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Defective Products

This archive displays posts tagged as relevant to defective pharmaceuticals and medical devices. You may also be interested in our pages:

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July 24, 2020

Several divisions of pharmaceutical company Indivior, which marketed of the opioid-addiction drug Suboxone, pleaded guilty to felony healthcare fraud, entered into a five-year Corporate Integrity Agreement, and will pay a total of $600 million in criminal fines, restitution, civil damages, and penalties.  In six separate cases brought by whistleblowers, Indivior was also alleged to have caused false claims to be submitted to government healthcare programs including by promoting the sale of Suboxone to physicians who were prescribing it outside of medically accepted indication, misrepresenting the likelihood of Suboxone being diverted, and taking steps to delay generic competition for Suboxone. Indivior admitted making false statements about the safety of the film version of Suboxone in order to promote its sale.  In addition, the FTC claimed that violated antitrust laws through a deceptive scheme to thwart lower priced generic competition with Suboxone.  The total settlement consists of criminal restitution of $289 million; a civil settlement of $300 million, with $209.3 million paid to resolve claims by the federal government and $90.7 million to participating states; and, $10 million in penalties to the Federal Trade Commission.  The settlement also requires Indivior to take steps including the dissolution of its Suboxone sales force. Indivior was until 2014 a subsidiary of Reckitt Benckiser Group PLC, which previously paid $1.4 billion to resolve claims related to Suboxone marketing.  DOJ; USAO NJ; FTC

January 30, 2020

Johnson & Johnson has been ordered to pay $344 million to the State of California for misrepresenting the safety of its pelvic mesh implants, which were sold from 2008 to 2014 and have resulted in over 35,000 personal injury lawsuits nationwide.  The State of California brought suit in 2016 after finding the company failed to inform patients and their doctors of possible severe complications, including chronic pain and permanent dysfunctional elimination.  Johnson and Johnson previously settled similar allegations with some 40 other states, for $117 million, in October of last year.  CA AG

October 17, 2019

Johnson & Johnson and its subsidiary, Ethicon, Inc., have agreed to pay $116.9 million to 41 states and the District of Columbia for endangering the health of women nationwide by deceptively marketing transvaginal surgical mesh devices and failing to adequately disclose possible serious complications.  A multistate investigation found that both Johnson & Johnson and Ethicon knew of the risks—including chronic pain and inflammation, fistula formation, incontinence, and mesh extrusion and erosion into the body—yet failed to warn consumers or their physicians.  As part of the settlement, the companies must refrain from falsely describing the mesh as “FDA approved,” as well as provide full disclosure of the device’s risks.  DE AG; PA AG; MI AG; NY AG; SC AG; TX AG

March 23, 2018

Massachusetts-based medical device manufacturer Alere Inc. agreed to pay $33.2 million to resolve allegations that Alere violated the False Claims Act by causing hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by knowingly selling unreliable point-of-care diagnostic testing devices marketed under the trade name Triage. According to the government, Alere received customer complaints that put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making. Nonetheless, the company failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Amanda Wu, who formerly worked for Alere as a senior quality control analyst. She will receive a whistleblower award of roughly $5.6 million from the proceeds of the government's recovery. DOJ

Alere to Pay $33.2 Million to Settle FCA Allegations Relating to Unreliable Diagnostic Testing Devices

Posted  03/23/18
By the C|C Whistleblower Lawyer Team Massachusetts-based medical device manufacturer Alere Inc. and its subsidiary Alere San Diego have agreed to pay the United States $33.2 million to resolve allegations that Alere caused hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices, the Justice...

January 19, 2018

A federal court in New Jersey imposed a $5 million civil penalty and entered a permanent injunction against Dr. Reddy’s Laboratories Inc., the North American subsidiary of Indian pharmaceutical company Dr. Reddy’s Laboratories Limited, for failing to comply with the Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act. Specifically, the company distributed household oral prescription drugs in blister packs that were not child resistant as required by the PPPA and despite being warned by its own employees that the blister packs had not been tested for PPPA compliance and that certain blister packs were expected to fail the PPPA’s child test protocol. DOJ

December 13th, 2017

Illinois announced a $12 million settlement with a company that manufactures a device used primarily in spinal surgeries. The settlement with Medtronic Sofamor Danek, Inc. and Medtronic Sofamor Danek USA, Inc. (Medtronic) resolves allegations that the company misled consumers about the safety of its Infuse® Bone Graft Device. According to Madigan’s complaint, Medtronic used deceptive company-sponsored scientific literature to make false and misleading claims about Infuse’s safety, effectiveness and quality. The false marketing created an artificial demand for Infuse in a range of fusion surgeries. The company’s fraudulent conduct was the subject of a 16-month investigation by the U.S. Senate Finance Committee. IL

October 13, 2016

Twenty-nine defendants who sold Auravie, Dellure, LéOR Skincare, and Miracle Face Kit branded skincare products have agreed to court orders with the FTC or had default orders entered against them. Jessica Rich, director of the FTC’s Bureau of Consumer Protection, said “these defendants tricked people into paying for skin care products and abused the credit card system to extend their scheme.” The agency’s original complaint, filed in June 2015, charged seven individuals and 15 companies with selling their skincare products through false advertisements for “risk-free trials.” According to the FTC, the defendants convinced consumers to provide their credit card information, purportedly to pay nominal shipping fees. However, the defendants allegedly used consumers’ credit card information to impose unauthorized recurring monthly charges of up to $97.88 per month for unordered products. FTC

September 9, 2016

Dmitriy V. Melnik, the owner and operator of Candy Color Lenses, a major online retailer of colored contact lenses, pleaded guilty to importing counterfeit and misbranded contact lenses from suppliers in Asia and then selling them over the internet without a prescription to tens of thousands of customers around the country.  According to the plea agreement, Melnik imported large quantities of colored contact lenses from China and South Korea that he knew were counterfeit and/or unauthorized by the FDA and many of which bore labels with counterfeit trademarks for Ciba Vision FreshLook COLORBLENDS, which are manufactured by Novartis International AG.  Melnik admitted that some of the contact lenses he sold were contaminated with potentially hazardous bacteria.  DOJ

July 6, 2016

New Jersey-based Pharmaceutical Innovations Inc. pleaded guilty to criminal charges and resolved a civil lawsuit arising from the company’s distribution of ultrasound gel contaminated with bacteria.  In addition to placing the company on two years probation, the court ordered the company to pay a criminal fine of $50,000 and to forfeit an additional $50,000 – the approximate value of the adulterated gel.  DOJ
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