Philadelphia County Court of Common Pleas Judge Arnold New denied GlaxoSmithKline‘s motions on July 12 to lift a stay on litigation over birth defects allegedly caused by the antidepressant Paxil, according to Law360.
The court entered the stay on April 21 over the mass tort litigation until an appeal is decided in the initial case, Rader et al. v. SmithKlineBeecham Corp. et al.
Braden Rader was born with tetralogy of fallot, a combination of several congenital heart defects, allegedly caused by his mother’s use of Paxil during her 2003 pregnancy.
GSK argued unsuccessfully that the stay should be lifted because the other Paxil cases (see below) have dispositive issues that are unconnected to the Rader decision, according to Law360. It also argued that the stay does not advance a timely resolution of the litigation.
Court Term & No.
In Re: Paxil Pregnancy Cases
Stayed By Order Of Court
Moore, Deceased Etal Vs Smithkline Beecham Corpor
Stayed By Order Of Court
Nieman Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court
Powell Etal Vs Smithkline Beecham Corporation Etal
A total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.
The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
2 billion to resolve its civil liabilities with the federal government under the False Claims Act. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.
The FDA is alerting healthcare professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan.
The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
Burkholderia cepacia is the name for a group or “complex” of bacteria that can be found in soil and water. The bacteria are often resistant to common antibiotics. Burkholderia cepacia poses little medical risk to healthy people; however, it is a known cause of infections in hospitalized patients. People with certain health conditions, like weakened immune systems or chronic lung diseases (particularly cystic fibrosis), may be more susceptible to infections with Burkholderia cepacia, according to Outbreak News Today.
In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue to identify other potentially contaminated liquid docusate sodium products.
PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles. The FDA joins the CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.
In June, a multi-state outbreak of Burkholderia cepacia infections started. These infections have occurred primarily in ventilated patients without cystic fibrosis and who are being treated in intensive care units.
Rugby Laboratories is a leading provider of Over the Counter, vitamin, and nutritional supplement products. “With more than 40 years of history, Rugby® has a comprehensive portfolio of products designed to enhance the quality of life for our consumers while reducing the cost of purchasing their medications,” its website states.
“Because of the high volume of telephone attendance, counsel attending by telephone should endeavor to minimize background noise and other interference during the call. Counsel should normally mute their telephones, so that they can hear the proceeding but other participants will not hear any unwanted noise or interference. Counsel should also avoid placing the Court on hold, which may have the unfortunate effect of playing “hold” music to all participants and throughout the courtroom. The cooperation of all counsel in observing these requirements is greatly appreciated,” he wrote
Plaintiffs accuse GlaxoSmithKline of concealing information tying Zofran to birth defects. They assert:
That since 1992, the company has received hundreds of reports of children who were born with serious abnormalities following pre-natal exposure to the drug.
That as early as 2006, studies have suggested that Zofran crosses the placental barrier in significant amounts when taken by pregnant women, which may potentially harm a developing fetus.
That Zofran has never been approved to treat pregnancy-related nausea and vomiting, and accuse Glaxo of improperly marketing the medication for this purpose.
In 2012, the drug maker agreed to pay $3 billion to resolve illegal marketing charges with the U.S. Department of Justice that involved a number of its medications. Among other things, the company had been accused of illegally promoting Zofran as an off-label treatment for morning sickness.
Fraudulent marketing campaign
In Flynn v. GlaxoSmithKline, the plaintiffs charge that because of GSK’s fraudulent marketing campaign, Zofran was placed into the hands of unsuspecting pregnant women throughout the US. These women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea
In contrast, GSK knew that Zofran was unsafe for ingestion by expectant mothers. In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformities in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta and exposed fetuses in substantial concentrations. GSK did not disclose this information to pregnant women or their physicians.
The drivers in multidistrict litigation who charge that GM’s ignition switch defect cover-up devalued their vehicles, wrote a letter to US District Judge Jesse M. Furman that separate rulings by the Second US Circuit Court of Appeal are sufficient to defeat GM’s bid to kill their third amended complaint, according to Law360.
The Second Circuit ruled on July 13, 2016 that General Motors’ 2009 bankruptcy does not shield it from lawsuits over a deadly ignition-switch defect that led to criminal charges against the automaker and prompted the recall of 2.6 million vehicles in 2014.
The Manhattan Appeals Court held that barring plaintiffs from suing GM over crashes and lost vehicle value stemming from the faulty switch would violate their constitutional rights to due process, because they had not been notified of the defect prior to GM’s bankruptcy.
Faulty ignition switches
The ruling effectively rebuffs GM’s attempts to block hundreds of customer lawsuits over faulty ignition switches, and other vehicles components, on grounds that they were automatically barred by the company’s 2009 bankruptcy sale to a new corporate entity, according to Reuters.
New GM falsely promoted all of its vehicles as safe, reliable, and high-quality.
New GM’s advertising and marketing literature falsely claimed that new GM placed safety and quality first.
New GM was aware of the Delta Ignition Switch Defect from the date of New GM’s inception.
New GM continues to conceal the ignition switch defect.
New GM received many complaints of power failures in the Delta Ignition Switch Vehicles.
“New GM was aware of these problems year after year and nationwide, as reflected not only by the internal documents reflecting knowledge and cover-up at high levels, but in the thousands of customer complaints, but also, and not by way of limitation, by New GM’s internal complaint logs and other documents,” the third amended complaint states.
Ischemic Stroke Cases Instituted By The Filing Of Long Form Complaints
All Plaintiffs who have previously filed Xarelto cases alleging ischemic stroke using a long form complaint shall file a Second Amended Long Form Complaint in the form within 20 days of this Order.
Expert John Ray, a leading consultant to the Mass Tort industry, explained the significance, saying, “these ischemic stroke cases are related to Xarelto being marketed as a one-time per day drug. All that the drug manufacturers did was double the dose and say you only need to take it once per day. They did this for a marketing advantage.
“The problem is that the patient is over-anticoagulated the first half of the day and under-anticoagulated the remaining time before next dose. This leaves the patient unprotected from what Xarelto is suppose to protect them from for the last half of the dose day and more likely to bleed in the first half of the day.”
The defendants in the state litigation include:
Janssen Research & Development LLC
2. Janssen Pharmaceuticals. Inc.
3. Janssen Ortho LLC
4. Johnson & Johnson.
5. Bayer Healthcare Pharmaceuticals. Inc.
6. Bayer Pharma AG.
7. Bayer Corporation.
8. Bayer Healthcare LLC.
9. Bayer Healthcare AG.
10. Bayer AG.
The Second Amended Master Long-Form Complaint and Jury Demand will substitute for and supersede all Complaints filed in individual Xarelto cases pending in the Philadelphia County Court of Common Pleas.
Defendants (other than those relieved from any answer obligation under CMO-3
shall have 60 days from the entry of this Order to answer or plead to the Second Amended Master Long-Form Complaint.
Short-Form Complaint–Previously Filed Cases
All Short Form Complaints previously filed on or before the date that the Clerk files the Second Amended Master Long-Form Complaint and Jury Demand pursuant to this Order are hereby deemed to incorporate the Second Amended Master Long-Form Complaint and Jury Demand without the need of any plaintiff to take any action to amend their Short Form Complaints that already been filed in this case.
Short-Form Complaint–Newly Filed Cases
All Xarelto cases filed after the date of this Order shall be instituted by the filing of a Writ of Summons or a Second Amended Short Form Complaint. If suit is instituted by a Writ of Summons, the Writ of Summons must denote the case to be part of this Mass Tort Program and any named Defendant may file a Rule to File a Complaint, which shall apply to the benefit of all named Defendants.
“This is very important news,” Ray said. “The Ischemic Stroke claims, often referred to as ‘efficacy’ claims, cannot be brought in the Federal multidistrict litigation docket (MDL) because the argument was not made there. Only hemorrhagic strokes can be brought in the federal MDL.”
A jury in Philadelphia ruled on July 8 that the antipsychotic drug Risperdal caused a Tennessee boy to grow breasts and imposed a $70 million verdict on its manufacturer, Janssen Pharmaceuticals.
Lawyers for the boy argued that scientists for the company were well aware of the risks and sought to downplay them. The company disputed that allegation during the Common Pleas Court trial and said that physicians were fully informed of potential side effects.
It was the fifth Risperdal lawsuit tried in Philadelphia, and by far the largest verdict so far. Earlier verdicts ranged from $500,000 to $2.2 million. the jury also found that Janssen “intentionally falsified, destroyed or concealed records.” That finding is necesdsary for plaintiffs to recover more than the $750,000 damages cap that Tennessee law imposes on noneconomic damages.
The products liability action, Case C.P. Philadelphia No. 130402094, was heard before Judge Paula Patrick.
Plaintiffs Counsel was Jason Itkin, Arnold & Itkin in Houston. Defense Counsel was David Abernethy, Drinker Biddle & Reath in Philadelphia. A spokeswoman for Janssen said the verdict went against the evidence, and the company will seek an appeal.
Lawyers for the plaintiff demonstrated that Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson, attempted to downplay the risks of the drug causing gynecomastia, a condition in which boys develop female breast tissue. While the drug was initially approved for a small market, those suffering from bipolar and schizophrenia related disorders, Janssen reportedly worked to expand doctors’ recommendations of the drug to include treatments for dementia, behavioral problems, and autism. At the time the plaintiff began taking the drug the Food and Drug Administration (FDA) had only approved it for adult use.
Drug and medical device company B. Braun Medical Inc. of Germany today agreed to pay $4.8 million in penalties and forfeiture and up to an additional $3 million in restitution to resolve its criminal liability for selling contaminated B. Braun pre-filled saline flush syringes in 2007, the Department of Justice announced today.
The saline syringes had a B. Braun label but were manufactured by another company. Braun bought syringes from AM2PAT, which were contaminated with Serratia marcescens bacteria, which can cause blood infections.
B. Braun, a medical device manufacturer, has global headquarters in Melsungen, Germany, and corporate headquarters in Bethlehem, Pennsylvania, with primary manufacturing facilities in Allentown, Pennsylvania, and Irvine, California.
Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, said, “Companies must take reasonable steps to ensure that their suppliers are making quality products that help rather than harm patients. Today’s settlement shows that the government will continue to hold companies accountable for failing to fulfill this critically important responsibility.”
“Patients were infected by adulterated syringes distributed by B. Braun,” said Acting U.S. Attorney John Stuart Bruce for the Eastern District of North Carolina. “This agreement helps to give justice for the victims and to deter such future conduct by distributors of medical devices.”
In March 2006, B. Braun started buying B. Braun saline syringes from AM2PAT, Inc. (AM2PAT), which manufactured the syringes at a small facility in North Carolina. The saline solution in pre-filled saline flush syringes must be sterile because it can enter a patient’s bloodstream when the syringes are used to flush out or clean medical devices that provide access to a patient’s veins, such as central lines, ports and short peripheral catheters.
As noted in the statement of facts, B. Braun was aware of manufacturing problems at AM2PAT, even before it began purchasing syringes from AM2PAT.
In separate audits, both the FDA and B. Braun had found that AM2PAT was having problems complying with current good manufacturing practices. Although AM2PAT addressed some of these initial problems, other problems persisted.
AM2PAT notified B. Braun that AM2PAT intended to move to a new manufacturing facility in the spring of 2007, and change the company that would sterilize the B. Braun saline syringes through a new radiation sterilization process. Sterilization, a vital step in the manufacture of these syringes, can be complex.
Before B. Braun’s quality department approved either of these changes, B. Braun began selling B. Braun saline syringes made at AM2PAT’s new facility and sterilized by the new sterilization company. B. Braun later approved both of these changes even though B. Braun had already received complaints about the syringes changing colors and information from AM2PAT that it was making changes to its radiation process to avoid “overcooking” the syringes.
B. Braun approved AM2PAT’s facility move without ever seeing AM2PAT’s operations at its new facility or confirming AM2PAT’s representations that it had properly validated its clean room and equipment after the move.
Dangerous white particles and bacteria
Less than two months after B. Braun started selling syringes that AM2PAT made at its new facility with the new sterilization company, B. Braun recalled all of them because the radiation sterilization process caused dangerous white particles to develop in the saline inside the syringes.
After the recall, AM2PAT told B. Braun that it gave B. Braun incorrect information about its new radiation sterilization process. It also sent B. Braun information showing that AM2PAT moved manufacturing equipment to its new facility without validating that the equipment worked as expected after the move. As explained in the statement of facts, even with this new information, B. Braun resumed buying B. Braun saline syringes from AM2PAT without going to AM2PAT’s new facility.
Less than a month after B. Braun resumed buying syringes from AM2PAT, AM2PAT manufactured B. Braun saline syringes contaminated with Serratia marcescens bacteria. S. marcescens can cause blood infections. These contaminated syringes infected patients in California, Texas, New York and Nebraska. The syringes were recalled.
B. Braun admits syringes were adulterated
In the government’s non-prosecution agreement with B. Braun, B. Braun admits that it distributed B. Braun-labeled syringes that were adulterated under the FDCA.
Under the terms of the agreement, B. Braun will increase oversight of its product suppliers by conducting on-site audits of companies that design and make finished products that bear the B. Braun name on the label or logo and testing such products for sterility, identity and purity, as appropriate, on a periodic basis.
B. Braun will also be monitored by an independent compliance auditor during the term of the agreement. The auditor will assess B. Braun’s implementation and maintenance of the enhanced compliance measures through on-site audits of B. Braun. B. Braun’s chief executive officer and board of directors will also check and certify B. Braun’s compliance efforts on an annual basis.
“Americans expect and deserve medical devices that are safe, effective, and that meet standards for quality,” said Director George M. Karavetsos of FDA’s Office of Criminal Investigations. “Today’s announcement should serve as a reminder of the FDA’s continued focus on companies that put profits ahead of the public health.”
Today’s settlement with B. Braun follows the earlier, related prosecution in the Eastern District of North Carolina of AM2PAT and three people who worked at AM2PAT. In 2008, Ravindra Kumar Sharma, AM2PAT’s quality control director and Aniruddha Patel, AM2PAT’s plant manager, both pleaded guilty to criminal informations charging conspiracy to commit a number of federal offenses including felony violations of the FDCA. Both were sentenced in 2009 to 54 months in prison. AM2PAT and its former president, Dushyant Patel, were indicted on similar charges in 2009. Patel fled the country and is currently on FDA’s Office of Criminal Investigations’ “Most Wanted” list.
Diagnostics company Alere Inc. announced a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR blood Monitoring Systems.
Patients taking blood thinners like Coumadin, Jantoven, Warfilone (warfarin), Pradaxa (dabigatran), Xarelto (rivaoxaban), or Lovenox (enoxaparin), can to monitor their blood levels at home instead of at a lab, by using the Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips (collectively the Alere INRatio Monitoring System) to monitor their international normalized ratio (INR) while undergoing anticoagulation therapy.
The monitor is supposed to perform a simple blood test, letting a patient and doctor doctor know if the medication is working properly or if a dose adjustment is needed.
Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.
FDA: Not effective
The FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.
Alere seeks an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. The FDA suggest that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.
In other news, Alere Inc. was hit with a securities fraud lawsuit on April 22, accusing it of artificially inflating its share prices ahead of the Feb. 1 announcement of its proposed $5.8 billion acquisition by Abbott Laboratories Inc.
The shareholder lawsuit, filed in federal court in Boston, accused Alere of misleading investors by stating that its financial reporting followed generally accepted accounting principles. The plaintiffs, a group of individual investors, cited a federal probe into the company’s accounting for overseas sales in arguing that Alere had not adhered to those principles.
In Pretrial Order #10A, US District Judge Eldon Fallon allowed plaintiffs who have not already served Bayer Pharma AG or Bayer Healthcare Pharmaceuticals Inc. (Bayer defendants) whose cases have already been docketed in Xarelto MDL 2592 an additional 90 days (to September 21, 2016) to serve the Complaint with a Summons.
The court further other that the plaintiffs whose cases are not docketed Xarelto MDL 2592 upon the entry of the June 23, 2016 order, but are docketed on or before July 11, 2016, shall have 90 days from the docketing of the Complaint in the MDL to serve the Complaint with a Summons.
The purpose is to streamline service on the Bayer defendants. As of June 15, 2016, there were 5,853 lawsuits consolidated for pretrial proceedings in MDL 2592, according to the Judicial Panel on Multidistrict Litigation.
Litigants charge Bayer and Janssen failed to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily, according to the Pennsylvania Record. Risks which the plaintiffs say, allegedly, would be greatly decreased if the drug was taken twice daily and monitored properly.
Before the main cases reach federal courtrooms, 40 bellwether cases are being selected as a result of Case Management Order #4 issued on December 17, 2015. These bellwether actions will enable litigants and counsel to see how jury panels react to evidence presented.
Other defendants include Janssen Research & Development LLC F/k/a Johnson and Johnson Pharmaceutical Research and Development Llc, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc. F/k/a Janssen Pharmaceutica Inc. F/k/a Ortho-Mcneil-Janssen Pharmaceuticals, Inc., Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma Ag, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare Ag, and Bayer Ag.
A federal judge consolidated a new class action lawsuit — brought by patients in 16 states against C.R. Bard, Inc., makers of the defective Bard IVC Filter — into a multidistrict litigation docket in Arizona.
Lied to the government about the widespread extent of patient deaths and adverse events.
Lied to its own sales force about the dangers of the medical device to preserve its market share and to boost its stock price.
Repeatedly introduced new models that had the same design and manufacturing defects as the older models.
Used a regulatory shortcut to bypass the FDA’s more rigorous approval process for new devices, and obtained “clearance” under Section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act
Tragically, it took the FDA 10 years to issue a safety communication stating on May 6, 2014 that “the risk of having an IVC filter in place is expected to outweigh the benefits.” Later that year the FDA started a nine-month investigation and issued two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC-filters facilities.
The case is Maria E. Barraza v. C.R. Bard, Inc., and Bard Peripheral Vascular, Inc., Case 2:16-cv-01374-DGC. The lead attorneys are Ramon R. Lopez of Lopez McHugh in Newport Beach, CA, and Wendy R. Fleishman of Lieff Cabraser Heimann & Bernstein of New York.
In a Master Answer, Bard denies that there is any factual or legal basis for relief.
The plaintiffs are seeking an injunction to create a court-supervised medical monitoring fund for plaintiffs. It would pay for:
A notice campaign to all class members informing them of the availability and necessity of the medical motoring protocol
A “catheter venography” to be performed on every class member who still has a Bard IVC filter installed by an interventional radiologist who will consult with the class member’s physician within 60 days to decide if retrieval is clinically necessary.
Also the plaintiffs seek +$5 million in damages for negligent design and manufacture, and fraudulent concealment of dangers Bard was aware of.
The lawsuit outlines the history of IVC filters that Bard rolled out:
Recovery Filter System, launched in 2004
G2 Filter System (permanent), launched in 2005
G2 Express System (removable), launched in 2008
Eclipse Filter System, launched in 2010
G2X System, launched in 2011
Meridian Filter System, launched in 2011
Denali Filter, launched in 2013
“The design of the Meridian is based on the Eclipse filter, which, in turn, is based entirely on the G2 filter, which, in turn, is based on the Recovery Filter,” the complaint says. All the “IVC filters were fracturing, perforating, migrating, and/or tilting in the patients in which they were implanted.”
“These devices are potential ticking time bombs implanted in unsuspecting patients.” An IVC filter is designed purportedly to filter or “catch” blood clots that travel from the lower portions of the body to the heart and lungs.
Patient injuries include:
Cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart)
Cardiac arrhythmia and other symptoms similar to myocardial infarction
To rush the devices to the market, Bard repeatedly used the Section 510(k) shortcut to get a “clearance,” from the FDA, claiming the filter was substantially similar to its existing device. A 510(k) review is completed in an average of 20 hours by the FDA.
Bard avoided the more rigorous “premarket approval” (PMA) process, which must include data sufficient to demonstrate that the IVC Filters is safe and effective. The FDA takes 1,200 hours to complete a PMA review.
Section 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed quickly.
Once placed on the market, Bard immediately became aware of numerous confirmed events where its Recovery filter fractured, migrated, or perforated the inferior vena cava, caused blood clots, and caused serious injury, including death. About a month after the full-scale launch of the Recovery filter, on February 9, 2004, Bard received notice of the first death associated with this filter.
On July 9, 2004, a Bard safety analysis found that the Recovery filter had a reported failure rate that was 28 times higher than all other IVC filters. Peer-reviewed medical literature found that among 363 patients implanted with the Recovery filter and 658 patients implanted with the G2 filter, the devices experienced fracture rates of 40% and 37.5%, respectively, after five and a half years.
A review of the FDA MAUDE database from 2004 through 2008 shows that Bard IVC Filters are responsible for the following percentages of all IVC filter adverse event reports:
50% of all adverse events
64% of all occurrences of migration of the IVC Filters
69% of all occurrences of vena cava wall perforation
70% of all occurrences of filter fracture.
Instead of pulling the Recovery filter off the market, Bard started a coverup. By April of 2004, at least three deaths had been reported to Bard. The company concealed this information from doctors and patients and hired the public relations firm Hill & Knowlton to address anticipated publicity that could affect stock prices and sales.
Bard lied to its own sales force to keep pushing the IVC filters. By December 2004, Bard’s own internal safety procedure deemed the Recovery filter not reasonably safe for human use. Yet the company gave mandatory scripts to its Bard IVC filter sales force, which required salespeople to falsely tell physicians that the Recovery filter was safe because it had the same reported failure rates as all other filters, according to the complaint.
Meanwhile Bard gave false information to the FDA’s MAUDE adverse-events database. The FDA discovered that Bard had reported multiple serious injuries and a death as non-injurious “malfunctions.”
FDA finally acts
In 2010, the FDA issued an advisory to physicians and clinicians noting that it had received 921 device adverse event reports involving IVC filters. But the FDA said only that it was “concerned” about the retrievable IVC filters. It recommended that physicians consider removing the filter as soon as protection from a pulmonary embolism is no longer needed.
In 2014, the FDA issued Bard two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC filter facilities. An audit showed that Bard had underreported 274 out of 939 adverse events.
Finally, on May 6, 2014, the FDA issued an updated safety communication about IVC filters. The FDA reported that “the risk of having an IVC filter in place is expected to outweigh the benefits.”
Accordingly, the plaintiffs’ proposed Medical Monitoring Protocol aims to reduce complications by aiding in the detection and remediation of any malfunction and also generally provides awareness of the issue so it can be investigated. Without this protocol, many if not most patients implanted with these IVC Filters will not even be aware of the serious risk they are in.