In the 1990s, millions of Americans were prescribed the weight loss therapy popularly known as Fen-phen. Fen-phen was a combination of the two (2) diet drugs, Pondimin (generically named “fenfluramine”) and phentermine. Similarly, Redux (“Dexfen”)—a chemical derivative of Pondimin—was increasingly prescribed. The Fen-phen craze continued until September 1997, when the manufacturer of these drugs, Wyeth, removed both Pondimin and Redux from the market. Removal occurred, however, only after FDA strongly advised Wyeth to do so. At that time, FDA clearly had linked Wyeth’s drugs to severe heart and lung damage, including: (1) Valvular Heart Disease (“VHD”); and, (2) “Primary Pulmonary Hypertension” (“PPH”), more recently labeled by doctors as “Pulmonary Arterial Hypertension” (“PAH”).
VHD is a deterioration in one or more of the valves of the heart (the aortic and mitral valves on the left and the pulmonary and tricuspid valves on the right). PPH (recently renamed in medicine “PAH” or especially, “IPAH”) is a disease of the vasculature of the lung, is serious and may be fatal.
Many lawsuits against Wyeth by patients and/or families of patients who developed Fen-phen related VHD concluded with a Nationwide Class Action Settlement Agreement. However, this settlement did not resolve claims by patients and families injured by PPH/PAH.
The drug and device injury lawyers at Becker Law Office have assisted PPH patients injured by taking dangerous drugs, like Fen-phen. The Becker Law Office has represented those injured by Fen-phen since before 1997, when the drugs were first removed from the market.
Pulmonary hypertension (“PH”) is high blood pressure in the lungs. Although simple high blood pressure in the lungs has many causes, it usually is not as serious as the specific subset of PH, known as PPH/PAH. PPH/PAH occurs when small blood vessels in the lungs become narrowed, scarred and cannot carry as much blood as they should. When this happens, pressure builds up. As the heart works harder to pump blood into the lungs, the strain leads to heart failure.
The Diet Pill MDL Judge, Louis Bechtle, in the case In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig., 2000 U.S. Dist. LEXIS 12275, *47-48 (D. Pa. 2000) (hereafter called PTO 1415), described PPH as follows:
…PPH is characterized by scarring and fibrosis of the pulmonary arteries which carry deoxygenated blood from the right side of the heart to the lungs. This scarring prevents blood cells from effectively absorbing oxygen as they pass the alveoli in the lungs.
Ultimately, this dilatation and hypertrophy of the right ventricle will cause the heart to fail and result in the patient’s death.
These side effects of Fen-phen led and are still leading to disability and death for millions of people, mostly women.
The first signs of PPH/PAh are shortness of breath or light-headedness during activity. The patient may also experience an increased heart rate (palpitations). As the condition worsens, symptoms will begin to occur with lighter activity or even while at rest. These signs and symptoms may go on for years without being formerly diagnosed.
Other symptoms may periodically include:
PPH/PAH is treated with the goal of controlling symptoms and preventing additional lung damage. At later stages, a PPH victim may need oxygen therapy and have trouble performing any activity, including day-to-day life activities. For instance, many PPH patients become out of breath, simply from the effort of making their own beds. Unfortunately, many patients are not diagnosed until the later stages of this disease.
In addition to the threat of death, the PPH patient faces ongoing treatment and its expenses, including the costs of assistive devices (walker, wheelchair, oxygen, etc.) and, eventually, long-term personal care and assistance. The financial and emotional burdens of PPH also adversely affect the patient’s family members.
Wyeth (formerly known as American Home Products or “WYETH”) knew since at least March 1995, that Pondimin (the FEN in Fen-phen) caused PPH/PAH. In March 1995, the interim results of an international, prospective case-controlled epidemiologic study (“International Primary Pulmonary Hypertension Study” or “IPPHS”) were presented to Wyeth. The March 1995 IPPHS interim results (and the final results which issued on July 26, 1996) established that diet drugs, including Pondimin and Redux, cause PAH.
Wyeth also knew that warning labels on its drugs were wholly inadequate to alert physicians of their true dangers. Wyeth’s entries in the Physician’s Desk Reference (“PDR”) for Pondimin between January 1989 and December 1996 mentioned only four (4) reported cases of Pulmonary Hypertension (“PH”), associated with fenfluramine use, and completely failed to mention the much more serious and frequently fatal, PPH/PAH. Wyeth, from its “safety surveillance” computer records, in fact, was aware by May 1996 of more than fifty (50) PH cases (from the period May 23, 1990, forward) associated with Pondimin and over 100 European cases of PAH reported in association with dexfenfluramine. Wyeth knew that Pondimin was associated with PPH/PAH, not PH. PH many times is much less serious than PPH, and may not be life-threatening in many instances; yet, Wyeth completely failed to mention PPH (versus PH) in its warning labelings distributed to doctors, prescribing these drugs.
Indeed, internal memos from Wyeth’s employees show that they, beginning June 23, 1994, repeatedly proposed and acknowledged the need for significant textual changes to the warnings in Wyeth’s diet drugs; yet, the company failed to act until late in 1996 – more than two full years after learning the need to strengthen warnings regarding the risks.
“Primary pulmonary hypertension” (PPH) is an older term for the condition sometimes called “idiopathic pulmonary arterial hypertension” (IPAH or “PAH”) today. Pulmonary hypertension (PH) can denote a much less lethal or serious process.
Becker Law Office continues to pursue claims for PPH, having appeared or made special appearances in multiple federal districts and state courts of general jurisdiction. Those actions include, but are not limited to:
Kay Ball v. American Home Products Corporation, et al. Case No. 02-CV-108, United States District Court, District of Minnesota (transferred to MDL 1203); Sharon Bennett and Clementina Tierney, et al. v. Wyeth, Inc., et al., Case No. 04-3190 Commonwealth of Massachusetts, Eastern Counties, SS Middlesex, SS; Amy Curry, et al. v. Wyeth, Inc., et al., Case No. 04-CI-00214, Commonwealth of Kentucky Hardin Circuit Court; Deborah Dawson-Crain, et al. v. Wyeth, et al., Case No. 04-CI-05644, Commonwealth of Kentucky, Jefferson Circuit Court; Estate of Shirley Mudri v. Wyeth, et al., Case No. 8:04-cv-2104-T27MSS, United States District Court, Middle District of Florida (transferred to MDL 1203); Jeanette Nash v. Wyeth, et al., Case No. 2:04-CV-00996-CNC, United States District Court, Eastern District of Wisconsin; Gordon Tim Phillips, et al. v. American Home Products, et al., Case No. 03514, Court of Common Pleas, Philadelphia County; Estate of Leslie Rowley, et al. v. Wyeth, et al., Case No. 2004-20617 United States District Court for the District of Columbia (transferred to MDL 1203), Lori Sobkowski v. Wyeth, Inc., et al., Case No. 2003 CA 003577, In the Circuit Court of the Fifth Judicial Circuit, In and for Lake County, Florida (removed and then transferred to MDL 1203); Betty Turley, et al. v. Wyeth, et al., Case No. 02-CI-00496, Commonwealth of Kentucky, Boyd Circuit Court, Helen Washington; Deborah Hebb; James Hebb; Marjorie Florka; Richard Florka; Patricia Roberts; Lewis Roberts; Katherine Rogers; Kent Rogers; Scottie Holloway; Teresa Sauerheber; and John Sauerheber v. American Home Products Corporation, et al., Case No. 02VS028451H, State of Georgia, In the State Court of Fulton County; Michelle Carter; Travis Finley; Dale Finley; Kathleen Biliani; Frank Biliani; Nancy Kirk; Dorothy Newell; Shanna Henry; Douglas Henry; Sharon McKnight; Junior McKnight; and Kerry McKenzie v. American Home Products Corporation, et al., Case No. 012-10437, State of Missouri, In the Circuit Court of the City of St. Louis. Most recently, in 2008, Bubalo made a special appearance in Stribling v. Wyeth, Superior Court of New Jersey, Bergen County, Docket No. BER-L-2352-07 MT, presenting a pharmacologist expert in a PPH Diet Drug case pending before a jury. Stribling ended in a $3,000,000 verdict. Similarly, in early 2009, Bubalo was trial counsel in Kohler v. Wyeth, Superior Court of the State of California, County of Los Angeles, Central Civil West, Diet Drug Case No. DD 004290. The trial sought damages for a young lawyer who had taken Wyeth’s defective drugs and was broadcast streaming live on the web between 3/4/09 to 4/22/09.
If you or a loved one of yours has been harmed by fen-phen, we can advise you about your legal options for seeking compensation for your medical expenses and other losses, and for your pain and suffering.
The drug and device injury lawyers at Becker Law Office are working to assist patients who have contracted PPH/PAH from the use of the dangerous diet combination drug therapy, known as “fen-phen.” A skilled attorney could review your or your loved one’s case for free and advise you of the legal options available if Fen-phen has caused a case of PPH in your family. You may be eligible for compensation for your medical expenses, pain, and suffering.
Call the Becker Law Office Fen-Phen PPH injury lawyers today or through our online contact form to set up a free initial consultation about your case.
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