How the Medical Device Industry Stays Unregulated

Michael Lin Baum is a lawyer who specializes in pharmaceutical litigation. Starting his career nearly 40 years ago, he is an experienced attorney who has represented thousands of people injured by prescription drugs and medical devices. In 2019, The National Trial Lawyers named Michael Lin Baum and his team Trial Team of the year in the mass torts category.

Several sophisticated medical devices come to the fore as technology continues to advance. Research has noted that about 10 percent of Americans have a medical device implanted in their bodies. Although medical devices come with their advantages, this industry is largely unregulated. According to research, some high-risk implanted devices are not subject to clinical trials and are grandfathered in. Many devices end up causing more harm than good. In fact, medical interventions have become the third leading cause of death in America.

Drugs usually have a more lengthy and rigid approval structure as they go through the Food and Drug Administration (FDA) agency. In contrast, the medical device industry is not subject to similar protocols.

Although the medical device industry became subject to the FDA in 1976, manufacturers of some medical devices still had permission to sell their devices without the requisite clinical testing that applies to drugs. Several medical devices were not subject to clinical testing as long as manufacturers could prove that the device they created is substantially equivalent to a device already in use.

HPV Vaccine Gardasil Linked to Serious Injuries

A Los Angeles, California-based lawyer with nearly four decades of legal experience, Michael Lin Baum serves as a senior partner of Wisner Baum. Through the firm, Attorney Michael Lin Baum has handled thousands of wrongful death and personal injury cases stemming from major pharmaceutical drugs, including the Human Papillomavirus vaccine Gardasil (HPV).

The HPV vaccine Gardasil has been linked to a host of debilitating injuries. Gardasil’s manufacturer Merck billed the vaccine as a solution for preventing cervical cancer caused by the human papillomavirus and curing genital warts, which are sometimes caused by certain strains of HPV, however, Gardasil is unproven at preventing cervical cancer. People who have taken this vaccine are contemporary sufferers of multiple alleged adverse effects.

Some serious injuries linked to Gardasil are reproductive disorders, miscarriage, premature ovarian failure, immune diseases, and seizure disorder. Many people allegedly suffer chronic pain from Gardasil. The drug has allegedly resulted in postural orthostatic tachycardia syndrome (POTS) countless times.

Gardasil Vaccine Misleadingly Marketed to Boys and Men

Serving the legal needs of clients nationwide, Attorney Michael Lin Baum practices in Los Angeles, California as a managing partner at Baum Hedlund Aristei & Goldman. Over the years, Michael Lin Baum has handled diverse wrongful death and personal injury matters related to harmful and defective pharmaceutical drugs.

An example is Merck & Co.’s Gardasil vaccine, which was primarily marketed as an effective way of eliminating human papillomavirus (HPV) risks among adolescent girls. Unfortunately, the data presented that led to the approval of Gardasil by the FDA was false and underreported or ignored potentially serious adverse effects, according to allegations in lawsuits being filed across the United States.

The vaccine also injured some boys and men, whom Merck targeted as consumers, according to the allegations. In 2009, the FDA approved Gardasil’s use in males age 9 to 26 to prevent genital warts related to a pair of HPV strains. The following year, approval was granted for the drug’s use in preventing anal cancer in patients of both sexes, age nine to 26. It is alleged that Merck never proved that Gardasil effectively prevented cancer, and its use was linked to increased cervical cancer rates.

With Merck having presented ads that pressured parents into getting sons vaccinated, a number of boys and teenagers who did receive the drug, reported neurological symptoms, chronic fatigue and pain and movement disorders. This gives them a legal right to sue Merck for health issues incurred.

Book Highlights Lawsuit Centered on Off-Label Use of InFUSE Bone Graft

A partner and president at Baum Hedlund Aristei & Goldman, Michael Lin Baum is an established Southern California lawyer who provides client-centered support to people across the country. Having handled several pharmaceutical drug cases, Attorney Michael Lin Baum has navigated issues of fraudulent clinical studies and misleading advertising that led to people taking prescribed medications harmful to them.

One of Baum Hedlund Aristei & Goldman’s cases was detailed in the book “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.” The lawsuit involved a client who sued her neurosurgeon and Medtronic, Inc. over alleged defects in the InFUSE Bone Graft Device, which led to it being dangerous and unsafe.

Approved by FDA in 2002, the genetically engineered product is for a form of spinal fusion surgery that addresses specific types of severe back pain. A decade later, a US Senate Finance Committee found that Medtronic had paid out hundreds of millions for physicians to manipulate studies and author articles favorable to the product. Beyond research, financial conflicts of interest, illegal off-label marketing, and underreporting of complications associated with InFUSE were at issue.

The woman who filed the complaint alleged many such violations, with the product promoted in a way that violated FDA regulations. This “improper off-label promotion” led to a prevalence of potentially dangerous off-label uses of InFUSE treatments. In particular, an FDA researcher found that a high percentage of adverse events associated with InFUSE were linked with off-label use.

The client further alleged that her physician recommended the off-label cervical fusion surgery she underwent due to “personal financial ties” with Medtronic. Following off-label cervical fusion surgery, she experienced ectopic bone overgrowth, accompanied by excruciating pain, which is legally actionable.