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Mostyn Law Urges FDA Pursue Criminal Investigation into Boston Scientific Counterfeit Chinese Mesh
Apr 12, 2016 | Mesh Medical Device News Desk
By Jane Akre
...Discovery in the ongoing pelvic mesh litigation showed Boston Scientific (BSC) allegedly sourced polypropylene resin, used to make pelvic mesh implants, from a known Chinese smuggler and BSC looked the other way when lot numbers didn’t match. -
25 Years of Big Pharma—Profits, Lost lives and Litigation, Part 1
Apr 12, 2016 | Black Voice News
By S.E. Williams
...Last year also saw 748 million dollars awarded in Transvaginal Mesh Lawsuits against a variety of companies; and yet, more than 70,000 Transvaginal Mesh lawsuits against seven companies are still pending in federal, multi-district litigation and thousands more are pending in state courts.
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Mostyn Law Urges FDA Pursue Criminal Investigation into Boston Scientific Counterfeit Chinese Mesh
Apr 12, 2016 | Mesh Medical Device News Desk
By Jane Akre
The Mostyn law firm, that uncovered an alleged scheme to import counterfeit plastic resin smuggled in from China, is now blasting the FDA for its lackluster response in pursing a criminal investigation.
Discovery in the ongoing pelvic mesh litigation showed Boston Scientific (BSC) allegedly sourced polypropylene resin, used to make pelvic mesh implants, from a known Chinese smuggler and BSC looked the other way when lot numbers didn’t match.
The Houston-based firm filed a class action lawsuit (Teresa Stevens v. Boston Scientific, Case no. 2:16-cv-00265) in Charleston, WV, on behalf of the women allegedly implanted with the mesh made from the Chinese resin, shown to contain high levels of the mineral selenium.
In response, the FDA in an April 1 safety alert, said it would allow Boston Scientific to conduct its own investigation see if the mesh is the equivalent to other pelvic meshes made by Boston Scientific used to treat incontinence and pelvic organ prolapse.
In a strongly-worded letter today, Amber Mostyn blasted FDA commissioner Dr. Robert Califf and Health and Human Services Secretary Sylvia Mathews Burwell asking if equivalence of the product would be a defense to trafficking in counterfeit material?
She says the equivalence of the end product is irrelevant.
n a strongly-worded letter today, Amber Mostyn blasted FDA commissioner Dr. Robert Califf and Health and Human Services Secretary Sylvia Mathews Burwell asking if equivalence of the product would be a defense to trafficking in counterfeit material?
She says the equivalence of the end product is irrelevant.
“The FDA‘s investigation should not be into the quality of the raw material, but rather the source of the raw material. Allowing the defense of equivalence undermines the public policy positions articulated in the very statutes Congress passed to prevent this type of criminal conduct.”
Waiting months to determine if the end mesh is equivalent does nothing to address the question of counterfeit conduct, a criminal violation of the Trademark Counterfeiting Act, 18 U.S. C. 2320, the letter says. It defines counterfeiting as trafficking in goods and services using a counterfeit mark, documentation or packaging that is false or a counterfeit mark used to “cause confusion, to cause mistake or to deceive,” and then traffic in those goods or services knowing they could cause harm.
The letter calls for the mesh product to be immediately recalled if the company violated federal counterfeit laws and Mostyn urges the FDA to immediately work with the Department of Justice for guidance.
Criminal penalties can range from 20 years in prison for serious bodily injury to $15 million fine for an organization. The penalties for dealing in counterfeit products are outlined in the Food and Drug Administration Safety and Innovation Act of 2012. The government has to prove the company has an awareness or firm believe that the mark used was counterfeit.
“Knowledge can also be proved with evidence that the defendant acted with willful blindness, conscious avoidance, or deliberate ignorance, which means the defendant ‘deliberately closed his eyes to whatever otherwise would have been obvious to him concerning the fact in question.”~Prosecuting Intellectual Property Crimes, 2013
On January 12, 2016, West Virginia resident Teresa Stevens filed a class action lawsuit alleging Racketeer Influenced and Corrupt Organizations Act (RICO) and filed a motion asking Judge Goodwin to stop the sale of Boston Scientific pelvic mesh. Judge Goodwin denied the motion and requested the FDA to look at the issue.
A citizen petition was filed the day the FDA issued its safety alert.
Evidence uncovered lays out a prima facia case of counterfeiting including:
*BSC lacked normal documentation that would accompany raw material
*BSC did not have import documentation for the raw PP resin to show it was originally imported to China
*Internal BSC documents list two different raw material suppliers in China
*BSC knew the companies counterfeited material yet it purchased the product from EMAI Plastic Raw Material
*The purchase price was unusually low compared to the current market price
*BSC split up the supplies and send them to different ports
*Their original supplier, Phillips had alerted BSC the lot numbers on the bags of raw material was invalid.
*Another division of BSC had rejected the plastic resin from the same distributor because the lot number was invalid and alerted all divisions of BSC.The Marlex bags said the polypropylene raw material came from La Porte but ended up being imported from China.
“How did all of this resin end up in China if it was made in Texas?” says an email from BSC’s import/export coordinator Robert Mullally (click on image at lower right).
The red circles indicate copies of trademarks registered in the US Patent and Trademark Office for companies such as Phillips Sumika, but the lot number was invalid (see image on left) and BSC had confirmed that fact, something Mostyn calls “direct evidence of trafficking in counterfeit goods by BSC.”
Trademarks are also important to the International Origination for Standardization (ISO) (here) which assures products are safe, reliable and consistent in their production.
The FDA should on its own contact the Department of Justice for guidance on the alleged criminal behavior, the firm asks.
Boston Scientific is facing 20,790 product liability lawsuits consolidated in multidistrict litigation in Charleston, WV. #
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25 Years of Big Pharma—Profits, Lost lives and Litigation, Part 1
Apr 12, 2016 | Black Voice News
By S.E. Williams
On March 31, the non-profit consumer rights advocacy group Public Citizen released an update to its 2012 analysis of all major financial settlements and court judgments between pharmaceutical manufacturers and federal and state governments. The new report covered the period 1991 through 2015—the original report ended in July of 2012.
The updated report revealed the pharmaceutical industry paid more than 30 billion dollars to settle allegations of numerous violations. Between 1991 and 2015 there were a total of 373 settlements reached between the federal and state governments and pharmaceutical manufacturers for a total of 35.7 billion dollars; 140 were settled at the federal level for 31.9 billion dollars and 233 were state settlements that totaled 3.8 billion dollars. Twenty-nine states and the District of Columbia reached at least one single-state settlement with a pharmaceutical company during the 25-year period studied.
Last May, the California Supreme Court slammed the industry in litigation related to a pay-for-delay scheme. Pay-for-delay agreements are situations where patent holders agree to make a payment to potential competitors who threaten to enter the market and challenge the patent holder’s right to the patent thus delaying when the competitor enters the market and keeping the price of the product high.
The ruling confirmed a consumer’s right to challenge pharmaceutical pay-for- delay settlements under the state‘s competition law. The California Supreme Court ruling reversed the summary judgment granted to Bayer and Barr whose $398.1 million deal blocked for almost seven years, access to a generic and more affordable version of the widely prescribed antibiotic, Cipro. The court declared, “[P]arties illegally restrain trade when they privately agree to substitute consensual monopoly in place of potential competition.”
In May 2014, two Los Angeles Counties, Santa Clara and Orange, sued five of the nation’s largest drug companies claiming they were creating a population of addicts to reap block buster profits on narcotic painkillers. They counties accused the industry of the fraudulent marketing of addictive pain killers in order to undermine the effect of warning labels required by the U.S. Drug Administration. As a result, according to the plaintiffs, the companies boosted sales of dangerous drugs and risked public health in the process. Of course, the companies denied these allegations.
In August 2015, an Orange County Superior Court Judge ruled in favor of the drug companies who had argued the case be dismissed on the grounds the Federal Drug Administration (FDA) had jurisdiction over the case and that having a single point of oversight best served the public interest. According to the drug companies, the FDA process was more efficient, relied on regulators’ specialized expertise and prevents confusion. The judge agreed, but did not dismiss the case. Instead, he placed it in suspend status until the FDA process is completed.In the meantime, Big Pharma continues to operate with impunity even as deaths, particularly of teens due to abuse of prescription painkillers, continue to increase.
In the meantime, people are dying. The facts are startling. In 2013, more Americans died from prescription and illegal drug overdoses than from car accidents or guns and yet there appears to be no real clear sense of urgency on the part of government officials to find a solution to this dilemma. In the meantime, Big Pharma continues to operate with impunity even as deaths, particularly of teens due to abuse of prescription painkillers, continue to increase.
However, painkillers are not the only culprits. Last year there were several large settlements against the industry for numbered and varied reasons.
In October 2015, Takeda Pharmaceuticals settled thousands of Actos bladder cancer lawsuits for 2.4 billion dollars—one of the largest settlements in drug and device history. This came on the heels of a 2014 nine billion dollars jury verdict against the company in favor of a plaintiff who was diagnosed with bladder cancer after taking Actos—Actos is a diabetes medication.
Last year also saw 748 million dollars awarded in Transvaginal Mesh Lawsuits against a variety of companies; and yet, more than 70,000 Transvaginal Mesh lawsuits against seven companies are still pending in federal, multi-district litigation and thousands more are pending in state courts.
Also in 2015, Stryker Corporation paid 1.4 billion dollars to settle hip implant cases; there was an 11 million dollar jury verdict against Wright Conserve; and the company Zimmer Biomet lost a 9.2 million dollar case.
Johnson & Johnson paid millions last year as well. That case involved lawsuits related to its antipsychotic drug Risperdal that cause men and boys to grow female-type breasts. There are millions of dollars in Risperdal cases still pending across the nation.
Another Big Pharma lawsuit settled last year involved a piece of surgical equipment identified as a power morcellator, a drill-like device with sharp blades used to remove fibroids and perform hysterectomies. In 2014 this equipment was found to spread undiagnosed uterine cancer.
In addition, from 1991 through 2015, the overcharging of government health insurance programs, mainly drug pricing fraud against state Medicaid programs, was the most common violation, while the unlawful promotion of drugs as the single violation that resulted in the largest financial penalties.
Beginning in 1991 through 2015, GlaxoSmithKline and Pfizer reached the most settlements, thirty-one each and paid the most in financial penalties, $7.9 billion and $3.9 billion, respectively. In addition, Johnson & Johnson, Merck, Abbott, Eli Lilly, Teva, Schering-Plough, Novartis, and AstraZeneca also paid more than $1 billion each in financial penalties.
Thirty-one companies entered into repeat settlements with the federal government during the report period. The companies with the most multiple settlement agreements included in descending order Pfizer, Merck, GlaxoSmithKline, Novartis, and Bristol-Myers Squibb.
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