Product Liability Summary
(1) Taught Product liability at CSU School of Law -- adjunct professor at Cleveland State University School of Law, 1976-77.
(2) Dalkon Shield IUD litigation (1975-1998). [See Dalkon Shield Saga]
- Background: The Dalkon Shield was an intrauterine device sold by the AH Robins Company for contraception. The IUD was inserted by a physician into a women's uterus. The device was defective -- it wicked bacteria from the woman's vagina to her uterus, causing severe pelvic infections. The infections resulted in infertility; and, in some cases, the infections precipitated a septic spontaneous mid trimester abortion, which resulted in death to the fetus.
1975: I filed the first case Dalkon Shield case against A. H. Robins in Ohio in 1975.
1984: I was a member of the Committee of Plaintiff Attorneys Opposing Robins' Request in Federal court in Richmond, Virginia to Certify a Punitive Damages Class on the basis of a "Limited Fund". The Committee was successful, and we overcame Robins attempt to limit compensation to victims. 1985: I was appointed by Federal District Court Judge Robert Merhige to the Dalkon Shield Claimants Committee, in the A.H. Robins bankruptcy, to protect the rights of Dalkon shield victims in the bankruptcy.
1986: By Order of Court, I began receiving all pleadings in the A.H. Robins Bankruptcy to disseminate (for a nominal copying fee) the bankruptcy pleadings to attorneys world-wide who requested them.
1990: I established the Dalkon Shield Depository at Brown & Szaller in Cleveland, Ohio.
The Depository housed all the medical literature (journal articles and textbooks) regarding the Dalkon Shield, and as compiled by the twelve full-time nurses hired by Brown & Szaller; all the depositions taken in the multi-District litigation in Wichita Kansas; all the relevant documents produced by the A. H. Robins Company in discovery; complete trial transcripts of many of the trials involving the Dalkon Shield; much of the A. H. Robins bankruptcy docket; and motions, pleadings and other various materials generated in trials and arbitrations against robins and the Dalkon Shield claimants trust. The depository had over 100 member law firms. The member law firms could avail themselves of all materials in the depository for a nominal copying fee. The depository was invaluable for all upcoming trials against the Dalkon Shield claimants trust, the successor in interest to the A. H. Robins Company that had available to it over $2 billion to resolve claims.
1995: Appeared in the United States Supreme Court as amicus curiae for Ohio Dalkon Shield victims and the Association of Trial Lawyers of America (ATLA).
1996: Sponsored legislation in Ohio (and put on evidence and witnesses during hearings in the Ohio House and Senate) to amend the Ohio statute of limitations to provide additional time for filing suit in Ohio by Dalkon Shield victims. The legislation passed almost unanimously, and the statue was amended.
For my efforts in the legislature, I received the Distinguished Service Award from the Ohio Academy of trial Lawyers. [See Distinguished Service Award]
1998: I resolved the last Dalkon Shield case in Ohio in 1998.
2001: I donated the Depository to the Harvard Law School for posterity. [See Harvard Press Release]
(3) Propulsid litigation, 2000 to present.
- Background: Propulsid was indicated for GERD (gastroesophageal reflux disease) -- i.e., heartburn -- but caused severe heart arrhythmias. Propulsid was marketed by Janssen Pharmaceutical, and removed from the market in 2000.
2000: I have served as Treasurer (an elected position) of the ATLA Propulsid Litigation Group from 2000 to the present. The Litigation Group provides materials, advice and lectures/seminars for ATLA member attorneys who represent clients injured by Propulsid.
(4) Baycol litigation, 2000 to 2003
- Background: Baycol was a statin, manufactured and sold by Bayer, approved by the FDA for cholesterol reduction. But it could cause rhabdomyalysis, a rare, serious disease that compromised the patient's kidneys and could result in permanent dialysis or even death.
2000 - 2003 I represented 18 individuals in Ohio who suffered rhabdomyalysis . Resolved all 18 lawsuits favorably for our clients. During the representation, took depositions, and reviewed documents, with a consortium of attorneys for use by all attorneys world-wide who represented Baycol victims.
2000-2007 Chaired the ATLA Baycol (600 member law firms). Elected as Chair by members in 2000, and even though my clients' cases settled in 2003, continued Chairing the Group until it was disbanded in 2007.
2007: I was the first recipient of an ATLA "Litigation Group Chair Award" for Chairing the Baycol Litigation Group.
(5) Fen-phen litigation, 2003-2004
- Background: Fen-phen, manufactured and sold by Wyeth, was an anti-obesity medication which consisted of two drugs: fenfluramine or dexfenfluramine, and phentermine. The drug quickly became very popular. In 2001, Fen-Phen was shown to cause potentially fatal pulmonary hypertension and heart valve problems, which eventually led to its withdrawal from the market at the request of the FDA.
2003-2004: I represented the estates of individuals who died as a result of their use of Fen-Phen. All cases were favorably resolved by settlement.
(6) Vioxx litigation, 2004 to present
- Background: Vioxx was a COX-2 inhibitor, a NSAID (nonsteroidal anti-inflammatory drug), approved by the FDA for relief of osteoarthritis, arthritis, acute pain, and primary dysmenorrhea. It was defective because it greatly increased the risks of heart attack and stroke. It was removed from the market in 2004.
2004: Filed 35 lawsuits in Ohio on behalf of Vioxx victims.
2006 to present : Resolved the claims of all Ohio Brown & Szaller clients by settlement.
(7) Pain Pump Litigation, 2007 to present
- Background: Pain pumps are medical devices, approximately the size of a cell phone, that are used to manage post-operative pain. They are manufactured and sold by a number of manufacturers. These pain control devices are used following surgery to deliver, by way of a catheter, continuous doses of pain relief medication. The pump delivers anesthetic pain medication directly into the operative site for a period ranging from 12 hours to 5 days, depending on the device brand and recommendation of the physician.
- There are generally two different options for carrying the pump. The first is through a shoulder strap built into the top of the pump. The second is a carrying case that is attached to an adjustable belt strap. After the pain pump is used, the catheter can be removed by the physician, nurse or patient, and it is thereafter discarded.
- The pain pump is designed and intended to be used with commonly used anesthetics such as lidocaine or marcaine, with or without epinephrine, in volumes of 250 cc's or more, depending upon the manufacturer. The continuous injection of such medications at such doses over time directly into the shoulder joint, however, can cause serious and permanent damage to the cartilage of the shoulder joint. Patients injured by pain pumps suffer a narrowing of the joint space and/or a condition called "chondrolysis," which is the complete or nearly complete loss of cartilage in the shoulder joint, an irreversible, degenerative, disabling, and extremely painful condition.
- Commonly used anesthetics likely to be used in their pain pumps, such as lidocaine and marcaine, with or without epinephrine, were harmful to human and animal articular cartilage;
- Use of the pain pump in a joint space had not been approved by the F.D.A., and in fact had been specifically rejected by the F.D.A.;
- Continuous injection of 250 cc's or more of such medications, through a catheter, directly into the shoulder joint, for two days or more, had not been adequately tested for safety or effectiveness;
- The risk of chondrolysis and other serious post-operative problems associated with using the pain pump as designed and instructed outweighed the possible benefits of such use.
Causes of Action:
2007-Present: I represent individuals in Ohio who suffered catastrophic injury from use of a pain pump. The litigation is ongoing.
(8) Hormone Therapy Litigation, 2003 to present
- Background: Menopausal women suffering from vasomotor symptoms have for decades used estrogen therapy (Premarin). In 1975 it was determined that estrogen therapy caused endometrial (uterine) cancer, and thus women who had a uterus (women who therefore had not had a hysterectomy) stopped using estrogen therapy for vasomotor relief Late in the 1970's, it was discovered that the addition of a progestin to estrogen (Prempro) alleviated the risk of uterine cancer, and thus the estrogen/progestin form o f hormonal therapy began widespread use.
- The marketing leader in sale of female hormones is Wyeth Pharmaceuticals (purchased by Pfizer in 2009). Over the decades, Wyeth has convinced women that menopause is a disease which needs treatment by medicine. This is not true. Menopause is a natural condition, and diet and exercise often help alleviate the difficult and uncomfortable symptoms of menopause.
- For the minority of women who do need medication, the only safe way to treat the condition of menopause is with the lowest doses of hormonal therapy for the shortest period of time. But Wyeth has continually tried to sell hormonal medications to women to use for an extended period time, by convincing them that it was good for a myriad of uses -- many of which had not been proven, and are not FDA approved.
- In 2002, the WHI (a United States government study) proved that hormone replacement therapy (estrogen/progestin, i.e, Prempro) carried greatly increased risks of breast cancer, stroke and blood clots.
2003: I filed 110 lawsuits on behalf of Ohio women injured by hormone replacement therapy.
2004: I was appointed to the 50-member Hormone Therapy Governing Committee in the MDL pending in Little Rock Arkansas. In the Federal District Court in Little Rock Arkansas all of the cases filed in federal courts throughout the country were consolidated for pretrial purposes. The 110 lawsuits filed in Ohio were consolidated in Little Rock Arkansas.
2004 -- Present: I reviewed approximately 2,000,000 Wyeth documents, and took many weeks of depositions of Wyeth employees, to assist all of the attorneys worldwide in the eventual trial of individual hormone therapy cases.
2004 -- Present: I spent over a month in Philadelphia on the first trial team to present evidence to a jury. The jury found in favor of the plaintiff, and awarded a seven figure verdict.
2004 -- Present: I perfected the complete story of the attempt by Wyeth pharmaceuticals to fabricate medical literature by using ghostwriters. Because the story was so large and so important to the public, I traveled to Washington to meet with Sen. Grassley (at his request) to discuss with him the ramifications of ghostwriting of medical literature. Government hearings are ongoing against the Wyeth company. [See Newspaper articles: N. Y. Times and others]
2004 -- Present: With the New York Times and the Public Library of Science, Medicine, we convinced a federal judge in Little Rock Arkansas to make available to the public the most revealing Wyeth documents and depositions regarding ghostwriting. [See Newspaper articles: N. Y. Times and others] 2004 -- present: continuing the effort to resolve the claims of over 100 Ohio hormone therapy victims.
