New Round of Essure Lawsuits Filed vs. Bayer Healthcare Pharmaceuticals, Inc in Pennsylvania Federal Court

“Bayer Facing New Litigation Over Essure Birth Control Device”

By Mark York (November 20, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS)  On November 2, 2017, fifty-three plaintiffs from Florida, Illinois, Texas and other states across the country have filed a lawsuit over allegations that Bayer’s Essure permanent female birth control device caused serious injuries. This filing is another in a series of ongoing Essure lawsuits against Bayer in different federal and state venues across the country, including the  Bayer Essure Litigation USDC Missouri Case No. 4:17-cv-00865.

The primary claims against Bayer, that upon insertion of the device, by insertiing micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage. However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.

Maria Gonzalez, Israel Gonzalez, and the other plaintiffs filed a multi-plaintiff complaint on Nov. 2 in the U.S. District Court for the Eastern District of Pennsylvania against Bayer Healthcare Pharmaceuticals Inc. alleging negligence and other counts under case number 2:17-cv-04936-JP, U.S. District Court for the Eastern District of Pennsylvania. Additionally there are other multi-plaintiff actions against Bayer, where Essure is the product in suit, see California JCCP Complex Litigation Docket consolidated Essure cases pending there, under Essure Product Cases and Actions, JCCP Proceeding No. 4887, Alameda County Superior Court.

According to the most recent federal complaint, the plaintiffs or their partners were implanted with defendant’s Essure device. They allege that the devices “migrated, fractured, punctured internal organs and/or caused other serious injuries.” The company has long been aware of the adverse events and concerns raised over the Essure products, but have yet to admit liability, and have vigorously defended all claims against the company and Essure.

The plaintiffs state that Bayer Healthcare Pharmaceuticals Inc. is responsible because the defendant “manipulated their reports to the FDA and presented false and misleading information, which, in turn, resulted in plaintiffs’ consent to implant not being informed because critical facts regarding the nature and quality of side effects from Essure were concealed from plaintiffs and their physicians,” as cited in the complaint.

The plaintiffs seek past and future general damages, economic and special damages, medical expenses, punitive and exemplary damages, court costs, interest and any further relief the court grants.

These 53 plaintiffs, combined with the other lawsuits filed in various courts across the country now total more than 1500 claims against Bayer, where women have asserted that the company was aware of the damage and healthcare risks of it’s Essure products, and has intentionally disregarded the ever growing evidence that shows the product to be dangerous. If Bayer Healthcare is taking the same position in this new round of claims as in others, plaintiffs will be in for a long and protracted legal fight, with Bayer being an unwilling party to come to the table for any worthwhile discussions. To follow this emerging litigation see Mass Tort Nexus Essure Litigation Case No. 2:17-cv-04936-RBS.

Case Docket: U.S. District Court for the Eastern District of Pennsylvania case number 2:17-cv-04936-JP

 

Read More

PA Superior Court Reverses Risperdal Defense Verdict as Court Strikes Janssen Pharmaceuticals Only Favorable Jury Verdict

“Johnson & Johnson Hit With Another Trial Verdict Reversal”

By Mark York (November 17, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS) The Superior Court of Pennsylvania reversed the single defense verdict reached in favor of Janssen Pharmaceuticals, the manufacturer of anti-psychotic drug Risperdal. The reversal and order for a new trial stemmed from a 2015 trial that resulted in the one Risperdal defense verdict to date. The case is part of the mass tort docket for Risperdal cases in the Philadelphia County Court of Common Pleas, (see RISPERDAL Case No 296 PHILADELPHIA COURT OF COMMON PLEAS BRIEFCASE), where more than 6,000 Risperdal cases are pending.

The 22-page unanimous Superior Court decision by Judge Jack Panella, reversed the Janssen defense win in the Risperdal trial where plaintiff William Cirba filed suit against Janssen Pharmaceuticals and lost, as well the subsequent denial of Mr. Cirba’s request for a retrial based on “erroneous evidentiary rulings.”

The ruling ordered a new trial and will now be limited to the issues of causation and damages.

LAYPERSON AT TRIAL IS NOT AN EXPERT

The Superior Court stated the trial court made a reversible error at trial, by allowing physician’s assistant Michelle Baker’s testimony to be weighed on the same level as that of a medical expert. Ms. Baker was involved in the treatment of Mr. Cirba from 2005 to 2013, as a physician’s assistant.

During the Cirba trial, a videotaped deposition from Baker was played in which she stated an opinion that Cirba’s gynecomastia (the development of breast tissue) was the result of “extreme weight gain” rather than negative side effects from Risperdal. Cirba had been prescribed the drug to treat oppositional defiant disorder.

Cirba’s counsel objected that it was improper that Baker’s layperson testimony was considered equal to that of an expert, since she was not designated or qualified prior to trial – while the defense believed Baker’s deposition did not cross over into expert testimony and “constituted permissible lay opinion testimony, as it was rationally based on her perception of plaintiff during treatment.” Which the Superior Court has obviously disagreed with.

The jury returned a verdict in favor of Janssen in March 2015, although the jury at that time believed Janssen failed to properly warn Cirba’s physicians of gynecomastia risks associated with Risperdal, it stopped short of finding Janssen negligent in directly causing Cirba’s gynecomastia.

The Superior Court sided with the plaintiff in believing admitting Baker’s testimony was an attempt to enter the realm of expert knowledge.

Defendants’ experts opined that weight gain rather than Risperdal ingestion caused plaintiff to appear to have gynecomastia. Baker’s testimony, in which she opined that plaintiff’s weight gain, rather than his Risperdal usage, caused him to appear to have gynecomastia, was causation testimony offered by a witness who personally treated the plaintiff” Panella said.

Panella added Baker’s opinion was “offered without the proper vetting and safeguards surrounding expert testimony.”

“Further, this opinion was introduced into evidence due to the trial court’s improper application of the law, which is clearly an abuse of discretion. Therefore, we find that the trial court abused its discretion in denying plaintiff’s request for a new trial, limited to the issues of causation and damages,” the panel stated, in reversing the judgment and remanding the case for further proceedings.

SAME PANEL STRIKES RISPERDAL SOL CLAIMS

In a separate 18-page ruling also issued Nov. 13, the exact same three-judge panel upheld the trial court’s striking down of arguments that the statute of limitations in two Risperdal cases, featuring plaintiffs Jonathan Saksek and Joshua Winter, should have been tolled until 2013.

Saksek and Winter were prescribed Risperdal in 1997 and 1998, allegedly began developing gynecomastia in 1998 and 2002, respectively, but didn’t file suit until 2014. Both plaintiffs brought suit after seeing television advertising connected to Risperdal litigation in 2013.

The defense agreed with the trial court that the statute of limitations mandated the grant of summary judgment, but contended if the discovery rule applied, it would have only tolled the statute of limitations until October 2006, when Risperdal’s prescribing label was changed to include a warning about gynecomastia.

In January 2015, Judge Arnold New granted a defense motion for summary judgment and ruled an applicable statute of limitations applied to both Saksek and Winter’s cases, feeling that they should have known of Risperdal’s gynecomastia-related injury risks by June 30, 2009.

Both plaintiffs appealed, and the appeals were consolidated, but the higher court agreed with the trial court.

“Plaintiffs were aware of their injuries when they began experiencing unexplained weight gain – and breast growth – after starting Risperdal treatment in 1998 and 2002. However, from 1998 and 2002 until 2013, when plaintiffs were notified of the commercial claiming a link between gynecomastia and Risperdal, they did nothing to uncover the cause of their unexplained breast growth and weight gain. Plaintiff cannot hope to establish that they acted with reasonable diligence, when they admit that they failed to act at all,” Panella stated.

Their breasts were there, and had been there, for years. And then, in October 2006, the label on Risperdal changed, expressly linking usage of the drug to gynecomastia. Their breasts were clearly not temporary by 2006. Accordingly, by that date, ‘reasonable minds would not differ in finding that’ plaintiffs knew, or should have known, of their injuries and the cause of those injuries by this point,” Panella added.

RULING AFFECTS OTHER CASES

Kline commented on the Superior Court’s statute of limitations ruling, indicating it could be far-reaching beyond merely the instant cases.

“We believe [this] harsh ruling, which may bar the claims of thousands of claimants who could not possibly have known of their gynecomastia injury and its cause, is legally and factually wrong. We plan to appeal further, seeking to reopen the courthouse doors to them,” Kline said.

Janssen’s stated:  “We are pleased the Superior Court affirmed Judge New’s ruling on the application of statute of limitations.

MASS TORT DOCKET GROWING

More than 6,400 Risperdal lawsuits – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over Xarelto  (See Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation PA State Court) and asbestos, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s. In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.

However, in 2017, the most recent CLC stats show that figure has jumped to an unprecedented 94 percent.

Appeal Docket: Superior Court of Pennsylvania case 2451 EDA 2015 & 576 EDA 2015

Trial Docket: Philadelphia County Court of Common Pleas case 130301803, 140200183 & 140301170

 

 

 

Read More

JOHNSON & JOHNSON ACCUSED OF WITNESS TAMPERING IN TWO DIFFERENT TRIALS CURRENTLY UNDERWAY

Does Win At Any Cost Apply to J&J Legal Strategy Even At Trial?

By Mark York (November 7, 2017)

 

 

 

 

 

(Mass Tort Nexus)  Federal Judge Edward Kinkeade has requested the US Attorneys Office and the Federal Bureau of Investigations (FBI) open an investigation and question witnesses regarding potential witness tampering in a currently underway DePuy Pinnacle hip implant trial. The trial is taking place in the US District Court of Texas in Dallas. The trial is the third bellwether trial in Multidistrict Litigation No. 2244, where thousands of plaintiffs have filed suit in the DePuy Orthopaedics MDL 2244 Pinnacle Hip Implant Litigation. The last trial resulted in a massive initial verdict of $1 billion, subsequently reduced by Judge Kinkeade to just over $500 million.

DePuy, a subsidiary of Johnson and Johnson, has been sued along with J&J for their metal-on-metal Pinnacle hip devices, due to the release of cobalt and chromium metals into a patient’s body, resulting in the onset of metallosis, pseudotumors, and other adverse medical conditions which require surgery to remove the defective device, as well as ongoing treatment to address the related side effects.

As to J&J’s alleged witness tampering, Judge Kinkeade stated the potential witness tampering was “disturbing and disconcerting to me”. The issue revolves around interaction between am upcoming trial witness Dr. David Shein and a sales representative for DePuy. Dr Shein claims that during a surgical procedure he was warned of business ramifications,  in connection with his planned appearance as a witness during the DePuy Pinnacle trial.

Lead plaintiff trial attorney Mark Lanier noted:

“It is extremely concerning to me when there are requirements under the federal law, as well as state law, that witnesses not be tampered with, that—that it’s a serious felony, that it involves prison time, that it cuts to the core of who we are as a people and what our courts are about”

In the other witness tampering allegation during a current trial, J&J subsidiary Janssen Pharmaceuticals is accused of interfering with a treating physician and witness in the just started Xarelto trial in the Philadelphia Court of Common Pleas, see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court). This trial is the first state court Xarelto trial, where plaintiff Lynn Hartman filed suit against Janssen and Bayer over claims that Xarelto caused a major gastrointestinal bleed. The trial start was delayed by word that a meeting took place between a key witness, Dr. Timothy Aldridge, the plaintiff’s treating physician, and a Janssen sales representative.

Hartman’s lawyers said that scheduled testimony from Dr. Aldridge had essentially changed from indicating that Hartman had suffered a gastrointestinal bleed complicated by Xarelto, to denying whether he knew Hartman had suffered from a gastrointestinal bleed and being hostile to Hartman’s attorney.

Janssen claimed the meeting was routine, but opposing counsel claims that this contact, as well as the DePuy Pinnacle trial witness contact show a pattern of interference and a willingness of Johnson & Johnson employees to attempt to influence legal proceedings in ways that are often consider illegal.

In unsuccessful legal maneuvering, J&J requested a gag order to prevent the public from knowing about the DePuy trial witness tampering issue, but the judge denied their request. Prior verdicts against DePuy for Pinnacle Hip Implant cases included jury awards of $1.4 billion and $498 million in the two prior bellwether trials. The Xarelto trial tampering issue is still being reviewed by the court.

 

 

Read More

Johnson & Johnson’s Ethicon Files Appeal in Court Ruling Where Defense Verdict in Mesh Trial Sidestepped By Judge

Plaintiffs Gets a Second Chance After Defense Trial Verdict

 

 

 

 

 

 

 

 

In another legal slam against Johnson & Johnson and their Ethicon mesh division, plaintiff Kimberly Adkins, who’s trial in June 2017 ended in a defense verdict, has been granted new life. In post trial pleadings, the judge granted the plaintiff’s petition for a hearing on damages, after determining that the jury findings had found the mesh was designed defectively, even though they entered a defense verdict. The manufacturer of the pelvic mesh involved, Ethicon Inc. (Ethicon), has appealed the judge’s ruling, when he ruled the matter can proceed to a damages hearing. In so doing, Ms. Adkins’ lawsuit, related to a TVT Secur mesh implant surgical deveice, has been revived, at least for the time being.
The primary defendant in the surgical mesh side effects lawsuit is Ethicon, a subsidiary of Johnson & Johnson, is now facing more than 100 lawsuits in the pelvic mesh mass torts currently consolidated in the Philadelphia Court of Common Pleas, Philadelphia. In what was the fifth case in the mass torts docket to go to trial, the jury on June 9 delivered for Ethicon, with what was  defendant’s first win in the 5 cases heard to date. Ethicon faces many thousands of other mesh lawsuits in federal and state courts across the country, and to date, have mounted vigorous defense in all cases.

Shortly after the defense verdict, Ms. Adkins’ trial team responded with a post-trial motion asserting that the jury’s findings were inconsistent with regard to the issue of whether or not a design defect, alleged in the surgical mesh complications lawsuit (a defect acknowledged by the jury) had been the cause of injuries to Adkins. They also stated that she was entitled to a review of the claim for damages based on the jury design defect determination.

The focus by plaintiffs is, that the jury had determined the Ethicon TVT-Secur mesh implanted in Adkins had, indeed been designed with certain defects. But in their verdict determination, by failing to identify that the product that may have caused Adkins’ injuries went against the weight of the evidence.

Adkins’ post-trial petition found merit with the judge in the Philadelphia Court, who revived the surgical mesh lawsuit in July and directed that the case be set for a hearing related to damages.

Ethicon promptly filed an appeal of the judge’s ruling with the Pennsylvania Superior Court. A spokesperson for Ethicon, Kristen Wallace, said in a statement that the trial jury in the Philadelphia Court of Common Pleas had, indeed determined that the Ethicon surgical mesh had not been the cause of the plaintiff’s injuries.

“We have filed an appeal to the Superior Court solely regarding the court granting a new hearing on damages, because we believe that it was not right to set aside what the jury decided,” Wallace said.

Adkins’ legal team announced it would be opposing the appeal, noting that any further delays incurred by Ethicon’s now standard legal strategy of appealing all rulings to delay final determination, will only delay the final determination of damages being awarded to the plaintiff, for the harm, and suffering experienced after she received the Ethicon TVT Secur mesh implant.

The primary plaintiff claims are that Adkins suffered extensive post-surgical injuries, when the Ethicon TVT Secur implant eroded into the plaintiff’s vaginal canal, causing Adkins severe and ongoing pain, after a portion of the surgical mesh was removed by way of follow up surgical procedure in September, 2012 – however the pain continued. even in the aftermath of the revision surgery. The plaintiff has been unable to return to the pre-implant active lifestyle she enjoyed including being unable to enjoy normal sexual relations with her partner of 20 years.

Ms. Adkins initially filed her complaint related to surgical mesh complications in July, 2013. The case is Kimberly Adkins v. Ethicon Inc. et al., Case No. 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

Read More

DePuy Pinnacle Hip Implant Trial Set for Today Delayed Based on Appellate Ruling of “Grave Error” By Sitting Judge

DePuy Pinnacle Hip Implant Bellwether Trial Set For September 5th Delayed After Appeals Court Cites Grave Error By Judge

 

 

 

 

 

DePuy Orthopaedics, Inc a subsidiary of Johnson & Johnson

By Mark A. York (September 5, 2017)

Federal Judge Ed Kinkeade has delayed the next DePuy Pinnacle hip implant bellwether trial that was set for today, Sept. 5, 2017 until later this month after a split federal appeals panel requested that he halt the proceedings due to a “grave error.”

In the August 31st opinion, two of three judges on a panel of the U.S. Court of Appeals for the Fifth Circuit refused to grant a petition for writ of mandamus filed by DePuy Orthopaedics Inc. to halt the trial. But two of the three also concluded that U.S. District Judge Ed Kinkeade, who is presiding over 9,300 cases alleging DePuy’s Pinnacle hip implants are defective, committed a “grave error” in allowing certain trials to take place before him, including the one scheduled this month on behalf of eight New York plaintiffs.

Opinion Outline

The opinion stated “despite finding serious error, a majority of this panel denies the writ that petitioners seek to prohibit the district court from proceeding to trial on plaintiffs’ cases,” wrote Circuit Judge Jerry Smith. “A majority requests the district court to vacate its ruling on waiver and to withdraw its order for a trial beginning September 5, 2017.”

Skadden, Arps, Slate, Meagher & Flom lead counsel for Johnson & Johnson, DePuy’s parent company, called on Judge Kinkeade to halt the trial, which is the fourth bellwether in the multidistrict litigation over the DePuy Pinnacle hip implant. This may help DePuy and J&J avoid a repeat of the last Pinnacle verdict in the prior bellwether trial where a Dallas jury awarded over $1 billion in damages, subsequently reduced by Judge Kinkeade, see DePuy Pinnacle Hip Implant Dec 2016 Trial Verdict Halved to Just $500 million in December 2016, which DePuy-J&J are appealing.

“We are pleased that the Fifth Circuit has determined that the MDL court does not have jurisdiction to conduct its planned trial of the claims of eight New York plaintiffs in a Texas courtroom,” Beisner wrote in an emailed statement after the ruling.

Plaintiff Counsel Surprised

Lead plaintiffs attorney Mark Lanier called it the “wildest opinion I’ve ever seen.”

“What this small panel has tried to do is change the law in the Fifth Circuit on a mandamus record, and that’s really frowned about,” said Lanier, of The Lanier Law Firm in Houston, who was joined in the appeal by former U.S. Solicitor General Kenneth Starr.

In addition to this month’s trial, the ruling could impact a separate case before the Fifth Circuit in which Johnson & Johnson has raised the same venue arguments in appealing a $1.04 billion verdict in the most recent Pinnacle trial. Oral argument on that appeal hasn’t yet been scheduled.

“Why this court issues an order on another court’s case, which is just an advisory opinion, is just absurd,” said Lanier. “It’s judicial activism.”

Lanier filed a petition for rehearing en banc on Friday. Later that afternoon, Kinkeade ordered the trial delayed until Sept. 18.

Final Bellwether trial

Kinkeade appeared to anticipate the Fifth Circuit’s intervention. On Aug. 25, he ordered that this month’s trial would “be the final bellwether case tried in the Dallas division of the Northern District of Texas” under which both sides have waived venue.  This was an unexpected ruling for the Pinnacle litigation, where Johnson & Johnson has appealed two other verdicts in Kinkeade’s courtroom, both involving consolidated cases that led to major awards in 2016,. Johnson & Johnson won the first verdict in 2014. But a second trial ended with a verdict of $502 million awarded to five Texas plaintiffs, while the third gave $1.04 billion verdict to six California plaintiffs.

All DePuy Hip Implant Litigation

These cases are part of the 8,707 actions consolidated before Judge Kinkeade in MDL 2244, In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, Case No. 3:11-md-02244, Northern District of Texas in Dallas.

Juries have found that DePuy and J&J have negligently designed the hip implant, failed to warn surgeons about dangerous conditions related to the implant, and concealed its risks. J&J stopped selling the devices in 2013 after the FDA issued a safety communication about artificial-hip damages.

Separately, DuPuy is facing 1,458 product liability actions consolidated before US District Judge Jeffrey J. Helmick in MDL 2197, In re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation in Toledo, Ohio.

J&J prevailed in the first Pinnacle hip case to go to trial in October 2014 after a jury rejected a Montana woman’s claims that the devices were defective and gave her metal poisoning. In March 2016, a Dallas jury ordered J&J to pay $502 million to a group of five patients who accused the company of hiding defects in the hips. A judge cut that verdict in July to about $150 million.

DePuy Claims “Lexecon” Error

DePuy and Johnson & Johnson have argued that Kinkeade lacked jurisdiction over the trials involving California and New York plaintiffs. MDL judges are assigned to oversee pretrial matters with the intention of sending cases back to their original courts for trial. But defendants often waive that right under the U.S. Supreme Court’s 1998 holding in Lexecon v. Milberg Weiss Bershad Hynes & Lerach, which allows bellwether trials to proceed before an MDL judge.

Johnson & Johnson claims it waived that right as to the first and second trials, but not the third or fourth. Plaintiffs’ attorneys have insisted that Johnson & Johnson agreed to a global waiver over all the trials.

Mass Tort Nexus will provide additional details of the ongoing trial dispute as information becomes available.

 

 

 

Read More

FDA Safety Notice Letter “Recommends The Continued Use Of Forced Air Thermal Regulation Systems During Surgery”

Does the August 30, 2017 FDA Medical Device Safety Notice Letter Impact the BAIR HUGGER MDL 2666 FORCED AIR WARMING DEVICES Litigation? 

3M™ Bair Hugger™ Blanket System

 

 

 

 

 

 

 

 

US Food & Drug Administration Healthcare Provider Notice, August 30, 2017

FDA Safety Information Notice: Forced Air Thermal Regulating Systems: Healthcare Provider Letter – Information About Use

08/30/2017 – Dear Health Care Provider Letter – FDA]

AUDIENCE: Surgery, Nursing, Anesthesia

ISSUE: The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

BACKGROUND: Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements.

RECOMMENDATION: FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

FDA Medical Device Safety Notice

“Official Notice Letter”

 Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers

August 30, 2017

Dear Health Care Provider,

The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements

As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

FDA ACTIONS

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration

 

Read More