March 16th, 1992 Walnut Creek California To January 30th, 2013 Montreal Québec
"And can it be that in a world so full and busy, the loss of one creature makes a void so wide and deep that nothing but the width and depth of eternity can fill it up" - Charles Dickens-
On the morning of Monday January 28th, 2013 at about 10:30 AM the telephone rang. We were about to receive the dreaded call that no parent ever wants to receive. I happened to have stayed home from work that morning nursing a cold and was in the kitchen making breakfast. My wife had the day off and was upstairs doing a load of laundry. I stared at the phone for a moment deciding if I was going to pick it up or let it ring to voicemail since most calls on that line are solicitors, surveyors, pollsters or political advocates. For whatever reason, I picked up the receiver to hear a woman’s voice speaking English with a French accent asking me if I was the father of Lauren Alexander. The cadence of her words and the background noise told me that there was a serious problem. At that instant, a cold chill passed through me and my heart skipped a beat. Her name was Elisabeth, a hospital social worker informing us that our beautiful twenty year old daughter Lauren, a 3rd year student majoring in Russian Studies and French Literature at McGill University in Montreal, Quebec had been brought to the Montreal General Hospital Emergency Room unresponsive after being found on the second floor landing in the stairwell of her apartment building that morning while returning from grocery shopping. Lauren was resuscitated and stabilized in the emergency room and was now being moved to the Intensive Care Unit. Lauren was in grave condition having been struck down suddenly and most unexpectedly by what turned out to be a massive pulmonary embolism. At that moment, our family’s lives and those of her friends and the multitude of people she had touched had changed forever. Within a few hours, my wife was boarding a flight out of SFO bound for Chicago and then on to Montreal. To complicate matters, I was unable to join her until the following day after having to resolve a passport issue. Jane arrived in the early hours of Tuesday morning at Pierre Trudeau International Airport where she was met by a dear family friend from Montreal and Lauren’s boyfriend who had been at Lauren’s side for much of the day. I arrived early Wednesday morning and rushed to the hospital to join my wife at Lauren’s bedside...
We were gripped by fear, and fatigue. A fog descended upon us perpetuated by the chaos of thoughts racing through our heads. Time flashed by yet strangely stood still. Lauren lay in a coma, her only lifeline being a spaghetti like tangle of wires and tubes connected to machines, breathing for her and keeping her heart beating. She laid there until further tests confirmed our worst fears; there was no brain activity. In the late afternoon of January 30th and just 6 weeks shy of her 21st birthday after being sustained on life support there was nothing further that could be done and life support was removed. She died in our arms in peace and in the company of her doctor, nurses and dozens of her McGill University friends having never regained consciousness. Her hospital room was like a meeting of the United Nations with kids from all over the world who were with her in her final hours.
Lauren was simply a joy. She had blossomed into an incredible, beautiful, strong and caring young woman. She was doing so well at the University with the brightest of futures ahead of her. As a graduating Las Lomas High School senior in Walnut Creek California, Lauren achieved a 4.35 GPA; she ranked in the 98th percentile nationally in the SAT, and having earned enough AP credits to begin college as a second year student. She was accepted at “A list” institutions across the United States. Imagine Cal & UCLA literally being her backup schools. Lauren always the one to take the path less traveled and to rise to any challenge matriculated to McGill University in Montreal, one of the worlds’ most respected academic institutions not because it was easy but, precisely because it was hard. She wanted an international experience in a world class city and that’s exactly what she was living, her dream. She absolutely adored the vibrancy and multi-cultural environment of Montréal and the University. She did however, despise the harsh winters. She made peace with the bitter cold but, it was the darkness of short winter days and long nights that bothered this California girl. She spoke French as if a native Parisian and Russian with the accent of a Muscovite. She quickly mastered Spanish and had even picked up conversational Turkish. She found love in a wonderful young man from Istanbul who was studying to be a lawyer. Her roommates and circle of friends were from all corners of the globe; Nigeria, Romania and across Canada, the USA, the Caribbean, Korea, Jordan, Pakistan, Bangladesh, France, Germany and the list goes on. These young people of different nationalities, ethnic backgrounds and religions, of differing ages, class standing, majors and interests, who lived in different parts of the city all had one thing that bonded them together and that was Lauren. Lauren, was a brilliant student, a linguist, a talented musician, an artist and gifted writer but her true impact was bringing people together through her compassion, tolerance, sense of truth, fairness, equality & justice of those who may be marginalized or simply “different”. The family and her countless friends from around the world are all heartbroken that her life was cut short of fulfilling the immense promise that she showed with such brilliance for one so young. Lauren did things not because they were easy but because they were hard. Lauren’s intellect and reasoning were well beyond her years as many who knew her well utter the same phrase; “She was an old soul”.
Lauren was President of her High School Gay Straight Alliance for two years and was passionate about social justice issues. She was the recipient of the Kaiser Equality Scholarship in 2010 for her work in bringing people together. Lauren by her sheer presence and intellect worked tirelessly and passionately to present a point of view that love and tolerance shall inevitably prevail over ignorance and hate. The time we have available on this earth is but a fleeting moment. Lauren lived more in 20 short years than many who simply exist for 80. Don’t waste such a precious gift. Live each moment of each waking hour as if it were your last. Perform random acts of kindness and tell your loved ones how you feel … It shall make you a better person and a cruel world a better place.
So one must now ask themselves the obvious question. How can such a thing happen? How does one explain why a 20 year old woman who is the picture of health suddenly collapses for no apparent reason in a stairwell after shopping for groceries? Lauren was totally asymptomatic as far as anyone knew. Lauren treated her body like a temple! She was 135 lbs., a vegan, and an exercise fanatic who worked out religiously at the gym. Lauren walked everywhere including the 1.5 kilometers to class each day from her apartment. She didn’t use recreational drugs and took no regular prescription medications with one exception... One very big exception; the generic oral contraceptive Loryna,
Although we will never definitively know, the facts strongly suggest that the likely root cause for the catastrophic clot was the generic oral contraceptive Loryna, generic Beyaz that was prescribed by Lauren’s OBGYN (nurse practitioner) back home in Walnut Creek less than six months earlier. Her Attending physician at Montreal General had never seen such a mass of clots in a person’s heart and lungs. Lauren’s injuries were catastrophic and the clots presented without warning. As we now know, an astounding 25% of individuals who first suffer from clotting symptoms suffer a catastrophic medical event. He suspects that the primary clot may have originated in the pelvic region and broken loose traveling through Lauren’s arterial system to the heart. He hypothesizes that as the clot broke free and blocked blood flow to the heart, Lauren’s blood pressure dropped and she passed out on the stairwell landing. Her heart continued pumping however, with no blood flow through the heart, irreversible damage was done to the brain and to her internal organs. It is unclear how long she laid undiscovered other than it was simply too long. She was found by a neighbor who immediately called emergency services. When the paramedics arrived, they performed CPR which broke the blockage into multiple clots which found their way into the lungs. The primary clot’s formation may potentially have been precipitated by some undiagnosed underlying blood condition coupled with Drospirenone and Ethinyl Estradiol, a medication known to increase the risk of clotting in women and to exponentially increase that risk of clotting in those that may already have a predisposition to clotting e.g. a family history of clotting disorder. For those women being prescribed a contraceptive, ask questions, be proactive and insist on providing a full personal and applicable family medical history as well as potentially being tested for clotting disorders prior to simply accepting a prescription.
An obstetrics practice prescribing such hormonal contraceptives to a new patient has a Hippocratic obligation to “do no harm” by being absolutely clear about the patient’s risk factors and to fail to do so is in retrospect inconceivable. In Lauren’s case and without going into detail, there was a long and known family history of a clotting disorder by the practice and its medical network however, the prescribing practitioner failed to connect the dots. The practitioner followed a flawed procedure where Lauren dutifully filled out a hard copy of her medical history which received a cursory review. The form did not however ask any questions regarding family history related to clotting, only patient history and was silent regarding clotting. This practice may be fine in perhaps dermatology or ophthalmology but inadequate in an Obstetrics practice that regularly prescribes drugs with known side effects associated with clotting. Lauren filled out the form precisely as instructed. She didn’t misread the form, she wasn’t asked about family history. She was never tested for any underlying conditions prior to receiving a prescription. She was simply given a two months’ supply of samples and a prescription for a medication known for an highly increased risk of clotting and an extraordinary increase in that probability in those with a personal or family history of clotting. In less than six months this vibrant and health 20 year old was dead, cut down by a massive blood clot i.e. a known side effect of a drug commonly prescribed by Obstetrics practices.
Loryna’s active ingredient is Drospirenone and Ethinyl Estradiol i.e. the identical formulation as the Yaz family of contraceptives manufactured by Bayer Pharmaceuticals. Unbeknownst to us at the time, the Yaz family of contraceptives had been implicated in thousands of injuries and hundreds of deaths suffered by young women across North America and had spawned over 12,000 law suits worldwide including a massive class action in the USA. These drugs are manufactured by Bayer Pharmaceuticals and sold under several branded and generic names including; Yaz, Yasmine, Beyaz, Ocella etc. Lauren used samples of Beyaz for a several months provided by her OBGYN office and then filled the prescription for the generic version, Loryna manufactured by the Spanish generic manufacturing subsidiary of Novartis, Sandoz Laboratories. This class of contraceptives is marketed as a wonder drug that eliminates acne and helps calm menstrual cramping and is in fact often times prescribed to women for other ailments not associated with contraception. Lauren died with clear skin just as advertised and just as the fine print says an “elevated” risk of clotting in a statistically small number of patients. The only statistic that I’m 100% confident in is that 50% of my daughters are now dead.
Lauren’s death has been an unimaginable blow. The time since her death has been a living nightmare as our family struggles to come to terms with her tragic, untimely and needless death. She was the light of our lives and we are all still reeling in disbelief that our beautiful daughter is gone. We continue to put the pieces back together and continue the healing process through therapy, encouragement and support of family, friends and colleagues.
In our journey, we did however discover two very frightening things regarding Federal law as it relates to consumer protection and California state law as it relates to medical malpractice.
Our first shocking revelation was that in the United States of America, a series of court decisions dating back decades has for all intents and purposes eliminated consumer protections regarding the use of generic prescription drugs. In June of 2013, a final stake was driven into the heart of consumer protection by the Supreme Court’s Decision in the case of Mutual Pharmaceutical Co Inc. vs. Bartlett. This Decision and subsequent inaction by the Food and Drug Administration (FDA) and Congress to correct the inequity have profound negative consequences for any person who takes generic prescription medications. By a 5 to 4 vote, the Court struck down a lower applet court ruling that essentially gives generic pharmaceutical manufacturers total immunity from liability if a drug they manufacture to the specifications of the patented name brand drug approved by the FDA injures or kills someone. Today roughly 80% of all prescriptions written in the United States are for generic rather than branded drugs. Given the push by the medical insurance industry and the federal government to cut prescription medication costs through the use of generic drugs, hundreds of millions of people are exposed and tens of thousands who may be injured or die have no legal recourse. Lesson #1: Take brand name drugs if you wish to have legal recourse in case you are injured but, be prepared to pay a hefty price at the register. After Lauren’s death we retained legal counsel, a premier firm, specializing in product liability litigation with the express objective of forcing the manufacturer to stop selling a defective product. How naïve we were. The firm advised us that if our daughter were taking the branded version of the drug, we would have a solid case against the manufacturer. Unfortunately due to a nonsensical “quirk” in Federal law, generic manufacturers are held harmless. The Supreme Court’s Decision essentially allows the manufacturers of generic drugs free reign to produce and place in the stream of commerce defective products and physicians will continue to prescribe these defective products with no fear of compensating unfortunate victims and their families. More to the point, many more people will unfortunately be injured or die.
To add insult to injury, holding the prescribing doctor’s feet to the fire is also a nonstarter since we are California residents. California’s Tort Reform statutes dating back to 1976 come into play with a $250,000 cap on medical malpractice awards on non-actual damages i.e. pain & suffering leaves us with zero legal remedies. Given the cap as a backstop, it is common practice for medical malpractice insurers to fight to the death to drive up litigation costs to the point that virtually no plaintiff’s attorney will take on a case even under the most egregiously of circumstances.
(A photo of how Lauren’s doctor left her room until they absolutely needed to use it again- a small memorial to say to everyone passing by that we are human and that something important happened in this place) For more information on the Lauren Alexander Support for Families Fund, please visit http://www.laurenalexander.ca/#!about-lauren/cggx