The fact that it was a short week and one in which the East Coast and a good deal of the South were experiencing a weather challenge means that there was not as much action as might otherwise be happening.
But I am taking advantage of the rather slow week to make a few observations as we make the transition from the sleepy holiday time to our regular course of business as well as providing the latest out of FDA.
Commissioner Announces New Steps to Speed Generics – In what has been a regular event now, Commissioner Gottlieb issued a media statement outlining new steps to enhance review of generic drugs that are part of the Drug Competition Action Plan announced in June, 2017.
While FDA is limited in what it can do on pricing, the swift approval of generics is one means to bring down costs and Commissioner Gottlieb noted that FDA took action on more applications in the last six months of 2017 than in any other 6-month period in the agency’s history.
OPDP Issues Warning Letter – With the close of 2018, enforcement by OPDP as expressed by the issuance of Warning or Untitled letters hit an all time low after trending lower the past few years.
While it is still possible for a 2017 letter to be posted, in mid-December FDA issued its fourth letter of the year.
It is the second letter of the year addressing an Exhibit Panel and the second letter of the year for a weight loss treatment.
The FDA added the new 2018 Advisory Committee Tentative Meetings Page on the agency website, but did not list any potential dates for meetings.
In short, this page no longer appears to have any relevance over the more up-to-date page of FDA Scheduled Advisory Committee Meetings.
January 9 and 10 – Meetings of Bone, Reproductive and Urologic Drugs Advisory Committee Meeting – to consider two NDAs, both oral testosterone replacement therapies – January 9 here, and January 10 here.
A woman suffering from permanent hair loss from chemotherapy has filed a lawsuit against the makers of Taxotere.
Marilyn says she received chemotherapy treatments for cancer in 2009.
She was aware that temporary hair loss from chemotherapy was a possible side effect, but she says she was unaware that Taxotere could lead to permanent hair loss, also known as permanent alopecia.
The drug is in a family of medications known as taxanes, which are chemotherapy agents derived from plants.
At first, Taxotere was approved by the FDA in May 1996 as a treatment for patients with advanced breast cancer after previous chemotherapy treatments failed.
The outcomes allegedly led Sanofi to claim superiority of Taxotere over other chemotherapy drugs that were approved to treat breast cancer.
Armed with those in-house results, Taxotere’s “marketing claims included claims of superior efficacy over the lower potency taxane product paclitaxel (Taxol), which was the primary competitor product to Taxotere,” says the master complaint from the Taxotere multidistrict litigation.
The company knew in 2005 that the study showed 9.2 percent of patients who underwent Taxotere treatments had persistent hair loss from chemotherapy for up to 10 years and five months.
Plaintiffs say the test results were withheld from U.S. healthcare providers and patients.
The Hair Loss from Chemotherapy Lawsuit is Case No.
Many patients have undergone hip replacement surgery to relieve severe hip pain or mend a joint that can only fixed through hip revision surgery.
A popular joint replacement device that is available to many patients is the DePuy ASR hip system.
However, many patients have complained of serious problems associated with their DePuy ASR hip system citing early failure and the need for revision surgery.
Those who have been implanted with a DePuy ASR hip system have complained that they have suffered from a host of difficulties as a result of their DePuy hip replacement.
Revision surgery is often much more complicated than the original implantation surgery.
But many DePuy ASR hip system devices last as little as five or seven years before the patient experiences complications.
The manufacturers of the DePuy ASR hip system are up against approximately 8,000 lawsuits regarding the DePuy ASR hip system and the DePuy Pinnacle hip system.
DePuy’s own website suggests that patients see a doctor to have their DePuy ASR hip system evaluated.
Other models of DePuy hip systems are also under fire.
Most recently, six plaintiffs were awarded a total of $247 million because of their injury claims regarding the DePuy Pinnacle hip system.
An Arthrex tibial tray recall was issued in March 2016, after the company discovered a problem with the knee implant.
According to the Arthrex tibial tray recall, the outer part of the knee implant had a smooth texture that made it incompatible with other components with a rough texture.
This incompatibility ultimately spurred the company to issue the Arthrex tibial tray recall.
The Arthrex tibial tray is a component of the Arthrex iBalance Total Knee Arthroplasty (TKA) system, which was designed to restore knee joints that were seriously damaged by disease or injury.
Arthrex marketed the iBalance TKA as an alternative to total knee replacement implants, with the company designing the product to reduce the need for revision surgery.
Typical knee replacement surgery involves using plastic or metal caps placed on the end of the bones, to form the knee joint and kneecap.
The iBalance TKA was approved through the FDA’s 510(k) process, which allows a medical device to be released into the market without the same preclinical testing as fully new devices.
Arthex reportedly sent Urgent Medical Device Voluntary Recall letters to distributors and healthcare facilities, with approximately 2,378 Arthrex iBalance tibial trays withdrawn from the market.
Three major knee replacement implant manufacturers have recently issued recalls, with DePuy and Exactech performing the same action as Arthrex.
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One thing is certain, it has been a busy year for FDA and on many levels, it was a game-changing time.
There were many more approvals of new molecular entities during 2017 (46) than there were last year and the total number just exceeded that of 2015 which was a huge year for approvals (45).
And it is not just the number of approvals, but there have been a number of “firsts” this year, including the first prescription app for use in treating opioid addiction.
Many of the releases this year were special statements by the Commissioner to provide additional commentary on developments at the agency.
Approvals in Cancer Treatments – Reviewing the list of approvals of new molecular entities for 2015, FDA has approved 12 new cancer-related treatments which is 8 more than were announced by FDA in 2016 and nearly as many as were approved in the banner year of 2015.
It is not just the number of cancer treatment approvals, but the scope as well.
There were a large number of approvals aimed at types of blood based cancers – AML/leukemia as well as breast cancer and the approval of the first biosimilar for use in breast and stomach cancer.
The August approval was for the treatment of acute lymphoblastic leukemia (ALL) and the second approval in October was for certain types of B-Cell lymphoma.
In July the agency announced a framework to facilitate the development and approval of digital health devices by releasing the Digital Health Innovation Action Plan which included a program for developers of devices and software to be pre-certified, shifting from a focus solely on the device to the entity that is developing it, characterizing the balance that FDA is seeking to strike between fostering innovation in fast-paced sector with ensuring high quality and safety of products.
Photos: Cancer Cell – NIH Image Gallery; CAR-T Schematic – National Cancer Institute; Stem Cell Photo- NIH Stem Cell Information; Dr. Scott Gottlieb – Senate HELP Committee
An opioid epidemic lawsuit was filed by shareholders of the company alleging these agreements were not kept by the corporation.
The named defendants in the lawsuit are individuals who operated as part of the board of trustee’s audit committee and were responsible for risk assessment, protection, and full compliance of the settlement agreement.
The filing plaintiff is a McKesson shareholder named Chalie S. Charlie accuses the corporation of failing to adhere to its own settlement terms by failing to flag suspicious and redundant opioid orders from the pharmacies that sparked the initial lawsuit in the first place.
They also were accused of filling orders by shady online pharmacies that did not require current prescriptions for opioids.
Opioid doses were allowed to flow outward from the drug distribution giant in an easily divertible manner, causing the corporation to contribute to the current opioid crisis in the U.S.
The lawsuit alleges that the board’s audit committee didn’t further discuss the need for improvement or how to make changes until 2013 when the DEA subpoenaed shipment records from McKesson warehouses.
This opioid epidemic lawsuit filed by a shareholder questions whether the massive profit last year and for many years was gained on the backs of people that have suffered addiction or even died from it.
The Opioid Epidemic Lawsuit is Case No.
In general, opioid addiction lawsuits are filed individually by each plaintiff and are not class actions.
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Johnson & Johnson and its subsidiary Ethicon Inc. face a new Proceed hernia mesh lawsuit filed by a Louisiana woman alleging she suffered severe injuries after undergoing hernia mesh repair surgery.
Plaintiff Shawanna S. filed the lawsuit on Dec 11, 2017, in Louisiana federal court.
According to the Proceed hernia mesh lawsuit, Shawanna says she was implanted with the Proceed hernia mesh, a product that utilizes a light-weight polypropylene, in December 2015.
As a result of the Proceed hernia mesh implant, she suffered from injuries including pain, hernia mesh recurrence, and having to undergo another surgery, the Proceed hernia mesh lawsuit states.
The Proceed hernia mesh lawsuit is filed on multiple counts including breach of express warranty, negligence, redhibition, breach of warranty of fitness for ordinary use, and breach of implied warranty.
According to the Proceed hernia mesh lawsuit, the Proceed hernia mesh utilizes a light-weight polypropylene.
Allegations contend that to reduce the adverse effects caused by the polypropylene, the company decided to add a protective layer to the Proceed hernia mesh.
The added protective layer is made of an oxidized cellulose, which, along with the polypropylene layer, is hit with radiation through a sterilization method.
Studies have examined the effects of sterilization methods on polypropylene such as one published in 2003 titled Sterilization Effects on Polypropylene: Technology and Polymer Type Effects.
Several hernia mesh products have been linked to severe complications and adverse effects, including Ethicon’s Proceed and Physiomesh hernia mesh, Covidien’s Parietex, Atrium’s C-Qur, and C.R.
The multidistrict litigation, or MDL, was developed in response to the large number of lawsuits with similar allegations filed after the Stryker LFIT V40 recall.
Husband and wife plaintiffs Jean W. and William W., residents of Wisconsin, jointly brought forth this claim against the metal hip implant manufacturer.
She was implanted with the LFIT femoral head that subsequently became part of the Stryker LFIT V40 recall.
In April 2017, Jean had the femoral head subject to the Stryker LFIT V40 recall explanted.
Jean claims she suffered injury to herself, and William claims loss of consortium and loss of services as a result of Jean’s implantation with the Stryker metal hip.
The problems Jean suffered and those that plagued William as a result were allegedly due to the device component that was subject to the Stryker LFIT V40 recall.
These excess levels of cobalt and chromium in Jean’s blood resutled from defects in the hip implant, the couple claims.
This metal debris can cause local adverse tissue reactions and can cause tissue death, also known as necrosis.
The couple is seeking compensatory damages, statutory damages, attorneys’ fees and costs, prejudgment interest, costs of suit, restitution, disgorgement of profits and any additional relief deemed just and proper by the Court.
The Stryker LFIT V40 Recall Lawsuit is Case No.
This medication, originally developed to treat cancer, is placed into syringes lubricated with silicone oil, then injected into the eyes.
The preparation of Avastin for injection could cause patients to develop Avastin injection floaters as the silicone oil leaks into patients’ eyes.
The drug is also prescribed to treat diabetic eye disease and other problems associated with the retina.
Avastin prevents the VEGF chemical from being made, thus preventing the excessive growth of blood vessels, and the diabetic eye disease and vision loss that follows when abnormal blood vessels leak and affect eye vision.
These syringes may be lubricated with silicone oil.
By the time the drug is injected into the patients’ eye, the silicone oil may migrate from the syringe’s needle, plunger, and barrel, and it mixes in with the Avastin drug itself.
This leads to a multitude of patient complications including their development of Avastin injection floaters.
The preparation of Avastin by compounding pharmacies has also increased the risk that an Avastin injection may cause bacterial eye infection.
In addition, one patient developed brain damage due to the bacterial eye infection.
Because of bacterial eye infection resulting from Avastin eye injections, the U.S. Food and Drug Administration (FDA) announced a recall of the syringes from specific pharmacies found to be the source of the bacteria.
Johnson & Johnson and Bayer HealthCare face a growing litigation consisting of Xarelto uncontrolled bleeding claims and Xarelto wrongful death allegations.
One of the most recent claims is a Xarelto wrongful death lawsuit from a woman alleging her loved one was not adequately warned against potential Xarelto uncontrolled bleeding.
Plaintiff Therese S. is filing this Xarelto wrongful death lawsuit on behalf of her loved one Adele S., who allegedly died from Xarelto uncontrolled bleeding.
This was allegedly the case of Adele, who allegedly died from Xarelto uncontrolled bleeding soon after her prescription began.
Xarelto was approved by the FDA in 2011 and is the second in line in the new generation anticoagulant medication class.
However, not long after its release, numerous patients began reporting incidents of Xarelto uncontrolled bleeding.
This feature reportedly made Pradaxa significantly more popular than warfarin, but it could also be a contributing factor to the numerous injury reports.
Even though Xarelto uncontrolled bleeding can be potentially fatal for patients, Bayer and Johnson & Johnson allegedly failed to warn against the possibility.
Therese is filing her Xarelto wrongful death lawsuit in MDL No.
Therese states Adele would not have used the medication if she had been aware of potential Xarelto uncontrolled bleeding.