Boston Scientific Pelvic Mesh Cases Removed From Philadelphia Court of Common Pleas Based on SCOTUS “Plavix” Ruling

Boston Scientific Mass Tort Mesh Cases Removed From Philadelphia Court of Common Pleas Based On Recent Supreme Court  June 2017, Bristol Myers vs. California Superior Court “Plavix” Ruling

 

 

 

 

 

 

Boston Scientific, Marlborough, MA

By Mark A. York (September 7, 2017)

Plaintiffs who filed suit against Boston Scientific in a Philadelphia court over allegedly defective pelvic mesh, have agreed to have their cases removed from the Pennsylvania Court to other venues based on the June 2017 “Bristol-Myers California Plavix” U.S. Supreme Court opinion.  The Plavix ruling has thrown thousands of non-resident drug and medical device state court cases across the country into turmoil, as the non-resident plaintiffs cannot continue their cases in state courts where they do not reside or the defendant companies are not corporate residents.  This was based on the Supreme Court ruling that stated Bristol-Myers R&D and sales activity in the State of California related to it’s Plavix blood thinner, (see Mass Tort Nexus “Plavix” CA State Court Briefcase) was not enough of a corporate presence to subject them to California state court jurisdiction, resulting in jurisdictional issue across the country for plaintiff firms.

Last month, Boston Scientific filed motions asking the court to remove any cases pending against it in the Philadelphia Court of Common Pleas, citing the Supreme Court’s both the “Bristol-Myers Squibb v. Superior Court of California”, see US Supreme Court Strikes Down State Court Jurisdiction and “BNSF Railway v. Tyrrell”, see SCOTUS Limits What State Court A Corporate Defendant Can Be Sued In.

According to one of the lead attorneys, the parties have agreed to litigate the cases in either Massachusetts, where Boston Scientific has its principal place of business, or in Delaware, it’s state of incorporation.

Kline & Specter attorney Shanin Specter said. “An agreement was reached with Boston Scientific to have the cases heard in a courtroom other than the Philadelphia Court of Common Pleas, so the cases can move forward and litigate without the jurisdictional issue creating legal issues. Although Boston Scientific’s motion last month sought to remove 94 cases, Specter said only three cases had been moving forward against Boston Scientific with calls placed to Boston Scientific defense counsel Shook, Hardy & Bacon and attorney Joseph Blum seeking comment have not been returned.

Judge New Asked to Reconsider

Last month, Boston Scientific had filed a motion requesting Philadelphia Court of Common Pleas Judge Arnold New reconsider his March 2015 decision that the state court had jurisdiction over the mesh cases.  New, who is the supervising judge of Philadelphia’s Complex Litigation Center, issued a one-page order saying Boston Scientific’s motion was moot.

As part of the motion, Boston Scientific had sought to have New’s 2015 ruling vacated to allow for additional arguments on the issue, and allowing defense counsel to begin pleading the removal of thousands of other non-resident plaintiff cases currently in in the court’s complex litigation docket.

Ethicon Mesh Motion for Removal

Another major defendant in over one thousand pelvic mesh mass cases , Johnson & Johnson subsidiary Ethicon, has also filed motions recently seeking to have the cases dismissed based the Supreme Court’s recent decisions. Plaintiffs, however, have requested Judge New pend any rulings on these issues, based on the Pennsylvania Superior Court has agreed to consider the matter in a case that is pending before the intermediate court on appeal.

The Supreme Court’s ruling from June 19, 2017 in Bristol-Myers vs. Superior Court of California (see US Supreme Court Denies California State Court Jurisdiction) now seen as the defining game-changing decision, for mass torts in state courts, that has promised to reshape the geography of mass tort litigation across the country. In the ruling, a majority of the Supreme Court determined that plaintiffs suing Bristol-Myers Squibb in California who were not California residents had failed to establish specific jurisdiction over the pharmaceutical giant, since there was no significant link between the claims and Bristol-Myers’ conduct in California. The ruling, according to observers, makes clear that out-of-state plaintiffs can’t sue companies in states where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury.

Johnson & Johnson Files For Missouri Removals

Earlier this month, J&J filed a motion in Missouri seeking to dismiss more than 1,300 lawsuits against it over talcum powder, claiming the lawyers had engaged in “blatant forum shopping on a grand scale.” On June 19, 2017 St Louis City Court Judge Rex Burlison declared a mistrial in the fifth talcum powder cancer trial being heard there, which was the afternoon of the SCOTUS “Plavix” ruling, declaring that the opinion earlier that day prevented the trial from moving forward. The trial was reset for October 2017, and the parties are currently arguing the jurisdictional issues of resuming the trial in front of Judge Burlison, see Mistrial Declared in J&J Talc Trial Due to SCOTUS Ruling.

Boston Scientific Argument

In requesting reconsideration regarding the recent Supreme Court decisions, Boston Scientific contends that Pennsylvania state courts no longer have jurisdiction over it. Specifically, the motion said Boston Scientific is a Delaware corporation with its principal place of business in Massachusetts, it does not have sufficient ties to Pennsylvania to render it “at home” in the state, and the plaintiffs are not Pennsylvania residents. The company further says that finding Pennsylvania has jurisdiction simply because the company complies with the state’s business registration statute violates the due process clause of the U.S. Constitution and the now precedent “California Plavix” decision, .

“It is undisputed that Boston Scientific’s principal place of business is Massachusetts while its place of incorporation is Delaware,” the motion said. “Those are the only two jurisdictions where Boston Scientific is so heavily engaged in activity as to render it ‘at home.”

State Court Removal and Refiling Across The Country

The Philadelphia Court of Common Please Complex Litigation Docket appears to be preparing for a departure of many of the thousands of product liability cases, which prior to June 19, 2017 were moving along quite well in the under the direction of Judge Arnold New. State court dockets across the country are now forced to consider the removal of many cases as well as the potential refiling of thousands of cases in the state of incorporation for the medical device and pharmaceutical manufacturers.

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Endo International Agrees To An Additional $775 Million to Settle Remaining Mesh Lawsuits For A Total of $2.6 Billion

 

Endo International Plc has agreed as of August 7, 2017 to set aside an additional $775 million to resolve the remaining lawsuits alleging the company’s vaginal-mesh implants eroded in some women, leaving them incontinent and in pain related to the Transvaginal Mesh Multidistrict Litigation pending in the US District Court of West Virginia, see the Mass Tort Nexus briefcase, American Medical Systems MDL 2325 TVM Litigation Link, a subsidiary of Endo sold to Boston Scientific in 2015.

The agreement to fund settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to finalize the litigation claims related to the American Medical Systems flawed medical devices, according to document filed with the U.S. Securities and Exchange Commission.

This comes a year after Dublin-based Endo shut down one of its units that makes mesh implants, used to support internal organs or treat incontinence, after being hit with many thousands of complaints over the devices.

“We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims,” Paul Campanelli, Endo’s president and chief executive officer, said Monday in a statement.

Other mesh-insert makers, including Johnson & Johnson and Boston Scientific Corp., still face thousands of claims in the U.S. and worldwide from women who blame the devices for injuring them. More than 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. About 75% of mesh lawsuits are consolidated in West Virginia federal court through seven multi-district litigation (MDL) cases. The rest are contained in state courts, including those in Pennsylvania and West Virginia.

J&J, based in New Brunswick, New Jersey, said in SEC filings in February that it was defending 54,800 cases over its inserts while Marlborough, Massachusetts-based Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits. The U.S. Food and Drug Administration increased regulatory restrictions on the mesh inserts after concluding in 2014 they were high-risk. The agency ordered Endo’s American Medical Systems unit, J&J and other mesh makers to study organ-damage rates linked to the devices. J&J dropped some of its mesh lines in 2012.

The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston). Endo paid $150 million in legal settlements related to its vaginal mesh in the 4th quarter of 2016 and now more payments are on the way. The company recorded a $834 million pretax charge to increase the estimated product liability accrual. It had already set aside $1.4 billion to cover the legal costs at the end of the previous settlements.

In 2015 Endo sold the men’s health portion of its American Medical Systems device unit to Boston Scientific for $1.6 billion, and renamed the remaining portion Astora Women’s Health. Endo had acquired AMS for $2.9 billion in 2011, making the purchase a significant misjudgment of corporate strategy in what was even then a highly litigated medical device area, as TVM was widely known as a product that was prone to high numbers of adverse events and regulatory scrutiny.

Endo International/American Medical Systems Settlement History

Endo International plc (Endo) acquired device maker American Medical Systems Holdings, Inc. (AMS) in 2011. Endo has agreed to pay out roughly $2.6 billion to settle cases claiming injuries from its vaginal mesh devices, which include the Perigee, Apogee and Elevate implants. The company has previously ceased production of AMS transvaginal mesh.

The following settlements amounts were agreed to by Endo in attempts to resolve mesh implants made by AMS:

$775 million settlement to resolve 22,000 mesh lawsuits in August 2017. This settlement resolves the remaining lawsuits against AMS mesh implants.

Approximately 450 mesh lawsuits resolved through two separate settlements in April and May 2015.

$400+ million to settle more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. With the move, Endo said that it resolved “substantially all” the remaining lawsuits against its AMS unit. The $400 million was in addition to $1.2 billion already pledged by Endo to cover mesh litigation.

$830 million settlement to resolve around 20,000 mesh lawsuits (~40,000 per case) in May 2014. The settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny. “The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo said in a statement at the time.

$55 million paid in June 2013 to settle an undisclosed number of lawsuits, according to a filing with the U.S. Securities and Exchange Commission.

 

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Brazilian Health Insurers Sue Boston Scientific, Arthrex and Zimmer Biomet Over Kickbacks to Doctors

boston scientificAn association of 177 health insurance companies and medical providers in Brazil sued Boston Scientific Corporation, Arthrex, Inc. and Zimmer Biomet Holdings, Inc. in US federal court, charging that the companies paid millions in kickbacks to doctors so they would use their medical products — regardless of the need or cost of the products.

Abramge (short for Associação Brasileira De Medicina De Grupo) is an organization that represents the health insurers and medical service providers in a complaint filed in US District Court in Delaware, Case. No. Case 1:16-cv-01184-GMS.

Brazil has the second-largest private health insurance market by population in the world after the US. The doctors were paid a 20% to 40% commission for using the companies’ medical devices, according to the complaint. The corrupt doctors induced Brazilian the medical providers to (1) buy medically unnecessary amounts of Defendants’ devices; (2) conduct unnecessary medical procedures, in order to use more of Defendants’ products; and (3) overbill insurers for Defendants’ products and medical procedures.

The “Prosthetic Mafia”

The Brazilian television news program Fantastico (similar to 60 Minutes) featured a series of reports in January 2015, showing Brazilian medical device distributors offering secret cash commissions to an undercover reporter posing as a Brazilian surgeon. This caused the National Congress of Brazil to conduct  hearings investigating the corruption by the “Prosthetic Mafia.”

The final report issued by the Brazilian congress found that the improper payments have “grown alarmingly” and that the fraudulent scheme was “endangering the lives of patients in favor of the companies’ profit.”

The defendants are:

  • Boston Scientific Corporation is a Delaware corporation headquartered in Massachusetts. It manufactures a vast array of products used in a range of interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology. Boston Scientific is a known for its stents, implantable cardioverter defibrillators, pacemakers, stents and spinal cord stimulator systems.
  • Arthrex, Inc. is a Delaware corporation headquartered in Florida. Arthrex manufactures implants for sports medicine and joint prosthetics. It also develops and manufactures orthobiologics, which are substances many orthopaedic surgeons use to assist in the healing process of injuries.
  • Zimmer Biomet Holdings, Inc. is a Delaware corporation headquartered in Indiana. It manufactures and markets orthopedic products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses.

Phony consulting agreements

The Brazilian Federal Police investigated the kickback scheme, launched in 2006, leading to the indictment of distributors and doctors in Brazil. A prominent São Paulo hospital studied the difference in certain medical procedures before and after the public disclosure of the medical device scandal and found a 30% reduction in those procedures.

According to the complaint, sales representatives working for Boston Scientific would approach doctors and offer to pay a fee for every Boston Scientific device or product the doctor used. The doctors signed phony consulting agreements to legitimize the bribery.

In one example Signus, on behalf of Boston Scientific, approached three doctors and paid them $27,000 per month for using its products. During six months from June to December 2012, the kickbacks totaled $189,000.

Back in the US in 2009, Boston Scientific agreed to pay $22 million to settle allegations brought by the Department of Justice that it paid kickbacks to doctors to participate in post-market studies, in order to boost sales of Boston Scientific pacemakers and defibrillators. Further, in 2011, two former employees of Boston Scientific filed a lawsuit in the District of New Jersey alleging that Boston Scientific paid kickbacks to doctors to encourage use of Boston Scientific’s spine products.

“Both of these instances are strikingly similar to what Plaintiff has discovered Boston Scientific has been doing in Brazil,” the complaint says. Arthrex and Zimmer Biomet are accused of similar acts.

In fact, on March 26, 2012, Biomet entered into a Deferred Prosecution Agreement with the DOJ and a Consent to Final Judgment with the U.S. Securities and Exchange Commission to end investigations into Biomet’s violations of the Foreign Corrupt Practices Act. Biomet was bribing doctors in Brazil as part of its marketing and sales strategy in that country.

The complaint, filed by attorney Karen B. Skomorucha Owens of Ashby & Geddes in Wilmington, Delaware, seeks damages for fraud, conspiracy, tortious interference, negligent misrepresentation and unjust enrichment.

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Boston Scientific Settles Nearly Half of 40,000 Transvaginal Mesh Cases


Boston scientific tvc pelvic mesh
In its latest 10-Q filing with the Securities and Exchange Commission, Boston Scientific announced that as of Oct. 31 it has settled 19,000 of 40,000 product liability cases filed against it concerning its transvaginal mesh product.

A total of 17,277 actions are filed in federal MDL 2326 consolidated before US District Judge Joseph R. Goodwin in In RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, Case No. 12-md-2326, D. Mass.).  The company said that more than 3,100 cases are pending in Massachusetts state court.

In addition, the company says it has “made substantial progress” in settlement talks underway with plaintiffs’ counsel representing approximately 3,000 additional cases and claims.

Multiple verdicts

All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing,” the company states.

Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.

Plaintiffs allege the company knew or should have known that the TVM devices created an increased risk of serious personal injury, including mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and, prolapse of organs.

Litigation is pending against 8 TVM manufacturers:

  1. Caldera TVM Class Action In California
  2. Boston Scientific TVM Litigation MDL 2362
  3. Bard TVM Litigation MDL 2187
  4. Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
  5. Neomedic TVM Litigation MDL 2511
  6. Cook TVM Litigation MDL 2440
  7. Coloplast TVM Litigation MDL 2387
  8. American Medical Systems TVM Litigation, MDL 2325

Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device.

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Judge Upholds $14.3 Million Verdict Against Boston Scientific in Pelvic Mesh Trial

vaginal-mesh-TVM-US District Judge Joseph R. Goodwin upheld $14.3 total verdict in favor of three women who suffered ongoing pain from the Obtrx transvaginal mesh system manufactured by Boston Scientific Corporation.

“There was more than sufficient evidence from which a reasonable jury could find in favor of the plaintiffs on each of their claims,” the judge wrote.

Boston Scientific was found liable of strict liability for defective design, strict liability for failure to warn, negligence and punitive damages. A jury in US District Court in the Southern District of West Virginia in Charleston returned the verdict for the plaintiffs in November 2014. The case is Carol Sue Campbell v. Boston Scientific Corporation, Case No. 2:12-cv-08633 (Oct. 3, 2016).

The case is part of consolidated litigation in MDL 2326, which contains 19,000 individual cases. There are six other MDLs against the transvaginal mesh manufacturers, with more than 70,000 cases currently pending:

  1. Boston Scientific TVM Litigation MDL 2326
  2. Bard TVM Litigation MDL 2187
  3. Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
  4. Neomedic TVM Litigation MDL 2511
  5. Cook TVM Litigation MDL 2440
  6. Coloplast TVM Litigation MDL 2387
  7. American Medical Systems TVM Litigation
  8. Caldera TVM Class Action In California

Plaintiffs Chris Wilson, Carol Campbell and Jeanie Blankenship had the Obtryx Transobturator Mid-Urethral Sling System implanted between 2009 and 2011. All suffered severe pain in their abdomen, pelvis, vagina, dyspareunia (painful intercourse) and painful urination. Each had unsuccessful revision surgery, which also left them with continuing pain.

  • Wilson recovered $3.75 million in compensatory damages and $1 million in punitive damages.
  • Campbell recovered $3.25 million in compensatory damages and $1 million in punitive damages.
  • Blankenship recovered $4.25 million in compensatory damages and $1 million in punitive damages.

Boston Scienfitif argued that it met the standard of care in the medical community, which did not require clinical trials. “However, as mentioned above, compliance with industry standards is not necessarily proof of reasonable conduct,” the judge held.

A key point of evidence was the Material Safety Data Sheet issued by Chevron Phillips Chemical Company LP with regard to their Marlex polypropylene. The plaintiffs presented evidence at trial that the MSDS included a Medical Application Caution, which stated: “Do not use [Chevron Phillips] material in medical applications involving permanent implantation in the human body . . . .”

Yet after learning this, Boston Scientific never performed any testing of their mesh inside the human body, didn’t halt the release of the Obtryx and didn’t disclose the new information.

The plaintiffs presented evidence related to a study conducted by Dr. Hilary Cholhan and funded in part by BSC. The Cholhan study “identified pariurethral banding as a previously unreported complication” of the Obtryx and noted that “[s]urgeons should be aware of the pariurethral banding and subsequent internal dyspareunia as a potential complication.”

When asked about the study, Alex Robbins, a BSC sales representative and training manager, stated that, because of its negative outcome, the study would not be useful to the sales force and should not be given to physicians.

The judge disagreed with Boston Scientific’s arguments that the verdict was against the weight of the evidence, that jury instructions were confusing, or that in closing arguments a plaintiff attorney improperly tried to appeal to the jury’s sympathy.

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Pelvic Mesh Case Revived Against Boston Scientific

Vaginal-Mesh-POP-331x269-e1370009513525
Some 39,000 pelvic mesh cases have been filed against Boston Scientific.

A Massachusetts appeals court revived a pelvic mesh product liability case against Boston Scientific Corp. (BSC) because the trial court had wrongly excluded three pieces of evidence to rebut the company’s claims that the FDA had “cleared” its Pinnacle pelvic floor repair kit for sale.

A state court jury returned a defense verdict in favor of the company in 2014 in the first product liability lawsuit involving the its pelvic mesh products to go to trial.

Plaintiff Diane Albright of Ohio filed suit in 2012 the Massachusetts Superior Court against BSC, which is based in Massachusetts, seeking damages for injuries after the Pinnacle device was surgically implanted to treat her pelvic organ prolapse (POP) condition.

“The repeated reference to the FDA’s clearance aided BSC’s defense, and handicapped Albright’s case, on the central product safety issue in the case,” the appeals court said. The case is Diane Albright v. Boston Scientific Corporation (PDF), No. 15-P-633 (Sept. 13, 2016).

Trial judge Diane M. Kottmyer erroneously excluded key evidence:

  1. A medical application caution in the 2004 material safety data sheet provided to BSC by its supplier of the polypropylene material used to fabricate the mesh in the Pinnacle device. It states, “Do not use this [polypropylene] material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” The appeals court ruled, ” the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that BSC, which had received the MSDS well before 2009, had notice or knowledge of the content of the caution.”
  2. A letter from the FDA ordering BSC to conduct a “postmarket surveillance” study of the Pinnacle device to address concerns as to the safety and efficacy of the device in treating POP.
  3. A second letter from the FDA, agreeing to a request from BSC to suspend its postmarket surveillance study because the company planned to stop the manufacture and marketing of the Pinnacle device.

“Albright ought to have been allowed to use the letters for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial,” the appeal court ruled.

The same documents have been allowed into other trials, including one in Delaware that landed a $100 million verdict last year. Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.

Some 39,000 pelvic mesh cases have been consolidated in MDL 2327 before US District Judge Joseph R. Goodwin in the Southern District of West Virginia. There are six other MDLS, making it the largest ongoing medical device litigation in the country. The Judicial Panel on Multidistrict litigation lists 75,000 cases in dockets involving different manufacturers.

A surgeon inserted the Pinnacle device into Albright in 2010. Within six months, she experienced pain and discomfort when urinating and other “hardto-describe” pain in her pelvic area. Two other doctors examined her and concluded that Albright was suffering from painful bladder syndrome and other complications due to the erosion and degradation of the mesh in her body.

 

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Family Sues Boston Scientific over Defective IVC Filter that Killed Truck Driver

Boston Scientific makes the dangerous Greenfield Vena Cava Filters.
Boston Scientific makes the dangerous Greenfield Vena Cava Filters.

Federal litigation is building against Boston Scientific Corp. over defects in its IVC filter, a device implanted to control pulmonary embolisms (PE), a sudden blockage in a lung artery.

The family of a woman truck driver from Ohio filed a wrongful death suit after the company’s IVC filter perforated her inferior vena cava vein, killing her.

Even though plaintiffs are filing more cases against Boston Scientific over its Greenfield Vena Cava Filter, today there is no multidistrict litigation docket (MDL) for the litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be filed in an effort to form an MDL,” said John Ray, a leading consultant who has advised attorneys who practice in Mass Torts for more than a decade.

Greenfield Vena Cava Filter
Greenfield Vena Cava Filter

Boston Scientific, headquartered in Marlborough, Massachusetts, designed, manufactured, marketed and sold the Greenfield IVC Filter. It is a basket-like structure with 6 struts, each with a curved hook, and is designed to catch blood clots.

FDA warning and recall

The FDA recalled the Greenfield IVC Filter in May 2007 after reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters, causing a risk of cardiac and pulmonary embolization.

It also issued a warning on August 9, 2010 against leaving IVC filters in for extended periods of time, because they have a tendency to cause life-threatening problems.

The FDA reported that since 2005, there were 921 adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved detachments of device components and embolizations, 70 involved perforation of the IVC, and 56 involved IVC filter breaks.

Dangerous medical device

The co-administrators of estate of Cindi K. Ratliff filed a lawsuit in US District Court for the Southern District of Ohio, Eastern Division, alleging product liability, breach of warranty, negligence and wrongful death, Case: 2:15-cv-00076-GLF-NMK.

In 2004 Ratliff, of East Fultonham, Ohio, was diagnosed with deep vein thrombosis (DVT), which occurs when a blood clot (thrombus) forms in one or more of the deep veins in your body, usually in your legs. That year a surgeon implanted a Boston Scientifi IVC filter in her right inferior vena cava.

On May 3, 2013, she was working as a long‐haul truck driver and traveled to Oregon. While stopped at a rest area located on I‐5 in the vicinity of Coburg, Oregon, she suffered a medical emergency.  Shortly afterwards she was pronounced dead by medics who had been called to the scene. An autopsy that day determined the immediate cause of death was “Perforation of Inferior Vena Cava by Greenfield Filter with Retroperitoneal Hemorrhage.”

The lawsuit charges:

  • Boston Scientific knew or should have known that its Greenfield Vena Cava Filter when used as expected and intended, carrie the risk of breaking free from its implantation site, migrating, perforating the vena cava, and causing serious injury and death to patients.
  • Boston Scientific failed to properly design and manufacture Greenfield Vena Cava Filter.
  • Boston Scientific failed to give adequate warnings about the hazards associated with the filter.
  • Boston Scientific violated Ohio’s Product Liability Act.

The next of kin seek damages for loss of support, loss of services, loss of society of the decedent including loss of companionship, loss of prospective inheritance, and extreme mental anguish as a result of her death.

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