Personal Injury and Social Security Disability Blog

L.A. Times Says Generic Drug Ruling Unfair to Consumers

As a follow-up to yesterday's post about the Supreme Court ruling that manufacturers of generic drugs have no duty to warn consumers of harmful side effects, here are excerpts from an editorial in the Los Angeles Times. The newspaper laments the fact that these manufacturers are being let off the hook, and says they have at least a moral, if not legal, duty to warn consumers.

Even Clarence Thomas, the Supreme Court justice who wrote the majority opinion saying that makers of generic drugs don't have to warn patients about newly discovered dangers, agreed that the idea made little sense. How is it that the maker of a brand-name pharmaceutical has to provide information about potential side effects but the companies that produce identical drugs don't? If this is the price the public is expected to pay for cheaper drugs, it's far too high.

In a 5-4 decision issued last week, the court rejected lawsuits by two women who suffered serious side effects from generic versions of a medication used for stomach ailments. The women claimed that state law in Minnesota and Louisiana required all drug manufacturers to update their warning labels when they have new information about potential dangers. But the court noted that federal law put the generic drug makers into a bind by requiring such medications to carry the exact same warning labels as their brand-name equivalents. Brand-name drug makers are held responsible for giving consumers updated warnings, but what happens when a generic manufacturer discovers new problems with the same medication?

The court rightly said that when federal and state laws conflict, the former takes precedence. And it would indeed be strange and confusing for identical drugs to carry different warnings. But there was nothing to keep the makers of these generic drugs from bringing key consumer safety information to the U.S. Food and Drug administration, or from contacting the brand-name maker to suggest a label change, both of which they failed to do.

If the federal rules don't do enough to protect consumers, manufacturers — of medicine or anything else — have a moral responsibility to protect the public from being harmed by their products. Any drug company that discovers a previously unknown danger from its medications should be required under federal law to report the information quickly to the FDA and recommend a label change; the agency should then require uniform warning labels by all the affected pharmaceutical companies. Generics should not be known as buy-at-your-own-risk drugs.

 

Supreme Court Rules Generic Drugmakers Are Shielded from Failure to Warn Suits

The Washington Post reported, "Makers of generic drugs cannot be sued for not warning patients of the drugs' dangerous side effects, the Supreme Court ruled Thursday, even though brand-name manufacturers can be found liable." The Post continued, "A five-member majority of the court recognized that it 'makes little sense' to bar suits against generic drug-makers while allowing them against brand-name manufacturers, but said federal law gave the justices no other choice." In dissent Justice Sonia Sotomayor wrote, "As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug." Attorney Louis Bograd of the Center for Constitutional Litigation echoed Sotomayor in noting that "the common use of generics means that 'three of four patients in America has just lost the right to sue for inadequate warnings.'"

The Los Angeles Times reported Gladys Mensing and Julie Demahy, "developed tardive dyskinesia, a severe neurological disorder, after taking metoclopramide, a generic form of the drug Reglan for digestive problems, including acid reflux. They sued, alleging that the drug maker failed to warn them of the danger of taking this drug for more than 12 weeks. Studies had suggested a potentially increased risk of the condition - and Reglan was eventually required to carry a 'black box' warning about it." Bograd, who represented Mensing, said patients "appear to be left without any legal remedy."

USA Today reported, "Justice Clarence Thomas, writing for the majority, said federal regulations, which require generic drugs to have the same warning labels as the brand-name prescription, override state personal injury law that lets people sue manufacturers for allegedly inadequate labels. The state laws at issue dictated that drug manufacturers strengthen their labels as they became aware of new risks. Thomas said the court was bound by the principle that federal law trumps the states and by relevant US regulations. Yet he acknowledged it 'makes little sense' that, based on court interpretation of varying US regulations, people who are injured by generic drugs have no state failure-to-warn claim but those injured by brand-name drugs do."

The Wall Street Journal added in her dissent, Sotomayor wrote "Today's decision leads to so many absurd consequences that I cannot fathom Congress would have intended to pre-empt state law in these cases."

CNN reported, American Association for Justice President Gibson Vance denounced the ruling saying, "Patients will now be taking generic drugs at their own risk." Vance added, "It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers -- not generics -- can be held accountable for their drugs' dangerous side-effects."

The Atlantic Wire reported on the AAJ's press release condemning the decision as "'disastrous to patient safety' and claiming a double-standard, as federal law already requires brand-name drugs to list the latest side-effects."

Bloomberg News reported Bograd said, "The ruling 'creates an absolutely untenable distinction in the law between name-brand and generic drugs.'" He added that "in some states patients who suffer injuries stemming from generic drugs may be able to sue the brand-name company that manufactured the original medicine. He said 1,000 lawsuits are pending over metoclopramide alone."

The New York Times explained, "Two years ago, in Wyeth v. Levine, the court decided the same question in the context of brand-name drugs but came to the opposite conclusion. That decision was based in large part on the fact that such drug companies can sometimes change the labels on their products without permission from the Food and Drug Administration." Justice Thomas wrote that generic drug makers "must use the same warning labels as the corresponding brand-name drugs, and they may not unilaterally alter those labels. That means, Justice Thomas wrote, that makers of generic drugs are caught in an impossible bind: they can comply with a state law requiring them to change their labels or the federal law prohibiting changes, but not both. Given that impossibility, federal law pre-empts state law under the Constitution's supremacy clause, he wrote."

The New Orleans Times-Picayune reported, "Noting that the majority opinion said 'Congress and the FDA retain the authority to change the law and regulations if they so desire,' Gibson Vance, president of the trial lawyers' American Association of Justice, called on Congress and the FDA to act quickly to 'address the huge legal disparity between brand-name and generic drugs.'"

The CNN "Chart Blog" reported AAJ statistics showing that "70% of all prescriptions are filled with generic versions, accounting for about 2.6 billion prescriptions every year." The blog noted the National Institute of Health "has website called DailyMed where consumers can look up their drug by class and brand name, and find up-to-date information about labeling, package inserts and more."

The Minneapolis Star Tribune reported the ruing was praised by generic drug makers, including the executive director of the Generic Pharmaceutical Association. Bob Billings said "the court recognized generic makers were "in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing."

The MedPage Today reported, "The Obama administration, 42 states and the District of Columbia, the American Medical Association (AMA) along with a number of state medical associations, and the American Association of Justice (AAJ) all filed amicus briefs on behalf of the injured women in the case."

SCOTUS rulings viewed as pro-business. In an overall commentary on the court's rulings, the Los Angeles Times reported the Supreme Court "has once again shown itself to be highly skeptical of large lawsuits against big business, regardless of whether the suits are intended to protect workers, consumers or the environment." Robin Conrad of the US Chamber of Commerce called the High Court's rulings "a 'mixed bag overall'" but said the ones restricting class actions were business victories. The American Association for Justice "saw no mixed picture," saying "by knocking out large lawsuits, the court is 'granting immunity to corporate wrongdoers who cheat customers or abuse employees.'" Noting the court's Wal-Mart ruling, AAJ President Gibson Vance said "ordinary employees and consumers will have no legal remedy if they cannot band together in a class-action claim. ... The Supreme Court has sent a loud and clear message to the American people: 'You're out of luck and on your own.'"

From the American Association for Justice news release.

Rental Companies Granted More Time to Buy Cribs That Meet New Safety Standards

The Consumer Product Safety Commission has voted to give rental companies more time to buy cribs that meet new safety standards.

The commission voted Friday to extend the deadline for short-term rental companies to buy the new cribs from today, June 28, 2011, to Dec. 28, 2012. That’s the same deadline for child-care facilities and hotels to buy the safer cribs.

The commission said that manufacturers and retailers will still be required to shift to the new designs by June 28, 2011.

The new standards halt the manufacture and sale of traditional drop-side cribs, which the commission says are dangerous. They will also require stronger mattress supports, more durable crib hardware and more rigorous safety testing.

More information on crib safety is available at the Consumer Product Safety Commission site.

Administration Unveils Rules for Third-Party Review of Denied Health Claims

The AP reported, "The Obama administration says most Americans will soon have the right to appeal to a third party referee when their health insurer denies a claim for a medical service." The regulations "released Wednesday carry out provisions of President Barack Obama's health care law. Insurers generally give customers a couple of chances to appeal internally, but access to outside review varies."

The Washington Post reported that the new rules change "the standards in ways that disappointed leading advocates for health-care consumers." The regulations "are intended to guarantee patients nationwide the same rights to appeal if their insurers do not cover care that they consider necessary. The federal standards...replace a patchwork of separate state policies." HHS "officials issued the rules 11 months ago, but they have been working to fine-tune them amid a blizzard of lobbying. Insurers and employers have been urging limited rights to appeal, while consumer groups have been arguing for stronger patient protections."

The Wall Street Journal said that the Administration is delaying the effective date of these rules until January 1 of 2012. They were supposed to take effect in July.

CQ reported that the regulations give "states until January 1, 2012 to adjust their insurance regulations to comply with a health law requirement that health plans establish a process for enrollees to appeal claim denials within the company and to take their complaints to an external review board if need be."

From the American Association for Justice news release.

Friday Fun

Let me introduce myself:

Strange Bedfellows — Pharmaceutical Companies and Fancy Restaurants

The Boston Globe ran an interesting article last week detailing how expensive restaurants have banded together to fight for repeal or amendment of a 2008 Massachusetts law banning pharmaceutical companies from giving gifts of $50 or more to doctors. The restaurants say this ban is hurting their business, because the pharmaceutical companies frequently bought expensive meals for the doctors they were trying to influence. Here are excerpts from the article:

With seating for 30 in a private dining room wired with projection equipment, Dalya’s Restaurant at Bedford Farms was well equipped to host dinners put on by pharmaceutical companies for doctors they hoped would use their products.

Owner Frans von Berkhout said doctors liked to come to his restaurant in Bedford because they knew they were in for a good meal. But in 2008, when the Legislature made such gatherings illegal as part of a broader effort to limit the relationship between physicians and marketers, Dalya’s lost about 10 percent of its business, he said.

He and other restaurant representatives appealed yesterday to a panel of lawmakers to roll back the law and allow the doctor dinners to go on, in the name of supporting small businesses.

Consumer advocates said the change would be a dangerous undoing of a law aimed at protecting patients and curbing prescription drugs costs, even as the national trend is toward stricter controls.

Some members of the Joint Committee on Community Development and Small Business said the negative impact on restaurants seemed like an unintended consequence of the 2008 law, generally referred to as the pharmaceutical gift ban, because it prohibits gifts of more than $50 to doctors.

But Senator Mark C. Montigny, a Democrat from New Bedford and an author of the original gift ban, said there was nothing unintended about the law.

“The corruption of the sacred doctor-patient relationship by the pharmaceutical industry by schmoozing at fancy restaurants is exactly the consequence that the law was intended to prevent,’’ he said.

Such dinners contribute to the “illegitimate relationship’’ between physicians and industry, he said. Advocates say such connections to marketers can make doctors feel obliged to prescribe high-cost brand name drugs, even when cheaper options may be more appropriate.

Such gifts aren’t free, said Amy Whitcomb Slemmer, executive director of the consumer group Health Care For All. “They come with strings attached.’’

The bill before the committee is one of two efforts to roll back the gift ban. In April, the House added a measure to its budget proposal, now being debated in conference committee, that would repeal the law altogether.

Advocates aid they are skeptical of the idea that the gift ban has hurt the economy. They point to talks of expanding the Boston Convention and Exhibition Center and to Department of Revenue numbers that show restaurant revenues are growing.

FDA Says Chantix May Slightly Increase Risk of Heart Attack

The AP reports, "Federal health regulators are warning doctors and patients that Pfizer's anti-smoking drug Chantix [varenicline] may slightly increase the risk of heart attack and other cardiovascular problems." On Thursday, the FDA "said...a study of 700-heart disease patients taking Chantix showed a small uptick in heart problems among those taking the smoking-cessation drug versus those taking placebo." The agency "will add new warnings to the drug's label about the study's findings."

Bloomberg News reports that the agency will also require "Pfizer...to further evaluate the heart risks with an analysis of existing studies."

Reuters reports that in a statement, the agency said, "The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease."

The Los Angeles Times "Booster Shots" blog pointed out that "heart problems aren't the only warning associated with Chantix. In 2009 the FDA warned that the drug might increase the risk of suicidal thoughts and behaviors."

From the American Association for Justice news release.

I'm Typing This While I'm Driving

But it's OK. Texas Governor Rick Perry vetoed a bill passed by the House and Senate that would have banned texting while driving in Texas. I assume writing blog posts is no worse than texting.

Governor Perry said the ban would be a misguided government effort to “micromanage” the behavior of adult drivers. The cynical side of me thinks perhaps the cell phone companies may have made political contributions so they can continue to rake in the profits from all those texting minutes.

Anyway, we're still good to go with typing while driving. My only real concern is that Governor Perry also vetoed a bill that would have allowed larger urban counties to regulate vendors in the right-of-way of a public road or highways. So now I not only have to keep an eye out for slow-moving traffic, but also for people selling flowers in the middle of the road. That's hard to do when you're correcting typos.

Over Half of Medical Malpractice Claims Relate to Outpatient Care

The Wall Street Journal "Health Blog" reported that over half (52%) of malpractice payments made by US physicians involved adverse events related to outpatient care in 2009, according to an analysis published in the Journal of the American Medical Association. In an interview, lead study author Dr. Tara Bishop, of Weill Cornell Medical College. told the "Health Blog" that the researchers were astounded to find such a high number of outpatient-related claims, suggested that more focus be placed on that area. The Journal quotes from the analysis, in which the study authors surmised, "Many outpatient sites may be too small to have well-trained staff who devote significant attention to improving patient safety."

HealthDay reported that the researchers analyzed data on malpractice claims paid on "behalf of physicians who work in hospitals or doctors' offices" from the US National Practitioner Data Bank.

Medscape reported that from 2005 to 2009, the "number of paid claims involving physicians declined 23.3%, from 14,006 to 10,739," according to Dr. Bishop. During that period, paid claims for "outpatient events decreased at a slower rate: 19.3%", and the hospital rate decrease was "considerably higher at 24.6%. Paid claims that spanned both settings declined 18.3%." At the same time, the proportion of paid claims involving outpatient settings "rose from 41.7% to 43.1%, while the inpatient proportion declined from 49.3% to 47.6%." Notably, the outpatient events "were not trivial. Roughly 70% involved death, a grave permanent injury such as brain damage, or a major injury, compared with 81% for inpatient outcomes."

According to Reuters, accompanying editorial pointed out that at present, there are no rigorous, evidence-based programs to help prevent outpatient safety errors.

From the American Association for Justice news release.

Friday Fun

OK, this one isn't really fun, but I think it's interesting. It's an interactive map that shows how the population center of the United States has moved both south and west each decade from 1790 until 2010.