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Ethicon 18/1
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Phila. Judge Increases $12.5M Award In Pelvic Mesh Suit for Delay Damages
Jan 18, 2016 | The Legal Intelligencer
By Max Mitchell
Philadelphia Court of Common Pleas Judge Mark I. Bernstein, who presided over the Hammons v. Ethicon trial that resulted in an award of $5.5 million in compensatory damages and $7 million in punitive damages, added $797,602 in delay damages to the verdict, and entered judgment at about $13.3 million. The decision was docketed Jan. 1 -
Bard Loses Appeal Of $2M Pelvic Mesh Verdict At 4th Circ.
Jan 15, 2016 | Law360
By Dani Kass
...Johnson & Johnson unit Ethicon Inc., Boston Scientific Corp. and Endo Pharmaceuticals unit American Medical Systems Holdings Inc. also face separate multidistrict litigation in West Virginia over their own implants... -
4th Circuit affirms $2 mln verdict in pelvic mesh trial
Jan 15, 2016 | Reuters
By Barbara Grzincic
A federal appeals court on Thursday affirmed an award of $2 million against manufacturer C.R. Bard in the first jury verdict in multidistrict litigation involving transvaginal mesh implants, upholding the trial judge's decision to exclude evidence of the device's approval by the Food and Drug Administration. -
Boston Scientific targeted for 'international conspiracy' in latest vaginal mesh suit
Jan 15, 2016 | Fierce Medical Devices
By Emily Wasserman
Boston Scientific is facing more legal pushback over defective vaginal mesh devices, but this time, it's not from women who claim injuries or serious side effects from the products. A Houston-based law firm is cracking down on the company for allegedly smuggling mesh materials out of China and putting women at risk for serious side effects. -
Boston Scientific smuggled counterfeit resin for pelvic mesh, racketeering lawsuit alleges
Jan 15, 2016 | Mass Device
By Brad Perriello
A purported class-action racketeering lawsuit filed this week accused Boston Scientific (NYSE:BSX) of illegally smuggling counterfeit resin made in China to make pelvic mesh, after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans. -
Boston Scientific used counterfeit resin from Chinese supplier to make vaginal meshes, lawsuit alleges
Jan 15, 2016 | Plastics Today
By Norbert Sparrow
...Thousands of lawsuits have been filed over the years, causing one manufacturer, Johnson & Johnson's Ethicon, to discontinue its line of vaginal mesh implants in 2012. Boston Scientific is one of a handful of companies that continues to supply the billion-dollar market. But those days may be numbered... -
Mesh lawsuit filed on behalf of Lincoln County woman
Jan 16, 2016 | Charleston Gazette-Mail
By Kate White
A lawsuit filed last week in federal court in Charleston on behalf of a Lincoln County woman accuses Boston Scientific Corp. of engaging in a conspiracy to smuggle material from China for use in vaginal surgical mesh. -
RICO Suit Accuses Boston Scientific of Fraud in Smuggling Defective Pelvic Mesh from China
Jan 15, 2016 | Mesh Medical Device News Desk
By Jane Akre
This week the Mostyn law firm of Houston filed a federal racketeering lawsuit against Boston Scientific, the transvaginal mesh manufacturer already the focus of thousands of pelvic mesh actions in federal court in West Virginia.
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Phila. Judge Increases $12.5M Award In Pelvic Mesh Suit for Delay Damages
Jan 18, 2016 | The Legal Intelligencer
By Max Mitchell
As post-trial disputes get under way in Philadelphia's first pelvic-mesh suit to hit trial, the judge has added nearly $800,000 to the $12.5 million verdict that was awarded in the case last month.
Philadelphia Court of Common Pleas Judge Mark I. Bernstein, who presided over the Hammons v. Ethicon trial that resulted in an award of $5.5 million in compensatory damages and $7 million in punitive damages, added $797,602 in delay damages to the verdict, and entered judgment at about $13.3 million. The decision was docketed Jan. 12.
The plaintiff entered a response Jan. 13 to the defendant's post-trial motions filed earlier in the month.
Ethicon's 80-page motion for post-trial relief asked the court to toss the verdict, grant a new trial, or modify the amount of damages.
The plaintiff, Patricia Hammons, had alleged the Gynecare Prolift pelvic mesh device was negligently designed, and Johnson & Johnson subsidiary Ethicon failed to properly warn health professionals about the risks of the device.
In 2009, the Prolift device had been implanted into Hammons, an Indiana resident who worked as a stocker for Wal-Mart, to address a prolapsed bladder.
Her counsel had argued, among other things, that the density of the mesh caused scar tissue to build up and contract, which eventually led to erosion of Hammons' bladder and "excruciating" pain during sex.
After the device failed, she had to have numerous surgeries, but will not be able to completely remove portions of the mesh that eventually adhered to the bladder, according to Hammons' attorney, Shanin Specter of Kline & Specter.
Ethicon's attorneys contended that doctors led the development of the device, and the risks of using pelvic mesh were well known throughout the medical community. They also contended that, despite the later complications, the mesh worked properly to support Hammons' bladder.
Among other things, Ethicon's post-trial motion cited a Texas court of appeals' decision last year to toss a $1.2 million verdict awarded in another pelvic mesh case.
The decision in Johnson & Johnson v. Batiste dismissed the verdict after finding that testimony from the plaintiff's medical causation expert failed to tie the plaintiff's pelvic pain to the alleged defects, the motion said.
According to the defendants, Hammons' causation expert likewise only generally linked the injuries to the Prolift surgery, which, Ethicon argued, would require the claims to be tossed under Indiana products liability law.
"Indiana law is no different, refusing to impose liability on a manufacturer simply because risks of a product were suffered by a plaintiff," the motion said.
The post-trial motion initially contended the Philadelphia courts did not have jurisdiction over the claims, and that the jury should not have been allowed to consider whether Hammons filed her case within the two-year statute of limitations.
The motion noted that she first experienced pain during sex within six weeks after the device was implanted in 2009, but did not file the suit until May 2013.
Hammons, the motion said, had authorized the release of medical records related to her implant for possible litigation in 2011, and therefore, she must have known the pain was related to the implant before that time.
"Plaintiff posited no event after January 2010 and August 2011 that would trigger her knowledge or constructive knowledge that her symptoms were the product or act of another, and the only logical inference is that she was on notice in January 2010 or shortly thereafter when she had been cleared for sex but her symptoms persisted," the motion said.
The filing raised a total of 21 issues, including arguments that the awards were excessive, and that the court should have dismissed a juror who was "demonstratively gesturing towards the plaintiff in sympathy" during the plaintiff's closing arguments.
The plaintiff filed her opposition to the post-trial arguments, saying that, while she joined Ethicon's request for a new trial on the amount of punitive damages, the rest of Ethicon's arguments "contain legal argument and characterizations of the trial record to which no response is required, and hence are denied."
Specter called Ethicon's post-trial motions "meritless."
"There is a suggestion in their post-trial motions that they would like a new trial on the punitive damages amount, and if that's what they're really seeking, we have told the court that's OK with us," Specter said.
The Hammons case was the first pelvic-mesh suit to go to trial in Philadelphia.
Although one suit had been set to begin Jan. 11, that suit was dismissed on summary judgment earlier this month. The next case set for trial, Carlino v. Ethicon, is expected to begin Jan. 25.
Molly E. Flynn of Drinker Biddle & Reath, who filed Ethicon's post-trial motion, referred comment to a company spokesperson, who did not return a call for comment. Specter also did not return a call seeking comment.
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Bard Loses Appeal Of $2M Pelvic Mesh Verdict At 4th Circ.
Jan 15, 2016 | Law360
By Dani Kass
C.R. Bard Inc. on Thursday lost its appeal of a jury’s $2 million verdict in a bellwether trial that found the medical device maker liable for a woman’s injuries from defective vaginal mesh implants when the Fourth Circuit found the trial court properly decided which evidence to exclude.
A three-judge panel turned down several arguments from Bard over whether evidence involving safety warnings for its Avaulta Plus transvaginal mesh device was properly excluded and evidence involving U.S. Food and Drug Administration clearance properly included in thetrial assessing the company’s responsibility for Donna Cisson's injuries. The court then affirmed that the $1.75 million in punitive damages, in comparison with $250,000 in compensatory damages, wasn't excessive.
Cisson won the multidistrict litigation’s first bellwether trial in August 2013, in which she claimed that after being implanted with the Avaulta Plus device to treat her rectal prolapse, she suffered bleeding, spotting, rectal pain, bladder spasms and pain during sexual intercourse. Cisson and the other bellwether plaintiffs each required invasive follow-up procedures to remove loose pieces of mesh that damaged their pelvic region, according to court records.
Bard's appeal first argued that the district court wrongly excluded evidence about the FDA’s approval of its product under the 510(k) premarket notification program meant for Class II medical devices, which are considered to be of moderate risk.
The circuit court found that the clearance didn’t measure the safety of the product, only how well it matched something already on the market, and was therefore properly excluded from the case. The evidence would likely have led to a “mini-trial” over its significance that would inflate its relevance in the eyes of the jury, the opinion said.
“While 510(k) clearance might, at least tangentially, say something about the safety of the cleared product, it does not say very much that is specific,” the panel said. “The vast majority of courts have said so, and having been thoroughly briefed not only by the parties but by several amici, we say so again today.”
Bard had also appealed the district court’s decision to allow the admission of a material data safety sheet warning that the materials in the mesh were not suitable to be implanted in humans, over the company’s objections that it was hearsay.
The Fourth Circuit ruled that while the lower court may have used the wrong exceptions to allow the safety sheet into evidence, Cisson properly used it only to show that a warning had been issued that Bard received, ignored and withheld, rather than used as evidence that the implant was unsafe.
While Cisson’s counsel made one questionable comment during closing arguments that made it appear they were using the warning’s facts as evidence, the panel said “that single stray comment was not enough to prejudice Bard and require a new trial.”
Bard also argued that the district court gave the wrong instructions to the jury regarding injury causation, but the panel said the company hadn’t pointed to any precedent supporting its case and affirmed that Cisson provided ample testimony about how the design defects led to her injuries.
Lastly, the court shot down the device maker’s claim that the $1.75 million in punitive damages, on top of $250,000 in compensatory damages, were unconstitutionally excessive. The ratio stated in precedent used by Bard is expressly nonbinding, the court said.
Bard and counsel for Cisson didn’t respond to requests for comment Friday.
Cisson’s suit is one of four bellwethers in the West Virginia MDL and is the first to go to trial in federal court out of a group of suits brought by thousands of women over injuries allegedly caused by the implants, which are used to treat pelvic organ prolapse or stress urinary incontinence.
Johnson & Johnson unit Ethicon Inc., Boston Scientific Corp. and Endo Pharmaceuticals unitAmerican Medical Systems Holdings Inc. also face separate multidistrict litigation in West Virginia over their own implants.
Cisson said her symptoms were tied to Bard’s use of pig-skin collagen in the mesh products, which she said the company knew increased the likelihood of chronic inflammation and adverse tissue reactions. Additionally, she claimed a thermoplastic polymer called polypropylene used in the products is prone to degradation and shrinkage once inside a patient.
The FDA on Jan. 6 finalized its April 2014 proposal to reclassify transvaginal mesh treatments for pelvic organ prolapse as Class III medical devices that must undergo the agency's rigorous premarket approval process.
Judges Roger Gregory, G. Steven Agee and Albert Diaz sat on the panel for the Fourth Circuit.
Cisson is represented by Elliot H. Scherker, Lori G. Cohen, R. Clifton Merrell II, Sean P. Jessee, Daniel I.A. Smulian, Brigid F. Cech Samole and Jay A. Yagoda of Greenberg Traurig LLP and Melissa Foster Bird of Nelson Mullins Riley & Scarborough LLP.
Bard is represented by Anthony J. Majestro of Powell & Majestro PLLC, Allison Van Laningham of Turning Point Litigation and Henry G. Garrard III and Josh B. Wages ofBlasingame Burch Garrard Ashley PC.
The case is Donna Cisson v. C. R. Bard Inc., case number 15-1102, in the U.S. Court of Appeals for the Fourth Circuit. -
4th Circuit affirms $2 mln verdict in pelvic mesh trial
Jan 15, 2016 | Reuters
By Barbara Grzincic
A federal appeals court on Thursday affirmed an award of $2 million against manufacturer C.R. Bard in the first jury verdict in multidistrict litigation involving transvaginal mesh implants, upholding the trial judge's decision to exclude evidence of the device's approval by the Food and Drug Administration.
The unanimous three-judge panel of the 4th U.S. Circuit Court of Appeals rejected arguments by Bard's attorneys at Greenberg Traurig, who had sought a new trial or a reduction of the $1.75 million punitive damages award to plaintiff Donna Cisson.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1TZRewr
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Boston Scientific targeted for 'international conspiracy' in latest vaginal mesh suit
Jan 15, 2016 | Fierce Medical Devices
By Emily Wasserman
Boston Scientific ($BSX) is facing more legal pushback over defective vaginal mesh devices, but this time, it's not from women who claim injuries or serious side effects from the products. A Houston-based law firm is cracking down on the company for allegedly smuggling mesh materials out of China and putting women at risk for serious side effects.
Mostyn Law filed a suit in a federal court in West Virginia against Boston Scientific and three other companies, claiming that Boston Scientific ran an "international conspiracy" and racketeering operation to get counterfeit supplies for its mesh devices, the firm said in a statement. Mostyn is asking the court to immediately ban Boston Scientific from selling any mesh products that contain the material.
After Boston Scientific lost its mesh supplier in the U.S., the company bought "unverified, substandard material from a known counterfeiter in China," the company said in a statement, "at times acting like a drug dealer" to cover up multiple overseas shipments. Mostyn's suit is also seeking unspecified damages for thousands of women who got a Boston Scientific mesh implant after September 2012. And according to the firm's calculations, that's as many as 55,000 women a year.[Webinar] Drug Manufacturing Solutions in a Complex Industry
"Boston Scientific knowingly sold a product that put women's health and their lives at risk. It conspired with questionable suppliers in China to get material that it couldn't get in the U.S. and went to great lengths to hide it," Amber Mostyn, head attorney at the firm, said in a statement.
Plus, the materials found in the counterfeit mesh could present harm to patients, Mostyn said in a statement. The firm's "latest scientific tests conclude their counterfeit mesh product contains dangerous selenium," Mostyn said. And the firm will meet Boston Scientific "anywhere and anytime to work together and get this dangerous counterfeit medical device off the market," she added, urging the company to turn over internal documents related to its supply transactions. "It is time for this company to do the right thing."
Boston Scientific is denying Mostyn's claims, saying that "patient safety is of the utmost important, and we dedicate significant resources to deliver safe, high-quality products," spokesman Tom Keppeler told The Boston Globe in a statement. "We don't believe the case has merit and intend to vigorously defend these claims."
The latest action adds to Boston Scientific's vaginal mesh woes. The company faces more than 20,000 claims related to vaginal mesh implants in U.S. state and federal courts, including cases consolidated before U.S. District Judge Joseph Goodwin in West Virginia.
In May, the company was ordered to fork over $100 million to a woman who claimed that Boston Scientific's vaginal mesh products caused her undue pain and suffering. The order came a month after the Marlborough, MA-based company agreed to shell out $119 million to resolve about 3,000 suits over the devices.
Mostyn's suit comes as the FDA ramps up its oversight of transvaginal meshdevices amid growing safety concerns. Earlier this month, the agency said it would reclassify surgical transvaginal mesh devices for pelvic organ prolapse (POP) from Class II to Class III, its most serious designation, and would require a premarket approval (PMA) application from manufacturers before signing off on related products.
Heightened scrutiny could spell out more trouble for Boston Scientific, which has a lot on the line with its mesh products. The company earned more than half a billion dollars in revenue in 2014 from mesh and other urology and women's health products, the Boston Globe points out, and additional legal action could put a dent in those spoils.
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Boston Scientific smuggled counterfeit resin for pelvic mesh, racketeering lawsuit alleges
Jan 15, 2016 | Mass Device
By Brad Perriello
A purported class-action racketeering lawsuit filed this week accused Boston Scientific (NYSE:BSX) of illegally smuggling counterfeit resin made in China to make pelvic mesh, after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans.
The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.
Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products.
Boston Scientific told CNNMoney that “patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products. We don’t believe the case has merit and intend to vigorously defend these claims.”
Boston Scientific won 510(k) approval from the FDA in 2002 for the Advantage Mesh, Advantage Fit and Lynx mesh products, manufactured using the Marlex polypropylene resin made in Texas by a joint venture between Chevron and Phillips, the lawsuit alleged.
But by 2005, Phillips allegedly decided to stop supplying Marlex to Boston Scientific because it’s not compatible with human tissue. By 2011, Boston was running out of Marlex and projected it would have none by the fall of 2012. At stake, according to the complaint, was the $120 million worth of pelvic mesh products Boston Scientific sold each year.
“After failing to convince the manufacturer, Phillips, to sell it any more Marlex, BSX made the fateful decision to smuggle counterfeit Marlex out of China,” according to the complaint.
The company then allegedly bought 34,000 pounds of polypropylene resin from a Chinese firm, EMAI Plastic Raw Material Co. of Guandong, projecting that it would be enough to last until 2032. The companies allegedly conspired to put counterfeit labels, including fake lot numbers, designed to look like Phillips markings, on the Boston Scientific product and then allegedly “overbagged” the shipments with blank labels to get them past Chinese and U.S. customs.
From June 2011 through the fall of 2012, the lawsuit alleged, the resin was sent to Belgium’s Luxilon Industries to be made into filament, which was then sent to Ireland for further processing by Proxy Biomedical. Finally, the allegedly counterfeit resin was shipped to Indiana for final mesh fabrication by Medventure, according to court documents.
“Interestingly, Boston Scientific appears to have approached this problem like a drug deal,” the lawsuit alleged, citing the alleged decision to split the 34,000 pounds into 5 separate shipments to different locations.
“Despite defendants’ knowledge that the Chinese material was adulterated and/or counterfeit, BSC, EMAI, Proxy and Luxilon continued with the purchase, distribution, manufacturing, advertising, packaging, labeling and selling the counterfeit mesh, along with the counterfeit bagging and/or marking, which resulted,” the lawsuit alleged.
The complaint charges Boston Scientific and co-defendants EMAI, Luxilon and Proxy with racketeering, mail fraud, wire fraud, intentional and negligent misrepresentation, unfair and deceptive acts and practices, fraud and unjust enrichment. Stevens asked Judge Joseph Goodwin for a jury trial, temporary and permanent injunctions barring the manufacture and sale of products using the allegedly fake Marlex, a warning to the public about it, punitive and consequential damages, legal costs, pre- and post-judgment interest and a temporary restraining order.
Goodwin declined to grant the temporary restraining order, ruling that Stevens’ counsel never told Boston Scientific’s attorneys that a motion for the TRO was planned, as strictly required by federal law, according to the documents. Goodwin reserved judgment on Stevens’ motion seeking a preliminary injunction.
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Jan 15, 2016 | Plastics Today
By Norbert Sparrow
The Gambino family . . . Hell's Angels . . . pedophile priests . . . and Boston Scientific. What do they have in common? They have all been sued under the Racketeering and Corrupt Organizations Act (RICO). Boston Scientific (Marlborough, MA) achieved that dubious distinction on Tuesday, when Houston-based Mostyn Law accused the multinational medical device manufacturer of engaging in an international conspiracy to sell defective vaginal surgical mesh made of counterfeit supplies smuggled out of China.
The class-action lawsuit alleges that Boston Scientific bought "unverified substandard material from a known counterfeiter in China" to produce the mesh when Chevron Phillips Chemical Co. stopped selling its polyproplene resin, branded as Marlex, for surgical mesh in 2005. "The company took extraordinary measures to avoid being caught by U.S. and Chinese authorities, at times acting like a drug dealer to hide multiple overseas shipments," the suit says. Mostyn Law filed the suit late Tuesday on behalf of a West Virginia woman with mesh-related health problems.
Boston Scientific concocted a scheme in 2011 and 2012 to smuggle from China 34,000 pounds of the material, without verifying or fully testing all the contents, the suit says. The material came from EMAI Plastic Raw Materials Inc., based in Guanghzou, China, that the suit claims is a "known counterfeiter of plastic products." The filing goes on to say that EMAI claimed to have Marlex resins in storage from Chevron Phillips Chemical but provided no documentation to Boston Scientific proving the origin of the resin.
Mostyn Law accuses the medical device firm of having discussed bribing Chinese officials and devising a plan to smuggle the resin out of China. In particular, lawyers allege that it divided the bulk product into several hundred bags and orchestrated three different shipments to lessen the likelihood of an inspection by customs agents.
"Boston Scientific knowingly sold a product that put women's health and their lives at risk," said Amber Mostyn in a news release. "It conspired with questionable suppliers in China to get material that it couldn't get in the United States and went to great lengths to hide it," she added.
Polypropylene-based transvaginal surgical mesh is used to treat pelvic organ prolapse, a common condition in which weakened pelvic floor muscles cause the bladder, bowels or uterus to descend into the vagina. This can result in pelvic pain, problems with intercourse and urinary issues. Shortly after the mesh was cleared by FDA in 2002, however, the agency began to receive adverse event reports, as patients who had undergone the procedure complained about pelvic pain, infections and sundry other ailments. Since then, FDA has issued warnings, and on January 4, 2016, reclassified the device from a moderate-risk Class II device to a high-risk Class III product.
Thousands of lawsuits have been filed over the years, causing one manufacturer, Johnson & Johnson's Ethicon, to discontinue its line of vaginal mesh implants in 2012. Boston Scientific is one of a handful of companies that continues to supply the billion-dollar market. But those days may be numbered.
The reclassification by FDA requires manufacturers to submit a premarket approval showing the product's safety and effectiveness if they want to continue manufacturing the mesh. The move by FDA and the thousands of lawsuits that have been filed over the years could have the product off the market by 2019, writes the Daily Beast.
It has been the most harrowing start to a new year for the medical device industry in recent memory. In addition to storied medical device firm Boston Scientific being accused of racketeering, earlier this week the U.S. Senate released a report indicating that the outbreaks of antibiotic-resistant infections linked to dirty medical scopes were more far-reaching than originally thought, and could have been prevented with more robust regulatory oversight.
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Mesh lawsuit filed on behalf of Lincoln County woman
Jan 16, 2016 | Charleston Gazette-Mail
By Kate White
A lawsuit filed last week in federal court in Charleston on behalf of a Lincoln County woman accuses Boston Scientific Corp. of engaging in a conspiracy to smuggle material from China for use in vaginal surgical mesh.
Unlike hundreds of other lawsuits filed against Boston Scientific over defective mesh, the lawsuit filed Tuesday, on behalf of Teresa Stevens, was filed under the Racketeering and Corrupt Organizations Act. The U.S. Justice Department typically uses the RICO statute and penalties to target criminal organizations, but private citizens can seek to apply it in civil cases.
The lawsuit claims that after Boston Scientific lost its U.S. supplier of synthetic resin to produce mesh, it bought unverified, substandard material from a counterfeiter in China.
“The company took extraordinary measures to avoid being caught by U.S. and Chinese authorities, at times acting like a drug dealer to hide multiple overseas shipments,” said a news release from Houston-based Mostyn Law, which is representing the plaintiffs.
The lawsuit asks that a judge grant class action status on behalf of thousands of women who had the mesh implanted. It asks for a judge to immediately stop the company from continuing to sell the mesh, which allegedly has been made with toxic ingredients.
Boston Scientific released a statement last week vowing to fight the lawsuit and stating that the case has been brought without merit.
Plaintiffs attorneys have provided information to the Department of Justice about the case.
Assistant U.S. Attorney Steve Ruby said Friday his office could not confirm or deny the existence an investigation.
For the past several years, U.S. District Court Judge Joseph Goodwin in Charleston has been handling thousands of cases over the implantation of vaginal mesh as part of federal litigation across the country.
Boston Scientific has had more than 30,000 cases filed against it over mesh.
Women claim the mesh produced by multiple companies degrades and shrinks, requiring replacement and causing other medical problems. The mesh was implanted to treat, among other things, stress urinary incontinence, which is usually caused by weak pelvic muscles.
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RICO Suit Accuses Boston Scientific of Fraud in Smuggling Defective Pelvic Mesh from China
Jan 15, 2016 | Mesh Medical Device News Desk
By Jane Akre
This week the Mostyn law firm of Houston filed a federal racketeering lawsuit against Boston Scientific, the transvaginal mesh manufacturer already the focus of thousands of pelvic mesh actions in federal court in West Virginia.
The charge – Boston Scientific (BSX) knowingly smuggled and used counterfeit material from China to make vaginal mesh implants.
According to the complaint, BSX was involved in a “scheme” to defraud regulators in both China and the U.S. The Massachusetts-based company could face criminal charges if the allegations are proven.
Reportedly when the BSX supplier of polypropylene resin used to make pelvic mesh, Chevron Phillips, stopped selling it to the company, they turned to China smuggling in 15 tons without verifying its contents.
The complaint says the resin the company purchased was unverified, substandard material from a known counterfeiter and the company “acted like a drug dealer” to hide overseas shipments from regulators in both China and the U.S. This reportedly occurred between June 2011 and the fall of 2012.
Amber Mostyn of the law firm says their goal is to try and stop the sale of transvaginal mesh implants made by Boston Scientific. They are seeking class action status. Mostyn told CNN Money BSX could still be using the counterfeit resin to make mesh implants.
Boston Scientfic issued a statement to MND saying, “At Boston Scientific, patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products. We don’t believe the case has merit and intend to vigorously defend these claims.”
The RICO action was filed in District Court in the Southern District of West Virginia before Judge Joseph Goodwin. The RICO (Racketeering and Corrupt Organizations Act) suit was filed as a class action on behalf of women who have been harmed by the Boston Scientific mesh. Lead plaintiff, Teresa Stevens is from West Virginia and the firm is seeking others to add to the action.
Stevens was reportedly implanted in 2014 with Chinese grade Marlex mesh – the Obtryx-Halo Urethral Sling System. The case is Stevens v. Boston Scientific Corp., et. al., 2:16-0265, U.S. District Court, Southern District of West Virginia (Charleston).
Chinese supplier, EMAI Plastics Raw Materials Inc. is also named in the action. The company is reported to be a “known counterfeiter of plastic products,” based in Guangzhou, China.
The emails that led to this discovery are under court seal unless Judge Goodwin orders them released. BSX subsidiaries, Proxy Biomedical Limited of Galway, Ireland and Luxilon Industries NV of Belgium are also named in the action as participants in the fraud.
The Chinese grade Marlex mesh, the proprietary name for the company’s mesh product, is reported to be inferior to mesh made in the U.S. The counterfeit mesh resin was said to have been divided into 500 bags and shipped in three different small shipments to evade customs agents.
Though discovery has occurred between the seven defendant companies and plaintiffs who have filed 100,000 defective product lawsuits over pelvic mesh, this action is ground breaking because it is the first to accuse a manufacturer of engaging in an international conspiracy.
“We have asked for the court to shut down sales from this company and to protect women from the pain and suffering that can result from this dangerous product,” said attorneyAmber Mostyn. She said Boston Scientific put profits ahead of health concerns, calling the company’s disrespect for women “disgusting and appalling.”
Boston Scientific is currently facing 19,767 lawsuits filed before Judge Goodwin in federal multidistrict litigation convened in Charleston, WV. #
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