Devon Reiff P.C. has authored many articles over the years on controversial subject matters pertaining to the Food and Drug Administration, The Department of Health and Human Services and other high powered organizations, fighting for clients rights along the way. Featured are the following articles:
Unsecured Beach Umbrellas Pose Extreme Risks
By: Devon Reiff, Esq.
Back in May of 2006, a settlement was reached with the State of New York in which it agreed to pay $200,000 to my client, a woman who narrowly escaped being killed by a flying beach umbrella at Robert Moses State Park.
That story was carried by the New York newspapers including the New York Times on May 18. As the Times reported, Phyllis Caliano-Bahaj “was lounging on the beach on July 19, 1999, watching her son…and three friends play in the sand when the weather turned stormy and gusty. A 6-foot, 15-pound striped umbrella that was either being used by a lifeguard or rented by a beach patron flew up and struck her in the forehead, ‘like a torpedo,’ her lawyer said. The resulting gash needed 13 stitches, and she was left with permanent nerve damage to her neck and persistent pain.”
Before that settlement was reached, in November 2003, New York State Court of Claims Judge S. Michael Nadel had held the State fully responsible for the accident — regardless of who actually owned the umbrella — saying that there had been ample warning that the weather was turning stormy and umbrellas needed to be taken down or secured, and that it was up to the State to “safeguard its patrons.” Given the judge’s decision, a spokesman for the New York State Attorney General agreed that settling the case seemed “appropriate.”
At the post-settlement press conference, Ms. Caliano-Bahaj’s attorney, I stated: “Summer’s coming…[and] Believe it or not, beach umbrellas like this can be a real hazard to your health.” When those at the press conference seemed to take that comment in a less-than-serious way, I was “a little worried about the reaction,” and so I added, “It’s no joke.”
No joke, indeed. Since at least as early as 1932, the New York courts have recognized that pole-style beach umbrellas are not to be taken lightly in terms of the potential risks they present. In the case of Gerhardt v. Manhattan Beach Park, Inc., 237 A.D. 832, 261 N.Y.S. 185 (2d Dept. 1932), the Appellate Division, Second Department, affirmed a jury verdict in favor of a woman who was struck in the head by a large beach umbrella that had been blown into the air by the wind at a private beach in Brooklyn.
In its opinion, the court stated: “The facts sufficiently established that the danger of one of the large beach umbrellas being carried through the air by the wind and weather was or could have been known to the defendants in time to prevent what occurred. The claim that there was a failure to prove defendants’ ownership of the particular beach umbrella in question is not controlling in the light of the duty of the defendants, who conducted a place of entertainment or recreation to which patrons were invited on payment of an admission fee, to safeguard their patrons from danger which might reasonably have been anticipated. In the circumstances, the defendants were obligated to see to it that danger should be minimized to the extent that reasonably prudent men might foresee the necessity of doing so.”
The New York Court of Appeals affirmed the Appellate Division holding at 262 N.Y. 698, 188 N.E. 126 (1933). While much has changed in the 84 years between 1932 and 2016 in terms of what people wear to the beach and the activities they engage in once they are there, very little has changed in terms of the danger posed by beach umbrellas. They remain little more than unguided missiles just waiting to be launched haphazardly into the air or along the ground by a strong gust of wind.
Since cell phones now capture almost everything on video, a number of instances where several large beach umbrellas are shown blowing around populated beaches can be found on YouTube and other news sources under such titles as: (1) “Dance of the Umbrellas;” (2) “Beach Family Ignores Flying Umbrella;” and (3) “Flying Beach Umbrellas.”
For the most part, these occurrences are often perceived as more comical than serious with lifeguards or resort employees chasing the umbrellas along the beach or even into the water. However, as I observed at the press conference for my seriously injured client Phyllis Caliano-Bahaj: “It’s no joke.”Unfortunately, with all of the litigation-driven advances in technology and safety in motor vehicles, consumer products, construction practices and medical care, beach umbrellas have somehow escaped improvement.
Most beach umbrellas are still simply stuck into the sand or a sleeve in a weighted base where they are just one wind gust away from causing a catastrophe. Life guards, parks department and resort employees as well as members of the public continue to treat beach umbrellas as a harmless devices that shade people from the sun instead of the “hazards” I warned the public about over 10 years ago and the New York Courts identified as a “danger” as far back as 1932. Regrettably, none of this helped Lottie Michelle Belk on June 22, when she was at “her favorite place,” Virginia Beach “celebrating her birthday and a marriage anniversary.” As the Washington Post reported (as did many other news outlets): “A big gust of wind lifted a beach umbrella out of the sand, blew it down, and struck Belk in the torso. She later died at a Virginia Beach hospital.” The article went on to state: While incidents have happened with beach umbrellas, it is rare for one to result in a death, many local rescuers said. A man from Henrico County in Virginia lost his eye after a wind-blown beach umbrella struck him last year at Bethany Beach in Delaware.”
An emergency service worker said “from time to time, people get hit by flying umbrellas or flying debris.” But, he said, “I’ve never heard of someone dying.” (Well, now you have.) While plaintiffs’ trial lawyers are often depicted as the “bad guys” who encourage frivolous law suits designed to earn their clients undeserved recoveries and enormous legal fees for themselves, quite the opposite is true. It is really those attorneys alone who are willing to spend years of their time and risk huge sums of their own money to fund groundbreaking litigation for catastrophically injured (or dead) clients who have made motor vehicles, planes, trains and countless other products safer; doctors, hospitals and pharmaceutical companies more accountable; construction sites safer for workers; and municipalities more responsible for their police departments. That is what makes Lottie Michelle Belk’s death all the more tragic. From all accounts, this was a kind, gentle lady who simply wanted to celebrate her birthday and anniversary at the place she loved best, the beach.
Trial attorneys have long argued (and proven) the danger posed by beach umbrellas is very real and “no joke.” For that very reason, it is difficult to imagine why beach umbrellas are not fitted with some sort of device or tether that presents then from flying away as soon as it gets windy. Lifeguards, parks department employees as well as the people working at hotels and resorts should be trained to immediately take down these umbrellas (not simply fold them up) as soon as the weather turns windy (or threatens to). It is far easier to reopen an umbrella than it is to undo the injuries suffered by people struck by one of them. In the case of a death, there is simply no excuse for continued inaction.
FDA Caught Red-handed Spying on Its Employees
An investigation by the Food and Drug Administration of a number of its employees, characterized as an effort to quell their communication with outside critics of the agency, particularly in the matter of medical review procedures, was the topic of a recent New York Times article.
In that article, reporters Eric Lichtblau and Scott Shane wrote that an initial review by the FDA of a small group of seemingly dissident scientists in its ranks in 2010 was expanded into a probe of several others within the agency. According to one agency memorandum, these employees were collaborating with non-FDA medical researchers, lawyers, journalists and Congressional members and aides, to conduct a campaign of defamation. FDA officials said they had no intention of impeding employees’ communications but were merely trying to determine if intelligence was being shared improperly.
Agency scientists and officials have maintained a years-long dispute about review procedures that the scientists have deemed faulty. Scientists assert that questionable reviews have resulted in grants of approval for medical imaging devices used in mammograms and colonoscopies, thereby exposing patients to perilous levels of radiation.
The Times report said the FDA used “spy” software initially to obtain screen images from the laptops of five agency scientists working in their offices and at home. Keystrokes were tracked, personal email intercepted, documents copied from the scientists’ flash drives and personal messages read as they were being drafted, Lichtblau and Shane said.
Wider surveillance yielded letters to Congressional offices and oversight committees, legal filing drafts and emails back and forth. The operation was handled by a private contractor hired by the FDA, which evidently blundered when it later posted much of the material on a public Web site, a move that, among other things, allowed the Times to review it closely and at length. The site was taken down in July, a day before the article was published.
A January 2011 article in the Washington Post first revealed the monitoring program. Current and former FDA scientists filed a lawsuit against the agency in September 2011, when they discovered that dozens of their emails had been intercepted and four of those scientists had been dismissed. With implications of the wide range of the FDA’s surveillance program quickly transpiring, the FDA issued a memo explaining that the original five scientists’ emails “were collected without regard to the identity of the individuals with whom the user may have been corresponding.” The agency further insisted that while the Congressional recipients of the emails and those it called other “actors” were in league with the scientists to generate negative publicity, they were never FDA surveillance targets, even though they were suspected of having received confidential information.
The Times article said that even with federal agencies’ power to monitor employees’ computer use, the FDA might have behaved illegally by seizing confidential information protected by law—which would include attorney-client exchanges, complaints to Congress by “whistle-blowers” and workplace grievances filed with the
Government. Expressing its concern about the situation, the White House Office of Management and Budget issued a memo this past June that deferred to the agency’s power of internal monitoring but deplored any attempt to intimidate whistle-blowers or otherwise interfere with “employees’ use of appropriate channels to disclose wrongdoing.”
Dismissed FDA scientists allege in one of the lawsuits that intimidation and interference were exactly what the FDA practiced in retaliation to the criticisms they made about the agency; particularly about its medical reviews. The Times article said that Stephen Kohn, the attorney representing six scientists who are suing the FDA, was seeking an injunction in federal court to end any surveillance that might be conducted against two medical researchers still in the agency’s employ. Within the documents that have already been made public there is no indication either that the FDA surveillance program is still going on or has been discontinued.
The Times could and did refer to a case and an article that might have led the FDA to initiate its surveillance program. In March 2010, the paper published an article revealing the concerns of two FDA scientists about the safety of two imaging devices submitted to the agency by GE Healthcare for approval. The two scientists, Dr. Robert C. Smith and Dr. Julian Nicholas, were later the subject of heavy surveillance, and Dr. Smith was identified in an agency memo as a “point man” for disgruntled scientists, since he wrote hundreds of emails advising them how to make their complaints known.
Attorneys for GE Healthcare said the Times article included proprietary information about the imaging devices, which may have been leaked to the press. The writer of the article, Gardiner Harris, later showed up high on the list of “media outlet actors” compiled by the FDA’s surveillance program monitors. FDA officials went to the Department of Health and Human Services, hoping to get its Inspector General to seek a criminal investigation of that alleged leak. The IG turned them down, saying there was no evidence of a crime and that “matters of public safety” are legal material for the media. That setback probably led to initiation of the surveillance program.
Dr. Smith’s “point man” status soon did him in. That same year, 2010, FDA monitors read emails that said several agency scientists were drafting a complaint they were going to take to the Office of Special Counsel. Before they could, Dr. Smith and another scientist were dismissed and a third person was suspended. At another time, the captured emails indicated that Paul T. Hardy, formerly a dissident employee but by then no longer with the FDA, had reapplied for a job there. He was described as “being considered for a position,” but he did not get it. Among the items pulled from his emails was one about possibly getting in contact with the people from Frontline, the Public Broadcasting System’s documentary program.
When the whole surveillance presentation was mistakenly put on a public Web site, it first of all defeated the efforts of GE Healthcare and other companies to keep proprietary information secret, since such information was extensively discussed in the myriad documents created by both the insurgent employees and the defense-minded.
Eventually, perhaps inevitably, it led to the employees’ discovery of the site. A researcher, making Google searches for the involved scientists, was tracking instances of negative publicity that might impinge on their chances of finding post-FDA employment. Soon, like Balboa beholding the Pacific, he was looking at the agency’s surveillance program.
“I couldn’t believe what I was seeing,” he told the Times, while requesting anonymity because of his own job search. “I thought,” ‘Oh my God, everything is out there. It’s all about us.’ It was just outrageous.”
Study Says, Nursing Home Residents Are Being Prescribed Antipsychotic Drugs Regardless of Potentially Hazardous Side Effects
According to a recent report by The Department of Health and Human Services (HHS) Office of the Inspector General (OIG), many nursing home residents suffering from dementia are being prescribed atypical antipsychotic drugs (AAP) despite potentially life-threatening consequences.
Atypical (or second-generation) antipsychotic drugs are used to treat various psychiatric conditions, such as schizophrenia and bipolar disorder. Many of these drugs, which include Astra Zeneca’s Seroquel, Johnson & Johnson’s Risperdal and Ely Lilly’s Zyprexa, have black box labels that warn of an increased risk of death when given to elderly patients with dementia.
In 2007, Sen. Charles Grassley (R-Iowa) asked OIG to examine the prescriptions given to nursing home residents with off-label conditions, including dementia. He was moved to do so after FDA epidemiologist David Graham testified before Congress that approximately 15,000 nursing home residents die per year due to off-label use of these kinds of medication.
The FDA (Food and Drug Administration) permits doctors to prescribe drugs for off-label usage based on their expertise and discretion, however pharmaceutical companies may only promote their drugs for the uses that appear on the drug’s label, which are the uses approved by the FDA.
Off-label prescribing occurs when a drug is used in a way for which it was not intended or as a therapy, cure, or treatment for one or more conditions for which it has not been approved. While this type of use can lead to a more expansive application of a successful drug, it can also cause a higher incidence of known side effects as well as unforeseen adverse reactions that can be quite serious − even deadly.
The off-label prescribing of drugs beyond the scope of their FDA approval has become a serious concern in recent years. Dosage levels, medical conditions, and treatment durations for which drugs were never intended or tested make the entire area of off-label use problematic at best. There is also the problem of off-label prescribing to age groups (infants, adolescents, and seniors) for which no, or insufficient, clinical data exists. At its worst, the practice can be downright deadly.
According to a 2011 article, Off-label indications (those not approved by the FDA) doubled from 1995 to 2008.
The incredibly strange thing about off-label use, however, is that doctors may prescribe drugs to treat conditions for which the Food and Drug Administration has even denied approval. Therefore, while a manufacturer cannot market a drug for an unapproved off-label use, a doctor may prescribe the drug for that use.
The aforementioned study, conducted over a six month period, showed that 88% of reimbursement claims given to Medicare for AAP prescriptions in nursing homes were for people with dementia.
Additionally, the study revealed that 83% of claims were for off-label use and 76% were for off-label use and dementia.
HHS Inspector General Daniel Levison thinks that pharmaceutical companies are ultimately to blame, as they continue to violate the federal government’s False Claims Act (FCA) by advertising their drugs for uses not approved by the FDA.
After the study was concluded, Levison found it troubling “that so many nursing home residents are prescribed these drugs in the first place.” He urged “government, taxpayers, nursing home residents, as well as their families” to be “outraged and seek solutions.”
Steven Levin, a Chicago attorney familiar with these types of cases, agreed. He said that “anecdotal evidence suggests that when the resident is placed on these drugs, something bad happens.”
In Levin’s opinion, the use of AAPs is so widespread in nursing homes, “because it’s easier to control the patient and requires fewer staff.” He concluded by saying that “nursing homes should never use antipsychotic drugs for the purpose of convenience.”
Levin has represented two patients that have suffered acute kidney failure resulting from dehydration while on Seroquel. In one instance the patient died, the other was diagnosed with brain damage.
According to Mr. Levin, attorneys that represent plaintiffs in similar situations need to be more aware of “the roles that these types of drugs might play in cases involving nursing home neglect.” He emphasized the importance of monitoring whether patients’ needs are being properly assessed, behavioral changes while on the drug and whether or not the drug is stopped if harmful side effects arise.
Off-label usage has become an ongoing issue. While this practice can be beneficial to an individual patient on a case-by-case basis, it can have very serious consequences when used generally and at no point should doctors prescribe drugs for off-label use as a “quick fix.”
Studies Show Oral Contraceptives Containing Drospirenone Increase the Risk of Blood Clots
The consumer watchdog organization Public Citizen, in its Worst Pills Best Pills Newsletter for May, 2011, highlighted the February review in the French medical journal Prescrire International, of four studies examining the link between blood clots and oral contraceptives containing the progestin drospirenone.
Although two of the studies found no increase in the risk of blood clots in women taking the drug, both studies were funded by Bayer, the company that manufactures Yasmin and Yaz both of which contain drospirenone.
The two independent studies showed increases in the risk of blood clots in women taking drospirenone.
Previously, industry-funded studies also found lower risks than independently funded studies with respect to the increased risk of blood clots with other oral contraceptives containing desogestrel. Accordingly, one must consider whether the industry-funded studies were accurate or designed to yield the very result they achieved.
The large publicly-funded Danish study conducted between 1995 and 2005, and published in 2009, showed a statistically significant increase in the risk of blood clots in women taking drospirenone compared to those taking a combined contraceptive containing the older progestin levonorgestrel. It included all women in Denmark, ages 15 to 49, who did not have a previous history of heart disease or cancer and was the equivalent of 3.3 million women years, or the equivalent of 3.3 million women using an oral contraceptive for one year.
The second study, done in The Netherlands between March 1999 and September 2004 and also published in 2009, was made up of 1,524 women ages 18 to 50 years of age and 1,760 controls. The results were similar to those in the Danish study, and showed an increased risk of blood clots in women taking drospirenone compared to those taking levonorgestrel (3.6 vs. 6.3).
The following Tables were compiled by Public Citizen and contained in its May 2011 Newsletter, Worst Pills Best Bills.
TABLE 1: Estimated Risk of Blood Clots with Combined Oral Contraceptives Containing Different Progestins
Experts express risk as the number of incidents per person-year of exposure to a drug. In Table 1, contains estimates for blood clots in women using combined contraceptives containing ethinyl estradiol and various progestins including drospirenone, desogestrel and levonorgestrel or norethisterone. As the table shows, the risk is clearly lower with combined contraceptives containing levonorgestrel or norethisterone.
Devon Reiff on “Ask The Lawyerz”
On July 6, 2016 Devon Reiff was the special guest on “Ask The Lawyerz” a new webinar hosted by Dan Abrams on LawNewz.com featuring “the nation’s top legal experts tackling your legal questions.”