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Endo 'reviewing options' for its incontinence device due to closure of its women's health unit
Apr 8, 2016 | Fierce Medical Devices
By Varun Saxena
Endo ($ENDP) is pulling out of the vaginal mesh business due to billions of dollars of litigation costs associated with the (often hazardous) devices for pelvic organ prolapse and urinary incontinence. -
Proposed FDA Powdered Glove Ban: Effect On Device Makers
Apr 8, 2016 | Law 360
By Nancy Stade, Brigid DeCoursey Bondoc, Andrew R. Van Haudte, Sydney Austin LLP
...This historic announcement from the FDA comes amidst calls for bans from a number of patient groups concerned about the safety of medical devices, such as vaginal mesh devices, power morcellators, certain birth control implants and metal-on-metal hip implants. -
Benicar MDL Defendants Can Hire Plaintiffs' Doctors as Experts
Apr 8, 2016 | New Jersey Law Journal
By Charles Toutant
...In allowing the defense to contact the plaintiffs' physicians about their retention as defense experts, Schneider said motions requesting such relief have become de rigueur in multidistrict litigation, including in the Xarelto litigation, as well as cases concerning the antipsychotic drug Seroquel and pelvic mesh products. -
Rising Star: Beasley Allen's Danielle Mason
Apr 11, 2016 | Law 360
By Jeff Overley
Danielle W. Mason of Beasley Allen Crow Methvin Portis & Miles PC blazed a new litigation trail by securing a $72 million verdict against Johnson & Johnson over a cancer death linked to talcum powder, placing her among Law360’s top life sciences lawyers under 40.
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Endo 'reviewing options' for its incontinence device due to closure of its women's health unit
Apr 8, 2016 | Fierce Medical Devices
By Varun Saxena
Endo ($ENDP) is pulling out of the vaginal mesh business due to billions of dollars of litigation costs associated with the (often hazardous) devices for pelvic organ prolapse and urinary incontinence. But the company has said that its investigational mesh-based Topas device to treat fecal incontinence among women "does not require transvaginal incision, or any incision or modifications to the pelvic floor muscle, and thus has a different safety profile than transvaginal mesh device." As a result, it could represent a viable financial opportunity. In light of the pending closure of Astora Women's Health, Endo is reviewing its best options for the "valuable" device, and has notified FDA accordingly, a company spokeswoman told FierceMedicalDevices. The agency's review process is continuing. In spite of the inevitable comparisons to vaginal mesh, the FDA's Gastroenterology-Urology Devices Panel unanimously voted that the device is safe and effective, making approval likely. It seems like a company that it is committed to devices will have the opportunity to commercialize the Topas, assuming it is willing to pay Endo an appropriate sum for the rights to the development program and technology.
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Proposed FDA Powdered Glove Ban: Effect On Device Makers
Apr 8, 2016 | Law 360
By Nancy Stade, Brigid DeCoursey Bondoc, Andrew R. Van Haudte, Sydney Austin LLP
On March 22, the U.S. Food and Drug Administration published aFederal Register notice proposing to ban powdered surgeons’ gloves, powdered patient evaluation gloves and absorbable powder for lubricating surgeons’ gloves. The announcement is noteworthy because the FDA has invoked its authority to ban a device only one other time in its history — to prohibit the manufacturing and distribution of prosthetic hair fibers in 1983 — despite having authority to do so since 1976. This proposal occurs in the context of multiple calls for bans from patient groups and some indication that the FDA may be dusting off this little-used authority for greater use. A closer look, however, suggests that the FDA’s interest in banning has occurred in response to close FDA scrutiny of extraordinary circumstances unlikely to repeat themselves except in unusual cases.
Section 516 of the Federal Food, Drug and Cosmetic Act (FDCA) grants the FDA the authority to ban, by regulation, any device the agency finds to present “an unreasonable and substantial risk of illness or injury” when that risk cannot be “corrected or eliminated by labeling or [a] change in labeling.” 21 U.S.C. § 360f.
Powder, most typically cornstarch, is a commonly used lubricant in surgeons’ gloves and patient evaluation gloves. According to the proposed regulation, the FDA has had longstanding concerns with powdered gloves. The agency was aware that “glove powder could cause inflammation and granulomas, and that aerosolized glove powder on natural rubber latex (NRL) gloves can carry allergenic proteins that have the potential to cause respiratory allergic reactions” as early as 1997, when it considered banning powdered gloves. Ultimately, the agency determined that no effective and widely available alternative existed at the time for glove lubrication. The most common alternative, chlorination, carried risks of damage to the gloves if not performed properly, and more effective alternatives, such as polymer coatings, were too expensive for widespread adoption.
After receiving several citizen petitions on the issue, the FDA published a request for comments on the use of powdered gloves, specifically on their risks and benefits, 76 Fed. Reg. 6684 (Feb. 7, 2011), and published a draft guidance recommending voluntary warnings on powdered gloves.
As described in detail in the proposed regulation, the FDA no longer believes that a warning in the product labeling would correct or eliminate the risks. The agency has concluded “that the risks posed by powdered gloves, including health care worker and patient sensitization to NRL allergens, surgical complications related to peritoneal adhesions, and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder, outweigh the benefits that these devices pose to patients.” The FDA also reviewed the available commercial information on sources for medical gloves, relative numbers and types of gloves and the costs of different glove types and concluded “both industry and glove users appear to be shifting away from the use of powdered gloves, which has led to an increase in the manufacturing and usage of alternative nonpowdered gloves” and that “powdered gloves now lag behind the state of the art.” According to the proposed regulation, the current state of the art includes numerous nonpowdered latex and synthetic gloves that are “readily available and that do not carry the risks posed by powdered gloves” and that are as easily donned as powdered gloves. In sum, the agency concluded that the benefits provided by powdered gloves are minimal and do not outweigh the risk of injury or illness.
The proposed regulation, if finalized, will amend the classification regulations for powdered surgeons’ gloves, 21 C.F.R. § 878.4460, powdered patient examination gloves, 21 C.F.R. § 880.6250, and absorbable powder for lubricating surgeons’ gloves, 21 C.F.R. § 878.4480, to make clear that the regulations apply only to nonpowdered gloves and will add the powdered versions of each glove type to the listing of banned devices in 21 C.F.R. Part 895. The ban would apply to powdered gloves currently used in the marketplace, making them adulterated and subject to enforcement action under the FDCA 21 U.S.C. § 351(g).
Other regulatory authorities and health care systems have already either banned or restricted the use of glove powder, and professional organizations, including the National Institute for Occupational Safety and Health, the American College of Surgeons and the American Nurses Association, have issued statements discouraging the use of powdered gloves.
This historic announcement from the FDA comes amidst calls for bans from a number of patient groups concerned about the safety of medical devices, such as vaginal mesh devices, power morcellators, certain birth control implants and metal-on-metal hip implants. So far, the FDA has not concluded there is sufficient scientific evidence of harm outweighing the clinical utility of any of these products and has responded by increasing its regulatory oversight in other ways, such as by reclassifying the device into Class III to require clinical data establishing that the benefits of the device outweigh the risks, moving to strengthen labeling statements or requiring post-market studies.
Although the FDA solicited the input of advisory panels on each of these devices, the FDA did not ask the panels to consider whether any of these devices met the criteria for banning. In contrast, banning was front and center in the panel materials for the neurological devices panel that met in April 2014 to consider the risks and benefits of electrical stimulation devices (ESDs) for aversive conditioning. The meeting was attended by representatives from the Judge Rotenberg Center (JRC) in Massachusetts, the only known facility in the country where the device is still being used to provide aversive conditioning to patients with self-injurious behavior (SIB) and aggressive behavior who had been diagnosed with autism or other developmental disabilities. JRC had received an untitled letter in 2011 and a warning letter in 2012 after disagreements with the agency over whether the devices required additional 510(k) clearances.
The JRC representatives provided background information about the use of the aversive conditioning device on patients “with extraordinary behavior disorders who have been expelled from or refused admission to other treatment centers.” A number of patient advocacy and civil rights groups testified before the panel as well, which also considered student and parent testimonies, anecdotal case histories and reports including a United Nations report likening use of the device to torture. Although a majority of the panel reached factual conclusions that would support a ban, the panel also concluded that the device could be ethically studied to improve the understanding of its risk-benefit profile so long as treatment was administered only by licensed health professionals, patient sequelae were adequately documented and use was limited to SIB and aggressive patients who have significant morbidity or life-threatening SIB.
In sum, though the recent proposal to ban powdered gloves comes close on the heels of actions showing renewed public interest in a ban, there are only two data points supporting any interest by the FDA in taking this extraordinary action. These two data points should not be mistaken for a trend. At most, they show that the Center for Devices and Radiological Health is willing to be more aggressive in putting problem devices to a rigorous risk-benefit analysis and to explore banning in cases where no demonstrated clinical benefit to patients exists and the balance is extremely lopsided. Overall, taking the example of the ESD aversive conditioning device and the proposed powdered glove action together suggests that banning may be the regulatory tool of choice only where the balance of harm versus utility is overwhelming and market forces have not resulted in the product’s complete removal from use. -
Benicar MDL Defendants Can Hire Plaintiffs' Doctors as Experts
Apr 8, 2016 | New Jersey Law Journal
By Charles Toutant
Drugmaker Daiichi-Sankyo has been granted permission in the multidistrict litigation over blood pressure drug Benicar to hire plaintiffs' prescribing physicians as experts or consultants for the defense. But a federal judge in New Jersey drew the line at the company's proposal to set restrictions on prescribing doctors' ex parte communications with plaintiffs and their attorneys.
Daiichi-Sankyo said in court papers that it sought approval for the measures as a way to prevent plaintiffs counsel from "woodshedding"—manipulating their clients' doctors' recollection of events and tainting their eventual testimony.
The company sought those measures as the parties prepare to select 20 bellwether cases out of some 1,300 that have been consolidated from around the country in federal court in Camden. The suits were filed by Benicar users who claim they suffered as many as 20 diarrhea attacks per day as well as other gastrointestinal effects.
U.S. Magistrate Judge Joel Schneider of the District of New Jersey said there was no credible evidence that plaintiffs counsel engaged in any improper contact with their clients' physicians. Nor is there any evidence that plaintiffs counsel made any efforts to steer the physicians' testimony regarding the defendants' liability, Schneider said In re Benicar (Olemesartan) Products Liability Litigation. The only instance the defense cited of plaintiffs lawyers coaching physicians in a products liability case was a 2013 California case involving a DePuy hip replacement joint, Schneider said.
The fact that the defendant cited only one instance out of thousands of mass tort and multidistrict litigation cases filed is "evidence that defendants are proposing a solution to a problem that does not exist," Schneider said.
Daiichi-Sankyo sought an order barring plaintiffs counsel from engaging in ex parte communications with plaintiffs' physicians regarding liability issues or theories, defendants' conduct, product warnings and documents produced in the case. The drugmaker said the order was needed to put the parties on "equal footing" and "as a matter of due process and fundamental fairness."
The company also argued that the restrictions were needed because some doctors are still prescribing Benicar and their analysis of the drug's risks and benefits might be unduly influenced by what they hear from plaintiffs attorneys. But Schneider called that concern "overblown," citing a ruling from the U.S. Circuit Court of Appeals for the Seventh Circuit in litigation related to the blood thinner Xarelto that said "physicians are learned professionals who have devoted themselves to the sciences. These individuals cannot be analogized to the cowed, reprimanded children referenced in the 'woodshed' idiom."
What's more, a physician-witness who is improperly coached faces the risk of being "obliterated" during cross-examination, Schneider said. In addition, defendants are free to question plaintiffs' physicians at depositions and at trial about their contacts with plaintiffs counsel, the judge said. Attempting to police communications between the physician and attorneys is "almost impossible and certainly problematic," he said.
In allowing the defense to contact the plaintiffs' physicians about their retention as defense experts, Schneider said motions requesting such relief have become de rigueur in multidistrict litigation, including in the Xarelto litigation, as well as cases concerning the antipsychotic drug Seroquel and pelvic mesh products. Schneider said a prohibition on hiring plaintiffs' doctors as defense experts would deprive defendants of a fair opportunity to present their case.
"At bottom, defendants' right to retain qualified experts may be impaired if plaintiffs' treating and prescribing physicians are completely off-limits," Schneider said.
Still, acknowledging the potential for misuse of such communications, he set rules to protect plaintiffs' interest. First, a plaintiff's physician cannot work on a case involving his or her current or former patient, or communicate about those patients. Second, no substantive communications can take place before a plaintiff's doctor expresses a bona fide interest in being considered as a retained expert. Third, defendants may only contact 25 physicians, but can have that number raised on the showing of good cause. And fourth, the physicians contacted shall be given a copy of the court's order before any material communications take place. Physicians are free to impose any further conditions they request, Schneider said.
The ruling carefully balanced the parties' interests, said Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, who represents the plaintiffs. He said the judge's decision not to restrict plaintiffs' communications with their doctors will have "a lot of significance outside of Benicar, across the board."
Slater said he thinks very few plaintiffs' doctors will accept offers to work for the defendants.
Defense lawyer Susan Sharko of Drinker Biddle & Reath in Florham Park did not respond to a call for comment on the decision.Drugmaker Daiichi-Sankyo has been granted permission in the multidistrict litigation over blood pressure drug Benicar to hire plaintiffs' prescribing physicians as experts or consultants for the defense. But a federal judge in New Jersey drew the line at the company's proposal to set restrictions on prescribing doctors' ex parte communications with plaintiffs and their attorneys.
Full text available here with subscription: http://www.njlawjournal.com/id=1202754507249/Benicar-MDL-Defendants-Can-Hire-Plaintiffs-Doctors-as-Experts?mcode=0&curindex=0&curpage=2
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Rising Star: Beasley Allen's Danielle Mason
Apr 11, 2016 | Law 360
By Jeff Overley
Danielle W. Mason ofBeasley Allen Crow Methvin Portis & Miles PC blazed a new litigation trail by securing a $72 million verdict against Johnson & Johnson over a cancer death linked to talcum powder, placing her among Law360’s top life sciences lawyers under 40.
The 38-year-old attorney, a newcomer to Law 360's Rising Stars list, has specialized in drug and device litigation since joining Beasley Allen in 2009. She made big marks even before the J&J verdict in February, and last year became the first African-American woman to make partner at Beasley Allen since the Alabama firm’s founding in 1979.
“Obviously, it’s always a great thing when you are given a distinction that no one else like you has had before,” Mason said. “It means to me that I have worked hard and proven myself.”
Some of Mason’s most prominent experience has involved injuries allegedly caused by generic versions of digestion drug Reglan, or metoclopramide, which has been linked to a nervous system disorder called tardive dyskinesia. She’s representing about 30 clients in suits that target Teva Pharmaceutical Industries Ltd., Allergan Inc. unit Watson Pharmaceuticals Inc. and Pfizer Inc. unit Hospira Inc., among others.
A central challenge is finding a way around the U.S. Supreme Court’s momentous 2011 decision in Pliva v. Mensing, which shielded generic-drug makers from failure-to-warn liability. Options include different legal theories, congressional action or regulatory changes allowing generics makers to unilaterally update their warning labels.
“It’s still a battle that we’re fighting,” Mason said. “We’re fighting it on a lot of different planes.”
She added that her clients are “always open to settlement and still working toward that end.”
Previously, Mason also had a hand in high-profile litigation centered on injuries involving transvaginal mesh implants and cancer cases tied to hormone replacement therapies. But it’s the J&J win that has sent her profile soaring.
Mason started mining the connection between talc and ovarian cancer in 2013, when a South Dakota jury found J&J liable for not warning of risks but didn’t award any damages. Her firm began taking out advertisements asking consumers to contact the firm if they had used talcum powder and been diagnosed with ovarian cancer, and thousands of calls came pouring in.
More than 1,000 cases have now been filed in St. Louis city court, creating a situation akin to multidistrict litigation at the federal court level. As with MDLs, bellwether trials are getting under way, and the first took place in February.
That trial involved the late Jacqueline Fox, who died in late 2015 of ovarian cancer that she blamed on her use of J&J baby powder for 35 years. Although Fox died before trial, Mason was able to play recordings of Fox’s deposition testimony before the jury, and she called it a gut-wrenching moment in the courtroom.
“Just hearing her voice — there wasn’t a dry eye in the room,” Mason said.
After four hours of deliberations, the nine-woman, three-man jury ordered J&J to pay $10 million in compensatory damages and $62 million in punitive damages. The outcome received heavy media attention, encouraging Beasley Allen’s team even more.
“I feel like what we’re doing is helping because we’re really getting the word out,” Mason said.
The verdict was a major breakthrough, but it also came in a case that Beasley Allen selected for its strong facts. The next case — which is just now getting under way — will be chosen from the pool of suits by J&J.
There are additional trials expected until early 2017. Because things are in their early stages, and because talcum powder has been widely used for decades, it’s possible that cases could play out for years to come, Mason said.
And if that happens, it could underscore what Mason said she values most about product liability litigation: its goal of ensuring that everyday goods are safe for Americans to use.
“It’s highly rewarding,” she said, “in the sense that we are making change on a large scale.”
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