Monday Morning Recap: The Week (9.22.14-9.28.14) in Drug & Device Law & Policy

September 29, 2014 by · Leave a Comment
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Picture3It’s that time again. Here’s our  Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. And once again, there’s been a lot going on…

1. On Friday, September 19th, the news broke that a Chinese court imposed a $500 million criminal fine on GlaxoSmithKline, which was accused of using third parties to pay bribes to doctors and hospitals in China. At the New York Times, Keith Bradsher and Chris Buckley highlighted the fact that “[i]n a rare move, authorities also prosecuted the foreign-born executive who ran Glaxo’s Chinese unit. After a one-day trial held in secrecy, the court sentenced Glaxo’s British former country manager, Mark Reilly, and four other company managers to potential prison terms of up to four years.” In a client alert, the law firm Davis Polk points out that “the Changsha Intermediate Court ruled that GSK violated Chinese laws prohibiting commercial bribery, rather than bribery of government officials. This suggests that Chinese authorities do not view the relevant healthcare professional to be government officials. However, this position does not preclude U.S. regulators from potentially penalizing GSK for bribery of foreign government officials, under the same facts, in violation of the Foreign Corrupt Practices Act; the U.S. regulators consider local law designations of ‘government official’ status as one of a number of factors when determining FCPA liability.

2. Also this week, as Roni Caryn Rabin reported at the New York Times, “the National Institutes of Health announced Tuesday that it will distribute $10.1 million in grants to more than 80 scientists studying a diverse array of subjects, including drug addiction, fetal development, migraines and stroke. The researchers will use the additional funds to include more human participants — generally women — in clinical trials and to ensure that their laboratory animals, even cell lines, are representative of both genders. The money also will be used to analyze gender differences in the resulting data[.]” Rabin quotes the NIH’s Dr. Janine Austin Clayton who said: “We literally know less about every aspect of female biology compared to male biology.”

3. On the device side, there were two interesting posts this week at Covington & Burling’s Inside Medical Devices blog. The first, by Tyler Evans, discussed a recently-settled False Claims Act case in which a device company was alleged to have failed to comply with the Trade Agreements Act when it “sold orthopedic devices on a federal supply schedule administered by the U.S. Department of Veterans Affairs (VA) after purchasing the devices from a third-party manufacturer in Malaysia.” Evans writes: “The settlement serves as a reminder to medical device manufacturers and suppliers that conducting due diligence regarding the country of origin of their products is typically necessary when doing business with the U.S. Government.  Medical device companies should be aware of the potential risk of comingling end products when sourcing items from countries that are not compliant with the TAA.”

4. The second post, by Brianne Bharkhda, highlights the importance of internal email to a jury in a products liability case. As Bharkhda explains, earlier this month, “a state court jury in Dallas awarded the plaintiffs in a pelvic mesh device litigation against Boston Scientific approximately $23.5 million in compensatory damages and $50 million in punitive damages.” At the trial, the plaintiffs introduced an August 2010 email in which “a Boston Scientific executive discussed a study published in December 2009 in the American Journal of Obstetrics and Gynecology comparing Boston Scientific’s Obtryx device with its Advantage sling system.  In the email, the executive stated, ‘I don’t feel this paper would be useful to the sales force in terms of helping defend business or selling more slings.’  ‘It actually is a fairly negative outcome in terms of our Obtryx sling.  I certainly wouldn’t hand this out to any physicians.’” As Bharkhda writes: “The . . . case is a prime example of how internal company communications can play a major, even decisive, role in medical device product liability trials.

 5. Finally, in an update circulated this past week, Sidley Austin writes that “[d]espite OIG guidance, Congressional reports, and press attention that has been critical of [physician-owned distributors ("PODs")], there was a noticeable lack of healthcare fraud and abuse enforcement activity involving PODs. That changed on September 8, 2014, when the Department of Justice (“DOJ”) filed a False Claims Act (“FCA”) suit against Reliance Medical Systems, LLC.  .  .  .  The medical device industry will want to follow Reliance closely as this case might signal either the start of an enforcement trend against PODs or simply reflect an action targeting a network of PODs that allegedly paid particularly lucrative profits to physicians, while placing intense pressure on them to increase utilization of Reliance devices.

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Lessons from Miss Idaho: Greater Acceptance of (but Not Necessarily Greater Access to) Diabetes Devices

Kate Greenwood Portrait

Cross-Posted at Bill of Health

Given the health law and policy topics that are this blog’s usual fare, some of you may have missed the fact that earlier this month the eighty-eighth annual Miss America pageant was held here in New Jersey, at Boardwalk Hall in Atlantic City. And you may have also missed it (I did) when, this past July, Miss Idaho, Sierra Sandison, a Type 1 diabetic, became a social and traditional media sensation after she competed in the swimsuit competition with her insulin pump clipped to her bikini bottom, visible for all to see. Sandison started a hashtag, #showmeyourpump, inspiring Type 1 diabetics from around the world to post photos of themselves with their pumps.

Although Sandison was the first contestant to compete in the Miss America pageant with her pump visible, she is not the first contestant with Type 1 diabetes, or the first to rely on a pump. In 1998, both Deana Herrerra, Miss New York, and Nicole Johnson, Miss Virginia, had the disease, and both relied on pumps to control it. Johnson went on to be crowned Miss America 1999, with a platform of diabetes awareness. Johnson explained to the Philadelphia Inquirer that, before getting the pump, “‘I stuck myself four or five times a day. I was getting scar tissue. I was feeling depressed, and I thought, `I’m never going to have an iota of freedom.’” Since getting the pump, Johnson said, “‘Now, I control the diabetes.”’

Sierra Sandison’s decision to wear her diabetes pump on her hip both contributed to and was the result of a trend toward greater acceptance of medical devices and our need for them. (As Miriam Tucker reported at NPR, “Amputees are increasingly using visible prostheses rather than covering them up. And the ostomy community has its own version of the ‘show me’ campaign.”) Nicole Johnson told Tucker that “‘Our culture seems to be more accepting today, as opposed to when I was diagnosed in 1993.’”

Perhaps unsurprisingly, the increase in acceptance has not translated into easy or uniform access to the medical devices that help diabetics manage their disease, including insulin pumps, insulin pens, and continuous glucose monitors. In its 1998 article about Johnson, the Philadelphia Inquirer reported that while “most health insurers” covered pumps, coverage for the accompanying supplies was less uniform. As a result, “Johnson and other advocates [were] calling for standard, universal [health insurance] coverage of pumps and all diabetic equipment.” Coverage of diabetes equipment and supplies is still an issue today. The American Diabetes Association indicates on its website that ensuring that private and public health insurance “provide access to the services, tools and education necessary to meet the needs of people with diabetes and prediabetes” is one of its top advocacy priorities.  The device company Medtronic writes on its website that, as was the case in 1998, most private insurance companies cover pumps, subject to any applicable deductible or co-insurance (which could be a substantial barrier, given that pumps can cost in excess of $6,000), but coverage by public insurance and, in particular, by Medicaid, is more variable.

Here, I circle back to New Jersey. A report issued earlier this year by the Center for Health Law & Policy Innovation at Harvard Law School indicates that New Jersey Medicaid “cover[s] diabetes equipment and supplies, as well as prescription drugs including metformin and insulin.” There are concerns about the quality of the coverage, though. The report indicates that New Jersey’s Medicaid managed care organizations (MCOs) “tend to frequently switch which brands of glucose meters and test strips they cover, as well as which brands of insulin they include on their drug formularies,” which causes patients to become confused. The providers that the Center for Health Law & Policy Innovation interviewed “described patients coming to primary care appointments with grocery bags filled with glucose monitors and test strips, completely unsure which strips go with which monitor and functionally left without any testing supplies as a result.” The report also flags as an issue monthly limits on test strips that are not grounded in medical necessity.

And that’s not all. Earlier this year, at the Center for Health Law & Policy Innovation’s blog, Alexandra Maron wrote the following:

As an attendee at the New Jersey Diabetes Leadership Forum, I had the pleasure of witnessing a real, live insulin demonstration. Fran Grabowski, Lead Diabetes Educator for the Camden Citywide Diabetes Collaborative and Program Manager at Cooper Diabetes Center, went around from table to table at the Forum throughout the day showing attendees the various tools available for those with diabetes to take their insulin. . . . Ms. Grabowski first demonstrated how to use a syringe to give insulin, and while she noted that the needle is much smaller than it was in the past, it is still uncomfortable for those with diabetes who have to give themselves insulin at least 4 times per day. Ms. Grabowski then showed attendees the insulin pen, which has a remarkably smaller needle than a syringe, but unfortunately is no longer covered under New Jersey Medicaid. She pointed out that this is very unfortunate for those with diabetes in New Jersey because they are forced to use methods that are more time consuming and more painful. She also described the mechanism of insulin delivery systems, such as pumps and patches, which are even easier ways for those with diabetes to receive insulin; however, Medicaid also does not cover those systems.

My initial response to reading Maron’s post was a visceral one. It feels wrong that our wealthy state forces individuals with diabetes who receive Medicaid to take care of themselves using methods that are painful, time consuming, and, for many, less effective. Beyond my gut feeling, it may also be penny-wise but pound-foolish. As the Center for Health Law & Policy Innovation concludes in its report:

“The limits on access to diabetes supplies and services mean that fewer patients are using these services. This is probably causing a number of unnecessary deaths and significant morbidity in the state, given that sustained reductions in A1C [a measure of average blood glucose level over the previous three months] are associated with a 21% lower risk of death. It is also probably costing New Jersey millions of dollars.”

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Monday Morning Recap: The Week (9.15.14-9.21.14) in Drug & Device Law & Policy

September 22, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3Welcome to the working week! Here’s our  Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. And once again, there’s been a lot going on…

1. President Barack Obama announced a multi-pronged plan of attack to fight antibiotic resistant bacteria. The White House’s summary is here. Kevin Outterson’s largely positive comments on the plan at The Incidental Economist is here. Among other things, Professor Outterson highlights the Obama administration’s “stunning” call for “replenish[ing Biomedical Advanced Research Development Authority] funding for public-private partnerships in antibiotic R&D, with approximately $800 million per year, roughly equal to one new antibiotic per year.” Diana R.H. Winters has a less positive take at Bill of Health, here. Professor Winters writes: “But in regards to the use of antibiotics for growth promotion in animals, the strategy does not provide the tools, or even the rhetoric, to support meaningful movement towards decreasing their use.”

 2. The Washington Post reported on progress being made toward an Ebola vaccine. The Post article begins: “A 48-year old British woman became the first volunteer to receive a dose of an experimental Ebola vaccine as a new trial began Wednesday at the University of Oxford.” The woman, Ruth Atkins, explained: “I volunteered because the situation in West Africa is so tragic and I thought being part of this vaccination process was something small I could do to hopefully make a huge impact[.]“

3. Also this week, New York State Attorney General Eric Schneiderman announced a “groundbreaking” antitrust lawsuit “seeking to prevent pharmaceutical manufacturer Actavis plc and its New-York based subsidiary Forest Laboratories from forcing Alzheimer’s patients to switch medications as part of an anti-competitive strategy designed to maintain high drug prices.” The press release, here, explains: “Actavis has announced a plan to withdraw its Alzheimer’s drug Namenda from the market. Namenda is protected by a patent that will expire shortly and the company will thus face competition from generic drug makers.  Instead of facing that competition, Actavis plans to force patients to switch unnecessarily to a very similar drug with a longer patent. Once patients switch to the new drug, Namenda XR, it’s likely that they will remain on that medication even after the Namenda generics hit the market due to the practical difficulties of switching back, thus allowing Actavis to insulate its profits from competition.”

4. On the device side, Reuters provided an update on Apple’s HealthKit, which is “a new healthcare system” that will gather information from “[r]egulated medical devices, such as glucose monitors with accompanying iPhone apps,” so that a patient’s data can be viewed by his or her doctor in one place. Reuters reports that “Stanford University Hospital doctors said they are working with Apple to let physicians track blood sugar levels for children with diabetes. Duke University is developing a pilot to track blood pressure, weight and other measurements for patients with cancer or heart disease.”

5. Finally, a bit of self-promotion. On October 20th Seton Hall Law Professor Jordan Paradise and I will be speaking at an academic symposium co-sponsored by Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and the Food and Drug Law Institute. At the symposium, titled “Emerging Issues and New Frontiers for FDA Regulation”, papers will be presented “on mobile health, stem cells, personalized medicine, and other novel medical product issues, as well as food regulation.”

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Reviewing Peer Review

sullivan_charlesPeer review is pervasive in hospitals as well as large clinical practices as a result of statutes, courts’ adoption of the corporate negligence doctrine, and accreditation standards.  And physicians subject to peer review are increasingly hospital employees or employees of large group practices.  It should come as no surprise, then, that employment-based challenges to particular peer reviews have increasingly arisen in the courts — with claims ranging from being used to retaliate for whistleblowing to allegations that such reviews were undertaken as a means of discrimination on a variety of bases.

Of course, where “employment” is not involved, such challenges, whatever their abstract merits, fail because the physician is simply not protected by the relevant law. But even as more physicians became employees, many challenges continue to be unsuccessful because of the “adverse employment action” requirement of antidiscrimination statutes.  Thus, the courts have construed Title VII and other laws as not proscribing discrimination per se but as prohibiting discrimination only if it results in sufficiently severe consequences.  The effect of this rule is to insulate relatively minor workplace decisions from challenge. Where retaliation for filing a charge or otherwise opposing discrimination is concerned, the federal laws are somewhat more protective. In such cases, if the employer’s action is of the kind reasonably likely to deter protected conduct, it is sufficiently severe to be actionable.

This structure, of course, raises the question of whether peer reviews can be sufficient for liability – assuming, of course, that the employee can establish the requisite causal nexus between the peer review and the prohibited employer conduct.

There are few cases dealing explicitly with the problem, but most courts have thought not: merely referring a patient’s case or a physician’s practice more generally for peer review is common and does not automatically result in any adverse consequences at all. But these cases often conflate the question of whether a referral is adverse with whether the plaintiff can establish that the referral was motivated by discrimination or retaliation. For example, the Seventh Circuit wrote:

Patt has not offered evidence to show that the peer review activities constituted an adverse employment action. The record shows that participating in peer review was a requirement of Patt’s contract (like all doctors at Family Health), and that her male colleagues also had cases referred to peer review. Patt has offered no basis to conclude that the number of her cases referred to peer review was inordinate when compared to the number of her male colleagues’ cases referred for review. Nor has she offered evidence to suggest that any of her cases were inappropriate for peer review. Accordingly, Patt has failed to establish an adverse employment action. . . .

Patt v. Family Health Sys., 280 F.3d 749, 754-755 (7th Cir. 2002).

But what if a doctor can show reason to believe that peer review was wielded for impermissible motivations? Romero v. County of Santa Clara, 2014 U.S. Dist. LEXIS 94643(N.D. Cal. July 10, 2014), permits suit in such cases.  In a kitchen-sink complaint, Dr. Luke Romero, an anesthesiologist, claimed a variety of claims for his treatment by the Santa Clara Valley Medical Center at which he worked. Although the district court dismissed most of his complaint, it upheld his retaliation claims where the alleged reprisal was via peer reviews. Dr. Romero had engaged in protected conduct, inter alia, by complaining about patient care issues and about discrimination. Beginning shortly thereafter, he was subjected to five peer review investigations.  Looking to the principle that an action is sufficiently adverse if it is likely to deter the protected conduct at issue, the court found peer review to satisfy that standard. Low peer review ratings could subject a physician to discipline, and even loss of privileges with an attendant report to the National Practitioner Data Bank.

Of course, being subjected to peer review does not necessarily result in unfavorable findings, and Romero was not, in fact, subject to corrective action or any other tangible consequences. Only one of the reviews resulted in an unfavorable finding. But the court found that the possibility remained that the peer reviews themselves were an adverse employment action, at least where retaliation was claimed (remember, it has a somewhat lower standard).

That still left the question of whether the reviews were retaliatory, but the court had little problem finding that Romero survived summary judgment on this issue: the peer reviews “came close on the heels” of his protected conduct, and, in the two years prior to that protected conduct, he had not had a single peer review referral. Although neither party compared Romero’s rate of peer reviews with the average doctor at the hospital, Romero offered evidence of both other doctors unfairly targeted and suspicious procedural problems with the reviews.

The case is a textbook example of a clash between desirable public policies, both related to public health: peer review is central to improved patient care in the modern healthcare system, and disincentives to use it when appropriate threaten its success. On the other hand, peer review creates the opportunity to keep employees in line, and discourage the kind of whistleblowing which is thought to help keep the entire system honest. It also creates opportunities for racial,  gender, or disability discrimination.  Whether Romero is an outlier or the first of a new line of jurisprudence on this issue remains to be seen.

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Monday Morning Recap: The Week (9.8.14-9.14.14) in Drug & Device Law & Policy

September 15, 2014 by · Leave a Comment
Filed under: Drugs & Devices, Monday Morning Recap 

Picture3Well, once again it’s been two weeks since we last did a Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. And there’s been a lot going on…

1. The September issue of The Milbank Quarterly contains an original empirical study by Genevieve Pham-Kanter analyzing the effects of the financial ties that members of the Food and Drug Administration’s advisory committees have with drug manufacturers.  Among her very interesting findings is the fact that while a committee member with ties to one manufacturer was more likely to recommend approval of that manufacturer’s drug, committee members with ties to multiple manufacturers did not show an overall bias in favor of approval. Aaron Carroll wrote about the study at the New York Times, here, and David Schlaes wrote about it here. Per Schlaes: “The take-home lesson to me is that experts are actually experts.  Those that are in demand by multiple companies for help in analyzing or developing their products are more likely to be the kind of experts the FDA is seeking and less likely to let their financial and other relationships with sponsors get in the way of their expertise.”

2. The contentious debate between the drug and device industry and the Department of Justice over where to draw the line between protected  speech, on the one hand, and punishable fraud, on the other, continues. In an article at FiercePharmaMarketing this week, Tracy Staton calls attention to a brief the government filed at the end of August. Staton writes: “In essence, the brief asks the court to determine that ‘speech that serves as a conduit for violations of the law’ isn’t protected by the First Amendment. PhRMA, of course, is asking for the opposite. It wants the court to decide that the law only prohibits ‘at most, false speech,’ which would give reps the chance to talk about off-label use of meds, as long as they’re telling the truth.”

3. This week also brought news that a supervisory pharmacist at the New England Compounding Center was arraigned and pled not guilty to a single count of mail fraud. Denise Lavoie of the AP reports: “Chin, a supervisory pharmacist, is accused of participating in a scheme to fraudulently cause one lot to be labeled as injectable, meaning it was sterile and fit for human use. The drug was shipped to Michigan Pain Specialists in Brighton, Michigan, and injected into patients. As a result, 217 patients contracted fungal meningitis, and 15 died. Chin is the first person to be charged criminally in the case, but prosecutors have said the prosecution is part of a larger criminal investigation of Chin and others.

4. At the New England Journal of Medicine, Rita Redberg argues that “[b]linded, randomized, controlled trials (RCTs), in which the proposed therapy is compared with a placebo or a ‘sham’ (nontherapeutic) intervention,”which are currently “rare for medical devices” need to become more common. Dr. Redberg recommends that “the risk associated with performing unnecessary procedures … be weighed against the risk of mistaking a placebo effect for therapeutic benefit and therefore subjecting thousands or millions of patients to a procedure that actually does them no good.”

5. Finally, at the New Yorker this week, Andrew Solomon discusses the “terrifying dilemma” confronting women with depression who must weigh a dizzying array of known and unknown risks when deciding whether to pursue treatment with antidepressant medication. Solomon writes:

The debate rages, and the choice is a difficult one: to be depressed during pregnancy, with troubling consequences, or to be on medication during pregnancy, with unclear ramifications. It is not helpful when the complexity of the decision is belittled. ‘Everyone’s happier with this idea that the medications are O.K.,’ [Roni Caryn] Rabin wrote, quoting an expert. Everyone is second most happy learning, as Rabin suggests, that the medications are poison but depression is fine—because clarity and simplicity make life easy. If the meds help more than they harm, you take them; if they harm more than they help, you don’t take them. The problem is that this is a highly nuanced question to which there is no consistent answer, and about which we know too little. That makes everyone excruciatingly uncomfortable.

In this article I wrote several years ago, I review some of the reasons for the dearth of information about the risk-benefit ratio of drugs when used during pregnancy and make recommendations for policy responses.

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