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The FAA’s Failing Helicopter Flight Regulations

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Helicopters and the Flight Into Regulatory Neglect

Another helicopter into the drink, killing five within sight of New York City’s East River shoreline. “Another” is used to characterize the tragedy, because helicopters seem to crash with disconcerting frequency in the city — and just about everywhere else (e.g., five killed in a February 2018 Grand Canyon tourist helicopter crash).

Once again, the Federal Aviation Administration (FAA) seems asleep, both before and after this latest disaster. Fully five days from the 11 March crash elapsed before the FAA banned “doors off” helicopter flights and promised a “top to bottom” review of such flights. This is typical; over the years the National Transportation Safety Board (NTSB) has repeatedly criticized the FAA for its lackluster oversight of the aviation industry.

In this case, the Eurocopter AS350 was owned and operated by Liberty Helicopter Tours. The FAA approved the certification of the helicopter design for passenger carrying use; it endorsed the passenger restraint systems (or should have), it concurred with flights without doors, it approved the installation of critical controls mounted on the floor, near passengers’ feet and carry-on baggage.

The NTSB has a lot to deal with, principally the FAA’s terminal case of regulatory neglect and lackluster oversight of operators.

Overview of the NYC Helicopter Crash

Let’s briefly review what has been publicly reported.

The single-engine turbine helicopter was flying five tourists on a picture-taking jaunt along the East River. A photo taken aboard shows the passengers happily yukking it up for the camera. Moments later, pilot Richard Vance radioed “Mayday … East River, engine failure.” The helicopter ploughed into the water, with skid-mounted flotation bags deployed, then promptly turned upside down. Only the pilot, with a five-point restraint system, was able to unbuckle with a quick, simple slap of the buckle, located right in front of him, and escape while his passengers were vainly struggling to unbuckle from harnesses designed to keep them inside the doorless passenger compartment. In the preflight brief, they had been advised of the small knife affixed to one of the straps by which they might cut themselves free. Suddenly upside down in freezing water, the frantic quest for air undoubtedly overrode preflight mention of a knife. If their restraints could not be swiftly unbuckled like the pilot’s, then obviously “one level of safety” for all aboard, an FAA mantra, was not followed.

The doors had been removed to give the passengers a better view, the complex restraint system designed to compensate by keeping viewers within the cabin. Let’s ask, what tests were conducted on real people, suddenly upside down in the water, to make sure the passengers released the restraints with one simple motion, without benefit of a knife or razor? What kind of “safety” system requires the use of a knife? The restraints were not part of original equipment for which the helicopter was FAA certified. Was the FAA involved in supplemental type certification of the passenger restraints? To what level of detail? E.g., on-site supervision of real-life dunking tests using everyday volunteers, not belt manufacturer volunteers?

There is a report that the engine quit due to a bag or its strap inadvertently jamming the floor-mounted fuel shutoff lever, forcing the ditching. If so, here’s a critical control mounted out of the pilot’s immediate line of sight, vulnerable to activation by a misplaced foot or carry-on item. If such was the case, how did the helicopter attain original design certification by the FAA? Did the agency simply endorse a spotty European certification?

The FAA’s Neglect of Helicopter Regulations

With flights in highly congested airspace over New York City, the skies crowded with tall buildings and other aircraft, the FAA nonetheless approved these tourist helicopter flights for single pilot operation. A co-pilot could be gainfully employed keeping a lookout, manning the radios, scanning the instruments, etc., thereby freeing the pilot from these mundane but necessary tasks to concentrate on aviating. In May 2013 the FAA declared that helicopters previously approved for two-pilot operation would be authorized for one pilot flights based on “advanced technologies … that can reduce pilot workload…” Did this helicopter feature these un-named “advanced technologies”?

Finding out what started the accident chain-of-events will be needlessly difficult because, unlike for jetliners, the FAA does not require electronic flight recorders for helicopters. The fact that the chance of being killed is about seven times higher for workers commuting by helicopter to offshore oil rigs than for other workers in the United States, according to a 2013 report by the Centers of Disease Control (https://www.cdc.gov/
mmwr/pdf/wk/ww6216.pdf) was not enough to stimulate the FAA to, finally, require helicopters to be equipped with electronic flight data recorders, the essential “black boxes” used to unravel the mysteries of airliner crashes.

The inflatable bags mounted in the helicopter’s landing skids clearly did not forestall the entire machine from fatally tipping over. There is an account that one of the bags did not fully inflate. If so, did real-life testing reveal a one-in-six bag (15%) failure and the consequent inversion of the helicopter?

And, surely, the FAA is aware of the European Aviation Safety Agency’s (EASA) work on helicopter ditching. A 2016 report (EASA report “Helicopter Ditching Occupant Survivability — NPA [Notice of Proposed Amendment]) reminded the helicopter industry that “an ‘air pocket’ large enough and accessible to all passengers in the cabin, following capsize, must be provided (both with the flotation system intact and with single float puncture)” and that the “helicopter must not sink with one flotation unit lost.”

A 2005 report on helicopter ditching by Britain’s Civil Aviation Authority (CAA Paper 2005/06) concluded, “… ditched helicopters are likely to capsize … they invariably turn completely upside down, leading to complete flooding of the cabin … When this happens the occupants must escape very quickly because of their limited breath-holding capability … Occupants who do not escape from the cabin within a matter of seconds are likely to down.”

A detailed report on EASA standards by Eurocopter (report EASA.2007.C16) underscored that “additional flotation devices high on the fuselage in the vicinity of the main rotor gearbox (the ‘side-floating concept’)” would prevent a total inversion of the helicopter in the event of ditching and would ensure “the retention of an airspace inside the cabin.”

The latest helicopter tragedy in New York City underscores deficiencies in regulatory oversight and design that have been documented for years. Likewise, workable solutions have been proposed. They have been dumped in the FAA’s “pending” box, without action. Benign regulatory neglect is too kind a gloss on deadly complacency.

ANATOMY OF A LAWSUIT

Pre-trial
• Litigation is the act of bringing a lawsuit against a person or company for a perceived wrong. A civil lawsuit can be settled out of court, or it can follow the steps of the litigation process. Before starting the litigation process, the wronged party, or plaintiff, usually tries to come to an agreement to resolve the conflict and avoid litigation. If no settlement can be agreed upon, the plaintiff files a complaint with the court and a copy is sent to the other party, or defendant, in the form of a summons. The defendant is given time to respond to the complaint. Once on notice, the defendant may choose to settle the case. A judge may order the suit into arbitration, in which a third party attempts to help the parties come to a compromise, or the case moves on to the next step.
Representation
• The hired attorney spends time reviewing the merits of the case, researching other legal precedents, interviewing witnesses and gathering facts. Discovery takes place between the representatives of both parties. They share information formally through written requests. Each attorney may choose to interview the other party’s witnesses in a deposition. During a deposition, the witnesses are under oath and the proceedings are recorded by a court reporter. Expert witnesses are found to testify for both sides about technical issues or bring their expertise to bear on the argument of either side by explaining what happened from their perspective. Both sides typically file motions to clarify procedures and resolve disputes prior to the trial. Sometimes evidence is asked to be held back or an attorney requests a summary judgment, asking the court to dismiss the case before it continues any further based on evidence that’s been gathered.
Trial
• A trial may be held in front of a jury or a judge. During the trial, both sides present their evidence. The plaintiff’s side goes first, and witnesses are called to testify, then cross-examined by the opposing counsel. After both sides present their evidence and witnesses, the attorneys speak to the jury in closing arguments that summarize their cases. The jury then leaves the room and enters a private place where they discuss the case and decide on a verdict. Once a decision has been reached, the losing party may ask for the decision to be changed by the judge. The losing party also may appeal the decision and request another court to review the case. An appeal can prolong the litigation process for up to a year or more.

Birth Control Pill Injury Report

FDA finds unidentified substance in Baxter’s blood-thinning drug heparin

A significant amount of an un-identified foreign substance contaminated Baxter International Inc.’s blood-thinning drug heparin, the U.S. Food and Drug Administration said Wednesday, raising the possibility of intentional tampering in a supply chain that begins with pig farms in China
.The mysterious substance, which has a chemical makeup similar to heparin, comprises as much as 20 percent of the active ingredient in nine suspect lots produced by Baxter since September, the FDA said Wednesday. The suspect lots are connected to at least four deaths reported nationwide since Baxter noted a spike in adverse reactions to the drug in late December.

The FDA on Wednesday said heparin is connected to as many as 19 deaths and 785 serious illnesses since

Jan. 1, 2007
Jan. 1, 2007

. But the FDA timeline extends well beyond the period from September to November, when Baxter’s Cherry Hill, N.J., plant produced the heparin connected to the recent rash of serious allergic reactions. The suspect active ingredient in heparin originated at a Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis.
“We don’t know whether the introduction of the contaminant was accidental, as part of the biological process, or if it was deliberate,” said Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.
At least one former top FDA official who helped lead the fight against counterfeit drugs indicated that some Chinese suppliers in the past have introduced foreign substances to boost production when supplies are tight. That’s what happened in the early 1990s with an antibiotic known as gentamicin sulphate, which produced adverse reactions and some deaths in the U.S.
“The obvious question is, ‘Are these plants back-dooring their supply in order to supplement their capacity?'” asked Benjamin England, who chaired the FDA’s Counterfeit Drug Working Group before leaving for a private law practice in

Washington, D.C.
, in 2003.Epidemic in

China
China

Heparin is produced from an enzyme in the mucous lining of pig intestines. The suspect lots of heparin were made beginning in September, just after the peak in an epidemic of an often-fatal disease known as “blue ear” that afflicted more than 250,000 pigs throughout

China
. More than half those pigs died or were exterminated.An FDA official at the press conference said it is possible supplies of the adulterated ingredient came from pig intestines. But FDA officials emphasized they have not pinpointed the source.

Conventional quality and safety testing typically does not discover a foreign substance,

England
England

added, because the tests are not designed for that purpose.The FDA in its press conference Wednesday said conventional tests performed by Baxter and Scientific Protein did not show any variation because the contaminant is so similar to heparin.

“It acts like heparin in this test, so it looks like everything is fine in the test,” Woodcock said.

Only after further testing, using nuclear magnetic resonance spectroscopy, did the differences in chemical makeup become apparent, the FDA said.
Scientific Protein’s plant obtains heparin from bulk providers of raw material. From its plant in

Changzhou, Scientific Protein ships raw heparin to the company’s headquarters outside Madison, Wis., then on to Baxter’s Cherry Hill
Changzhou, Scientific Protein ships raw heparin to the company’s headquarters outside Madison, Wis., then on to Baxter’s Cherry Hill

plant for final processing, packaging and shipping.Pointing fingers

Baxter, in its own press conference, sought to point the investigative spotlight back to

China
China

. Baxter executives said the active pharmaceutical ingredient sourced from its China-based supplier is the focus of the company’s investigation.”Either the problem lies further back in the supply chain, somewhere before the material gets to the processing plant, or there’s something in the processing before it comes to Baxter,” said Peter Arduini, president of Baxter’s medication delivery business.

Arduini said the company’s

Cherry Hill
Cherry Hill

manufacturing plant, where multidose vials of heparin are finished and filled before shipment to hospitals and dialysis centers, recently passed an FDA inspection.Arduini said Baxter’s investigation centers further into the “supply stream” in

China
China

. There could be “process issues” associated with Scientific Protein’s Chinese manufacturing plant, he said.Baxter also took issue with the numbers provided by the FDA, which said heparin has played a role in 19 patient deaths since

Jan. 1, 2007
Jan. 1, 2007

. Baxter insists that four deaths so far may be connected to adverse reactions to the suspect heparin.For its part, Scientific Protein disagreed with the FDA’s interpretation of test results that seems to focus the investigation on a possible adulterated material being added during Scientific Protein’s production process.

“During the call with the media, FDA speculated that the source of the adverse events may be a contaminant,” Scientific Protein said in a statement. “It is important to note that this theory is speculation at this point, and [Scientific Protein] is participating actively in working with the FDA to pursue this theory as well as others so that we can understand the cause of the adverse events.”
Scientific Protein’s

Changzhou
Changzhou

plant, owned in a joint venture with a Chinese partner, is preparing a response to an FDA inspection report last week that criticized the plant’s record-keeping, reporting and processes. “It is important to emphasize that the root cause of the heparin adverse events has not been tied to any of the agency’s observations,” Scientific Protein said in a statement.FDA inspections

Dr. Andrew C. von Eschenbach, commissioner of the FDA, declined to say whether the FDA physically inspects the more than 700 Chinese facilities that ship pharmaceutical ingredients and drug products to the

U.S. The FDA has deployed a “risk-based” system that seeks to focus inspection on plants that might potentially cause the most harm to U.S.
U.S. The FDA has deployed a “risk-based” system that seeks to focus inspection on plants that might potentially cause the most harm to U.S.

consumers.Von Eschenbach said the agency is beginning to reallocate resources to better address the problems presented by the huge growth in foreign-made drugs. “We recognize that the number of sites that we must pay attention to that are beyond our borders are going to require us to address this systematically,” he said.

The FDA plans to increase the number of inspectors, base inspectors in key foreign cities, and build stronger working relationships with foreign regulators, Von Eschenbach added.

Suit alleges Baxter’s heparin killed wife

Baxter International Inc. faces a growing number of lawsuits from families who blame the company’s blood-thinning drug heparin for deaths of loved ones. Heparin was used by millions of people to prevent blood clots during dialysis and other medical procedures.

The latest wrongful death suit was filed Wednesday in Cook County Circuit Court by the widower of an Iowa woman who died at home during kidney dialysis Nov. 30. Mark Scott of Davenport accuses Baxter of selling defective heparin that caused her death.His wife, Melissa Scott, 53, began experiencing nausea and vomiting after treatment began in August, said Tom Ellis, a spokesman of the Nolan Law Group in Chicago

Chicago, which brought the suit on behalf of Mark Scott. On Nov. 30, Ellis said, an allergic reaction to the heparin caused Scott to fall and as a result disconnect from the machine. Mark Scott found his wife on the floor after she called out to him during a treatment. The death certificate said death was caused by an air embolism in the heart, Ellis said. An autopsy was not performed.”Mark wants to know for sure what happened to his wife,” Ellis said. “His wife was well trained on the dialysis machine.”

A Baxter spokeswoman said the company had not yet seen the Scott suit and declined to comment on its specific allegations. But she said the company is aware of at least four other wrongful death suits in the

U.S.
U.S.

“No patient deaths have been confirmed by medical or epidemiological evaluation by Baxter or [the U.S. Food and Drug Administration] to have been caused by the allergic-type reactions associated with the current heparin recall,” said Baxter spokeswoman Erin Gardiner. “None of these suits includes any credible medical information to allow the company to medically evaluate these claims.”The Deerfield-based company also is defending at least five suits brought by patients who allege they were harmed by tainted heparin.

The FDA is investigating whether heparin is connected to as many as 19 deaths and more than 700 serious illnesses since

Jan. 1, 2007
. Baxter insists that four deaths so far may be connected to adverse reactions to heparin.Baxter recalled the drug in February after a spike in severe allergic reactions in patients. Further investigation revealed a significant amount of an unidentified foreign substance contaminated batches of heparin.

The suspect active ingredient originated at a

Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis. Last month the FDA disclosed that low-cost animal cartilage made its way into Baxter’s heparin but has not determined a specific link to allergic reactions.
Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis. Last month the FDA disclosed that low-cost animal cartilage made its way into Baxter’s heparin but has not determined a specific link to allergic reactions.

test

Eye on YAZ Litigation

YAZ lawsuits are increasing throughout the country. As of recently, a total of 32 federal lawsuits have been filed throughout the United States on behalf of YAZ victims. These suits state claims sounding in strict liability, negligence, and failure to warn.

On July 24, 2009, lawyers representing YAZ victims filed a petition with the United States Judicial Panel on Multidistrict Litigation seeking consolidation and centralization of all federal Yasmin and YAZ suits in front of Judge Carr in the United States District Court for the Northern District of Ohio. Consolidating all of the cases in a multidistrict litigation (MDL) would bring all individual cases in front of one judge for pretrial purposes, such as discovery, depositions, and settlement discussions. Utilizing an MDL promotes efficiency and consistency—rather than having many individual cases throughout the country, each and every case is grouped in front of a single court prior to trial. The Panel will hold a hearing on September 24, 2009 to determine if consolidation in the MDL is appropriate.

The suits are against Bayer Pharmaceuticals Corporation and other Bayer related companies—companies responsible for the manufacturing of Yasmin and YAZ products.

Bayer is a global medical conglomerate which has reported sales in the billions of dollars since the launch of Yasmin and YAZ in the birth control market in 2001. This birth control has been reported as one of the highest earning drugs manufactured by Bayer in recent years. In 2008, Bayer made more than $600 million dollars from it!

Despite the growing numbers of lawsuits against it, Bayer is still raking in huge profits from women who use YAZ and Yasmin. It recently published its 2009 Second Quarter Financial Report labeling the group of YAZ contraceptives to be its best selling pharmaceutical line with an increase of 4.1% since last quarter. Its combined sales from these drugs amounted to an astonishing $915 million for just the first half of 2009! Showing just how large of a company Bayer is, these YAZ products account for about 12.32% of all of Bayer’s pharmaceutical sales during this second quarter of 2009.

Interestingly, Bayer’s report mentions another type of progestin that may be used in its drugs. In October 2008, Bayer announced European approval for the launch of a new oral contraceptive using yet another new synthetic progestin called Dienogest. In its release, Bayer states “For the first time, the use of estradiol in oral contraceptives is made possible with Qlaira® through the combination of estradiol with the progestin dienogest in a unique dosing regimen.” The product is currently unavailable in the United States; it is only available in certain European countries, including Germany. However, Bayer states that “further launches are planned for the fall of 2009.” This will be an interesting development if the drug is approved for use in the United States.

Two recent articles published in the British Medical Journal confirm the dangerous risks posed by YAZ and Yasmin. One of those studies assesses the thrombotic risk associated with the oral contraceptive and the other likewise assesses the increased risk of venous thrombosis in women using these contraceptives.

If you, or someone you love, have experienced birth control side effects from using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.

Sudden Engine Failure; Where Are the Regulators?

Engine reliability has a lot to do with staying airborne and choosing a suitable place to land. When the engine sputters and shuts down, the options for landing are severely limited. Given that general aviation pilots generally have less experience than transport category airline pilots, one would think that assured engine reliability would be a matter of high priority, especially with regard to certification by the Federal Aviation Administration (FAA). It appears, however, that light sports aircraft engines (and other components) are failure prone, showing a weakness in the regulations and in certification of engines for this category of aircraft.

Case in point: the Rotax 503 TLC piston engine, which has found favor in ultralight and experimental aircraft. Recently, two pilots from Winter Haven, Florida, were forced to land their Challenger experimental plane on a highway when the engine failed (more than once) in flight. The co-pilot was the owner of an audio visual production company, and he outfitted the airplane with two cameras for the plane ride.

landingy

While the cockpit camera was not specifically oriented to capture the flying pilot’s control inputs or instrument readings, the video does show why the National Transportation Safety Board (NTSB) wants image recorders in cockpits of on-demand and charter aircraft not now equipped with cockpit voice or flight data recorders.

The pilot of this particular aircraft exhibited good airmanship skills, and he was also lucky that truck or auto traffic was absent from the side of the highway on which he chose to land. The engine failure occurred shortly after takeoff, but the runway was just on the edge of the airplane’s glide range.

According to Lake Aviation, which produces the Challenger kit for assembly, sudden engine stoppage is not unusual for the two-cylinder two-cycle engine. Herewith, quotations from Lake Aviation, abbreviated from their website:

“The Rotax manual states ‘WARNING: This engine, by its design, is subject to sudden stoppage. Engine stoppage can result in crash landings, forced landings, or no power landings. Such crash landings can lead to serious bodily injury or death.’ (Rotax Operators Manual, Page 4.2) ….

“No further explanation regarding ‘sudden engine stoppage’ is given at that point in the manual … Some indicators are given throughout the manual but they are scattered about in the instructions … A nice concise summary for this critical event is in order so that an operator can take the careful steps to avoid it …

“The 6 key reasons for Rotax 503 sudden engine stoppage:

Fuel Filter Clogged

“The standard fuel filter sent with the Challenger kit has a paper filter element. This works fine in most operating conditions. However, in cold weather climates, such as Canada and the northern United States, this fuel filter is not suitable for winter operations. A higher quality Bosch model [filter] is recommended because it has a metal element ….

Alcohol in Gasoline

“One of the great advantages of the Rotax engines is that they run on Mogas (gas for cars). This saves us a lot of money on fuel. Unfortunately, Mogas often has alcohol in the form of ethanol added to it. Alcohol is bad for aircraft engines, especially 2 stroke Rotax engines …

“Alcohol is corrosive and may be incompatible with the rubber seals and other materials. If these materials break down because of contact with alcohol, they will cause leakage. Any rubber material may be carried with the fuel and clog the filter or carburetors. The alcohol may cause some seals to swell. This swelling may cause a component to stick or malfunction …

“Alcohol separates oil from gasoline. Since a 2 stroke engine is lubricated by the oil mixed into the gasoline, any separation of the two components prior to entering the cylinders is going to cause excessive wear or, in severe cases, even a sudden engine stoppage ….

Old Stale Fuel

“It was highlighted during the engine course that gas ages rapidly, especially after it has been mixed with 2 stroke oil. In fact, the Rotax factory states ‘when fuel is premixed with 2-stroke oil, the octane rating is reduced by about 2 points. An 87 octane fuel would therefore become 85 octane.’ (The minimum recommended octane for the engine is 87.) Over the course of a couple of weeks, the octane rating of gas drops off even more. Over a couple of months maybe 10 points. Thus, old mixed fuel in the tank may well have an octane rating well below the minimum required for the engine to continue running ….

Inadvertent Mixture Leaning in Flight

“In a high speed dive the propeller becomes unloaded and will spin at a higher rpm than normal. The propeller rpm is, of course, directly proportional to the engine rpm. The engine will thus be turning faster than it normally would for the given throttle setting. The pistons will thus be sucking in a larger than normal amount of air. However, if the throttle is retarded to idle during this high rpm dive, the amount of gasoline being drawn into the cylinders will be much less than normal for that engine speed. High air volume combined with a small fuel volume is a lean mixture.

“Therefore in a high speed dive with the engine at idle, an inadvertent lean mixture is introduced to the engine, causing engine temperatures to soar. A sudden engine stoppage is likely to occur ….

Engine Warm Up and Shock Cooling

“The Rotax 503 engine is manufactured using a lot of aluminum including in the pistons. The cylinder sleeves, however, are manufactured from steel. Whereas the designers no doubt had very good reasons for these material choices, including weight saving, the different metals used in the hot section of the engine can cause sudden engine stoppage and premature wear if misused …

Air Filter Clogged

“The air filter used on a Rotax 503 has a very fine element that is soaked with oil and entrains harmful particles before they enter the engine. Over time, as more and more particles are absorbed, the filter becomes clogged. If allowed to remain untreated, the filter will eventually restrict the amount of air entering the engine. This will change the fuel air mixture to an excessively rich condition. This excessive rich mixture will cause the engine to run rough, lose power and even suddenly stop ….”

It seems that the Rotax engine may be okay for snowmobiles but a poor safety bet for a light sports aircraft’s primary source of power.

When one looks at light sport aircraft, there appear to be numerous examples of regulatory slackitude, as it were. The designs don’t pass muster, and/or the aircraft are not adequately inspected by FAA officials during and following their construction. Here is one example:

February 2008, 3 injured, none killed: The NTSB determined that the cause of this amateur-built experimental airplane crash was “a total loss of engine power while on approach due to the electrical overload of a fuse caused by the inadequate design and installation by the builder of the electrical ignition switch.”