defendants responded to this accusation by detailing the specific accusations against them they deemed to be false. First, they were accused of improper testing prior to release, as well as lacking a black box warning about potential bleeding risks. Second, they said they were accused of failing to inform doctors about certain testing. The latter theory was eventually rejected in three multi district litigation (MDL) trials.

Michael M. Weinkowitz, a member of the plaintiff’s legal counsel, claimed the reversal had more to do with the doctor who wrote Hartman’s prescription: “The dismissal was based on a very narrow issue related to Mrs. Hartman’s prescribing physician. However, the court also ruled that the jury’s punitive damages verdict was appropriate and that sufficient evidence existed for the jury to find that the defendants acted with reckless disregard for human life.”

Weinkowitz went a step further in suggesting that the jury’s $26 million in punitive damages “has far broader implications for the Xarelto litigation as a whole”, thus implying that this ruling could be the turning of the tide.

The Defendant’s Decision Bears Similarities To An Older Case

In 2014, German pharmaceutical manufacturer Boehringer Ingelheim paid $650 million to settle approximately 4,000 lawsuits over their drug Pradaxa, which was facing similar accusations of injuries and bleeding deaths. Their response was strikingly similar to Johnson & Johnson and Bayer’s: “Time and again, the benefits and safety of Pradaxa have been confirmed.”



Surgical Staplers

FDA Moves On Surgical Stapler Malfunctions

Surgical staplers and implantable staples are used in a variety of surgical procedures, including gynecological surgery, gastrointestinal surgery, appendectomies, lung surgery, heart surgery, and thoracic surgery. Compared to manual suturing, surgical staplers and staples drastically reduce the overall time it takes to complete a procedure. The staples can be placed relatively quickly, cause negligible tissue reaction, and carry a low risk of infection. However, this does not imply they are not without serious problems.

A recent U.S. Food and Drug Administration (FDA) internal analysis reveals that between January 1, 2011 to March 31, 2018, the agency received more than 41,000 MDRs regarding surgical staplers and staples. Incidents listed in the reports consisted of over 32,000 malfunctions, 9,000 serious injuries, and 366 deaths. Unfortunately, this information was not made available to the public until very recently.

According to FDA data, common problems included opened staple lines, malformed staples, and misfiring staplers. Another recurring issue was misapplied staples, which can occur in two ways: when a staple is applied to the wrong area, or when a staple of the wrong size is used. Complications from surgical stapler and internal staple malfunctions can be severe and can result in an extended surgical procedure, additional surgeries, and further complications such as bleeding, tearing of the organs and surrounding tissue, and death.

This Previous Ruling Could Be Indicative Of Future Trends

In 2015, a California jury awarded approximately $80 million in damages ($10 million in compensatory and $70 million in punitive) against Ethicon, a Johnson & Johnson subsidiary. The plaintiff, a former police officer, was injured when doctors accidentally stapled her anus shut during a hemorrhoid operation. The accident resulted in scars and a deformed bowel, which necessitated the use of a colostomy bag.

The plaintiff’s complaint alleged that the surgeon could not fire the stapler properly due to a severe defect, and that this defect could be detected in almost one third of Ethicon’s hemorrhoid staplers. The jury agreed, concluding that the device lacked essential lubrication as the result of a manufacturing defect. However, the jury did not assign blame to the surgeon, who the plaintiff also listed as a defendant. The doctor could not have been responsible, they concluded, because they received no warning of the device’s defectiveness. The jury assigned the blame to Ethicon, who they alleged was aware of the device’s issues but instead opted to blame the doctors rather than work to improve the manufacturing processes.

During the trial, evidence was presented that showed Ethicon may have been aware of the hemorrhoid stapler’s problems for over a decade but failed to take action until a Class 1 recall in 2011. Class 1 recalls are reserved for devices or drugs that can cause severe health problems, up to and including death.

Reporting-Exemptions and Litigation Complaint Summary Reporting

Dr. Douglass Kwazneski was assisting a Pittsburgh surgeon with the removal of an appendix when the surgical stapler they were using locked up. After the event, Kwazneski scoured the Manufacturer and User Facility Device Experience (MAUDE) database, the FDA’s public database for tracking medical device failures, and could not find anything related to his inquiry. Shocked, Kwazneski consulted several prominent surgeons and discovered that approximately two-thirds had either experienced similar problems or were aware of someone who did.

Following Kwazneski’s inquiry, Kaiser Health News (KHN) launched an investigation that subsequently discovered that the FDA had granted an exemption to makers of surgical staplers that allowed them to sidestep MAUDE and file reports pertaining to device malfunctions in a secret repository. According to an article in the Miami Herald, since 2016 over 1.1 million incidents were diverted from the publicly available MAUDE and stored in this repository.

The FDA eventually confirmed the existence of a reporting-exemption program, as well as acknowledged thousands of instances of injury or device malfunctions that had never been made public. In 2018, the exemption program was nearly eliminated (they still remain in place for implantable defibrillators and pacemaker electrodes), resulting in an alarming slew of surgical stapler-related reports. For example, Medtronic analyzed reports of Covidien’s surgical staples and found 1,000 malfunctions in 2015 compared to 11,000 in 2018.

Another tool the FDA has handed device manufacturers is litigation complaint summary reporting, which allows manufacturers to file a single “summary” report with up to 1,175 individual patient injury reports attached. If one were counting the number of injuries related to a particular product, that summary report would emerge as a single injury. To put this in perspective, FDA records provided to KHN show that the program kept over 480,000 injuries or malfunctions from public view.

The FDA’s Solution: Reclassification

Hours after KHN’s investigative findings were published, the FDA sent a letter to healthcare providers that signaled their awareness of the rising number of medical device reports (MDRs) involving surgical staplers and surgical staples. The letter also outlined two safety precautions the agency is planning in the coming months: a public advisory hearing and a draft guidance with labeling instructions for manufacturers. According to the agency, the goal of each of these steps is to improve the safety of surgical staplers and implantable staples.

As of this writing, surgical staplers are regulated as Class I medical devices, meaning premarket submission to the FDA is not mandatory. Conversely, implantable surgical staples are Class II and require premarket review. The FDA is essentially considering reclassifying surgical staplers to Class II, which would enable the use of several key tools, such as strict performance testing, usability demonstrations, and labeling comprehension.

Looking to the Future

The Global Surgical Staplers market is expected to exceed $4 billion by 2024. This is largely due to the growing number of surgical procedures performed per diem, the rising popularity of medical tourism, various technological advancements, and the development of minimally invasive procedures. Given the severity of potential injuries, the lack of publicly available information, and current litigation trends, it is very likely that we will witness a slew of device-related mass-tort trials in the near future.